EN - EN - REGULATION (EC) No 1907/2006 of the European

CORRIGENDA

Corrigendum to Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December

2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing

a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No

793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission

Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC

(Official Journal of the European Union L 396 of 30 December 2006)

Regulation (EC) No 1907/2006 should read as follows:

REGULATION (EC) No 1907/2006 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

of 18 December 2006

concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH),

establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council

Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Direc-

tive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC

(Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EURO-

PEAN UNION,

Having regard to the Treaty establishing the European Com-

munity, and in particular Article 95 thereof,

Having regard to the proposal from the Commission,

Having regard to the opinion of the European Economic and

Social Committee (

Having regard to the opinion of the Committee of the

Regions (

Acting in accordance with the procedure laid down in

Article 251 of the Treaty (

Whereas:

(1) This Regulation should ensure a high level of protection

of human health and the environment as well as the free

movement of substances, on their own, in preparations

and in articles, while enhancing competitiveness and

innovation. This Regulation should also promote the

development of alternative methods for the assessment of

hazards of substances.

(2) The efficient functioning of the internal market for

substances can be achieved only if requirements for

substances do not differ significantly from Member State

to Member State.

(3) A high level of human health and environmental protec-

tion should be ensured in the approximation of legisla-

tion on substances, with the goal of achieving sustainable

development. That legislation should be applied in a non-

discriminatory manner whether substances are traded on

the internal market or internationally in accordance with

the Community's international commitments.

(4) Pursuant to the implementation plan adopted on

4 September 2002 at the Johannesburg World Summit

on sustainable development, the European Union is

aiming to achieve that, by 2020, chemicals are produced

and used in ways that lead to the minimisation of signifi-

cant adverse effects on human health and the environ-

ment.

(5) This Regulation should apply without prejudice to Com-

munity workplace and environment legislation.

(6) This Regulation should contr ibute to fulfilment of the

Strategic Approach to International Chemical Manage-

ment (SAICM) adopted on 6 February 2006 in Dubai.

(7) To preserve the integrity of the internal market and to

ensure a high level of protection for human health, espe-

cially the health of workers, and the environment, it is

necessary to ensure that manufacturing of substances in

the Community complies with Community law, even if

those substances are exported.

29.5.2007 L 136/3Official Journal of the European Union

(

) OJ C 112, 30.4.2004, p. 92 and OJ C 294, 25.11.2005, p. 38.

(

) OJ C 164, 5.7.2005, p. 78.

(

) Opinion of the European Parliament of 17 November 2005 (OJ C 280 E,

18.11.2006, p. 303), Council Common Position of 27 June 2006 (OJ

C 276 E, 14.11.2006, p. 1) and Position of the European Parliament of

13 December 2006 (not yet published in the Official Journal). Council

Decision of 18 December 2006.

(8) Special account should be taken of the potential impact

of this Regulation on small- and medium-sized enter-

prises (SMEs) and the need to avoid any discrimination

against them.

(9) The assessment of the operation of the four main legal

instruments governing chemicals in the Community, i.e.

Council Directive 67/548/EEC of 27 June 1967 on the

approximation of the laws, regulations and administrative

provisions relating to the classification, packaging and

labelling of dangerous substances (

), Council Direc-

tive 76/769/EEC of 27 July 1976 on the approximation

of the laws, regulations and administrative provisions of

the Member States relating to restrictions on the

marketing and use of certain dangerous substances and

preparations (

), Directive 1999/45/EC of the European

Parliament and of the Council of 31 May 1999

concerning the approximation of the laws, regulations

and administrative provisions of the Member States

relating to the classification, packaging and labelling of

dangerous preparations (

) and Council Regulation (EEC)

No 793/93 of 23 March 1993 on the evaluation and

control of the r isks of existing substances (

), identified a

number of problems in the functioning of Community

legislation on chemicals, resulting in disparities between

the laws, regulations and administrative provisions in

Member States directly affecting the functioning of the

internal market in this field, and the need to do more to

protect public health and the environment in accordance

with the precautionary principle.

(10) Substances under customs supervision which are in

temporary storage, in free zones or free warehouses with

a view to re-exportation or in transit are not used within

the meaning of this Regulation and should therefore be

excluded from its scope. The carriage of dangerous

substances and of dangerous preparations by rail, road,

inland waterways, sea or air should also be excluded

from its scope as specific legislation already applies to

such carriage.

(11) To ensure workability and to maintain the incentives for

waste recycling and recovery, wastes should not be

regarded as substances, preparations or articles within the

meaning of this Regulation.

(12) An important objective of the new system to be estab-

lished by this Regulation is to encourage and in certain

cases to ensure that substances of high concern are even-

tually replaced by less dangerous substances or technolo-

gies where suitable economically and technically viable

alternatives are available. This Regulation does not affect

the application of Directives on worker protection and

the environment, especially Directive 2004/37/EC of the

European Parliament and of the Council of 29 April

2004 on the protection of workers from the risks related

to exposure to carcinogens or mutagens at work

(Sixth individual Directive within the meaning of

Article 16(1) of Council Directive 89/391/EEC) (

) and

Council Directive 98/24/EC of 7 April 1998 on the

protection of the health and safety of workers from the

risks related to chemical agents at work (fourteenth indi-

vidual Directive within the meaning of Article 16(1) of

Directive 89/391/EEC) (

) under which employers are

required to eliminate dangerous substances, wherever

technically possible, or to substitute dangerous substances

with less dangerous substances.

(13) This Regulation should apply without prejudice to the

prohibitions and restrictions laid down in Council Direc-

tive 76/768/EEC of 27 July 1976 on the approximation

of the laws of the Member States relating to cosmetic

products (

) in so far as substances are used and marketed

as cosmetic ingredients and are within the scope of this

Regulation. A phase-out of testing on vertebrate animals

for the purpose of protecting human health as specified

in Directive 76/768/EEC should take place with regard to

the uses of those substances in cosmetics.

(14) This Regulation will generate information on substances

and their uses. Available information, including that

generated by this Regulation, should be used by the rele-

vant actors in the application and implementation of

appropriate Community legislation, for example that

covering products, and Community voluntary instru-

ments, such as the eco-labelling scheme. The Commission

should consider in the review and development of rele-

vant Community legislation and voluntary instruments

how information generated by this Regulation should be

used, and examine possibilities for establishing a Euro-

pean quality mark.

(15) There is a need to ensure effective management of the

technical, scientific and administrative aspects of this

Regulation at Community level. A central entity should

therefore be created to fulfil this role. A feasibility study

on the resource requirements for this central entity

concluded that an independent central entity offered a

number of long-term advantages over other options. A

European Chemicals Agency (hereinafter referred to as

the Agency) should therefore be established.

29.5.2007L 136/4 Official Journal of the European Union

(

) OJ 196, 16.8.1967, p. 1. Directive as last amended by Commission

Directive 2004/73/EC (OJ L 152, 30.4.2004, p. 1). Corrected in OJ

L 216, 16.6.2004, p. 3.

(

) OJ L 262, 27.9.1976, p. 201. Directive as last amended by Commission

Directive 2006/139/EC (OJ L 384, 29.12.2006, p. 94).

(

) OJ L 200, 30.7.1999, p. 1. Directive as last amended by Commission

Directive 2006/8/EC (OJ L 19, 24.1.2006, p. 12).

(

) OJ L 84, 5.4.1993, p. 1. Regulation as amended by Regulation (EC)

No 1882/2003 of the European Parliament and of the Council (OJ

L 284, 31.10.2003, p. 1).

(

) OJ L 158, 30.4.2004, p. 50, corrected in OJ L 229, 29.6.2004, p. 23.

(

) OJ L 131, 5.5.1998, p. 11.

(

) OJ L 262, 27.9.1976, p. 169. Directive as last amended by Commission

Directive 2007/1/EC (OJ L 25, 1.2.2007, p. 9).

(16) This Regulation lays down specific duties and obligations

on manufacturers, impor ters and downstream users of

substances on their own, in preparations and in

articles. This Regulation is based on the principle that

industry should manufacture, import or use substances

or place them on the market with such responsibility and

care as may be required to ensure that, under reasonably

foreseeable conditions, human health and the environ-

ment are not adversely affected.

(17) All available and relevant information on substances on

their own, in preparations and in articles should be

collected to assist in identifying hazardous properties,

and recommendations about risk management measures

should systematically be conveyed through supply chains,

as reasonably necessary, to prevent adverse effects on

human health and the environment. In addition, commu-

nication of technical advice to support risk management

should be encouraged in the supply chain, where appro-

priate.

(18) Responsibility for the management of the risks of

substances should lie with the natural or legal persons

that manufacture, import, place on the market or use

these substances. Information on the implementation of

this Regulation should be easily accessible, in particular

for SMEs.

(19) Therefore, the registration provisions should require

manufacturers and importers to generate data on the

substances they manufacture or import, to use these data

to assess the risks related to these substances and to

develop and recommend appropriate risk management

measures. To ensure that they actually meet these obliga-

tions, as well as for transparency reasons, registration

should require them to submit a dossier containing all

this information to the Agency. Registered substances

should be allowed to circulate on the internal market.

(20) The evaluation provisions should provide for follow-up

to registration, by allowing for checks on whether regis-

trations are in compliance with the requirements of this

Regulation and if necessary by allowing for generation of

more information on the properties of substances. If the

Agency in cooperation with the Member States considers

that there are grounds for considering that a substance

constitutes a risk to human health or the environment,

the Agency should, after having included the substance in

the Community rolling action plan for substance evalua-

tion, relying on the competent authorities of Member

States, ensure that this substance is evaluated.

(21) Although the information yielded on substances through

evaluation should be used in the first place by manufac-

turers and importers to manage the risks related to their

substances, it may also be used to initiate the authorisa-

tion or restrictions procedures under this Regulation or

risk management procedures under other Community

legislation. Therefore it should be ensured that this infor-

mation is available to the competent authorities and may

be used by them for the purpose of such procedures.

(22) The authorisation provisions should ensure the good

functioning of the inter nal market while assuring that the

risks from substances of very high concern are properly

controlled. Authorisations for the placing on the market

and use should be granted by the Commission only if the

risks arising from their use are adequately controlled,

where this is possible, or the use can be justified for

socio-economic reasons and no suitable alternatives are

available, which are economically and technically viable.

(23) The restriction provisions should allow the manufac-

turing, placing on the market and use of substances

presenting risks that need to be addressed, to be made

subject to total or partial bans or other restrictions, based

on an assessment of those risks.

(24) In preparation for this Regulation, the Commission has

launched REACH Implementation Projects (RIPs), invol-

ving relevant experts from stakeholder groups. Some of

those projects aim at developing draft guidelines and

tools which should help the Commission, the Agency,

Member States, manufacturers, importers and down-

stream users of substances to fulfil, in concrete terms,

their obligations under this Regulation. This work should

enable the Commission and the Agency to make available

appropriate technical guidance, in due time, with regard

to the deadlines introduced by this Regulation.

(25) The responsibility to assess the risks and hazards of

substances should be given, in the first place, to the

natural or legal persons that manufacture or import

substances, but only when they do so in quantities

exceeding a certain volume, to enable them to carry the

associated burden. Natural or legal persons handling

chemicals should take the necessary risk management

measures in accordance with the assessment of the risks

of substances and pass on relevant recommendations

along the supply chain. This should include describing,

documenting and notifying in an appropriate and trans-

parent fashion the risks stemming from the production,

use and disposal of each substance.

(26) In order to undertake chemical safety assessments of

substances effectively, manufacturers and importers of

substances should obtain information on these

substances, if necessary by performing new tests.

29.5.2007 L 136/5Official Journal of the European Union

(27) For purposes of enforcement and evaluation and for

reasons of transparency, the information on these

substances, as well as related information, including on

risk management measures, should normally be

submitted to authorities.

(28) Scientific research and development normally takes place

in quantities below one tonne per year. There is no need

to exempt such research and development because

substances in those quantities do not have to be regis-

tered in any case. However, in order to encourage innova-

tion, product and process oriented research and develop-

ment should be exempted from the obligation to register

for a certain time period where a substance is not yet

intended to be placed on the market to an indefinite

number of customers because its application in prepara-

tions or articles still requires further research and devel-

opment performed by the potential registrant himself or

in cooperation with a limited number of known custo-

mers. In addition, it is appropriate to provide for a

similar exemption to downstream users using the

substance for the purposes of product and process

oriented research and development, provided that the

risks to human health and the environment are

adequately controlled in accordance with the require-

ments of legislation for the protection of workers and

the environment.

(29) Since producers and importers of articles should be

responsible for their articles, it is appropriate to impose a

registration requirement on substances which are

intended to be released from articles and have not been

registered for that use. In the case of substances of very

high concern which are present in ar ticles above tonnage

and concentration thresholds, where exposure to the

substance cannot be excluded and where the substance

has not been registered by any person for this use, the

Agency should be notified. The Agency should also be

empowered to request that a registration be submitted if

it has grounds for suspecting that the release of a

substance from the article may present a risk to human

health or the environment and the substance is present

in those articles in quantities totalling over one tonne per

producer or importer per year. The Agency should

consider the need for a proposal for a restriction where it

considers that the use of such substances in articles poses

a risk to human health or the environment that is not

adequately controlled.

(30) The requirements for undertaking chemical safety assess-

ments by manufacturers and importers should be defined

in detail in a technical annex to allow them to meet their

obligations. To achieve fair burden shar ing with their

customers, manufacturers and importers should in their

chemical safety assessment address not only their own

uses and the uses for which they place their substances

on the market, but also all uses which their customers

ask them to address.

(31) The Commission, in close cooperation with industry,

Member States and other relevant stakeholders, should

develop guidance to fulfil the requirements under this

Regulation related to preparations (in particular with

regard to safety data sheets incorporating exposure

scenarios) including assessment of substances incorpo-

rated into special preparations — such as metals incorpo-

rated in alloys. In doing so, the Commission should take

full account of the work that will have been carried out

within the framework of the RIPs and should include the

necessary guidance on this matter in the overall REACH

guidance package. This guidance should be available

before the application of this Regulation.

(32) A chemical safety assessment should not need to be

performed for substances in preparations in certain very

small concentrations which are considered as not giving

rise to concern. Substances in preparations in such low

concentrations should also be exempt from authorisation.

These provisions should apply equally to preparations

that are solid mixtures of substances until a specific

shape is given to such a preparation that transforms it

into an article.

(33) Joint submission and the sharing of information on

substances should be provided for in order to increase

the efficiency of the registration system, to reduce costs

and to reduce testing on vertebrate animals. One of a

group of multiple registrants should submit information

on behalf of the others according to rules which ensure

that all the required information is submitted, while

allowing sharing of the costs burden. A registrant should

be able to submit information directly to the Agency in

certain specified cases.

(34) Requirements for generation of information on

substances should be tiered according to the volumes of

manufacture or importation of a substance, because these

provide an indication of the potential for exposure of

man and the environment to the substances, and should

be described in detail. To reduce the possible impact on

low volume substances, new toxicological and ecotoxico-

logical information should only be required for priority

substances between 1 and 10 tonnes. For other

substances in that quantity range there should be incen-

tives to encourage manufacturers and importers to

provide this information.

(35) The Member States, the Agency and all interested parties

should take full account of the results of the RIPs, in par-

ticular with regard to the registration of substances which

occur in nature.

(36) It is necessary to consider the application of Article 2(7)

(a) and (b) and Annex XI to substances derived from

mineralogical processes and the review of Annexes IV

and V should fully take this into account.

29.5.2007L 136/6 Official Journal of the European Union

(37) If tests are per formed, they should comply with the rele-

vant requirements of protection of laboratory animals,

set out in Council Directive 86/609/EEC of 24 November

1986 on the approximation of laws, regulations and

administrative provisions of the Member States regarding

the protection of animals used for experimental and

other scientific purposes (

), and, in the case of ecotoxico-

logical and toxicological tests, good laboratory practice,

set out in Directive 2004/10/EC of the European Parlia-

ment and of the Council of 11 February 2004 on the

harmonisation of laws, regulations and administrative

provisions relating to the application of the principles of

good laboratory practice and the verification of their

application for tests on chemical substances (

(38) The generation of information by alternative means

offering equivalence to prescribed tests and test methods

should also be allowed, for example when this informa-

tion comes from valid qualitative or quantitative structure

activity models or from structurally related substances.

To this end the Agency, in cooperation with Member

States and interested par ties, should develop appropriate

guidance. It should also be possible not to submit certain

information if appropriate justification can be provided.

Based on experience gained through RIPs, criteria should

be developed defining what constitutes such justification.

(39) In order to help companies, and in particular SMEs, to

comply with the requirements of this Regulation,

Member States, in addition to the operational guidance

documents provided by the Agency, should establish

national helpdesks.

(40) The Commission, Member States, industry and other

stakeholders should continue to contribute to the promo-

tion of alternative test methods on an international and

national level including computer supported methodolo-

gies, in vitro methodologies, as appropriate, those based

on toxicogenomics, and other relevant methodologies.

The Community's strategy to promote alternative test

methods is a priority and the Commission should ensure

that within its future Research Framework Programmes

and initiatives such as the Community Action Plan on

the Protection and Welfare of Animals 2006 to 2010

this remains a priority topic. Participation of stakeholders

and initiatives involving all interested parties should be

sought.

(41) For reasons of workability and because of their special

nature, specific registration requirements should be laid

down for intermediates. Polymers should be exempted

from registration and evaluation until those that need to

be registered due to the risks posed to human health or

the environment can be selected in a practicable and

cost-efficient way on the basis of sound technical and

valid scientific criteria.

(42) To avoid overloading authorities and natural or legal

persons with the work arising from the registration of

phase-in substances already on the internal market, that

registration should be spread over an appropriate period

of time, without introducing undue delay. Deadlines for

the registration of these substances should therefore be

set.

(43) Data for substances already notified in accordance with

Directive 67/548/EEC should be eased into the system

and should be upgraded when the next tonnage quantity

threshold is reached.

(44) In order to provide a harmonised, simple system, all

registrations should be submitted to the Agency. To

ensure a consistent approach and efficient use of

resources, it should perform a completeness check on all

registrations and take responsibility for any final rejec-

tions of registrations.

(45) The European Inventory of Existing Commercial

Chemical Substances (EINECS) included certain complex

substances in a single entry. UVCB substances (substances

of unknown or variable composition, complex reaction

products or biological materials) may be registered as a

single substance under this Regulation, despite their vari-

able composition, provided that the hazardous properties

do not differ significantly and warrant the same classifica-

tion.

(46) To ensure that the information gathered through the

registration is kept up-to-date, an obligation on regis-

trants to inform the Agency of certain changes to the

information should be introduced.

(47) In accordance with Directive 86/609/EEC, it is necessary

to replace, reduce or refine testing on vertebrate animals.

Implementation of this Regulation should be based on

the use of alternative test methods, suitable for the assess-

ment of health and environmental hazards of chemicals,

wherever possible. The use of animals should be avoided

by recourse to alternative methods validated by the

Commission or international bodies, or recognised by the

Commission or the Agency as appropriate to meet the

information requirements under this Regulation. To this

end, the Commission, following consultation with rele-

vant stakeholders, should propose to amend the future

Commission Regulation on test methods or this Regu-

lation, where appropriate, to replace, reduce or refine

animal testing. The Commission and the Agency should

ensure that reduction of animal testing is a key considera-

tion in the development and maintenance of guidance for

stakeholders and in the Agency's own procedures.

29.5.2007 L 136/7Official Journal of the European Union

(

) OJ L 358, 18.12.1986, p. 1. Directive as amended by Directive

2003/65/EC of the European Parliament and of the Council (OJ L 230,

16.9.2003, p. 32).

(

) OJ L 50, 20.2.2004, p. 44.

(48) This Regulation should be without prejudice to the full

and complete application of the Community competition

rules.

(49) In order to avoid duplication of work, and in particular

to reduce testing involving vertebrate animals, the provi-

sions concerning preparation and submission of registra-

tions and updates should require sharing of information

where this is requested by any registrant. If the informa-

tion concerns vertebrate animals, the registrant should be

obliged to request it.

(50) It is in the public interest to ensure the quickest possible

circulation of test results on human health or environ-

mental hazards of certain substances to those natural or

legal persons which use them, in order to limit any risks

associated with their use. Sharing of information should

occur where this is requested by any registrant, in par-

ticular in the case of information involving tests on verte-

brate animals, under conditions that ensure a fair

compensation for the company that has undertaken the

tests.

(51) In order to strengthen the competitiveness of Community

industry and to ensure that this Regulation is applied as

efficiently as possible, it is appropriate to make provision

for the sharing of data between registrants on the basis

of fair compensation.

(52) In order to respect the legitimate property rights of those

generating testing data, the owner of such data should,

for a period of 12 years, be able to claim compensation

from those registrants who benefit from that data.

(53) In order to allow a potential registrant of a phase-in

substance to proceed with his registration, even if he

cannot reach agreement with a previous registrant, the

Agency, on request, should allow use of any summary or

robust study summary of tests already submitted. The

registrant who receives these data should be obliged to

pay a contribution to the costs to the owner of the data.

For non-phase-in substances, the Agency may ask for

evidence that a potential registrant has paid the owner of

a study before the Agency gives permission for the

potential registrant to use that information in his registra-

tion.

(54) In order to avoid duplication of work, and in particular

to avoid duplication of testing, registrants of phase-in

substances should pre-register as early as possible with a

database managed by the Agency. A system should be

established in order to provide for the establishment of

Substance Information Exchange Forums (SIEF) to help

exchange of information on the substances that have

been registered. SIEF participants should include all rele-

vant actors submitting information to the Agency on the

same phase-in substance. They should include both

potential registrants, who must provide and be supplied

with any information relevant to the registration of their

substances, and other participants, who may receive

financial compensation for studies they hold but are not

entitled to request information. In order to ensure the

smooth functioning of that system they should fulfil

certain obligations. If a member of a SIEF does not fulfil

his obligations, he should be penalised accordingly but

other members should be enabled to continue preparing

their own registration. In cases where a substance has not

been pre-registered, measures should be taken to help

downstream users find alternative sources of supply.

(55) Manufacturers and importers of a substance on its own

or in a preparation should be encouraged to communi-

cate with the downstream users of the substance with

regard to whether they intend to register the substance.

Such information should be provided to a downstream

user sufficiently in advance of the relevant registration

deadline if the manufacturer or importer does not intend

to register the substance, in order to enable the down-

stream user to look for alternative sources of supply.

(56) Part of the responsibility of manufacturers or importers

for the management of the risks of substances is the

communication of information on these substances to

other professionals such as downstream users or distribu-

tors. In addition, producers or importers of articles

should supply information on the safe use of articles to

industrial and professional users, and consumers on

request. This important responsibility should also apply

throughout the supply chain to enable all actors to meet

their responsibility in relation to management of risks

arising from the use of substances.

(57) As the existing safety data sheet is already being used as

a communication tool within the supply chain of

substances and preparations, it is appropriate to develop

it further and make it an integral part of the system

established by this Regulation.

(58) In order to have a chain of responsibilities, downstream

users should be responsible for assessing the risks arising

from their uses of substances if those uses are not

covered by a safety data sheet received from their

suppliers, unless the downstream user concerned takes

more protective measures than those recommended by

his supplier or unless his supplier was not required to

assess those risks or provide him with information on

those risks. For the same reason, downstream users

should manage the risks arising from their uses of

substances. In addition, it is appropriate that any

producer or importer of an article containing a substance

of very high concern should provide sufficient informa-

tion to allow safe use of such an article.

29.5.2007L 136/8 Official Journal of the European Union

(59) The requirements for undertaking chemical safety assess-

ments by downstream users should also be prescribed in

detail to allow them to meet their obligations. These

requirements should only apply above a total quantity of

one tonne of substance or preparation. In any case,

however, the downstream users should consider the use

and identify and apply appropriate risk management

measures. Downstream users should report certain basic

information on use to the Agency.

(60) For enforcement and evaluation purposes, downstream

users of substances should be required to report to the

Agency certain basic information if their use is outside

the conditions of the exposure scenario detailed in the

safety data sheet communicated by their original manu-

facturer or importer and to keep such reported informa-

tion up-to-date.

(61) For reasons of workability and proportionality, it is

appropriate to exempt downstream users using low quan-

tities of a substance from such reporting.

(62) Communication up and down the supply chain should

be facilitated. The Commission should develop a system

categorising brief general descriptions of uses taking into

account the outcomes of the RIPs.

(63) It is also necessary to ensure that generation of informa-

tion is tailored to real information needs. To this end

evaluation should require the Agency to decide on the

programmes of testing proposed by manufacturers and

importers. In cooperation with Member States, the

Agency should give priority to certain substances, for

instance those which may be of very high concern.

(64) In order to prevent unnecessary animal testing, interested

par ties should have a period of 45 days during which

they may provide scientifically valid information and

studies that address the relevant substance and hazard

end-point, which is addressed by the testing proposal.

The scientifically valid information and studies received

by the Agency should be taken into account for decisions

on testing proposals.

(65) In addition, it is necessary to instil confidence in the

general quality of registrations and to ensure that the

public at large as well as all stakeholders in the chemicals

industry have confidence that natural or legal persons are

meeting the obligations placed upon them. Accordingly,

it is appropriate to provide for recording which informa-

tion has been reviewed by an assessor possessing appro-

priate experience, and for a percentage of registrations to

be checked for compliance by the Agency.

(66) The Agency should also be empowered to require further

information from manufacturers, importers or down-

stream users on substances suspected of posing a risk to

human health or the environment, including by reason

of their presence on the internal market in high volumes,

on the basis of evaluations performed. Based on the

criteria for prioritising substances developed by the

Agency in cooperation with the Member States a Com-

munity rolling action plan for substance evaluation

should be established, relying on Member State compe-

tent authorities to evaluate substances included therein. If

a risk equivalent to the level of concern arising from the

use of substances subject to authorisation arises from the

use of isolated intermediates on site, the competent

authorities of the Member States should also be allowed

to require further information, when justified.

(67) Collective agreement within the Agency's Member State

Committee on its draft decisions should provide the basis

for an efficient system that respects the principle of subsi-

diarity, while maintaining the internal market. If one or

more Member States or the Agency do not agree to a

draft decision, it should be adopted subject to a centra-

lised procedure. If the Member State Committee fails to

reach unanimous agreement, the Commission should

adopt a decision in accordance with a Committee proce-

dure.

(68) Evaluation may lead to the conclusion that action should

be taken under the restriction or authorisation proce-

dures or that risk management action should be consid-

ered in the framework of other appropriate legislation.

Information on the progress of evaluation proceedings

should therefore be made public.

(69) To ensure a sufficiently high level of protection for

human health, including having regard to relevant human

population groups and possibly to certain vulnerable

sub-populations, and the environment, substances of very

high concer n should, in accordance with the precau-

tionary principle, be subject to careful attention. Authori-

sation should be granted where natural or legal persons

applying for an authorisation demonstrate to the granting

authority that the risks to human health and the environ-

ment arising from the use of the substance are adequately

controlled. Otherwise, uses may still be authorised if it

can be shown that the socio-economic benefits from the

use of the substance outweigh the risks connected with

its use and there are no suitable alternative substances or

technologies that are economically and technically viable.

Taking into account the good functioning of the internal

market it is appropriate that the Commission should be

the granting authority.

29.5.2007 L 136/9Official Journal of the European Union

(70) Adverse effects on human health and the environment

from substances of very high concern should be

prevented through the application of appropriate risk

management measures to ensure that any risks from the

uses of a substance are adequately controlled, and with a

view to progressively substituting these substances with a

suitable safer substance. Risk management measures

should be applied to ensure, when substances are manu-

factured, placed on the market and used, that exposure to

these substances including discharges, emissions and

losses, throughout the whole life-cycle is below the

threshold level beyond which adverse effects may occur.

For any substance for which authorisation has been

granted, and for any other substance for which it is not

possible to establish a safe level of exposure, measures

should always be taken to minimise, as far as technically

and practically possible, exposure and emissions with a

view to minimising the likelihood of adverse effects.

Measures to ensure adequate control should be identified

in any Chemical Safety Report. These measures should be

applied and, where appropriate, recommended to other

actors down the supply chain.

(71) Methodologies to establish thresholds for carcinogenic

and mutagenic substances may be developed taking into

account the outcomes of RIPs. The relevant Annex may

be amended on the basis of these methodologies to allow

thresholds where appropriate to be used while ensuring a

high level of protection of human health and the envir-

onment.

(72) To support the aim of eventual replacement of substances

of very high concern by suitable alternative substances or

technologies, all applicants for authorisation should

provide an analysis of alternatives considering their risks

and the technical and economic feasibility of substitution,

including information on any research and development

the applicant is undertaking or intends to undertake.

Fur thermore, authorisations should be subject to time-

limited review whose periods would be determined on a

case-by-case basis and normally be subject to conditions,

including monitoring.

(73) Substitution of a substance on its own, in a preparation

or in an article should be required when manufacture,

use or placing on the market of that substance causes an

unacceptable risk to human health or to the environ-

ment, taking into account the availability of suitable safer

alternative substances and technologies, and the socio-

economic benefits from the uses of the substance posing

an unacceptable risk.

(74) Substitution of a substance of very high concern by

suitable safer alternative substances or technologies

should be considered by all those applying for authorisa-

tions of uses of such substances on their own, in prepara-

tions or for incorporation of substances into articles by

making an analysis of alternatives, the risks involved in

using any alternative and the technical and economic

feasibility of substitution.

(75) The possibility of introducing restrictions on the manu-

facturing, placing on the market and use of dangerous

substances, preparations and articles applies to all

substances falling within the scope of this Regulation,

with minor exemptions. Restrictions on the placing on

the market and the use of substances which are carcino-

genic, mutagenic or toxic to reproduction, category 1 or

2, for their use by consumers on their own or in prepara-

tions should continue to be introduced.

(76) Experience at international level shows that substances

with characteristics rendering them persistent, liable to

bioaccumulate and toxic, or very persistent and very

liable to bioaccumulate, present a ver y high concern,

while criteria have been developed allowing the identifi-

cation of such substances. For certain other substances

concerns are sufficiently high to address them in the

same way on a case-by-case basis. The criteria in

Annex XIII should be reviewed taking into account the

current and any new experience in the identification of

these substances and if appropriate, be amended with a

view to ensuring a high level of protection for human

health and the environment.

(77) In view of workability and practicality considerations,

both as regards natural or legal persons, who have to

prepare application files and take appropriate risk

management measures, and as regards the authorities,

who have to process authorisation applications, only a

limited number of substances should be subjected to the

authorisation procedure at the same time and realistic

deadlines should be set for applications, while allowing

certain uses to be exempted. Substances identified as

meeting the criteria for authorisation should be included

in a candidate list for eventual inclusion in the authorisa-

tion procedure. Within this list, substances on the Agen-

cy's work programme should be clearly identified.

(78) The Agency should provide advice on the prioritisation

of substances to be made subject to the authorisation

procedure, to ensure that decisions reflect the needs of

society as well as scientific knowledge and developments.

(79) A total ban on a substance would mean that none of its

uses could be authorised. It would therefore be pointless

to allow the submission of applications for authorisation.

In such cases the substance should be removed from the

list of substances for which applications can be submitted

and added to the list of restricted substances.

29.5.2007L 136/10 Official Journal of the European Union

(80) The proper interaction between the provisions on author-

isation and restriction should be ensured in order to

preserve the efficient functioning of the internal market

and the protection of human health, safety and the envir-

onment. Restrictions that exist when the substance in

question is added to the list of substances for which

applications for authorisation can be submitted, should

be maintained for that substance. The Agency should

consider whether the risk from substances in articles is

adequately controlled and, if it is not, prepare a dossier in

relation to introduction of further restrictions for

substances for which the use requires authorisation.

(81) In order to provide a harmonised approach to the

authorisation of the uses of particular substances, the

Agency should issue opinions on the risks arising from

those uses, including whether or not the substance is

adequately controlled and on any socio-economic

analysis submitted to it by third parties. These opinions

should be taken into account by the Commission when

considering whether or not to grant an authorisation.

(82) To allow effective monitoring and enforcement of the

authorisation requirement, downstream users benefiting

from an authorisation granted to their supplier should

inform the Agency of their use of the substance.

(83) It is suitable in these circumstances that final decisions

granting or refusing authorisations be adopted by the

Commission pursuant to a regulatory procedure in order

to allow for an examination of their wider implications

within the Member States and to associate the latter

more closely with the decisions.

(84) In order to accelerate the current system the restr iction

procedure should be restr uctured and Directive 76/769/

EEC, which has been substantially amended and adapted

several times, should be replaced. In the interests of

clarity and as a starting point for this new accelerated

restriction procedure, all the restrictions developed under

that Directive should be incorporated into this Regu-

lation. Where appropriate, the application of Annex XVII

of this Regulation should be facilitated by guidance devel-

oped by the Commission.

(85) In relation to Annex XVII Member States should be

allowed to maintain for a transitional period more strin-

gent restrictions, provided that these restrictions have

been notified according to the Treaty. This should

concern substances on their own, substances in prepara-

tions and substances in articles, the manufacturing, the

placing on the market and the use of which is restricted.

The Commission should compile and publish an inven-

tory of these restrictions. This would provide an opportu-

nity for the Commission to review the measures

concerned with a view to possible harmonisation.

(86) It should be the responsibility of the manufacturer,

importer and downstream user to identify the appro-

priate risk management measures needed to ensure a

high level of protection for human health and the envir-

onment from the manufacturing, placing on the market

or use of a substance on its own, in a preparation or in

an article. However, where this is considered to be insuffi-

cient and where Community legislation is justified,

appropriate restrictions should be laid down.

(87) In order to protect human health and the environment,

restrictions on the manufacture, placing on the market or

use of a substance on its own, in a preparation or in an

article may include any condition for, or prohibition of,

the manufacture, placing on the market or use. Therefore

it is necessary to list such restrictions and any amend-

ments thereto.

(88) In order to prepare a restrictions proposal and in order

for such legislation to operate effectively, there should be

good cooperation, coordination and information between

the Member States, the Agency, other bodies of the Com-

munity, the Commission and the interested parties.

(89) In order to give Member States the opportunity to

submit proposals to address a specific risk for human

health and the environment, they should prepare a

dossier in conformity with detailed requirements. The

dossier should set out the justification for Community-

wide action.

(90) In order to provide a harmonised approach to restric-

tions, the Agency should fulf il a role as coordinator of

this procedure, for example by appointing the relevant

rapporteurs and verifying conformity with the require-

ments of the relevant Annexes. The Agency should main-

tain a list of substances for which a restriction dossier is

being prepared.

(91) In order to give the Commission the opportunity to

address a specific risk for human health and the environ-

ment that needs to be addressed Community wide, it

should be able to entrust the Agency with the prepara-

tion of a restriction dossier.

(92) For reasons of transparency, the Agency should publish

the relevant dossier including the suggested restrictions

while requesting comments.

29.5.2007 L 136/11Official Journal of the European Union

(93) In order to finalise the procedure in due time, the

Agency should submit its opinions on the suggested

action and its impact on the basis of a draft opinion

prepared by a rapporteur.

(94) In order to speed up the procedure for restrictions, the

Commission should prepare its draft amendment within

a specific time limit of receiving the Agency's opinions.

(95) The Agency should be central to ensuring that chemicals

legislation and the decision-making processes and scien-

tific basis underlying it have credibility with all stake-

holders and the public. The Agency should also play a

pivotal role in coordinating communication around this

Regulation and in its implementation. The confidence in

the Agency of the Community institutions, the Member

States, the general public and interested parties is there-

fore essential. For this reason, it is vital to ensure its inde-

pendence, high scientific, technical and regulatory capaci-

ties, as well as transparency and efficiency.

(96) The structure of the Agency should be suitable for the

tasks that it should fulfil. Experience with similar Com-

munity agencies provides some guidance in this respect

but the structure should be adapted to meet the specific

needs of this Regulation.

(97) The effective communication of information on chemical

risks and how they can be managed is an essential part

of the system established by this Regulation. Best practice

from the chemicals and other sectors should be consid-

ered in the preparation of guidance by the Agency to all

stakeholders.

(98) In the interests of efficiency, the staff of the Agency

Secretariat should perform essentially technical-adminis-

trative and scientific tasks without calling on the scien-

tific and technical resources of the Member States. The

Executive Director should ensure the efficient execution

of the Agency's tasks in an independent manner. To

ensure that the Agency fulfils its role, the composition of

the Management Board should be designed to represent

each Member State, the Commission and other interested

par ties appointed by the Commission in order to ensure

the involvement of stakeholders, and the European Parlia-

ment and to secure the highest standard of competence

and a broad range of relevant expertise in chemicals

safety or the regulation of chemicals, whilst ensuring that

there is relevant expertise in the field of general financial

and legal matters.

(99) The Agency should have the means to perform all the

tasks required to carry out its role.

(100) A Commission Regulation should specify the structure

and amounts of fees, including specifying the circum-

stances under which a proportion of the fees will be

transferred to the relevant Member State competent

authority.

(101) The Management Board of the Agency should have the

necessary powers to establish the budget, check its imple-

mentation, draw up internal rules, adopt financial regula-

tions and appoint the Executive Director.

(102) Through a Committee for Risk Assessment and a

Committee for Socio-economic Analysis, the Agency

should take over the role of the Scientific Committees

attached to the Commission in issuing scientific opinions

in its field of competence.

(103) Through a Member State Committee, the Agency should

aim to reach agreement amongst Member States' authori-

ties on specific issues which require a harmonised

approach.

(104) It is necessary to ensure close cooperation between the

Agency and the competent authorities working within

the Member States so that the scientific opinions of the

Committee for Risk Assessment and the Committee for

Socio-economic Analysis are based on the broadest

possible scientific and technical expertise appropriate

which is available within the Community. To the same

end, these Committees should be able to rely on addi-

tional particular expertise.

(105) In the light of the increased responsibility of natural or

legal persons for ensuring safe use of chemicals, enforce-

ment needs to be strengthened. The Agency should there-

fore provide a Forum for Member States to exchange

information on and to coordinate their activities related

to the enforcement of chemicals legislation. The currently

informal cooperation between Member States in this

respect would benefit from a more for mal framework.

(106) A Board of Appeal should be set up within the Agency

to guarantee processing of appeals for any natural or

legal person affected by decisions taken by the Agency.

29.5.2007L 136/12 Official Journal of the European Union

(107) The Agency should be financed partly by fees paid by

natural or legal persons and partly by the general budget

of the European Communities. The Community

budgetary procedure should remain applicable as far as

any subsidies chargeable to the general budget of the

European Communities are concerned. Moreover, the

auditing of accounts should be undertaken by the Cour t

of Auditors in accordance with Article 91 of

Commission Regulation (EC, Euratom) No 2343/2002 of

23 December 2002 on the framework Financial Regu-

lation for the bodies referred to in Article 185 of

Council Regulation (EC, Euratom) No 1605/2002 on the

Financial Regulation applicable to the general budget of

the European Communities (

(108) Where the Commission and Agency consider it appro-

priate, it should be possible for representatives of third

countries to participate in the work of the Agency.

(109) The Agency should contribute, through cooperation with

organisations having interests in the harmonisation of

international regulations, to the role of the Community

and the Member States in such harmonisation activities.

To promote broad international consensus the Agency

should take account of existing and emerging interna-

tional standards in the regulation of chemicals such as

the Globally Harmonised System (GHS) of classification

and labelling of chemicals.

(110) The Agency should provide the infrastructure needed for

natural or legal persons to meet their obligations under

the data-sharing provisions.

(111) It is important to avoid confusion between the mission

of the Agency and the respective missions of the Euro-

pean Medicines Agency (EMEA) established by Regulation

(EC) No 726/2004 of the European Parliament and of

the Council of 31 March 2004 laying down Community

procedures for the authorisation and supervision of

medicinal products for human and veterinary use and

establishing a European Medicines Agency (

), the Euro-

pean Food Safety Authority (EFSA) established by Regu-

lation (EC) No 178/2002 of the European Parliament and

of the Council of 28 January 2002 laying down the

general principles and requirements of food law, estab-

lishing the European Food Safety Authority and laying

down procedures in matters of food safety (

) and the

Advisory Committee on Safety, Hygiene and Health

Protection at Work set up by the Council Decision of

22 July 2003 (

). Consequently, the Agency should estab-

lish rules of procedure where cooperation with the EFSA

or the Advisory Committee on Safety, Hygiene and

Health Protection at Work is necessary. This Regulation

should otherwise be without prejudice to the competence

conferred on the EMEA, the EFSA and the Advisory

Committee on Safety, Hygiene and Health Protection at

Work by Community legislation.

(112) In order to achieve the functioning of the internal market

for substances on their own or in preparations, while at

the same time ensuring a high level of protection for

human health and the environment, rules should be

established for a classification and labelling inventory.

(113) The classification and labelling for any substance either

subject to registration or covered by Article 1 of Direc-

tive 67/548/EEC and placed on the market should there-

fore be notified to the Agency to be included in the

inventory.

(114) To ensure a harmonised protection for the general public,

and, in particular, for persons who come into contact

with certain substances, and the proper functioning of

other Community legislation relying on the classification

and labelling, an inventory should record the classifica-

tion in accordance with Directive 67/548/EEC and Direc-

tive 1999/45/EC agreed by manufacturers and importers

of the same substance, if possible, as well as decisions

taken at Community level to harmonise the classification

and labelling of some substances. This should take full

account of the work and experience accumulated in

connection with the activities under Directive

67/548/EEC, including the classification and labelling of

specific substances or groups of substances listed in

Annex I of Directive 67/548/EEC.

(115) Resources should be focused on substances of the highest

concern. A substance should therefore be added to

Annex I of Directive 67/548/EEC if it meets the criteria

for classification as carcinogenic, mutagenic or toxic for

reproduction categories 1, 2 or 3, as a respiratory sensi-

tiser, or in respect of other effects on a case-by-case basis.

Provision should be made to enable competent authori-

ties to submit proposals to the Agency. The Agency

should give its opinion on the proposal while interested

parties should have an opportunity to comment. The

Commission should take a decision subsequently.

(116) Regular reports by the Member States and the Agency on

the operation of this Regulation will be an indispensable

means of monitoring the implementation of this Regu-

lation as well as trends in this field. Conclusions drawn

from findings in the reports will be useful and practical

tools for reviewing this Regulation and, where necessary,

for formulating proposals for amendments.

29.5.2007 L 136/13Official Journal of the European Union

(

) OJ L 357, 31.12.2002, p. 72.

(

) OJ L 136, 30.4.2004, p. 1. Regulation as amended by Regulation (EC)

No 1901/2006 (OJ L 378, 27.12.2006, p. 1).

(

) OJ L 31, 1.2.2002, p. 1. Regulation as last amended by Commission

Regulation (EC) No 575/2006 (OJ L 100, 8.4.2006, p. 3).

(

) OJ C 218, 13.9.2003, p. 1.

(117) EU citizens should have access to information about

chemicals to which they may be exposed, in order to

allow them to make informed decisions about their use

of chemicals. A transparent means of achieving this is to

grant them free and easy access to basic data held in the

Agency's database, including brief profiles of hazardous

properties, labelling requirements and relevant Com-

munity legislation including authorised uses and risk

management measures. The Agency and Member States

should allow access to information in accordance with

Directive 2003/4/EC of the European Parliament and

of the Council of 28 January 2003 on public access to

environmental information (

), Regulation (EC) No 1049/

2001 of the European Parliament and of the Council of

30 May 2001 regarding public access to European Parlia-

ment, Council and Commission documents (

) and with

the UNECE Convention on Access to Information, Public

Participation in Decision-Making and Access to Justice in

Environmental Matters, to which the European Com-

munity is a party.

(118) Disclosure of information under this Regulation is

subject to the specific requirements of Regulation (EC)

No 1049/2001. That Regulation sets binding deadlines

for the release of information as well as procedural guar-

antees, including the right of appeal. The Management

Board should adopt the practical arrangements for appli-

cation of those requirements to the Agency.

(119) Apart from their participation in the implementation of

Community legislation, Member State competent authori-

ties should, because of their closeness to stakeholders in

the Member States, play a role in the exchange of infor-

mation on r isks of substances and on the obligations of

natural or legal persons under chemicals legislation. At

the same time, close cooperation between the Agency,

the Commission and the competent authorities of the

Member States is necessary to ensure the coherence and

efficiency of the global communication process.

(120) In order for the system established by this Regulation to

operate effectively, there should be good cooperation,

coordination and exchange of information between the

Member States, the Agency and the Commission

regarding enforcement.

(121) In order to ensure compliance with this Regulation,

Member States should put in place effective monitoring

and control measures. The necessary inspections should

be planned, carried out and their results should be

reported.

(122) In order to ensure transparency, impartiality and consis-

tency in the level of enforcement activities by Member

States, it is necessary for Member States to set up an

appropriate framework for penalties with a view to

imposing effective, proportionate and dissuasive penalties

for non-compliance, as non-compliance can result in

damage to human health and the environment.

(123) The measures necessary for the implementation of this

Regulation and certain amendments to it should be

adopted in accordance with Council Decision 1999/468/

EC of 28 June 1999 laying down the procedures for the

exercise of implementing powers conferred on the

Commission (

(124) In particular, power should be conferred on the Commis-

sion to amend the Annexes in certain cases, to set rules

on test methods, to vary the percentage of dossiers

selected for compliance checking and to modify the

criteria for their selection, and to set the cr iteria defining

what constitutes adequate justification that testing is tech-

nically not possible. Since these measures are of general

scope and are designed to amend non-essential elements

of this Regulation or supplement this Regulation by

adding new non-essential elements thereto, they should

be adopted in accordance with the regulatory procedure

with scrutiny provided for in Article 5a of Decision

1999/468/EC.

(125) It is essential that chemicals be regulated in an effective

and timely manner during the transition to full applic-

ability of the provisions of this Regulation and, in par-

ticular, during the start-up period of the Agency. Provi-

sion should therefore be made for the Commission to

provide the necessary suppor t towards the setting up of

the Agency, including the conclusion of contracts and the

appointment of an Executive Director ad interim until the

Agency's Management Board can appoint an Executive

Director itself.

(126) To take full advantage of the work performed under

Regulation (EEC) No 793/93 as well as under Direc-

tive 76/769/EEC and to avoid such work being lost, the

Commission should be empowered during the start-up

period to initiate restrictions based on that work without

following the full restrictions procedure laid down in this

Regulation. All those elements should be used, as soon as

this Regulation enters into force, to support risk reduc-

tion measures.

29.5.2007L 136/14 Official Journal of the European Union

(

) OJ L 41, 14.2.2003, p. 26.

(

) OJ L 145, 31.5.2001, p. 43.

(

) OJ L 184, 17.7.1999, p. 23. Decision as amended by Decision

2006/512/EC (OJ L 200, 22.7.2006, p. 11).

(127) It is appropriate for the provisions of this Regulation to

enter into force in a staggered way to smooth the transi-

tion to the new system. Moreover, a gradual entry into

force of the provisions should allow all parties involved,

authorities, natural or legal persons as well as stake-

holders, to focus resources in the preparation for new

duties at the right times.

(128) This Regulation replaces Directive 76/769/EEC, Commis-

sion Directive 91/155/EEC (

), Commission Directive 93/

67/EEC (

), Commission Directive 93/105/EC (

Commission Directive 2000/21/EC (

), Regulation

(EEC) No 793/93 and Commission Regulation (EC)

No 1488/94 (

). These Directives and Regulations should

therefore be repealed.

(129) For the sake of consistency, Directive 1999/45/EC which

already addresses matters covered by this Regulation

should be amended.

(130) Since the objectives of this Regulation, namely laying

down rules for substances and establishing a European

Chemicals Agency, cannot be sufficiently achieved by the

Member States and can therefore be better achieved at

Community level, the Community may adopt measures,

in accordance with the principle of subsidiarity as set out

in Article 5 of the Treaty. In accordance with the prin-

ciple of proportionality, as set out in that Article, this

Regulation does not go beyond what is necessar y in

order to achieve those objectives.

(131) The Regulation observes the fundamental rights and prin-

ciples which are acknowledged in particular in the

Charter of Fundamental Rights of the European

Union (

). In particular, it seeks to ensure full compliance

with the principles of environmental protection and

sustainable development guaranteed by Article 37 of that

Charter,

HAVE ADOPTED THIS REGULATION:

29.5.2007 L 136/15Official Journal of the European Union

(

) Commission Directive 91/155/EEC of 5 March 1991 defining and

laying down the detailed arrangements for the system of specific infor-

mation relating to dangerous preparations in implementation of

Article 10 of Directive 88/379/EEC (OJ L 76, 22.3.1991, p. 35). Direc-

tive as last amended by Directive 2001/58/EC (OJ L 212, 7.8.2001,

p. 24).

(

) Commission Directive 93/67/EEC of 20 July 1993 laying down the

principles for assessment of risks to man and the environment of

substances notified in accordance with Council Directive 67/548/EEC

(OJ L 227, 8.9.1993, p. 9).

(

) Commission Directive 93/105/EC of 25 November 1993 laying down

Annex VII D, containing information required for the technical dossier

referred to in Article 12 of the seventh amendment of Council Direc-

tive 67/548/EEC (OJ L 294, 30.11.1993, p. 21).

(

) Commission Directive 2000/21/EC of 25 April 2000 concerning the

list of Community legislation referred to in the fifth indent of Article 13

(1) of Council Directive 67/548/EEC (OJ L 103, 28.4.2000, p. 70).

(

) Commission Regulation (EC) No 1488/94 of 28 June 1994 laying

down the principles for the assessment of risks to man and the environ-

ment of existing substances in accordance with Council Regulation

(EEC) No 793/93 (OJ L 161, 29.6.1994, p. 3).

(

) OJ C 364, 18.12.2000, p. 1.

TABLE OF CONTENTS

Page

TITLE I GENERAL ISSUES 18

Chapter 1 Aim, scope and application 18

Chapter 2 Definitions and general provision 19

TITLE II REGISTRATION OF SUBSTANCES 22

Chapter 1 General obligation to register and information requirements 22

Chapter 2 Substances regarded as being registered 27

Chapter 3 Obligation to register and information requirements for certain types of isolated intermedi-

ates 28

Chapter 4 Common provisions for all registrations 29

Chapter 5 Transitional provisions applicable to phase-in substances and notified substances 31

TITLE III DATA SHARING AND AVOIDANCE OF UNNECESSARY TESTING 32

Chapter 1 Objectives and general rules 32

Chapter 2 Rules for non-phase-in substances and registrants of phase-in substances who have not pre-

registered 32

Chapter 3 Rules for phase-in-substances 33

TITLE IV INFORMATION IN THE SUPPLY CHAIN 35

TITLE V DOWNSTREAM USERS 37

TITLE VI EVALUATION 39

Chapter 1 Dossier evaluation 39

Chapter 2 Substance evaluation 40

Chapter 3 Evaluation of intermediates 42

Chapter 4 Common provisions 42

TITLE VII AUTHORISATION 44

Chapter 1 Authorisation requirement 44

Chapter 2 Granting of authorisations 46

Chapter 3 Authorisations in the supply chain 50

TITLE VIII RESTRICTIONS ON THE MANUFACTURING, PLACING ON THE MARKET AND USE OF

CERTAIN DANGEROUS SUBSTANCES AND PREPARATIONS 50

Chapter 1 General issues 50

Chapter 2 Restrictions process 50

TITLE IX FEES AND CHARGES 52

TITLE X AGENCY 53

TITLE XI CLASSIFICATION AND LABELLING INVENTORY 63

TITLE XII INFORMATION 64

TITLE XIII COMPETENT AUTHORITIES 66

TITLE XIV ENFORCEMENT 66

TITLE XV TRANSITIONAL AND FINAL PROVISIONS 66

ANNEX I GENERAL PROVISIONS FOR ASSESSING SUBSTANCES AND PREPARING

CHEMICAL SAFETY REPORTS 72

ANNEX II GUIDE TO THE COMPILATION OF SAFETY DATA SHEETS 84

ANNEX III CRITERIA FOR SUBSTANCES REGISTERED IN QUANTITIES BETWEEN 1 AND 10

TONNES 93

ANNEX IV EXEMPTIONS FROM THE OBLIGATION TO REGISTER IN ACCORDANCE WITH

ARTICLE 2(7)(a) 94

ANNEX V EXEMPTIONS FROM THE OBLIGATION TO REGISTER IN ACCORDANCE WITH

ARTICLE 2(7)(b) 98

29.5.2007L 136/16 Official Journal of the European Union

Page

ANNEX VI INFORMATION REQUIREMENTS REFERRED TO IN ARTICLE 10 99

ANNEX VII STANDARD INFORMATION REQUIREMENTS FOR SUBSTANCES MANUFAC-

TURED OR IMPORTED IN QUANTITIES OF ONE TONNE OR MORE 103

ANNEX VIII STANDARD INFORMATION REQUIREMENTS FOR SUBSTANCES MANUFAC-

TURED OR IMPORTED IN QUANTITIES OF 10 TONNES OR MORE 107

ANNEX IX STANDARD INFORMATION REQUIREMENTS FOR SUBSTANCES MANUFAC-

TURED OR IMPORTED IN QUANTITIES OF 100 TONNES OR MORE 111

ANNEX X STANDARD INFORMATION REQUIREMENTS FOR SUBSTANCES MANUFAC-

TURED OR IMPORTED IN QUANTITIES OF 1 000 TONNES OR MORE 116

ANNEX XI GENERAL RULES FOR ADAPTATION OF THE STANDARD TESTING REGIME SET

OUT IN ANNEXES VII TO X 119

ANNEX XII GENERAL PROVISIONS FOR DOWNSTREAM USERS TO ASSESS SUBSTANCES

AND PREPARE CHEMICAL SAFETY REPORTS 122

ANNEX XIII CRITERIA FOR THE IDENTIFICATION OF PERSISTENT, BIOACCUMULATIVE AND

TOXIC SUBSTANCES, AND VERY PERSISTENT AND VERY BIOACCUMULATIVE

SUBSTANCES 124

ANNEX XIV LIST OF SUBSTANCES SUBJECT TO AUTHORISATION 125

ANNEX XV DOSSIERS 126

ANNEX XVI SOCIO-ECONOMIC ANALYSIS 128

ANNEX XVII RESTRICTIONS ON THE MANUFACTURE, PLACING ON THE MARKET AND USE

OF CERTAIN DANGEROUS SUBSTANCES, PREPARATIONS AND ARTICLES 129

29.5.2007 L 136/17Official Journal of the European Union

TITLE I

GENERAL ISSUES

CHAPTER 1

Aim, scope and application

Article 1

Aim and scope

1. The purpose of this Regulation is to ensure a high level of

protection of human health and the environment, including the

promotion of alternative methods for assessment of hazards of

substances, as well as the free circulation of substances on the

internal market while enhancing competitiveness and innova-

tion.

2. This Regulation lays down provisions on substances and

preparations within the meaning of Article 3. These provisions

shall apply to the manufacture, placing on the market or use of

such substances on their own, in preparations or in articles and

to the placing on the market of preparations.

3. This Regulation is based on the principle that it is for

manufacturers, importers and downstream users to ensure that

they manufacture, place on the market or use such substances

that do not adversely affect human health or the environment.

Its provisions are underpinned by the precautionary principle.

Article 2

Application

1. This Regulation shall not apply to:

(a) radioactive substances within the scope of Council Direc-

tive 96/29/Euratom of 13 May 1996 laying down basic

safety standards for the protection of the health of workers

and the general public against the dangers arising from

ionising radiation (

);

(b) substances, on their own, in a preparation or in an article,

which are subject to customs supervision, provided that they

do not undergo any treatment or processing, and which are

in temporary storage, or in a free zone or free warehouse

with a view to re-exportation, or in transit;

(d) the carriage of dangerous substances and dangerous

substances in dangerous preparations by rail, road, inland

waterway, sea or air.

2. Waste as defined in Directive 2006/12/EC of the European

Parliament and of the Council (

) is not a substance, preparation

or article within the meaning of Article 3 of this Regulation.

3. Member States may allow for exemptions from this Regu-

lation in specific cases for certain substances, on their own, in a

preparation or in an article, where necessary in the interests of

defence.

4. This Regulation shall apply without prejudice to:

(a) Community workplace and environmental legislation,

including Council Directive 89/391/EEC of 12 June 1989

on the introduction of measures to encourage improvements

in the safety and health of workers at work (

), Council

Directive 96/61/EC of 24 September 1996 concerning inte-

grated pollution prevention and control (

); Directive 98/24/

EC, Directive 2000/60/EC of the European Parliament and

of the Council of 23 October 2000 establishing a frame-

work for Community action in the field of water policy (

)

and Directive 2004/37/EC;

(b) Directive 76/768/EEC as regards testing involving vertebrate

animals within the scope of that Directive.

5. The provisions of Titles II, V, VI and VII shall not apply to

the extent that a substance is used:

(a) in medicinal products for human or veterinary use within

the scope of Regulation (EC) No 726/2004, Directive 2001/

82/EC of the European Parliament and of the Council of

6 November 2001 on the Community code relating to

veterinary medicinal products (

) and Directive 2001/83/EC

of the European Parliament and of the Council of

6 November 2001 on the Community code relating to

medicinal products for human use (

);

(b) in food or feedingstuffs in accordance with Regulation (EC)

No 178/2002 including use:

(i) as a food additive in foodstuffs within the scope of

Council Directive 89/107/EEC of 21 December 1988

on the approximation of the laws of the Member States

concerning food additives authorised for use in food-

stuffs intended for human consumption (

);

29.5.2007L 136/18 Official Journal of the European Union

(

) OJ L 159, 29.6.1996, p. 1.

(

) OJ L 114, 27.4.2006, p. 9.

(

) OJ L 183, 29.6.1989, p. 1. Directive as amended by Regulation (EC)

No 1882/2003.

(

) OJ L 257, 10.10.1996, p. 26. Directive as last amended by Regulation

(EC) No 166/2006 of the European Parliament and of the Council (OJ

L 33, 4.2.2006, p. 1).

(

) OJ L 327, 22.12.2000, p. 1. Directive as amended by Decision

No 2455/2001/EC (OJ L 331, 15.12.2001, p. 1).

(

) OJ L 311, 28.11.2001, p. 1. Directive as last amended by Directive

2004/28/EC (OJ L 136, 30.4.2004, p. 58).

(

) OJ L 311, 28.11.2001, p. 67. Directive as last amended by Regulation

(EC) No 1901/2006.

(

) OJ L 40, 11.2.1989, p. 27. Directive as last amended by Regulation (EC)

No 1882/2003.

(ii) as a flavouring in foodstuffs within the scope of

Council Directive 88/388/EEC of 22 June 1988 on the

approximation of the laws of the Member States

relating to flavourings for use in foodstuffs and to

source materials for their production (

) and Commis-

sion Decision 1999/217/EC of 23 Febr uary 1999

adopting a register of flavouring substances used in or

on foodstuffs drawn up in application of Regulation

(EC) No 2232/96 of the European Parliament and of

the Council (

);

(iii) as an additive in feedingstuffs within the scope of Regu-

lation (EC) No 1831/2003 of the European Parliament

and of the Council of 22 September 2003 on additives

for use in animal nutrition (

);

(iv) in animal nutrition within the scope of Council Direc-

tive 82/471/EEC of 30 June 1982 concerning certain

products used in animal nutrition (

6. The provisions of Title IV shall not apply to the following

preparations in the finished state, intended for the final user:

(a) medicinal products for human or veterinary use, within the

scope of Regulation (EC) No 726/2004 and Directive

2001/82/EC and as defined in Directive 2001/83/EC;

(b) cosmetic products as defined in Directive 76/768/EEC;

contact with the human body in so far as Community

measures lay down provisions for the classification and

labelling of dangerous substances and preparations which

ensure the same level of information provision and protec-

tion as Directive 1999/45/EC;

(d) food or feedingstuffs in accordance with Regulation (EC)

No 178/2002 including use:

(i) as a food additive in foodstuffs within the scope of

Directive 89/107/EEC;

(ii) as a flavouring in foodstuffs within the scope of Direc-

tive 88/388/EEC and Decision 1999/217/EC;

(iii) as an additive in feedingstuffs within the scope of Regu-

lation (EC) No 1831/2003;

(iv) in animal nutrition within the scope of Directive

82/471/EEC.

7. The following shall be exempted from Titles II, V and VI:

(a) substances included in Annex IV, as sufficient information is

known about these substances that they are considered to

cause minimum risk because of their intrinsic properties;

(b) substances covered by Annex V, as registration is deemed

inappropriate or unnecessary for these substances and their

exemption from these Titles does not prejudice the objec-

tives of this Regulation;

accordance with Title II, exported from the Community by

an actor in the supply chain and re-imported into the Com-

munity by the same or another actor in the same supply

chain who shows that:

(i) the substance being re-imported is the same as the

exported substance;

(ii) he has been provided with the information in accord-

ance with Articles 31 or 32 relating to the exported

substance;

(d) substances, on their own, in preparations or in articles,

which have been registered in accordance with Title II and

which are recovered in the Community if:

(i) the substance that results from the recovery process is

the same as the substance that has been registered in

accordance with Title II; and

(ii) the information required by Articles 31 or 32 relating

to the substance that has been registered in accordance

with Title II is available to the establishment undertaking

the recovery.

8. On-site isolated intermediates and transported isolated

intermediates shall be exempted from:

(a) Chapter 1 of Title II, with the exception of Articles 8 and 9;

and

(b) Title VII.

9. The provisions of Titles II and VI shall not apply to poly-

mers.

CHAPTER 2

Definitions and general provision

Article 3

Definitions

For the purposes of this Regulation:

1. substance: means a chemical element and its compounds in

the natural state or obtained by any manufacturing process,

including any additive necessary to preserve its stability and

any impurity deriving from the process used, but excluding

any solvent which may be separated without affecting the

stability of the substance or changing its composition;

29.5.2007 L 136/19Official Journal of the European Union

(

) OJ L 184, 15.7.1988, p. 61. Directive as last amended by Regulation

(EC) No 1882/2003.

(

) OJ L 84, 27.3.1999, p. 1. Decision as last amended by Decision

2006/253/EC (OJ L 91, 29.3.2006, p. 48).

(

) OJ L 268, 18.10.2003, p. 29. Regulation as amended by Commission

Regulation (EC) No 378/2005 (OJ L 59, 5.3.2005, p. 8).

(

) OJ L 213, 21.7.1982, p. 8. Directive as last amended by Commission

Directive 2004/116/EC (OJ L 379, 24.12.2004, p. 81).

2. preparation: means a mixture or solution composed of two

or more substances;

3. article: means an object which during production is given a

special shape, surface or design which determi nes its func-

tion to a greater degree than does its chemical composition;

4. producer of an article: means any natural or legal person

who makes or assembles an article within the Community;

5. polymer: means a substance consisting of molecules charac-

terised by the sequence of one or more types of monomer

units. Such molecules must be distributed over a range of

molecular weights wherein differences in the molecular

weight are primarily attributable to differences in the

number of monomer units. A polymer comprises the

following:

(a) a simple weight majority of molecules containing at

least three monomer units which are covalently bound

to at least one other monomer unit or other reactant;

(b) less than a simple weight majority of molecules of the

same molecular weight.

In the context of this definition a ‘monomer unit’ means

the reacted form of a monomer substance in a polymer;

6. monomer: means a substance which is capable of forming

covalent bonds with a sequence of additional like or unlike

molecules under the conditions of the relevant polymer-

forming reaction used for the particular process;

7. registrant: means the manufacturer or the importer of a

substance or the producer or importer of an article submit-

ting a registration for a substance;

8. manufacturing: means production or extraction of

substances in the natural state;

9. manufacturer: means any natural or legal person established

within the Community who manufactures a substance

within the Community;

10. import: means the physical introduction into the customs

territory of the Community;

11. importer: means any natural or legal person established

within the Community who is responsible for import;

12. placing on the market: means supplying or making avail-

able, whether in retur n for payment or free of charge, to a

third party. Import shall be deemed to be placing on the

market;

13. downstream user: means any natural or legal person estab-

lished within the Community, other than the manufacturer

or the importer, who uses a substance, either on its own or

in a preparation, in the course of his industrial or profes-

sional activities. A distributor or a consumer is not a down-

stream user. A re-importer exempted pursuant to Article 2

(7)(c) shall be regarded as a downstream user;

14. distributor: means any natural or legal person established

within the Community, including a retailer, who only stores

and places on the market a substance, on its own or in a

preparation, for third parties;

15. intermediate: means a substance that is manufactured for

and consumed in or used for chemical processing in order

to be transformed into another substance (hereinafter

referred to as synthesis):

(a) non-isolated intermediate: means an intermediate that

during synthesis is not intentionally removed (except

for sampling) from the equipment in which the synth-

esis takes place. Such equipment includes the reaction

vessel, its ancillary equipment, and any equipment

through which the substance(s) pass(es) during a contin-

uous flow or batch process as well as the pipework for

transfer from one vessel to another for the purpose of

the next reaction step, but it excludes tanks or other

vessels in which the substance(s) are stored after the

manufacture;

(b) on-site isolated intermediate: means an intermediate not

meeting the criteria of a non-isolated intermed iate and

where the manufacture of the intermediate and the

synthesis of (an)other substance(s) from that inter-

mediate take place on the same site, operated by one or

more legal entities;

mediate not meeting the criteria of a non-isolated inter-

mediate and transported between or supplied to other

sites;

16. site: means a single location, in which, if there is more than

one manufacturer of (a) substance(s), certain infrastructure

and facilities are shared;

17. actors in the supply chain: means all manufacturers and/or

importers and/or downstream users in a supply chain;

18. Agency: means the European Chemicals Agency as estab-

lished by this Regulation;

19. competent authority: means the authority or authorities or

bodies established by the Member States to carry out the

obligations arising from this Regulation;

20. phase-in substance: means a substance which meets at least

one of the following criteria:

(a) it is listed in the European Inventory of Existing

Commercial Chemical Substances (EINECS);

(b) it was manufactured in the Community, or in the coun-

tries acceding to the European Union on 1 January

1995 or on 1 May 2004, but not placed on the market

by the manufacturer or importer, at least once in the

15 years before the entry into force of this Regulation,

provided the manufacturer or importer has documen-

tary evidence of this;

29.5.2007L 136/20 Official Journal of the European Union

the countries acceding to the European Union on

1 January 1995 or on 1 May 2004, before entry into

force of this Regulation by the manufacturer or

importer and was considered as having been notified in

accordance with the first indent of Article 8(1) of Direc-

tive 67/548/EEC but does not meet the definition of a

polymer as set out in this Regulation, provided the

manufacturer or importer has documentary evidence of

this;

21. notified substance: means a substance for which a notifica-

tion has been submitted and which could be placed on the

market in accordance with Directive 67/548/EEC;

22. product and process orientated research and development:

means any scientific development related to product devel-

opment or the further development of a substance, on its

own, in preparations or in articles in the course of which

pilot plant or production trials are used to develop the

production process and/or to test the fields of application

of the substance;

23. scientific research and development: means any scientific

experimentation, analysis or chemical research carried out

under controlled conditions in a volume less than one

tonne per year;

24. use: means any processing, formulation, consumption,

storage, keeping, treatment, filling into containers, transfer

from one container to another, mixing, production of an

article or any other utilisation;

25. registrant's own use: means an industrial or professional

use by the registrant;

26. identified use: means a use of a substance on its own or in

a preparation, or a use of a preparation, that is intended by

an actor in the supply chain, including his own use, or that

is made known to him in writing by an immediate down-

stream user;

27. full study report: means a complete and comprehensive

description of the activity performed to generate the infor-

mation. This covers the complete scientific paper as

published in the literature describing the study performed

or the full report prepared by the test house describing the

study performed;

28. robust study summary: means a detailed summary of the

objectives, methods, results and conclusions of a full study

report providing sufficient information to make an inde-

pendent assessment of the study minimising the need to

consult the full study report;

29. study summary: means a summary of the objectives,

methods, results and conclusions of a full study report

providing sufficient information to make an assessment of

the relevance of the study;

30. per year: means per calendar year, unless stated otherwise,

for phase-in substances that have been imported or manu-

factured for at least three consecutive years, quantities

per year shall be calculated on the basis of the average

production or import volumes for the three preceding

calendar years;

31. restriction: means any condition for or prohibition of the

manufacture, use or placing on the market;

32. supplier of a substance or a preparation: means any manu-

facturer, importer, downstream user or distributor placing

on the market a substance, on its own or in a preparation,

or a preparation;

33. supplier of an article: means any producer or importer of

an article, distributor or other actor in the supply chain

placing an article on the market;

34. recipient of a substance or a preparation: means a down-

stream user or a distributor being supplied with a substance

or a preparation;

35. recipient of an article: means an industrial or professional

user, or a distributor, being supplied with an article but

does not include consumers;

36. SME: means small and medium-sized enterprises as defined

in the Commission Recommendation of 6 May 2003

concerning the definition of micro, small and medium-

sized enterprises (

);

37. exposure scenario: means the set of conditions, including

operational conditions and risk management measures, that

describe how the substance is manufactured or used during

its life-cycle and how the manufacturer or importer

controls, or recommends downstream users to control,

exposures of humans and the environment. These exposure

scenarios may cover one specific process or use or several

processes or uses as appropriate;

38. use and exposure category: means an exposure scenario

covering a wide range of processes or uses, where the

processes or uses are communicated, as a minimum, in

terms of the brief general description of use;

39. substances which occur in nature: means a naturally occur-

ring substance as such, unprocessed or processed only by

manual, mechanical or gravitational means, by dissolution

in water, by flotation, by extraction with water, by steam

distillation or by heating solely to remove water, or which

is extracted from air by any means;

40. not chemically modified substance: means a substance

whose chemical structure remains unchanged, even if it has

undergone a chemical process or treatment, or a physical

mineralogical transformation, for instance to remove impu-

rities;

41. alloy: means a metallic material, homogenous on a macro-

scopic scale, consisting of two or more elements so

combined that they cannot be readily separated by mechan-

ical means.

29.5.2007 L 136/21Official Journal of the European Union

(

) OJ L 124, 20.5.2003, p. 36.

Article 4

General provision

Any manufacturer, importer, or where relevant downstream

user, may, whilst retaining full responsibility for complying with

his obligations under this Regulation, appoint a third party

representative for all proceedings under Article 11, Article 19,

Title III and Article 53 involving discussions with other manu-

facturers, importers, or where relevant downstream users. In

these cases, the identity of a manufacturer or importer or down-

stream user who has appointed a representative shall not

normally be disclosed by the Agency to other manufacturers,

importers, or, where relevant, downstream users.

TITLE II

REGISTRATION OF SUBSTANCES

CHAPTER 1

General obligation to register and information requirements

Article 5

No data, no market

Subject to Articles 6, 7, 21 and 23, substances on their own, in

preparations or in articles shall not be manufactured in the

Community or placed on the market unless they have been

registered in accordance with the relevant provisions of this

Title where this is required.

Article 6

General obligation to register substances on their own or

in preparations

1. Save where this Regulation provides otherwise, any manu-

facturer or importer of a substance, either on its own or in one

or more preparation(s), in quantities of one tonne or more per

year shall submit a registration to the Agency.

2. For monomers that are used as on-site isolated intermedi-

ates or transported isolated intermediates, Articles 17 and 18

shall not apply.

3. Any manufacturer or importer of a polymer shall submit a

registration to the Agency for the monomer substance(s) or any

other substance(s), that have not already been registered by an

actor up the supply chain, if both the following conditions are

met:

(a) the polymer consists of 2 % weight by weight (w/w) or

more of such monomer substance(s) or other substance(s) in

the form of monomeric units and chemically bound

substance(s);

(b) the total quantity of such monomer substance(s) or other

substance(s) makes up one tonne or more per year.

4. A submission for registration shall be accompanied by the

fee required in accordance with Title IX.

Article 7

Registration and notification of substances in articles

1. Any producer or importer of articles shall submit a regis-

tration to the Agency for any substance contained in those arti-

cles, if both the following conditions are met:

(a) the substance is present in those articles in quantities total-

ling over one tonne per producer or importer per year;

(b) the substance is intended to be released under normal or

reasonably foreseeable conditions of use.

A submission for registration shall be accompanied by the fee

required in accordance with Title IX.

2. Any producer or importer of articles shall notify the

Agency, in accordance with paragraph 4 of this Article, if a

substance meets the criteria in Article 57 and is identified in

accordance with Article 59(1), if both the following conditions

are met:

(a) the substance is present in those articles in quantities total-

ling over one tonne per producer or importer per year;

(b) the substance is present in those articles above a concentra-

tion of 0,1 % weight by weight (w/w).

3. Paragraph 2 shall not apply where the producer or

importer can exclude exposure to humans or the environment

during normal or reasonably foreseeable conditions of use

including disposal. In such cases, the producer or importer shall

supply appropriate instructions to the recipient of the article.

4. The information to be notified shall include the following:

(a) the identity and contact details of the producer or importer

as specified in section 1 of Annex VI, with the exception of

their own use sites;

(b) the registration number(s) referred to in Article 20(1), if

available;

29.5.2007L 136/22 Official Journal of the European Union

2.3.4 of Annex VI;

(d) the classification of the substance(s) as specified in

sections 4.1 and 4.2 of Annex VI;

(e) a brief description of the use(s) of the substance(s) in the

article as specified in section 3.5 of Annex VI and of the

uses of the article(s);

(f) the tonnage range of the substance(s), such as 1 to

10 tonnes, 10 to 100 tonnes and so on.

5. The Agency may take decisions requiring producers or

importers of articles to submit a registration, in accordance with

this Title, for any substance in those articles, if all the following

conditions are met:

(a) the substance is present in those articles in quantities total-

ling over one tonne per producer or importer per year;

(b) the Agency has grounds for suspecting that:

(i) the substance is released from the articles, and

(ii) the release of the substance from the articles presents a

risk to human health or the environment;

A submission for registration shall be accompanied by the fee

required in accordance with Title IX.

6. Paragraphs 1 to 5 shall not apply to substances that have

already been registered for that use.

7. From 1 June 2011 paragraphs 2, 3 and 4 of this Article

shall apply six months after a substance is identified in accord-

ance with Article 59(1).

8. Any measures for the implementation of paragraphs 1 to

7 shall be adopted in accordance with the procedure refer red to

in Article 133(3).

Article 8

Only representative of a non-Community manufacturer

1. A natural or legal person established outside the Com-

munity who manufactures a substance on its own, in prepara-

tions or in articles, formulates a preparation or produces an

article that is imported into the Community may by mutual

agreement appoint a natural or legal person established in the

Community to fulfil, as his only representative, the obligations

on importers under this Title.

2. The representative shall also comply with all other obliga-

tions of importers under this Regulation. To this end, he shall

have a sufficient background in the practical handling of

substances and the information related to them and, without

prejudice to Article 36, shall keep available and up-to-date infor-

mation on quantities imported and customers sold to, as well as

information on the supply of the latest update of the safety data

sheet referred to in Article 31.

3. If a representative is appointed in accordance with para-

graphs 1 and 2, the non-Community manufacturer shall inform

the importer(s) within the same supply chain of the appoint-

ment. These importers shall be regarded as downstream users

for the purposes of this Regulation.

Article 9

Exemption from the general obligation to register for

product and process orientated research and development

(PPORD)

1. Articles 5, 6, 7, 17, 18 and 21 shall not apply for a

period of five years to a substance manufactured in the Com-

munity or imported for the purposes of product and process

orientated research and development by a manufacturer or

importer or producer of articles, by himself or in cooperation

with listed customers and in a quantity which is limited to the

purpose of product and process orientated research and devel-

opment.

2. For the purpose of paragraph 1, the manufacturer or

importer or producer of articles shall notify the Agency of the

following information:

(a) the identity of the manufacturer or importer or producer of

articles as specified in section 1 of Annex VI;

(b) the identity of the substance, as specified in section 2 of

Annex VI;

of Annex VI, if any;

(d) the estimated quantity as specified in section 3.1 of

Annex VI;

(e) the list of customers referred to in paragraph 1, including

their names and addresses.

The notification shall be accompanied by the fee required in

accordance with Title IX.

The period set out in paragraph 1 shall begin at receipt of the

notification at the Agency.

3. The Agency shall check the completeness of the informa-

tion supplied by the notifier and Article 20(2) shall apply

adapted as necessary. The Agency shall assign a number to the

notification and a notification date, which shall be the date of

receipt of the notification at the Agency, and shall forthwith

communicate that number and date to the manufacturer, or

importer, or producer of articles concerned. The Agency shall

also communicate this information to the competent authority

of the Member State(s) concerned.

29.5.2007 L 136/23Official Journal of the European Union

4. The Agency may decide to impose conditions with the

aim of ensuring that the substance or the preparation or article

in which the substance is incorporated will be handled only by

staff of listed customers as referred to in paragraph 2(e) in

reasonably controlled conditions, in accordance with the

requirements of legislation for the protection of workers and

the environment, and will not be made available to the general

public at any time either on its own or in a preparation or

article and that remaining quantities will be re-collected for

disposal af ter the exemption period.

In such cases, the Agency may ask the notifier to provide addi-

tional necessary information.

5. In the absence of any indication to the contrary, the

manufacturer or importer of the substance or the producer or

importer of articles may manufacture or import the substance

or produce or import the articles not earlier than two weeks

after the notification.

6. The manufacturer or importer or producer of articles shall

comply with any conditions imposed by the Agency in accord-

ance with paragraph 4.

7. The Agency may decide to extend the five-year exemption

period by a further maximum of five years or, in the case of

substances to be used exclusively in the development of medic-

inal products for human or veterinary use, or for substances

that are not placed on the market, for a further maximum of

ten years, upon request if the manufacturer or importer or

producer of articles can demonstrate that such an extension is

justified by the research and development programme.

8. The Agency shall forthwith communicate any draft deci-

sions to the competent authorities of each Member State in

which the manufacture, import, production or product and

process orientated research takes place.

When taking decisions as provided for in paragraphs 4 and 7,

the Agency shall take into account any comments made by such

competent authorities.

9. The Agency and the competent authorities of the Member

States concerned shall always keep confidential the information

submitted in accordance with paragraphs 1 to 8.

10. An appeal may be brought, in accordance with Arti-

cles 91, 92 and 93, against Agency decisions under paragraphs 4

and 7 of this Article.

Article 10

Information to be submitted for general registration

purposes

A registration required by Article 6 or by Ar ticle 7(1) or (5)

shall include all the following information:

(a) a technical dossier including:

(i) the identity of the manufacturer(s) or importer(s) as

specified in section 1 of Annex VI;

(ii) the identity of the substance as specified in section 2

of Annex VI;

(iii) information on the manufacture and use(s) of the

substance as specified in section 3 of Annex VI; this

information shall represent all the registrant's identi-

fied use(s). This information may include, if the regis-

trant deems appropriate, the relevant use and exposure

categories;

(iv) the classification and labelling of the substance as

specified in section 4 of Annex VI;

(v) guidance on safe use of the substance as specified in

Section 5 of Annex VI;

(vi) study summaries of the information derived from the

application of Annexes VII to XI;

(vii) robust study summaries of the information derived

from the application of Annexes VII to XI, if required

under Annex I;

(viii) an indication as to which of the information submitted

under (iii), (iv), (vi), (vii) or subparagraph (b) has been

reviewed by an assessor chosen by the manufacturer

or importer and having appropriate experience;

(ix) proposals for testing where listed in Annexes IX and

(x) for substances in quantities of 1 to 10 tonnes, expo-

sure information as specified in section 6 of Annex VI;

(xi) a request as to which of the information in Article 119

(2) the manufacturer or importer considers should not

be made available on the Internet in accordance with

Article 77(2)(e), including a justification as to why

publication could be harmful for his or any other

concerned party's commercial interests.

Except in cases covered under Article 25(3), Article 27(6) or

Article 30(3), the registrant shall be in legitimate possession

of or have permission to refer to the full study report

summarised under (vi) and (vii) for the purpose of registra-

tion;

29.5.2007L 136/24 Official Journal of the European Union

(b) a chemical safety report when required under Article 14, in

the format specified in Annex I. The relevant sections of this

report may include, if the registrant considers appropriate,

the relevant use and exposure categories.

Article 11

Joint submission of data by multiple registrants

1. When a substance is intended to be manufactured in the

Community by one or more manufacturers and/or imported by

one or more importers, and/or is subject to registration under

Article 7, the following shall apply.

Subject to paragraph 3, the information specified in Article 10

(a)(iv), (vi), (vii) and (ix), and any relevant indication under

Article 10(a)(viii) shall first be submitted by the one registrant

acting with the agreement of the other assenting registrant(s)

(hereinafter referred to as the lead registrant).

Each registrant shall subsequently submit separately the infor-

mation specified in Article 10(a)(i), (ii), (iii) and (x), and any rele-

vant indication under Article 10(a)(viii).

The registrants may decide themselves whether to submit the

information specified in Article 10(a)(v) and (b) and any relevant

indication under Article 10(a)(viii) separately or whether one

registrant is to submit this information on behalf of the others.

2. Each registrant need only comply with paragraph 1 for

items of information specified in Ar ticle 10(a)(iv), (vi), (vii) and

(ix) that are required for the purposes of registration within his

tonnage band in accordance with Article 12.

3. A registrant may submit the information referred to in

Article 10(a)(iv), (vi), (vii) or (ix) separately if:

(a) it would be disproportionately costly for him to submit this

information jointly; or

(b) submitting the information jointly would lead to disclosure

of information which he considers to be commercially sensi-

tive and is likely to cause him substantial commercial detri-

ment; or

information.

If points (a), (b) or (c) apply, the registrant shall submit, along

with the dossier, an explanation as to why the costs would be

disproportionate, why disclosure of information was likely to

lead to substantial commercial detriment or the nature of the

disagreement, as the case may be.

4. A submission for registration shall be accompanied by the

fee required in accordance with Title IX.

Article 12

Information to be submitted depending on tonnage

1. The technical dossier referred to in Article 10(a) shall

include under points (vi) and (vii) of that provision all physico-

chemical, toxicological and ecotoxicological information that is

relevant and available to the registrant and as a minimum the

following:

(a) the information specified in Annex VII for non-phase-in

substances, and for phase-in substances meeting one or

both of the criteria specified in Annex III, manufactured or

imported in quantities of one tonne or more per year per

manufacturer or importer;

(b) the information on physicochemical properties specified in

Annex VII, section 7 for phase-in substances manufactured

or imported in quantities of one tonne or more per year per

manufacturer or importer which do not meet either of the

criteria specified in Annex III;

substances manufactured or imported in quantities of

10 tonnes or more per year per manufacturer or importer;

(d) the information specified in Annexes VII and VIII and

testing proposals for the provision of the information speci-

fied in Annex IX for substances manufactured or imported

in quantities of 100 tonnes or more per year per manufac-

turer or importer;

(e) the information specified in Annexes VII and VIII and

testing proposals for the provision of the information speci-

fied in Annexes IX and X for substances manufactured or

imported in quantities of 1 000 tonnes or more per year

per manufacturer or importer.

2. As soon as the quantity of a substance per manufacturer

or importer that has already been registered reaches the next

tonnage threshold, the manufacturer or importer shall inform

the Agency immediately of the additional information he would

require under paragraph 1. Article 26(3) and (4) shall apply

adapted as necessary.

29.5.2007 L 136/25Official Journal of the European Union

3. This Article shall apply to producers of articles adapted as

necessary.

Article 13

General requirements for generation of information on

intrinsic properties of substances

1. Information on intr insic properties of substances may be

generated by means other than tests, provided that the condi-

tions set out in Annex XI are met. In particular for human toxi-

city, information shall be generated whenever possible by means

other than vertebrate animal tests, through the use of alternative

methods, for example, in vitro methods or qualitative or quanti-

tative structure-activity relationship models or from information

from structurally related substances (grouping or read-across).

Testing in accordance with Annex VIII, Sections 8.6 and 8.7,

Annex IX and Annex X may be omitted where justified by infor-

mation on exposure and implemented risk management

measures as specified in Annex XI, section 3.

2. These methods shall be regularly reviewed and improved

with a view to reducing testing on vertebrate animals and the

number of animals involved. The Commission, following

consultation with relevant stakeholders, shall, as soon as

possible, make a proposal, if appropriate, to amend the

Commission Regulation on test methods adopted in accordance

with the procedure referred to in Article 133(4), and the

Annexes of this Regulation, if relevant, so as to replace, reduce

or refine animal testing. Amendments to that Commission

Regulation shall be adopted in accordance with the procedure

specified in paragraph 3 and amendments to the Annexes of

this Regulation shall be adopted in accordance with the proce-

dure referred to in Article 131.

3. Where tests on substances are required to generate infor-

mation on intrinsic properties of substances, they shall be

conducted in accordance with the test methods laid down in a

Commission Regulation or in accordance with other interna-

tional test methods recognised by the Commission or the

Agency as being appropriate. The Commission shall adopt that

Regulation, designed to amend the non-essential elements of

this Regulation by supplementing it, in accordance with the

procedure referred to in Article 133(4).

Information on intrinsic properties of substances may be gener-

ated in accordance with other test methods provided that the

conditions set out in Annex XI are met.

4. Ecotoxicological and toxicological tests and analyses shall

be carried out in compliance with the pr inciples of good labora-

tory practice provided for in Directive 2004/10/EC or other

international standards recognised as being equivalent by the

Commission or the Agency and with the provisions of Direc-

tive 86/609/EEC, if applicable.

5. If a substance has already been registered, a new registrant

shall be entitled to refer to the study summaries or robust study

summaries, for the same substance submitted earlier, provided

that he can show that the substance that he is now registering is

the same as the one previously registered, including the degree

of purity and the nature of impurities, and that the previous

registrant(s) have given permission to refer to the full study

repor ts for the purpose of registration.

A new registrant shall not refer to such studies in order to

provide the information required in Section 2 of Annex VI.

Article 14

Chemical safety report and duty to apply and recommend

risk reduction measures

1. Without prejudice to Article 4 of Directive 98/24/EC, a

chemical safety assessment shall be performed and a chemical

safety report completed for all substances subject to registration

in accordance with this Chapter in quantities of 10 tonnes or

more per year per registrant.

The chemical safety report shall document the chemical safety

assessment which shall be conducted in accordance with para-

graphs 2 to 7 and with Annex I for either each substance on its

own or in a preparation or in an article or a group of

substances.

2. A chemical safety assessment in accordance with para-

graph 1 need not be performed for a substance which is present

in a preparation if the concentration of the substance in the

preparation is less than the lowest of any of the following:

(a) the applicable concentrations defined in the table of

Article 3(3) of Directive 1999/45/EC;

(b) the concentration limits given in Annex I to Directive 67/

548/EEC;

Directive 1999/45/EC;

(d) the concentration limits given in Part B of Annex III to

Directive 1999/45/EC;

29.5.2007L 136/26 Official Journal of the European Union

(e) the concentration limits given in an agreed entry in the clas-

sification and labelling inventory established under Title XI

of this Regulation;

(f) 0,1 % weight by weight (w/w), if the substance meets the

criteria in Annex XIII of this Regulation.

3. A chemical safety assessment of a substance shall include

the following steps:

(a) human health hazard assessment;

(b) physicochemical hazard assessment;

(d) persistent, bioaccumulative and toxic (PBT) and very persis-

tent and very bioaccumulative (vPvB) assessment.

4. If, as a result of carrying out steps (a) to (d) of paragraph 3,

the registrant concludes that the substance meets the cr iteria for

classification as dangerous in accordance with Directive 67/548/

EEC or is assessed to be a PBT or vPvB, the chemical safety

assessment shall include the following additional steps:

(a) exposure assessment including the generation of exposure

scenario(s) (or the identification of relevant use and expo-

sure categories if appropriate) and exposure estimation;

(b) risk characterisation.

The exposure scenarios (where appropriate the use and exposure

categories), exposure assessment and risk characterisation shall

address all identified uses of the registrant.

5. The chemical safety report need not include consideration

of the risks to human health from the following end uses:

(a) in food contact materials within the scope of Regulation

(EC) No 1935/2004 of the European Parliament and of the

Council of 27 October 2004 on materials and articles

intended to come into contact with food (

);

(b) in cosmetic products within the scope of Directive 76/768/

EEC.

6. Any registrant shall identify and apply the appropriate

measures to adequately control the risks identified in the

chemical safety assessment, and where suitable, recommend

them in the safety data sheets which he supplies in accordance

with Article 31.

7. Any registrant required to conduct a chemical safety

assessment shall keep his chemical safety report available and

up to date.

CHAPTER 2

Substances regarded as being registered

Article 15

Substances in plant protection and biocidal products

1. Active substances and co-formulants manufactured or

imported for use in plant protection products only and included

either in Annex I to Council Directive 91/414/EEC (

) or in

Commission Regulation (EEC) No 3600/92 (

), Commission

Regulation (EC) No 703/2001 (

), Commission Regulation (EC)

No 1490/2002 (

), or Commission Decision 2003/565/EC (

)

and for any substance for which a Commission Decision on the

completeness of the dossier has been taken pursuant to Article 6

of Directive 91/414/EEC shall be regarded as being registered

and the registration as completed for manufacture or import for

the use as a plant protection product and therefore as fulfilling

the requirements of Chapters 1 and 5 of this Title.

29.5.2007 L 136/27Official Journal of the European Union

(

) OJ L 338, 13.11.2004, p. 4.

(

) Council Directive 91/414/EEC of 15 July 1991 concerning the placing

of plant protection products on the market (OJ L 230, 19.8.1991, p. 1).

Directive as last amended by Commission Directive 2006/136/EC (OJ

L 349, 12.12.2006, p. 42).

(

) Commission Regulation (EEC) No 3600/92 of 11 December 1992

laying down the detailed rules for the implementation of the first stage

of the programme of work referred to in Article 8(2) of Council Direc-

tive 91/414/EEC concerning the placing of plant protection products

on the market (OJ L 366, 15.12.1992, p. 10). Regulation as last

amended by Regulation (EC) No 2266/2000 (OJ L 259, 13.10.2000,

p. 27).

(

) Commission Regulation (EC) No 703/2001 of 6 April 2001 laying

down the active substances of plant protection products to be assessed

in the second stage of the work programme referred to in Article 8(2)

of Council Directive 91/414/EEC and revising the list of Member States

designated as rapporteurs for those substances (OJ L 98, 7.4.2001,

p. 6).

(

) Commission Regulation (EC) No 1490/2002 of 14 August 2002 laying

down further detailed rules for the implementation of the third stage of

the programme of work referred to in Article 8(2) of Council Directive

91/414/EEC (OJ L 224, 21.8.2002, p. 23). Regulation as last amended

by Regulation (EC) No 1744/2004 (OJ L 311, 8.10.2004, p. 23).

(

) Commission Decision 2003/565/EC of 25 July 2003 extending the

time period provided for in Article 8(2) of Council Directive

91/414/EEC (OJ L 192, 31.7.2003, p. 40).

2. Active substances manufactured or imported for use in

biocidal products only and included either in Annexes I, IA or

IB to Directive 98/8/EC of the European Parliament and of the

Council of 16 February 1998 concerning the placing of biocidal

products on the market (

) or in Commission Regulation (EC)

No 2032/2003 (

)on the second phase of the 10-year work

programme referred to in Article 16(2) of Directive 98/8/EC,

until the date of the decision referred to in the second sub-

paragraph of Article 16(2) of Directive 98/8/EC, shall be

regarded as being registered and the registration as completed

for manufacture or import for the use in a biocidal product and

therefore as fulfi lling the requirements of Chapters 1 and 5 of

this Title.

Article 16

Duties of the Commission, the Agency and registrants of

substances regarded as being registered

1. The Commission or the relevant Community body shall

make information equivalent to that required by Article 10

available to the Agency for substances regarded as registered

according to Article 15. The Agency shall include this informa-

tion or a reference thereto in its databases and notify the

competent authorities thereof by 1 December 2008.

2. Articles 21, 22 and 25 to 28 shall not apply to uses of

substances regarded as registered according to Article 15.

CHAPTER 3

Obligation to register and information requirements for

certain types of isolated intermediates

Article 17

Registration of on-site isolated intermediates

1. Any manufacturer of an on-site isolated intermediate in

quantities of one tonne or more per year shall submit a registra-

tion to the Agency for the on-site isolated intermediate.

2. A registration for an on-site isolated intermediate shall

include all the following information, to the extent that the

manufacturer is able to submit it without any additional testing:

(a) the identity of the manufacturer as specified in Section 1 of

Annex VI;

(b) the identity of the intermediate as specified in Sections 2.1

to 2.3.4 of Annex VI;

of Annex VI;

(d) any available existing information on physicochemical,

human health or environmental properties of the inter-

mediate. Where a full study report is available, a study

summary shall be submitted;

(e) a brief general description of the use, as specified in

Section 3.5 of Annex VI;

(f) details of the risk management measures applied.

Except in cases covered under Article 25(3), Article 27(6) or

Article 30(3), the registrant shall be in legitimate possession of

or have permission to refer to the full study report summarised

under (d) for the purpose of registration.

The registration shall be accompanied by the fee required in

accordance with Title IX.

3. Paragraph 2 shall apply only to on-site isolated intermedi-

ates if the manufacturer confirms that the substance is only

manufactured and used under strictly controlled conditions in

that it is rigorously contained by technical means during its

whole lifecycle. Control and procedural technologies shall be

used to minimise emission and any resulting exposure.

If these conditions are not fulfilled, the registration shall include

the information specified in Article 10.

Article 18

Registration of transported isolated intermediates

1. Any manufacturer or importer of a transported isolated

intermediate in quantities of one tonne or more per year shall

submit a registration to the Agency for the transported isolated

intermediate.

2. A registration for a transported isolated intermediate shall

include all the following infor mation:

(a) the identity of the manufacturer or importer as specified in

Section 1 of Annex VI;

(b) the identity of the intermediate as specified in Sections 2.1

to 2.3.4 of Annex VI;

of Annex VI;

(d) any available existing information on physicochemical,

human health or environmental properties of the inter-

mediate. Where a full study report is available, a study

summary shall be submitted;

(e) a brief general description of the use, as specified in

Section 3.5 of Annex VI;

29.5.2007L 136/28 Official Journal of the European Union

(

) OJ L 123, 24.4.1998, p. 1. Directive as last amended by Commission

Directive 2006/140/EC (OJ L 414, 30.12.2006, p. 78).

(

) OJ L 307, 24.11.2003, p. 1. Regulation as last amended by Regulation

(EC) No 1849/2006 (OJ L 355, 15.12.2006, p. 63).

(f) information on risk management measures applied and

recommended to the user in accordance with paragraph 4.

Except in cases covered under Article 25(3), Article 27(6) or

Article 30(3), the registrant shall be in legitimate possession of

or have permission to refer to the full study report summarised

under (d) for the purpose of registration.

The registration shall be accompanied by the fee required in

accordance with Title IX.

3. A registration for a transported isolated intermediate in

quantities of more than 1 000 tonnes per year per manufacturer

or importer shall include the information specified in Annex VII

in addition to the information required under paragraph 2.

For the generation of this information, Article 13 shall apply.

4. Paragraphs 2 and 3 shall apply only to transported

isolated intermediates if the manufacturer or importer confirms

himself or states that he has received confir mation from the

user that the synthesis of (an)other substance(s) from that inter-

mediate takes place on other sites under the following strictly

controlled conditions:

(a) the substance is rigorously contained by technical means

during its whole lifecycle including manufacture, purifica-

tion, cleaning and maintenance of equipment, sampling,

analysis, loading and unloading of equipment or vessels,

waste disposal or purification and storage;

(b) procedural and control technologies shall be used that mini-

mise emission and any resulting exposure;

substance;

(d) in the case of cleaning and maintenance works, special

procedures such as purging and washing are applied before

the system is opened and entered;

(e) in cases of accident and where waste is generated, proce-

dural and/or control technologies are used to minimise

emissions and the resulting exposure during purification or

cleaning and maintenance procedures;

(f) substance-handling procedures are well documented and

strictly supervised by the site operator.

If the conditions listed in the first subparagraph are not fulfilled,

the registration shall include the information specified in

Article 10.

Article 19

Joint submission of data on isolated intermediates by

multiple registrants

1. When an on-site isolated intermediate or transported

isolated intermediate is intended to be manufactured in the

Community by one or more manufacturers and/or imported by

one or more importers, the following shall apply.

Subject to paragraph 2 of this Article, the information specified

in Article 17(2)(c) and (d) and Article 18(2)(c) and (d) shall first

be submitted by one manufacturer or importer acting with the

agreement of the other assenting manufacturer(s) or importer(s)

(hereinafter referred to as ‘the lead registrant’).

Each registrant shall subsequently submit separately the infor-

mation specified in Article 17(2)(a), (b), (e) and (f) and Article 18

(2)(a),(b), (e) and (f).

2. A manufacturer or impor ter may submit the information

referred to in Article 17(2)(c) or (d) and Article 18(2)(c) or (d)

separately if:

(a) it would be disproportionately costly for him to submit this

jointly; or

(b) submitting the information jointly would lead to disclosure

of information which he considers to be commercially sensi-

tive and is likely to cause him substantial commercial detri-

ment; or

information.

If points (a), (b) or (c) apply, the manufacturer or importer shall

submit, along with the dossier, an explanation as to why the

costs would be disproportionate, why disclosure of information

was likely to lead to substantial commercial detriment, or the

nature of the disagreement, as the case may be.

3. A submission for registration shall be accompanied by the

fee required in accordance with Title IX.

CHAPTER 4

Common provisions for all registrations

Article 20

Duties of the Agency

1. The Agency shall assign a submission number to each

registration, which is to be used for all correspondence

regarding the registration until the registration is deemed to be

complete, and a submission date, which shall be the date of

receipt of the registration at the Agency.

2. The Agency shall undertake a completeness check of each

registration in order to ascertain that all the elements required

under Articles 10 and 12 or under Articles 17 or 18, as well as

the registration fee referred to in Article 6(4), Article 7(1) and

(5), Ar ticle 17(2) or Article 18(2), have been provided. The

completeness check shall not include an assessment of the

quality or the adequacy of any data or justifications submitted.

29.5.2007 L 136/29Official Journal of the European Union

The Agency shall undertake the completeness check within

three weeks of the submission date, or within three months of

the relevant deadline of Article 23, as regards registrations of

phase-in substances submitted in the course of the two-month

period immediately preceding that deadline.

If a registration is incomplete, the Agency shall inform the regis-

trant, before expiry of the three-week or three-month period

referred to in the second subparagraph, as to what further infor-

mation is required in order for the registration to be complete,

while setting a reasonable deadline for this. The registrant shall

complete his registration and submit it to the Agency within the

deadline set. The Agency shall confirm the submission date of

the further information to the registrant. The Agency shall

perform a further completeness check, considering the further

information submitted.

The Agency shall reject the registration if the registrant fails to

complete his registration within the deadline set. The registra-

tion fee shall not be reimbursed in such cases.

3. Once the registration is complete, the Agency shall assign

a registration number to the substance concerned and a registra-

tion date, which shall be the same as the submission date. The

Agency shall without delay communicate the registration

number and registration date to the registrant concerned. The

registration number shall be used for all subsequent correspond-

ence regarding registration.

4. The Agency shall notify the competent authority of the

relevant Member State within 30 days of the submission date,

that the following information is available in the Agency data-

base:

(a) the registration dossier together with the submission or

registration number;

(b) the submission or registration date;

(d) any request for further information and deadline set in

accordance with the third subparagraph of paragraph 2.

The relevant Member State shall be the Member State within

which the manufacture takes place or the importer is estab-

lished.

If the manufacturer has production sites in more than one

Member State, the relevant Member State shall be the one in

which the head office of the manufacturer is established. The

other Member States where the production sites are established

shall also be notified.

The Agency shall forthwith notify the competent authority of

the relevant Member State(s) when any further information

submitted by the registrant is available on the Agency database.

5. An appeal may be brought, in accordance with Articles 91,

92 and 93, against Agency decisions under paragraph 2 of this

Article.

6. Where additional information for a particular substance is

submitted to the Agency by a new registrant, the Agency shall

notify the existing registrants that this information is available

on the database for the purposes of Article 22.

Article 21

Manufacturing and import of substances

1. A registrant may start or continue the manufacture or

import of a substance or production or import of an article, if

there is no indication to the contrary from the Agency in

accordance with Article 20(2) within the three weeks after the

submission date, without prejudice to Article 27(8).

In the case of registrations of phase-in substances, such a regis-

trant may continue the manufacture or import of the substance

or production or import of an article, if there is no indication

to the contrary from the Agency in accordance with Ar ticle 20

(2) within the three weeks after the submission date or, if

submitted within the two-month period before the relevant

deadline of Article 23, if there is no indication to the contrary

from the Agency in accordance with Article 20(2) within the

three months from that deadline, without prejudice to Article 27

(8).

In the case of an update of a registration according to Article 22

a registrant may continue the manufacture or impor t of the

substance, or the production or import of the article, if there is

no indication to the contrary from the Agency in accordance

with Article 20(2) within the three week s after the update date,

without prejudice to Article 27(8).

2. If the Agency has informed the registrant that he is to

submit further information in accordance with the third sub-

paragraph of Article 20(2), the registrant may start the manufac-

ture or import of a substance or production or import of an

article if there is no indication to the contrary from the Agency

within the three weeks after receipt by the Agency of the

further information necessary to complete his registration,

without prejudice to Article 27(8).

3. If a lead registrant submits parts of the registration on

behalf of one or more other registrants, as provided for in Arti-

cles 11 or 19, any of the other registrants may manufacture or

import the substance or produce or import the articles only

after the expiry of the time-limit laid down in paragraph 1 or 2

of this Article and provided that there is no indication to the

contrary from the Agency in respect of the registration of the

lead registrant acting on behalf of the others and his own regis-

tration.

29.5.2007L 136/30 Official Journal of the European Union

Article 22

Further duties of registrants

1. Following registration, a registrant shall be responsible on

his own initiative for updating his registration without undue

delay with relevant new information and submitting it to the

Agency in the following cases:

(a) any change in his status, such as being a manufacturer, an

importer or a producer of articles, or in his identity, such as

his name or address;

(b) any change in the composition of the substance as given in

Section 2 of Annex VI;

imported by him or in the quantities of substances present

in articles produced or imported by him if these result in a

change of tonnage band, including cessation of manufacture

or import;

(d) new identified uses and new uses advised against as in

Section 3.7 of Annex VI for which the substance is manu-

factured or imported;

(e) new knowledge of the risks of the substance to human

health and/or the environment of which he may reasonably

be expected to have become aware which leads to changes

in the safety data sheet or the chemical safety report;

(f) any change in the classification and labelling of the

substance;

(g) any update or amendment of the chemical safety report or

Section 5 of Annex VI;

(h) the registrant identifies the need to perform a test listed in

Annex IX or Annex X, in which cases a testing proposal

shall be developed;

(i) any change in the access granted to information in the regis-

tration.

The Agency shall communicate this information to the compe-

tent authority of the relevant Member State.

2. A registrant shall submit to the Agency an update of the

registration containing the information required by the decision

made in accordance with Articles 40, 41 or 46 or take into

account a decision made in accordance with Ar ticles 60 and 73,

within the deadline specified in that decision. The Agency shall

notify the competent authority of the relevant Member State

that the information is available on its database.

3. The Agency shall undertake a completeness check

according to Article 20(2) first and second subparagraphs of

each updated registration. In cases where the update is in

accordance with Article 12(2) and with paragraph 1(c) of this

Article then the Agency shall check the completeness of the

information supplied by the registrant and Article 20(2) shall

apply adapted as necessary.

4. In cases covered by Articles 11 or 19, each registrant shall

submit separately the information specified in paragraph 1(c) of

this Article.

5. An update shall be accompanied by the relevant part of

the fee required in accordance with Title IX.

CHAPTER 5

Transitional provisions applicable to phase-in substances and

notified substances

Article 23

Specific provisions for phase-in substances

1. Article 5, Article 6, Article 7(1), Article 17, Article 18 and

Article 21 shall not apply until 1 December 2010 to the

following substances:

(a) phase-in substances classified as carcinogenic, mutagenic or

toxic to reproduction, category 1 or 2, in accordance with

Directive 67/548/EEC and manufactured in the Community

or imported, in quantities reaching one tonne or more per

year per manufacturer or per importer, at least once after

1 June 2007;

(b) phase-in substances classified as very toxic to aquatic organ-

isms which may cause long-term adverse effects in the

aquatic environment (R50/53) in accordance with Directive

67/548/EEC, and manufactured in the Community or

imported in quantities reaching 100 tonnes or more per

year per manufacturer or per importer, at least once after

1 June 2007;

imported, in quantities reaching 1 000 tonnes or more per

year per manufacturer or per importer, at least once after

1 June 2007.

2. Article 5, Article 6, Article 7(1), Article 17, Article 18 and

Article 21 shall not apply until 1 June 2013 to phase-in

substances manufactured in the Community or imported, in

quantities reaching 100 tonnes or more per year per manufac-

turer or per impor ter, at least once after 1 June 2007.

3. Article 5, Article 6, Article 7(1), Article 17, Article 18 and

Article 21 shall not apply until 1 June 2018 to phase-in

substances manufactured in the Community or imported, in

quantities reaching one tonne or more per year per manufac-

turer or per impor ter, at least once after 1 June 2007.

4. Without prejudice to paragraphs 1 to 3, a registration can

be submitted at any time before the relevant deadline.

5. This Article shall also apply to substances registered under

Article 7 adapted as necessary.

29.5.2007 L 136/31Official Journal of the European Union

Article 24

Notified substances

1. A notification in accordance with Directive 67/548/EEC

shall be regarded as a registration for the purposes of this Title

and the Agency shall assign a registration number by

1 December 2008.

2. If the quantity of a notified substance manufactured or

imported per manufacturer or importer reaches the next

tonnage threshold under Article 12, the additional required

information corresponding to that tonnage threshold, as well as

to all the lower tonnage thresholds, shall be submitted in

accordance with Articles 10 and 12, unless it has already been

submitted in accordance with those Articles.

TITLE III

DATA SHARING AND AVOIDANCE OF UNNECESSARY

TESTING

CHAPTER 1

Objectives and general rules

Article 25

Objectives and general rules

1. In order to avoid animal testing, testing on vertebrate

animals for the purposes of this Regulation shall be under taken

only as a last resor t. It is also necessary to take measures

limiting duplication of other tests.

2. The sharing and joint submission of information in

accordance with this Regulation shall concern technical data

and in particular information related to the intrinsic properties

of substances. Registrants shall refrain from exchanging infor-

mation concerning their market behaviour, in particular as

regards production capacities, production or sales volumes,

import volumes or market shares.

3. Any study summaries or robust study summaries of

studies submitted in the framework of a registration under this

Regulation at least 12 years previously can be used for the

purposes of registration by another manufacturer or importer.

CHAPTER 2

Rules for non-phase-in substances and registrants of phase-in

substances who have not pre-registered

Article 26

Duty to inquire prior to registration

1. Every potential registrant of a non-phase-in substance, or

potential registrant of a phase-in substance who has not pre-

registered in accordance with Article 28, shall inquire from the

Agency whether a registration has already been submitted for

the same substance. He shall submit all the following informa-

tion to the Agency with the inquiry:

(a) his identity as specified in Section 1 of Annex VI, with the

exception of the use sites;

(b) the identity of the substance, as specified in Section 2 of

Annex VI;

involving vertebrate animals to be carr ied out by him;

(d) which information requirements would require other new

studies to be carried out by him.

2. If the same substance has previously not been registered,

the Agency shall inform the potential registrant accordingly.

3. If the same substance has previously been registered less

than 12 years earlier, the Agency shall inform the potential

registrant without delay of the names and addresses of the

previous registrant(s) and of the relevant summaries or robust

study summaries, as the case may be, already submitted by

them.

Studies involving vertebrate animals shall not be repeated.

The Agency shall simultaneously inform the previous registrants

of the name and address of the potential registrant. The avail-

able studies shall be shared with the potential registrant in

accordance with Article 27.

4. If several potential registrants have made an inquiry in

respect of the same substance, the Agency shall inform all

potential registrants without delay of the name and address of

the other potential registrants.

Article 27

Sharing of existing data in the case of registered substances

1. Where a substance has previously been registered less than

12 years earlier as referred to in Article 26(3), the potential

registrant:

(a) shall, in the case of information involving tests on vertebrate

animals; and

(b) may, in the case of information not involving tests on verte-

brate animals,

request from the previous registrant(s) the information he

requires with respect to Article 10(a)(vi) and (vii) in order to

29.5.2007L 136/32 Official Journal of the European Union

2. When a request for information has been made according

to paragraph 1, the potential and the previous registrant(s) as

referred to in paragraph 1 shall make every effort to reach an

agreement on the sharing of the information requested by the

potential registrant(s) with respect to Article 10(a)(vi) and (vii).

Such an agreement may be replaced by submission of the

matter to an arbitration board and acceptance of the arbitration

order.

3. The previous registrant and potential registrant(s) shall

make every effort to ensure that the costs of sharing the infor-

mation are determined in a fair, transparent and non-discrimina-

tory way. This may be facilitated by following cost sharing

guidance based on those principles which is adopted by the

Agency in accordance with Article 77(2)(g). Registrants are only

required to share in the costs of information that they are

required to submit to satisfy their registration requirements.

4. On agreement on the sharing of the information, the

previous registrant shall make available to the new registrant the

agreed information and shall give the new registrant the permis-

sion to refer to the previous registrant's full study report.

5. If there is failure to reach such an agreement, the potential

registrant(s) shall inform the Agency and the previous registrant

(s) thereof at the earliest one month after receipt, from the

Agency, of the name and address of the previous registrant(s).

6. Within one month from the receipt of the information

referred to in paragraph 5, the Agency shall give the potential

registrant per mission to refer to the information requested by

him in his registration dossier, subject to the potential registrant

providing, upon request by the Agency, proof that he has paid

the previous registrant(s) for that information a share of cost

incurred. The previous registrant(s) shall have a claim on the

potential registrant for a proportionate share of the cost

incurred by him. Calculation of the proportionate share may be

facilitated by the guidance adopted by the Agency in accordance

with Article 77(2)(g). Provided he makes the full study report

available to the potential registrant, the previous registrant(s)

shall have a claim on the potential registrant for an equal share

of the cost incurred by him, which shall be enforceable in the

national courts.

7. An appeal may be brought, in accordance with Articles 91,

92 and 93, against Agency decisions under paragraph 6 of this

Article.

8. The registration waiting period in accordance with

Article 21(1) for the new registrant shall be extended by a

period of four months, if the previous registrant so requests.

CHAPTER 3

Rules for phase-in-substances

Article 28

Duty to pre-register for phase-in substances

1. In order to benefit from the transitional regime provided

for in Article 23 each potential registrant of a phase-in

substance in quantities of one tonne or more per year, including

without limitation intermediates, shall submit all the following

information to the Agency:

(a) the name of the substance as specified in Section 2 of

Annex VI, including its EINECS and CAS number or, if not

available, any other identity codes;

(b) his name and address and the name of the contact person

and, where appropriate, the name and address of the person

representing him in accordance with Article 4 as specified

in Section 1 of Annex VI;

band;

(d) the name(s) of substance(s) as specified in Section 2 of

Annex VI, including their EINECS and CAS number or, if

not available, any other identity codes, for which the avail-

able information is relevant for the application of

Sections 1.3 and 1.5 of Annex XI.

2. The information referred to in paragraph 1 shall be

submitted within a time period starting on 1 June 2008 and

ending on 1 December 2008.

3. Registrants who do not submit the information required

under paragraph 1 shall not be able to rely on Article 23.

4. The Agency shall by 1 January 2009 publish on its

website a list of the substances referred to in paragraph 1(a) and

(d). That list shall comprise only the names of the substances,

including their EINECS and CAS number if available and other

identity codes, and the first envisaged registration deadline.

5. After the publication of the list a downstream user of a

substance not appearing on the list may notify the Agency of

his interest in the substance, his contact details and the details

of his current supplier. The Agency shall publish on its website

the name of the substance and on request provide contact

details of the downstream user to a potential registrant.

29.5.2007 L 136/33Official Journal of the European Union

6. Potential registrants who manufacture or import for the

first time a phase-in substance in quantities of one tonne or

more per year or use for the first time a phase-in substance in

the context of production of articles or import for the first time

an article containing a phase-in substance that would require

registration, after 1 December 2008, shall be entitled to rely on

Article 23 provided that they submit the information referred to

in paragraph 1 of this Article to the Agency within six months

of first manufacturing, importing or using the substance in

quantities of one tonne or more per year and no later than 12

months before the relevant deadline in Article 23.

7. Manufacturers or importers of phase-in substances in

quantities of less than one tonne per year that appear on the list

published by the Agency in accordance with paragraph 4 of this

Article, as well as downstream users of those substances and

third parties holding information on those substances, may

submit the information referred to in paragraph 1 of this

Article or any other relevant information to the Agency for

those substances, with the intention of being part of the

substance information exchange forum as referred to in

Article 29.

Article 29

Substance Information Exchange Forums

1. All potential registrants, downstream users and third

parties who have submitted information to the Agency in

accordance with Article 28, or whose information is held by the

Agency in accordance with Article 15, for the same phase-in

substance, or registrants who have submitted a registration for

that phase-in substance before the deadline set out in Article 23

(3), shall be participants in a substance information exchange

forum (SIEF).

2. The aim of each SIEF shall be to:

(a) facilitate, for the pur poses of registration, the exchange of

the information specified in Article 10(a) (vi) and (vii)

between potential registrants, thereby avoiding the duplica-

tion of studies; and

(b) agree classification and labelling where there is a difference

in the classification and labelling of the substance between

potential registrants.

3. SIEF participants shall provide other participants with

existing studies, react to requests by other participants for infor-

mation, collectively identify needs for further studies for the

purposes of paragraph 2(a) and arrange for such studies to be

carried out. Each SIEF shall be operational until 1 June 2018.

Article 30

Sharing of data involving tests

1. Before testing is carried out in order to meet the informa-

tion requirements for the purposes of registration, a SIEF partici-

pant shall inquire whether a relevant study is available by

communicating within his SIEF. If a relevant study involving

tests on vertebrate animals is available within the SIEF, a partici-

pant of that SIEF shall request that study. If a relevant study not

involving tests on vertebrate animals is available within the SIEF,

a SIEF participant may request that study.

Within one month of the request, the owner of the study shall

provide proof of its cost to the participant(s) requesting it. The

par ticipant(s) and the owner shall make every effort to ensure

that the costs of sharing the information are determined in a

fair, transparent and non discriminator y way. This may be facili-

tated by following any cost sharing guidance which is based on

those principles and is adopted by the Agency in accordance

with Article 77(2)(g). If they cannot reach such an agreement,

the cost shall be shared equally. The owner shall give permission

to refer to the full study report for the purpose of registration

within two weeks of receipt of payment. Registrants are only

required to share in the costs of information that they are

required to submit to satisfy their registration requirements.

2. If a relevant study involving tests is not available within

the SIEF, only one study shall be conducted per information

requirement within each SIEF by one of its participants acting

on behalf of the others. They shall take all reasonable steps to

reach an agreement within a deadline set by the Agency as to

who is to carry out the test on behalf of the other participants

and to submit a summary or robust study summary to the

Agency. If no agreement is reached, the Agency shall specify

which registrant or downstream user shall perform the test. All

par ticipants of the SIEF who require a study shall contribute to

the costs for the elaboration of the study with a share corre-

sponding to the number of participating potential registrants.

Those participants that do not carry out the study themselves

shall have the right to receive the full study report within two

weeks following payment to the participant that carried out the

study.

3. If the owner of a study as refer red to in paragraph 1

which involves testing on vertebrate animals refuses to provide

either proof of the cost of that study or the study itself to (an)

other participant(s), he shall not be able to proceed with regis-

tration until he provides the information to the other partici-

pants(s). The other participant(s) shall proceed with registration

without fulfilling the relevant information requirement,

explaining the reason for this in the registration dossier. The

study shall not be repeated unless within 12 months of the date

of registration of the other participant(s), the owner of this

information has not provided it to them and the Agency decides

that the test should be repeated by them. However, if a registra-

tion containing this information has already been submitted by

another registrant, the Agency shall give the other par ticipant(s)

permission to refer to the information in his registration dossier

(s). The other registrant shall have a claim on the other partici-

pant(s) for an equal share of the cost, provided he makes the

full study report available to the other participant(s), which shall

be enforceable in the national courts.

29.5.2007L 136/34 Official Journal of the European Union

4. If the owner of a study as referred to in paragraph 1

which does not involve testing on vertebrate animals refuses to

provide either proof of the cost of that study or the study itself

to (an)other participant(s), the other SIEF participants shall

proceed with registration as if no relevant study was available in

the SIEF.

5. An appeal may be brought, in accordance with Articles 91,

92 and 93, against Agency decisions under paragraphs 2 or 3

of this Article.

6. The owner of the study who has refused to provide either

proof of the cost or the study itself, as referred to in paragraph 3

or 4 of this Article, shall be penalised in accordance with

Article 126.

TITLE IV

INFORMATION IN THE SUPPLY CHAIN

Article 31

Requirements for safety data sheets

1. The supplier of a substance or a preparation shall provide

the recipient of the substance or preparation with a safety data

sheet compiled in accordance with Annex II:

(a) where a substance or preparation meets the criteria for clas-

sification as dangerous in accordance with Directives 67/

548/EEC or 1999/45/EC; or

(b) where a substance is persistent, bioaccumulative and toxic

or very persistent and very bioaccumulative in accordance

with the criteria set out in Annex XIII; or

accordance with Article 59(1) for reasons other than those

referred to in points (a) and (b).

2. Any actor in the supply chain who is required, under Arti-

cles 14 or 37, to carry out a chemical safety assessment for a

substance shall ensure that the information in the safety data

sheet is consistent with the information in this assessment. If

the safety data sheet is developed for a preparation and the

actor in the supply chain has prepared a chemical safety assess-

ment for that preparation, it is sufficient if the information in

the safety data sheet is consistent with the chemical safety

report for the preparation instead of with the chemical safety

report for each substance in the preparation.

3. The supplier shall provide the recipient at his request with

a safety data sheet compiled in accordance with Annex II, where

a preparation does not meet the criteria for classification as

dangerous in accordance with Articles 5, 6 and 7 of Direc-

tive 1999/45/EC, but contains:

(a) in an individual concentration of ≥ 1 % by weight for non-

gaseous preparations and ≥ 0,2 % by volume for gaseous

preparations at least one substance posing human health or

environmental hazards; or

(b) in an individual concentration of ≥ 0,1 % by weight for

non-gaseous preparations at least one substance that is

persistent, bioaccumulative and toxic or very persistent and

very bioaccumulative in accordance with the criteria set out

in Annex XIII or has been included for reasons other than

those referred to in point (a) in the list established in accord-

ance with Article 59(1); or

exposure limits.

4. The safety data sheet need not be supplied where

dangerous substances or preparations offered or sold to the

general public are provided with sufficient information to enable

users to take the necessary measures as regards the protection of

human health, safety and the environment, unless requested by

a downstream user or distributor.

5. The safety data sheet shall be supplied in an official

language of the Member State(s) where the substance or

preparation is placed on the market, unless the Member State(s)

concerned provide otherwise.

6. The safety data sheet shall be dated and shall contain the

following headings:

1. identification of the substance/preparation and of the

company/undertaking;

2. hazards identification;

3. composition/information on ingredients;

4. first-aid measures;

5. fire-fighting measures;

6. accidental release measures;

7. handling and storage;

8. exposure controls/personal protection;

9. physical and chemical properties;

10. stability and reactivity ;

11. toxicological information;

12. ecological information;

13. disposal considerations;

14. transpor t information;

15. regulatory information;

16. other information.

7. Any actor in the supply chain who is required to prepare a

chemical safety report according to Articles 14 or 37 shall place

the relevant exposure scenarios (including use and exposure

categories where appropriate) in an annex to the safety data

sheet covering identified uses and including specific conditions

resulting from the application of Section 3 of Annex XI.

Any downstream user shall include relevant exposure scenarios,

and use other relevant information, from the safety data sheet

supplied to him when compiling his own safety data sheet for

identified uses.

29.5.2007 L 136/35Official Journal of the European Union

Any distributor shall pass on relevant exposure scenarios, and

use other relevant information, from the safety data sheet

supplied to him when compiling his own safety data sheet for

uses for which he has passed on information according to

Article 37(2).

8. A safety data sheet shall be provided free of charge on

paper or electronically.

9. Suppliers shall update the safety data sheet without delay

on the following occasions:

(a) as soon as new information which may affect the risk

management measures, or new information on hazards

becomes available;

(b) once an authorisation has been granted or refused;

The new, dated version of the information, identified as ‘Revi-

sion: (date)’, shall be provided free of charge on paper or electro-

nically to all former recipients to whom they have supplied the

substance or preparation within the preceding 12 months. Any

updates following registration shall include the registration

number.

Article 32

Duty to communicate information down the supply chain

for substances on their own or in preparations for which a

safety data sheet is not required

1. Any supplier of a substance on its own or in a preparation

who does not have to supply a safety data sheet in accordance

with Article 31 shall provide the recipient with the following

information:

(a) the registration number(s) refer red to in Article 20(3), if

available, for any substances for which information is

communicated under points (b), (c) or (d) of this paragraph;

(b) if the substance is subject to authorisation and details of any

authorisation granted or denied under Title VII in this

supply chain;

(d) any other available and relevant information about the

substance that is necessary to enable appropriate risk

management measures to be identified and applied including

specific conditions resulting from the application of

Section 3 of Annex XI.

2. The information referred to in paragraph 1 shall be

communicated free of charge on paper or electronically at the

latest at the time of the first delivery of a substance on its own

or in a preparation after 1 June 2007.

3. Suppliers shall update this information without delay on

the following occasions:

(a) as soon as new information which may affect the risk

management measures, or new information on hazards

becomes available;

(b) once an authorisation has been granted or refused;

In addition, the updated information shall be provided free of

charge on paper or electronically to all former recipients to

whom they have supplied the substance or preparation within

the preceding 12 months. Any updates following registration

shall include the registration number.

Article 33

Duty to communicate information on substances in articles

1. Any supplier of an article containing a substance meeting

the criteria in Article 57 and identified in accordance with

Article 59(1) in a concentration above 0,1 % weight by weight

(w/w) shall provide the recipient of the article with sufficient

information, available to the supplier, to allow safe use of the

article including, as a minimum, the name of that substance.

2. On request by a consumer any supplier of an article

containing a substance meeting the criteria in Article 57 and

identified in accordance with Article 59(1) in a concentration

above 0,1 % weight by weight (w/w) shall provide the consumer

with sufficient information, available to the supplier, to allow

safe use of the article including, as a minimum, the name of

that substance.

The relevant information shall be provided, free of charge,

within 45 days of receipt of the request.

Article 34

Duty to communicate information on substances and

preparations up the supply chain

Any actor in the supply chain of a substance or a preparation

shall communicate the following information to the next actor

or distributor up the supply chain:

(a) new information on hazardous properties, regardless of the

uses concerned;

29.5.2007L 136/36 Official Journal of the European Union

(b) any other information that might call into question the

appropriateness of the risk management measures identified

in a safety data sheet supplied to him, which shall be

communicated only for identified uses.

Distributors shall pass on that information to the next actor or

distributor up the supply chain.

Article 35

Access to information for workers

Workers and their representatives shall be granted access by

their employer to the information provided in accordance with

Articles 31 and 32 in relation to substances or preparations

that they use or may be exposed to in the course of their work.

Article 36

Obligation to keep information

1. Each manufacturer, importer, downstream user and distri-

butor shall assemble and keep available all the information he

requires to carry out his duties under this Regulation for a

period of at least 10 years after he last manufactured, imported,

supplied or used the substance or preparation. That manufac-

turer, importer, downstream user or distributor shall submit this

information or make it available without delay upon request to

any competent authority of the Member State in which he is

established or to the Agency, without prejudice to Titles II

and VI.

2. In the event of a registrant, downstream user or distributor

ceasing activity, or transferring part or all of his operations to a

third party, the party responsible for liquidating the registrant,

downstream user or distributor's undertaking or assuming

responsibility for the placing on the market of the substance or

preparation concerned shall be bound by the obligation in para-

graph 1 in place of the registrant, downstream user or distri-

butor.

TITLE V

DOWNSTREAM USERS

Article 37

Downstream user chemical safety assessments and duty to

identify, apply and recommend risk reduction measures

1. A downstream user or distributor may provide informa-

tion to assist in the preparation of a registration.

2. Any downstream user shall have the right to make a use,

as a minimum the brief general description of use, known in

writing (on paper or electronically) to the manufacturer,

importer, downstream user or distributor who supplies him

with a substance on its own or in a preparation with the aim of

making this an identified use. In making a use known, he shall

provide sufficient information to allow the manufacturer,

importer or downstream user who has supplied the substance,

to prepare an exposure scenario, or if appropriate a use and

exposure category, for his use in the manufacturer, importer or

downstream user's chemical safety assessment.

Distributors shall pass on such information to the next actor or

distributor up the supply chain. Downstream users in receipt of

such information may prepare an exposure scenario for the

identified use(s), or pass the information to the next actor up

the supply chain.

3. For registered substances, the manufacturer, importer or

downstream user shall comply with the obligations laid down in

Article 14 either before he next supplies the substance on its

own or in a preparation to the downstream user making the

request referred to in paragraph 2 of this Article, provided that

the request was made at least one month before the supply, or

within one month after the request, whichever is the later.

For phase-in substances, the manufacturer, importer or down-

stream user shall comply with this request and with the obliga-

tions laid down in Article 14 before the relevant deadline in

Article 23 has expired, provided that the downstream user

makes his request at least 12 months before the deadline in

question.

Where the manufacturer, importer or downstream user, having

assessed the use in accordance with Article 14, is unable to

include it as an identified use for reasons of protection of

human health or the environment, he shall provide the Agency

and the downstream user with the reason(s) for that decision in

writing without delay and shall not supply downstream user(s)

with the substance without including these reason(s) in the

information referred to under Articles 31 or 32. The manufac-

turer or importer shall include this use in Section 3.7 of

Annex VI in his update of the registration in accordance with

Article 22(1)(d).

4. A downstream user of a substance on its own or in a

preparation shall prepare a chemical safety report in accordance

with Annex XII for any use outside the conditions described in

an exposure scenar io or if appropriate a use and exposure cate-

gory communicated to him in a safety data sheet or for any use

his supplier advises against.

A downstream user need not prepare such a chemical safety

repor t in any of the following cases:

(a) a safety data sheet is not required to be communicated with

the substance or preparation in accordance with Article 31;

(b) a chemical safety report is not required to be completed by

his supplier in accordance with Article 14;

29.5.2007 L 136/37Official Journal of the European Union

total quantity of less than one tonne per year;

(d) the downstream user implements or recommends an expo-

sure scenario which includes as a minimum the conditions

described in the exposure scenario communicated to him in

the safety data sheet;

(e) the substance is present in a preparation in a concentration

lower than any of the concentrations set out in Article 14

(2);

(f) the downstream user is using the substance for the purposes

of product and process oriented research and development,

provided that the risks to human health and the environ-

ment are adequately controlled in accordance with the

requirements of legislation for the protection of workers

and the environment.

5. Any downstream user shall identify, apply and where

suitable, recommend, appropriate measures to adequately

control r isks identified in any of the following:

(a) the safety data sheet(s) supplied to him;

(b) his own chemical safety assessment;

him in accordance with Article 32.

6. Where a downstream user does not prepare a chemical

safety report in accordance with paragraph 4(c), he shall

consider the use(s) of the substance and identify and apply any

appropriate risk management measures needed to ensure that

the risks to human health and the environment are adequately

controlled. Where necessary, this information shall be included

in any safety data sheet prepared by him.

7. Downstream users shall keep their chemical safety report

up to date and available.

8. A chemical safety report prepared in accordance with

paragraph 4 of this Article need not include consideration of

the r isks to human health from the end uses set out in

Article 14(5).

Article 38

Obligation for downstream users to report information

1. Before commencing or continuing with a particular use of

a substance that has been registered by an actor up the supply

chain in accordance with Articles 6 or 18, the downstream user

shall report to the Agency the information specified in para-

graph 2 of this Article, in the following cases:

(a) the downstream user has to prepare a chemical safety report

in accordance with Article 37(4); or

(b) the downstream user is relying on the exemptions in

Article 37(4)(c) or (f).

2. The information reported by the downstream user shall

include the following:

(a) his identity and contact details as specified in Section 1.1 of

Annex VI;

(b) the registration number(s) referred to in Article 20(3), if

available;

2.3.4 of Annex VI;

(d) the identity of the manufacturer(s) or the importer(s) or

other supplier as specified in Section 1.1 of Annex VI;

(e) a br ief general description of the use(s), as specified in

Section 3.5 of Annex VI, and of the conditions of use(s);

(f) except where the downstream user is relying on the exemp-

tion in Article 37(4)(c), a proposal for additional testing on

vertebrate animals, where this is considered necessary by the

downstream user to complete his chemical safety assess-

ment.

3. The downstream user shall update this information

without delay in the event of a change in the information

repor ted in accordance with paragraph 1.

4. A downstream user shall report to the Agency if his classi-

fication of a substance is different to that of his supplier.

5. Except where a downstream user is relying on the exemp-

tion in Article 37(4)(c), reporting in accordance with para-

graphs 1 to 4 of this Article shall not be required in respect of a

substance, on its own or in a preparation, used by the down-

stream user in quantities of less than one tonne per year for

that particular use.

Article 39

Application of downstream user obligations

1. Downstream users shall be required to comply with the

requirements of Article 37 at the latest 12 months after

receiving a registration number communicated to them by their

suppliers in a safety data sheet.

2. Downstream users shall be required to comply with the

requirements of Article 38 at the latest six months after

receiving a registration number communicated to them by their

suppliers in a safety data sheet.

29.5.2007L 136/38 Official Journal of the European Union

TITLE VI

EVALUATION

CHAPTER 1

Dossier evaluation

Article 40

Examination of testing proposals

1. The Agency shall examine any testing proposal set out in

a registration or a downstream user report for provision of the

information specified in Annexes IX and X for a substance.

Priority shall be given to registrations of substances which have

or may have PBT, vPvB, sensitising and/or carcinogenic, muta-

genic or toxic for reproduction (CMR) properties, or substances

classified as dangerous according to Directive 67/548/EEC above

100 tonnes per year with uses resulting in widespread and

diffuse exposure.

2. Information relating to testing proposals involving tests

on vertebrate animals shall be published on the Agency website.

The Agency shall publish on its website the name of the

substance, the hazard end-point for which vertebrate testing is

proposed, and the date by which any third party information is

required. It shall invite third parties to submit, using the format

provided by the Agency, scientifically valid information and

studies that address the relevant substance and hazard end-

point, addressed by the testing proposal, within 45 days of the

date of publication. All such scientifically valid information and

studies received shall be taken into account by the Agency in

preparing its decision in accordance with paragraph 3.

3. On the basis of the examination under paragraph 1, the

Agency shall draft one of the following decisions and that deci-

sion shall be taken in accordance with the procedure laid down

in Articles 50 and 51:

(a) a decision requiring the registrant(s) or downstream user(s)

concerned to carry out the proposed test and setting a dead-

line for submission of the study summary, or the robust

study summary if required by Annex I;

(b) a decision in accordance with point (a), but modifying the

conditions under which the test is to be carried out;

requiring registrant(s) or downstream user(s) to carry out

one or more additional tests in cases of non-compliance of

the testing proposal with Annexes IX, X and XI;

(d) a decision rejecting the testing proposal;

(e) a decision in accordance with points (a), (b) or (c), if several

registrants or downstream users of the same substance have

submitted proposals for the same test, giving them the

opportunity to reach an agreement on who will perform the

test on behalf of all of them and to inform the Agency

accordingly within 90 days. If the Agency is not informed

of such agreement within such 90 days, it shall designate

one of the registrants or downstream users, as appropriate,

to perform the test on behalf of all of them.

4. The registrant or downstream user shall submit the infor-

mation required to the Agency by the deadline set.

Article 41

Compliance check of registrations

1. The Agency may examine any registration in order to

verify any of the following:

(a) that the information in the technical dossier(s) submitted

pursuant to Article 10 complies with the requirements of

Articles 10, 12 and 13 and with Annexes III and VI to X;

(b) that the adaptations of the standard information require-

ments and the related justifications submitted in the tech-

nical dossier(s) comply with the rules governing such adap-

tations set out in Annexes VII to X and with the general

rules set out in Annex XI;

safety report comply with the requirements of Annex I and

that the proposed risk management measures are adequate;

(d) that any explanation(s) submitted in accordance with

Article 11(3) or Article 19(2) have an objective basis.

2. The list of dossiers being checked for compliance by the

Agency shall be made available to Member States competent

authorities.

3. On the basis of an examination made pursuant to para-

graph 1, the Agency may, within 12 months of the start of the

compliance check, prepare a draft decision requiring the regis-

trant(s) to submit any information needed to bring the registra-

tion(s) into compliance with the relevant information require-

ments and specifying adequate time limits for the submission of

further information. Such a decision shall be taken in accord-

ance with the procedure laid down in Articles 50 and 51.

4. The registrant shall submit the information required to the

Agency by the deadline set.

29.5.2007 L 136/39Official Journal of the European Union

5. To ensure that registration dossiers comply with this Regu-

lation, the Agency shall select a percentage of those dossiers, no

lower than 5 % of the total received by the Agency for each

tonnage band, for compliance checking. The Agency shall give

priority, but not exclusively, to dossiers meeting at least one of

the following criteria:

(a) the dossier contains information in Article 10(a)(iv), (vi)

and/or (vii) submitted separately as per Article 11(3); or

(b) the dossier is for a substance manufactured or imported in

quantities of one tonne or more per year and does not meet

the requirements of Annex VII applying under either

Article 12(1)(a) or (b), as the case may be; or

rolling action plan referred to in Article 44(2).

6. Any third party may electronically submit information to

the Agency relating to substances that appear on the list referred

to in Article 28(4). The Agency shall consider this information

together with the information submitted according to

Article 124 when checking and selecting dossiers.

7. The Commission may, after consulting with the Agency,

take a decision to vary the percentage of dossiers selected and

amend or include further criteria in paragraph 5 in accordance

with the procedure referred to in Article 133(4).

Article 42

Check of information submitted and follow-up to dossier

evaluation

1. The Agency shall examine any information submitted in

consequence of a decision taken under Articles 40 or 41, and

draft any appropriate decisions in accordance with these Arti-

cles, if necessary.

2. Once the dossier evaluation is completed, the Agency shall

notify the Commission and the competent authorities of the

Member States of the information obtained and any conclusions

made. The competent authorities shall use the information

obtained from this evaluation for the purposes of Article 45(5),

Article 59(3) and Article 69(4). The Agency shall use the infor-

mation obtained from this evaluation for the purposes of

Article 44.

Article 43

Procedure and time per iods for examination of tes ting

proposals

1. In the case of non phase-in substances, the Agency shall

prepare a draft decision in accordance with Article 40(3) within

180 days of receiving a registration or downstream user report

containing a testing proposal.

2. In the case of phase-in substances, the Agency shall

prepare the draft decisions in accordance with Article 40(3):

(a) by 1 December 2012 for all registrations received by

1 December 2010 containing proposals for testing in order

to fulfil the information requirements in Annexes IX and X;

(b) by 1 June 2016 for all registrations received by 1 June 2013

containing proposals for testing in order to fulfil the infor-

mation requirements in Annex IX only;

proposals received by 1 June 2018.

3. The list of registration dossiers being evaluated under

Article 40 shall be made available to Member States.

CHAPTER 2

Substance evaluation

Article 44

Criteria for substance evaluation

1. In order to ensure a harmonised approach, the Agency

shall in cooperation with the Member States develop criteria for

prioritising substances with a view to further evaluation. Priori-

tisation shall be on a risk-based approach. The criteria shall

consider:

(a) hazard information, for instance str uctural similarity of the

substance with known substances of concern or with

substances which are persistent and liable to bio-accumulate,

suggesting that the substance or one or more of its transfor-

mation products has properties of concern or is persistent

and liable to bio-accumulate;

(b) exposure information;

submitted by several registrants.

29.5.2007L 136/40 Official Journal of the European Union

2. The Agency shall use the criteria in paragraph 1 for the

purpose of compiling a draft Community rolling action plan

which shall cover a period of three years and shall specify

substances to be evaluated each year. Substances shall be

included if there are grounds for considering (either on the basis

of a dossier evaluation carried out by the Agency or on the

basis of any other appropriate source, including information in

the registration dossier) that a given substance constitutes a risk

to human health or the environment. The Agency shall submit

the first draft rolling action plan to the Member States by

1 December 2011. The Agency shall submit draft annual

updates to the rolling action plan to the Member States by 28

February each year.

The Agency shall adopt the final Community rolling action plan

on the basis of an opinion from the Member State Committee

set up under Article 76(1)(e) (hereinafter referred to as the

Member State Committee) and shall publish the plan on its

website, identifying the Member State who will carry out the

evaluation of the substances listed therein as determined

according to Article 45.

Article 45

Competent authority

1. The Agency shall be responsible for coordinating the

substance evaluation process and ensuring that substances on

the Community rolling action plan are evaluated. In doing so,

the Agency shall rely on the competent authorities of Member

States. In carrying out an evaluation of a substance, the compe-

tent authorities may appoint another body to act on their

behalf.

2. A Member State may choose (a) substance(s) from the

draft Community rolling action plan, with the aim of becoming

a competent authority for the purposes of Articles 46, 47 and

48. In the event of a substance from the draft Community

rolling action plan not being chosen by any Member State, the

Agency shall ensure that the substance is evaluated.

3. In cases where two or more Member States have expressed

an interest in evaluating the same substance and they cannot

agree who should be the competent authority, the competent

authority for the purposes of Articles 46, 47 and 48 shall be

determined in accordance with the following procedure.

The Agency shall refer the matter to the Member State

Committee, in order to agree which authority shall be the

competent authority, taking into account the Member State in

which the manufacturer(s) or importer(s) is located, the respec-

tive proportions of total Community gross domestic product,

the number of substances already being evaluated by a Member

State and the expertise available.

If, within 60 days of the refer ral, the Member State Committee

reaches unanimous agreement, the Member States concerned

shall adopt substances for evaluation accordingly.

If the Member State Committee fails to reach a unanimous

agreement, the Agency shall submit the conflicting opinions to

the Commission, which shall decide which authority shall be

the competent authority, in accordance with the procedure

referred to in Article 133(3), and the Member States concerned

shall adopt substances for evaluation accordingly.

4. The competent authority identified in accordance with

paragraphs 2 and 3 shall evaluate the allocated substances in

accordance with this Chapter.

5. A Member State may notify the Agency at any time of a

substance not on the Community rolling action plan, whenever

it is in possession of information which suggests that the

substance is a priority for evaluation. The Agency shall decide

whether to add this substance to the Community rolling action

plan on the basis of an opinion from the Member State

Committee. If the substance is added to the Community rolling

action plan, the proposing Member State, or another Member

State who agrees, shall evaluate that substance.

Article 46

Requests for further information and check of information

submitted

1. If the competent authority considers that further informa-

tion is required, including, if appropriate, information not

required in Annexes VII to X, it shall prepare a draft decision,

stating reasons, requiring the registrant(s) to submit the further

information and setting a deadline for its submission. A draft

decision shall be prepared within 12 months of the publication

of the Community rolling action plan on the Agency's website

for substances to be evaluated that year. The decision shall be

taken in accordance with the procedure laid down in Articles 50

and 52.

2. The registrant shall submit the information required to the

Agency by the deadline set.

3. The competent authority shall examine any information

submitted, and shall draft any appropriate decisions in accord-

ance with this Article, if necessary, within 12 months of the

information being submitted.

4. The competent authority shall finish its evaluation activ-

ities within 12 months of the start of the evaluation of the

substance or within 12 months of the information being

submitted under paragraph 2, and notify the Agency accord-

ingly. If this deadline is exceeded, the evaluation shall be

deemed to be finished.

29.5.2007 L 136/41Official Journal of the European Union

Article 47

Coherence with other activities

1. An evaluation of a substance shall be based on all relevant

information submitted on that particular substance and on any

previous evaluation under this Title. Where information on

intrinsic proper ties of a substance has been generated by refer-

ence to structurally related substance(s), the evaluation may also

cover these related substances. In cases where a decision on an

evaluation has been previously taken in accordance with

Article 51 or Article 52, any draft decision requiring further

information under Article 46 may be justified only by a change

of circumstances or acquired knowledge.

2. In order to ensure a harmonised approach to requests for

further information, the Agency shall monitor draft decisions

under Article 46 and shall develop criteria and priorities. Where

appropriate, implementing measures shall be adopted in accord-

ance with the procedure referred to in Article 133(3).

Article 48

Follow-up to substance evaluation

Once the substance evaluation has been completed, the compe-

tent authority shall consider how to use the information

obtained from this evaluation for the purposes of Article 59(3),

Article 69(4) and Article 115(1). The competent authority shall

inform the Agency of its conclusions as to whether or how to

use the information obtained. The Agency shall in turn inform

the Commission, the registrant and the competent authorities of

the other Member States.

CHAPTER 3

Evaluation of intermediates

Article 49

Further information on on-site isolated intermediates

For on-site isolated intermediates that are used in strictly

controlled conditions, neither dossier nor substance evaluation

shall apply. However, where the competent authority of the

Member State in whose territory the site is located considers

that a risk to human health or the environment, equivalent to

the level of concern arising from the use of substances meeting

the criteria in Article 57, arises from the use of an on-site

isolated intermediate and that risk is not properly controlled, it

may:

(a) require the registrant to submit further information directly

related to the risk identified. This request shall be accompa-

nied by a written justification;

(b) examine any information submitted and, if necessary,

recommend any appropriate risk reduction measures to

address the risks identified in relation to the site in question.

The procedure provided for in the first paragraph may be under-

taken only by the competent authority refer red to therein. The

competent authority shall inform the Agency of the results of

such an evaluation, which shall then inform the competent

authorities of the other Member States and make the results

available to them.

CHAPTER 4

Common provisions

Article 50

Registrants' and downstream users' rights

1. The Agency shall notify any draft decision under Arti-

cles 40, 41 or 46 to the registrant(s) or downstream user(s)

concerned, informing them of their right to comment within

30 days of receipt. If the concerned registrant(s) or downstream

user(s) wish to comment, they shall provide their comments to

the Agency. The Agency in turn shall inform the competent

authority of the submission of the comments without delay.

The competent authority (for decisions taken under Article 46)

and the Agency (for decisions taken under Articles 40 and 41)

shall take any comments received into account and may amend

the draft decision accordingly.

2. If a registrant has ceased the manufacture or import of the

substance, or the production or import of an article, or the

downstream user the use, he shall inform the Agency of this

fact with the consequence that the registered volume in his

registration, if appropriate, shall be put to zero and no further

information may be requested with respect to that substance,

unless the registrant notifies the restart of the manufacture or

import of the substance or the production or import of the

article, or the downstream user notifies the restart of the use.

The Agency shall inform the competent authority of the

Member State in which the registrant or downstream user is

located.

3. The registrant may cease the manufacture or import of the

substance or the production or import of the article, or the

downstream user the use, upon receipt of the draft decision. In

such cases, the registrant, or downstream user, shall inform the

Agency of this fact with the consequence that his registration,

or report, shall no longer be valid, and no further information

may be requested with respect to that substance, unless he

submits a new registration or report. The Agency shall inform

the competent authority of the Member State in which the regis-

trant or downstream user is located.

29.5.2007L 136/42 Official Journal of the European Union

4. Notwithstanding paragraphs 2 and 3, further information

may be required in accordance with Article 46 in either or both

of the following cases:

(a) where the competent authority prepares a dossier in accord-

ance with Annex XV concluding that there is a potential

long-term risk to human health or the environment justi-

fying the need for further information;

(b) where the exposure to the substance manufactured or

imported by the registrant(s), or to the substance in the

article produced or imported by the registrant(s), or to the

substance used by the downstream user(s) contributes signif-

icantly to that r isk.

The procedure in Articles 69 to 73 shall apply mutatis mutandis.

Article 51

Adoption of decisions under dossier evaluation

1. The Agency shall notify its draft decision in accordance

with Articles 40 or 41, together with the comments of the

registrant, to the competent authorities of the Member States.

2. Within 30 days of circulation, the Member States may

propose amendments to the draft decision to the Agency.

3. If the Agency does not receive any proposals, it shall take

the decision in the version notified under paragraph 1.

4. If the Agency receives a proposal for amendment, it may

modify the draft decision. The Agency shall refer a draft deci-

sion, together with any amendments proposed, to the Member

State Committee within 15 days of the end of the 30-day

period referred to in paragraph 2.

5. The Agency shall forthwith communicate any proposal for

amendment to any registrants or downstream users concerned

and allow them to comment within 30 days. The Member State

Committee shall take any comments received into account.

6. If, within 60 days of the referral, the Member State

Committee reaches a unanimous agreement on the draft deci-

sion, the Agency shall take the decision accordingly.

7. If the Member State Committee fails to reach unanimous

agreement, the Commission shall prepare a draft decision to be

taken in accordance with the procedure referred to in

Article 133(3).

8. An appeal may be brought, in accordance with Articles 91,

92 and 93, against Agency decisions under paragraphs 3 and 6

of this Article.

Article 52

Adoption of decisions under substance evaluation

1. The competent authority shall circulate its draft decision

in accordance with Article 46, together with any comments by

the registrant or downstream user, to the Agency and to the

competent authorities of the other Member States.

2. The provisions of Article 51(2) to (8) shall apply mutatis

mutandis.

Article 53

Cost sharing for tests without an agreement between regis-

trants and/or downstream users

1. Where registrants or downstream users are required to

perform a test as a result of a decision taken under this Title,

those registrants or downstream users shall make every effort to

reach an agreement as to who is to carry it out on behalf of the

other registrants or downstream users and to inform the

Agency accordingly within 90 days. If the Agency is not

informed of such agreement within such 90 days, it shall desig-

nate one of the registrants or downstream users to perform the

test on behalf of all of them.

2. If a registrant or downstream user performs a test on

behalf of others, they shall all share the cost of that study

equally.

3. In the case referred to in paragraph 1, the registrant or

downstream user who performs the test shall provide each of

the others concerned with a copy of the full study report.

4. The person performing and submitting the study shall

have a claim against the others accordingly. Any person

concerned shall be able to make a claim in order to prohibit

another person from manufacturing, importing or placing the

substance on the market if that other person either fails to pay

his share of the cost or to provide security for that amount or

fails to hand over a copy of the full study report of the study

performed. All claims shall be enforceable in the national

courts. Any person may choose to submit their claims for remu-

neration to an arbitration board and accept the arbitration

order.

Article 54

Publication of information on evaluation

By 28 February of each year, the Agency shall publish on its

website a report on the progress made over the previous

calendar year towards discharging the obligations incumbent

upon it in relation to evaluation. This report shall include, in

par ticular, recommendations to potential registrants in order to

improve the quality of future registrations.

29.5.2007 L 136/43Official Journal of the European Union

TITLE VII

AUTHORISATION

CHAPTER 1

Authorisation requirement

Article 55

Aim of authorisation and considerations for substitution

The aim of this Title is to ensure the good functioning of the

internal market while assuring that the risks from substances of

very high concern are properly controlled and that these

substances are progressively replaced by suitable alternative

substances or technologies where these are economically and

technically viable. To this end all manufacturers, importers and

downstream users applying for authorisations shall analyse the

availability of alternatives and consider their risks, and the tech-

nical and economic feasibility of substitution.

Article 56

General provisions

1. A manufacturer, importer or downstream user shall not

place a substance on the market for a use or use it himself if

that substance is included in Annex XIV, unless:

(a) the use(s) of that substance on its own or in a preparation

or the incorporation of the substance into an article for

which the substance is placed on the market or for which

he uses the substance himself has been authorised in accord-

ance with Articles 60 to 64; or

(b) the use(s) of that substance on its own or in a preparation

or the incorporation of the substance into an article for

which the substance is placed on the market or for which

he uses the substance himself has been exempted from the

authorisation requirement in Annex XIV itself in accordance

with Article 58(2); or

reached; or

(d) the date referred to in Article 58(1)(c)(i) has been reached

and he made an application 18 months before that date but

a decision on the application for authorisation has not yet

been taken; or

(e) in cases where the substance is placed on the market,

authorisation for that use has been granted to his immediate

downstream user.

2. A downstream user may use a substance meeting the

criteria set out in paragraph 1 provided that the use is in accord-

ance with the conditions of an authorisation granted to an actor

up his supply chain for that use.

3. Paragraphs 1 and 2 shall not apply to the use of

substances in scientific research and development. Annex XIV

shall specify if paragraphs 1 and 2 apply to product and process

orientated research and development as well as the maximum

quantity exempted.

4. Paragraphs 1 and 2 shall not apply to the following uses

of substances:

(a) uses in plant protection products within the scope of Direc-

tive 91/414/EEC;

(b) uses in biocidal products within the scope of Directive 98/8/

EC;

European Parliament and of the Council of 13 October

1998 relating to the quality of petrol and diesel fuels (

);

(d) uses as fuel in mobile or fixed combustion plants of mineral

oil products and use as fuels in closed systems.

5. In the case of substances that are subject to authorisation

only because they meet the criteria in Article 57(a), (b) or (c) or

because they are identified in accordance with Article 57(f) only

because of hazards to human health, paragraphs 1 and 2 of this

Article shall not apply to the following uses:

(a) uses in cosmetic products within the scope of Directive 76/

768/EEC;

(b) uses in food contact materials within the scope of Regu-

lation (EC) No 1935/2004.

6. Paragraphs 1 and 2 shall not apply to the use of

substances when they are present in preparations:

(a) for substances referred to in Article 57(d), (e) and (f), below

a concentration limit of 0,1 % weight by weight (w/w);

(b) for all other substances, below the lowest of the concentra-

tion limits specified in Directive 1999/45/EC or in Annex I

to Directive 67/548/EEC which result in the classification of

the preparation as dangerous.

29.5.2007L 136/44 Official Journal of the European Union

(

) OJ L 350, 28.12.1998, p. 58. Directive as amended by Regulation (EC)

No 1882/2003.

Article 57

Substances to be included in Annex XIV

The following substances may be included in Annex XIV in

accordance with the procedure laid down in Article 58:

(a) substances meeting the criteria for classification as carcino-

genic category 1 or 2 in accordance with Directive 67/548/

EEC;

(b) substances meeting the criteria for classification as muta-

genic category 1 or 2 in accordance with Directive 67/548/

EEC;

reproduction category 1 or 2 in accordance with Direc-

tive 67/548/EEC;

(d) substances which are persistent, bioaccumulative and toxic

in accordance with the criteria set out in Annex XIII of this

Regulation;

(e) substances which are very persistent and very bioaccumula-

tive in accordance with the cr iteria set out in Annex XIII of

this Regulation;

(f) substances — such as those having endocr ine disrupting

properties or those having persistent, bioaccumulative and

toxic properties or very persistent and very bioaccumulative

properties, which do not fulfil the criteria of points (d) or

(e) — for which there is scientific evidence of probable

serious effects to human health or the environment which

give rise to an equivalent level of concern to those of other

substances listed in points (a) to (e) and which are identified

on a case-by-case basis in accordance with the procedure set

out in Article 59.

Article 58

Inclusion of substances in Annex XIV

1. Whenever a decision is taken to include in Annex XIV

substances referred to in Article 57, such a decision shall be

taken in accordance with the procedure referred to in

Article 133(4). It shall specify for each substance:

(a) the identity of the substance as specified in Section 2 of

Annex VI;

(b) the intrinsic property (properties) of the substance referred

to in Article 57;

(i) the date(s) from which the placing on the market and

the use of the substance shall be prohibited unless an

authorisation is granted (hereinafter referred to as the

sunset date) which should take into account, where

appropriate, the production cycle specified for that use;

(ii) a date or dates at least 18 months before the sunset date

(s) by which applications must be received if the appli-

cant wishes to continue to use the substance or place it

on the market for certain uses after the sunset date(s);

these continued uses shall be allowed after the sunset

date until a decision on the application for authorisation

is taken;

(d) review periods for certain uses, if appropriate;

(e) uses or categories of uses exempted from the authorisation

requirement, if any, and conditions for such exemptions, if

any.

2. Uses or categories of uses may be exempted from the

authorisation requirement provided that, on the basis of the

existing specific Community legislation imposing minimum

requirements relating to the protection of human health or the

environment for the use of the substance, the risk is properly

controlled. In the establishment of such exemptions, account

shall be taken, in particular, of the proportionality of risk to

human health and the environment related to the nature of the

substance, such as where the risk is modified by the physical

form.

3. Prior to a decision to include substances in Annex XIV,

the Agency shall, taking into account the opinion of the

Member State Committee, recommend priority substances to be

included specifying for each substance the items set out in para-

graph 1. Priority shall normally be given to substances with:

(a) PBT or vPvB properties; or

(b) wide dispersive use; or

The number of substances included in Annex XIV and the dates

specified under paragraph 1 shall also take account of the Agen-

cy's capacity to handle applications in the time provided for.

The Agency shall make its first recommendation of priority

substances to be included in Annex XIV by 1 June 2009. The

Agency shall make further recommendations at least every

second year with a view to including further substances in

Annex XIV.

4. Before the Agency sends its recommendation to the

Commission it shall make it publicly available on its website,

clearly indicating the date of publication, taking into account

Articles 118 and 119 on access to information. The Agency

shall invite all interested parties to submit comments within

three months of the date of publication, in particular on uses

which should be exempt from the authorisation requirement.

The Agency shall update its recommendation, taking into

account the comments received.

29.5.2007 L 136/45Official Journal of the European Union

5. Subject to paragraph 6, after inclusion of a substance in

Annex XIV, this substance shall not be subjected to new restric-

tions under the procedure outlined in Title VIII covering the

risks to human health or the environment from the use of the

substance on its own, in a preparation or incorporation of a

substance in an article arising from the intrinsic properties

specified in Annex XIV.

6. A substance listed in Annex XIV may be subjected to new

restrictions under the procedure outlined in Title VIII covering

the risks to human health or the environment from the

presence of the substance in (an) article(s).

7. Substances for which all uses have been prohibited under

Title VIII or by other Community legislation shall not be

included in Annex XIV or shall be removed from it.

8. Substances which as a result of new information no

longer meet the criteria of Article 57 shall be removed from

Annex XIV in accordance with the procedure referred to in

Article 133(4).

Article 59

Identification of substances referred to in Article 57

1. The procedure set out in paragraphs 2 to 10 of this

Article shall apply for the purpose of identifying substances

meeting the criteria referred to in Article 57 and establishing a

candidate list for eventual inclusion in Annex XIV. The Agency

shall indicate, within this list, the substances that are on its

work programme according to Article 83(3)(e).

2. The Commission may ask the Agency to prepare a dossier

in accordance with relevant Sections of Annex XV for

substances which in its opinion meet the criteria set out in

Article 57. The dossier may be limited, if appropr iate, to a refer-

ence to an entry in Annex I of Directive 67/548/EEC. The

Agency shall make this dossier available to the Member States.

3. Any Member State may prepare a dossier in accordance

with Annex XV for substances which in its opinion meet the

criteria set out in Article 57 and forward it to the Agency. The

dossier may be limited, if appropriate, to a reference to an entry

in Annex I of Directive 67/548/EEC. The Agency shall make

this dossier available within 30 days of receipt to the other

Member States.

4. The Agency shall publish on its website a notice that an

Annex XV dossier has been prepared for a substance. The

Agency shall invite all interested parties to submit comments

within a specified deadline to the Agency.

5. Within 60 days of circulation, the other Member States or

the Agency may comment on the identification of the substance

in relation to the criteria in Article 57 in the dossier to the

Agency.

6. If the Agency does not receive or make any comments, it

shall include this substance on the list referred to in paragraph 1.

The Agency may include this substance in its recommendations

under Article 58(3).

7. When comments are made or received, the Agency shall

refer the dossier to the Member State Committee within 15 days

of the end of the 60-day period referred to in paragraph 5.

8. If, within 30 days of the referral, the Member State

Committee reaches a unanimous agreement on the identifica-

tion, the Agency shall include the substance in the list referred

to in paragraph 1. The Agency may include that substance in its

recommendations under Article 58(3).

9. If the Member State Committee fails to reach a unanimous

agreement, the Commission shall prepare a draft proposal on

the identification of the substance within three months of

receipt of the opinion of the Member State Committee. A final

decision on the identification of the substance shall be taken in

accordance with the procedure refer red to in Article 133(3).

10. The Agency shall publish and update the list referred to

in paragraph 1 on its website without delay after a decision on

inclusion of a substance has been taken.

CHAPTER 2

Granting of authorisations

Article 60

Granting of authorisations

1. The Commission shall be responsible for taking decisions

on applications for authorisations in accordance with this Title.

2. Without prejudice to paragraph 3, an authorisation shall

be granted if the risk to human health or the environment from

the use of a substance arising from the intrinsic properties

specified in Annex XIV is adequately controlled in accordance

with Section 6.4 of Annex I and as documented in the appli-

cant's chemical safety report, taking into account the opinion of

the Committee for Risk Assessment referred to in Article 64(4)

(a). When granting the authorisation, and in any conditions

imposed therein, the Commission shall take into account all

discharges, emissions and losses, including risks arising from

diffuse or dispersive uses, known at the time of the decision.

29.5.2007L 136/46 Official Journal of the European Union

The Commission shall not consider the risks to human health

arising from the use of a substance in a medical device regulated

by Council Directive 90/385/EEC of 20 June 1990 on the

approximation of the laws of the Member States relating to

active implantable medical devices (

), Council Directive 93/42/

EEC of 14 June 1993 concerning medical devices (

) or Direc-

tive 98/79/EC of the European Parliament and of the Council of

27 October 1998 on in vitro diagnostic medical devices (

3. Paragraph 2 shall not apply to:

(a) substances meeting the criteria in Article 57(a), (b), (c) or (f)

for which it is not possible to determine a threshold in

accordance with Section 6.4 of Annex I;

(b) substances meeting the criteria in Article 57(d) or (e);

bioaccumulative and toxic properties or very persistent and

very bioaccumulative properties.

4. If an authorisation cannot be granted under paragraph 2

or for substances listed in paragraph 3, an authorisation may

only be granted if it is shown that socio-economic benefits

outweigh the risk to human health or the environment arising

from the use of the substance and if there are no suitable alter-

native substances or technologies. This decision shall be taken

after consideration of all of the following elements and taking

into account the opinions of the Committee for Risk Assess-

ment and the Committee for Socio-economic Analysis referred

to in Article 64(4)(a) and (b):

(a) the risk posed by the uses of the substance, including the

appropriateness and effectiveness of the risk management

measures proposed;

(b) the socio-economic benefits arising from its use and the

socio-economic implications of a refusal to authorise as

demonstrated by the applicant or other interested parties;

under Article 62(4)(e) or any substitution plan submitted by

the applicant under Article 62(4)(f), and any third party

contributions submitted under Article 64(2);

(d) available information on the risks to human health or the

environment of any alternative substances or technologies.

5. When assessing whether suitable alternative substances or

technologies are available, all relevant aspects shall be taken into

account by the Commission, including:

(a) whether the transfer to alternatives would result in reduced

overall risks to human health and the environment, taking

into account the appropriateness and effectiveness of risk

management measures;

(b) the technical and economic feasibility of alternatives for the

applicant.

6. A use shall not be authorised if this would constitute a

relaxation of a restriction set out in Annex XVII.

7. An authorisation shall be granted only if the application is

made in conformity with the requirements of Article 62.

8. Authorisations shall be subject to a time-limited review

without prejudice to any decision on a future review period and

shall normally be subject to conditions, including monitoring.

The duration of the time-limited review for any authorisation

shall be determined on a case-by-case basis taking into account

all relevant information including the elements listed in para-

graph 4(a) to (d), as appropriate.

9. The authorisation shall specify:

(a) the person(s) to whom the authorisation is granted;

(b) the identity of the substance(s);

(d) any conditions under which the authorisation is granted;

(e) the time-limited review period;

(f) any monitoring arrangement.

10. Notwithstanding any conditions of an authorisation, the

holder shall ensure that the exposure is reduced to as low a level

as is technically and practically possible.

Article 61

Review of authorisations

1. Authorisations granted in accordance with Ar ticle 60 shall

be regarded as valid until the Commission decides to amend or

withdraw the authorisation in the context of a review, provided

that the holder of the authorisation submits a review report at

least 18 months before the expiry of the time-limited review

period. R ather than re-submitting all elements of the original

application for the current authorisation, the holder of an

authorisation may submit only the number of the current

authorisation, subject to the second, third and fourth sub-

paragraphs.

29.5.2007 L 136/47Official Journal of the European Union

(

) OJ L 189, 20.7.1990, p. 17. Directive as last amended by Regulation

(EC) No 1882/2003.

(

) OJ L 169, 12.7.1993, p. 1. Directive as last amended by Regulation (EC)

No 1882/2003.

(

) OJ L 331, 7.12.1998, p. 1. Directive as last amended by Regulation (EC)

No 1882/2003.

A holder of an authorisation granted in accordance with

Article 60 shall submit an update of the analysis of alternatives

referred to in Article 62(4)(e), including information about any

relevant research and development activities by the applicant, if

appropriate, and any substitution plan submitted under

Article 62(4)(f). If the update of the analysis of alter natives

shows that there is a suitable alternative available taking into

account the elements in Article 60(5), he shall submit a substi-

tution plan, including a timetable for proposed actions by the

applicant. If the holder cannot demonstrate that the risk is

adequately controlled, he shall also submit an update of the

socio-economic analysis contained in the original application.

If he can now demonstrate that the risk is adequately controlled,

he shall submit an update of the chemical safety report.

If any other elements of the original application have changed,

he shall also submit updates of these element(s).

When any updated information is submitted in accordance with

this paragraph, any decision to amend or withdraw the authori-

sation in the context of the review shall be taken in accordance

with the procedure referred to in Article 64 applied mutatis

mutandis.

2. Authorisations may be reviewed at any time if:

(a) the circumstances of the original authorisation have

changed so as to affect the risk to human health or the

environment, or the socio-economic impact; or

(b) new information on possible substitutes becomes available.

The Commission shall set a reasonable deadline by which the

holder(s) of the authorisation may submit further information

necessary for the review and indicate by when it will take a deci-

sion in accordance with Article 64.

3. In its review decision the Commission may, if circum-

stances have changed and taking into account the principle of

proportionality, amend or withdraw the authorisation, if under

the changed circumstances it would not have been granted or if

suitable alternatives in accordance with Article 60(5) become

available. In the latter case the Commission shall require the

holder of the authorisation to present a substitution plan if he

has not already done so as part of his application or update.

In cases where there is a serious and immediate risk for human

health or the environment, the Commission may suspend the

authorisation pending the review, taking into account the prin-

ciple of proportionality.

4. If an environmental quality standard referred to in Direc-

tive 96/61/EC is not met, the authorisations granted for the use

of the substance concerned may be reviewed.

5. If the environmental objectives as referred to in Article 4

(1) of Directive 2000/60/EC are not met, the authorisations

granted for the use of the substance concerned in the relevant

river basin may be reviewed.

6. If a use of a substance is subsequently prohibited or other-

wise restricted in Regulation (EC) No 850/2004 of the European

Parliament and of the Council of 29 April 2004 on persistent

organic pollutants (

), the Commission shall withdraw the

authorisation for that use.

Article 62

Applications for authorisations

1. An application for an authorisation shall be made to the

Agency.

2. Applications for authorisation may be made by the manu-

facturer(s), importer(s) and/or downstream user(s) of the

substance. Applications may be made by one or several persons.

3. Applications may be made for one or several substances,

that meet the definition of a group of substances in Section 1.5

of Annex XI, and for one or several uses. Applications may be

made for the applicant's own use(s) and/or for uses for which

he intends to place the substance on the market.

4. An application for authorisation shall include the

following information:

(a) the identity of the substance(s), as referred to in Section 2 of

Annex VI;

(b) the name and contact details of the person or persons

making the application;

authorisation is sought and covering the use of the

substance in preparations and/or the incorporation of the

substance in articles, where this is relevant;

(d) unless already submitted as part of the registration, a

chemical safety report in accordance with Annex I covering

the risks to human health and/or the environment from the

use of the substance(s) arising from the intrinsic properties

specified in Annex XIV;

(e) an analysis of the alternatives considering their risks and the

technical and economic feasibility of substitution and

including, if appropriate information about any relevant

research and development activities by the applicant;

29.5.2007L 136/48 Official Journal of the European Union

(

) OJ L 158, 30.4.2004, p. 7, corrected in OJ L 229, 29.6.2004, p. 5.

Regulation as amended by Council Regulation (EC) No 1195/2006 (OJ

L 217, 8.8.2006, p. 1).

(f) where the analysis referred to in point (e) shows that

suitable alternatives are available, taking into account the

elements in Article 60(5), a substitution plan including a

timetable for proposed actions by the applicant.

5. The application may include:

(a) a socio-economic analysis conducted in accordance with

Annex XVI;

(b) a justification for not considering risks to human health and

the environment arising either from:

(i) emissions of a substance from an installation for which

a permit was granted in accordance with Directive

96/61/EC; or

(ii) discharges of a substance from a point source governed

by the requirement for prior regulation referred to in

Article 11(3)(g) of Directive 2000/60/EC and legislation

adopted under Article 16 of that Directive.

6. The application shall not include the risks to human

health arising from the use of a substance in a medical device

regulated by Directives 90/385/EEC, 93/42/EEC or 98/79/EC.

7. An application for an authorisation shall be accompanied

by the fee required in accordance with Title IX.

Article 63

Subsequent applications for authorisation

1. If an application has been made for a use of a substance, a

subsequent applicant may refer to the appropriate parts of the

previous application submitted in accordance with Article 62(4)

(d), (e) and (f) and (5)(a), provided that the subsequent applicant

has permission from the previous applicant to refer to these

parts of the application.

2. If an authorisation has been granted for a use of a

substance, a subsequent applicant may refer to the appropriate

parts of the previous application submitted in accordance with

Article 62(4)(d), (e) and (f) and (5)(a), provided that the subse-

quent applicant has permission from the holder of the authori-

sation to refer to these parts of the application.

3. Before referring to any previous application in accordance

with paragraphs 1 and 2, the subsequent applicant shall update

the information of the original application as necessary.

Article 64

Procedure for authorisation decisions

1. The Agency shall acknowledge the date of receipt of the

application. The Agency's Committees for Risk Assessment and

Socio-economic Analysis shall give their draft opinions within

ten months of the date of receipt of the application.

2. The Agency shall make available on its web-site broad

information on uses, taking into account Articles 118 and 119

on access to information, for which applications have been

received and for reviews of authorisations, with a deadline by

which information on alternative substances or technologies

may be submitted by interested third parties.

3. In preparing its opinion, each Committee referred to in

paragraph 1 shall first check that the application includes all the

information specified in Article 62 that is relevant to its remit.

If necessary, the Committees shall, in consultation with each

other, make a joint request to the applicant for additional infor-

mation to bring the application into conformity with the

requirements of Article 62. The Committee for Socio-economic

Analysis may, if it deems it necessary, require the applicant or

request third parties to submit, within a specified time period,

additional information on possible alternative substances or

technologies. Each Committee shall also take into account any

information submitted by third parties.

4. The draft opinions shall include the following elements:

(a) Committee for Risk Assessment: an assessment of the risk

to human health and/or the environment arising from the

use(s) of the substance, including the appropriateness and

effectiveness of the risk management measures as described

in the application and, if relevant, an assessment of the risks

arising from possible alternatives;

(b) Committee for Socio-economic Analysis: an assessment of

the socio-economic factors and the availability, suitability

and technical feasibility of alternatives associated with the

use(s) of the substance as described in the application, when

an application is made in accordance with Article 62 and of

any third party contributions submitted under paragraph 2

of this Article.

5. The Agency shall send these draft opinions to the appli-

cant by the end of the deadline set out in paragraph 1. Within

one month of receipt of the draft opinion, the applicant may

provide written notice that he wishes to comment. The draft

opinion shall be deemed to have been received seven days after

the Agency has sent it.

29.5.2007 L 136/49Official Journal of the European Union

If the applicant does not wish to comment, the Agency shall

send these opinions to the Commission, the Member States and

the applicant, within 15 days of the end of the period within

which the applicant may comment or within 15 days of receipt

of notice from the applicant that he does not intend to

comment.

If the applicant wishes to comment, he shall send his written

argumentation to the Agency within two months of the receipt

of the draft opinion. The Committees shall consider the

comments and adopt their final opinions within two months of

receipt of the written argumentation, taking this argumentation

into account where appropriate. Within a further 15 days the

Agency shall send the opinions, with the written argumentation

attached, to the Commission, the Member States and the appli-

cant.

6. The Agency shall determi ne in accordance with Arti-

cles 118 and 119 which parts of its opinions and parts of any

attachments thereto should be made publicly available on its

website.

7. In cases covered by Article 63(1), the Agency shall treat

the applications together, provided the deadlines for the first

application can be met.

8. The Commission shall prepare a draft authorisation deci-

sion within three months of receipt of the opinions from the

Agency. A final decision granting or refusing the authorisation

shall be taken in accordance with the procedure referred to in

Article 133(3).

9. Summaries of the Commission decisions, including the

authorisation number and the reasons for the decision, in par-

ticular where suitable alternatives exist, shall be published in the

Official Journal of the European Union and shall be made

publicly available in a database established and kept up to date

by the Agency.

10. In cases covered by Article 63(2), the deadline set out in

paragraph 1 of this Article shall be shortened to five months.

CHAPTER 3

Authorisations in the supply chain

Article 65

Obligation of holders of authorisations

Holders of an authorisation, as well as downstream users

referred to in Article 56(2) including the substances in a

preparation, shall include the authorisation number on the label

before they place the substance or a preparation containing the

substance on the market for an authorised use without prejudice

to Directive 67/548/EEC and Directive 1999/45/EC. This shall

be done without delay once the authorisation number has been

made publicly available in accordance with Article 64(9).

Article 66

Downstream users

1. Downstream users using a substance in accordance with

Article 56(2) shall notify the Agency within three months of the

first supply of the substance.

2. The Agency shall establish and keep up to date a register

of downstream users who have made a notification in accord-

ance with paragraph 1. The Agency shall grant access to this

TITLE VIII

RESTRICTIONS ON THE MANUFACTURING, PLACING ON THE

MARKET AND USE OF CERTAIN DANGEROUS SUBSTANCES,

PREPARATIONS AND ARTICLES

CHAPTER 1

General issues

Article 67

General provisions

1. A substance on its own, in a preparation or in an article,

for which Annex XVII contains a restriction shall not be manu-

factured, placed on the market or used unless it complies with

the conditions of that restriction. This shall not apply to the

manufacture, placing on the market or use of a substance in

scientific research and development. Annex XVII shall specify if

the restriction shall not apply to product and process orientated

research and development, as well as the maximum quantity

exempted.

2. Paragraph 1 shall not apply to the use of substances in

cosmetic products, as defined by Directive 76/768/EEC, with

regard to restrictions addressing the risks to human health

within the scope of that Directive.

3. Until 1 June 2013, a Member State may maintain any

existing and more stringent restrictions in relation to

Annex XVII on the manufacture, placing on the market or use

of a substance, provided that those restrictions have been noti-

fied according to the Treaty. The Commission shall compile and

publish an inventory of these restrictions by 1 June 2009.

CHAPTER 2

Restrictions process

Article 68

Introducing new and amending current restrictions

1. When there is an unacceptable risk to human health or

the environment, ar ising from the manufacture, use or placing

on the market of substances, which needs to be addressed on a

Community-wide basis, Annex XVII shall be amended in accord-

ance with the procedure referred to in Article 133(4) by

adopting new restrictions, or amending current restrictions in

Annex XVII, for the manufacture, use or placing on the market

of substances on their own, in preparations or in articles,

pursuant to the procedure set out in Articles 69 to 73. Any

such decision shall take into account the socio-economic impact

of the restriction, including the availability of alternatives.

29.5.2007L 136/50 Official Journal of the European Union

The first subparagraph shall not apply to the use of a substance

as an on-site isolated intermediate.

2. For a substance on its own, in a preparation or in an

article which meets the criteria for classification as carcinogenic,

mutagenic or toxic to reproduction, category 1 or 2, and could

be used by consumers and for which restrictions to consumer

use are proposed by the Commission, Annex XVII shall be

amended in accordance with the procedure referred to in

Article 133(4). Articles 69 to 73 shall not apply.

Article 69

Preparation of a proposal

1. If the Commission considers that the manufacture, placing

on the market or use of a substance on its own, in a preparation

or in an article poses a risk to human health or the environ-

ment that is not adequately controlled and needs to be

addressed, it shall ask the Agency to prepare a dossier which

conforms to the requirements of Annex XV.

2. After the date referred to in Article 58(1)(c)(i) for a

substance listed in Annex XIV, the Agency shall consider

whether the use of that substance in articles poses a risk to

human health or the environment that is not adequately

controlled. If the Agency considers that the risk is not

adequately controlled, it shall prepare a dossier which conforms

to the requirements of Annex XV.

3. Within 12 months of the receipt of the request from the

Commission in paragraph 1 and if this dossier demonstrates

that action on a Community-wide basis is necessary, beyond

any measures already in place, the Agency shall suggest restric-

tions, in order to initiate the restrictions process.

4. If a Member State considers that the manufacture, placing

on the market or use of a substance on its own, in a preparation

or in an article poses a risk to human health or the environ-

ment that is not adequately controlled and needs to be

addressed it shall notify the Agency that it proposes to prepare

a dossier which confor ms to the requirements of the relevant

sections of Annex XV. If the substance is not on the list main-

tained by the Agency referred to in paragraph 5 of this Article,

the Member State shall prepare a dossier which conforms to the

requirements of Annex XV within 12 months of the notification

to the Agency. If this dossier demonstrates that action on a

Community-wide basis is necessary, beyond any measures

already in place, the Member State shall submit it to the Agency

in the format outlined in Annex XV, in order to initiate the

restrictions process.

The Agency or Member States shall refer to any dossier,

chemical safety report or risk assessment submitted to the

Agency or Member State under this Regulation. The Agency or

Member States shall also refer to any relevant risk assessment

submitted for the purposes of other Community Regulations or

Directives. To this end other bodies, such as agencies, established

under Community law and carrying out a similar task shall

provide information to the Agency or Member State concer ned

on request.

The Committee for Risk Assessment and the Committee for

Socio-economic Analysis shall check whether the dossier

submitted conforms to the requirements of Annex XV. Within

30 days of receipt, the respective Committee shall inform the

Agency or the Member State suggesting restrictions, as to

whether the dossier conforms. If the dossier does not conform,

the reasons shall be given to the Agency or the Member State in

writing within 45 days of receipt. The Agency or the Member

State shall bring the dossier into conformity within 60 days of

the date of receipt of the reasons from the Committees, other-

wise the procedure under this Chapter shall be terminated. The

Agency shall publish without delay the intention of the

Commission or of a Member State to instigate a restriction

procedure for a substance and shall inform those who submitted

a registration for that substance.

5. The Agency shall maintain a list of substances for which a

dossier conforming to the requirements of Annex XV is planned

or underway by either the Agency or a Member State for the

purposes of a proposed restriction. If a substance is on the list,

no other such dossier shall be prepared. If it is proposed by

either a Member State or the Agency that an existing restriction

listed in Annex XVII should be re-examined a decision on

whether to do so shall be taken in accordance with the proce-

dure referred to in Article 133(2) based on evidence presented

by the Member State or the Agency.

6. Without prejudice to Articles 118 and 119, the Agency

shall make publicly available on its website all dossiers

conforming with Annex XV including the restrictions suggested

pursuant to paragraphs 3 and 4 of this Article without delay,

clearly indicating the date of publication. The Agency shall

invite all interested parties to submit individually or jointly

within six months of the date of publication:

(a) comments on dossiers and the suggested restrictions;

(b) a socio-economic analysis, or information which can contri-

bute to one, of the suggested restrictions, examining the

advantages and drawbacks of the proposed restrictions. It

shall conform to the requirements in Annex XVI.

29.5.2007 L 136/51Official Journal of the European Union

Article 70

Agency opinion: Committee for Risk Assessment

Within nine months of the date of publication referred to in

Article 69(6), the Committee for Risk Assessment shall formu-

late an opinion as to whether the suggested restrictions are

appropriate in reducing the risk to human health and/or the

environment, based on its consideration of the relevant parts of

the dossier. This opinion shall take account of the Member State

dossier or of the dossier prepared by the Agency at the request

of the Commission, and the views of interested parties referred

to in Article 69(6)(a).

Article 71

Agency opinion: Committee for Socio-economic Analysis

1. Within 12 months of the date of publication referred to

in Article 69(6), the Committee for Socio-economic Analysis

shall formulate an opinion on the suggested restrictions, based

on its consideration of the relevant parts of the dossier and the

socio-economic impact. It shall prepare a draft opinion on the

suggested restrictions and on the related socio-economic impact,

taking account of the analyses or information according to

Article 69(6)(b), if there are any. The Agency shall publish the

draft opinion on its website without delay. The Agency shall

invite interested parties to give their comments on the draft

opinion no later than 60 days from the publication of that draft

opinion.

2. The Committee for Socio-economic Analysis shall without

delay adopt its opinion, taking into account where appropriate

further comments received by the deadline set. This opinion

shall take account of the comments and socio-economic

analyses of interested parties submitted under Article 69(6)(b)

and under paragraph 1 of this Article.

3. Where the opinion of the Committee for Risk Assessment

diverges significantly from the restrictions suggested, the Agency

may postpone the deadline for the opinion of the Committee

for Socio-economic Analysis by a maximum of 90 days.

Article 72

Submission of an opinion to the Commission

1. The Agency shall submit to the Commission without delay

the opinions of the Committees for Risk Assessment and Socio-

economic Analysis on restr ictions suggested for substances on

their own, in preparations or in articles. If one or both of the

Committees do not formulate an opinion by the deadline set in

Article 70 and Article 71(1) the Agency shall inform the

Commission accordingly, stating the reasons.

2. Without prejudice to Articles 118 and 119 the Agency

shall publish the opinions of the two Committees on its website

without delay.

3. The Agency shall provide the Commission and/or Member

State on request with all documents and evidence submitted to

or considered by it.

Article 73

Commission decision

1. If the conditions laid down in Article 68 are fulfilled, the

Commission shall prepare a draft amendment to Annex XVII,

within three months of receipt of the opinion of the Committee

for Socio-economic Analysis or by the end of the deadline

established under Ar ticle 71 if that Committee does not form

an opinion, whichever is the earlier.

Where the draft amendment diverges from the original proposal

or if it does not take the opinions from the Agency into

account, the Commission shall annex a detailed explanation of

the reasons for the differences.

2. A final decision shall be taken in accordance with the

procedure referred to in Article 133(4). The Commission shall

send the draft amendment to the Member States at least 45 days

before voting.

TITLE IX

FEES AND CHARGES

Article 74

Fees and charges

1. The fees that are required according to Article 6(4),

Article 7(1) and (5), Article 9(2), Article 11(4), Article 17(2),

Article 18(2), Article 19(3), Article 22(5), Article 62(7) and

Article 92(3) shall be specified in a Commission Regulation

adopted in accordance with the procedure referred to in

Article 133(3) by 1 June 2008.

2. A fee need not be paid for a registration of a substance in

a quantity of between 1 and 10 tonnes where the registration

dossier contains the full information in Annex VII.

3. The structure and amount of the fees referred to in para-

graph 1 shall take account of the work required by this Regu-

lation to be carried out by the Agency and the competent

authority and shall be fixed at such a level as to ensure that the

revenue derived from them when combined with other sources

of the Agency's revenue pursuant to Article 96(1) is sufficient to

cover the cost of the services delivered. The fees set for registra-

tion shall take into account the work that may be done pursuant

to Title VI.

29.5.2007L 136/52 Official Journal of the European Union

In the case of Article 6(4), Article 7(1) and (5), Article 9(2),

Article 11(4), Article 17(2) and Article 18(2), the str ucture and

amount of fees shall take account of the tonnage range of the

substance being registered.

In all cases, a reduced fee shall be set for SMEs.

In the case of Article 11(4), the structure and amount of fees

shall take into account whether information has been submitted

jointly or separately.

In the case of a request made under Article 10(a)(xi), the struc-

ture and amount of fees shall take into account the work

required by the Agency in assessing the justification.

4. The Regulation referred to in paragraph 1 shall specify the

circumstances under which a proportion of the fees will be

transferred to the relevant Member State competent authority.

5. The Agency may collect charges for other services it

provides.

TITLE X

AGENCY

Article 75

Establishment and review

1. A European Chemicals Agency is established for the

purposes of managing and in some cases carrying out the tech-

nical, scientific and administrative aspects of this Regulation and

to ensure consistency at Community level in relation to these

aspects.

2. The Agency shall be subject to a review by 1 June 2012.

Article 76

Composition

1. The Agency shall comprise:

(a) a Management Board, which shall exercise the responsibil-

ities set out in Article 78;

(b) an Executive Director, who shall exercise the responsibilities

set out in Article 83;

sible for preparing the opinion of the Agency on evalua-

tions, applications for authorisation, proposals for restric-

tions and proposals for classification and labelling under

Title XI and any other questions that arise from the opera-

tion of this Regulation relating to risks to human health or

the environment;

(d) a Committee for Socio-economic Analysis, which shall be

responsible for preparing the opinion of the Agency on

applications for authorisation, proposals for restrictions, and

any other questions that arise from the operation of this

Regulation relating to the socio-economic impact of possible

legislative action on substances;

(e) a Member State Committee, which shall be responsible for

resolving potential divergences of opinions on draft deci-

sions proposed by the Agency or the Member States under

Title VI and proposals for identification of substances of

very high concern to be subjected to the authorisation

procedure under Title VII;

(f) a Forum for Exchange of Information on Enforcement (here-

inafter referred to as the Forum) which shall coordinate a

network of Member States author ities responsible for enfor-

cement of this Regulation;

(g) a Secretariat, which shall work under the leadership of the

Executive Director and provide technical, scientific and

administrative support for the Committees and the Forum

and ensure appropriate coordination between them. It shall

also undertake the work required of the Agency under the

procedures for pre-registration, registration and evaluation

as well as preparation of guidance, database maintenance

and information provision;

(h) a Board of Appeal, which shall decide on appeals against

decisions taken by the Agency.

2. The Committees referred to in points (c), (d) and (e) of

paragraph 1 (hereinafter referred to as the Committees) and the

Forum may each establish working groups. For this purpose

they shall adopt, in accordance with their rules of procedure,

precise arrangements for delegating certain tasks to these

working groups.

3. The Committees and the Forum may, if they consider it

appropriate, seek advice on important questions of a general

scientific or ethical nature from appropriate sources of expertise.

Article 77

Tasks

1. The Agency shall provide the Member States and the insti-

tutions of the Community with the best possible scientific and

technical advice on questions relating to chemicals which fall

within its remit and which are referred to it in accordance with

the provisions of this Regulation.

2. The Secretariat shall undertake the following tasks:

(a) performing the tasks allotted to it under Title II; including

facilitating the efficient registration of impor ted substances,

in a way consistent with the Community's international

trading obligations towards third countries;

(b) performing the tasks allotted to it under Title III;

29.5.2007 L 136/53Official Journal of the European Union

(d) performing the tasks allotted to it under Title VIII;

(e) establishing and maintaining database(s) with information

on all registered substances, the classification and labelling

inventory and the har monised classification and labelling

list. It shall make the information identified in Article 119

(1) and (2) in the database(s) publicly available, free of

charge, over the Internet, except where a request made

under Article 10(a)(xi) is considered justified. The Agency

shall make other information in the databases available on

request in accordance with Article 118;

(f) making publicly available information as to which

substances are being, and have been evaluated within 90

days of receipt of the information at the Agency, in accord-

ance with Article 119(1);

(g) providing technical and scientific guidance and tools where

appropriate for the operation of this Regulation in particu-

lar to assist the development of chemical safety reports (in

accordance with Article 14, Article 31(1) and Article 37(4))

and application of Article 10(a)(viii), Article 11(3) and

Article 19(2) by industry and especially by SMEs; and tech-

nical and scientific guidance for the application of Article 7

by producers and importers of articles;

(h) providing technical and scientific guidance on the operation

of this Regulation for Member State competent authorities

and providing support to the helpdesks established by

Member States under Title XIII;

(i) providing guidance to stakeholders including Member State

competent authorities on communication to the public of

information on the risks and safe use of substances, on

their own, in preparations or in articles;

(j) providing advice and assistance to manufacturers and

importers registering a substance in accordance with

Article 12(1);

(k) preparing explanatory information on this Regulation for

other stakeholders;

(l) at the Commission's request, providing technical and scien-

tific support for steps to improve cooperation between the

Community, its Member States, international organisations

and third countries on scientific and technical issues

relating to the safety of substances, as well as active partici-

pation in technical assistance and capacity building activ-

ities on sound management of chemicals in developing

countries;

(m) keeping a Manual of Decisions and Opinions based on

conclusions from the Member State Committee regarding

interpretation and implementation of this Regulation;

(n) notification of decisions taken by the Agency;

(o) provision of formats for submission of information to the

Agency.

3. The Committees shall undertake the following tasks:

(a) performing the tasks allotted to them under Titles VI to XI;

(b) at the Executive Director's request, providing technical and

scientific support for steps to improve cooperation between

the Community, its Member States, international organisa-

tions and third countries on scientific and technical issues

relating to the safety of substances, as well as active partici-

pation in technical assistance and capacity building activities

on sound management of chemicals in developing coun-

tries;

on any other aspects concerning the safety of substances on

their own, in preparations or in articles.

4. The Forum shall undertake the following tasks:

(a) spreading good practice and highlighting problems at Com-

munity level;

(b) proposing, coordinating and evaluating harmonised enforce-

ment projects and joint inspections;

(d) identifying enforcement strategies, as well as best practice in

enforcement;

(e) developing working methods and tools of use to local

inspectors;

(f) developing an electronic information exchange procedure;

(g) liaising with industry, taking particular account of the

specific needs of SMEs, and other stakeholders, including

relevant international organisations, as necessary;

(h) examining proposals for restrictions with a view to advising

on enforceability.

Article 78

Powers of the Management Board

The Management Board shall appoint the Executive Director

pursuant to Article 84 and an accounting officer in accordance

with Article 43 of Regulation (EC, Euratom) No 2343/2002.

It shall adopt:

(a) by 30 April each year, the general report of the Agency for

the previous year;

(b) by 31 October each year the work programme of the

Agency for the coming year;

29.5.2007L 136/54 Official Journal of the European Union

the beginning of the financial year, adjusting it, where neces-

sary, according to the Community contribution and any

other revenue of the Agency;

(d) a multiannual work programme, which shall be regularly

revised.

It shall adopt the internal rules and procedures of the Agency.

These rules shall be made public.

It shall perform its duties in relation to the Agency's budget

pursuant to Articles 96, 97 and 103.

It shall exercise disciplinary authority over the Executive

Director.

It shall adopt its rules of procedure.

It shall appoint the Chairman, the members and alternates of

the Board of Appeal in accordance with Article 89.

It shall appoint the members of the Agency committees as set

out in Article 85.

It shall forward annually any information relevant to the

outcome of the evaluation procedures in accordance with

Article 96(6).

Article 79

Composition of the Management Board

1. The Management Board shall be composed of one repre-

sentative from each Member State and a maximum of six repre-

sentatives appointed by the Commission, including three indivi-

duals from interested parties without voting rights and in addi-

tion two independent persons appointed by the European Parlia-

ment.

Each Member State shall nominate a member to the Manage-

ment Board. The members thus nominated shall be appointed

by the Council.

2. Members shall be appointed on the basis of their relevant

experience and expertise in the field of chemical safety or the

regulation of chemicals whilst ensuring there is relevant exper-

tise amongst the board members in the fields of general, finan-

cial and legal matters.

3. The duration of the term of office shall be four years. The

term of off ice may be renewed once. However, for the first

mandate, the Commission shall identify half of its appointees,

and the Council shall identify 12 of its appointees, for whom

this period shall be six years.

Article 80

Chairmanship of the Management Board

1. The Management Board shall elect a Chairman and a

Deputy-Chairman from among the members with voting rights.

The Deputy-Chairman shall automatically take the place of the

Chairman if he is prevented from attending to his duties.

2. The terms of office of the Chairman and the Deputy-

Chairman shall be two years and shall expire when they cease to

be members of the Management Board. The term of office shall

be renewable once.

Article 81

Meetings of the Management Board

1. The meetings of the Management Board shall be convened

by invitation of its Chairman or at the request of at least one

third of the Board members.

2. The Executive Director shall take part in the meetings of

the Management Board, without voting rights.

3. The Chairmen of the Committees and the Chair man of

the Forum, as referred to in Article 76(1)(c) to (f), are entitled to

attend the meetings of the Management Board without voting

rights.

Article 82

Voting of the Management Board

The Management Board shall adopt rules of procedure for

voting, including the conditions for a member to vote on behalf

of another member. The Management Board shall act by a two-

thirds majority of all members with the right to vote.

Article 83

Duties and powers of the Executive Director

1. The Agency shall be managed by its Executive Director,

who shall perform his duties in the interests of the Community,

and independently of any specific interests.

2. The Executive Director shall be the legal representative of

the Agency. He shall be responsible for:

(a) the day-to-day administration of the Agency;

(b) managing all the Agency resources necessary for carrying

out its tasks;

legislation for the adoption of opinions by the Agency are

complied with;

(d) ensuring appropriate and timely coordination between the

Committees and the Forum;

(e) concluding and managing necessary contracts with service

providers;

(f) the preparation of the statement of revenue and expendi-

ture and the implementation of the budget of the Agency

pursuant to Articles 96 and 97;

(g) all staff matters;

(h) providing the secretariat for the Management Board;

29.5.2007 L 136/55Official Journal of the European Union

(i) preparing draft opinions of the Management Board

concerning the proposed rules of procedure of the

Committees and of the Forum;

(j) making arrangements, upon request from the Management

Board, for the execution of any further function(s) (within

the remit of Article 77) allotted to the Agency by delega-

tion from the Commission;

(k) establishing and maintaining a regular dialogue with the

European Parliament;

(l) determining the terms and conditions for use of software

packages;

(m) rectifying a decision made by the Agency following an

appeal and after consulting the Chairman of the Board of

Appeal.

3. Each year, the Executive Director shall submit the

following to the Management Board for approval:

(a) a draft report covering the activities of the Agency in the

previous year, including information about the number of

registration dossiers received, the number of substances eval-

uated, the number of applications for authorisation received,

the number of proposals for restriction received by the

Agency and opined upon, the time taken for completion of

the associated procedures, and the substances authorised,

dossiers rejected, substances restricted; complaints received

and the action taken; an overview of the activities of the

Forum;

(b) a draft work-programme for the coming year;

(d) the draft forecast budget for the coming year;

(e) a draft multiannual work programme.

The Executive Director shall, following approval by the Manage-

ment Board, forward the work programme for the coming year

and the multiannual work programme to the Member States,

the European Parliament, the Council and the Commission, and

shall have them published.

The Executive Director shall, following approval by the Manage-

ment Board, forward the Agency's general report to the Member

States, the European Parliament, the Council, the Commission,

the European Economic and Social Committee and the Court of

Auditors, and shall have it published.

Article 84

Appointment of the Executive Director

1. The Executive Director of the Agency shall be appointed

by the Management Board on the basis of a list of candidates

proposed by the Commission following a call for expressions of

interest published in the Official Journal of the European Union

and in other periodicals or on Internet sites.

The Executive Director shall be appointed on the grounds of

merit and documented administrative and management skills, as

well as his relevant experience in the fields of chemical safety or

regulation. The Management Board shall take its decision by a

two-thirds majority of all members with a right to vote.

Power to dismiss the Executive Director shall lie with the

Management Board, in accordance with the same procedure.

Before being appointed, the candidate selected by the Manage-

ment Board shall be invited as soon as possible to make a state-

ment before the European Parliament and to answer questions

from Members of Parliament.

2. The term of the office of the Executive Director shall be

five years. It may be prolonged by the Management Board once

for another period of up to five years.

Article 85

Establishment of the Committees

1. Each Member State may nominate candidates to member-

ship of the Committee for Risk Assessment. The Executive

Director shall establish a list of the nominees, which shall be

published on the Agency's website, without prejudice to

Article 88(1). The Management Board shall appoint the

members of the Committee from this list, including at least one

member but not more than two from the nominees of each

Member State that has nominated candidates. Members shall be

appointed for their role and experience in performing the tasks

specified in Article 77(3).

2. Each Member State may nominate candidates to member-

ship of the Committee for Socio-economic Analysis. The Execu-

tive Director shall establish a list of the nominees, which shall

be published on the Agency's website, without prejudice to

Article 88(1). The Management Board shall appoint the

members of the Committee from this list, including at least one

member but not more than two from the nominees of each

Member State that has nominated candidates. Members shall be

appointed for their role and experience in performing the tasks

specified in Article 77(3).

3. Each Member State shall appoint one member to the

Member State Committee.

29.5.2007L 136/56 Official Journal of the European Union

4. The Committees shall aim to have a broad range of rele-

vant expertise among their members. To this end each

Committee may co-opt a maximum of five additional members

chosen on the basis of their specific competence.

Members of the Committees shall be appointed for a term of

three years which shall be renewable.

The members of the Management Board may not be members

of the Committees.

The members of each Committee may be accompanied by advi-

sers on scientific, technical or regulatory matters.

The Executive Director or his representative and representatives

of the Commission shall be entitled to attend all the meetings

of the Committees and working groups convened by the

Agency or its committees as observers. Stakeholders may also

be invited to attend meetings as observers, as appropriate, at the

request of the Committee members, or the Management Board.

5. The members of each Committee appointed following

nomination by a Member State shall ensure that there is appro-

priate coordination between the tasks of the Agency and the

work of their Member State competent authority.

6. The members of the Committees shall be supported by

the scientific and technical resources available to the Member

States. To this end, Member States shall provide adequate scien-

tific and technical resources to the members of the Committees

that they have nominated. Each Member State competent

authority shall facilitate the activities of the Committees and

their working groups.

7. The Member States shall refrain from giving the members

of the Committee for Risk Assessment or of the Committee for

Socio-Economic Analysis, or their scientific and technical advi-

sers and experts, any instruction which is incompatible with the

individual tasks of those persons or with the tasks, responsibil-

ities and independence of the Agency.

8. When preparing an opinion, each Committee shall use its

best endeavours to reach a consensus. If such a consensus

cannot be reached, the opinion shall consist of the position of

the majority of members, including their grounds. The minority

position(s), including their grounds, shall also be published.

9. Each Committee shall draft a proposal for its own rules of

procedure, to be approved by the Management Board, within six

months of the Committees first being appointed.

These rules shall in particular lay down the procedures for repla-

cing members, the procedures for delegating certain tasks to

working groups, the creation of working groups and the estab-

lishment of a procedure for the urgent adoption of opinions.

The Chairman of each Committee shall be an employee of the

Agency.

Article 86

Establishment of the Forum

1. Each Member State shall appoint, for a three-year term,

which shall be renewable, one member to the Forum. Members

shall be chosen for their role and experience in enforcement of

chemicals legislation and shall maintain relevant contacts with

the Member State competent authorities.

The Forum shall aim to have a broad range of relevant expertise

among its members. To this end the Forum may co-opt a

maximum of five additional members chosen on the basis of

their specific competence. These members shall be appointed for

a term of three years, which shall be renewable. Members of the

Management Board may not be members of the Forum.

The members of the Forum may be accompanied by scientific

and technical advisers.

The Executive Director of the Agency or his representative and

representatives of the Commission shall be entitled to attend all

the meetings of the Forum and its working groups. Stakeholders

may also be invited to attend meetings as observers, as appro-

priate, at the request of Forum members, or the Management

Board.

2. The members of the Forum appointed by a Member State

shall ensure that there is appropriate coordination between the

tasks of the Forum and the work of their Member State compe-

tent authority.

3. The members of the Forum shall be supported by the

scientific and technical resources available to the competent

authorities of the Member States. Each Member State competent

authority shall facilitate the activities of the Forum and its

working groups. The Member States shall refrain from giving

the Forum members, or their scientific and technical advisers

and experts any instruction which is incompatible with the indi-

vidual tasks of those persons or with the tasks and responsibil-

ities of the Forum.

4. The Forum shall draft a proposal for its own rules of

procedure, to be adopted by the Management Board, within six

months of the Forum first being appointed.

These rules shall in particular lay down the procedures for

appointing and replacing the Chairman, replacing members and

the procedures for delegating certain tasks to working groups.

29.5.2007 L 136/57Official Journal of the European Union

Article 87

Rapporteurs of Committees and use of experts

1. Where, in accordance with Article 77, a Committee is

required to provide an opinion or consider whether a Member

State dossier conforms with the requirements of Annex XV, it

shall appoint one of its members as a rapporteur. The

Committee concerned may appoint a second member to act as

co-rapporteur. For each case, rapporteurs and co-rapporteurs

shall undertake to act in the interests of the Community and

shall make a declaration of commitment to fulfil their duties

and a declaration of interests in writing. A member of a

Committee shall not be appointed rapporteur for a particular

case if he indicates any interest that might be prejudicial to the

independent consideration of that case. The Committee

concerned may replace the rapporteur or co-rapporteur by

another one of its members at any time, if, for example, they

are unable to fulfil their duties within the prescribed time limits,

or if a potentially prejudicial interest comes to light.

2. Member States shall transmit to the Agency the names of

experts with proven experience in the tasks required by

Article 77, who would be available to serve on working groups

of the Committees, together with an indication of their qualifi-

cations and specific areas of expertise.

The Agency shall keep an up-to-date list of experts. The list

shall include the experts referred to in the first subparagraph

and other experts identified directly by the Secretariat.

3. The provision of services by Committee members or any

expert serving on a working group of the Committees or

Forum, or performing any other task for the Agency shall be

governed by a written contract between the Agency and the

person concerned, or where appropriate between the Agency

and the employer of the person concerned.

The person concerned, or his employer, shall be remunerated by

the Agency in accordance with a scale of fees to be included in

the financial arrangements established by the Management

Board. Where the person concerned fails to fulfil his duties, the

Executive Director has the right to terminate or suspend the

contract or withhold remuneration.

4. The provision of services for which there are several

potential providers may require a call for an expression of

interest:

(a) if the scientific and technical context allows; and

(b) if it is compatible with the duties of the Agency, in par ticu-

lar the need to provide a high level of protection of human

health and the environment.

The Management Board shall adopt the appropriate procedures

on a proposal from the Executive Director.

5. The Agency may use the services of experts for the

discharge of other specific tasks for which it is responsible.

Article 88

Qualification and interests

1. The membership of the Committees and of the Forum

shall be made public. Individual members may request that their

names not be made public if they believe that such publication

could place them at risk. The Executive Director shall decide

whether to agree to such requests. When each appointment is

published, the professional qualifications of each member shall

be specified.

2. Members of the Management Board, the Executive

Director and members of the Committees and of the Forum

shall make a declaration of commitment to fulfil their duties

and a declaration of interests which could be considered to be

prejudicial to their independence. These declarations shall be

made annually in writing and, without prejudice to paragraph 1,

be entered in a register held by the Agency which is accessible

to the public, on request, at the Agency's offices.

3. At each of their meetings, members of the Management

Board, the Executive Director, members of the Committees and

of the Forum and any experts participating in the meeting shall

declare any interests which could be considered to be prejudicial

to their independence with respect to any points on the agenda.

Anyone declaring such interests shall not participate in any

voting on the relevant agenda point.

Article 89

Establishment of the Board of Appeal

1. The Board of Appeal shall consist of a Chairman and two

other members.

2. The Chairman and the two members shall have alternates

who shall represent them in their absence.

3. The Chairman, the other members and the alternates shall

be appointed by the Management Board on the basis of a list of

candidates proposed by the Commission following a call for

expressions of interest published in the Official Journal of the

European Union and in other periodicals or on Internet sites.

They shall be appointed on the basis of their relevant experience

and expertise in the field of chemical safety, natural sciences or

regulatory and judicial procedures from a list of qualified candi-

dates adopted by the Commission.

The Management Board may appoint additional members and

their alternates, on recommendation by the Executive Director,

following the same procedure, if this is necessar y to ensure that

the appeals can be processed at a satisfactory rate.

4. The qualifications required for the members of the Board

of Appeal shall be determined by the Commission in accordance

with the procedure referred to in Article 133(3).

5. The Chairman and the members shall have equal voting

rights.

29.5.2007L 136/58 Official Journal of the European Union

Article 90

Members of the Board of Appeal

1. The term of office of the members of the Board of

Appeal, including the Chairman and the alternates shall be

five years. It may be prolonged once.

2. The members of the Board of Appeal shall be indepen-

dent. In making their decisions they shall not be bound by any

instructions.

3. The members of the Board of Appeal may not perform

any other duties in the Agency.

4. The members of the Board of Appeal may not be

removed either from office or from the list during their respec-

tive terms, unless there are serious grounds for such removal

and the Commission, after obtaining the opinion of the

Management Board, takes a decision to this effect.

5. Members of the Board of Appeal may not take part in any

appeal proceedings if they have any personal interest therein, or

if they have previously been involved as representatives of one

of the parties to the proceedings, or if they par ticipated in the

decision under appeal.

6. If a member of the Board of Appeal considers for reasons

mentioned in paragraph 5 that he must not take part in a

specific appeal proceedings, he shall inform the Board of Appeal

accordingly. Members of the Board may be objected to by any

party to the appeal proceedings on any of the grounds

mentioned in paragraph 5, or if suspected of partiality. No

objection may be based on the nationality of members.

7. The Board of Appeal shall decide as to the action to be

taken in the cases specified in paragraphs 5 and 6 without the

participation of the member concerned. For the purposes of

taking this decision, the member concerned shall be replaced on

the Board of Appeal by an alternate.

Article 91

Decisions subject to appeal

1. An appeal may be brought against decisions of the

Agency taken pursuant to Article 9, Article 20, Article 27(6),

Article 30(2) and (3) and Article 51.

2. An appeal lodged pursuant to paragraph 1 shall have

suspensive effect.

Article 92

Persons entitled to appeal, time-limits, fees and form

1. Any natural or legal person may appeal against a decision

addressed to that person, or against a decision which, although

addressed to another person, is of direct and individual concern

to the former.

2. The appeal, together with the statements of the grounds

thereof, shall be filed in writing to the Agency within three

months of the notification of the decision to the person

concerned, or in the absence thereof, of the day on which it

became known to the latter, unless otherwise provided in this

Regulation.

3. A fee may be payable by persons bringing an appeal

against an Agency decision, in accordance with Title IX.

Article 93

Examination and decisions on appeal

1. If, after consultation with the Chairman of the Board of

Appeal, the Executive Director considers the appeal to be admis-

sible and well founded he may rectify the decision within

30 days of the appeal being filed in accordance with Article 92

(2).

2. In cases other than those referred to in paragraph 1 of

this Article, the Chairman of the Board of Appeal shall examine

whether the appeal is admissible within 30 days of the appeal

being filed in accordance with Article 92(2). In the affirmative,

the appeal shall be remitted to the Board of Appeal for examina-

tion of the grounds. Parties to the appeal proceedings shall be

entitled to make an oral presentation during the procedure.

3. The Board of Appeal may exercise any power which lies

within the competence of the Agency or remit the case to the

competent body of the Agency for further action.

4. The procedures for the Board of Appeal shall be deter-

mined by the Commission in accordance with the procedure

referred to in Article 133(3).

Article 94

Actions before the Court of First Instance and the Court of

Justice

1. An action may be brought before the Court of First

Instance or the Court of Justice, in accordance with Article 230

of the Treaty, contesting a decision taken by the Board of

Appeal or, in cases where no right of appeal lies before the

Board, by the Agency.

2. Should the Agency fail to take a decision, proceedings for

failure to act may be brought before the Court of First Instance

or the Court of Justice in accordance with Article 232 of the

Treaty.

3. The Agency shall be required to take the necessary

measures to comply with the judgment of the Court of First

Instance or the Court of Justice.

29.5.2007 L 136/59Official Journal of the European Union

Article 95

Conflicts of opinion with other bodies

1. The Agency shall take care to ensure early identification of

potential sources of conflict between its opinions and those of

other bodies established under Community law, including Com-

munity Agencies, carrying out a similar task in relation to issues

of common concern.

2. Where the Agency identifies a potential source of conflict,

it shall contact the body concerned in order to ensure that any

relevant scientific or technical information is shared and to iden-

tify the scientific or technical points which are potentially

contentious.

3. Where there is a fundamental conflict over scientific or

technical points and the body concerned is a Community

Agency or a scientific committee, the Agency and the body

concerned shall work together either to solve the conflict or to

submit a joint document to the Commission clarifying the

scientific and/or technical points of conflict.

Article 96

The budget of the Agency

1. The revenues of the Agency shall consist of:

(a) a subsidy from the Community, entered in the general

budget of the European Communities (Commission

Section);

(b) the fees paid by undertakings;

2. The expenditure of the Agency shall include the staff,

administrative, infrastructure and operational expenses.

3. By 15 February of each year at the latest, the Executive

Director shall draw up a preliminary draft budget covering the

operational expenditure and the programme of work anticipated

for the following financial year, and shall forward this preli-

minary draft to the Management Board together with an estab-

lishment plan accompanied by a provisional list of posts.

4. Revenue and expenditure shall be in balance.

5. Each year the Management Board, on the basis of a draft

drawn up by the Executive Director, shall produce an estimate

of revenue and expenditure for the Agency for the following

financial year. This estimate, which shall include a draft estab-

lishment plan, shall be forwarded by the Management Board to

the Commission by 31 March at the latest.

6. The estimate shall be forwarded by the Commission to the

European Parliament and the Council (hereinafter referred to as

the budgetary authority) together with the preliminary draft

budget of the European Communities.

7. On the basis of the estimate, the Commission shall enter

in the preliminary draft budget of the European Communities

the estimates it considers necessary for the establishment plan

and the amount of the subsidy to be charged to the general

budget, which it shall place before the budgetary authority in

accordance with Article 272 of the Treaty.

8. The budgetary authority shall authorise the appropriations

for the subsidy to the Agency.

The budgetary authority shall adopt the establishment plan for

the Agency.

9. The budget of the Agency shall be adopted by the Manage-

ment Board. It shall become final following final adoption of

the general budget of the European Communities. Where appro-

priate, it shall be adjusted accordingly.

10. Any modification to the budget, including the establish-

ment plan, shall follow the procedure refer red to above.

11. The Management Board shall, without delay, notify the

budgetary authority of its intention to implement any project

which may have signifi cant financial implications for the

funding of its budget, in particular any projects relating to prop-

erty such as the rental or purchase of buildings. It shall inform

the Commission thereof.

Where a branch of the budgetary authority has notified its

intention to deliver an opinion, it shall forward its opinion to

the Management Board within a period of six weeks from the

date of notification of the project.

Article 97

Implementation of the budget of the Agency

1. The Executive Director shall perform the duties of author-

ising officer and shall implement the Agency's budget.

2. Monitor ing of the commitment and payment of all the

Agency's expenditure and of the establishment and recovery of

all the Agency's revenue shall be carried out by the Accounting

Officer of the Agency.

3. By 1 March at the latest following each financial year, the

Agency's accounting off icer shall communicate the provisional

accounts to the Commission's accounting officer together with

a report on the budgetary and financial management for that

financial year. The Commission's accounting officer shall conso-

lidate the provisional accounts of the institutions and decentra-

lised bodies in accordance with Article 128 of Council Regu-

lation (EC, Euratom) No 1605/2002 of 25 June 2002 on the

Financial Regulation applicable to the general budget of the

European Communities (

29.5.2007L 136/60 Official Journal of the European Union

(

) OJ L 248, 16.9.2002, p. 1. Regulation as amended by Regulation (EC,

Euratom) No 1995/2006 (OJ L 390, 30.12.2006, p. 1).

4. By 31 March at the latest following each financial year, the

Commission's accounting officer shall forward the Agency's

provisional accounts to the Court of Auditors, together with a

report on the budgetary and financial management for that

financial year. The report on the budgetary and financial

management for that financial year shall also be forwarded to

the European Parliament and the Council.

5. On receipt of the Court of Auditors' observations on the

Agency's provisional accounts, pursuant to Article 129 of Regu-

lation (EC, Euratom) No 1605/2002, the Executive Director

shall draw up the Agency's final accounts under his own respon-

sibility and forward them to the Management Board for an

opinion.

6. The Management Board shall deliver an opinion on the

Agency's final accounts.

7. By 1 July of the following year at the latest, the Executive

Director shall send the final accounts, together with the opinion

of the Management Board, to the European Parliament, the

Council, the Commission and the Court of Auditors.

8. The final accounts shall be published.

9. The Executive Director shall send the Court of Auditors a

reply to its observations by 30 September at the latest. He shall

also send this reply to the Management Board.

10. The European Parliament, upon a recommendation from

the Council, shall, before 30 April of year N + 2, give a

discharge to the Executive Director in respect of the implemen-

tation of the budget for year N.

Article 98

Combating fraud

1. In order to combat fraud, corruption and other unlawful

activities, the provisions of Regulation (EC) No 1073/1999 of

the European Parliament and of the Council of 25 May 1999

concerning investigations conducted by the European Anti-

Fraud Off ice (OLAF) (

) shall apply without restrictions to the

Agency.

2. The Agency shall be bound by the Interinstitutional Agree-

ment of 25 May 1999 between the European Parliament, the

Council of the European Union and the Commission of the

European Communities concerning internal investigations by

the European Anti-Fraud Office (OLAF) (

) and shall issue,

without delay, the appropriate provisions applicable to all of its

staff.

3. The decisions concerning funding and the implementing

agreements and instruments resulting from them shall explicitly

stipulate that the Court of Auditors and OLAF may carry out, if

necessary, on-the-spot checks of the recipients of the Agency's

funding and the agents responsible for allocating it.

Article 99

Financial rules

The financial rules applicable to the Agency shall be adopted by

the Management Board after the Commission has been

consulted. They may not depart from Regulation (EC, Euratom)

No 2343/2002 unless specifically necessary for the Agency's

operation and with the Commission's prior consent.

Article 100

Legal personality of the Agency

1. The Agency shall be a body of the Community and shall

have legal personality. In each Member State it shall enjoy the

most extensive legal capacity accorded to legal persons under

their laws. In particular it may acquire and dispose of movable

and immovable property and may be a party to legal proceed-

ings.

2. The Agency shall be represented by its Executive Director.

Article 101

Liability of the Agency

1. The contractual liability of the Agency shall be governed

by the law applicable to the contract in question. The Court of

Justice shall have jurisdiction pursuant to any arbitration clause

contained in a contract concluded by the Agency.

2. In the case of non-contractual liability, the Agency shall,

in accordance with the general principles common to the laws

of the Member States, make good any damage caused by it or

by its servants in the performance of their duties.

The Court of Justice shall have jurisdiction in any dispute

relating to compensation for such damages.

3. The personal financial and disciplinary liability of its

servants towards the Agency shall be governed by the relevant

rules applying to the staff of the Agency.

29.5.2007 L 136/61Official Journal of the European Union

(

) OJ L 136, 31.5.1999, p. 1.

(

) OJ L 136, 31.5.1999, p. 15.

Article 102

Privileges and immunities of the Agency

The Protocol on the Privileges and Immunities of the European

Communities shall apply to the Agency.

Article 103

Staff rules and regulations

1. The staff of the Agency shall be subject to the Regulations

and Rules applicable to officials and other ser vants of the Euro-

pean Communities. In respect of its staff, the Agency shall exer-

cise the powers which have been devolved to the appointing

authority.

2. The Management Board shall, in agreement with the

Commission, adopt the necessary implementing provisions.

3. The Agency's staff shall consist of officials assigned or

seconded by the Commission or Member States on a temporary

basis and of other servants recruited by the Agency as necessary

to carry out its tasks. The Agency shall recruit its personnel on

the basis of a staffing plan to be included in the multiannual

work programme referred to in Article 78(d).

Article 104

Languages

1. Regulation No 1 of 15 April 1958 determining the

languages to be used in the European Economic Community (

)

shall apply to the Agency.

2. The translation services required for the functioning of the

Agency shall be provided by the Translation Centre of the

bodies of the European Union.

Article 105

Duty of confidentiality

Members of the Management Board, members of the Commit-

tees and of the Forum, experts and officials and other servants

of the Agency, shall be required, even after their duties have

ceased, not to disclose information of the kind covered by the

duty of professional secrecy.

Article 106

Participation of third countries

The Management Board may, in agreement with the relevant

Committee or the Forum, invite representatives of third coun-

tries to participate in the work of the Agency.

Article 107

Participation of international organisations

The Management Board may, in agreement with the relevant

Committee or the Forum, invite representatives of international

organisations with interests in the field of chemicals regulation

to participate as observers in the work of the Agency.

Article 108

Contacts with stakeholder organisations

The Management Board shall, in agreement with the Commis-

sion, develop appropriate contacts between the Agency and rele-

vant stakeholder organisations.

Article 109

Rules on transparency

To ensure transparency, the Management Board shall, on the

basis of a proposal by the Executive Director and in agreement

with the Commission, adopt rules to ensure the availability to

the public of regulatory, scientific or technical information

concerning the safety of substances on their own, in prepara-

tions or in articles which is not of a confidential nature.

Article 110

Relations with relevant Community bodies

1. The Agency shall cooperate with other Community bodies

to ensure mutual support in the accomplishment of their

respective tasks in particular to avoid duplication of work.

2. The Executive Director, having consulted the Committee

on Risk Assessment and the European Food Safety Authority,

shall establish rules of procedure concerning substances for

which an opinion has been sought in a food safety context.

These rules of procedure shall be adopted by the Management

Board, in agreement with the Commission.

This Title shall not otherwise affect the competences vested in

the European Food Safety Authority.

3. This Title shall not affect the competences vested in the

European Medicines Agency.

4. The Executive Director, having consulted the Committee

on Risk Assessment, the Committee on Socio-economic

Analysis and the Advisory Committee on Safety, Hygiene and

Health Protection at Work, shall establish rules of procedure

concerning worker protection issues. These rules of procedure

shall be adopted by the Management Board, in agreement with

the Commission.

29.5.2007L 136/62 Official Journal of the European Union

(

) OJ 17, 6.10.1958, p. 385/58. Regulation as last amended by Council

Regulation (EC) No 920/2005 (OJ L 156, 18.6.2005, p. 3).

This Title shall not affect the competences vested in the Advi-

sory Committee on Safety, Hygiene and Health Protection at

Work and the European Agency for Health and Safety at Work.

Article 111

Formats and software for submission of information to the

Agency

The Agency shall specify formats and make them available free

of charge, and software packages and make them available on

its website for any submissions to the Agency. Member States,

manufactures, importers, distributors or downstream users shall

use these formats and packages in their submissions to the

Agency pursuant to this Regulation. In particular, the Agency

shall make available software tools to facilitate the submission

of all information relating to substances registered in accordance

with Article 12(1).

For the purposes of registration, the format of the technical

dossier refer red to in Article 10(a) shall be IUCLID. The Agency

shall coordinate the further development of this format with the

Organisation for Economic Cooperation and Development to

ensure maximum harmonisation.

TITLE XI

CLASSIFICATION AND LABELLING INVENTORY

Article 112

Scope

This Title shall apply to:

(a) substances subject to registration;

(b) substances within the scope of Article 1 of Directive 67/

548/EEC, which meet the criteria for classification as

dangerous in accordance with that Directive, and which are

placed on the market either on their own, or in a prepara-

tion above the concentration limits specified in Direc-

tive 1999/45/EC, where relevant, which results in the classi-

fication of the preparation as dangerous.

Article 113

Obligation to notify the Agency

1. Any manufacturer, producer of articles or importer, or

group of manufacturers or producers of articles or importers,

who place on the market a substance within the scope of

Article 112, shall notify to the Agency the following informa-

tion in order for it to be included in the inventory in accordance

with Article 114, unless submitted as part of the registration:

(a) the identity(ies) of the manufacturer(s), producer(s) of arti-

cles or importer(s) responsible for placing the substance(s)

on the market as specified in Section 1 of Annex VI;

(b) the identity of the substance(s) as specified in Sections 2.1

to 2.3.4 of Annex VI;

the application of Articles 4 and 6 of Directive 67/548/EEC;

(d) the hazard label for the substance(s), resulting from the

application of Article 23(c) to (f), of Directive 67/548/EEC;

(e) specific concentration limits, where applicable, resulting

from the application of Article 4(4) of Directive 67/548/

EEC and Articles 4 to 7 of Directive 1999/45/EC.

2. Where the obligation under paragraph 1 results in

different entries on the inventory for the same substance, the

notifiers and registrants shall make every effort to come to an

agreed entry to be included in the inventory.

3. The information listed in paragraph 1 shall be updated by

the notifier(s) whenever:

(a) any new scientific or technical information is generated

which results in a change to the classification and labelling

of the substance;

(b) notifiers and registrants of differing entries for a single

substance come to an agreed entry in accordance with para-

graph 2.

Article 114

Classification and labelling inventory

1. A classification and labelling inventory, listing the infor-

mation referred to in Article 113(1), both for information noti-

fied under Article 113(1) as well as for information submitted

as part of a registration, shall be established and maintained by

the Agency in the form of a database. The information in this

database identified in Article 119(1) shall be publicly accessible.

The Agency shall grant access to the other data on each

substance in the inventory to the notifiers and registrants who

have submitted information on that substance in accordance

with Article 29(1).

The Agency shall update the inventory when it receives updated

information in accordance with Article 113(3).

29.5.2007 L 136/63Official Journal of the European Union

2. In addition to the information referred to in paragraph 1,

the Agency shall record the following information, where appro-

priate, against each entry:

(a) whether, in respect of the entry, there is a harmonised classi-

fication and labelling at Community level by inclusion in

Annex I of Directive 67/548/EEC;

(b) whether, in respect of the entry, it is a joint entry between

registrants of the same substance as per Article 11(1);

the same substance;

(d) the relevant registration number(s), if available.

Article 115

Harmonisation of classification and labelling

1. Harmonised classification and labelling at Community

level shall, from 1 June 2007, normally be added to Annex I of

Directive 67/548/EEC for classif ication of a substance as carci-

nogenic, mutagenic or toxic for reproduction category 1, 2 or

3, or as a respiratory sensitiser. Harmonised classification and

labelling for other effects may also be added to Annex I of

Directive 67/548/EEC on a case-by-case basis if justification is

provided demonstrating the need for action at Community level.

To this end, Member State competent authorities may submit

proposals to the Agency for harmonised classification and label-

ling in accordance with Annex XV.

2. The Committee for Risk Assessment shall adopt an

opinion on the proposal, giving parties concerned the opportu-

nity to comment. The Agency shall forward this opinion and

any comments to the Commission, which shall take a decision

in accordance with Article 4(3) of Directive 67/548/EEC.

Article 116

Transitional arrangements

The obligations set out in Article 113 shall apply from

1 December 2010.

TITLE XII

INFORMATION

Article 117

Reporting

1. Every five years, Member States shall submit to the

Commission a report on the operation of this Regulation in

their respective territories, including sections on evaluation and

enforcement as described in Article 127.

The first report shall be submitted by 1 June 2010.

2. Every five years, the Agency shall submit to the Commis-

sion a report on the operation of this Regulation. The Agency

shall include in its report information on the joint submission

of information in accordance with Article 11 and an overview

of the explanations given for submitting information separately.

The first report shall be submitted by 1 June 2011.

3. Every three years the Agency, in accordance with the

objective of promoting non-animal testing methods, shall

submit to the Commission a report on the status of implemen-

tation and use of non-animal test methods and testing strategies

used to generate information on intrinsic properties and for risk

assessment to meet the requirements of this Regulation.

The first report shall be submitted by 1 June 2011.

4. Every five years, the Commission shall publish a general

repor t on:

(a) the experience acquired with the operation of this Regu-

lation, including the information referred to in paragraphs 1,

2 and 3 and;

(b) the amount and distribution of funding made available by

the Commission for the development and evaluation of

alternative test methods.

The first report shall be published by 1 June 2012.

Article 118

Access to information

1. Regulation (EC) No 1049/2001 shall apply to documents

held by the Agency.

2. Disclosure of the following information shall normally be

deemed to undermine the protection of the commercial interests

of the concerned person:

(a) details of the full composition of a preparation;

(b) without prejudice to Article 7(6) and Article 64(2), the

precise use, function or application of a substance or

preparation, including information about its precise use as

an intermediate;

factured or placed on the market;

29.5.2007L 136/64 Official Journal of the European Union

(d) links between a manufacturer or importer and his distribu-

tors or downstream users.

Where urgent action is essential to protect human health, safety

or the environment, such as emergency situations, the Agency

may disclose the information referred to in this paragraph.

3. The Management Board shall adopt the practical arrange-

ments for implementing Regulation (EC) No 1049/2001,

including appeals or remedies necessary for reviewing a partial

or full rejection of a confidentiality request, by 1 June 2008.

4. Decisions taken by the Agency pursuant to Article 8 of

Regulation (EC) No 1049/2001 may form the subject of a

complaint to the Ombudsman or of an action before the Court

of Justice, under the conditions laid down in Articles 195 and

230 of the Treaty respectively.

Article 119

Electronic public access

1. The following information held by the Agency on

substances whether on their own, in preparations or in articles,

shall be made publicly available, free of charge, over the Internet

in accordance with Article 77(2)(e):

(a) the name in the IUPAC Nomenclature, for dangerous

substances within the meaning of Directive 67/548/EEC,

without prejudice to paragraph 2(f) and (g);

(b) if applicable, the name of the substance as given in EINECS;

(d) physicochemical data concerning the substance and on

pathways and environmental fate;

(e) the result of each toxicological and ecotoxicological study;

(f) any derived no-effect level (DNEL) or predicted no-effect

concentration (PNEC) established in accordance with

Annex I;

(g) the guidance on safe use provided in accordance with

Sections 4 and 5 of Annex VI;

(h) analytical methods if requested in accordance with

Annexes IX or X which make it possible to detect a

dangerous substance when discharged into the environment

as well as to determine the direct exposure of humans.

2. The following information on substances whether on their

own, in preparations or in articles, shall be made publicly avail-

able, free of charge, over the Internet in accordance with

Article 77(2)(e) except where a party submitting the information

submits a justification in accordance with Article 10(a)(xi),

accepted as valid by the Agency, as to why such publication is

potentially harmful for the commercial interests of the registrant

or any other party concerned:

(a) if essential to classification and labelling, the degree of

purity of the substance and the identity of impurities and/or

additives which are known to be dangerous;

(b) the total tonnage band (i.e. 1 to 10 tonnes, 10 to 100

tonnes, 100 to 1 000 tonnes or over 1 000 tonnes) within

which a particular substance has been registered;

information referred to in paragraph 1(d) and (e);

(d) information, other than that listed in paragraph 1, contained

in the safety data sheet;

(e) the trade name(s) of the substance;

(f) the name in the IUPAC Nomenclature for non-phase-in

substances which are dangerous within the meaning of

Directive 67/548/EEC for a period of six years;

(g) the name in the IUPAC Nomenclature for dangerous

substances within the meaning of Directive 67/548/EEC that

are only used as one or more of the following:

(i) as an intermediate;

(ii) in scientif ic research and development;

(iii) in product and process orientated research and develop-

ment.

Article 120

Cooperation with third countries and international organi-

sations

Notwithstanding Articles 118 and 119, information received by

the Agency under this Regulation may be disclosed to any

government or national authority of a third country or an inter-

national organisation in accordance with an agreement

concluded between the Community and the third party

concerned under Regulation (EC) No 304/2003 of the European

Parliament and of the Council of 28 January 2003 concerning

the export and import of dangerous chemicals (

) or under

Article 181a(3) of the Treaty, provided that both the following

conditions are met:

(a) the purpose of the agreement is cooperation on the imple-

mentation or management of legislation concerning chemi-

cals covered by this Regulation;

29.5.2007 L 136/65Official Journal of the European Union

(

) OJ L 63, 6.3.2003, p. 1. Regulation as last amended by Commission

Regulation (EC) No 777/2006 (OJ L 136, 24.5.2006, p. 9).

(b) the third party protects the confidential information as

mutually agreed.

TITLE XIII

COMPETENT AUTHORITIES

Article 121

Appointment

Member States shall appoint the competent authority or compe-

tent authorities responsible for performing the tasks allotted to

competent authorities under this Regulation and for cooperating

with the Commission and the Agency in the implementation of

this Regulation. Member States shall place adequate resources at

the disposal of the competent authorities to enable them, in

conjunction with any other available resources, to fulfil their

tasks under this Regulation in a timely and effective manner.

Article 122

Cooperation between competent authorities

The competent authorities shall cooperate with each other in

the performance of their tasks under this Regulation and shall

give the competent authorities of other Member States all the

necessary and useful support to this end.

Article 123

Communication to the public of information on risks of

substances

The competent authorities of the Member States shall inform

the general public about the risks arising from substances where

this is considered necessary for the protection of human health

or the environment. The Agency, in consultation with compe-

tent authorities and stakeholders and drawing as appropriate on

relevant best practice, shall provide guidance for the communi-

cation of information on the risks and safe use of chemical

substances, on their own, in preparations or in articles, with a

view to coordinating Member States in these activities.

Article 124

Other responsibilities

Competent authorities shall submit electronically to the Agency

any available information that they hold on substances regis-

tered in accordance with Article 12(1) whose dossiers do not

contain the full information referred to in Annex VII, in particu-

lar whether enforcement or monitoring activities have identified

suspicions of risk. The competent authority shall update this

information as appropriate.

Member States shall establish national helpdesks to provide

advice to manufacturers, importers, downstream users and any

other interested parties on their respective responsibilities and

obligations under this Regulation, in particular in relation to the

registration of substances in accordance with Article 12(1), in

addition to the operational guidance documents provided by the

Agency under Article 77(2)(g).

TITLE XIV

ENFORCEMENT

Article 125

Tasks of the Member States

Member States shall maintain a system of official controls and

other activities as appropriate to the circumstances.

Article 126

Penalties for non-compliance

Member States shall lay down the provisions on penalties applic-

able for infringement of the provisions of this Regulation and

shall take all measures necessary to ensure that they are imple-

mented. The penalties provided for must be effective, propor-

tionate and dissuasive. The Member States shall notify those

provisions to the Commission no later than 1 December 2008

and shall notify it without delay of any subsequent amendment

affecting them.

Article 127

Report

The report referred to in Article 117(1) shall, in relation to

enforcement, include the results of the official inspections, the

monitoring carried out, the penalties provided for and the other

measures taken pursuant to Articles 125 and 126 during the

previous reporting period. The common issues to be covered in

the reports shall be agreed by the Forum. The Commission shall

make these reports available to the Agency and the Forum.

TITLE XV

TRANSITIONAL AND FINAL PROVISIONS

Article 128

Free movement

1. Subject to paragraph 2, Member States shall not prohibit,

restrict or impede the manufacturing, import, placing on the

market or use of a substance, on its own, in a preparation or in

an article, falling within the scope of this Regulation, which

complies with this Regulation and, where appropriate, with

Community acts adopted in implementation of this Regulation.

29.5.2007L 136/66 Official Journal of the European Union

2. Nothing in this Regulation shall prevent Member States

from maintaining or laying down national rules to protect

workers, human health and the environment applying in cases

where this Regulation does not harmonise the requirements on

manufacture, placing on the market or use.

Article 129

Safeguard clause

1. Where a Member State has justifiable grounds for

believing that urgent action is essential to protect human health

or the environment in respect of a substance, on its own, in a

preparation or in an article, even if satisfying the requirements

of this Regulation, it may take appropriate provisional measures.

The Member State shall immediately inform the Commission,

the Agency and the other Member States thereof, giving reasons

for its decision and submitting the scientific or technical infor-

mation on which the provisional measure is based.

2. The Commission shall take a decision in accordance with

the procedure referred to in Article 133(3) within 60 days of

receipt of the information from the Member State. This decision

shall either:

(a) authorise the provisional measure for a time period defined

in the decision; or

(b) require the Member State to revoke the provisional measure.

3. If, in the case of a decision as referred to in paragraph 2

(a), the provisional measure taken by the Member State consists

in a restriction on the placing on the market or use of a

substance, the Member State concerned shall initiate a Com-

munity restrictions procedure by submitting to the Agency a

dossier, in accordance with Annex XV, within three months of

the date of the Commission decision.

4. In the case of a decision as referred to in paragraph 2(a),

the Commission shall consider whether this Regulation needs to

be adapted.

Article 130

Statement of reasons for decisions

The competent authorities, the Agency and the Commission

shall state the reasons for all decisions they take under this

Regulation.

Article 131

Amendments to the Annexes

The Annexes may be amended in accordance with the proce-

dure referred to in Article 133(4).

Article 132

Implementing legislation

The measures necessary to put the provisions of this Regulation

efficiently into effect shall be adopted in accordance with the

procedure referred to in Article 133(3).

Article 133

Committee procedure

1. The Commission shall be assisted by a Committee.

2. Where reference is made to this paragraph, Ar ticles 3 and

7 of Decision 1999/468/EC shall apply, having regard to the

provisions of Article 8 thereof.

3. Where reference is made to this paragraph, Ar ticles 5 and

7 of Decision 1999/468/EC shall apply, having regard to the

provisions of Article 8 thereof.

The period laid down in Article 5(6) of Decision 1999/468/EC

shall be set at three months.

4. Where reference is made to this paragraph, Article 5a(1)

to (4), and Article 7 of Decision 1999/468/EC shall apply,

having regard to the provisions of Article 8 thereof.

5. The Committee shall adopt its Rules of Procedure.

Article 134

Preparation of establishment of the Agency

1. The Commission shall afford the necessary support

towards the establishment of the Agency.

2. For that purpose, until such time as the Executive Director

takes up his duties following his appointment by the Manage-

ment Board of the Agency in accordance with Article 84, the

Commission, on behalf of the Agency, and using the budget

provided for the latter, may:

(a) appoint personnel, including a person who shall fulfil the

administrative functions of the Executive Director on an

interim basis; and

(b) conclude other contracts.

Article 135

Transitional measures regarding notified substances

1. The requests to notifiers to provide further information to

the competent authority in accordance with Article 16(2) of

Directive 67/548/EEC, shall be considered as decisions adopted

in accordance with Article 51 of this Regulation.

29.5.2007 L 136/67Official Journal of the European Union

2. The requests to a notifier to provide further information

for a substance in accordance with Article 16(1) of Directive

67/548/EEC, shall be considered as decisions adopted in accord-

ance with Article 52 of this Regulation.

Such substance shall be regarded as being included in the Com-

munity rolling action plan in accordance with Article 44(2) of

this Regulation and shall be regarded as being chosen in accord-

ance with Article 45(2) of this Regulation by the Member State

whose competent authority has requested further information in

accordance with Article 7(2) and Article 16(1) of Directive 67/

548/EEC.

Article 136

Transitional measures regarding existing substances

1. The requests to manufacturers and importers to submit

information to the Commission made by a Commission Regu-

lation in application of Article 10(2) of Regulation (EEC)

No 793/93, shall be considered as decisions adopted in accord-

ance with Article 52 of this Regulation.

The competent authority for the substance shall be the compe-

tent authority from the Member State identified as rapporteur in

accordance with Article 10(1) of Regulation (EEC) No 793/93

and shall carry out the tasks of Article 46(3) and Article 48 of

this Regulation.

2. The requests to manufacturers and importers to submit

information to the Commission made by a Commission Regu-

lation in application of Article 12(2) of Regulation (EEC)

No 793/93, shall be considered as decisions adopted in accord-

ance with Article 52 of this Regulation. The Agency shall iden-

tify the competent authority for the substance to carry out the

tasks of Article 46(3) and Article 48 of this Regulation.

3. A Member State whose rapporteur has not forwarded by

1 June 2008 the risk evaluation and, where appropriate, the

strategy for limiting the risks, in accordance with Article 10(3)

of Regulation (EEC) No 793/93, shall:

(a) document information on hazard and risk in accordance

with Annex XV, Part B of this Regulation;

(b) apply Article 69(4) of this Regulation on the basis of the

information referred to in point (a); and

risks identified would need to be addressed by action other

than an amendment of Annex XVII of this Regulation.

The information referred to above shall be submitted to the

Agency by 1 December 2008.

Article 137

Transitional measures regarding restrictions

1. By 1 June 2010, the Commission shall, if necessary,

prepare a draft amendment to Annex XVII in accordance with

either of the following:

(a) any risk evaluation and recommended strategy for limiting

risks that has been adopted at Community level in accord-

ance with Article 11 of Regulation (EEC) No 793/93 as far

as it includes proposals for restrictions in accordance with

Title VIII of this Regulation but for which a decision under

Directive 76/769/EEC has not yet been taken;

(b) any proposal, which has been submitted to the relevant

institutions but has not yet been adopted, concerning the

introduction or the amendment of restrictions under Direc-

tive 76/769/EEC.

2. Until 1 June 2010, any dossier referred to in Article 129

(3) shall be submitted to the Commission. The Commission

shall, if necessary, prepare a draft amendment to Annex XVII.

3. Any amendment to the restrictions adopted under Direc-

tive 76/769/EEC from 1 June 2007 shall be incorporated in

Annex XVII with effect from 1 June 2009.

Article 138

Review

1. By 1 June 2019, the Commission shall carry out a review

to assess whether or not to extend the application of the obliga-

tion to perform a chemical safety assessment and to document

it in a chemical safety report to substances not covered by this

obligation because they are not subject to registration or subject

to registration but manufactured or imported in quantities of

less than 10 tonnes per year. However, for substances meeting

the cr iteria for classification as carcinogenic, mutagenic or toxic

for reproduction, category 1 or 2, in accordance with Direc-

tive 67/548/EEC, the review shall be carried out by 1 June

2014. When carrying out the review the Commission shall take

into account all relevant factors, including:

(a) the costs for manufacturers and importers of drawing up

the chemical safety reports;

(b) the distribution of costs between actors in the supply chain

and the downstream user;

On the basis of these reviews, the Commission may, if appro-

priate, present legislative proposals to extend this obligation.

29.5.2007L 136/68 Official Journal of the European Union

2. The Commission may present legislative proposals as soon

as a practicable and cost-efficient way of selecting polymers for

registration on the basis of sound technical and valid scientific

criteria can be established, and after publishing a report on the

following:

(a) the risks posed by polymers in comparison with other

substances;

(b) the need, if any, to register certain types of polymer, taking

account of competitiveness and innovation on the one hand

and the protection of human health and the environment

on the other.

3. The report, referred to in Article 117(4), on the experience

acquired with the operation of this Regulation shall include a

review of the requirements relating to registration of substances

manufactured or imported only in quantities starting at one

tonne but less than 10 tonnes per year per manufacturer or

importer. On the basis of that review, the Commission may

present legislative proposals to modify the information require-

ments for substances manufactured or impor ted in quantities of

one tonne or more up to 10 tonnes per year per manufacturer

or importer, taking into account the latest developments, for

example in relation to alternative testing and (quantitative) struc-

ture-activity relationships ((Q)SARs).

4. The Commission shall carry out a review of Annexes I, IV

and V by 1 June 2008, with a view to proposing amendments,

if appropriate, to them in accordance with the procedure

referred to in Article 131.

5. The Commission shall carr y out a review of Annex XIII by

1 December 2008, to assess the adequacy of the criteria for

identifying substances which are persistent, bioaccumulative and

toxic or very persistent and very bioaccumulative, with a view

to proposing an amendment to it, if appropriate, in accordance

with the procedure referred to in Article 133(4).

6. By 1 June 2012 the Commission shall carry out a review

to assess whether or not to amend the scope of this Regulation

to avoid overlaps with other relevant Community provisions.

On the basis of that review, the Commission may, if appropriate,

present a legislative proposal.

7. By 1 June 2013 the Commission shall carry out a review

to assess whether or not, taking into account latest develop-

ments in scientif ic knowledge, to extend the scope of Article 60

(3) to substances identified under Article 57(f) as having endo-

crine disrupting properties. On the basis of that review the

Commission may, if appropriate, present legislative proposals.

8. By 1 June 2019, the Commission shall carry out a review

to assess whether or not to extend the scope of Article 33 to

cover other dangerous substances, taking into account the prac-

tical exper ience in implementing that Article. On the basis of

that review, the Commission may, if appropriate, present legisla-

tive proposals to extend that obligation.

9. In accordance with the objective of promoting non-animal

testing and the replacement, reduction or refinement of animal

testing required under this Regulation, the Commission shall

review the testing requirements of Section 8.7 of Annex VIII by

1 June 2019. On the basis of this review, while ensuring a high

level of protection of health and the environment, the Commis-

sion may propose an amendment in accordance with the proce-

dure referred to in Article 133(4).

Article 139

Repeals

Directive 91/155/EEC shall be repealed.

Directives 93/105/EC and 2000/21/EC and Regulations (EEC)

No 793/93 and (EC) No 1488/94 shall be repealed with effect

from 1 June 2008.

Directive 93/67/EEC shall be repealed with effect from 1 August

2008.

Directive 76/769/EEC shall be repealed with effect from 1 June

2009.

References to the repealed acts shall be construed as references

to this Regulation.

Article 140

Amendment of Directive 1999/45/EC

Article 14 of Directive 1999/45/EC shall be deleted.

Article 141

Entry into force and application

1. This Regulation shall enter into force on 1 June 2007.

2. Titles II, III, V, VI, VII, XI and XII as well as Articles 128

and 136 shall apply from 1 June 2008.

3. Article 135 shall apply from 1 August 2008.

4. Title VIII and Annex XVII shall apply from 1 June 2009.

29.5.2007 L 136/69Official Journal of the European Union

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 18 December 2006.

For the European Parliament

The President

J. BORRELL FONTELLES

For the Council

The President

M. VANHANEN

29.5.2007L 136/70 Official Journal of the European Union

LIS T OF ANNEXES

ANNEX I GENERAL PROVISIONS FOR ASSESSING SUBSTANCES AND PREPARING CHEMICAL SAFETY

REPORTS

....................................................................................................................... 72

ANNEX II GUIDE TO THE COMPILATION OF SAFETY DATA SHEETS

................................................... 84

ANNEX III CRITERIA FOR SUBSTANCES REGISTERED IN QUANTITIES BETWEEN 1 AND 10 TONNES

....... 93

ANNEX IV EXEMPTIONS FROM THE OBLIGATION TO REGISTER IN ACCORDANCE WITH ARTICLE

2(7)(a)

........................................................................................................................... 94

ANNEX V EXEMPTIONS FROM THE OBLIGATION TO REGISTER IN ACCORDANCE WITH ARTICLE

2(7)(b)

........................................................................................................................... 98

ANNEX VI INFORMATION REQUIREMENTS REFERRED TO IN ARTICLE 10

............................................ 99

ANNEX VII STANDARD INFORMATION REQUIREMENTS FOR SUBSTANCES MANUFACTURED OR

IMPORTED IN QUANTITIES OF ONE TONNE OR MORE

....................................................... 103

ANNEX VIII STANDARD INFORMATION REQUIREMENTS FOR SUBSTANCES MANUFACTURED OR

IMPORTED IN QUANTITIES OF 10 TONNES OR MORE

........................................................ 107

ANNEX IX STANDARD INFORMATION REQUIREMENTS FOR SUBSTANCES MANUFACTURED OR

IMPORTED IN QUANTITIES OF 100 TONNES OR MORE

...................................................... 111

ANNEX X STANDARD INFORMATION REQUIREMENTS FOR SUBSTANCES MANUFACTURED OR

IMPORTED IN QUANTITIES OF 1 000 TONNES OR MORE

................................................... 116

ANNEX XI GENERAL RULES FOR ADAPTATION OF THE STANDARD TESTING REGIME SET OUT IN

ANNEXES VII TO X

......................................................................................................... 119

ANNEX XII GENERAL PROVISIONS FOR DOWNSTREAM USERS TO ASSESS SUBSTANCES AND PREPARE

CHEMICAL SAFETY REPORTS

........................................................................................... 122

ANNEX XIII CRITERIA FOR THE IDENTIFICATION OF PERSISTENT, BIOACCUMULATIVE AND TOXIC

SUBSTANCES, AND VERY PERSISTENT AND VERY BIOACCUMULATIVE SUBSTANCES

............. 124

ANNEX XIV LIST OF SUBSTANCES SUBJECT TO AUTHORISATION

......................................................... 125

ANNEX XV DOSSIERS

..................................................................................................................... 126

ANNEX XVI SOCIO-ECONOMIC ANALYSIS

.......................................................................................... 128

ANNEX XVII RESTRICTIONS ON THE MANUFACTURE, PLACING ON THE MARKET AND USE OF CERTAIN

DANGEROUS SUBSTANCES, PREPARATIONS AND ARTICLES

............................................... 129

29.5.2007 L 136/71Official Journal of the European Union

ANNEX I

GENERAL PROVISIONS FOR ASSESSING SUBSTANCES AND PREPARING CHEMIC AL SAFETY REPORTS

0. INTRODUCTION

0.1. The purpose of this Annex is to set out how manufacturers and importers are to assess and document that the

risks arising from the substance they manufacture or import are adequately controlled during manufacture and

their own use(s) and that others further down the supply chain can adequately control the risks. This Annex shall

also apply adapted as necessary to producers and importers of articles required to make a chemical safety assess-

ment as par t of a registration.

0.2. The chemical safety assessment shall be prepared by one or more competent person(s) who have appropriate

experience and received appropriate training, including refresher training.

0.3. The chemical safety assessment of a manufacturer shall address the manufacture of a substance and all the identi-

fied uses. The chemical safety assessment of an importer shall address all identified uses. The chemical safety assess-

ment shall consider the use of the substance on its own (including any major impurities and additives), in a

preparation and in an article, as defined by the identified uses. The assessment shall consider all stages of the life-

cycle of the substance resulting from the manufacture and identified uses. The chemical safety assessment shall be

based on a comparison of the potential adverse effects of a substance with the known or reasonably foreseeable

exposure of man and/or the environment to that substance taking into account implemented and recommended

risk management measures and operational conditions.

0.4. Substances whose physicochemical, toxicological and ecotoxicological properties are likely to be similar or follow a

regular pattern as a result of structural similarity may be considered as a group, or ‘category’ of substances. If the

manufacturer or importer considers that the chemical safety assessment carried out for one substance is sufficient

to assess and document that the risks arising from another substance or from a group or ‘category’ of substances

are adequately controlled then he can use that chemical safety assessment for the other substance or group or ‘cate-

gory’ of substances. The manufacturer or importer shall provide a justification for this.

0.5. The chemical safety assessment shall be based on the information on the substance contained in the technical

dossier and on other available and relevant information. Manufacturers or importers submitting a proposal for

testing in accordance with Annexes IX and X shall record this under the relevant heading of the chemical safety

report. Available information from assessments carried out under other international and national programmes

shall be included. Where available and appropriate, an assessment carried out under Community legislation (e.g.

risk assessments completed under Regulation (EEC) No 793/93) shall be taken into account in the development of,

and reflected in, the chemical safety report. Deviations from such assessments shall be justified.

Thus the information to be considered includes information related to the hazards of the substance, the exposure

arising from the manufacture or import, the identified uses of the substance, operational conditions and risk

management measures applied or recommended to downstream users to be taken into account.

In accordance with section 3 of Annex XI in some cases, it may not be necessary to generate missing information,

because risk management measures and operational conditions which are necessary to control a well-characterised

risk may also be sufficient to control other potential risks, which will not therefore need to be characterised

precisely.

If the manufacturer or importer considers that further information is necessary for producing his chemical safety

report and that this information can only be obtained by performing tests in accordance with Annex IX or X, he

shall submit a proposal for a testing strategy, explaining why he considers that additional information is necessary

and record this in the chemical safety report under the appropriate heading. While waiting for results of further

testing, he shall record in his chemical safety report, and include in the exposure scenario developed, the interim

risk management measures that he has put in place and those he recommends to downstream users intended to

manage the risks being explored.

0.6. A chemical safety assessment performed by a manufacturer or an importer for a substance shall include the

following steps in accordance with the respective sections of this Annex:

1. Human health hazard assessment.

2. Human health hazard assessment of physicochemical properties.

29.5.2007L 136/72 Official Journal of the European Union

3. Environmental hazard assessment.

4. PBT and vPvB assessment.

If as a result of steps 1 to 4 the manufacturer or importer concludes that the substance or the preparation meets

the criteria for classification as dangerous according to Directive 67/548/EEC or Directive 1999/45/EC or is

assessed to be a PBT or vPvB, the chemical safety assessment shall also consider the following steps:

5. Exposure assessment

5.1. The generation of exposure scenario(s) or the generation of relevant use and exposure categories if appro-

priate.

5.2. Exposure estimation.

6. Risk characterisation

A summar y of all the relevant information used in addressing the points above, shall be presented under the rele-

vant heading of the Chemical Safety Repor t (Section 7).

0.7. The main element of the exposure part of the chemical safety report is the description of the exposure scenario(s)

implemented for the manufacturer's production, the manufacturer or importer's own use, and those recommended

by the manufacturer or importer to be implemented for the identified use(s).

An exposure scenario is the set of conditions that describe how the substance is manufactured or used during its

life-cycle and how the manufacturer or importer controls, or recommends downstream users to control, exposures

of humans and the environment. These sets of conditions contain a descr iption of both the risk management

measures and operational conditions which the manufacturer or importer has implemented or recommends to be

implemented by downstream users.

If the substance is placed on the market, the relevant exposure scenario(s), including the risk management measures

and operational conditions shall be included in an annex to the safety data sheet in accordance with Annex II.

0.8. The level of detail required in describing an exposure scenario will vary substantially from case to case, depending

on the use of a substance, its hazardous properties and the amount of information available to the manufacturer

or importer. Exposure scenarios may describe the appropriate risk management measures for several individual

processes or uses of a substance. An exposure scenario may thereby cover a large range of processes or uses. Expo-

sure scenarios covering a wide range of processes or uses may be referred to as Exposure Categories. Further

mention of Exposure Scenario in this Annex and Annex II includes Exposure Categories if they are developed.

0.9. Where information is not necessary in accordance with Annex XI, this fact shall be stated under the appropriate

heading of the chemical safety report and a reference shall be made to the justification in the technical dossier. The

fact that no information is required shall also be stated in the safety data sheet.

0.10. In relation to particular effects, such as ozone depletion, photochemical ozone creation potential, strong odour and

tainting, for which the procedures set out in Sections 1 to 6 are impracticable, the risks associated with such

effects shall be assessed on a case-by-case basis and the manufacturer or importer shall include a full description

and justification of such assessments in the chemical safety report and summarised in the safety data sheet.

0.11. When assessing the risk of the use of one or more substances incorporated into a special preparation (for instance

alloys), the way the constituent substances are bonded in the chemical matrix shall be taken into account.

0.12. Where the methodology described in this Annex is not appropriate, details of alternative methodology used shall

be explained and justified in the chemical safety report.

29.5.2007 L 136/73Official Journal of the European Union

0.13. Part A of the chemical safety report shall include a declaration that the risk management measures outlined in the

relevant exposure scenarios for the manufacturer's or importer's own use(s) are implemented by the manufacturer

or importer and that those exposure scenar ios for the identified uses are communicated to distributors and down-

stream users in the safety data sheet(s).

1. HUMAN HEALTH HAZARD ASSESSMENT

1.0. Introduction

1.0.1. The objective of the human health hazard assessment shall be:

— to determine the classification and labelling of a substance in accordance with Directive 67/548/EEC, and

— to derive levels of exposure to the substance above which humans should not be exposed. This level of expo-

sure is known as the Derived No-Effect Level (DNEL).

1.0.2. The human health hazard assessment shall consider the toxicokinetic profile (i.e. absorption, metabolism, distribu-

tion and elimination) of the substance and the following groups of effects, (1) acute effects (acute toxicity, irritation

and cor rosivity), (2) sensitisation, (3) repeated dose toxicity and (4) CMR effects (carcinogenity, mutagenicity and

toxicity for reproduction). Based on all the available information, other effects shall be considered when necessary.

1.0.3. The hazard assessment shall comprise the following four steps:

Step 1: Evaluation of non-human information.

Step 2: Evaluation of human information.

Step 3: Classification and Labelling.

Step 4: Derivation of DNELs.

1.0.4. The first three steps shall be undertaken for every effect for which information is available and shall be recorded

under the relevant section of the Chemical Safety Report and where required and in accordance with Article 31,

summarised in the Safety Data Sheet under headings 2 and 11.

1.0.5. For any effect for which no relevant information is available, the relevant section shall contain the sentence: ‘This

information is not available’. The justification, including reference to any literature search car ried out, shall be

included in the technical dossier.

1.0.6. Step 4 of the human health hazard assessment shall be undertaken by integrating the results from the first three

steps and shall be included under the relevant heading of the Chemical Safety Report and summarised in the Safety

Data Sheet under heading 8.1.

1.1. Step 1: Evaluation of non-human information

1.1.1. The evaluation of non-human information shall comprise:

— the hazard identification for the effect based on all available non-human information,

— the establishment of the quantitative dose (concentration)-response (effect) relationship.

1.1.2. When it is not possible to establish the quantitative dose (concentration)-response (effect) relationship, then this

should be justified and a semi-quantitative or qualitative analysis shall be included. For instance, for acute effects it

is usually not possible to establish the quantitative dose (concentration)-response (effect) relationship on the basis

of the results of a test conducted in accordance with test methods laid down in a Commission Regulation as speci-

fied in Article 13(3). In such cases it suffices to determine whether and to which degree the substance has an

inherent capacity to cause the effect.

1.1.3. All non-human information used to assess a particular effect on humans and to establish the dose (concentration)-

response (effect) relationship, shall be briefly presented, if possible in the form of a table or tables, distinguishing

between in vitro, in vivo and other information. The relevant test results (e.g. LD50, NO(A)EL or LO(A)EL) and test

conditions (e.g. test duration, route of administration) and other relevant information shall be presented, in interna-

tionally recognised units of measurement for that effect.

29.5.2007L 136/74 Official Journal of the European Union

1.1.4. If one study is available then a robust study summary should be prepared for that study. If there are several studies

addressing the same effect, then, having taken into account possible variables (e.g. conduct, adequacy, relevance of

test species, quality of results, etc.), normally the study or studies giving rise to the highest concern shall be used to

establish the DNELs and a robust study summary shall be prepared for that study or studies and included as part

of the technical dossier. Robust summaries will be required of all key data used in the hazard assessment. If the

study or studies giving rise to the highest concern are not used, then this shall be fully justified and included as

part of the technical dossier, not only for the study being used but also for all studies demonstrating a higher

concern than the study being used. It is important irrespective of whether hazards have been identified or not that

the validity of the study be considered.

1.2. Step 2: Evaluation of human information

If no human information is available, this part shall contain the statement: ‘No human information is available’.

However, if human information is available, it shall be presented, if possible in the form of a table.

1.3. Step 3: Classification and Labelling

1.3.1. The appropriate classif ication and labelling developed in accordance with the criteria in Directive 67/548/EEC shall

be presented and justified. Where applicable Specific Concentration limits, resulting from the application of

Article 4(4) of Directive 67/548/EEC and Articles 4 to 7 of Directive 1999/45/EC, shall be presented and, if they

are not included in Annex I to Directive 67/548/EEC, justified. The assessment should always include a statement

as to whether the substance fulfils or does not fulfil the criteria given in Directive 67/548/EEC for CMR, cate-

gories 1 and 2.

1.3.2. If the information is inadequate to decide whether a substance should be classified for a particular end-point, the

registrant shall indicate and justify the action or decision he has taken as a result.

1.4. Step 4: Identification of DNEL(s)

1.4.1. Based on the outcomes of steps 1 and 2, (a) DNEL(s) shall be established for the substance, reflecting the likely

route(s), duration and frequency of exposure. For some endpoints, especially mutagenicity and carcinogenicity, the

available information may not enable a threshold, and therefore a DNEL, to be established. If justified by the expo-

sure scenario(s), a single DNEL may be sufficient. However, taking into account the available information and the

exposure scenar io(s) in Section 9 of the Chemical Safety Report it may be necessary to identify different DNELs for

each relevant human population (e.g. workers, consumers and humans liable to exposure indirectly via the environ-

ment) and possibly for certain vulnerable sub-populations (e.g. children, pregnant women) and for different routes

of exposure. A full justification shall be given specifying, inter alia, the choice of the information used, the route of

exposure (oral, dermal, inhalation) and the duration and frequency of exposure to the substance for which the

DNEL is valid. If more than one route of exposure is likely to occur, then a DNEL shall be established for each

route of exposure and for the exposure from all routes combined. When establishing the DNEL, the following

factors shall, inter alia, be taken into account:

(a) the uncertainty arising, among other factors, from the variability in the experimental information and from

intra- and inter-species variation;

(b) the nature and severity of the effect;

sure applies.

1.4.2. If it is not possible to identify a DNEL, then this shall be clearly stated and fully justified.

2. PHYSICOCHEMICAL HAZARD ASSESSMENT

2.1. The objective of the hazard assessment for physicochemical properties shall be to determine the classification and

labelling of a substance in accordance with Directive 67/548/EEC.

2.2. As a minimum, the potential effects to human health shall be assessed for the following physicochemical proper-

ties:

— explosivity,

— flammability,

— oxidising potential.

If the information are inadequate to decide whether a substance should be classified for a particular end-point, the

registrant shall indicate and justify the action or decision he has taken as a result.

29.5.2007 L 136/75Official Journal of the European Union

2.3. The assessment of each effect shall be presented under the relevant heading of the Chemical Safety Report

(Section 7) and where required and in accordance with Article 31, summarised in the Safety Data Sheet under

headings 2 and 9.

2.4. For every physicochemical property, the assessment shall entail an evaluation of the inherent capacity of the

substance to cause the effect resulting from the manufacture and identified uses.

2.5. The appropriate classification and labelling developed in accordance with the criteria in Directive 67/548/EEC shall

be presented and justified.

3. ENVIRONMENTAL HAZARD ASSESSMENT

3.0. Introduction

3.0.1. The objective of the environmental hazard assessment shall be to determine the classification and labelling of a

substance in accordance with Directive 67/548/EEC and to identify the concentration of the substance below

which adverse effects in the environmental sphere of concern are not expected to occur. This concentration is

known as the Predicted No-Effect Concentration (PNEC).

3.0.2. The environmental hazard assessment shall consider the potential effects on the environment, comprising the

(1) aquatic (including sediment), (2) terrestrial and (3) atmospheric compartments, including the potential effects

that may occur (4) via food-chain accumulation. In addition, the potential effects on the (5) microbiological activity

of sewage treatment systems shall be considered. The assessment of the effects on each of these five environmental

spheres shall be presented under the relevant heading of the Chemical Safety Report (Section 7) and where required

and in accordance with Article 31, summarised in the Safety Data Sheet under headings 2 and 12.

3.0.3. For any environmental sphere, for which no effect information is available, the relevant section of the chemical

safety report shall contain the sentence: ‘This information is not available’. The justification, including reference to

any literature research carried out, shall be included in the technical dossier. For any environmental sphere for

which information is available, but the manufacturer or importer believes that it is not necessary to conduct the

hazard assessment, the manufacturer or importer shall present a justification, with reference to pertinent informa-

tion, under the relevant heading of the Chemical Safety Report (Section 7) and where required and in accordance

with Article 31, summarised in the Safety Data Sheet under heading 12.

3.0.4. The hazard assessment shall comprise the following three steps, which shall be clearly identified as such in the

Chemical Safety Report:

Step 1: Evaluation of information.

Step 2: Classification and Labelling.

Step 3: Derivation of the PNEC.

3.1. Step 1: Evaluation of information

3.1.1. The evaluation of all available information shall comprise:

— the hazard identification based on all available information,

— the establishment of the quantitative dose (concentration)-response (effect) relationship.

3.1.2. When it is not possible to establish the quantitative dose (concentration)-response (effect) relationship, then this

should be justified and a semi-quantitative or qualitative analysis shall be included.

3.1.3. All information used to assess the effects on a specific environmental sphere shall be briefly presented, if possible

in the form of a table or tables. The relevant test results (e.g. LC50 or NOEC) and test conditions (e.g. test duration,

route of administration) and other relevant information shall be presented, in internationally recognised units of

measurement for that effect.

29.5.2007L 136/76 Official Journal of the European Union

3.1.4. All information used to assess the environmental fate of the substance shall be briefly presented, if possible in the

form of a table or tables. The relevant test results and test conditions and other relevant information shall be

presented, in internationally recognised units of measurement for that effect.

3.1.5. If one study is available then a robust study summary should be prepared for that study. Where there is more than

one study addressing the same effect, then the study or studies giving rise to the highest concern shall be used to

draw a conclusion and a robust study summar y shall be prepared for that study or studies and included as part of

the technical dossier. Robust summaries will be required of all key data used in the hazard assessment. If the study

or studies giving rise to the highest concer n are not used, then this shall be fully justified and included as part of

the technical dossier, not only for the study being used but also for all studies reaching a higher concern than the

study being used. For substances where all available studies indicate no hazards an overall assessment of the validity

of all studies should be performed.

3.2. Step 2: Classification and Labelling

3.2.1. The appropriate classif ication and labelling developed in accordance with the criteria in Directive 67/548/EEC shall

be presented and justified. Where applicable Specific Concentration limits, resulting from the application of

Article 4(4) of Directive 67/548/EEC and Articles 4 to 7 of Directive 1999/45/EC, shall be presented and, if they

are not included in Annex I to Directive 67/548/EEC, justified.

3.2.2. If the information are inadequate to decide whether a substance should be classified for a particular end-point, the

registrant shall indicate and justify the action or decision he has taken as a result.

3.3. Step 3: Identification of the PNEC

3.3.1. Based on the available information, the PNEC for each environmental sphere shall be established. The PNEC may

be calculated by applying an appropriate assessment factor to the effect values (e.g. LC50 or NOEC). An assessment

factor expresses the difference between effects values derived for a limited number of species from laboratory tests

and the PNEC for the environmental sphere (

3.3.2. If it is not possible to derive the PNEC, then this shall be clearly stated and fully justified.

4. PBT AND VPVB ASSESSMENT

4.0. Introduction

4.0.1. The objective of the PBT and vPvB assessment shall be to determine if the substance fulfils the criteria given in

Annex XIII and if so, to characterise the potential emissions of the substance. A hazard assessment in accordance

with Sections 1 and 3 of this Annex addressing all the long-term effects and the estimation of the long-term expo-

sure of humans and the environment as carried out in accordance with Section 5 (Exposure Assessment), step 2

(Exposure Estimation), cannot be carried out with sufficient reliability for substances satisfying the PBT and vPvB

criteria in Annex XIII. Therefore, a separate PBT and vPvB assessment is required.

4.0.2. The PBT and vPvB assessment shall comprise the following two steps, which shall be clearly identified as such in

Part B, Section 8 of the Chemical Safety Report:

Step 1: Compar ison with the Criteria.

Step 2: Emission Characterisation.

The assessment shall also be summarised in the Safety Data Sheet under heading 12.

4.1. Step 1: Comparison with the Criteria

This part of the PBT and vPvB assessment shall entail the comparison of the available information, which is

submitted as part of the technical dossier, with the criteria given in Annex XIII and a statement of whether the

substance fulfils or does not fulfil the criteria.

If the available information is not sufficient to decide whether the substance fulfils the criteria in Annex XIII, then

other evidence like monitoring data available for the registrant and giving rise to an equivalent level of concern

shall be considered on a case-by-case basis.

29.5.2007 L 136/77Official Journal of the European Union

(

) In general, the more extensive the data and the longer the duration of the tests, the smaller is the degree of uncertainty and the size of the

assessment factor. An assessment factor of 1 000 is typically applied to the lowest of three short term L(E)C50 values derived from species

representing different trophic levels and a factor of 10 to the lowest of three long-term NOEC values derived from species representing

different trophic levels.

If the technical dossier contains for one or more endpoints only information as required in Annexes VII and VIII,

the registrant shall consider information relevant for screening for P, B and T properties to decide whether further

information needs to be generated to fulfil the objective of the PBT and vPvB assessment. In case the generation of

further information is necessary and would require testing on vertebrate animals, the registrant shall submit a

testing proposal. However, such further information does not need to be generated if the registrant implements or

recommends sufficient risk management measures and operational conditions that enable derogation according to

Section 3 of Annex XI from testing relevant for PBT and vPvB assessment.

4.2. Step 2: Emission Characterisation

If the substance fulfils the criteria an emission characterisation shall be conducted comprising the relevant parts of

the exposure assessment as described in Section 5. In particular it shall contain an estimation of the amounts of

the substance released to the different environmental compartments during all activities carried out by the manu-

facturer or importer and all identified uses, and an identification of the likely routes by which humans and the

environment are exposed to the substance.

5. EXPOSURE ASSESSMENT

5.0. Introduction

The objective of the exposure assessment shall be to make a quantitative or qualitative estimate of the dose/concen-

tration of the substance to which humans and the environment are or may be exposed. The assessment shall

consider all stages of the life-cycle of the substance resulting from the manufacture and identified uses and shall

cover any exposures that may relate to the hazards identified in Sections 1 to 4. The exposure assessment shall

entail the following two steps, which shall be clearly identified as such in the Chemical Safety Report:

Step 1: Generation of exposure scenario(s) or the generation of relevant use and exposure categories.

Step 2: Exposure Estimation.

Where required and in accordance with Article 31, the exposure scenario shall also be included in an annex to the

Safety Data Sheet.

5.1. Step 1: Development of exposure scenar ios

5.1.1. Exposure scenarios as described in Sections 0.7 and 0.8 shall be generated. Exposure scenarios are the core of the

process to carry out a chemical safety assessment. The chemical safety assessment process may be iterative. The

first assessment will be based on the required minimum and all available hazard information and on the exposure

estimation that corresponds to the initial assumptions about the operating conditions and risk management

measures (an initial exposure scenario). If the initial assumptions lead to a risk characterisation indicating that risks

to human health and the environment are not adequately controlled, then it is necessary to carry out an iterative

process with amendment of one or a number of factors in hazard or exposure assessment with the aim to demon-

strate adequate control. The refinement of hazard assessment may require generation of additional hazard informa-

tion. The refinement of exposure assessment may involve appropriate alteration of the operational conditions or

risk management measures in the exposure scenario or more precise exposure estimation. The exposure scenario,

resulting from the final iteration (a final exposure scenario), shall be included in the chemical safety report and

attached to the safety data sheet in accordance with Article 31.

The final exposure scenario shall be presented under the relevant heading of the chemical safety report, and

included in an annex to the safety data sheet, using an appropriate short title giving a brief general description of

the use, consistent with those given in Section 3.5 of Annex VI. Exposure scenarios shall cover any manufacture in

the Community and all identified uses.

In particular, an exposure scenario includes, where relevant, a description of:

Operational conditions

— the processes involved, including the physical form in which the substance is manufactured, processed and/or

used,

— the activities of workers related to the processes and the duration and frequency of their exposure to the

substance,

— the activities of consumers and the duration and frequency of their exposure to the substance,

29.5.2007L 136/78 Official Journal of the European Union

— the duration and frequency of emissions of the substance to the different environmental compartments and

sewage treatment systems and the dilution in the receiving environmental compartment.

Risk management measures

— the risk management measures to reduce or avoid direct and indirect exposure of humans (including workers

and consumers) and the different environmental compartments to the substance,

— the waste management measures to reduce or avoid exposure of humans and the environment to the substance

during waste disposal and/or recycling.

5.1.2. Where a manufacturer, importer or downstream user applies for an application for an authorisation for a specific

use, exposure scenarios need only be developed for that use and the subsequent life-cycle steps.

5.2. Step 2: Exposure Estimation

5.2.1. The exposure shall be estimated for each exposure scenario developed and shall be presented under the relevant

heading of the Chemical Safety Report and where required and in accordance with Article 31, summarised in an

annex to the safety data sheet. The exposure estimation entails three elements: (1) emission estimation;

(2) assessment of chemical fate and pathways; and (3) estimation of exposure levels.

5.2.2. The emission estimation shall consider the emissions during all relevant parts of the life-cycle of the substance

resulting from the manufacture and each of the identified uses. The life-cycle stages resulting from the manufacture

of the substance cover, where relevant, the waste stage. The life-cycle stages resulting from identified uses cover,

where relevant, the service-life of articles and the waste stage. The emission estimation shall be performed under

the assumption that the risk management measures and operational conditions described in the exposure scenario

have been implemented.

5.2.3. A characterisation of possible degradation, transformation, or reaction processes and an estimation of environ-

mental distribution and fate shall be performed.

5.2.4. An estimation of the exposure levels shall be performed for all human populations (workers, consumers and

humans liable to exposure indirectly via the environment) and environmental spheres for which exposure to the

substance is known or reasonably foreseeable. Each relevant route of human exposure (inhalation, oral, dermal and

combined through all relevant routes and sources of exposure) shall be addressed. Such estimations shall take

account of spatial and temporal variations in the exposure pattern. In particular, the exposure estimation shall take

account of:

— adequately measured, representative exposure data,

— any major impurities and additives in the substance,

— the quantity in which the substance is produced and/or imported,

— the quantity for each identified use,

— implemented or recommended risk management, including the degree of containment,

— duration and frequency of exposure according to the operational conditions,

— the activities of workers related to the processes and the duration and frequency of their exposure to the

substance,

— the activities of consumers and the duration and frequency of their exposure to the substance,

— the duration and frequency of emissions of the substance to the different environmental compartments and the

dilution in the receiving environmental compartment,

29.5.2007 L 136/79Official Journal of the European Union

— the physicochemical properties of the substance,

— transformation and/or degradation products,

— the likely routes of exposure of and potential for absorption in humans,

— the likely pathways to the environment and environmental distribution and degradation and/or transformation

(see also Section 3 Step 1),

— scale (geographical) of exposure,

— matrix dependent release/migration of the substance.

5.2.5. Where adequately measured representative exposure data are available, special consideration shall be given to them

when conducting the exposure assessment. Appropriate models can be used for the estimation of exposure levels.

Relevant monitoring data from substances with analogous use and exposure patterns or analogous properties can

also be considered.

6. RISK CHARACTERISATION

6.1. The risk characterisation shall be carried out for each exposure scenario and shall be presented under the relevant

heading of the Chemical Safety Report.

6.2. The risk characterisation shall consider the human populations (exposed as workers, consumers or indirectly via

the environment and if relevant a combination thereof) and the environmental spheres for which exposure to the

substance is known or reasonably foreseeable, under the assumption that the risk management measures described

in the exposure scenarios in the Section 5 have been implemented. In addition, the overall environmental risk

caused by the substance shall be reviewed by integrating the results for the overall releases, emissions and losses

from all sources to all environmental compartments.

6.3. The risk characterisation consists of:

— a comparison of the exposure of each human population known to be or likely to be exposed with the appro-

priate DNEL,

— a comparison of the predicted environmental concentrations in each environmental sphere with the PNECs,

and

— an assessment of the likelihood and severity of an event occurring due to the physicochemical properties of the

substance.

6.4. For any exposure scenario, the risk to humans and the environment can be considered to be adequately controlled,

throughout the lifecycle of the substance that results from manufacture or identified uses, if:

— the exposure levels estimated in Section 6.2 do not exceed the appropriate DNEL or the PNEC, as determined

in Sections 1 and 3, respectively, and,

— the likelihood and severity of an event occurring due to the physicochemical properties of the substance as

determined in Section 2 is negligible.

6.5. For those human effects and those environmental spheres for which it was not possible to determine a DNEL or a

PNEC, a qualitative assessment of the likelihood that effects are avoided when implementing the exposure scenario

shall be carried out.

For substances satisfying the PBT and vPvB criteria, the manufacturer or importer shall use the information as

obtained in Section 5, Step 2 when implementing on its site, and recommending for downstream users, risk

management measures which minimise exposures and emissions to humans and the environment, throughout the

lifecycle of the substance that results from manufacture or identified uses.

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7. CHEMICAL SAFETY REPORT FORMAT

The Chemical Safety Report shall include the following headings:

CHEMICAL SAFETY REPORT FORMAT

PART A

1. SUMMARY OF RISK MANAGEMENT MEASURES

2. DECLARATION THAT RISK MANAGEMENT MEASURES ARE IMPLEMENTED

3. DECLARATION THAT RISK MANAGEMENT MEASURES ARE COMMUNICATED

PART B

1. IDENTITY OF THE SUBSTANCE AND PHYSICAL AND CHEMICAL PROPERTIES

2. MANUFACTURE AND USES

2.1. Manufacture

2.2. Identified uses

2.3. Uses advised against

3. CLASSIFICATION AND LABELLING

4. ENVIRONMENTAL FATE PROPERTIES

4.1. Degradation

4.2. Environmental distribution

4.3. Bioaccumulation

4.4. Secondary poisoning

5. HUMAN HEALTH HAZARD ASSESSMENT

5.1. Toxicokinetics (absorption, metabolism, distribution and elimination)

5.2. Acute toxicity

5.3. Irritation

5.3.1. Skin

5.3.2. Eye

5.3.3. Respiratory tract

5.4. Corrosivity

5.5. Sensitisation

5.5.1. Skin

5.5.2. Respiratory system

5.6. Repeated dose toxicity

5.7. Mutagenicity

5.8. Carcinogenicity

5.9. Toxicity for reproduction

5.9.1. Effects on fertility

5.9.2. Developmental toxicity

5.10. Other effects

5.11. Derivation of DNEL(s)

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CHEMICAL SAFETY REPORT FORMAT

6. HUMAN HEALTH HAZARD ASSESSMENT OF PHYSICOCHEMICAL PROPERTIES

6.1. Explosivity

6.2. Flammability

6.3. Oxidising potential

7. ENVIRONMENTAL HAZARD ASSESSMENT

7.1. Aquatic compartment (including sediment)

7.2. Terrestrial compartment

7.3. Atmospheric compartment

7.4. Microbiological activity in sewage treatment systems

8. PBT AND VPVB ASSESSMENT

9. EXPOSURE ASSESSMENT

9.1. (Title of exposure scenario 1)

9.1.1. Exposure scenario

9.1.2. Exposure estimation

9.2. (Title of exposure scenario 2)

9.2.1. Exposure scenario

9.2.2. Exposure estimation

(etc.)

10. RISK CHARACTERISATION

10.1. (Title of exposure scenario 1)

10.1.1. Human health

10.1.1.1. Workers

10.1.1.2. Consumers

10.1.1.3. Indirect exposure to humans via the environment

10.1.2. Environment

10.1.2.1. Aquatic compartment (including sediment)

10.1.2.2. Terrestrial compartment

10.1.2.3. Atmospheric compartment

10.1.2.4. Microbiological activity in sewage treatment systems

10.2. (Title of exposure scenario 2)

10.2.1. Human health

10.2.1.1. Workers

10.2.1.2. Consumers

10.2.1.3. Indirect exposure to humans via the environment

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CHEMICAL SAFETY REPORT FORMAT

10.2.2. Environment

10.2.2.1. Aquatic compartment (including sediment)

10.2.2.2. Terrestrial compartment

10.2.2.3. Atmospheric compartment

10.2.2.4. Microbiological activity in sewage treatment systems

(etc.)

10.x. Overall exposure (combined for all relevant emission/release sources)

10.x.1. Human health (combined for all exposure routes)

10.x.1.1.

10.x.2. Environment (combined for all emission sources)

10.x.2.1.

29.5.2007 L 136/83Official Journal of the European Union

ANNEX II

GUIDE TO THE COMPILATION OF SAFETY DATA SHEETS

This Annex sets out the requirements for a Safety Data Sheet that is provided for a substance or a preparation in accord-

ance with Article 31. The Safety Data Sheet provides a mechanism for transmitting appropriate safety information on clas-

sified substances and preparations, including information from the relevant Chemical Safety Report(s) down the supply

chain to the immediate downstream user(s). The information provided in the Safety Data Sheet shall be consistent with

the information in the Chemical Safety Report, where one is required. Where a Chemical Safety Report has been

performed, the relevant exposure scenario(s) shall be placed into an annex of the Safety Data Sheet, to make reference to

them under the relevant headings of the Safety Data Sheet easier.

The purpose of this Annex is to ensure consistency and accuracy in the content of each of the mandatory headings listed

in Article 31, so that the resulting Safety Data Sheets will enable users to take the necessary measures relating to protec-

tion of human health and safety at the workplace, and protection of the environment.

The information provided by Safety Data Sheets shall also meet the requirements set out in Directive 98/24/EC on the

protection of the health and safety of workers from the risks related to chemical agents at work. In particular, the Safety

Data Sheet shall enable the employer to determine whether any hazardous chemical agents are present in the workplace,

and to assess any risk to the health and safety of workers ar ising from their use.

The information in the Safety Data Sheet shall be written in a clear and concise manner. The Safety Data Sheet shall be

prepared by a competent person who shall take into account the specific needs of the user audience, as far as it is known.

Persons placing substances and preparations on the market shall ensure that competent persons have received appropriate

training, including refresher training.

For preparations not classified as dangerous, but for which a Safety Data Sheet is required according to Article 31, propor-

tionate information shall be provided under each heading.

Additional information may be necessary in some cases in view of the wide range of properties of the substances and

preparations. If in other cases it emerges that infor mation on certain properties is of no significance or that it is techni-

cally impossible to provide, the reasons for this shall be clearly stated under each heading. Information shall be provided

for each hazardous property. If it is stated that a particular hazard does not apply, clearly differentiate between cases

where no information is available to the classifier, and cases where negative test results are available.

Give the date of issue of the Safety Data Sheet on the first page. When a safety data sheet has been revised, the changes

shall be brought to the attention of the recipient and identify it as ‘Revision: (date)’.

Note

Safety data sheets are also required for certain special substances and preparations (e.g. metals in massive form, alloys,

compressed gases, etc.) listed in chapters 8 and 9 of Annex VI to Directive 67/548/EEC, for which there are labelling dero-

gations.

1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND OF THE COMPANY/UNDERTAKING

1.1. Identification of the substance or preparation

The term used for identification shall be identical to that provided on the label as set out in Annex VI to Direc-

tive 67/548/EEC.

For substances subject to registration, the term shall be consistent with that provided under registration and the

registration number assigned under Article 20(1) of this Regulation shall also be indicated.

Other means of identification available may also be indicated.

1.2. Use of the substance/preparation

Indicate the uses of the substance or preparation as far as they are known. Where there are many possible uses,

only the most impor tant or common uses need to be listed. This shall include a brief description of what it actually

does, e.g. flame retardant, anti-oxidant, etc.

Where a Chemical Safety Report is required, the Safety Data Sheet shall contain information on all the identified

uses relevant to the recipient of the Safety Data Sheet. This information shall be consistent with the identified uses

and exposure scenarios set out in the annex to the Safety Data Sheet.

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1.3. Company/undertaking identification

Identify the person responsible for placing the substance or preparation on the market within the Community,

whether it is the manufacturer, importer or distributor. Give the full address and telephone number of this person

as well as the e-mail address of the competent person responsible for the Safety Data Sheet.

In addition, where this person is not located in the Member State where the substance or preparation is placed on

the market, give a full address and telephone number for the person responsible in that Member State, if possible.

For registrants, the person identified shall be consistent with the information on the identity of the manufacturer

or importer provided in the registration.

1.4. Emergency telephone

In addition to the above mentioned information, supply the emergency telephone number of the company and/or

relevant official advisory body (this may be the body responsible for receiving information relating to health, which

is referred to in Article 17 of Directive 1999/45/EC). Specify if this phone number is available only during office

hours.

2. HAZARDS IDENTIFICATION

Give here the classification of the substance or preparation which arises from application of the classification rules

in Directives 67/548/EEC or 1999/45/EC. Indicate clearly and briefly the hazards the substance or preparation

presents to man and the environment.

Distinguish clearly between preparations which are classified as dangerous and preparations which are not classified

as dangerous according to Directive 1999/45/EC.

Describe the most important adverse physicochemical, human health and environmental effects and symptoms

relating to the uses and possible misuses of the substance or preparation that can reasonably be foreseen.

It may be necessary to mention other hazards, such as dustiness, cross-sensitisation, suffocation, freezing, high

potency for odour or taste or environmental effects such as hazards to soil-dwelling organisms, ozone depletion,

photochemical ozone creation potential, etc., which do not result in classification but which may contribute to the

overall hazards of the material.

The information shown on the label shall be given under heading 15.

The classification of the substance shall be consistent with the classification provided to the classification and label-

ling inventory according to Title XI.

3. COMPOSITION/INFORMATION ON INGREDIENTS

The information given shall enable the recipient to identify readily the hazards of the components of the prepara-

tion. The hazards of the preparation itself shall be given under heading 2.

3.1. It is not necessary to give the full composition (nature of the ingredients and their concentration), although a

general description of the components and their concentrations can be helpful.

3.2. For a preparation classified as dangerous according to Directive 1999/45/EC, the following substances shall be indi-

cated, together with their concentration or concentration range in the preparation:

(a) substances presenting a health or environmental hazard within the meaning of Directive 67/548/EEC, if they

are present in concentrations equal to or greater than the lowest of:

— the applicable concentrations defined in the table of Article 3(3) of Directive 1999/45/EC, or

— the concentration limits given in Annex I to Directive 67/548/EEC, or

— the concentration limits given in Part B of Annex II to Directive 1999/45/EC, or

— the concentration limits given in Part B of Annex III Directive 1999/45/EC, or

— the concentration limits given in Annex V to Directive 1999/45/EC, or

— the concentration limits given in an agreed entry in the classification and labelling inventory established

under Title XI of this Regulation;

29.5.2007 L 136/85Official Journal of the European Union

(b) substances for which there are Community workplace exposure limits, which are not already included under

point (a);

ance with the criteria set out in Annex XIII, if the concentration of an individual substance is equal to or

greater than 0,1 %.

3.3. For a preparation not classified as dangerous according to Directive 1999/45/EC, the substances shall be indicated,

together with their concentration or concentration range, if they are present in an individual concentration of

either:

(a) ≥ 1 % by weight for non-gaseous preparations and ≥ 0,2 % by volume for gaseous preparations and

— the substances present a health or environmental hazard within the meaning of Directive 67/548/EEC (

— the substances are assigned Community workplace exposure limits, or

(b) ≥ 0,1 % by weight and the substances are persistent, bioaccumulative and toxic or very persistent and very

bioaccumulative in accordance with the criteria set out in Annex XIII.

3.4. The classification (derived either from Articles 4 and 6 of Directive 67/548/EEC, from Annex I to Directive 67/

548/EEC or from an agreed entry in the classification and labelling inventory established under Title XI of this

Regulation) of the above substances shall be given, including the symbol letters and R phrases which are assigned

in accordance with their physicochemical, human health and environmental hazards. The R phrases do not need to

be written out in full here: reference shall be made to heading 16, where the full text of each relevant R phrase

shall be listed. If the substance does not meet the classification criteria, the reason for indicating the substance in

section 3 shall be described, such as ‘PBT-substance’ or ‘substance with a Community workplace exposure limit’.

3.5. The name and the Registration number, assigned under Ar ticle 20(1) of this Regulation, EINECS or ELINCs

number, if available, of the above substances shall be given in accordance with Directive 67/548/EEC. The CAS

number and IUPAC name (if available) may also be helpful. For substances listed by a generic name, according to

Article 15 of Directive 1999/45/EC or the footnote to Section 3.3 of this Annex, a precise chemical identifier is

not necessary.

3.6. If, in accordance with the provisions of Article 15 of Directive 1999/45/EC or the footnote to Section 3.3 of this

Annex, the identity of certain substances is to be kept confidential, their chemical nature shall be descr ibed in

order to ensure safe handling. The name used shall be the same as that which derives from the above procedures.

4. FIRST AID MEASURES

Describe the first-aid measures.

Specify first whether immediate medical attention is required.

The information on first aid shall be brief and easy to understand by the victim, bystanders and first-aiders. The

symptoms and effects shall be briefly summarised. The instructions shall indicate what is to be done on the spot in

the case of an accident and whether delayed effects can be expected after exposure.

Subdivide the information according to the different routes of exposure, i.e. inhalation, skin and eye contact and

ingestion, under different subheadings.

Indicate whether professional assistance by a doctor is needed or advisable.

For some substances or preparations it may be important to emphasise that special means to provide specific and

immediate treatment shall be available at the workplace.

5. FIRE-FIGHTING MEASURES

Refer to requirements for fighting a fire caused by the substance or preparation, or arising in its vicinity by indi-

cating:

— suitable extinguishing media,

29.5.2007L 136/86 Official Journal of the European Union

(

) Where the person responsible for placing the preparation on the market can demonstrate that the disclosure in the safety data sheet of the

chemical identity of a substance which is exclusively classified as irritant with the exception of those assigned R41 or irritant in combination

with one or more of the properties mentioned in point 2.3.4 of Article 10 of Directive 1999/45/EC, or harmful or harmful in combination

with one or more of the properties mentioned in point 2.3.4 of Article 10 of Directive 1999/45/EC presenting acute lethal effects alone, will

put at r isk the confidential nature of his intellectual property, he may, in accordance with the provisions of Part B of Annex VI to Directive

1999/45/EC, refer to that substance either by means of a name that identifies the most important functional chemical groups, or by means

of an alternative name.

— extinguishing media which shall not be used for safety reasons,

— special exposure hazards arising from the substance or preparation itself, combustion products, resulting gases,

— special protective equipment for fire-fighters.

6. ACCIDENTAL RELEASE MEASURES

Depending on the substance or preparation involved, information may be needed on:

personal precautions such as:

— removal of ignition sources, provision for sufficien t ventilation/respiratory protection, control of dust, preven-

tion of skin and eye contact,

environmental precautions such as:

— keeping away from drains, surface- and ground-water and soil, possible need to alert the neighbourhood,

methods for cleaning up such as:

— use of absorbent material (e.g. sand, diatomaceous earth, acid binder, universal binder, sawdust, etc.), reduction

of gases/fumes with water, dilution.

Also consider the need for indications such as: ‘never use, neutralise with ...’.

Note

If appropriate refer to headings 8 and 13.

7. HANDLING AND STORAGE

Note

Information in this section shall relate to the protection of human health, safety and the environment. It shall assist

the employer in devising suitable working procedures and organisational measures according to Article 5 of Direc-

tive 98/24/EC.

Where a chemical safety report or a registration is required, the information in this section shall be consistent with

the information given, for the identified uses and exposure scenarios set out in the annex to the Safety Data Sheet.

7.1. Handling

Specify precautions for safe handling including advice on technical measures such as:

— containment, local and general ventilation, measures to prevent aerosol and dust generation and fire, measures

required to protect the environment (e.g. use of filters or scrubbers on exhaust ventilation, use in a bunded

area, measures for collection and disposal of spillages, etc.) and any specific requirements or rules relating to

the substance or preparation (e.g. procedures or equipment which are prohibited or recommended) and if

possible give a brief description.

7.2. Storage

Specify the conditions for safe storage such as:

— specific design for storage rooms or vessels (including retention walls and ventilation), incompatible materials,

conditions of storage (temperature and humidity limit/range, light, inert gas, etc.) special electrical equipment

and prevention of static electricity.

Give advice if relevant on quantity limits under storage conditions. In particular indicate any special requirements

such as the type of material used in the packaging/containers of the substance or preparation.

7.3. Specific use(s)

For end products designed for specific use(s), recommendations shall refer to the identified use(s) and be detailed

and operational. If possible, reference shall be made to industry- or sector-specific approved guidance.

8. EXPOSURE CONTROLS/PERSONAL PROTECTION

8.1. Exposure limit values

Specify currently applicable specific control parameters including occupational exposure limit values and/or biolo-

gical limit values. Values shall be given for the Member State where the substance or preparation is placed on the

market. Give information on currently recommended monitoring procedures.

29.5.2007 L 136/87Official Journal of the European Union

Where a Chemical Safety Report is required, the relevant DNELs and PNECs for the substance shall be given for

the exposure scenarios set out in the annex to the Safety Data Sheet.

For preparations, it is useful to provide values for those constituent substances which are required to be listed in

the Safety Data Sheet according to heading 3.

8.2. Exposure controls

For the purposes of this document exposure control means the full range of specific risk management measures to

be taken during use in order to minimise worker and environmental exposure. Where a chemical safety report is

required, a summary of the risk management measures shall be given in Section 8 of the Safety Data Sheet for the

identified uses set out in the Safety Data Sheet.

8.2.1. Occupational exposure controls

This information will be taken into account by the employer in carrying out an assessment of risk to the health

and safety of workers for the substance or preparation under Article 4 of Directive 98/24/EC, which requires, in

the order of priority:

— design of appropriate work processes and engineering controls, the use of adequate equipment and materials,

— the application of collective protection measures at source, such as adequate ventilation and appropriate organi-

sational measures, and

— where exposure cannot be prevented by other means the use of individual protection measures, such as

personal protection equipment.

Therefore provide suitable and adequate information on these measures to enable a proper risk assessment to be

carried out under Article 4 of Directive 98/24/EC. This information shall complement that already given under

heading 7.1.

Where individual protection measures are needed, specify in detail which equipment will provide adequate and

suitable protection. Take into account Council Directive 89/686/EEC of 21 December 1989 on the approximation

of the laws of the Member States relating to personal protective equipment (

) and make reference to the appro-

priate CEN standards:

(a) Respiratory protection

For dangerous gases, vapours or dust, specify the type of protective equipment to be used, such as:

— self contained breathing apparatus, adequate masks and filters.

(b) Hand protection

Specify clearly the type of gloves to be worn when handling the substance or preparation, including:

— the type of material,

— the breakthrough time of the glove material, with regard to the amount and duration of dermal exposure.

If necessary indicate any additional hand protection measures.

Specify the type of eye protection equipment required such as:

— safety glasses, safety goggles, face shield.

(d) Skin protection

If it is necessary to protect a part of the body other than the hands, specify the type and quality of protection

equipment required, such as:

— apron, boots and full protective suit.

If necessary, indicate any additional skin protection measures and specific hygiene measures.

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(

) OJ L 399, 30.12.1989, p. 18. Directive as last amended by Regulation (EC) No 1882/2003.

8.2.2. Environmental exposure controls

Specify the information required by the employer to fulfil his commitments under Community environmental

protection legislation.

Where a chemical safety report is required, a summary of the risk management measures that adequately control

exposure of the environment to the substance shall be given for the exposure scenarios set out in the annex to the

Safety Data Sheet.

9. PHYSICAL AND CHEMICAL PROPERTIES

To enable proper control measures to be taken, provide all relevant information on the substance or preparation,

particularly the information listed under heading 9.2. The information in this section shall be consistent with the

information provided in a registration where one is required.

9.1. General information

Appearance:

indicate the physical state (solid, liquid, gas) and the colour of the substance or preparation as supplied.

Odour:

if odour is perceptible, give a brief description of it.

9.2. Important health, safety and environmental information

pH:

indicate the pH of the substance or preparation as supplied or of an aqueous solution; in the latter case, indicate

the concentration.

Boiling point/boiling range

Flash point

Flammability (solid, gas)

Explosive properties

Oxidising properties

Vapour pressure

Relative density

Solubility

Water solubility

Partition coefficient: n-octanol/water

Viscosity

Vapour density

Evaporation rate

9.3. Other information

Indicate other important safety parameters, such as miscibility, fat solubility (solvent — oil to be specified), conduc-

tivity, melting point/melting range, gas group (useful for Directive 94/9/EC of the European Parliament and the

Council of 23 March 1994 on the approximation of the laws of the Member States concerning equipment and

protective systems intended for use in potentially explosive atmospheres (

)), auto-ignition temperature, etc.

Note 1

The above properties shall be determined in accordance with the specifications laid down in the Commission Regu-

lation on testing methods referred to in Article 13(3) or any other comparable method.

Note 2

For preparations, information shall nor mally be given on the properties of the preparation itself. However, if it is

stated that a particular hazard does not apply, clearly differentiate between cases where no information is available

to the classif ier, and cases where negative test results are available. If it is considered necessary to give information

about the properties of individual components, please indicate clearly what the data refers to.

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(

) OJ L 100, 19.4.1994, p. 1. Directive as amended by Regulation (EC) No 1882/2003.

10. STABILITY AND REACTIVITY

State the stability of the substance or preparation and the possibility of hazardous reactions occurring under

cer tain conditions of use and also if released into the environment.

10.1. Conditions to avoid

List those conditions such as temperature, pressure, light, shock, etc., which may cause a dangerous reaction and if

possible give a brief description.

10.2. Materials to avoid

List materials such as water, air, acids, bases, oxidising agents or any other specific substance which may cause a

dangerous reaction and if possible give a br ief description.

10.3. Hazardous decomposition products

List hazardous materials produced in dangerous amounts upon decomposition.

Note

Address specifically:

— the need for and the presence of stabilisers,

— the possibility of a hazardous exothermic reaction,

— safety significa nce, if any, of a change in physical appearance of the substance or preparation,

— hazardous decomposition products, if any, formed upon contact with water,

— possibility of degradation to unstable products.

11. TOXICOLOGICAL INFORMATION

This section deals with the need for a concise but complete and comprehensible description of the various toxico-

logical (health) effects, which can arise if the user comes into contact with the substance or preparation.

The information shall include dangerous-to-health effects from exposure to the substance or preparation, based on

the conclusion from, for example, test data and experience. The information shall also include, where appropriate,

delayed, immediate and chronic effects from short- and long-term exposure such as sensitisation, narcosis, carcino-

genicity, mutagenicity and reproductive toxicity (developmental toxicity and fertility). It shall also include informa-

tion on the different routes of exposure (inhalation, ingestion, skin and eye contact), and describe the symptoms

related to the physical, chemical and toxicological characteristics.

Taking account of the information already provided under heading 3, composition/information on ingredients, it

may be necessar y to make reference to specific health effects of certain substances in the preparation.

The information in this section shall be consistent with the information provided for in a registration where

required and/or in a Chemical Safety Repor t where required and shall give information on the following groups of

potential effects:

— toxicokinetics, metabolism and distr ibution,

— acute effects (acute toxicity, irritation and corrosivity),

— sensitisation,

— repeated dose toxicity, and

— CMR effects (carcinogenity, mutagenicity and toxicity for reproduction).

For substances subject to registration, summaries of the information derived from the application of Annexes VII

to XI of this Regulation shall be given. The information shall also include the result of the comparison of the avail-

able data with the criteria given in Directive 67/548/EEC for CMR, categories 1 and 2, following paragraph 1.3.1

of Annex I of this Regulation.

12. ECOLOGICAL INFORMATION

Describe the possible effects, behaviour and environmental fate of the substance or preparation in air, water and/or

soil. Where available, give relevant test data (e.g. LC50 fish ≤ 1 mg/l).

29.5.2007L 136/90 Official Journal of the European Union

The information in this section shall be consistent with the information provided for in a registration where

required and/or in a Chemical Safety Report where required.

Describe the most important characteristics likely to have an effect on the environment owing to the nature of the

substance or preparation and likely methods of use. Information of the same kind shall be supplied for dangerous

products arising from the degradation of substances and preparations. This may include the following:

12.1. Ecotoxicity

This shall include relevant available data on aquatic toxicity, both acute and chronic for fish, crustaceans, algae and

other aquatic plants. In addition, toxicity data on soil micro- and macro-organisms and other environmentally rele-

vant organisms, such as birds, bees and plants, shall be included when available. Where the substance or prepara-

tion has inhibitory effects on the activity of micro-organisms, the possible impact on sewage treatment plants shall

be mentioned.

For substances subject to registration, summaries of the information derived from the application of Annexes VII

to XI shall be included.

12.2. Mobility

The potential of the substance or the appropriate constituents of a preparation (

), if released to the environment,

to transport to groundwater or far from the site of release.

Relevant data might include:

— known or predicted distribution to environmental compartments,

— surface tension,

— absorption/desorption.

For other physicochemical properties see heading 9.

12.3. Persistence and degradability

The potential of the substance or the appropriate constituents of a preparation (

) to degrade in relevant environ-

mental media, either through biodegradation or other processes such as oxidation or hydrolysis. Degradation half

lives shall be quoted where available. The potential of the substance or appropriate constituents of a preparation (

)

to degrade in sewage treatment plants shall also be mentioned.

12.4. Bioaccumulative potential

The potential of the substance or the appropriate constituents of a preparation (

) to accumulate in biota and, even-

tually, to pass through the food chain, with reference to the octanol-water partition coefficient (Kow) and biocon-

centration factor (BCF), if available.

12.5. Results of PBT assessment

Where a Chemical Safety Report is required, the results of the PBT assessment as set in the Chemical Safety Report

shall be given.

12.6. Other adverse effects

If available, include information on any other adverse effects on the environment, e.g. ozone depletion potential,

photochemical ozone creation potential, endocrine disrupting potential and/or global warming potential.

Remarks

Ensure that infor mation relevant to the environment is provided under other headings of the Safety Data Sheet,

especially advice for controlled release, accidental release measures, transport and disposal considerations under

headings 6, 7, 13, 14 and 15.

13. DISPOSAL CONSIDERATIONS

If the disposal of the substance or preparation (surplus or waste resulting from the foreseeable use) presents a

danger, a description of these residues and information on their safe handling shall be given.

29.5.2007 L 136/91Official Journal of the European Union

(

) This information cannot be given for the preparation because it is substance specific. It should therefore be given, where available and appro-

priate, for each constituent substance in the preparation which is required to be listed in the Safety Data Sheet according to the rules under

Section 3 of this Annex.

Specify the appropriate methods of disposal of both the substance or preparation and any contaminated packaging

(incineration, recycling, landfilling, etc.)

Where a Chemical Safety Report is required, the information on the waste management measures that adequately

control exposure of humans and the environment to the substance shall be consistent with the exposure scenarios

set out in the annex to the Safety Data Sheet.

Note

Refer to any relevant Community provisions relating to waste. In their absence, it is useful to remind the user that

national or regional provisions may be in force.

14. TRANSPORT INFORMATION

Indicate any special precautions which a user needs to be aware of or needs to comply with in connection with

transport or conveyance either within or outside his premises. Where relevant, provide information on the trans-

port classification for each of the modal regulations: IMDG (sea), ADR (Council Directive 94/55/EC of 21 November

1994 on the approximation of the laws of the Member States with regard to the transport of dangerous goods by

road (

)), RID (Council Directive 96/49/EC of 23 July 1996 on the approximation of the laws of the Member

States with regard to the transport of dangerous goods by rail (

)), ICAO/IATA (air). This might include inter alia:

— UN number,

— class,

— proper shipping name,

— packing group,

— marine pollutant,

— other applicable information.

15. REGULATORY INFORMATION

Indicate if a Chemical Safety Assessment has been carried out for the substance (or a substance in the preparation).

Give the health, safety and environmental information shown on the label according to Directives 67/548/EEC and

1999/45/EC.

If the substance or preparation covered by this safety data sheet is the subject of specific provisions in relation to

protection of man or the environment at Community level (e.g. authorisations given under Title VII or restrictions

under Title VIII) these provisions shall, as far as is possible, be stated.

Also mention, where possible, the national laws which implement these provisions and any other national

measures that may be relevant.

16. OTHER INFORMATION

Indicate any other information which the supplier assesses as being of importance for the health and safety of the

user and for the protection of the environment, for example:

— list of relevant R phrases. Write out the full text of any R phrases referred to under headings 2 and 3 of the

Safety Data Sheet,

— training advice,

— recommended restrictions on use (i.e. non-statutory recommendations by supplier),

— further information (written references and/or technical contact point),

— sources of key data used to compile the Safety Data Sheet.

For a revised Safety Data Sheet, indicate clearly the information, which has been added, deleted or revised (unless

this has been indicated elsewhere).

29.5.2007L 136/92 Official Journal of the European Union

(

) OJ L 319, 12.12.1994, p. 7. Directive as last amended by Commission Directive 2004/111/EC (OJ L 365, 10.12.2004, p. 25).

(

) OJ L 235, 17.9.1996, p. 25. Directive as last amended by Commission Directive 2004/110/EC (OJ L 365, 10.12.2004, p. 24).

ANNEX III

CRITERIA FOR SUBSTANCES REGISTERED IN QUANTITIES BETWEEN 1 AND 10 TONNES

Criteria for substances registered between 1 and 10 tonnes, with reference to Article 12(1)(a) and (b):

(a) substances for which it is predicted (ie by the application of (Q)SARs or other evidence) that they are likely to meet

the criteria for category 1 or 2 classification for carcinogenicity, mutagenicity or reproductive toxicity or the criteria in

Annex XIII;

(b) substances:

(i) with dispersive or diffuse use(s) particularly where such substances are used in consumer preparations or incorpo-

rated into consumer articles; and

(ii) for which it is predicted (i.e. by application of (Q)SARs or other evidence) that they are likely to meet the classifi-

cation criteria for any human health or environmental effects endpoints under Directive 67/548/EEC.

29.5.2007 L 136/93Official Journal of the European Union

ANNEX IV

EXEMPTIONS FROM THE OBLIGATION TO REGISTER IN ACCORDANCE WITH ARTICLE 2(7)(a)

EINECS No Name/group CAS No

200-061-5 D-glucitol C

50-70-4

200-066-2 Ascorbic acid C

50-81-7

200-075-1 Glucose C

50-99-7

200-294-2 L-lysine C

56-87-1

200-312-9 Palmitic acid, pure C

57-10-3

200-313-4 Stearic acid, pure C

57-11-4

200-334-9 Sucrose, pure C

57-50-1

200-405-4 α-tocopheryl acetate C

58-95-7

200-432-1 DL-methionine C

S 59-51-8

200-711-8 D-mannitol C

69-65-8

201-771-8 1-sorbose C

87-79-6

204-007-1 Oleic acid, pure C

112-80-1

204-664-4 Glycerol stearate, pure C

123-94-4

204-696-9 Carbon dioxide CO

124-38-9

205-278-9 Calcium pantothenate, D-form C

5.1/2

Ca 137-08-6

205-582-1 Lauric acid, pure C

143-07-7

205-590-5 Potassium oleate C

K 143-18-0

205-756-7 DL-phenylalanine C

150-30-1

208-407-7 Sodium gluconate C

.Na 527-07-1

212-490-5 Sodium stearate, pure C

.Na 822-16-2

215-279-6 Limestone

A noncombustible solid characteristic of sedimentary rock. It

consists primarily of calcium carbonate

1317-65-3

215-665-4 Sorbitan oleate C

1338-43-8

216-472-8 Calcium distearate, pure C

2.1/2

Ca 1592-23-0

231-147-0 Argon Ar 7440-37-1

231-153-3 Carbon C 7440-44-0

231-783-9 Nitrogen N

7727-37-9

231-791-2 Water, distilled, conductivity or of similar purity H

O 7732-18-5

231-955-3 Graphite C 7782-42-5

29.5.2007L 136/94 Official Journal of the European Union

EINECS No Name/group CAS No

232-273-9 Sunflower oil

Extractives and their physically modified derivatives. It consists

primarily of the glycerides of the fatty acids linoleic, and oleic.

(Helianthus annuus, Compositae).

8001-21-6

232-274-4 Soybean oil

Extractives and their physically modified derivatives. It consists

primarily of the glycerides of the fatty acids linoleic, oleic, palmitic

and stearic (Soja hispida, Leguminosae).

8001-22-7

232-276-5 Safflower oil

Extractives and their physically modified derivatives. It consists

primarily of the glycerides of the fatty acid linoleic (Carthamus tinc-

torius, Compositae).

8001-23-8

232-278-6 Linseed oil

Extractives and their physically modified derivatives. It consists

primarily of the glycerides of the fatty acids linoleic, linolenic and

oleic (Linum usitatissimum, Linaceae).

8001-26-1

232-281-2 Corn oil

Extractives and their physically modified derivatives. It consists

primarily of the glycerides of the fatty acids linoleic, oleic, palmitic

and stearic. (Zea mays, Gramineae).

8001-30-7

232-293-8 Castor Oil

Extractives and their physically modified derivatives. It consists

primarily of the glycerides of the fatty acid ricinoleic (Ricinus

communis, Euphorbiaceae).

8001-79-4

232-299-0 Rape oil

Extractives and their physically modified derivatives. It consists

primarily of the glycerides of the fatty acids erucic, linoleic and oleic

(Brassica napus, Cruciferae).

8002-13-9

232-307-2 Lecithins

The complex combination of diglycerides of fatty acids linked to the

choline ester of phosphoric acid.

8002-43-5

232-436-4 Syrups, hydrolyzed starch

A complex combination obtained by the hydrolysis of cornstarch by

the action of acids or enzymes. It consists primarily of d-glucose,

maltose and maltodextrins.

8029-43-4

232-442-7 Tallow, hydrogenated 8030-12-4

232-675-4 Dextrin 9004-53-9

232-679-6 Starch

High-polymeric carbohydrate material usually derived form cereal

grains such as corn, wheat and sorghum, and from roots and tubers

such as potatoes and tapioca. Includes starch which has been prege-

latinised by heating in the presence of water.

9005-25-8

232-940-4 Maltodextrin 9050-36-6

234-328-2 Vitamin A 11103-57-4

29.5.2007 L 136/95Official Journal of the European Union

EINECS No Name/group CAS No

238-976-7 Sodium D-gluconate C

.xNa 14906-97-9

248-027-9 D-glucitol monostearate C

26836-47-5

262-988-1 Fatty acids, coco, Me esters 61788-59-8

262-989-7 Fatty acids, tallow, Me esters 61788-61-2

263-060-9 Fatty acids, castor-oil 61789-44-4

263-129-3 Fatty acids, tallow 61790-37-2

265-995-8 Cellulose Pulp 65996-61-4

266-925-9 Fatty acids, C

12-18

This substance is identified by SDA Substance Name: C

12-

alkyl

carboxylic acid and SDA Reporting No: 16-005-00.

67701-01-3

266-928-5 Fatty acids C

16-18

This substance is identified by SDA Substance Name: C

-C

alkyl

carboxylic acid and SDA Reporting No: 19-005-00.

67701-03-5

266-929-0 Fatty acids, C

8-18

and C

-unsaturated

This substance is identified by SDA Substance Name: C

-C

and C

unsaturated alkyl carboxylic acid and SDA Reporting No: 01-005-00.

67701-05-7

266-930-6 Fatty acids, C

14-18

and C

16-18

-unsaturated

This substance is identified by SDA Substance Name: C

-C

and

-C

unsaturated alkyl carboxylic acid and SDA Reporting No: 04-

005-00.

67701-06-8

266-932-7 Fatty acids, C

-C

and C

-unsaturated

This substance is identified by SDA Substance Name: C

-C

and C

unsaturated alkyl carboxylic acid and SDA Reporting No: 11-005-00.

67701-08-0

266-948-4 Glycerides, C

16-18

and C

-unsaturated

This substance is identified by SDA Substance Name: C

-C

and C

unsaturated trialkyl glyceride and SDA Reporting No: 11-001-00.

67701-30-8

267-007-0 Fatty acids, C

14-18

and C

16-18

-unsaturated., Me esters

This substance is identified by SDA Substance Name: C

-C

and

-C

unsaturated alkyl carboxylic acid methyl ester and SDA Reporting

No: 04-010-00.

67762-26-9

267-013-3 Fatty acids, C

6-12

This substance is identified by SDA Substance Name: C

-C

alkyl

carboxylic acid and SDA Reporting No: 13-005-00.

67762-36-1

29.5.2007L 136/96 Official Journal of the European Union

EINECS No Name/group CAS No

268-099-5 Fatty acids, C

14-22

and C

16-22

unsaturated

This substance is identified by SDA Substance Name: C

-C

and

-C22 unsaturated alkyl carboxylic acid and SDA Reporting No: 07-

005-00.

68002-85-7

268-616-4 Syrups, corn, dehydrated 68131-37-3

269-657-0 Fatty acids, soya 68308-53-2

269-658-6 Glycerides, tallow mono-, di- and tri-, hydrogenated 68308-54-3

270-298-7 Fatty acids, C

14-22

68424-37-3

270-304-8 Fatty acids, linseed-oil 68424-45-3

270-312-1 Glycerides, C

16-18

and C

-unsaturated. mono- and di-

This substance is identified by SDA Substance Name: C

-C

and C

unsaturated alkyl and C

16-

and C

unsaturated dialkyl glyceride and

SDA Reporting No: 11-002-00.

68424-61-3

288-123-8 Glycerides, C

10-18

85665-33-4

292-771-7 Fatty acids, C

12-14

90990-10-6

292-776-4 Fatty acids, C

12-18

and C

-unsaturated 90990-15-1

296-916-5 Fatty acids, rape-oil, erucic acid-low 93165-31-2

29.5.2007 L 136/97Official Journal of the European Union

ANNEX V

EXEMPTIONS FROM THE OBLIGATION TO REGISTER IN ACCORDANCE WITH ARTICLE 2(7)(b)

1. Substances which result from a chemical reaction that occurs incidental to exposure of another substance or article to

environmental factors such as air, moisture, microbial organisms or sunlight.

2. Substances which result from a chemical reaction that occurs incidental to storage of another substance, preparation or

article.

3. Substances which result from a chemical reaction occurring upon end use of other substances, preparations or articles

and which are not themselves manufactured, imported or placed on the market.

4. Substances which are not themselves manufactured, imported or placed on the market and which result from a

chemical reaction that occurs when:

(a) a stabiliser, colorant, flavouring agent, antioxidant, filler, solvent, carrier, surfactant, plasticiser, corrosion inhibitor,

antifoamer or defoamer, dispersant, precipitation inhibitor, desiccant, binder, emulsifier, de-emulsifier, dewatering

agent, agglomerating agent, adhesion promoter, flow modifier, pH neutraliser, sequesterant, coagulant, flocculant,

fire retardant, lubricant, chelating agent, or quality control reagent functions as intended; or

(b) a substance solely intended to provide a specific physicochemical characteristic functions as intended.

5. By-products, unless they are imported or placed on the market themselves.

6. Hydrates of a substance or hydrated ions, formed by association of a substance with water, provided that the substance

has been registered by the manufacturer or importer using this exemption.

7. The following substances which occur in nature, if they are not chemically modified:

minerals, ores, ore concentrates, cement clinker, natural gas, liquefied petroleum gas, natural gas condensate, process

gases and components thereof, crude oil, coal, coke.

8. Substances occurring in nature other than those listed under paragraph 7, if they are not chemically modified, unless

they meet the criteria for classification as dangerous according to Directive 67/548/EEC.

9. Basic elemental substances for which hazards and risks are already well known:

hydrogen, oxygen, noble gases (argon, helium, neon, xenon), nitrogen.

29.5.2007L 136/98 Official Journal of the European Union

ANNEX VI

INFORMATION REQUIREMENTS REFERRED TO IN ARTICLE 10

GUIDANCE NOTE ON FULFILLING THE REQUIREMENTS OF ANNEXES VI TO XI

Annexes VI to XI specify the information that shall be submitted for registration and evaluation pur poses according to

Articles 10, 12, 13, 40, 41 and 46. For the lowest tonnage level, the standard requirements are in Annex VII, and every

time a new tonnage level is reached, the requirements of the corresponding Annex have to be added. For each registration

the precise information requirements will differ, according to tonnage, use and exposure. The Annexes shall thus be

considered as a whole, and in conjunction with the overall requirements of registration, evaluation and the duty of care.

STEP 1 — GATHER AND SHARE EXISTING INFORMATION

The registrant should gather all existing available test data on the substance to be registered, this would include a literature

search for relevant information on the substance. Wherever practicable, registrations should be submitted jointly, in

accordance with Articles 11 or 19. This will enable test data to be shared, thereby avoiding unnecessary testing and redu-

cing costs. The registrant should also collect all other available and relevant information on the substance regardless

whether testing for a given endpoint is required or not at the specific tonnage level. This should include information from

alternative sources (e.g. from (Q)SARs, read-across from other substances, in vivo and in vitro testing, epidemiological data)

which may assist in identifying the presence or absence of hazardous properties of the substance and which can in cer tain

cases replace the results of animal tests.

In addition, information on exposure, use and risk management measures in accordance with Article 10 and this Annex

should be collected. Considering all this information together, the registrant will be able to determine the need to generate

further information.

STEP 2 — CONSIDER INFORMATION NEEDS

The registrant shall identify what information is required for the registration. First, the relevant Annex or Annexes to be

followed shall be identified, according to tonnage. These Annexes set out the standard information requirements, but shall

be considered in conjunction with Annex XI, which allows variation from the standard approach, where it can be justified.

In particular, information on exposure, use and risk management measures shall be considered at this stage in order to

determine the information needs for the substance.

STEP 3 — IDENTIFY INFORMATION GAPS

The registrant shall then compare the information needs for the substance with the information already available and

identify where there are gaps. It is important at this stage to ensure that the available data is relevant and has sufficient

quality to fulfil the requirements.

STEP 4 — GENERATE NEW DATA/PROPOSE TESTING STRATEGY

In some cases it will not be necessary to generate new data. However, where there is an information gap that needs to be

filled, new data shall be generated (Annexes VII and VIII), or a testing strategy shall be proposed (Annexes IX and X),

depending on the tonnage. New tests on vertebrates shall only be conducted or proposed as a last resort when all other

data sources have been exhausted.

In some cases, the rules set out in Annexes VII to XI may require certain tests to be undertaken earlier than or in addition

to the standard requirements.

NOTES

Note 1: If it is not technically possible, or if it does not appear scientifically necessary to give information, the reasons

shall be clearly stated, in accordance with the relevant provisions.

Note 2: The registrant may wish to declare that certain information submitted in the registration dossier is commercially

sensitive and its disclosure might harm him commercially. If this is the case, he shall list the items and provide a justifica-

tion.

29.5.2007 L 136/99Official Journal of the European Union

INFORMATION REFERRED TO IN ARTICLE 10(a) (i) TO (v)

1. GENERAL REGISTRANT INFORMATION

1.1. Registrant

1.1.1. Name, address, telephone number, fax number and e-mail address

1.1.2. Contact person

1.1.3. Location of the registrant's production and own use site(s), as appropriate

1.2. Joint submission of data

Articles 11 or 19 foresee that parts of the registration may be submitted by a lead registrant on behalf of other

registrants.

In this case, the lead registrant shall identify the other registrants specifying:

— their name, address, telephone number, fax number and e-mail address,

— parts of the present registration which apply to other registrants.

Mention the number(s) given in this Annex or Annexes VII to X, as appropriate.

Any other registrant shall identify the lead registrant submitting on his behalf specifying:

— his name, address, telephone number, fax number and e-mail address,

— parts of the registration which are submitted by the lead registrant.

Mention the number(s) given in this Annex or Annexes VII to X, as appropriate.

1.3 Third party appointed under Article 4

1.3.1. Name, address, telephone number, fax number and e-mail address

1.3.2. Contact person

2. IDENTIFICATION OF THE SUBSTANCE

For each substance, the information given in this section shall be sufficient to enable each substance to be identi-

fied. If it is not technically possible or if it does not appear scientifically necessary to give information on one or

more of the items below, the reasons shall be clearly stated.

2.1. Name or other identifier of each substance

2.1.1. Name(s) in the IUPAC nomenclature or other international chemical name(s)

2.1.2. Other names (usual name, trade name, abbreviation)

2.1.3. EINECS or ELINCs number (if available and appropriate)

2.1.4. CAS name and CAS number (if available)

2.1.5. Other identity code (if available)

2.2. Information related to molecular and structural formula of each substance

2.2.1. Molecular and structural formula (including SMILES notation, if available)

2.2.2. Information on optical activity and typical ratio of (stereo) isomers (if applicable and appropriate)

2.2.3. Molecular weight or molecular weight range

2.3. Composition of each substance

2.3.1. Degree of purity ( %)

2.3.2. Nature of impurities, including isomers and by-products

2.3.3. Percentage of (significant) main impurities

2.3.4. Nature and order of magnitude (… ppm, … %) of any additives (e.g. stabilising agents or inhibitors)

2.3.5. Spectral data (ultra-violet, infra-red, nuclear magnetic resonance or mass spectrum)

29.5.2007L 136/100 Official Journal of the European Union

2.3.6. High-pressure liquid chromatogram, gas chromatogram

2.3.7. Description of the analytical methods or the appropriate bibliographical references for the identification of the

substance and, where appropriate, for the identification of impurities and additives. This information shall be suffi-

cient to allow the methods to be reproduced.

3. INFORMATION ON MANUFACTURE AND USE(S) OF THE SUBSTANCE(S)

3.1. Overall manufacture, quantities used for production of an article that is subject to registration, and/or imports in

tonnes per registrant per year in:

the calendar year of the registration (estimated quantity)

3.2. In the case of a manufacturer or producer of articles: brief description of the technological process used in manu-

facture or production of articles.

Precise details of the process, particularly those of a commercially sensitive nature, are not required.

3.3. An indication of the tonnage used for his own use(s)

3.4. Form (substance, preparation or article) and/or physical state under which the substance is made available to down-

stream users. Concentration or concentration range of the substance in preparations made available to downstream

users and quantities of the substance in articles made available to downstream users.

3.5. Brief general description of the identified use(s)

3.6. Information on waste quantities and composition of waste resulting from manufacture of the substance, the use in

articles and identified uses

3.7. Uses advised against (see Safety Data Sheet heading 16)

Where applicable, an indication of the uses which the registrant advises against and why (i.e. non-statutory recom-

mendations by supplier). This need not be an exhaustive list.

4. CLASSIFICATION AND LABELLING

4.1. The hazard classification of the substance(s), resulting from the application of Articles 4 and 6 of Directive

67/548/EEC.

In addition, for each entry, the reasons why no classification is given for an endpoint should be provided (i.e. if

data are lacking, inconclusive, or conclusive but not sufficient for classification).

4.2. The resulting hazard label for the substance(s), resulting from the application of Articles 23, 24 and 25 of Directive

67/548/EEC.

4.3. Specific concentration limits, where applicable, resulting from the application of Article 4(4) of Directive

67/548/EEC and Articles 4 to 7 of Directive 1999/45/EC.

5. GUIDANCE ON SAFE USE CONCERNING:

This information shall be consistent with that in the Safety Data Sheet, where such a Safety Data Sheet is required

according to Article 31.

5.1. First-aid measures (Safety Data Sheet heading 4)

5.2. Fire-fighting measures (Safety Data Sheet heading 5)

5.3. Accidental release measures (Safety Data Sheet heading 6)

5.4. Handling and storage (Safety Data Sheet heading 7)

5.5. Transport information (Safety Data Sheet heading 14)

Where a Chemical Safety Report is not required, the following additional information is required:

5.6. Exposure controls/personal protection (Safety Data Sheet heading 8)

5.7. Stability and reactivity (Safety Data Sheet heading 10)

29.5.2007 L 136/101Official Journal of the European Union

5.8. Disposal considerations

5.8.1. Disposal considerations (Safety Data Sheet heading 13)

5.8.2. Information on recycling and methods of disposal for industry

5.8.3. Information on recycling and methods of disposal for the public.

6. INFORMATION ON EXPOSURE FOR SUBSTANCES REGISTERED IN QUANTITIES BETWEEN 1 AND 10

TONNES PER YEAR PER MANUFATCURER OR IMPORTER

6.1. Main use category:

6.1.1. (a) industrial use; and/or

(b) professional use; and/or

6.1.2. Specif ication for industrial and professional use:

(a) used in closed system; and/or

(b) use resulting in inclusion into or onto matrix; and/or

(d) dispersive use.

6.2. Significant route(s) of exposure:

6.2.1. Human exposure:

(a) oral; and/or

(b) dermal; and/or

6.2.2. Environmental exposure:

(a) water; and/or

(b) air; and/or

(d) soil.

6.3. Pattern of exposure:

(a) accidental/infrequent; and/or

(b) occasional; and/or

29.5.2007L 136/102 Official Journal of the European Union

ANNEX VII

STANDARD INFORMATION REQUIREMENTS FOR SUBSTANCES MANUFACTURED OR IMPORTED IN

QUANTITIES OF ONE TONNE OR MORE (

)

Column 1 of this Annex establishes the standard information required for:

(a) non-phase-in substances manufactured or imported in quantities of 1 to 10 tonnes;

(b) phase-in substances manufactured or imported in quantities of 1 to 10 tonnes and meeting the criteria in Annex III in

accordance with Article 12(1)(a) and (b); and

Any other relevant physicochemical, toxicological and ecotoxicological information that is available shall be provided. For

substances not meeting the criteria in Annex III only the physicochemical requirements as set out in section 7 of this

Annex are required.

Column 2 of this Annex lists specific rules according to which the required standard information may be omitted,

replaced by other information, provided at a different stage or adapted in another way. If the conditions are met under

which column 2 of this Annex allows adaptations, the registrant shall clearly state this fact and the reasons for each adap-

tation under the appropriate headings in the registration dossier.

In addition to these specific rules, a registrant may adapt the required standard information set out in column 1 of this

Annex according to the general rules contained in Annex XI with the exception of Section 3 on substance-tailored expo-

sure waiving. In this case as well, he shall clearly state the reasons for any decision to adapt the standard information

under the appropriate headings in the registration dossier referring to the appropr iate specific rule(s) in column 2 or in

Annex XI (

Before new tests are carried out to determine the properties listed in this Annex, all available in vitro data, in vivo data,

historical human data, data from valid (Q)SARs and data from structurally related substances (read-across approach) shall

be assessed first. In vivo testing with corrosive substances at concentration/dose levels causing cor rosivity shall be avoided.

Prior to testing, further guidance on testing strategies should be consulted in addition to this Annex.

When, for certain endpoints, information is not provided for other reasons than those mentioned in column 2 of this

Annex or in Annex XI, this fact and the reasons shall also be clearly stated.

7. INFORMATION ON THE PHYSICOCHEMICAL PROPERTIES OF THE SUBSTANCE

COLUMN 1

STANDARD INFORMATION

REQUIRED

COLUMN 2

SPECIFIC RULES FOR ADAPTATION FROM COLUMN 1

7.1. State of the substance

at 20 °C and 101,3 kPa

7.2. Melting/freezing point 7.2. The study does not need to be conducted below a lower limit of - 20 °C.

7.3. Boiling point 7.3. The study does not need to be conducted:

— for gases, or

— for solids which either melt above 300 °C or decompose before boiling. In such cases the boiling

point under reduced pressure may be estimated or measured, or

— for substances which decompose before boiling (e.g. auto-oxidation, rearrangement, degradation,

decomposition, etc.).

7.4. Relative density 7.4. The study does not need to be conducted if:

— the substance is only stable in solution in a particular solvent and the solution density is similar to

that of the solvent. In such cases, an indication of whether the solution density is higher or lower

than the solvent density is sufficient, or

— the substance is a gas. In this case, an estimation based on calculation shall be made from its mole-

cular weight and the Ideal Gas Laws.

29.5.2007 L 136/103Official Journal of the European Union

(

) This Annex shall apply to producers of articles that are required to register in accordance with Article 7 and to other downstream users that

are required to carry out tests under this Regulation adapted as necessary.

(

) Note: conditions for not requiring a specific test that are set out in the appropriate test methods in the Commission Regulation on test

methods as specified in Article 13(3) that are not repeated in column 2, also apply.

COLUMN 1

STANDARD INFORMATION

REQUIRED

COLUMN 2

SPECIFIC RULES FOR ADAPTATION FROM COLUMN 1

7.5. Vapour pressure 7.5. The study does not need to be conducted if the melting point is above 300 °C.

If the melting point is between 200 °C and 300 °C, a limit value based on measurement or a recognised

calculation method is sufficient.

7.6. Surface tension 7.6. The study need only be conducted if:

— based on structure, surface activity is expected or can be predicted, or

— surface activity is a desired property of the material.

If the water solubility is below 1 mg/l at 20 °C the test does not need to be conducted.

7.7. Water solubility 7.7. The study does not need to be conducted if:

— the substance is hydrolytically unstable at pH 4, 7 and 9 (half-life less than 12 hours), or

— the substance is readily oxidisable in water.

If the substance appears ‘insoluble’ in water, a limit test up to the detection limit of the analytical

method shall be performed.

7.8. Partition coefficient n-

octanol/water

7.8. The study does not need to be conducted if the substance is inorganic. If the test cannot be performed

(e.g. the substance decomposes, has a high surface activity, reacts violently during the performance of

the test or does not dissolve in water or in octanol, or it is not possible to obtain a sufficiently pure

substance), a calculated value for log P as well as details of the calculation method shall be provided.

7.9. Flash-point 7.9. The study does not need to be conducted if:

— the substance is inorganic, or

— the substance only contains volatile organic components with flash-points above 100 °C for

aqueous solutions, or

— the estimated flash-point is above 200 °C, or

— the flash-point can be accurately predicted by interpolation from existing characterised materials.

7.10. Flammability 7.10. The study does not need to be conducted:

— if the substance is a solid which possesses explosive or pyrophoric properties. These properties

should always be considered before considering flammability, or

— for gases, if the concentration of the flammable gas in a mixture with inert gases is so low that,

when mixed with air, the concentration is all time below the lower limit, or

— for substances which spontaneously ignite when in contact with air.

7.11. Explosive properties 7.11. The study does not need to be conducted if:

— there are no chemical groups associated with explosive properties present in the molecule, or

— the substance contains chemical groups associated with explosive properties which include oxygen

and the calculated oxygen balance is less than -200, or

— the organic substance or a homogenous mixture of organic substances contains chemical groups

associated with explosive properties, but the exothermic decomposition energy is less than 500 J/g

and the onset of exothermic decomposition is below 500 °C, or

— for mixtures of inorganic oxidising substances (UN Division 5.1) with organic materials, the concen-

tration of the inorganic oxidising substance is:

— less than 15 %, by mass, if assigned to UN Packaging Group I (high hazard) or II (medium

hazard),

— less than 30 %, by mass, if assigned to UN Packaging Group III (low hazard).

Note: Neither a test for propagation of detonation nor a test for sensitivity to detonative shock is

required if the exothermic decomposition energy of organic materials is less than 800 J/g.

29.5.2007L 136/104 Official Journal of the European Union

COLUMN 1

STANDARD INFORMATION

REQUIRED

COLUMN 2

SPECIFIC RULES FOR ADAPTATION FROM COLUMN 1

7.12. Self-ignition temperature 7.12. The study does not need to be conducted:

— if the substance is explosive or ignites spontaneously with air at room temperature, or

— for liquids non flammable in air, e.g. no flash point up to 200 °C, or

— for gases having no flammable range, or

— for solids, if the substance has a melting point ≤ 160 °C, or if preliminary results exclude self-

heating of the substance up to 400 °C.

7.13. Oxidising properties 7.13. The study does not need to be conducted if:

— the substance is explosive, or

— the substance is highly flammable, or

— the substance is an organic peroxide, or

— the substance is incapable of reacting exothermically with combustible materials, for example on the

basis of the chemical structure (e.g. organic substances not containing oxygen or halogen atoms and

these elements are not chemically bonded to nitrogen or oxygen, or inorganic substances not

containing oxygen or halogen atoms).

The full test does not need to be conducted for solids if the preliminary test clearly indicates that the

test substance has oxidising properties.

Note that as there is no test method to determine the oxidising properties of gaseous mixtures, the

evaluation of these properties must be realised by an estimation method based on the comparison of

the oxidising potential of gases in a mixture with that of the oxidising potential of oxygen in air.

7.14. Granulometry 7.14. The study does not need to be conducted if the substance is marketed or used in a non solid or granular

form.

8. TOXICOLOGICAL INFORMATION

COLUMN 1

STANDARD INFORMATION

REQUIRED

COLUMN 2

SPECIFIC RULES FOR ADAPTATION FROM COLUMN 1

8.1. Skin irritation or skin

corrosion

The assessment of this

endpoint shall comprise the

following consecutive steps:

(1) an assessment of the

available human and

animal data,

(2) an assessment of the

acid or alkaline reserve,

(3) in vitro study for skin

corrosion,

(4) in vitro study for skin

irritation.

8.1. Steps 3 and 4 do not need to be conducted if:

— the available information indicates that the criteria are met for classification as corrosive to the skin

or irritating to eyes, or

— the substance is flammable in air at room temperature, or

— the substance is classified as very toxic in contact with skin, or

— an acute toxicity study by the dermal route does not indicate skin irritation up to the limit dose

level (2 000 mg/kg body weight).

8.2. Eye irritation

The assessment of this

endpoint shall comprise the

following consecutive steps:

(1) an assessment of the

available human and

animal data,

(2) an assessment of the

acid or alkaline reserve,

(3) in vitro study for eye

irritation.

8.2. Step 3 does not need to be conducted if:

— the available information indicates that the criteria are met for classification as corrosive to the skin

or irritating to eyes, or

— the substance is flammable in air at room temperature;

29.5.2007 L 136/105Official Journal of the European Union

COLUMN 1

STANDARD INFORMATION

REQUIRED

COLUMN 2

SPECIFIC RULES FOR ADAPTATION FROM COLUMN 1

8.3. Skin sensitisation

The assessment of this

endpoint shall comprise the

following consecutive steps:

(1) an assessment of the

available human,

animal and alternative

data,

(2) In vivo testing.

8.3. Step 2 does not need to be conducted if:

— the available information indicates that the substance should be classified for skin sensitisation or

corrosivity, or

— the substance is a strong acid (pH ≤ 2,0) or base (pH ≥ 11,5), or

— the substance is flammable in air at room temperature.

The Murine Local Lymph Node Assay (LLNA) is the firs t-choice method for in vivo testing. Only in

exceptional circumstances should another test be used. Justification for the use of another test shall be

provided.

8.4. Mutagenicity 8.4. Further mutagenicity studies shall be considered in case of a positive result.

8.4.1. In vitro gene mutation study

in bacteria

8.5. Acute toxicity 8.5. The study/ies do(es) not generally need to be conducted if:

— the substance is classified as corrosive to the skin.

8.5.1. By oral route The study need not be conducted if a study on acute toxicity by the inhalation route (8.5.2) is available.

9. ECOTOXICOLOGICAL INFORMATION

COLUMN 1

STANDARD INFORMATION

REQUIRED

COLUMN 2

SPECIFIC RULES FOR ADAPTATION FROM COLUMN 1

9.1. Aquatic toxicity

9.1.1. Short-term toxicity testing

on invertebrates (preferred

species Daphnia)

The registrant may consider

long-term toxicity testing

instead of short-term.

9.1.1. The study does not need to be conducted if:

— there are mitigating factors indicating that aquatic toxicity is unlikely to occur, for instance if the

substance is highly insoluble in water or the substance is unlikely to cross biological membranes, or

— a long-term aquatic toxicity study on invertebrates is available, or

— adequate information for environmental classification and labelling is available.

The long-term aquatic toxicity study on Daphnia (Annex IX, section 9.1.5) shall be considered if the

substance is poorly water soluble.

9.1.2. Growth inhibition study

aquatic plants (algae

preferred)

9.1.2. The study does not need to be conducted if there are mitigating factors indicating that aquatic toxicity is

unlikely to occur for instance if the substance is highly insoluble in water or the substance is unlikely to

cross biological membranes.

9.2. Degradation

9.2.1. Biotic

9.2.1.1. Ready biodegradability 9.2.1.1. The study does not need to be conducted if the substance is inorganic.

Any other relevant physicochemical, toxicological and ecotoxicological information that is available shall be provided.

29.5.2007L 136/106 Official Journal of the European Union

ANNEX VIII

STANDARD INFORMATION REQUIREMENTS FOR SUBSTANCES MANUFACTURED OR IMPORTED IN

QUANTITIES OF 10 TONNES OR MORE (

)

Column 1 of this Annex establishes the standard information required for all substances manufactured or imported in

quantities of 10 tonnes or more in accordance with Ar ticle 12(1)(c). Accordingly, the information required in column 1

of this Annex is additional to that required in column 1 of Annex VII. Any other relevant physicochemical, toxicological

and ecotoxicological information that is available shall be provided. Column 2 of this Annex lists specific rules according

to which the required standard information may be omitted, replaced by other information, provided at a different stage

or adapted in another way. If the conditions are met under which column 2 of this Annex allows adaptations, the regis-

trant shall clearly state this fact and the reasons for each adaptation under the appropriate headings in the registration

dossier.

In addition to these specific rules, a registrant may adapt the required standard information set out in column 1 of this

Annex according to the general rules contained in Annex XI. In this case as well, he shall clearly state the reasons for any

decision to adapt the standard information under the appropriate headings in the registration dossier referring to the

appropriate specific rule(s) in column 2 or in Annex XI (

Before new tests are carried out to determine the properties listed in this Annex, all available in vitro data, in vivo data,

historical human data, data from valid (Q)SARs and data from structurally related substances (read-across approach) shall

be assessed first. In vivo testing with corrosive substances at concentration/dose levels causing cor rosivity shall be avoided.

Prior to testing, further guidance on testing strategies should be consulted in addition to this Annex.

When, for certain endpoints, information is not provided for other reasons than those mentioned in column 2 of this

Annex or in Annex XI, this fact and the reasons shall also be clearly stated.

8. TOXICOLOGICAL INFORMATION

COLUMN 1

STANDARD INFORMATION

REQUIRED

COLUMN 2

SPECIFIC RULES FOR ADAPTATION FROM COLUMN 1

8.1. Skin irritation

8.1.1. In vivo skin irritation 8.1.1. The study does not need to be conducted if:

— the substance is classified as corrosive to the skin or as a skin irritant, or

— the substance is a strong acid (pH ≤ 2,0) or base (pH ≥ 11,5), or

— the substance is flammable in air at room temperature, or

— the substance is classified as very toxic in contact with skin, or

— an acute toxicity study by the dermal route does not indicate skin irritation up to the limit dose

level (2 000 mg/kg body weight).

8.2. Eye irritation

8.2.1. In vivo eye irritation 8.2.1. The study does not need to be conducted if:

— the substance is classified as irritating to eyes with risk of serious damage to eyes, or

— the substance is classified as corrosive to the skin and provided that the registrant classified the

substance as eye irritant, or

— the substance is a strong acid (pH ≤ 2,0) or base (pH ≥ 11,5), or

— the substance is flammable in air at room temperature.

8.4. Mutagenicity

8.4.2. In vitro cytogenicity study

in mammalian cells or in

vitro micronucleus study

8.4.2. The study does not usually need to be conducted

— if adequate data from an in vivo cytogenicity test are available, or

— the substance is known to be carcinogenic category 1 or 2 or mutagenic category 1, 2 or 3.

29.5.2007 L 136/107Official Journal of the European Union

(

) This Annex shall apply to producers of articles that are required to register in accordance with Article 7 and to other downstream users that

are required to carry out tests under this Regulation adapted as necessary.

(

) Note: conditions for not requiring a specific test that are set out in the appropriate test methods in the Commission Regulation on test

methods as specified in Article 13(3) that are not repeated in column 2, also apply.

COLUMN 1

STANDARD INFORMATION

REQUIRED

COLUMN 2

SPECIFIC RULES FOR ADAPTATION FROM COLUMN 1

8.4.3. In vitro gene mutation study

in mammalian cells, if a

negative result in Annex VII,

Section 8.4.1. and

Annex VIII, Section 8.4.2.

8.4.3. The study does not usually need to be conducted if adequate data from a reliable in vivo mammalian

gene mutation test are available.

8.4. Appropriate in vivo mutagenicity studies shall be considered in case of a positive result in any of the

genotoxicity studies in Annex VII or VIII.

8.5. Acute toxicity 8.5. The study/ies do(es) not generally need to be conducted if:

— the substance is classified as corrosive to the skin.

In addition to the oral route (8.5.1), for substances other than gases, the information mentioned under

8.5.2 to 8.5.3 shall be provided for at least one other route. The choice for the second route will

depend on the nature of the substance and the likely route of human exposure. If there is only one

route of exposure, information for only that route need be provided.

8.5.2. By inhalation 8.5.2. Testing by the inhalation route is appropriate if exposure of humans via inhalation is likely taking into

account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or

droplets of an inhalable size.

8.5.3. By dermal route 8.5.3. Testing by the dermal route is appropriate if:

(1) inhalation of the substance is unlikely; and

(2) skin contact in production and/or use is likely; and

(3) the physicochemical and toxicological properties suggest potential for a significant rate of absorption

through the skin.

8.6. Repeated dose toxicity

8.6.1. Short-term repeated dose

toxicity study (28 days),

one species, male and

female, most appropriate

route of administration,

having regard to the likely

route of human exposure.

8.6.1. The short-term toxicity study (28 days) does not need to be conducted if:

— a reliable sub-chronic (90 days) or chronic toxicity study is available, provided that an appropriate

species, dosage, solvent and route of administration were used, or

— where a substance undergoes immediate disintegration and there are sufficient data on the cleavage

products, or

— relevant human exposure can be excluded in accordance with Annex XI Section 3.

The appropriate route shall be chosen on the following basis:

Testing by the dermal route is appropriate if:

(1) inhalation of the substance is unlikely; and

(2) skin contact in production and/or use is likely; and

(3) the physicochemical and toxicological properties suggest potential for a significant rate of absorption

through the skin.

Testing by the inhalation route is appropriate if exposure of humans via inhalation is likely taking into

account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or

droplets of an inhalable size.

The sub-chronic toxicity study (90 days) (Annex IX, Section 8.6.2) shall be proposed by the registrant if:

the frequency and duration of human exposure indicates that a longer term study is appropriate;

29.5.2007L 136/108 Official Journal of the European Union

COLUMN 1

STANDARD INFORMATION

REQUIRED

COLUMN 2

SPECIFIC RULES FOR ADAPTATION FROM COLUMN 1

and one of the following conditions is met:

— other available data indicate that the substance may have a dangerous property that cannot be

detected in a short-term toxicity study, or

— appropriately designed toxicokinetic studies reveal accumulation of the substance or its metabolites

in certain tissues or organs which would possibly remain undetected in a short-term toxicity study

but which are liable to result in adverse effects after prolonged exposure.

Further studies shall be proposed by the registrant or may be required by the Agency in accordance

with Article 40 or 41 in case of:

— failure to identify a NOAEL in the 28 or the 90 days study, unless the reason for the failure to iden-

tify a NOAEL is absence of adverse toxic effects, or

— toxicity of particular concern (e.g. serious/severe effects), or

— indications of an effect for which the available evidence is inadequate for toxicological and/or risk

characterisation. In such cases it may also be more appropriate to perform specific toxicological

studies that are designed to investigate these effects (e.g. immunotoxicity, neurotoxicity), or

— the route of exposure used in the initial repeated dose study was inappropriate in relation to the

expected route of human exposure and route-to-route extrapolation cannot be made, or

— particular concern regarding exposure (e.g. use in consumer products leading to exposure levels

which are close to the dose levels at which toxicity to humans may be expected), or

— effects shown in substances with a clear relationship in molecular structure with the substance being

studied, were not detected in the 28 or the 90 days study.

8.7. Reproductive toxicity

8.7.1. Screening for reproductive/

developmental toxicity, one

species (OECD 421 or

422), if there is no evidence

from available information

on structurally related

substances, from (Q)SAR

estimates or from in vitro

methods that the substance

may be a developmental

toxicant

8.7.1. This study does not need to be conducted if:

— the substance is known to be a genotoxic carcinogen and appropriate risk management measures

are implemented, or

— the substance is known to be a germ cell mutagen and appropriate risk management measures are

implemented, or

— relevant human exposure can be excluded in accordance with Annex XI section 3, or

— a pre-natal developmental toxicity study (Annex IX, 8.7.2) or a two-generation reproductive toxicity

study (Annex IX, Section 8.7.3) is available.

If a substance is known to have an adverse effect on fertility, meeting the criteria for classification as

Repr Cat 1 or 2: R60, and the available data are adequate to support a robust risk assessment, then no

further testing for fertility will be necessary. However, testing for development toxicity must be consid-

ered.

If a substance is known to cause developmental toxicity, meeting the criteria for classification as Repr

Cat 1 or 2: R61, and the available data are adequate to support a robust risk assessment, then no

further testing for developmental toxicity will be necessary. However, testing for effects on fertility must

be considered.

In cases where there are serious concerns about the potential for adverse effects on fertility or develop-

ment, either a pre-natal developmental toxicity study (Annex IX, Section 8.7.2) or a two-generation

reproductive toxicity study (Annex IX, Section 8.7.3) may be proposed by the registrant instead of the

screening study.

8.8. Toxicokinetics

8.8.1. Assessment of the toxicoki-

netic behaviour of the

substance to the extent that

can be derived from the

relevant available informa-

tion

29.5.2007 L 136/109Official Journal of the European Union

9. ECOTOXICOLOGICAL INFORMATION

COLUMN 1

STANDARD INFORMATION

REQUIRED

COLUMN 2

SPECIFIC RULES FOR ADAPTATION FROM COLUMN 1

9.1.3. Short-term toxicity testing

on fish: the registrant may

consider long-term toxicity

testing instead of short-

term.

9.1.3. The study does not need to be conducted if:

— there are mitigating factors indicating that aquatic toxicity is unlikely to occur, for instance if the

substance is highly insoluble in water or the substance is unlikely to cross biological membranes, or

— a long-term aquatic toxicity study on fish is available.

Long-term aquatic toxicity testing as described in Annex IX shall be considered if the chemical safety

assessment according to Annex I indicates the need to investigate further effects on aquatic organisms.

The choice of the appropriate test(s) will depend on the results of the chemical safety assessment.

The long-term aquatic toxicity study on fish (Annex IX, Section 9.1.6) shall be considered if the

substance is poorly water soluble.

9.1.4. Activated sludge respiration

inhibition testing

9.1.4. The study does not need to be conducted if:

— there is no emission to a sewage treatment plant, or

— there are mitigating factors indicating that microbial toxicity is unlikely to occur, for instance the

substance is highly insoluble in water, or

— the substance is found to be readily biodegradable and the applied test concentrations are in the

range of concentrations that can be expected in the influent of a sewage treatment plant.

The study may be replaced by a nitrification inhibition test if available data show that the substance is

likely to be an inhibitor of microbial growth or function, in particular nitrifying bacteria.

9.2. Degradation 9.2. Further degradation testing shall be considered if the chemical safety assessment according to Annex I

indicates the need to investigate further the degradation of the substance. The choice of the appropriate

test(s) will depend on the results of the chemical safety assessment.

9.2.2. Abiotic

9.2.2.1. Hydrolysis as a function of

pH.

9.2.2.1. The study does not need to be conducted if:

— the substance is readily biodegradable, or

— the substance is highly insoluble in water.

9.3. Fate and behaviour in the

environment

9.3.1. Adsorption/desor ption

screening

9.3.1. The study does not need to be conducted if:

— based on the physicochemical properties the substance can be expected to have a low potential for

adsorption (e.g. the substance has a low octanol water partition coefficient), or

— the substance and its relevant degradation products decompose rapidly.

29.5.2007L 136/110 Official Journal of the European Union

ANNEX IX

STANDARD INFORMATION REQUIREMENTS FOR SUBSTANCES MANUFACTURED OR IMPORTED IN

QUANTITIES OF 100 TONNES OR MORE (

)

At the level of this Annex, the registrant must submit a proposal and a time schedule for fulfilling the information

requirements of this Annex in accordance with Article 12(1)(d).

Column 1 of this Annex establishes the standard information required for all substances manufactured or imported in

quantities of 100 tonnes or more in accordance with Article 12(1)(d). Accordingly, the information required in column 1

of this Annex is additional to that required in column 1 of Annexes VII and VIII. Any other relevant physicochemical,

toxicological and ecotoxicological information that is available shall be provided. Column 2 of this Annex lists specific

rules according to which the registrant may propose to omit the required standard information, replace it by other infor-

mation, provide it at a later stage or adapt it in another way. If the conditions are met under which column 2 of this

Annex allows an adaptation to be proposed, the registrant shall clearly state this fact and the reasons for proposing each

adaptation under the appropriate headings in the registration dossier.

In addition to these specific rules, a registrant may propose to adapt the required standard information set out in

column 1 of this Annex according to the general rules contained in Annex XI. In this case as well, he shall clearly state

the reasons for any decision to propose adaptations to the standard information under the appropriate headings in the

registration dossier referring to the appropriate specific rule(s) in column 2 or in Annex XI (

Before new tests are carried out to determine the properties listed in this Annex, all available in vitro data, in vivo data,

historical human data, data from valid (Q)SARs and data from structurally related substances (read-across approach) shall

be assessed first. In vivo testing with corrosive substances at concentration/dose levels causing cor rosivity shall be avoided.

Prior to testing, further guidance on testing strategies should be consulted in addition to this Annex.

When, for certain endpoints, it is proposed not to provide information for other reasons than those mentioned in

column 2 of this Annex or in Annex XI, this fact and the reasons shall also be clearly stated.

7. INFORMATION ON THE PHYSICOCHEMICAL PROPERTIES OF THE SUBSTANCE

COLUMN 1

STANDARD INFORMATION

REQUIRED

COLUMN 2

SPECIFIC RULES FOR ADAPTATION FROM COLUMN 1

7.15. Stability in organic solvents

and identity of relevant

degradation products

Only required if stability of

the substance is considered

to be critical.

7.15. The study does not need to be conducted if the substance is inorganic.

7.16. Dissociation constant 7.16. The study does not need to be conducted if:

— the substance is hydrolytically unstable (half-life less than 12 hours) or is readily oxidisable in water,

— it is scientifically not possible to perform the test for instance if the analytical method is not sensi-

tive enough.

7.17. Viscosity

29.5.2007 L 136/111Official Journal of the European Union

(

) This Annex shall apply to producers of articles that are required to register in accordance with Article 7 and to other downstream users that

are required to carry out tests under this Regulation adapted as necessary.

(

) Note: conditions for not requiring a specific test that are set out in the appropriate test methods in the Commission Regulation on test

methods as specified in Article 13(3) that are not repeated in column 2, also apply.

8. TOXICOLOGICAL INFORMATION

COLUMN 1

STANDARD INFORMATION

REQUIRED

COLUMN 2

SPECIFIC RULES FOR ADAPTATION FROM COLUMN 1

8.4. If there is a positive result in any of the in vitro genotoxicity studies in Annex VII or VIII and there are

no results available from an in vivo study already, an appropriate in vivo somatic cell genotoxicity study

shall be proposed by the registrant.

If there is a positive result from an in vivo somatic cell study available, the potential for germ cell muta-

genicity should be considered on the basis of all available data, including toxicokinetic evidence. If no

clear conclusions about germ cell mutagenicity can be made, additional investigations shall be consid-

ered.

8.6. Repeated dose toxicity

8.6.1. Short-term repeated dose

toxicity study (28 days),

one species, male and

female, most appropriate

route of administration,

having regard to the likely

route of human exposure,

unless already provided as

part of Annex VIII require-

ments or if tests according

to Section 8.6.2 of this

Annex is proposed. In this

case, Section 3 of Annex XI

shall not apply.

8.6.2. Sub-chronic toxicity study

(90-day), one species,

rodent, male and female,

most appropriate route of

administration, having

regard to the likely route of

human exposure.

8.6.2. The sub-chronic toxicity study (90 days) does not need to be conducted if:

— a reliable short-term toxicity study (28 days) is available showing severe toxicity effects according to

the criteria for classifying the substance as R48, for which the observed NOAEL-28 days, with the

application of an appropriate uncertainty factor, allows the extrapolation towards the NOAEL-

90 days for the same route of exposure, or

— a reliable chronic toxicity study is available, provided that an appropriate species and route of admin-

istration were used, or

— a substance undergoes immediate disintegration and there are sufficient data on the cleavage

products (both for systemic effects and effects at the site of uptake), or

— the substance is unreactive, insoluble and not inhalable and there is no evidence of absorption and

no evidence of toxicity in a 28-day ‘limit test’, particularly if such a pattern is coupled with limited

human exposure.

The appropriate route shall be chosen on the following basis:

Testing by the dermal route is appropriate if:

(1) skin contact in production and/or use is likely; and

(2) the physicochemical properties suggest a significant rate of absorption through the skin; and

(3) one of the following conditions is met:

— toxicity is observed in the acute dermal toxicity test at lower doses than in the oral toxicity test,

— systemic effects or other evidence of absorption is observed in skin and/or eye irritation studies,

— in vitro tests indicate significant dermal absorption, or

— significant der mal toxicity or dermal penetration is recognised for structurally-related substances.

29.5.2007L 136/112 Official Journal of the European Union

COLUMN 1

STANDARD INFORMATION

REQUIRED

COLUMN 2

SPECIFIC RULES FOR ADAPTATION FROM COLUMN 1

Testing by the inhalation route is appropriate if:

— exposure of humans via inhalation is likely taking into account the vapour pressure of the substance

and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size.

Further studies shall be proposed by the registrant or may be required by the Agency in accordance

with Articles 40 or 41 in case of:

— failure to identify a NOAEL in the 90 days study unless the reason for the failure to identify a

NOAEL is absence of adverse toxic effects, or

— toxicity of particular concern (e.g. serious/severe effects), or

— indications of an effect for which the available evidence is inadequate for toxicological and/or risk

characterisation. In such cases it may also be more appropriate to perform specific toxicological

studies that are designed to investigate these effects (e.g. immunotoxicity, neurotoxicity), or

— particular concern regarding exposure (e.g. use in consumer products leading to exposure levels

which are close to the dose levels at which toxicity to humans may be expected).

8.7. Reproductive toxicity 8.7. The studies do not need to be conducted if:

— the substance is known to be a genotoxic carcinogen and appropriate risk management measures

are implemented, or

— the substance is known to be a germ cell mutagen and appropriate risk management measures are

implemented, or

— the substance is of low toxicological activity (no evidence of toxicity seen in any of the tests avail-

able), it can be proven from toxicokinetic data that no systemic absorption occurs via relevant

routes of exposure (e.g. plasma/blood concentrations below detection limit using a sensitive method

and absence of the substance and of metabolites of the substance in urine, bile or exhaled air) and

there is no or no significant human exposure.

If a substance is known to have an adverse effect on fertility, meeting the criteria for classification as

Repr Cat 1 or 2: R60, and the available data are adequate to support a robust risk assessment, then no

further testing for fertility will be necessary. However, testing for development toxicity must be consid-

ered.

If a substance is known to cause developmental toxicity, meeting the criteria for classification as Repr

Cat 1 or 2: R61, and the available data are adequate to support a robust risk assessment, then no

further testing for developmental toxicity will be necessary. However, testing for effects on fertility must

be considered.

8.7.2. Pre-natal developmental

toxicity study, one species,

most appropriate route of

administration, having

regard to the likely route of

human exposure (B.31 of

the Commission Regulation

on test methods as speci-

fied in Article 13(3) or

OECD 414).

8.7.2. The study shall be initially performed on one species. A decision on the need to perform a study at this

tonnage level or the next on a second species should be based on the outcome of the first test and all

other relevant available data.

29.5.2007 L 136/113Official Journal of the European Union

COLUMN 1

STANDARD INFORMATION

REQUIRED

COLUMN 2

SPECIFIC RULES FOR ADAPTATION FROM COLUMN 1

8.7.3. Two-generation reproduc-

tive toxicity study,

one species, male and

female, most appropriate

route of administration,

having regard to the likely

route of human exposure, if

the 28-day or 90-day study

indicates adverse effects on

reproductive organs or

tissues.

8.7.3. The study shall be initially performed on one species. A decision on the need to perform a study at this

tonnage level or the next on a second species should be based on the outcome of the first test and all

other relevant available date.

9. ECOTOXICOLOGICAL INFORMATION

COLUMN 1

STANDARD INFORMATION

REQUIRED

COLUMN 2

SPECIFIC RULES FOR ADAPTATION FROM COLUMN 1

9.1. Aquatic toxicity 9.1. Long-term toxicity testing shall be proposed by the registrant if the chemical safety assessment according

to Annex I indicates the need to investigate further the effects on aquatic organisms. The choice of the

appropriate test(s) depends on the results of the chemical safety assessment.

9.1.5. Long-term toxicity testing

on invertebrates (preferred

species Daphnia), (unless

already provided as part of

Annex VII requirements)

9.1.6. Long-term toxicity testing

on fish, (unless already

provided as part of

Annex VIII requirements)

The information shall be

provided for one of the

Sections 9.1.6.1, 9.1.6.2 or

9.1.6.3.

9.1.6.2. Fish early-life stage (FELS)

toxicity test

9.1.6.2. Fish short-term toxicity test

on embryo and sac-fry

stages

9.1.6.3. Fish, juvenile growth test

9.2. Degradation 9.2. Further biotic degradation testing shall be proposed by the registrant if the chemical safety assessment

according to Annex I indicates the need to investigate further the degradation of the substance and its

degradation products. The choice of the appropr iate test(s) depends on the results of the chemical safety

assessment and may include simulation testing in appropriate media (e.g. water, sediment or soil).

9.2.1. Biotic

9.2.1.2. Simulation testing on ulti-

mate degradation in surface

water

9.2.1.2. The study need not be conducted if:

— the substances is highly insoluble in water, or

— the substance is readily biodegradable.

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COLUMN 1

STANDARD INFORMATION

REQUIRED

COLUMN 2

SPECIFIC RULES FOR ADAPTATION FROM COLUMN 1

9.2.1.3. Soil simulation testing (for

substances with a high

potential for adsorption to

soil)

9.2.1.3. The study need not be conducted:

— if the substance is readily biodegradable, or

— if direct and indirect exposure of soil is unlikely.

9.2.1.4. Sediment simulation testing

(for substances with a high

potential for adsorption to

sediment)

9.2.1.4. The study need not be conducted:

— if the substance is readily biodegradable, or

— if direct and indirect exposure of sediment is unlikely.

9.2.3. Identification of degrada-

tion products

9.2.3. Unless the substance is readily biodegradable

9.3. Fate and behaviour in the

environment

9.3.2. Bioaccumulation in aquatic

species, preferably fish

9.3.2. The study need not be conducted if:

— the substance has a low potential for bioaccumulation (for instance a log Kow ≤ 3) and/or a low

potential to cross biological membranes, or

— direct and indirect exposure of the aquatic compartment is unlikely.

9.3.3. Further information on

adsorption/desorption

depending on the results of

the study required in

Annex VIII

9.3.3. The study need not be conducted if:

— based on the physicochemical properties the substance can be expected to have a low potential for

adsorption (e.g. the substance has a low octanol water partition coefficient), or

— the substance and its degradation products decompose rapidly.

9.4. Effects on terrestrial organ-

isms

9.4. These studies do not need to be conducted if direct and indirect exposure of the soil compartment is

unlikely.

In the absence of toxicity data for soil organisms, the equilibrium partitioning method may be applied

to assess the hazard to soil organisms. The choice of the appropriate tests depends on the outcome of

the chemical safety assessment.

In particular for substances that have a high potential to adsorb to soil or that are very persistent, the

registrant shall consider long-term toxicity testing instead of short-term.

9.4.1. Short-term toxicity to

invertebrates

9.4.2. Effects on soil micro-organ-

isms

9.4.3. Short-term toxicity to

plants

10. METHODS OF DETECTION AND ANALYSIS

Description of the analytical methods shall be provided on request, for the relevant compartments for which studies were

performed using the analytical method concerned. If the analytical methods are not available this shall be justified.

29.5.2007 L 136/115Official Journal of the European Union

ANNEX X

STANDARD INFORMATION REQUIREMENTS FOR SUBSTANCES MANUFACTURED OR IMPORTED IN

QUANTITIES OF 1 000 TONNES OR MORE (

)

At the level of this Annex, the registrant must submit a proposal and a time schedule for fulfilling the information

requirements of this Annex in accordance with Article 12(1)(e).

Column 1 of this Annex establishes the standard information required for all substances manufactured or imported in

quantities of 1 000 tonnes or more in accordance with Article 12(1)(e). Accordingly, the information required in column

1 of this Annex is additional to that required in column 1 of Annexes VII, VIII and IX. Any other relevant physicochem-

ical, toxicological and ecotoxicological information that is available shall be provided. Column 2 of this Annex lists

specific rules according to which the registrant may propose to omit the required standard information, replace it by

other information, provide it at a later stage or adapt it in another way. If the conditions are met under which column 2

of this Annex allows an adaptation to be proposed, the registrant shall clearly state this fact and the reasons for proposing

each adaptation under the appropriate headings in the registration dossier.