Lost in REACH? Not anymore! Try our new REACH Compliance Website
- Assessment of REACH obligations
- Letter of Access (LoA) negotiation
- SDS authoring with 100% guarantee
- REACH and CLP consulting
- REACH Registration
- REACH Compliance auditing
- REACH Certificate and declaration
- REACH Only Representative (ROR) services
Contact REACH and CLP experts NOW!
REACH - Registration
Corrigendum to Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the
(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
(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,
Having regard to the Treaty establishing the European Community, and in particular Article 95
Having regard to the proposal from the Commission,
Having regard to the opinion of the European Economic and Social Committee (1),
Having regard to the opinion of the Committee of the Regions (2),
Acting in accordance with the procedure laid down in Article 251 of the Treaty (3),
(1) This Regulation should ensure a high level of protection of human health and the environment as well as the free movement
, 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 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 non-discriminatory manner whether
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 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 the Strategic Approach to International Chemical Management (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, especially
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
(8) Special account should be taken of the potential impact of 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 the approximation of the laws, regulations and administrative
provisions relating to the classification, packaging and labelling of dangerous substances (4)
, Council Directive 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 (5)
, 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 (6)
and Council Regulation (EEC) No 793/93 of 23 March 1993 on the evaluation
and control of the risks of existing substances (7)
, 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.
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
, preparations or articles within the meaning of this Regulation.
(12) An important objective of the new system to be established by this Regulation is to encourage and in certain 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 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) (8)
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 individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC) (9)
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 Directive 76/768/EEC
of 27 July 1976 on the approximation of the laws of the Member States
relating to cosmetic products (10)
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
(14) This Regulation will generate information on substances
and their uses. Available information, including that generated by this Regulation, should be used by the relevant actors
in the application and implementation of appropriate Community legislation, for example that covering 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 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.
(16) This Regulation lays down specific duties and obligations on manufacturers
and downstream users
on their own, in preparations and in articles. This Regulation is based on the principle that industry should manufacture,
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 environment 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, communication
of technical advice to support risk management should be encouraged in the supply
chain, where appropriate.
(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
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 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.
(20) The evaluation
provisions should provide for follow-up to registration
, by allowing for checks on whether registrations
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,
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.
(21) Although the information yielded on substances
should be used in the first place by manufacturers
to manage the risks related to their substances
, it may also be used to initiate the authorisation
or restrictions procedures under this Regulation or risk 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 good functioning of the internal 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
reasons and no suitable alternatives are available, which are economically and technically viable.
(23) The restriction
provisions should allow the manufacturing, 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), involving 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
and downstream users
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 transparent fashion the risks stemming
from the production, use and disposal of each substance.
(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
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 or in cooperation with a limited number of known customers. 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 requirements
of legislation for the protection of workers and the environment.
(29) Since producers
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 articles 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
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 assessments
should be defined in detail in a technical annex to allow them to meet their obligations. To achieve fair burden sharing
with their customers, manufacturers
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
incorporated into special preparations — such as metals incorporated 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 ecotoxicological information should only be required for priority substances
between 1 and 10 tonnes. For other substances
in that quantity range there should be incentives to encourage manufacturers
to provide this information.
(36) It is necessary to consider the application of Article 2
(7)(a) and (b) and Annex XI
derived from mineralogical processes and the review of Annexes IV
should fully take this into account.
(37) 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 and administrative provisions
of the Member States
regarding the protection of animals used for experimental and other scientific purposes (11)
, 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 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 (12)
(38) The generation of information by alternative means offering 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, 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 promotion of alternative test methods on an international
and national 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 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
should be exempted from registration
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 rejections of registrations
(45) The European Inventory of Existing Commercial Chemical Substances
) included certain complex substances
in a single entry. UVCB substances
of unknown or variable composition, complex reaction products or biological materials) may be registered
as a single 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 the registration
is kept up-to-date, an obligation on registrants 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 assessment 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 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 for
stakeholders and in the Agency
's own procedures.
(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 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 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 registration
(54) In order to avoid duplication of work, and in particular to avoid duplication of testing, registrants of phase-in substances
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 relevant 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
of a substance on its own or in a preparation should be encouraged to communicate 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 downstream user to look for alternative sources of supply
(56) Part of the responsibility of manufacturers
for the management of the risks of substances
is the communication of information on these substances
to other professionals such as downstream users
. In addition, producers
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
(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 information to allow safe use of such
(59) The requirements for undertaking chemical safety assessments
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
(61) For reasons of workability and proportionality, it is appropriate 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
. 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 parties 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 information has been reviewed by an assessor possessing appropriate experience, and for a percentage
to be checked for compliance by the Agency
(66) The Agency
should also be empowered to require further information from manufacturers
or downstream users
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 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 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 subsidiarity, 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 centralised procedure. If the Member State Committee
fails to reach unanimous agreement, the Commission should adopt a decision in accordance with a Committee procedure.
may lead to the conclusion that action should be taken under the restriction
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 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 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 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.
(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 manufactured, 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
(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 environment.
(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. Furthermore, 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 environment, 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 authorisations of uses of such substances
on their own, in preparations 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 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
which are carcinogenic, mutagenic
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 substances
with characteristics rendering them persistent
, liable to bioaccumulate 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 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.
identified as meeting 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 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
(80) The proper interaction between the provisions on authorisation
should be ensured in order to preserve the efficient functioning of the internal market and the protection of human health,
safety and the environment. 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 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
(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 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 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 Regulation. Where appropriate,
the application of Annex XVII
of this Regulation should be facilitated by guidance developed by the Commission.
(85) In relation to Annex XVII Member States
should be allowed to maintain for a transitional period more stringent restrictions, provided that these restrictions have
been notified according to the Treaty. This should concern substances
on their own, substances
in preparations 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 inventory of these restrictions. This would provide an opportunity 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 appropriate risk management measures needed to ensure a high 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 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 amendments 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 Community, 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 restrictions, the Agency
should fulfil a role as coordinator of this 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 is being prepared.
(91) In order to give the Commission the opportunity to address 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
(92) For reasons of transparency, the Agency
should publish the relevant dossier including the suggested restrictions while requesting comments.
(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
(95) 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 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 therefore essential. For this reason, it is vital to ensure its independence,
high scientific, technical and regulatory capacities, 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 Community 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 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 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 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 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 circumstances 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 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 opinions in its field
(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 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 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 this respect 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
(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 Court of Auditors in accordance with Article 91 of Commission
Regulation (EC, Euratom) No 2343/2002 of 23 December 2002 on the framework Financial Regulation 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 (13)
(108) Where the Commission and Agency
consider it appropriate, 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 international 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 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 and establishing a European Medicines Agency (14)
, the European Food Safety Authority (EFSA) established by Regulation (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, establishing the European Food
Safety Authority and laying down procedures in matters of food safety (15)
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 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 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 Directive 67/548/EEC and placed on the market should therefore 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
, and the proper functioning of other Community legislation relying on the classification and labelling, an inventory should
record the classification in accordance with Directive 67/548/EEC and Directive 1999/45/EC agreed by manufacturers
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 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 indispensable means 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.
(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 Community 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 (17)
, 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 (18)
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 Community 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 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 of Community 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 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 consistency 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 (19).
(124) In particular, power should be conferred on the Commission 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 criteria defining what constitutes adequate justification that testing is technically 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 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 to provide the necessary support 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 Directive 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 reduction measures.
(127) It is appropriate for the provisions of this Regulation to 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.
(128) This Regulation replaces Directive 76/769/EEC, Commission Directive 91/155/EEC (20), Commission Directive 93/67/EEC (21), Commission Directive 93/105/EC (22), Commission Directive 2000/21/EC (23), Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 (24). 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
(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 principle of proportionality, as set out in that Article, this Regulation does not
go beyond what is necessary in order to achieve those objectives.
(131) The Regulation observes the fundamental rights and principles which are acknowledged in particular in the Charter of
Fundamental Rights of the European Union (25). 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: