29.5.2007

EN

Official Journal of the European Union

L 136/3

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), establishinga 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 Directive 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 EUROPEAN UNION,(3)

A high level of human health and environmental protection should be ensured in the approximation of legislation on substances, with the goal of achieving sustainable
development. That legislation should be applied in a nondiscriminatory 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 isaiming to achieve that, by 2020, chemicals are produced
and used in ways that lead to the minimisation of significant adverse effects on human health and the environment.

(5)This Regulation should apply without prejudice to Community workplace and environment legislation.

(6)

This Regulation should contribute to fulfilment of theStrategic Approach to International Chemical Management (SAICM) adopted on 6 February 2006 in Dubai.

(7)

To preserve the integrity of the internal market and toensure a high level of protection for human health, especially the health of workers, and the environment, it isnecessary to ensure that manufacturing of substances in
the Community complies with Community law, even if
those substances are exported.

Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof,
Having regard to the proposal from the Commission,
Having regard to the opinion of the European Economic andSocial Committee (1),Having regard to the opinion of the Committee of theRegions (2),Acting in accordance with the procedure laid down in
Article 251 of the Treaty (3),Whereas:(1)(2)

This Regulation should ensure a high level of protectionof human health and the environment as well as the freemovement of substances, on their own, in preparations
and in articles, while enhancing competitiveness andinnovation. This Regulation should also promote thedevelopment of alternative methods for the assessment of
hazards of substances.
The efficient functioning of the internal market for
substances can be achieved only if requirements for
substances do not differ significantly from Member Stateto Member State.

(1) OJ C 112, 30.4.2004, p. 92 and OJ C 294, 25.11.2005, p. 38.
(2) OJ C 164, 5.7.2005, p. 78.
(3) 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 (OJC 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.

L 136/4

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Official Journal of the European Union(8)

Special account should be taken of the potential impactof this Regulation on small- and medium-sized enterprises (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 theapproximation of the laws, regulations and administrative
provisions relating to the classification, packaging andlabelling of dangerous substances (1), Council Directive 76/769/EEC of 27 July 1976 on the approximationof the laws, regulations and administrative provisions of
the Member States relating to restrictions on themarketing and use of certain dangerous substances andpreparations (2), 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 (3) and Council Regulation (EEC)
No 793/93 of 23 March 1993 on the evaluation andcontrol of the risks of existing substances (4), identified anumber 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 theinternal market in this field, and the need to do more toprotect public health and the environment in accordancewith the precautionary principle.

(10)

(11)

(12)

Substances under customs supervision which are intemporary storage, in free zones or free warehouses witha 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 tosuch carriage.

cases to ensure that substances of high concern are eventually replaced by less dangerous substances or technologies where suitable economically and technically viable
alternatives are available. This Regulation does not affectthe application of Directives on worker protection andthe environment, especially Directive 2004/37/EC of theEuropean 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) (5) andCouncil Directive 98/24/EC of 7 April 1998 on theprotection of the health and safety of workers from therisks related to chemical agents at work (fourteenth individual Directive within the meaning of Article 16(1) of
Directive 89/391/EEC) (6) under which employers are
required to eliminate dangerous substances, wherevertechnically possible, or to substitute dangerous substanceswith less dangerous substances.

(13)

This Regulation should apply without prejudice to theprohibitions and restrictions laid down in Council Directive 76/768/EEC of 27 July 1976 on the approximationof the laws of the Member States relating to cosmetic
products (7) in so far as substances are used and marketed
as cosmetic ingredients and are within the scope of thisRegulation. 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 thatgenerated by this Regulation, should be used by the relevant actors in the application and implementation of
appropriate Community legislation, for example thatcovering products, and Community voluntary instruments, such as the eco-labelling scheme. The Commission
should consider in the review and development of relevant Community legislation and voluntary instruments
how information generated by this Regulation should be
used, and examine possibilities for establishing a European quality mark.

(15)

There is a need to ensure effective management of thetechnical, scientific and administrative aspects of thisRegulation 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 anumber of long-term advantages over other options. A
European Chemicals Agency (hereinafter referred to as
the Agency) should therefore be established.

To ensure workability and to maintain the incentives for
waste recycling and recovery, wastes should not be
regarded as substances, preparations or articles within themeaning of this Regulation.

An important objective of the new system to be established by this Regulation is to encourage and in certain(1) 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.
2( ) 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).
(3) 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).
(4) 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).

29.5.2007(5) OJ L 158, 30.4.2004, p. 50, corrected in OJ L 229, 29.6.2004, p. 23.
(6) OJ L 131, 5.5.1998, p. 11.
(7) 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).

29.5.2007
(16)

(17)

(18)

(19)

(20)

(21)

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Official Journal of the European Union

This Regulation lays down specific duties and obligations
on manufacturers, importers and downstream users of
substances on their own, in preparations and inarticles. This Regulation is based on the principle thatindustry should manufacture, import or use substancesor place them on the market with such responsibility andcare as may be required to ensure that, under reasonably
foreseeable conditions, human health and the environment are not adversely affected.

turers and importers to manage the risks related to theirsubstances, it may also be used to initiate the authorisation or restrictions procedures under this Regulation orrisk management procedures under other Community
legislation. Therefore it should be ensured that this information 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 goodfunctioning of the internal market while assuring that therisks 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 therisks arising from their use are adequately controlled,
where this is possible, or the use can be justified forsocio-economic reasons and no suitable alternatives areavailable, which are economically and technically viable.

(23)

The restriction provisions should allow the manufacturing, placing on the market and use of substancespresenting risks that need to be addressed, to be madesubject to total or partial bans or other restrictions, basedon an assessment of those risks.

(24)

In preparation for this Regulation, the Commission has
launched REACH Implementation Projects (RIPs), involving relevant experts from stakeholder groups. Some ofthose projects aim at developing draft guidelines andtools which should help the Commission, the Agency,
Member States, manufacturers, importers and downstream 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 ofsubstances should be given, in the first place, to thenatural or legal persons that manufacture or importsubstances, but only when they do so in quantities
exceeding a certain volume, to enable them to carry the
associated burden. Natural or legal persons handlingchemicals should take the necessary risk management
measures in accordance with the assessment of the risksof substances and pass on relevant recommendations
along the supply chain. This should include describing,
documenting and notifying in an appropriate and transparent fashion the risks stemming from the production,
use and disposal of each substance.

(26)

In order to undertake chemical safety assessments ofsubstances effectively, manufacturers and importers of
substances should obtain information on thesesubstances, if necessary by performing new tests.

All available and relevant information on substances on
their own, in preparations and in articles should becollected 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 onhuman health and the environment. In addition, communication of technical advice to support risk management
should be encouraged in the supply chain, where appropriate.

Responsibility for the management of the risks ofsubstances should lie with the natural or legal persons
that manufacture, import, place on the market or use
these substances. Information on the implementation ofthis Regulation should be easily accessible, in particularfor SMEs.

Therefore, the registration provisions should require
manufacturers and importers to generate data on thesubstances they manufacture or import, to use these datato assess the risks related to these substances and todevelop and recommend appropriate risk management
measures. To ensure that they actually meet these obligations, 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.

The evaluation provisions should provide for follow-up
to registration, by allowing for checks on whether registrations are in compliance with the requirements of thisRegulation 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 substanceconstitutes a risk to human health or the environment,
the Agency should, after having included the substance in
the Community rolling action plan for substance evaluation, relying on the competent authorities of Member
States, ensure that this substance is evaluated.

Although the information yielded on substances throughevaluation should be used in the first place by manufac-

L 136/5

L 136/6

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Official Journal of the European Union(27)

For purposes of enforcement and evaluation and forreasons of transparency, the information on thesesubstances, as well as related information, including on
risk management measures, should normally besubmitted to authorities.

(28)

Scientific research and development normally takes placein quantities below one tonne per year. There is no needto exempt such research and development because
substances in those quantities do not have to be registered in any case. However, in order to encourage innovation, product and process oriented research and development 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 preparations or articles still requires further research and development performed by the potential registrant himself orin cooperation with a limited number of known customers. In addition, it is appropriate to provide for asimilar exemption to downstream users using thesubstance for the purposes of product and process
oriented research and development, provided that therisks to human health and the environment are
adequately controlled in accordance with the requirements of legislation for the protection of workers andthe environment.

(29)

(30)

Since producers and importers of articles should be
responsible for their articles, it is appropriate to impose aregistration requirement on substances which areintended to be released from articles and have not beenregistered for that use. In the case of substances of very
high concern which are present in articles above tonnage
and concentration thresholds, where exposure to thesubstance cannot be excluded and where the substancehas not been registered by any person for this use, theAgency 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 humanhealth 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 posesa risk to human health or the environment that is notadequately controlled.

The requirements for undertaking chemical safety assessments by manufacturers and importers should be definedin detail in a technical annex to allow them to meet their
obligations. To achieve fair burden sharing with theircustomers, manufacturers and importers should in theirchemical safety assessment address not only their own
uses and the uses for which they place their substanceson the market, but also all uses which their customers
ask them to address.

29.5.2007(31)

The Commission, in close cooperation with industry,Member States and other relevant stakeholders, should
develop guidance to fulfil the requirements under thisRegulation related to preparations (in particular withregard to safety data sheets incorporating exposure
scenarios) including assessment of substances incorporated into special preparations — such as metals incorporated in alloys. In doing so, the Commission should takefull account of the work that will have been carried out
within the framework of the RIPs and should include thenecessary 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 verysmall 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 specificshape 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 agroup of multiple registrants should submit information
on behalf of the others according to rules which ensurethat all the required information is submitted, whileallowing sharing of the costs burden. A registrant shouldbe able to submit information directly to the Agency incertain specified cases.

(34)

Requirements for generation of information on
substances should be tiered according to the volumes ofmanufacture or importation of a substance, because theseprovide 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 ecotoxicological information should only be required for priority
substances between 1 and 10 tonnes. For othersubstances in that quantity range there should be incentives to encourage manufacturers and importers toprovide this information.

(35)

The Member States, the Agency and all interested parties
should take full account of the results of the RIPs, in particular 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 frommineralogical processes and the review of Annexes IV
and V should fully take this into account.

29.5.2007
(37)

(38)

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Official Journal of the European Union

If tests are performed, they should comply with the relevant requirements of protection of laboratory animals,
set out in Council Directive 86/609/EEC of 24 November
1986 on the approximation of laws, regulations andadministrative provisions of the Member States regarding
the protection of animals used for experimental andother scientific purposes (1), and, in the case of ecotoxicological and toxicological tests, good laboratory practice,
set out in Directive 2004/10/EC of the European Parliament and of the Council of 11 February 2004 on theharmonisation of laws, regulations and administrative
provisions relating to the application of the principles ofgood laboratory practice and the verification of theirapplication for tests on chemical substances (2).

The generation of information by alternative meansoffering equivalence to prescribed tests and test methods
should also be allowed, for example when this information 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 parties, 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, tocomply 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 otherstakeholders should continue to contribute to the promotion of alternative test methods on an international andnational level including computer supported methodologies, 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 ensurethat 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 besought.

(41)

For reasons of workability and because of their special
nature, specific registration requirements should be laid
down for intermediates. Polymers should be exemptedfrom registration and evaluation until those that need tobe registered due to the risks posed to human health or
the environment can be selected in a practicable andcost-efficient way on the basis of sound technical andvalid scientific criteria.

(1) 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).
(2) OJ L 50, 20.2.2004, p. 44.

L 136/7(42)

To avoid overloading authorities and natural or legal
persons with the work arising from the registration ofphase-in substances already on the internal market, that
registration should be spread over an appropriate periodof time, without introducing undue delay. Deadlines forthe 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 systemand should be upgraded when the next tonnage quantity
threshold is reached.

(44)

In order to provide a harmonised, simple system, allregistrations should be submitted to the Agency. To
ensure a consistent approach and efficient use ofresources, it should perform a completeness check on all
registrations and take responsibility for any final rejections of registrations.

(45)

The European Inventory of Existing Commercial
Chemical Substances (EINECS) included certain complex
substances in a single entry. UVCB substances (substancesof unknown or variable composition, complex reaction
products or biological materials) may be registered as asingle substance under this Regulation, despite their variable composition, provided that the hazardous properties
do not differ significantly and warrant the same classification.

(46)

To ensure that the information gathered through theregistration is kept up-to-date, an obligation on registrants to inform the Agency of certain changes to theinformation 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 assessment of health and environmental hazards of chemicals,
wherever possible. The use of animals should be avoided
by recourse to alternative methods validated by theCommission or international bodies, or recognised by theCommission or the Agency as appropriate to meet the
information requirements under this Regulation. To thisend, the Commission, following consultation with relevant stakeholders, should propose to amend the future
Commission Regulation on test methods or this Regulation, where appropriate, to replace, reduce or refine
animal testing. The Commission and the Agency should
ensure that reduction of animal testing is a key consideration in the development and maintenance of guidance forstakeholders and in the Agency's own procedures.

L 136/8

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Official Journal of the European Union(48)

This Regulation should be without prejudice to the fulland 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 provisions concerning preparation and submission of registrations and updates should require sharing of information
where this is requested by any registrant. If the information 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 environmental 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 particular in the case of information involving tests on vertebrate animals, under conditions that ensure a faircompensation for the company that has undertaken thetests.

(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 basisof fair compensation.

(52)

In order to respect the legitimate property rights of thosegenerating testing data, the owner of such data should,
for a period of 12 years, be able to claim compensationfrom 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 hecannot reach agreement with a previous registrant, theAgency, 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 forevidence that a potential registrant has paid the owner ofa study before the Agency gives permission for the
potential registrant to use that information in his registration.

(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 beestablished in order to provide for the establishment of
Substance Information Exchange Forums (SIEF) to help
exchange of information on the substances that havebeen registered. SIEF participants should include all relevant actors submitting information to the Agency on thesame phase-in substance. They should include both29.5.2007

potential registrants, who must provide and be suppliedwith any information relevant to the registration of theirsubstances, and other participants, who may receive
financial compensation for studies they hold but are notentitled to request information. In order to ensure thesmooth 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 butother members should be enabled to continue preparing
their own registration. In cases where a substance has notbeen 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 communicate with the downstream users of the substance withregard 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 downstream 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 thecommunication of information on these substances toother professionals such as downstream users or distributors. In addition, producers or importers of articles
should supply information on the safe use of articles toindustrial and professional users, and consumers onrequest. This important responsibility should also apply
throughout the supply chain to enable all actors to meettheir 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 systemestablished by this Regulation.

(58)

In order to have a chain of responsibilities, downstream
users should be responsible for assessing the risks arisingfrom their uses of substances if those uses are notcovered by a safety data sheet received from their
suppliers, unless the downstream user concerned takes
more protective measures than those recommended byhis supplier or unless his supplier was not required toassess those risks or provide him with information on
those risks. For the same reason, downstream users
should manage the risks arising from their uses ofsubstances. In addition, it is appropriate that any
producer or importer of an article containing a substanceof very high concern should provide sufficient information to allow safe use of such an article.

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Official Journal of the European Union(59)

The requirements for undertaking chemical safety assessments by downstream users should also be prescribed indetail 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 thesafety data sheet communicated by their original manufacturer or importer and to keep such reported information up-to-date.

(61)

For reasons of workability and proportionality, it isappropriate to exempt downstream users using low quantities 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 information is tailored to real information needs. To this end
evaluation should require the Agency to decide on the
programmes of testing proposed by manufacturers andimporters. In cooperation with Member States, theAgency should give priority to certain substances, forinstance those which may be of very high concern.

(64)

(65)

In order to prevent unnecessary animal testing, interested
parties should have a period of 45 days during which
they may provide scientifically valid information andstudies 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.

In addition, it is necessary to instil confidence in thegeneral 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 aremeeting the obligations placed upon them. Accordingly,
it is appropriate to provide for recording which information has been reviewed by an assessor possessing appropriate experience, and for a percentage of registrations to
be checked for compliance by the Agency.

L 136/9(66)

The Agency should also be empowered to require further
information from manufacturers, importers or downstream users on substances suspected of posing a risk tohuman health or the environment, including by reasonof their presence on the internal market in high volumes,on the basis of evaluations performed. Based on thecriteria for prioritising substances developed by the
Agency in cooperation with the Member States a Community rolling action plan for substance evaluation
should be established, relying on Member State competent authorities to evaluate substances included therein. If
a risk equivalent to the level of concern arising from theuse of substances subject to authorisation arises from theuse of isolated intermediates on site, the competentauthorities 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 subsidiarity, while maintaining the internal market. If one ormore Member States or the Agency do not agree to adraft decision, it should be adopted subject to a centralised procedure. If the Member State Committee fails toreach unanimous agreement, the Commission should
adopt a decision in accordance with a Committee procedure.

(68)

Evaluation may lead to the conclusion that action should
be taken under the restriction or authorisation procedures or that risk management action should be considered 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 forhuman health, including having regard to relevant humanpopulation groups and possibly to certain vulnerable
sub-populations, and the environment, substances of very
high concern should, in accordance with the precautionary principle, be subject to careful attention. Authorisation 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 environment 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 theuse of the substance outweigh the risks connected with
its use and there are no suitable alternative substances ortechnologies that are economically and technically viable.
Taking into account the good functioning of the internalmarket it is appropriate that the Commission should be
the granting authority.

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Official Journal of the European Union

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 theuses of a substance are adequately controlled, and with aview to progressively substituting these substances with asuitable safer substance. Risk management measures
should be applied to ensure, when substances are manufactured, placed on the market and used, that exposure tothese substances including discharges, emissions andlosses, throughout the whole life-cycle is below thethreshold 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 notpossible to establish a safe level of exposure, measures
should always be taken to minimise, as far as technicallyand practically possible, exposure and emissions with aview to minimising the likelihood of adverse effects.
Measures to ensure adequate control should be identified
in any Chemical Safety Report. These measures should beapplied and, where appropriate, recommended to otheractors 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 ahigh level of protection of human health and the environment.

(72)

To support the aim of eventual replacement of substancesof very high concern by suitable alternative substances ortechnologies, 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.
Furthermore, authorisations should be subject to timelimited review whose periods would be determined on acase-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 anunacceptable risk to human health or to the environment, taking into account the availability of suitable safer
alternative substances and technologies, and the socioeconomic benefits from the uses of the substance posing
an unacceptable risk.

(74)

Substitution of a substance of very high concern bysuitable safer alternative substances or technologies
should be considered by all those applying for authorisa-

29.5.2007

tions of uses of such substances on their own, in preparations or for incorporation of substances into articles bymaking an analysis of alternatives, the risks involved inusing any alternative and the technical and economic
feasibility of substitution.

(75)

The possibility of introducing restrictions on the manufacturing, 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 carcinogenic, mutagenic or toxic to reproduction, category 1 or
2, for their use by consumers on their own or in preparations should continue to be introduced.

(76)

Experience at international level shows that substanceswith characteristics rendering them persistent, liable tobioaccumulate and toxic, or very persistent and very
liable to bioaccumulate, present a very high concern,
while criteria have been developed allowing the identification of such substances. For certain other substances
concerns are sufficiently high to address them in thesame way on a case-by-case basis. The criteria in
Annex XIII should be reviewed taking into account thecurrent and any new experience in the identification ofthese substances and if appropriate, be amended with aview to ensuring a high level of protection for humanhealth and the environment.

(77)

In view of workability and practicality considerations,both as regards natural or legal persons, who have toprepare application files and take appropriate risk
management measures, and as regards the authorities,
who have to process authorisation applications, only alimited number of substances should be subjected to theauthorisation procedure at the same time and realistic
deadlines should be set for applications, while allowing
certain uses to be exempted. Substances identified asmeeting the criteria for authorisation should be included
in a candidate list for eventual inclusion in the authorisation procedure. Within this list, substances on the Agency's work programme should be clearly identified.

(78)

The Agency should provide advice on the prioritisationof substances to be made subject to the authorisation
procedure, to ensure that decisions reflect the needs ofsociety 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 thelist of substances for which applications can be submitted
and added to the list of restricted substances.

29.5.2007
(80)

(81)

(82)

(83)

(84)

(85)

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The proper interaction between the provisions on authorisation and restriction should be ensured in order topreserve the efficient functioning of the internal market
and the protection of human health, safety and the environment. Restrictions that exist when the substance inquestion is added to the list of substances for whichapplications for authorisation can be submitted, should
be maintained for that substance. The Agency should
consider whether the risk from substances in articles isadequately controlled and, if it is not, prepare a dossier in
relation to introduction of further restrictions for
substances for which the use requires authorisation.

In order to provide a harmonised approach to theauthorisation of the uses of particular substances, theAgency should issue opinions on the risks arising fromthose uses, including whether or not the substance isadequately 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.

To allow effective monitoring and enforcement of theauthorisation requirement, downstream users benefitingfrom an authorisation granted to their supplier should
inform the Agency of their use of the substance.

It is suitable in these circumstances that final decisions
granting or refusing authorisations be adopted by theCommission 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.

In order to accelerate the current system the restriction
procedure should be restructured and Directive 76/769/
EEC, which has been substantially amended and adapted
several times, should be replaced. In the interests ofclarity and as a starting point for this new accelerated
restriction procedure, all the restrictions developed underthat Directive should be incorporated into this Regulation. Where appropriate, the application of Annex XVIIof this Regulation should be facilitated by guidance developed by the Commission.

In relation to Annex XVII Member States should beallowed to maintain for a transitional period more stringent restrictions, provided that these restrictions havebeen notified according to the Treaty. This should
concern substances on their own, substances in preparations and substances in articles, the manufacturing, theplacing on the market and the use of which is restricted.
The Commission should compile and publish an inven-

L 136/11

tory of these restrictions. This would provide an opportunity for the Commission to review the measuresconcerned with a view to possible harmonisation.

(86)

It should be the responsibility of the manufacturer,
importer and downstream user to identify the appropriate risk management measures needed to ensure ahigh level of protection for human health and the environment 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 insufficient 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 anarticle 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 amendments thereto.

(88)

In order to prepare a restrictions proposal and in orderfor such legislation to operate effectively, there should begood cooperation, coordination and information between
the Member States, the Agency, other bodies of the Community, the Commission and the interested parties.

(89)

In order to give Member States the opportunity tosubmit proposals to address a specific risk for humanhealth and the environment, they should prepare adossier in conformity with detailed requirements. The
dossier should set out the justification for Communitywide action.

(90)

In order to provide a harmonised approach to restrictions, the Agency should fulfil a role as coordinator ofthis procedure, for example by appointing the relevant
rapporteurs and verifying conformity with the requirements of the relevant Annexes. The Agency should maintain a list of substances for which a restriction dossier isbeing prepared.

(91)

In order to give the Commission the opportunity toaddress a specific risk for human health and the environment that needs to be addressed Community wide, it
should be able to entrust the Agency with the preparation of a restriction dossier.

(92)

For reasons of transparency, the Agency should publish
the relevant dossier including the suggested restrictions
while requesting comments.

L 136/12(93)

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Official Journal of the European Union

there is relevant expertise in the field of general financial
and legal matters.

In order to finalise the procedure in due time, theAgency should submit its opinions on the suggested
action and its impact on the basis of a draft opinion
prepared by a rapporteur.
(99)

(94)

(95)

(96)

In order to speed up the procedure for restrictions, theCommission should prepare its draft amendment withina specific time limit of receiving the Agency's opinions.

The Agency should be central to ensuring that chemicals
legislation and the decision-making processes and scientific basis underlying it have credibility with all stakeholders and the public. The Agency should also play apivotal role in coordinating communication around thisRegulation and in its implementation. The confidence in
the Agency of the Community institutions, the Member
States, the general public and interested parties is therefore essential. For this reason, it is vital to ensure its independence, high scientific, technical and regulatory capacities, as well as transparency and efficiency.

The structure of the Agency should be suitable for thetasks that it should fulfil. Experience with similar Community agencies provides some guidance in this respect
but the structure should be adapted to meet the specificneeds of this Regulation.

29.5.2007

The Agency should have the means to perform all thetasks required to carry out its role.

(100) A Commission Regulation should specify the structure

and amounts of fees, including specifying the circumstances under which a proportion of the fees will betransferred to the relevant Member State competentauthority.

(101) The Management Board of the Agency should have thenecessary powers to establish the budget, check its implementation, draw up internal rules, adopt financial regulations 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 opinionsin its field of competence.

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

aim to reach agreement amongst Member States' authorities on specific issues which require a harmonised
approach.

(104) It is necessary to ensure close cooperation between the(97)

The effective communication of information on chemicalrisks and how they can be managed is an essential partof the system established by this Regulation. Best practicefrom the chemicals and other sectors should be considered 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-administrative and scientific tasks without calling on the scientific and technical resources of the Member States. The
Executive Director should ensure the efficient executionof 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
parties appointed by the Commission in order to ensure
the involvement of stakeholders, and the European Parliament 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

Agency and the competent authorities working within
the Member States so that the scientific opinions of theCommittee for Risk Assessment and the Committee forSocio-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 additional particular expertise.

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

legal persons for ensuring safe use of chemicals, enforcement needs to be strengthened. The Agency should therefore 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 thisrespect would benefit from a more formal 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.

29.5.2007

EN

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 budgetof the European Communities. The Community
budgetary procedure should remain applicable as far as
any subsidies chargeable to the general budget of theEuropean Communities are concerned. Moreover, theauditing of accounts should be undertaken by the Courtof Auditors in accordance with Article 91 ofCommission Regulation (EC, Euratom) No 2343/2002 of
23 December 2002 on the framework Financial Regulation for the bodies referred to in Article 185 ofCouncil Regulation (EC, Euratom) No 1605/2002 on the
Financial Regulation applicable to the general budget of
the European Communities (1).

(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.

L 136/13

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 atthe same time ensuring a high level of protection forhuman health and the environment, rules should beestablished for a classification and labelling inventory.

(113) The classification and labelling for any substance either

subject to registration or covered by Article 1 of Directive 67/548/EEC and placed on the market should therefore be notified to the Agency to be included in theinventory.

(109) The Agency should contribute, through cooperation withorganisations having interests in the harmonisation ofinternational 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 international standards in the regulation of chemicals such as
the Globally Harmonised System (GHS) of classificationand labelling of chemicals.

(110) The Agency should provide the infrastructure needed fornatural or legal persons to meet their obligations under
the data-sharing provisions.

(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 ofother Community legislation relying on the classificationand labelling, an inventory should record the classification in accordance with Directive 67/548/EEC and Directive 1999/45/EC agreed by manufacturers and importersof the same substance, if possible, as well as decisions
taken at Community level to harmonise the classificationand labelling of some substances. This should take fullaccount of the work and experience accumulated inconnection with the activities under Directive
67/548/EEC, including the classification and labelling ofspecific substances or groups of substances listed in
Annex I of Directive 67/548/EEC.

(111) It is important to avoid confusion between the missionof the Agency and the respective missions of the European 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 andestablishing a European Medicines Agency (2), the European Food Safety Authority (EFSA) established by Regulation (EC) No 178/2002 of the European Parliament andof the Council of 28 January 2002 laying down thegeneral principles and requirements of food law, establishing the European Food Safety Authority and laying
down procedures in matters of food safety (3) and theAdvisory Committee on Safety, Hygiene and HealthProtection at Work set up by the Council Decision of
22 July 2003 (4). Consequently, the Agency should establish rules of procedure where cooperation with the EFSA
or the Advisory Committee on Safety, Hygiene and
Health Protection at Work is necessary. This Regulation(1) OJ L 357, 31.12.2002, p. 72.
(2) 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).
(3) 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).
(4) OJ C 218, 13.9.2003, p. 1.

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

concern. A substance should therefore be added toAnnex 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 sensitiser, or in respect of other effects on a case-by-case basis.
Provision should be made to enable competent authorities 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 indispensablemeans of monitoring the implementation of this Regulation 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.

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Official Journal of the European Union(117) EU citizens should have access to information aboutchemicals to which they may be exposed, in order toallow them to make informed decisions about their useof 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 Community legislation including authorised uses and risk
management measures. The Agency and Member Statesshould allow access to information in accordance with
Directive 2003/4/EC of the European Parliament andof the Council of 28 January 2003 on public access toenvironmental information (1), Regulation (EC) No 1049/
2001 of the European Parliament and of the Council of
30 May 2001 regarding public access to European Parliament, Council and Commission documents (2) and with
the UNECE Convention on Access to Information, Public
Participation in Decision-Making and Access to Justice inEnvironmental Matters, to which the European Community is a party.

29.5.2007

be planned, carried out and their results should bereported.

(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 toimposing effective, proportionate and dissuasive penalties
for non-compliance, as non-compliance can result indamage to human health and the environment.

(123) The measures necessary for the implementation of thisRegulation 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 theCommission (3).

(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 guarantees, including the right of appeal. The Management
Board should adopt the practical arrangements for application of those requirements to the Agency.

(119) Apart from their participation in the implementation ofCommunity legislation, Member State competent authorities should, because of their closeness to stakeholders in
the Member States, play a role in the exchange of information on risks 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 theMember States is necessary to ensure the coherence andefficiency of the global communication process.

(120) In order for the system established by this Regulation tooperate effectively, there should be good cooperation,
coordination and exchange of information between theMember 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(1) OJ L 41, 14.2.2003, p. 26.
(2) OJ L 145, 31.5.2001, p. 43.

(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 thecriteria for their selection, and to set the criteria defining
what constitutes adequate justification that testing is technically not possible. Since these measures are of generalscope and are designed to amend non-essential elementsof this Regulation or supplement this Regulation byadding 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 applicability of the provisions of this Regulation and, in particular, during the start-up period of the Agency. Provision should therefore be made for the Commission toprovide the necessary support towards the setting up of
the Agency, including the conclusion of contracts and theappointment 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 Directive 76/769/EEC and to avoid such work being lost, theCommission should be empowered during the start-up
period to initiate restrictions based on that work without
following the full restrictions procedure laid down in thisRegulation. All those elements should be used, as soon as
this Regulation enters into force, to support risk reduction measures.
(3) OJ L 184, 17.7.1999, p. 23. Decision as amended by Decision
2006/512/EC (OJ L 200, 22.7.2006, p. 11).

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L 136/15(127) It is appropriate for the provisions of this Regulation to(130) Since the objectives of this Regulation, namely laying

enter into force in a staggered way to smooth the transition 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 stakeholders, to focus resources in the preparation for new
duties at the right times.

down rules for substances and establishing a European
Chemicals Agency, cannot be sufficiently achieved by theMember States and can therefore be better achieved atCommunity 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 principle of proportionality, as set out in that Article, thisRegulation does not go beyond what is necessary inorder to achieve those objectives.

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

sion Directive 91/155/EEC (1), Commission Directive 93/
67/EEC (2), Commission Directive 93/105/EC (3),Commission Directive 2000/21/EC (4), Regulation(EEC) No 793/93 and Commission Regulation (EC)No 1488/94 (5). 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.

(1) Commission Directive 91/155/EEC of 5 March 1991 defining andlaying down the detailed arrangements for the system of specific information relating to dangerous preparations in implementation of
Article 10 of Directive 88/379/EEC (OJ L 76, 22.3.1991, p. 35). Directive as last amended by Directive 2001/58/EC (OJ L 212, 7.8.2001,
p. 24).
(2) Commission Directive 93/67/EEC of 20 July 1993 laying down theprinciples 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).
(3) Commission Directive 93/105/EC of 25 November 1993 laying down
Annex VII D, containing information required for the technical dossierreferred to in Article 12 of the seventh amendment of Council Directive 67/548/EEC (OJ L 294, 30.11.1993, p. 21).
4( ) Commission Directive 2000/21/EC of 25 April 2000 concerning thelist 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).
(5) Commission Regulation (EC) No 1488/94 of 28 June 1994 laying
down the principles for the assessment of risks to man and the environment of existing substances in accordance with Council Regulation(EEC) No 793/93 (OJ L 161, 29.6.1994, p. 3).

(131) The Regulation observes the fundamental rights and prin-ciples which are acknowledged in particular in theCharter of Fundamental Rights of the European
Union (6). In particular, it seeks to ensure full compliancewith the principles of environmental protection andsustainable development guaranteed by Article 37 of that
Charter,
HAVE ADOPTED THIS REGULATION:(6) OJ C 364, 18.12.2000, p. 1.