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Procedure : 2003/0256(COD)
Document stages in plenary
Document selected : A6-0315/2005

Texts tabled :

A6-0315/2005

Debates :

PV 15/11/2005 - 14

Votes :

PV 17/11/2005 - 4.1

Texts adopted :

P6_TA(2005)0434

Texts adopted
DOC 1341k
Thursday, 17 November 2005 - Strasbourg Final edition
REACH ***I
P6_TA(2005)0434A6-0315/2005
Resolution
 Consolidated text

European Parliament legislative resolution on the proposal for a regulation of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency and amending Directive 1999/45/EC and Regulation (EC) No …/… [on Persistent Organic Pollutants] (COM(2003)0644 - C5-0530/2003 - 2003/0256(COD))

(Codecision procedure: first reading)

The European Parliament ,

–   having regard to the Commission proposal to the European Parliament and to the Council (COM(2003)0644)(1) ,

–   having regard to Article 251(2) and Article 95 of the EC Treaty, pursuant to which the proposal was submitted by the Commission (C5-0530/2003),

–   having regard to the opinion of the Committee on Legal Affairs on the proposed legal basis,

–   having regard to Rules 51 and 35 of its Rules of Procedure,

–   having regard to the report of the Committee on the Environment, Public Health and Food Safety and the opinions of the Committee on International Trade, the Committee on Budgets, the Committee on Economic and Monetary Affairs, the Committee on Employment and Social Affairs,the Committee on Industry, Research and Energy, the Committee on the Internal Market and Consumer Protection, the Committee on Legal Affairs, the Committee on Women's Rights and Gender Equality and the Committee on Petitions (A6-0315/2005),

1.  Approves the Commission proposal as amended;

2.  Calls on the Commission to refer the matter to Parliament again if it intends to amend the proposal substantially or replace it with another text;

3.  Instructs its President to forward its position to the Council and Commission.

(1) Not yet published in OJ.


Position of the European Parliament adopted at first reading on 17 November 2005 with a view to the adoption of Regulation (EC) No .../2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency and amending Directive 1999/45/EC
P6_TC1-COD(2003)0256

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

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 and Social Committee(1) ,

Acting in accordance with the procedure laid down in Article 251 of the Treaty(2) ,

Whereas:

(1)  The free, safe and unbureaucratic movement of substances at reasonable cost , on their own, in preparations and in articles, is an essential aspect of the internal market and contributes significantly to the health and well-being of consumers and workers, and to their social and economic interests, to the protection of flora and fauna, as well as to the competitiveness of the chemical industry.

(2)  The efficient functioning of the internal market for substances within the Community can be achieved only if requirements for the safe management of substances are defined precisely and comprehensively and do not differ significantly from Member State to Member State.

(3)  A high level of health and environmental protection should be ensured in the approximation of legislation on substances, with the goal of achieving sustainable development and safeguarding innovation capacity and competitiveness ; that legislation should be applied in a non-discriminatory manner consistent with World Trade Organisation (WTO) rules , whether chemical substances are traded on the internal market or internationally.

(4)  Pursuant to the implementation plan adopted on 4 September 2002 at the Johannesburg World Summit on sustainable development, chemicals must, by 2020, be produced and used in a way which is not damaging to human health or the environment.

(5)  Capacity building in the new Member States towards securing a high level of health and environmental protection should be an objective of Community chemicals legislation.

(6)  To preserve the integrity of the internal market and ensure a high level of protection for the environment and human health, especially the health of workers and that of vulnerable populations, it is necessary to ensure that all substances that are manufactured or placed on the market in the Community comply with Community law, even if they are exported.

(7)  REACH should be so designed and applied as to avoid weakening the competitiveness of European trade and industry or damaging trade with third countries. The Regulation must not impose any requirements on the European Union's trading partners other than that they should be compatible with the free-trade principles in force under WTO provisions.

(8)  The assessment(3) of the operation of the four main legal instruments governing chemicals in the Community (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 88/379/EEC of 7 June 1988 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations(5) (in the meantime replaced by 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) ), Council Regulation (EEC) No 793/93 of 23 March 1993 on the evaluation and control of the risks of existing substances(7) and 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(8) ) 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 a failure to protect public health and the environment in a precautionary manner .

(9)  Substances under customs supervision which are in temporary storage, in free zones or free warehouses with a view to re-exportation or in transit are not used within the meaning of this Regulation and are therefore to be excluded from its scope.

(10)  An important objective of the new system to be established by this Regulation is to ensure that dangerous substances are substituted by less dangerous substances or technologies where suitable alternatives are available. This Regulation does not affect the application of Directives on worker protection, 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 and mutagens at work (Sixth individual Directive within the meaning of Article 16(1) of Council 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.

(11)  The objective of the new system to be established by this Regulation is to deal with the most dangerous substances as a matter of priority. Hazard evaluation and risk assessment must also take into account the effects of substances on foetal development and the health of women and children.

(12)  Responsibility for the management of, and information on, the risks of substances should lie with the enterprises that manufacture, import, place on the market or use these substances. Information on the implementation of REACH should be easily accessible, particularly for very small businesses, which should not be disproportionately penalised by the implementation procedures. Small and medium-sized enterprises should mean such enterprises as defined in Commission Recommendation 2003/361/EC (10) .

(13)  Producers, importers and downstream users of a substance in its basic form or as a component of a preparation or of an article are required to manufacture, import or use that substance (or place it on the market) in such a way as to ensure that, under reasonably foreseeable conditions, no damage is caused to human health or to the environment.

(14)  It is clear from current liability law that any producer, importer or downstream user who carries out or plans to carry out operations involving a substance or preparation, or an article containing such substance or preparation – including its production, import or use – and who knows or could reasonably have foreseen that these operations might have a detrimental impact on human health or the environment, should make every effort which may reasonably be expected of him to prevent, limit or remedy such effects.

(15)  Management of the risks of substances should concern in equal measure both the chemical substances manufactured in the European Union and imported substances manufactured in third countries, in order to prevent non-European production being favoured and boosted by the excessive burdens imposed on European manufacturers.

(16)  For these reasons, the registration provisions require manufacturers and importers to generate data on the substances they manufacture or import, 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 requires them to submit a dossier containing all this information to the Agency to be established by this Regulation. Registered substances should be allowed to circulate on the internal market.

(17)  The evaluation provisions provide for follow-up to registration, by checking that registrations are in compliance with the requirements of this Regulation and by allowing for generation of more information on the properties of substances. The Agency, relying on the body/bodies designated for that purpose by each Member State, should evaluate such substances if it has reasons for suspecting that such substances present a risk to health or the environment, after having included them in the Community rolling plan .

(18)  Although the information yielded on substances through evaluation should be used in the first place by manufacturers and importers to manage the risks related to their substances, it may 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 appropriate authorities and may be used by them for the purpose of such procedures.

(19)  The authorisation provisions provide for authorisations, of limited duration, for the placing on the market and use of substances of very high concern to be granted by the Commission where no suitable alternative substances or technologies exist, where the use of such substances can be justified on socio-economic grounds and where the risks arising from their use are adequately controlled .

(20)  The restrictions provisions 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.

(21)  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.

(22)  A feasibility study on the resource requirements for a 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.

(23)  To further limit costs and facilitate international trade, the Agency must take the greatest possible account of existing and emerging international standards in the regulation of chemicals, with a view to promoting the broadest possible international consensus.

(24)  The Agency must be the guarantor of legal certainty for enterprises, and must therefore have sole competence for the evaluation of the risks associated with substances and of test results. This also means that the burden of proof will lie with an enterprise or Member State which questions an evaluation by the Agency.

(25)  Experience has shown that it is inappropriate to require Member States to assess the risks of all chemical substances. Responsibility for fulfilling the duty of care should therefore be given, in the first place, to the enterprises 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. Those enterprises should take the necessary risk management measures in accordance with their assessment of the risks of their substances and pass on relevant recommendations along the supply chains . This includes the duty to describe, document and notify in an appropriate and transparent fashion the risks stemming from the production, use and disposal of each substance. Producers and downstream users should select a substance for production and use on the basis of the safest substances available.

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

(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 be submitted to authorities, except in defined cases where such submission would be disproportionate.

(28)  Scientific research and development normally takes place in quantities below 1 tonne per year, there is no need to 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, research on products 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 a limited number of known customers.

(29)  Since producers and importers of articles should be responsible for their articles, it is appropriate to impose a registration requirement on substances which are intended to be released from articles. In the case of substances which fulfill the criteria of Article 63 and have, therefore, been included in the list of substances that meet the criteria for authorisation (Annex XIII(a)), the relevant authorities should be informed and consulted immediately and the Agency should be notified. The provisions relating to authorisation should apply to the producers and importers of those substances as soon as they are included in the list of substances subject to authorisation (Annex XIII(b)).

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

(31)  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.

(32)  One of a group of multiple registrants should be allowed to 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.

(33)  Requirements for generation of information on substances should be tiered according to the volume 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.

(34)  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 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) .

(35)  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.

(36)  In the light of the particular circumstances of small and medium-sized enterprises (SMEs), Member States should adopt measures to provide special assistance to such enterprises for conducting the tests needed to collect the information required under this Regulation.

(37)  In order to help companies, and in particular SMEs, to comply with the requirements of this Regulation, the Member States, in cooperation with the Commission, should put in place a comprehensive support network.

(38)  Prescribed test methods should be consolidated for reasons of transparency as well as to facilitate good application of the requirements by enterprises.

(39)  For reasons of workability and because of their special nature, specific registration requirements should be laid down for intermediates; polymers should be exempted from registration and evaluation until those that need to be registered due to the risks posed to human health or the environment can be selected in a practicable and cost efficient way on the basis of sound technical and valid scientific criteria.

(40)  For reasons of workability, wastes and materials used as secondary raw material or as a source of energy should be exempted. Generating value ("valorisation") from wastes and materials used as secondary raw material or as a source of energy in recovery operations contributes to the European Union's objective of sustainable development, and this Regulation must not introduce requirements which reduce the incentives for such recycling and recovery.

(41)  To avoid overloading authorities and enterprises with the work arising from the registration of 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.

(42)  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.

(43)  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.

(44)  To ensure that the information available to the authorities is kept up-to-date, a reciprocal obligation for the Agency to inform the national authorities of certain changes and, conversely, for the national authorities to inform the Agency, which bears overall responsibility, should be introduced.

(45)  The sharing and joint submission of information should be encouraged to increase the efficiency of this Regulation throughout the Community.

(46)  It is appropriate to reduce to a minimum the number of vertebrate animals used for experimental purposes in accordance with the provisions of Directive 86/609/EEC; wherever possible the use of animals should be avoided by recourse to alternative methods validated by the European Centre for the Validation of Alternative Methods (ECVAM) or other international bodies.

(47)  Better coordination of resources at Community level will contribute to increasing the scientific knowledge indispensable for the development of alternative methods to that of experimentation on vertebrate animals. It is essential, for this purpose, that the Community continue and increase its efforts and take the necessary measures for the promotion of research and the development of new non-animal alternative methods, in particular within its Seventh Framework Programme for Research and Technological Development.

(48)  In order to promote non-animal testing, the Commission, Member States and industry should allocate more resources to the development, validation and acceptance of non-animal tests. Part of the fees paid to the Agency should be allocated for that purpose.

(49)  This Regulation should be without prejudice to the full and complete application of the Community competition rules.

(50)  In order to avoid duplication of work, and in particular to reduce testing involving vertebrate animals, the requirements concerning preparation and submission of registrations and updates should encourage registrants to check the databases established at the Agency and to take all reasonable steps to reach an agreement on the sharing of information.

(51)  It is in the public interest to ensure the quickest possible circulation of test results on the human health or environmental hazards of certain substances to those enterprises which use them, in order to limit any risks associated with their use. Sharing of information should therefore be encouraged, under conditions that ensure a fair recompense for the company that has undertaken the tests.

(52)  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.

(53)  In order to respect the legitimate property rights of those generating testing data, the generator of such data should, for a period of 10 years, be able to claim compensation from those registrants who benefit from that data.

(54)  In order to allow a potential registrant to proceed with his registration, even if he cannot reach agreement with a previous registrant, the Agency, on request, should make available 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 generator of the data.

(55)  If a potential registrant and/or participant in a substance information exchange forum (SIEF) fails to pay his share of the cost of a study involving tests on vertebrate animals or another study that may prevent animal testing, he should not be able to register his substance.

(56)  In order to avoid duplication of work, and in particular to avoid duplication of testing, registrants of phase-in substances should pre-register as early as possible with a database managed by the Agency. A system should be established in order to help registrants to find other registrants and form consortia. 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 is breaching the Regulation and should be penalised accordingly but other members should be enabled to continue preparing their own registration.

(57)  If the owner of a study involving tests on vertebrate animals or another study that may prevent animal testing fails to make the study available to the Agency and/or other potential registrants, he should not be able to register his substance.

(58)  Part of the responsibility for the management of the risks of substances is the communication of information on these substances to other professionals and to non-professionals via the most appropriate means possible ; this is also indispensable for professionals to meet their responsibility as regards the use of substances and preparations and the management or elimination of risks .

(59)  Risk communication is a vital part of the process of informing and advising people about how they can manage potential risks and so use a substance or preparation safely and effectively. Risk communication requires an understanding by the manufacturer of the information needs of users, and the subsequent provision of that information, advice and help to support the safe use of the substance or preparation by the end user. The development of an appropriate risk-based communication system, including the provision of complementary information using, for example, websites and educational campaigns, should be pursued in order to satisfy the right of consumers to know about the substances and preparations they use. This will further enhance the safe use of, and confidence in, substances and preparations. Such a system will be valuable to consumer organisations in setting a framework that will address the true concerns of consumers through REACH and to industry in building consumer confidence in the use of substances and preparations containing chemicals.

(60)  As the existing safety data sheet is already being used as a communication tool within the supply chain of substances and preparations, it is appropriate to develop it further and make it an integral part of the system established by this Regulation. However, other methods of communicating information on the risks and safe use of substances and preparations should be considered for consumers.

(61)  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 and provide information on their safe use down the supply chain to the ultimate user - the consumer.

(62)  The requirements for undertaking chemical safety assessments by downstream users should also be prescribed in detail to allow them to meet their obligations. The downstream user must report the risks as highlighted in the chemical safety assessment by the most effective and relevant means possible for the user of the substance or preparation at a given point in the supply chain/life-cycle and provide advice on safe use for consumers.

(63)  For enforcement and evaluation purposes, downstream users of substances should be required to report certain information if their use is outside the conditions of the exposure scenario detailed in the safety data sheet communicated by their original manufacturer or importer and to keep such reported information up-to-date.

(64)  For reasons of workability and proportionality, it is appropriate to exempt downstream users using low quantities of a substance from such reporting.

(65)  If a manufacturer of a substance or an importer of a substance, either on its own or in a preparation, does not intend to submit a registration for a substance, he must notify the Agency and his downstream users accordingly.

(66)  A significant number of animals would have to be used in testing to fulfil the information requirements in Annexes V to VIII , if those information requirements were automatically applied. Significant costs for enterprises may be associated with testing. It is therefore necessary to ensure that generation of such information is tailored to real information needs; to this end evaluation should require Member States to prepare decisions and the Agency to decide on the programmes of testing proposed by manufacturers and importers. The Member State in which the manufacture takes place or the importer is established should be responsible for the evaluation of testing proposals.

(67)  In order to prevent duplication of animal testing, interested parties should have a period of 90 days during which they may comment on testing proposals that include vertebrate animal tests. Comments received during this period should be taken into account by the registrant or the downstream user.

(68)  To prevent animal testing and save costs, ECVAM should be consulted on testing proposals that include vertebrate animal tests.

(69)  Confidence in the general quality of registrations can only be improved by giving the Agency full responsibility for the management of the new chemicals policy. To this end, this Regulation must be dealt with and monitored in a uniform way in all the Member States, and both consumers and the chemicals industry must be able to rely on the rules being complied with, and compliance monitored. In evaluating registrations in compliance with the rules, the authorities in the Member States should work in close collaboration with the Agency.

(70)  The Agency should also be empowered to require further information from manufacturers, importers or downstream users on substances suspected of posing a risk to health or the environment, including by reason of their presence on the internal market in high volumes, on the basis of the evaluations performed. A Community rolling plan for substance evaluation should be established. 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, Member States should also be allowed to require further information, when justified.

(71)  Agreement within the Agency's Member State Committee on a draft decision provides 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 made subject to a centralised procedure. The Agency should take the decisions following from the application of these procedures.

(72)  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.

(73)  To ensure a sufficiently high level of protection for human health, in particular that of vulnerable populations, and the environment, substances with properties of very high concern should be treated in a precautionary manner and should only be authorised if enterprises using them demonstrate to the granting authority that there are no suitable alternative substances or technologies, that the benefits to society deriving from the use of the substance outweigh the risks connected with its use and that the risks are adequately controlled . The granting authority should then verify that these requirements are met through an authorisation procedure on the basis of applications by enterprises. Since authorisations should ensure a high level of protection throughout the internal market, it is appropriate that the Commission should be the granting authority.

(74)  Experience at the 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.

(75)  In view of workability and practicality considerations, both as regards enterprises, 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.

(76)  The Agency, acting on its own authority, should determine 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.

(77)  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.

(78)  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 and on any socio-economic analysis submitted to it by third parties.

(79)  To allow effective monitoring and enforcement of the authorisation requirement, downstream users benefiting from an authorisation granted to their supplier should inform the Agency of their use of the substance.

(80)  In order to accelerate the current system the restriction procedure should be restructured and should replace Directive 76/769/EEC, which has been substantially amended and adapted several times. The acquis of the harmonised rules under the Annex to that Directive should be taken over in a recast version in the interests of clarity and as a starting point for this new accelerated restriction procedure. This recast follows the rules set out within the Interinstitutional Agreement concerning recasting techniques.

(81)  It is the responsibility of the manufacturer, importer and the 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.

(82)  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.

(83)  This Regulation should contribute to the prevention of occupational diseases related to exposure to and the use of chemicals. The European Union should invest in detoxification methods to cure professional diseases related to chemicals.

(84)  In order to prepare a restrictions proposal and in order for such legislation to operate effectively, there should be good co-operation, co-ordination and information between the Member States, the Agency, other bodies of the Community, the Commission and the interested parties.

(85)  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.

(86)  In order to provide a harmonised approach to restrictions, the Agency should fulfil a role as co-ordinator of this procedure, for example by appointing the relevant rapporteurs and verifying conformity with the requirements of the relevant Annexes.

(87)  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 dossier.

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

(89)  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.

(90)  In order to speed up the procedure for restrictions, the Commission should prepare its draft amendment within three months of receiving the Agency's opinions.

(91)  The Agency should be central to ensuring that the chemicals law and the decision-making processes and scientific basis underlying it have credibility with all stakeholders and the public so that the public and all parties concerned have confidence in the safety of the substances and preparations they use. It should also play a pivotal role in coordinating communication around REACH 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 and sound communication skills , transparency and efficiency.

(92)  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. In this respect, a centre of excellence should be created within the Agency, specialised in communication of the risks and dangers associated with certain substances and preparations.

(93)  In the interests of efficiency, the staff of the Agency 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 secure the highest standard of competence and a broad range of relevant expertise in chemicals safety or the regulation of chemicals.

(94)  The Agency should have the means to perform all the tasks required to enable it to carry out its role.

(95)  The Management Board should have the necessary powers to establish the budget, check its implementation, set the structure and amount of the fees, draw up internal rules, adopt financial regulations and appoint the Executive Director. In line with the objective to promote non-animal testing, part of the fees should be allocated to the development of non-animal test methods.

(96)  It is appropriate for the Management Board of the Agency to include representatives from other interested parties, such as industry, non-governmental organisations and academia, in order to ensure the involvement of stakeholders.

(97)  Through the Committee for Risk and Alternative Assessment and the Committee for Socio-economic Analysis, the Agency should take over the role of the Scientific Committees attached to the Commission in issuing scientific opinions in its field of competence.

(98)  Through the Member State Committee, the Agency should aim to reach agreement amongst Member States' authorities on specific issues which require a harmonised approach.

(99)  It is necessary to ensure close co-operation between the Agency and the competent authorities working within the Member States so that the scientific opinions of the Committee for Risk and Alternative 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, the Committees should be able to rely on additional particular expertise.

(100)  In order to promote non-animal testing, the Agency should have the task of developing and implementing a policy for the development, validation and legal acceptance of non-animal test methods and to ensure their use in intelligent stepwise risk assessment to meet the requirements of this Regulation. To this end, the Agency should include a Committee for Alternative Test Methods, consisting of experts from ECVAM, animal welfare organisations and other relevant stakeholders, to ensure the broadest possible appropriate scientific and technical expertise which is available within the Community.

(101)  The Agency should also provide a Forum for Member States to exchange information on and to co-ordinate their activities related to the enforcement of chemicals legislation. The currently informal co-operation between Member States in this respect would benefit from a more formal framework.

(102)  A Board of Appeal should be set up within the Agency to guarantee legal rights of appeal for the operators affected by decisions taken by the Agency.

(103)  The Agency should be financed partly by fees paid by enterprises 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) .

(104)  Where the Commission and Agency consider it appropriate, it should be possible for other countries to participate in the work of the Agency.

(105)  The Agency should contribute, through co-operation with organisations having interests in the harmonisation of international regulations, to the role of the Community and the Member States in such harmonisation activities.

(106)  In order to reduce its costs and improve its international acceptability, the European approach should be as closely aligned as possible with international initiatives including the UNEP "Strategic Approach to International Chemicals Management", the Organization for Economic Cooperation and Development's "Council Act on High Production Volume (HPV) Chemicals", the International Council of Chemical Associations HPV Initiative and the US Environmental Protection Agency's HPV Challenge.

(107)  The Agency should provide the infrastructure needed for enterprises to meet their obligations under the data-sharing provisions.

(108)  It is important to avoid confusion between the mission of the Agency and the respective missions of the European Medicines Agency 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 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 (16) . Consequently, the Agency should establish rules of procedure where co-operation with the European Food Safety Authority or the Advisory Committee on Safety, Hygiene and Health Protection at Work is necessary. It is necessary to establish that this Regulation is otherwise without prejudice to the competence conferred on the European Medicines Agency , the European Food Safety Authority and the Advisory Committee on Safety, Hygiene and Health Protection at Work by Community legislation.

(109)  The feasibility study on the resource requirements for a central entity concluded that the most significant challenge to the effective functioning of the Agency was likely to be its ability to attract the right staff, including those working in the European Chemicals Bureau of the Commission's Joint Research Centre; the location should therefore enable the Agency to obtain the right staff in the start-up period as well as in the longer term.

(110)  In order to achieve the functioning of the internal market for substances on their own or in preparations, while at the time ensuring a high level of protection for human health and the environment, rules should be established for a classification and labelling inventory.

(111)  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.

(112)  To ensure a harmonised protection for the general public, and, in particular, for persons who come into contact with certain substances, an inventory should record the classification in accordance with Directives 67/548/EEC and 1999/45/EC agreed by manufacturers and importers of the same substance, if possible, as well as decisions taken at Community level to harmonise the classification and labelling of some substances.

(113)  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, or as a respiratory sensitiser, or is recognised by authoritative scientific studies as a threat to human health and the environment. Provision should be made to enable competent authorities to submit proposals to the Agency. The Agency should give its opinion on the proposal while parties concerned should have an opportunity to comment. The Commission should take a decision subsequently.

(114)  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 chemicals legislation as well as trends in this field; conclusions drawn from findings in the reports will be useful and practical tools for reviewing the Regulation and, where necessary, for formulating proposals for amendments. To this end, the Commission should undertake an ex post impact assessment of the Regulation after the first five years of its implementation, to assess whether the targets initially set have been met and whether the functioning of, and competition within, the internal market have been preserved.

(115)  REACH should enable citizens, workers and consumers to trust that any product brought onto the market in the Community is safe and that there is no risk of being exposed to chemicals in quantities or mixtures that present a risk to their health or to the environment.

(116)  Community 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, in their own language (on condition that it is an official language of the European Union), free and easy access to basic non-confidential 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 (the "Aarhus Convention"), to which the European Community is a party.

(117)  The Commission should consider the desirability of creating a European quality mark designed to identify and promote articles which, at each stage of the production process, have been produced in compliance with the requirements stemming from this Regulation.

(118)  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 enterprises under chemicals legislation; at the same time, close co-operation 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.

(119)  In order for the system established by this Regulation to operate effectively, there must be good co-operation and co-ordination between the authorities of the Member States, the Agency and the Commission regarding enforcement. The Agency will nevertheless bear central responsibility for managing this Regulation.

(120)  In order to ensure compliance with this Regulation, Member States should put in place effective monitoring and control measures.

(121)  In order to ensure transparency, impartiality and consistency in the level of enforcement activities by Member States, it is necessary to set up an appropriate framework for sanctions with a view to imposing effective, proportionate and dissuasive sanctions for non-compliance, as non-compliance can result in damage to human health and the environment.

(122)  The necessary inspections should be planned, carried out and their results should be reported.

(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)  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 fulfil the functions of the Agency at least in the start-up period; if necessary, the Commission should be able to appoint an Executive Director ad interim until the Agency's Management Board can appoint an Executive Director itself.

(125)  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 going to waste, 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.

(126)  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, enterprises as well as stakeholders, to focus resources in the preparation for new duties at the right times, including through the conclusion of voluntary agreements, coordinated by the Commission, between industry and other interested parties .

(127)  This Regulation replaces Directive 76/769/EEC, Council Directive 91/157/EEC of 18 March 1991 on batteries and accumulators containing certain dangerous substances(20) , Commission Directive 93/67/EEC of 20 July 1993 laying down the principles for assessment of risks to man and the environment of substances notified in accordance with Council Directive 67/548/EEC(21) , Commission Directive 93/105/EC of 25 November 1993 laying down Annex VII D, containing information required for the technical dossier referred to in Article 12 of the seventh amendment of Council Directive 67/548/EEC(22) , Commission Directive 2000/21/EC of 25 April 2000 concerning the list of Community legislation referred to in the fifth indent of Article 13(1) of Council Directive 67/548/EEC(23) , Regulation (EEC) No 793/93 and 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(24) .

(128)  This Regulation applies without prejudice to general Council Directive 92/85/EEC of 19 October 1992 on the introduction of measures to encourage improvements in the safety and health at work of pregnant workers and workers who have recently given birth or are breastfeeding (tenth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC) (25) and specific 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) (26) . Directive 98/24/EC continues to be the key legal instrument concerning the protection of the health and safety of workers from the risks related to chemical agents at work. Member States and the social partners are urged to ensure the most effective implementation and enforcement of Directive 98/24/EC.

(129)  For the sake of consistency, Directive 1999/45/EC, which already addresses matters covered by this Regulation, should be amended.

(130)  In accordance with the principle of proportionality, it is necessary and appropriate for the achievement of the basic objective of this Regulation to lay down rules for chemical substances and to establish a European Chemicals Agency. This Regulation does not go beyond what is necessary in order to achieve the objectives pursued, in accordance with the third paragraph of Article 5 of the Treaty.

(131)  The Regulation observes the fundamental rights and principles which are acknowledged in particular in the Charter of Fundamental Rights of the European Union(27) . In particular, it seeks to ensure full compliance with the principles of environmental protection and sustainable development guaranteed by its Article 37.

(132)  The Commission should make efforts to guarantee that the growing openness of European Union markets to world-wide imports is accompanied by the introduction of more demanding requirements in relation to the "fairness" of trade (including in the WTO context). As soon as possible, REACH requirements must be included,

HAVE ADOPTED THIS REGULATION:

SUBJECT-MATTER AND SCOPE

Article 1

Subject-matter

1.  This Regulation lays down provisions on substances within the meaning of Article 3(1). These provisions shall apply to the manufacture, import, placing on the market or use of such substances on their own, in preparations or in articles, if so stated.

2.  The purpose of this Regulation is to ensure the free circulation of such substances on the internal market in accordance with the duty of care, and having due regard for the obligations entered into by the European Union and its Member States in the framework of international trade agreements, in particular within the WTO .

3.  This Regulation is based on the principle that it is up to manufacturers, importers and downstream users to ensure that they manufacture, place on the market, import or use such substances that do not adversely affect human health or the environment under normal or reasonably foreseeable conditions of use. Its provisions are underpinned by the precautionary principle(28) .

4.  Any manufacturer, importer or downstream user performing or intending to perform operations involving a substance or a preparation, or an article containing such a substance or preparation, including the manufacturing, importation and application thereof, who knows or could reasonably have foreseen that these operations could adversely affect human health or the environment, shall make every effort that may reasonably be required of him to prevent, limit or remedy such effects.

5.  Any manufacturer, importer or downstream user that provides, in the pursuit of his profession or business, a substance or preparation, or an article containing such a substance or preparation, to a manufacturer, importer or downstream user shall, to the extent this may reasonably be required, ensure adequate communication and information exchange, including where appropriate technical assistance, reasonably necessary to prevent, limit or remedy adverse effects on human health or the environment.

6.  This includes the duty to describe, document and notify in an appropriate and transparent fashion the risks stemming from the production, use and disposal of each substance. Producers and downstream users shall select a substance for production and use on the basis of the safest substances available.

7.  The implementation and operation of the provisions of this Regulation may under no circumstances involve an increase in the bureaucratic and administrative burden on small and medium-sized enterprises.

8.  In implementing this Regulation, the European Union shall establish mechanisms for providing aid and support to small and medium-sized enterprises.

Article 2

Scope

1.  This Regulation shall not apply to:

   a) radioactive substances within the scope of Council Directive 96/29/Euratom(29) ;
   b) substances, on their own, in a preparation or in an article, which are subject to customs supervision, provided that they do not undergo any treatment or processing, and which are in temporary storage, or in a free zone or free warehouse with a view to re-exportation, or in transit;
   c) non-isolated intermediates;
   d) waste, as defined by Council Directive 75/442/EEC (30) ;
   e) food, as defined by Regulation (EC) No 178/2002;
   f) flavourings, as defined by Council Directive 88/388/EEC (31) ;
   g) substances in tobacco products within the scope of Directive 2001/37/EC of the European Parliament and of the Council (32) ;
   h) substances in batteries within the scope of Directive 91/157/EEC.

2.  This Regulation shall apply without prejudice to:

   (a) Community legislation on health and safety at the workplace ;
   (b) Community legislation on the carriage of dangerous substances and dangerous substances in preparations by rail, road, inland waterway, sea or air;
  c) 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 (33) , concerning:
   i) the prohibition of animal testing of finished cosmetic products and the ingredients or combinations of ingredients thereof; and
   ii) the marketing of cosmetic products of which some or all of the ingredients, or the final formulation, have been tested on animals.

To the extent that substances used only as cosmetic ingredients are covered by this Regulation, no animal testing that is prohibited pursuant to Directive 76/768/EEC shall be permitted for the purposes of the same assessment required by this Regulation with regard to such substances;

   (d) Community legislation on the environment.

3.  This Regulation shall apply to every substance, article and preparation imported into the European Union.

This Regulation may in no way give rise to differences in treatment between substances, articles and preparations produced in the European Union and substances, articles and preparations that are produced in third countries but imported into the European Union.

The Commission shall set out guidelines for ensuring this rule is applied.

4.  The provisions in Titles II, III, V and VI shall not apply to the extent that a substance is manufactured or imported for use in the following end products or to the extent a substance is used in them:

   a) medicinal products for human or veterinary use within the scope of Regulation (EC) No 726/2004 of the European Parliament and of the Council (34) , Directive 2001/82/EC or Directive 2001/83/EC;
  b) food as defined in Regulation (EC) No 178/2002, including:
   i) food additives in foodstuffs within the scope of Council Directive 89/107/EEC (35) ;
   ii) flavouring in foodstuffs within the scope of Directive 88/388/EEC;
  c) animal feed, including:
   i) additives in feedingstuffs within the scope of Regulation (EC) No 1831/2003 of the European Parliament and of the Council (36) ; and
   ii) animal nutrition within the scope of Council Directive 82/471/EEC(37) ;
   d) food contact materials within the scope of Regulation (EC) No 1935/2004 of the European Parliament and of the Council (38) ;
   e) medical devices within the scope of Council Directive 90/385/EEC (39) , Council Directive 93/42/EEC (40) or Directive 98/79/EC of the European Parliament and of the Council (41) ;
   f) plant protection products within the scope of Council Directive 91/414/EEC (42) ;
   g) biocidal products within the scope of Directive 98/8/EC of the European Parliament and of the Council (43) .

5.  The provisions in Title VII shall not apply to the uses of substances set out in paragraph 4 and in addition to the following uses:

   a) use as on-site isolated intermediates or transported isolated intermediates;
   b) use as motor fuels covered by Directive 98/70/EC of the European Parliament and of the Council (44) ;
   c) use as fuel in mobile or fixed combustion plants of mineral oil products and use as fuels in closed systems.

6.  The provisions in Titles IV and X shall not apply to preparations listed in points (a) to (g) of paragraph 4 or to substances in those preparations.

DEFINITIONS

Article 3

Definitions

For the purposes of this Regulation:

1.  Substance means a chemical element and its compounds in the natural state or obtained by any manufacturing process, including any additive necessary to preserve its stability and any impurity deriving from the process used, but excluding any solvent which may be separated without affecting the stability of the substance or changing its composition;

2.  Preparation means a mixture or solution composed of two or more substances; metallic alloys are special types of preparations that need to be assessed on the basis of their own specific intrinsic properties;

3.  Metallic alloy means a metallic material, homogeneous on a macroscopic scale, consisting of two or more elements so combined that they cannot readily be separated by mechanical means;

4.  Article means a man-made object containing or composed of substance(s) and/or preparation(s) which during production is given a specific shape, surface or design relevant for its use function ;

5.  Polymer means a substance consisting of molecules characterised by the sequence of one or more types of monomer units and comprising a simple weight majority of molecules containing at least three monomer units which are bound to at least one other monomer unit or other reactant, with the substance consisting of less than a simple weight majority of molecules of the same molecular weight . Such molecules must be distributed over a range of molecular weights wherein differences in the molecular weight are primarily attributable to differences in the number of monomer units .

In the context of this definition a "monomer unit" means the reacted form of a monomer substance in a polymer;

6.  Registrant means the manufacturer or the importer submitting a registration;

7.  Manufacturing means production and extraction of substances in the natural state;

8.  Manufacturer means any natural or legal person established within the Community who manufactures a substance within the Community;

9.  Import means the physical introduction into the customs territory of the Community;

10.  Producer of an article means a natural or legal person who:

   - manufactures and sells under his own brand;
   - resells under his own brand a product produced by another supplier, a reseller not being regarded as the producer if the brand of the manufacturer appears on the product;
   - on a professional basis imports into the Community market;

11.  Importer means any natural or legal person established within the Community who is responsible for import;

12.  Placing on the market means supplying or making available, whether in return for payment or free of charge, to a third party. Import into the customs territory of the Community shall be deemed to be placing on the market;

13.  Downstream user means any natural or legal person established within the Community, other than the manufacturer or the importer, who uses a substance, either on its own or in a preparation, in the course of his industrial or professional activities. A distributor or a consumer is not a downstream user. A re-importer exempted pursuant to Article 4(1)(d) shall be regarded as a downstream user;

14.  Use means any processing, formulation, consumption, storage, keeping, treatment, filling into containers, transfer from one container to another, mixing, production of an article or any other utilisation;

15.  Distributor means any natural or legal person established within the Community, including a retailer, who only stores and places on the market a substance, on its own or in a preparation, for third parties;

16.  Intermediate means a substance or preparation that is solely manufactured for and consumed in or used for chemical processing in order to be transformed into another substance (hereinafter called 'synthesis' ):

   a) non-isolated intermediate means an intermediate that during synthesis is not intentionally removed (except for sampling) from the equipment in which the synthesis takes place. Such equipment includes the reaction vessel, its ancillary equipment, and any equipment through which the substance(s) pass(es) during a continuous flow or batch process as well as the pipework for transfer from one vessel to another for the purpose of the next reaction step, but it excludes tanks or other vessels in which the substance(s) are stored after the manufacture;
   b) on-site isolated intermediate means an intermediate not meeting the criteria of a non-isolated intermediate and where the manufacture of the intermediate and the synthesis of (an)other substance(s) from that intermediate take place on the same site, operated by one more legal entities;
   c) transported isolated intermediate means an intermediate not meeting the criteria of a non-isolated intermediate and transported between or supplied to other sites;

17.  Site means a single location, in which, if there is more than one manufacturer of (a) substance(s), certain infrastructure and facilities are shared;

18.  Actors in the supply chain means all manufacturers and/or importers and/or downstream users;

19.  Communicate down the supply chain means that each actor in the supply chain communicates to the downstream user whom he supplies with a substance;

20.  Communicate up the supply chain means that a downstream user communicates to the actor in the supply chain who has supplied him with a substance;

21.  Competent authority means the authority or authorities or bodies established by the Member States to carry out the obligations arising from this Regulation;

22.  Phase-in substance means a substance which meets at least one of the following criteria:

   a) it is listed in the European Inventory of Existing Commercial Chemical Substances (Einecs);
   b) it was manufactured in the Community, or in the countries acceding to the European Union on 1 May 2004, but not placed on the market by the manufacturer or importer at least once in the 15 years before the entry into force of this Regulation ;
   c) it was placed on the market in the Community, or in the countries acceding to the European Union on 1 May 2004, and between 18 September 1981 and 31 October 1993 inclusive it was also placed on the market by the manufacturer or importer and was considered as having been notified in accordance with the first indent of Article 8 (1) of Directive 67/548/EEC, as amended by Directive 79/831/EEC(45) , but does not meet the definition of a polymer set out in Directive 67/548/EEC, as amended by Directive 92/32/EEC(46) ;
provided the manufacturer or importer has documentary evidence of this;

23.  Notified substance means a substance for which a notification has been submitted and which could be placed on the market in accordance with Directive 67/548/EEC;

24.  Product and process orientated research and development means any scientific development (including preparations and articles used for pilot tests under real conditions) related to product development, the further development of a substance, on its own, in preparations or in articles, in the course of which pilot plant or production trials are used to develop the production process and/or to test the fields of application of the substance;

25.  Scientific research and development means any scientific experimentation, analysis or chemical research carried out under controlled conditions ;

26.  Registrant's own use means an industrial or professional use by the registrant;

27.  Identified use means a use of a substance on its own or in a preparation, or a use of a preparation, that is intended by an actor in the supply chain, including his own use, or that is made known to him in writing by an immediate downstream user and that is covered in the safety data sheet communicated to the downstream user concerned;

28.  Unsupported use means a use by downstream users which the registrant advises against by providing scientifically based arguments against the safety of this use ;

29.  Robust study summary means a detailed summary of the objectives, methods, results and conclusions of a full study report providing sufficient information to make an independent assessment of the study minimising the need to consult the full study report;

30.  Per year means per calendar year. Save in the case of new substances, and unless stated otherwise, quantities per year shall be calculated on the basis of the average production volumes for the three immediately preceding calendar years during which the substance has actually been produced by the manufacturer ;

31.  Restriction means any condition for, or prohibition of, the manufacture, use or placing on the market;

32.  Small and medium-sized enterprises (SMEs) means enterprises as defined in Recommendation 2003/361/EC;

33.  Vulnerable populations means susceptible humans including neonates, infants, children, pregnant women, nursing mothers, the infirm and immuno-compromised, elderly persons, those with individual genetic susceptibilities and other identified groups of concern;

34.  Exposure scenario means the set of conditions including risk management measures that describe how the substance is manufactured or used during its life-cycle and how the manufacturer and importer controls, or recommends to downstream users that they may control, exposures of humans and the environment. These exposure scenarios may cover one specific process or use or several processes or uses, as appropriate, where these processes or uses may be described in terms of use and exposure categories, as defined;

35.  Use and exposure category means the main use categories (e.g. industrial use, professional use, consumer use) and the significant routes of exposure (e.g. oral, dermal, inhalation, environmental) and patterns of exposure (e.g. frequent, accidental, occasional, continuous);

36.  Mineral means a combination of inorganic constituents as found in the earth's crust, with a characteristic set of chemical compositions, crystalline forms and physicochemical properties.

SCOPE

Article 4

Scope

1.  The following shall be exempted from this Title:

   a) substances included in Annex II;
   b) substances covered by Annex III;
   c) polymers;
  d) substances on their own or in preparations, registered in accordance with this Title, exported from the Community by an actor in the supply chain and re-imported into the Community by another actor in the same supply chain who shows that:
   i) the substance being re-imported is the same as the exported substance;
   ii) he has been provided with the information in accordance with Articles 34 and 35 relating to the exported substance;
   e) substances in preparations meeting the criteria for registration, that have already been registered for that use by an actor in the supply chain;
  f) substances on their own or in preparations, which have been registered in accordance with this Title by a manufacturer or importer and which are recycled in the Community by another manufacturer or importer who shows that:
   i) the substance resulting from the recycling process is the same as the already registered substance; and
   ii) he has been provided with the information in accordance with Articles 33 and 34 relating to the registered substance.

2.  On-site isolated intermediates or transported isolated intermediates shall be exempted from Chapters 2 and 3, without prejudice to Chapters 4, 5 and 6.

GENERAL OBLIGATION TO REGISTER AND INFORMATION REQUIREMENTS

Article 5

General obligation to register substances on their own or in preparations

1.  Save where this Regulation provides otherwise, any manufacturer of a substance in quantities of 1 tonne or more per year shall submit a registration to the Agency.

Save where this Regulation provides otherwise, any importer of a substance, either on its own or in a preparation, in quantities of 1 tonne or more per year shall submit a registration to the Agency.

2.  For monomers that are used as o n-site isolated intermediates or transported isolated intermediates, Articles 17 and 18 shall not apply.

3.   Any manufacturer or importer of a polymer shall submit a registration to the Agency for the non-registered monomer substance(s) not registered by an upstream actor in the supply chain or other non-registered substance(s), except where such monomer substances are formed during synthesis and cannot be isolated, if both the following conditions are met:

   a) the polymer consists of 2% weight by weight (w/w) or more of such monomer substance(s) or other substance(s);
   b) the total quantity of such monomer substance(s) or other substance(s) makes up 1 tonne or more per year.

A notification for such monomer/substance shall include the following information in the format specified by the Agency in accordance with Article 119:

   i) the identity and contact details of the producer or importer;
   ii) the identity of the monomer/substance as specified in section 2 of Annex IV;
   iii) the classification of the substance;
   iv) a brief description of the use of the polymer.

A registration under this Title shall be made for the non-registered monomer substance manufactured or imported in quantities of more than 1000 tonnes per year. This registration shall include the information specified in Annex V in addition to the information required above.

Non-registered monomer substances or other non-registered substances are substances that have not been registered by the manufacturer who supplies such substances to the polymer manufacturer.

However, where non-registered monomer substances or other substances were registered by the original manufacturer or by a designated representative thereof, the polymer manufacturer may make use of this registration provided that the registrant has indicated that it is used in the manufacture of polymers.

4.  A submission for registration shall be accompanied by the fee as set by the Agency.

Article 6

General obligation to register substances in articles

1.  Any producer or importer of articles shall submit a registration to the Agency for any substance contained in those articles, if all the following conditions are met:

   a) the substance is present in those articles in quantities totalling over 1 tonne per producer or importer per year ;
   b) the substance meets the criteria for classification as dangerous in accordance with Directive 67/548/EEC;
   c) the substance is intended to be released under normal and reasonably foreseeable conditions of use.

2.  Paragraph 1(a) shall not apply to substances which are ingredients added to tobacco products within the meaning of Article 2(1) and (5) of Directive 2001/37/EC.

3.  Any producer or importer of articles shall notify the Agency of any substance listed in Annex XIII(a) contained in those articles in accordance with paragraph 4 where :

   a) it is present above a concentration limit of 0,1%, for substances referred to in Article 63(d), (e) and (f);
   b) it is present above the concentration limits specified in Directive 1999/45/EC for classification as dangerous, for all other substances;
   c) the producer or importer cannot exclude any exposure of the public or the environment to the substance during the full life-cycle of the article.

4 .  If the conditions in paragraph 3 are met, the information to be notified shall include the following, in the format specified by the Agency in accordance with Article 119 :

   a) the identity and contact details of the producer or importer;
   b) the registration number(s) referred to in Article 20(1), if available;
   c) the identity of the substance(s) as specified in section 2 of Annex IV;
   d) the classification of the substance;
   e) a brief description of the use(s) of the article;
   f) the tonnage range of the substance, such as 1-10 tonnes, 10-100 tonnes and so on.

5.  The Agency may take decisions requiring producers or importers of articles to register, in accordance with this Title, any substance contained in those articles and notified in accordance with paragraph 4 where the Agency has grounds for suspecting that:

   a) the substance presents a risk to human health or the environment;
   b) the substance has not been registered for the use in question .

6 .  Paragraphs 1 to 5 shall not apply to substances that have already been registered for that use by an actor up the supply chain.

7 .  Paragraphs 1 and 5 shall apply 3 months after the deadline specified in Article 23(3) .

Paragraphs 3 and 4 shall apply to substances, contained in articles, that fulfill the criteria of Article 63 three months after the date these substances are listed in Annex XIII(a).

8.  When a substance is included in Annex XIII(b), the Agency shall notify all producers and importers of articles containing that substance about its inclusion in that Annex. Title VII shall apply mutatis mutandis to the producer and the importer of articles containing that substance as from the date of the notification.

9.  Any measures for the implementation of paragraphs 1 to 8 shall be adopted in accordance with the procedure referred to in Article 141(3) .

10.  The Agency shall provide guidelines to help the producers and importers of articles as well as the competent authorities.

Article 7

Only representative of a non-Community manufacturer

1.  A natural or legal person established outside the Community who manufactures a substance, preparation or article imported into the Community may by mutual agreement appoint a natural or legal person established in the Community to fulfil, as his representative , the obligations on importers under this Title.

2.  The representative shall also comply with all other obligations of importers under this Regulation. To this end, he shall have a sufficient background in the practical handling of substances and the information related to them and, without prejudice to Article 38 , he shall keep available and up-to-date information on quantities imported and customers sold to, as well as information on the supply of the latest update of the safety data sheet.

3.  If a representative is appointed in accordance with paragraphs 1 and 2, the non-Community exporter shall inform the importer(s) within the same supply chain of the appointment. These importers shall be regarded as downstream users for the purposes of this Regulation.

Article 8

European quality mark

Not later than …. (47) , the Commission shall present to the European Parliament and the Council a report and, if appropriate, a legislative proposal on the creation of a European quality mark designed to identify and promote articles which, at each stage of the production process, have been produced in compliance with the requirements stemming from this Regulation.

Article 9

Transfer and splitting of registrations and 'collective registrations'

1.  The legal entitlement acquired through registration shall be both transferable and divisible. The party acquiring such an entitlement shall take over the rights and obligations of the original registrant. Where a registration is split, the Agency shall assign a new registration number to the new holder.

2.  Where a manufacturer is a subsidiary of another legal person (termed the 'parent company'), the parent company may undertake and maintain a registration on behalf of the subsidiary. Conversely, a subsidiary may also undertake and maintain a registration for its parent company or for other subsidiaries. In such cases registration shall be required once only. The legal person designated for collective registration purposes shall be responsible for performance of duties under this Regulation.

3.  Paragraph 2 shall also apply where the registered office of the parent company or the subsidiary is not located in the European Union. The legal person designated for collective registration purposes must have his registered office in the Union.

Article 10

Exemption from the general obligation to register for product and process orientated research and development (PPORD)

1.  A substance manufactured in the Community, or imported for the purposes of product and process orientated research and development in a quantity which is limited to the purpose of product and process orientated research and development shall be exempt from the obligation to register set out in Articles 5, 6, 17, 18 and 21 for a period of five years, provided that the manufacturer or importer notifies the Agency of the following information in the format specified by the Agency in accordance with Article 119 :

   a) the identity of the manufacturer or importer;
   b) the identity of the substance;
   c) the classification of the substance, if any;
   d) the estimated quantity;
   e) if relevant, the list of customers to which the substance is being supplied ; and
   f) sufficient information on the research and development programme to enable the Agency to take informed decisions under this Article .

The period set out in this paragraph shall begin at receipt of the notification at the Agency.

2.  The Agency shall assign a number to the notification and a notification date, which shall be the date of receipt of the notification at the Agency, and shall forthwith communicate that number and date to the manufacturer or importer concerned and shall forward the information notified and the number and date to the competent authority of each Member State in which the substance is manufactured, imported or used for the purpose of the product and process orientated research and development .

3.  The Agency may decide to impose conditions to ensure that the substance is used in such a way that risks to human health and/or the environment are controlled. The manufacturer or importer shall comply with any conditions imposed by the Agency .

4.  In the absence of any indication to the contrary, the manufacturer or importer of the substance may manufacture or import the substance not earlier than four weeks after the notification .

5.  The Agency may extend the five-year exemption period by a further maximum of 10 years upon request of the manufacturer or importer, if the manufacturer or importer can demonstrate that such an extension is justified by the research and development programme.

6.  The Agency shall forthwith communicate any draft decisions to the competent authorities of each Member State in which the manufacture, import or product and process orientated research takes place .

7.  The Agency and the competent authorities of the respective Member State(s) shall always keep confidential the information submitted in accordance with paragraph 1 . The Agency shall not release this information to any other competent authority.

8.  An appeal may be brought, in accordance with Articles 98, 99 and 100 , against negative decisions under paragraphs 3 and 5 .

When taking decisions as provided for in paragraphs 3 and 5, the Agency shall take into account any comments made by competent authorities of the respective Member States.

Article 11

Information to be submitted for general registration purposes

A registration required by Article 5 or by Article 6(1) or (5) shall include all the following information in the format specified by the Agency in accordance with Article 119 :

  a) a technical dossier including:
   i) the identity of the manufacturer(s) or importer(s) as specified in section 1 of Annex IV;
   ii) the identity of the substance(s) as specified in section 2 of Annex IV;
   iii) information on the manufacture and use(s) of the substance as specified in section 3 of Annex IV; this information shall represent all the registrant's identified use(s);
   iv) (iv) information on use and exposure categories as specified in section 6 of Annex IV;
   v) (v) the classification and labelling of the substance as specified in section 4 of Annex IV;
   vi) (vi) guidance on safe use of the substance as specified in Section 5 of Annex IV;
   vii) (vii) summaries of the information derived from the application of Annexes V to IX;
   viii) (viii) robust study summaries of the information derived from the application of Annexes V to IX, if required under Annex I;
   ix) (ix) a statement as to whether or not information has been generated by testing on vertebrate animals, including which tests on vertebrate animals have been carried out and the number of animals used ;
   x) (x) confirmation that the registrant is the owner of all original studies from which study summaries or robust study summaries are derived and submitted, or has the written consent of the owner(s) of the original studies to refer to them;
   xi) (xi) proposals for testing where required by the application of Annexes V to IX ;
   b) a chemical safety report when required under Article 15 .

  The registrant, at the time of submitting the information needed for registration under the terms of points (a) and (b), may ask for specifically designated documents or parts of documents to be treated confidentially. The registrant shall provide reasons for such a request. The authority which receives the information shall, with due reference to Article 127, decide which information is to remain confidential.

  Information required under the first paragraph and generated under other European Union, OECD or international legislation and/or chemicals programmes may be submitted in its original format and shall be presumed to meet the requirements of this Article.

Article 12

Joint submission of data by multiple registrants

1.   When a substance is intended to be manufactured in the Community by one or more manufacturers and/or imported by one or more importers, the following shall apply:

Each registrant shall submit separately the information specified in Article 11 (a)(i), (ii), (iii), (iv) and (ix) .

The registrants may decide themselves whether to submit the information specified in Article 11 (a)(vi) and (b) separately or whether one or more manufacturers or importers are to submit this information in full or in part on behalf of the others.

2.   As regards the information specified in Article 11(a)(v), (vii), (viii) and (x), this shall be submitted by one manufacturer or importer acting with the agreement of the other manufacturer(s) or importer(s). If a registrant does not agree with the selection of the information specified in Article 11(a)(v), (vii), (viii) or (x) or if he is not able to participate in the joint submission of single data or multiple data points for other reasons, then he shall submit to the Agency an indication of his reasons along with his registration.

Such reasons are:

   - the information is not applicable (e.g. due to differences in the substance composition); or
   - the disproportionality of the costs of reaching an agreement or the costs of a joint registration (e.g. the company is an SME or costs due to language problems exist); or
   - problems with regard to confidentiality or competition issues; or
   - the intent to register at an earlier or later date than that required for the other registrants.

No indication of reasons shall be required in respect of physicochemical information specified in section 5 of Annexes V and VII.

3.  Where a substance has been registered by a single registrant, other manufacturers and/or importers may refer to relevant parts of that registration when submitting the information pursuant to Article 11, provided that the written consent of the manufacturer or importer who carried out the registration is provided, without prejudice to Article 28.

In the case of a full reference, at the request of the manufacturers/importers making that reference the Agency shall assign the same registration number.

4.  Any manufacturer, importer or consortium may appoint a third party as representative for all proceedings under this Article.

5.  In order to support manufacturers or importers who belong to consortia, the Commission shall draft guidelines for compliance with competition law.

6.  Each registrant who is a member of a consortium shall pay a proportionate share of the registration fee.

Article 13

Information to be submitted depending on tonnage

1.  The technical dossier referred to in Article 11(a) shall include under points (vii), (viii) and (ix) of that provision as a minimum the following:

   a) the information on physicochemical properties specified in Annex V and any other relevant physicochemical, toxicological and ecotoxicological information that is available for substances manufactured or imported in quantities of 1 tonne or more per year per manufacturer or importer, and where a substance is not a phase-in substance or one or more of the screening criteria in Annex Ic are met, the registrant shall provide the information specified in Annex V. Where the substance meets criterion (a) of Annex Ic then a chemical safety assessment shall be undertaken;
   b) the information specified in Annexes V and VI for substances manufactured or imported in quantities of 10 tonnes or more per year per manufacturer or importer;
   c) the information specified in Annexes V and VI and testing proposals for the provision of the information specified in Annex VII for substances manufactured or imported in quantities of 100 tonnes or more per year per manufacturer or importer;
   d) the information specified in Annexes V and VI and testing proposals for the provision of the information specified in Annexes VII and VIII for substances manufactured or imported in quantities of 1 000 tonnes or more per year per manufacturer or importer.

2.   As soon as the quantity of a substance that has already been registered reaches the next tonnage threshold the appropriate additional information required under paragraph 1, as well as any updates of the other elements of the registration in the light of this additional information, shall be submitted to the Agency. The additional information to be submitted shall be provided to the Agency in a time-frame agreed between the registrant and the Agency and in parallel with the manufacturer/importer placing the substance on the market .

3.  The quantity of a substance per year for a phase-in substance shall be determined by the average quantity manufactured or imported in the preceding 3 years before the submission of the registration dossier.

4.  Priority shall be given to in vitro methods and the use of (quantitative) structure activity relationships ((Q)SARs). To this end, the Commission shall make available to companies a list of tests, databases and approved models.

Article 14

General requirements for generation of information on intrinsic properties of substances

1.  Information on intrinsic properties of substances , in particular for human toxicity, shall be generated whenever possible by means other than vertebrate animal tests, in particular through the use of qualitative or quantitative structure-activity relationship models or from information from structurally related substances, provided that the conditions set out in Annex IX are met , or through toxicogenomics .

2.  Where tests on substances are required to generate information on intrinsic properties of substances, they shall be conducted in accordance with the test methods laid down in Annex X.

These methods shall be regularly reviewed and improved with a view to reducing experimentation on vertebrate animals and the number of animals involved. In particular, if ECVAM declares an alternative test method valid and ready for regulatory acceptance, the Agency shall submit within 14 days a draft decision amending the relevant Annex(es) to this Regulation, in accordance with the procedure provided for in Article 139, with a view to replacing the animal test method with the alternative one.

Information on intrinsic properties of substances may be generated in accordance with other test methods provided that the conditions set out in Annex IX are met.

3.   New laboratory tests involving vertebrate animals shall be carried out in compliance with the principles of good laboratory practice provided for in Directive 87/18/EEC and with the provisions of Directive 86/609/EEC.

4.  If a substance has already been registered, a new registrant shall be entitled to refer to studies and test reports, hereinafter "studies", for the same substance submitted earlier, provided that he can show that the substance that he is now registering is the same as the one previously registered. The substance shall be considered to be the same if the degree of purity and the nature of impurities are similar and do not modify its toxicity profile . The new registrant shall submit a letter of access from the previous registrant(s) .

However, a new registrant shall not refer to such studies in order to provide the information required in section  2 of Annex IV.

Article 15

Chemical safety report and duty to apply and recommend risk reduction measures

1.   Without prejudice to Article 4 of Directive 98/24/EC, a chemical safety assessment shall be performed and a chemical safety report completed for all substances subject to registration in accordance with this Chapter .

The chemical safety report shall document the chemical safety assessment which shall be conducted in accordance with paragraphs 2 to 8 and with Annex I for either each substance on its own or in a preparation or a group of substances.

2.  A chemical safety assessment in accordance with paragraph 1 need not be performed for a substance which is present in a preparation if the concentration of the substance in the preparation is less than the lowest of any of the following:

   a) the applicable concentrations defined in the table of Article 3(3) of Directive 1999/45/EC;
   b) the concentration limits given in Annex I to Directive 67/548/EEC;
   c) the concentration limits given in Part B of Annex II to Directive 1999/45/EC;
   d) the concentration limits given in Part B of Annex III to Directive 1999/45/EC;
   e) the concentration limits given in an agreed entry in the classification and labelling inventory established under Title X;
   f) 0,1 %, if the substance meets the criteria in Annex XII.

3.  A chemical safety assessment and chemical safety report in accordance with paragraph 1 shall not be required for substances classified as dangerous according to Directive 67/548/EEC, or persistent, bioaccumulative and toxic (PBT) substances or very persistent and very bioaccumulative (vPvB) substances, which are present in massive preparations exempted from labelling in accordance with Article 12(2) of Directive 1999/45/EC and point 9.3 of Annex VI to Directive 67/548/EEC.

4.  A chemical safety assessment of a substance shall include the following steps:

   a) human health hazard assessment;
   b) human health hazard assessment of physicochemical properties;
   c) environmental hazard assessment;
   (d) PBT and vPvB assessment.

5.  If, as a result of carrying out steps (a) to (d) of paragraph 4 , the manufacturer or importer concludes that the substance meets the criteria for classification as dangerous in accordance with Directive 67/548/EEC or is assessed to be a PBT or vPvB, the chemical safety assessment shall include the following additional steps:

   a) exposure assessment;
   b) risk characterisation.

The exposure assessment and the risk characterisation shall address all identified uses of the manufacturer or importer.

6.  The chemical safety report need not include consideration of the risks to human health from the following end uses:

   a) in food contact materials within the scope of Regulation (EC) No 1935/2004 ;
   b) in cosmetic products within the scope of Directive 76/768/EEC .

7.  Any manufacturer or importer shall identify and apply the appropriate measures to adequately control the risks identified in the chemical safety assessment, and where suitable, recommend them in the safety data sheets which he supplies in accordance with Article 33 .

8.  Any manufacturer or importer required to conduct a chemical safety assessment shall keep his chemical safety report available and up to date.

9.  The manufacturer or importer of a substance or preparation who supplies such a substance or preparation to a downstream user shall, at the request of the downstream user and in so far as this can reasonably be requested, supply the information needed to assess the effects of the substance or preparation on human health or the environment in the context of the operations or use indicated by the downstream user in his request.

10.  The downstream user shall supply, at the request of his supplier and in so far as this can reasonably be requested, the information needed by the supplier to assess the effects of the substance or preparation on human health or the environment in the context of the operations or use of the substance or preparation by the downstream user.

REGISTRATION OF POLYMERS

Article 16

Polymers

Polymers are exempted from registration under this Title.

OBLIGATION TO REGISTER AND INFORMATION REQUIREMENTS FOR CERTAIN TYPES OF ISOLATED INTERMEDIATES

Article 17

Registration of on-site isolated intermediates

1.  Any manufacturer of an on-site isolated intermediate in quantities of 1 tonne or more per year shall submit a registration to the Agency for the on-site isolated intermediate.

2.  A registration for an on-site isolated intermediate shall include all the following information, in the format specified by the Agency in accordance with Article 119 , to the extent that the manufacturer is able to submit it without any additional testing:

   a) the identity of the manufacturer as specified in section  1 of Annex IV;
   b) the identity of the intermediate as specified in section  2 of Annex IV;
   c) the classification of the intermediate;
   d) any available existing information on physicochemical, human health or environmental properties of the intermediate.

Article 18

Registration of transported isolated intermediates

1.  Any manufacturer or importer of a transported isolated intermediate in quantities of 1 tonne or more per year shall submit a registration to the Agency for the transported isolated intermediate.

2.  A registration for a transported isolated intermediate shall include all the following information in the format specified by the Agency in accordance with Article 119 :

   a) the identity of the manufacturer or importer as specified in section  1 of Annex IV;
   b) the identity of the intermediate as specified in section  2 of Annex IV;
   c) the classification of the intermediate;
   d) any available existing information on physicochemical, human health or environmental properties of the intermediate.

3.  A registration for a transported isolated intermediate in quantities of more than 1 000 tonnes per year shall include the information specified in Annex V in addition to the information required under paragraph 2.

For the generation of this information, Article 14 shall apply.

4.  Paragraphs 2 and 3 shall apply only to transported isolated intermediates the transport of which to other sites takes place under strict contractual control, including toll or contract manufacture, and where the synthesis of (an)other substance(s) from that intermediate takes place on those other sites under the following strictly controlled conditions:

   a) the substance is rigorously contained by technical means during its whole life-cycle including manufacture, transportation (including transport by rail, road, inland waterway, sea or air and pipeline transfer), purification, cleaning and maintenance, sampling, analysis, loading and unloading of equipment or vessels, waste disposal or purification and storage;
   b) where there is potential for exposure, procedural and control technologies are available which minimise emission and the resulting exposure;
   c) only properly trained and authorised personnel handle the substance;
   d) in the case of cleaning and maintenance work , special procedures such as purging and washing are applied before the system is opened and entered;
   e) transport operations are in compliance with the requirements of Directive 94/55/EC and of appropriate rules for the carriage of dangerous goods by air and sea, fulfilling the provisions of the Rotterdam Convention concerning the transport of dangerous chemical products;
   f) in cases of accident and where waste is generated, procedural and/or control technologies are used to minimise emissions and the resulting exposure during purification or cleaning and maintenance procedures;
   g) substance-handling procedures are well documented and strictly supervised by the site operator;
   h) the registrant operates a system of product stewardship and monitors users to ensure compliance with the conditions listed in points (a) to (g).

If the conditions listed in the first subparagraph are not fulfilled, the registration shall include the information specified in Article 11 .

Article 19

Joint submission of data by members of consortia

1.   When an on-site isolated intermediate or transported isolated intermediate is intended to be manufactured in the Community by two or more manufacturers and/or imported by two or more importers, they may form, in full compliance with the rules on competition, a consortium for the purposes of registration. Parts of the registration shall be submitted by one manufacturer or importer acting, with their agreement, on behalf of other manufacturers and/or importers in accordance with the second and third subparagraphs.

Each member of the consortium shall submit separately the information specified in Article 17(2)(a) and  (b) and Article 18(2)(a) and (b).

The one manufacturer or importer submitting on behalf of the other members of the consortium shall submit the information specified in Article 17(2)(c) and (d) and Article 18(2)(c) and (d) and (3), where relevant.

2.  Each registrant who is a member of a consortium shall pay only one-third of the fee.

3.   Any manufacturer, importer or consortium may appoint a third party as representative for all proceedings under this Article.

COMMON PROVISIONS FOR ALL REGISTRATIONS

Article 20

Duties of the Agency

1.  The Agency shall assign a number to each registration, which is to be used for all correspondence regarding the registration, and a registration date, which shall be the date of receipt of the registration at the Agency. The Agency shall forthwith communicate the registration number and the registration date to the manufacturer or importer concerned.

2.  The Agency shall, within three weeks of the registration date, undertake a completeness check of each registration in order to ascertain that all the elements required under Article s 11 and 13 or under Article  17 or 18 have been provided. In the case of any registration of phase-in substances submitted in the course of the 2-month period immediately preceding the relevant deadline of Article 23 , the Agency shall undertake that check within three months of that deadline. The completeness check shall not comprise an assessment of the quality or the adequacy of any data or justifications submitted.

If a registration is incomplete, the Agency shall inform the registrant, within three weeks of the registration date, as to what further information is required in order for the registration to be complete in accordance with this Title, while setting a reasonable deadline for this. The registrant shall submit such further information to the Agency within the deadline set. The Agency shall confirm the submission date of the further information to the registrant. The Agency shall perform a further completeness check, considering the further information submitted.

The Agency shall reject the registration if the registrant fails to complete his registration within the deadline set.

3.  The Agency shall communicate the registration dossier together with the registration number, the registration date, the result of the completeness check and any request for further information and deadline set in accordance with the second subparagraph of paragraph 2 to the competent authority of the relevant Member State within 30 days of the registration date. The relevant Member State shall be the Member State within which the manufacture takes place or the importer is established.

The Agency shall forthwith communicate to the competent authority of the relevant Member State any further information submitted by the registrant.

4.  An appeal may be brought, in accordance with Articles 98, 99 and 100 , against Agency decisions under paragraph 2 of this Article.

Article 21

Manufacturing and import of substances

1.  Subject to Article 23 , substances shall not be manufactured in the Community or imported unless they have been registered in accordance with the relevant provisions of this Title.

A registrant may start the manufacture or import of a substance, if there is no indication to the contrary from the Agency in accordance with Article 20(2) within the three weeks after the registration date, without prejudice to Article 28(10) .

In the case of registrations of phase-in substances submitted within 2 months before the relevant deadline of Article 23 as referred to in Article 20(2) , a registrant may continue the manufacture or import of the substance for 3 months from that deadline or until any rejection by the Agency, whichever is the earlier.

2.  If the Agency has informed the registrant that he is to submit further information in accordance with the second subparagraph of Article 20(2) , the registrant may start the manufacture or import if there is no indication to the contrary from the Agency, within the three weeks after receipt by the Agency of the further information necessary to complete his registration, without prejudice to Article 28(10) .

3.  If one manufacturer or importer submits parts of the registration on behalf of other manufacturers and/or importers, as provided for in Article  12 or 19 , those other manufacturers and/or importers may manufacture the substance in the Community or import it only after the expiry of the time-limit laid down in paragraph 1 or 2 of this Article and provided that there is no indication to the contrary from the Agency in respect of the registration of the one manufacturer or importer acting on behalf of others.

4.  Paragraphs 1, 2 and 3 shall apply to on-site isolated intermediates or transported isolated intermediates.

Article 22

Further duties of registrants

1.  Following registration, a registrant shall be responsible on his own initiative for immediately informing the Agency in writing of the following in the format specified by the Agency in accordance with Article 119 :

   a) any change in his status, such as manufacturer or importer, or in his identity, such as his name or address;
   b) any change in the composition of the substance as given in Annex IV;
   c) significant changes in the annual or total quantities manufactured or imported by him;
   d) new uses for which the substance is manufactured or imported of which he may reasonably be expected to have become aware;
   e) significant new knowledge of the risks of the substance for human health and/or the environment of which he may reasonably be expected to have become aware;
   f) any change in the classification and labelling of the substance;
   g) any update or amendment of the chemical safety report .

The Agency shall communicate this information to the competent authority of the relevant Member State.

2.  In cases covered by Article 12 or 19 , each registrant shall submit separately the information specified in paragraph 1(c).

TRANSITIONAL PROVISIONS APPLICABLE TO PHASE-IN SUBSTANCES AND NOTIFIED SUBSTANCES

Article 23

Specific provisions for phase-in substances

1.   Article 21 shall not apply to the following substances until ... (48) :

   a) phase-in substances classified as carcinogenic, mutagenic or toxic to reproduction, categories 1 and 2, in accordance with Directive 67/548/EEC and manufactured in the Community or imported, in quantities reaching 1 tonne or more per year per manufacturer or per importer, at least once following the entry into force of this Regulation;
   b) phase-in substances classified as very toxic to aquatic organisms that may cause long-term adverse effects in the aquatic environment (R50/53) in accordance with Directive 67/548/EEC and manufactured in the Community or imported in quantities reaching 100 tonnes or more per year per manufacturer or per importer;
   c) phase-in substances manufactured in the Community or imported, in quantities reaching 1 000 tonnes or more per year per manufacturer or per importer, at least once following the entry into force of this Regulation.

2.  Article 21 shall not apply until ... (49) to phase-in substances classified as very toxic to aquatic organisms that may cause long-term adverse effects in the aquatic environment (R50/53) in accordance with Directive 67/548/EEC and manufactured in the Community or imported in quantities reaching 1 tonne or more per year per manufacturer or per importer or to phase-in substances manufactured in the Community or imported, in quantities reaching 100 tonnes or more per year per manufacturer or per importer, at least once following the entry into force of this Regulation.

3.  Article  21 shall not apply until ... (50) * to phase-in substances manufactured in the Community or imported, in quantities reaching 1 tonne or more per year per manufacturer or per importer, at least once following the entry into force of this Regulation.

Article 24

Notification of intention not to register a substance

1.  Manufacturers or importers of a substance, either on its own or in a preparation, who do not intend to submit an application for registration of the substance shall notify the Agency and downstream users of their intention.

2.  The notification referred to in paragraph 1 shall be forwarded:

   a) 12 months before the deadline laid down in Article 23(1) for phase-in substances manufactured or imported in quantities reaching 1 000 tonnes or more per year;
   b) 24 months before the deadline laid down in Article 23(2) for phase-in substances manufactured or imported in quantities reaching 100 tonnes or more per year;
   c) 36 months before the deadline laid down in Article 23(3) for phase-in substances manufactured or imported in quantities reaching 1 tonne or more per year.

3.  Should the manufacturer or importer fail to notify the Agency or downstream users of his intention not to register the substance, he shall be required to submit a registration application for the substance.

Article 25

Notified substances

1.  A notification submitted in accordance with Directive 67/548/EEC shall be regarded as a registration for the purposes of this Title and the Agency shall assign a registration number not later than ... (51) .

2.  If the quantity of a notified substance manufactured or imported per manufacturer or importer reaches the next tonnage threshold under Article  13 , the additional required information corresponding to that tonnage threshold, as well as to all the lower tonnage thresholds, shall be submitted in accordance with Article s 11 and 13 , unless it has already been submitted in accordance with those Article s.

OBJECTIVES AND GENERAL RULES

Article 26

Objectives and general rules

1.  Manufacturers or importers shall share between them and make available the information specified in Article 11(a) (vii) and (viii) for the purposes of registration, so that the duplication of studies is avoided.

In circumstances (other than in matters requiring data from animal testing) where:

   a) the costs of sharing the information would be disproportionate;
   b) the data is not relevant for a substance; or
   c) the information is commercially confidential and the registrant justifiably considers that he may suffer loss of business as a result of requirements to share the information concerned,
the registrant shall submit to the Agency a justification for not sharing the information in part or in whole.

At the request of another potential registrant, and on payment of a fee, the Agency shall consider wheher a justification is well-founded. SMEs shall pay only a reduced fee. If the Agency finds that a justification is not well-founded, the exemption from sharing shall not be allowed to the original registrant, and the costs of the Agency related to its consideration shall be borne by him. In such cases, the fee paid shall be reimbursed.

No justification shall be required for not sharing physicochemical information specified in section 5 of Annexes V and VII.

2.  In order to avoid unnecessary animal testing, testing on vertebrate animals for the purposes of this Regulation shall be undertaken only as a last resort .

3.  The sharing and joint submission of information in accordance with this Regulation shall concern technical data and in particular information related to the intrinsic properties of substances. Registrants shall refrain from exchanging information concerning their market behaviour, in particular as regards production capacities, production or sales volumes, import volumes or market shares.

4.  Any summaries or robust study summaries of studies relating to both animal and to non-animal tests submitted in the framework of a registration at least 15 years previously may be made freely available by the Agency to any other registrants or potential registrants .

5.  Any producer, importer or downstream user may appoint a third party as representative in all proceedings under this Title.

RULES FOR NON-PHASE-IN SUBSTANCES

Article 27

Duty to inquire prior to registration

1.  Before testing is carried out in order to meet information requirements for the purposes of registration, paragraphs 2, 3 and 4 shall apply.

2.  The potential registrant shall consult the database referred to in Article  83(4)(d) in order to find out whether the same substance has already been registered.

3.  The potential registrant shall inquire from the Agency whether a registration has already been submitted for the same substance. He shall submit all the following information to the Agency with the inquiry:

   a) his identity;
   b) the identity of the substance, as referred to in sections 2.1 and 2.3 of Annex IV;
   c) which information requirements would require new studies involving vertebrate animals to be carried out by him .

4.  If the same substance has previously been registered less than 10 years earlier , the Agency shall inform the potential registrant without delay of the name(s) and address(es) of the previous registrant(s) and of the relevant summaries or robust study summaries of the studies, as the case may be, already submitted by them .

The available studies must be shared with the potential registrant in accordance with Article 28.

5.  If another potential registrant has made an inquiry in respect of the same substance, the Agency shall inform both potential registrants, or their third party representative appointed under Article 26(5), without delay of the name and address of the other potential registrant .

Article 28

Sharing of existing data between registrants

1.  In the case of substances previously registered less than 15 years earlier, the potential registrant shall ask the previous registrant(s) for the information he requires with respect to Article 11(a)(vii) and (viii) in order to register .

2.  The potential and the previous registrant(s) for the same substance shall take all reasonable steps to reach an agreement on the sharing and making available of studies involving any type of test. Such an agreement may be replaced by submission of the matter to an arbitration board and acceptance of the arbitration order.

3.  If an agreement on the sharing of studies has been reached, the previous registrant(s) shall grant a letter of access to the potential registrant for the studies concerned within two weeks of receipt of payment.

The new registrant shall refer to these studies in his registration dossier and shall submit the letter of access from the previous registrant(s).

4.  If there is failure to reach such an agreement, the potential registrant may inform the Agency and the previous registrant(s) thereof at least 1 month after receipt, from the Agency, of the name and address of the previous registrant(s).

5.  The previous registrant(s) shall have 1 month from the receipt of the information referred to in paragraph 4 to inform the potential registrant and the Agency of the cost incurred by him for the study concerned. At the request of the potential registrant, the Agency shall take the decision to make available to him the summaries or robust study summaries, as the case may be, of the studies concerned, or the results thereof, on receipt of proof that he has paid the previous registrant(s) a share of the cost shown by the latter, calculated in accordance with paragraph 6 .

6.  The sharing of the actual costs incurred by the original registrant(s) for the study concerned shall be calculated in a way which is proportional to each party's production/import volume.

Where the original total cost has already been shared between two or more registrants, any subsequent potential registrant(s) shall pay each registrant a fair share of his contribution to costs.

7.  If the potential registrant fails to pay his share of the cost of a study involving tests on vertebrate animals or another study that may prevent animal testing, he shall not be able to register his substance.

8.  If the previous registrant(s) fail(s) to inform the potential registrant and the Agency of the cost within the deadline set in paragraph 5, the Agency, on request, shall take the decision to make available to the potential registrant the summaries or robust study summaries, as the case may be, of the studies concerned as required by him. The previous registrant(s) shall have a claim on the potential registrant for a share of the cost, calculated in accordance with paragraph 6, which shall be enforceable in the national courts.

9.  An appeal may be brought, in accordance with Articles 98, 99 and 100 , against Agency decisions under paragraphs 5 and 8 of this Article

10.  The registration waiting period in accordance with Article  21(1) for the new registrant shall be extended by a period of 4 months, if the previous registrant so requests.

RULES FOR PHASE-IN-SUBSTANCES

Article 29

Duty to pre-register for phase-in substances

1.  In order to benefit from the transitional regime provided for in Article 23 each potential registrant of a phase-in substance shall submit all the following information to the Agency in the format specified by the Agency in accordance with Article 119 :

   a) the name of the substance and, where applicable, the group of substances, including its Einecs and CAS number, if available;
   b) his name and address and the name of the contact person and, where appropriate, the name and address of any third party appointed by mutual agreement to act as contact person for the potential registrant for the purposes of this Article and Articles 30 and 31;
   c) a statement indicating whether consent is given for the publication, pursuant to Article 30, of the name and address of the manufacturer or importer or a third party as referred to in point (b);
   d) the envisaged deadline for the registration/tonnage band ;
   e) a brief general description of identified uses; as a minimum initial information on use and exposure categories as specified in section 6 of Annex IV;
   f) a list of the uses which he intends to support through registration.

The potential registrant may limit the information to be submitted under the first subparagraph to those endpoints/properties for which tests were required.

2.  Anyone in possession of studies or information on a substance derived through experiments on animals shall be required to forward such information to the Agency not later than ... * .

3.  The information referred to in paragraph 1 shall be submitted not later than ... (52) .

4.  If the deadline laid down in paragraph 3 has elapsed, the Agency shall, upon request by a downstream user of a substance that has not been pre-registered, permit late notification to the register of substances by any person other than the original supplier of that substance to the downstream user for a further six months after the publication of the register. Such notification shall enable the potential registrant to benefit from the transitional regime.

5.  Subject to paragraph 4, registrants who do not submit the information required under paragraph 1 shall not be able to rely on Article 23 .

6.  The Agency shall:

   a) within one month of the expiry of the deadline laid down in paragraph 3, make a list of the substances pre-registered in accordance with that paragraph publicly available over the Internet. The list shall comprise only the names of the substances, including their EINECS and CAS number if available;
   b) if the same substance has been previously registered less than 10 years earlier, inform the potential registrant(s) without delay of the name(s) and address(es) of the previous registrant(s) and of the relevant summaries or robust study summaries of the studies, as the case may be, already submitted by them.

The available studies must be shared with the potential registrant(s).

7.  Manufacturers and importers shall forward to the Agency any information in their possession deriving from experiments on vertebrate animals and other information that could prevent animal experimentation, in relation also to substances they have ceased to manufacture or import. Registrants who later make use of such information shall share the costs of creating such information in a manner that is proportional to each party's production volume. Anyone coming into possession of the results of studies or other information on a substance derived from experiments on vertebrate animals after the expiry of the deadline referred to in paragraph 2 shall forward such information to the Agency.

8.  Manufacturers and importers of phase-in substances in quantities of less than 1 tonne per year, as well as downstream users, may submit the information referred to in paragraph 1 to the Agency in the format specified by the Agency in accordance with Article 119 .

9.  The Agency shall record the information submitted in accordance with paragraphs 1 to 8 in a database. It shall grant access to these data held on each substance to the manufacturers and importers who have submitted information on that substance in accordance with paragraphs 1 to 8 . The competent authorities of the Member States shall also have access to these data.

Article 30

Register of substances

1.  The Agency shall operate a register of substances containing the information specified in Article 29.

2.  The Agency shall publish all pre-registered substances in the register of substances within one month after the expiry of the deadline laid down in Article 29(3), indicating:

   a) the name of the substance and, where applicable, the group of substances, including EINECS and CAS numbers, if available;
   b) where applicable, the name and address of the manufacturer or importer or the third party representative, provided that consent pursuant to Article 29(1)(c) has been given;
   c) a general description of identified uses; as a minimum, initial information on use and exposure in accordance with Article 29(1)(e);
   d) the first deadline for the registration of each substance in accordance with Article 23.

3.  The Agency shall publish the name of the substance and, where applicable, the group of substances, including EINECS and CAS numbers, if available, in respect of which late notification has been requested, immediately following the receipt of such requests.

4.  Within one month of the expiry of the late notification period pursuant to Article 29(4), the Agency shall update the register of substances to include those substances for which late pre-registrations have been received.

5.  The Agency shall publish together with the publication of the register of substances, pursuant to paragraphs 1 and 4, a request to anyone who owns studies on vertebrate animals which are not publicly available to submit indications on the availability of such studies.

6.  Anyone who owns such studies may send indications on the availability of such studies to the Agency, within six months of the publication of the register of substances, pursuant to paragraph 4, and the Agency shall include this information in the database in accordance with Article 29(9). Such studies shall be used in accordance with Article 32.

Article 31

Substance Information Exchange Fora

1.  All manufacturers and importers who have submitted information to the Agency in accordance with Article 29 for the same phase-in substance shall be participants in a substance information exchange forum (Sief).

2.  The aim of each Sief shall be to minimise the duplication of tests by exchanging information. Sief participants shall provide other participants with existing studies, react to requests by other participants for information, collectively identify needs for further studies and arrange for them to be carried out.

3.  Sief participants shall make every effort to agree on the interpretation of the information that they exchange.

Article 32

Sharing of data involving tests between registrants

1.  Before testing is carried out in order to meet the information requirements for the purposes of registration, a Sief participant shall inquire whether a relevant study is available by consulting the database referred to in Article 29(9) and by communicating within his Sief. If a relevant study is available within the Sief, a participant of that Sief who would have to carry out a test shall request that study within two months of the deadline set in Article 29(3) .

Within two weeks of the request, the owner of the study shall provide proof of its cost to the participant(s) requesting it. The participant(s) and the owner shall take all reasonable steps to reach an agreement on how to share the cost. If they cannot reach such an agreement, the cost shall be shared in a way which is proportional to each party's production volume . The owner shall provide the study within two weeks of receipt of payment.

2.  Failure to make available to the Agency vertebrate animal data or other information that could prevent animal testing will result in potential registrants forfeiting their right to register the substance concerned.

3.  If the other participant(s) fail to pay their share of the cost, they shall not be able to register their substance.

4.  If the owner of the study fails to make the study available to the Agency, he shall not be able to register his substance.

5.  If a relevant study involving tests is not available within the Sief, the participant shall contact other participants of that Sief who have submitted information about the same or a similar use of the substance and who might need to carry out that study. They shall take all reasonable steps to reach an agreement as to who is to carry it out on behalf of the other participants.

6.  If the owner of a study as referred to in paragraph 5 refuses to provide either proof of the cost of that study or the study itself to another participant(s), the other participant(s) shall proceed as if no relevant study were available within the Sief, unless a registration containing the summary or robust study summary, as the case may be, of the study has already been submitted by another registrant. In such cases, the Agency shall take the decision to make available to the other participant(s) that summary or robust study summary, as the case may be. The other registrant shall have a claim on the participants for a share of the cost which is proportional to his production volume, which shall be enforceable in the national courts.

7.  If the other participant(s) fail to pay their share of the cost, they shall not be able to register their substance.

8.  An appeal may be brought, in accordance with Articles 98, 99 and 100 , against Agency decisions under paragraph 6 of this Article.

9.   The owner of the study who has refused to provide either the costs or the study itself, as referred to in paragraph 6 , shall be penalised in accordance with Article 134 .

INFORMATION IN THE SUPPLY CHAIN

Article 33

Requirements for Safety Data Sheets

1.   Where a substance or preparation meets the criteria for classification as dangerous in accordance with Directives 67/548/EEC or 1999/45/EC, or meets the criteria referred to in Article 63(a) to (e), or has been identified in accordance with Article 63(f) , the person responsible for placing that substance or preparation on the market, whether the manufacturer, importer, downstream user or distributor, shall supply the recipient, who is a downstream user or distributor of the substance or preparation, free of charge, with a safety data sheet relating to the substance or the preparation and compiled in accordance with Annex Ia.

2.  Any actor in the supply chain who is required, under Articles 15 or 39 , to carry out a chemical safety assessment as part of his registration for a substance shall ensure that the information in the safety data sheet is consistent with the information in this assessment.

If the safety data sheet is developed for a preparation, the actor in the supply chain may prepare a chemical safety assessment for the preparation in accordance with Annex Ib. In that case, it is sufficient if the information in the safety data sheet is consistent with the chemical safety report for the preparation instead of with the chemical safety report for each substance in the preparation.

3.  Where a preparation does not meet the criteria for classification as dangerous in accordance with Articles 5, 6 and 7 of Directive 1999/45/EC, but contains in an individual concentration of ≥ 1 % by weight for non-gaseous preparations and ≥ 0,2 % by volume for gaseous preparations at least one substance posing health or environmental hazards, or one substance for which there are Community workplace exposure limits, the person who is responsible for placing that preparation on the market, whether the manufacturer, importer, downstream user or distributor, shall supply the downstream user free of charge with a safety data sheet compiled in accordance with Annex Ia.

4.   The safety data sheet need not be supplied where dangerous substances or preparations offered or sold to the general public are provided with sufficient information to enable users to take the necessary measures as regards the protection of health, safety and the environment, unless requested by a downstream user.

5.  The safety data sheet shall be supplied in the official languages of the Member States in which the substance or preparation is placed on the market.

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

   1. identification of the substance/preparation and of the company/undertaking;
   2. hazards identification;
   3. composition/information on ingredients;
   4. first-aid measures;
   5. fire-fighting measures;
   6. accidental release measures;
   7. handling and storage;
   8. exposure controls/personal protection;
   9. physicochemical properties;
   10. stability and reactivity;
   11. toxicological information;
   12. ecological information;
   13. disposal considerations;
   14. transport information;
   15. regulatory information;
   16. other information.

Where a chemical safety assessment is performed the relevant exposure scenarios and the corresponding description of the risk, and the related use and exposure categories, shall be placed in an annex to the safety data sheet.

7.  For identified uses, a downstream user shall use appropriate information from the safety data sheet supplied to him.

8.   A safety data sheet shall be supplied on paper or electronically free of charge at the latest at the time of the first delivery of a substance following the entry into force of this Regulation, unless a safety data sheet has been supplied, in accordance with these provisions, prior to the entry into force of this Regulation . Suppliers shall update it without delay on the following occasions:

   a) as soon as new data which may affect the risk management measures becomes available ;
   b) if an authorisation has been granted or refused;
   c) if a restriction has been imposed.

The new, dated version of the information, identified as 'Revision: (date)', shall be provided free of charge to all former recipients to whom they have supplied the substance or preparation within the preceding 12 months.

9.   The Commission shall organise the development of technical guidelines setting minimum requirements for safety data sheets, to ensure the provision of clear and adequate information of optimal use to all actors up and down the supply chain.

Article 34

Duty to communicate information down the supply chain for substances and preparations for which a safety data sheet is not required

1.  All actors in the supply chain or distributors of a substance on its own or in a preparation who do not have to supply a safety data sheet in accordance with Article 33 shall communicate free of charge the following information down the supply chain to the immediate downstream user or distributor:

   a) the registration number(s) referred to in Article 20(1), if available , for any substances for which information is communicated under this point or points (b) or (c) of this paragraph;
   b) whether the substance is subject to authorisation and details of any authorisation granted or denied under Title VII in this supply chain;
   c) details of any restriction imposed under Title VIII;
   d) any other available and relevant information about the substance which may affect the risk management measures as soon as it becomes available.

2.  Information shall be communicated in writing or electronically at the latest at the time of the first delivery of a substance following the entry into force of this Regulation. Suppliers shall update this information and communicate it down the supply chain without delay on the following occasions:

   a) as soon as new data which may be necessary to enable appropriate risk management measures to be identified and applied become available;
   b) once the substance has been registered;
   c) once an authorisation has been granted or refused;
   d) once a restriction has been imposed.

That new information shall be provided free of charge to all former recipients to whom they have supplied the substance or preparation within the preceding 12 months.

Article 35

Duty to communicate information on substances and preparations up the supply chain

Any actor in the supply chain of a substance or a preparation shall communicate the following information to the next actor or distributor up the supply chain:

   a) new information on hazardous properties, regardless of the uses concerned;
   b) any other information that might call into question the appropriateness of the risk management measures identified in a safety data sheet supplied to him, which shall be communicated only for identified uses.

Distributors shall pass on that information to the next actor or distributor up the supply chain.

Article 36

Duty to communicate information on substances contained in articles

1.  Any manufacturer or importer of a substance listed in Annex XIII, or a preparation or article containing such a substance, shall at the request of the downstream user, in so far as this may reasonably be required, furnish the information necessary to assess the effects of the substance on human health or the environment with respect to the operations and uses indicated in that request.

2.  The information requirements specified in paragraph 1 shall apply mutatis mutandis up the supply chain.

3.  Downstream users who incorporate into an article a substance or preparation for which a safety data sheet was established, and those who subsequently handle or further process that article, shall pass on the safety data sheet to any recipient of the article or its derivative. Recipients shall not include consumers.

Consumers shall have the right to ask the producer or importer for information on the substances present in an article produced or imported by him.

Producers or importers shall, on request and within 15 working days, enable any individual consumer to obtain, free of charge, full details of safety and use information concerning the substances present in any article they have produced or imported.

Article 37

Access to the safety data sheet information for workers

Workers and their representatives shall be granted access by their employer or the producer to the information provided in accordance with Articles 33 and 34 in relation to substances they use or may be exposed to in the course of their work.

The seller of a dangerous substance or preparation or a product containing dangerous substances shall grant the client, consumer bodies, or other interested bodies access to the information on those substances, preparations and products provided under Articles 33 and 34.

Article 38

Obligation to keep information

All actors in the supply chain shall assemble and keep available all the information they require to carry out their duties under this Regulation for a period of at least 10 years after they last manufactured, imported, supplied or used the substance on its own, or in a preparation. Any actor in the supply chain shall submit this information or make it available without delay upon request to any competent authority of the Member State in which that actor in the supply chain is established or to the Agency , without prejudice to Titles II and VI.

DOWNSTREAM USERS

Article 39

Downstream user chemical safety assessments and duty to apply and recommend risk reduction measures

1.  A downstream user may provide information to assist in the preparation of a registration. The information may be submitted directly to the Agency. The provisions of Title III relating to data sharing shall apply to the downstream user, mutatis mutandis.

2.  Any downstream user shall have the right to make a use known in writing to the manufacturer, importer or downstream user who supplies him with a substance with the aim of making this an identified use. In so doing, he shall provide sufficient information to allow his supplier to prepare an exposure scenario for his use in the supplier's chemical safety assessment.

3.  For registered substances, the manufacturer or importer shall comply with the obligation laid down in Article 15 before he next supplies the substance to the downstream user making the request, provided that the request was made at least one month before the supply, or within 1 month after the request, whichever is the later. For phase-in substances, the manufacturer or importer shall comply with this request and with the obligations laid down in Article 15 before the relevant deadline in Article 23 , provided that the downstream user makes his request at least 12 months before the deadline in question.

4.  A downstream user of a substance on its own or in a preparation shall prepare a chemical safety report in accordance with Annex XI for any use outside the conditions described in an exposure scenario communicated to him in a safety data sheet.

If the downstream user implements or recommends an exposure scenario which includes as a minimum the conditions described in the exposure scenario communicated to him, he need not prepare a chemical safety report.

The downstream user need not prepare a chemical safety report in either of the following cases:

   a) a safety data sheet is not required to be communicated with the substance;
   b) a chemical safety report is not required to be completed by his supplier.

5.  Any downstream user shall identify, apply and, where suitable, recommend appropriate measures to adequately control risks identified in either of the following:

   a) the safety data sheet(s) supplied to him;
   b) his own chemical safety assessment.

6.  Downstream users shall keep their chemical safety report available and up to date.

7.  Article 15(2) and (6) shall apply mutatis mutandis.

Article 40

Obligation for downstream users to report information

1.  Before commencing a particular use of a substance that has been registered by an actor up the supply chain in accordance with Article  5 or 18 , any downstream user shall report to the Agency the information specified in paragraph 2 of this Article, if a safety data sheet is communicated to him that includes an exposure scenario and the downstream user is using the substance outside the conditions described in that exposure scenario.

2.  The information reported by the downstream user shall include the following in the format specified by the Agency in accordance with Article 119 :

   a) his identity and contact details;
   b) the registration number(s) referred to in Article 20(1), if available;
   c) the identity of the substance(s) as specified in section 2 of Annex IV;
   d) if known, the identity of the manufacturer(s) or the importer(s);
   e) a brief general description of the use(s);
   f) a proposal for additional testing on vertebrate animals, where this is considered necessary by the downstream user to complete his chemical safety assessment.

Where such data are not available, the procedure under Article 28 shall apply.

3.  The downstream user shall update this information without delay in the event of a change in the information reported in accordance with paragraph 1.

4.  A downstream user shall report to the Agency in the format specified by the Agency in accordance with Article 119 if his classification of a substance is different to that of his supplier.

5.  Reporting in accordance with paragraphs 1 to 4 shall not be required in respect of a substance, on its own or in a preparation, used by the downstream user in quantities of less than 1 tonne per year.

Article 41

Procedure for compulsory notification of information by SMEs

1.  Where the downstream user is an SME within the meaning of Article 3(32), the notification procedure provided for in Article 40 shall apply, with the exception of paragraphs 2(f), 3, 4 and 5 thereof.

2.  Further more detailed tests on vertebrate and non-vertebrate animals which prove necessary as a result of the Agency's assessment shall be identified by the Agency from among existing tests.

3.  If the tests referred to in paragraph 2 do not already exist, the Agency shall instruct the Member State in which the SME has its head office to carry out the tests. Results which are useful to the safety assessments shall be notified to the SME following conclusion of the tests.

4.  The Agency shall as soon as possible notify the applicant (SME) and the Member State in which it has its head office if the results of the tests are negative with a view to blocking the use of the substance which has been tested.

5.  The downstream user SME shall be required to update the information reported under paragraph 1 as soon as any change occurs in this information.

6.  A downstream user SME shall report to the Agency in the format specified by the Agency in accordance with Article 119 if his classification of a substance is different from that of his supplier.

7.  Reporting in accordance with paragraphs 1 to 6 shall not be required in respect of a substance, on its own or in a preparation, used by the downstream user SME in quantities of less than one tonne per year.

Article 42

Application of downstream user obligations

1.  Downstream users shall be required to comply with the requirements of Article 39 at the latest 12 months after receiving a registration number communicated to them by their suppliers in a safety data sheet.

2.  Downstream users shall be required to comply with the requirements of Article 40 at the latest 6 months after receiving a registration number communicated to them by their suppliers in a safety data sheet.

SCOPE

Article 43

Scope

Polymers are exempted from evaluation under this Title.

DOSSIER EVALUATION

Article 44

Responsibility of the Agency for dossier evaluation

1.  The Agency shall be responsible for the evaluation of the testing proposals and registration dossiers.

2.  The Agency shall rely, for these evaluations, on the bodies designated for that purpose by each Member State.

3.  All communication between the Agency and the registrant may be handled in a language chosen by the registrant.

Article 45

Examination of testing proposals

1.  The Agency shall examine any testing proposal set out in a registration or a downstream user report for provision of the information specified in Annexes V to VIII which involves vertebrate animal testing for a substance.

2.  In order to prevent duplication of animal testing, any testing proposal involving tests on vertebrate animals shall be open for comment by interested parties for a period of 90 days. All comments received shall be taken into account by the registrant or the downstream user, who shall notify the Agency whether, in the light of the comments received, he nonetheless believes that it is necessary to carry out the proposed test and of his reasons therefor.

3.  ECVAM shall be consulted before a decision as referred to in paragraph 4 on a testing proposal that includes vertebrate animal tests is drafted.

4.  On the basis of the examination under paragraphs 1, 2 and 3 , the Agency shall draft one of the following decisions and that decision shall be taken in accordance with the procedure laid down in Articles 56 and 57 :

   a) a decision requiring the registrant(s) or downstream user(s) concerned to carry out the proposed test and setting a deadline for submission of the summary of the test result, or the robust study summary if required by Annex I;
   b) a decision in accordance with point (a), but modifying the conditions under which the test is to be carried out;
   c) a decision rejecting the testing proposal.

5.  The registrant shall submit the information required to the Agency.

Article 46

Compliance check of registrations

1.  The Agency may examine any registration in order to verify either or both of the following:

   a) that the information in the technical dossier(s) submitted pursuant to Article 11 complies with the requirements of Articles 11, 13 and 14 and with Annexes IV to VIII;
   b) that the adaptations of the standard information requirements and the related justifications submitted in the technical dossier(s) comply with the rules governing such adaptations set out in Annexes V to VIII and with the general rules set out in Annex IX.

2.  On the basis of an examination made pursuant to paragraph 1, the Agency may prepare a draft decision within 12 months of the publication of the annual evaluation plan referred to in paragraph 4 requiring the registrant(s) to submit any information needed to bring the registration(s) into compliance with the relevant information requirements and that decision shall be taken in accordance with Articles  56 and 57.

3.  The registrant shall submit the information required to the Agency within a reasonable deadline to be set by the Agency. This deadline shall not exceed six months. The agency shall withdraw the registration number if the registrant fails to submit the relevant information within the deadline set .

4.   The Agency shall establish an annual evaluation plan for registration dossiers, in particular to evaluate their overall quality. The plan shall specify, in particular, the minimum percentage of registration dossiers to be evaluated during that period. This percentage shall not be lower than 5% of the average number of registration dossiers of the last three years. The plan shall be published on the Agency's website.

5.  The Agency shall prepare an annual report on the results of the evaluation of the registration dossiers. This report shall include, in particular, recommendations to registrants in order to improve the quality of future registrations. The report shall be published on the Agency's website.

Article 47

Check of information submitted and follow-up to dossier evaluation

1.  The Agency shall examine any information submitted in consequence of a decision taken under Article 45 or 46 , and draft any appropriate decisions in accordance with Article 45 or 46 , if necessary.

2.  Once the dossier evaluation is completed, the Agency shall use the information obtained from this evaluation for the purposes of Articles 51 (1), 65(4) and 75(2 ), and shall transmit the information obtained to the Commission and the Member States. The Agency shall inform the Commission, the registrant and the Member States on its conclusions as to whether or how to use the information obtained.

Article 48

Procedure and time periods for examination of testing proposals

1.  The Agency shall prepare a draft decision in accordance with Article 45(4) within 120 days of receiving a registration or downstream user report containing a testing proposal .

2.  In the case of phase-in substances, the Agency shall prepare the draft decisions in accordance with Article 45(4) :

   a) not later than ... (53) for all registrations received within the deadline referred to in Article 23(1) containing proposals for testing in order to fulfil the information requirements in Annexes V to VIII ;
   b) not later than ... (54) * for all registrations received within the deadline referred to in Article 23(2) containing proposals for testing in order to fulfil the information requirements in Annexes V to VII ;
   c) after the deadlines set in points (a) and (b) for any registrations containing testing proposals received within the deadline referred to in Article 23(3) .

3.   The list of registration dossiers which are evaluated in accordance with Articles 45 and 46 shall be made available to the Member States.

4.  The information requirements shall be fulfilled within two years after the finalisation of the evaluation of the testing proposals.

Article 49

Procedure and time periods for compliance check

The Agency shall prepare a draft decision in accordance with Article 46(2) within 12 months of the start of the evaluation of the substance.

SUBSTANCE EVALUATION

Article 50

Criteria for substance evaluation

In order to provide a harmonised approach, the Agency shall develop criteria for prioritising substances with a view to further evaluation. Prioritisation shall be on a risk-based approach and a risk-assessment scheme which will be based on the relation dose/effect . The criteria for evaluation shall include consideration of hazard data, exposure data and tonnage bands. The Agency shall take a decision on the criteria for the prioritisation of substances for further evaluation .

The Agency shall publish the list of priority substances for evaluation on its website.

Article 51

Community rolling plan

1.  The Agency shall establish a draft Community rolling plan for the purposes of Articles 52, 53 and 54 , on the basis of the criteria established under Article 50 and if, either as a result of a dossier evaluation or from any other relevant source, including information in the registration dossier(s), it has reasons for suspecting that the substance presents a risk to health or the environment, in particular for example on the basis of either of the following:

   a) structural similarity of the substance with known substances of concern or with substances which are persistent and liable to bio-accumulate, suggesting that the substance or one or more of its transformation products has properties of concern or is persistent and liable to bio-accumulate;
   b) aggregated tonnage from the registrations submitted by several registrants.

The Agency shall submit the draft Community rolling plan to Member States by 31 December of each year.

2.  Member States may provide their comments, including proposals to include additional substances, on the content of the draft Community rolling plan to the Agency, and propose to take charge of an evaluation through national bodies by 31 January of each year. A Member State may not propose to take charge of the evaluation of a substance which it has itself proposed to add to the draft Community rolling plan.

3.  The Agency shall be responsible for the evaluation of the substances included in the Community rolling plan. To perform these evaluations the Agency may rely on the body(ies) designated for that purpose by each Member State and appearing on the list drawn up pursuant to Article 94(3), selecting them on the basis of Member States' proposals formulated in accordance with paragraph 2 of this Article.

4.  The Community rolling plan as referred to in paragraph 1 shall cover a period of three years, updated annually, and shall specify the substances which are planned to be evaluated each year at Community level either by the Agency, or, where applicable, in the Member States who have made a proposal in accordance with paragraph 2 . The Agency shall submit the Community rolling plan to the Member States by 28 February each year .

5.  In cases where there have been no comments on the Community rolling plan, the Agency shall adopt this rolling plan. Otherwise, the Agency shall prepare a new draft rolling plan that shall be submitted to the Member States. If within 30 days no new comments have been issued on the content of the Community rolling plan, the Agency shall adopt it. If differences of opinion subsist, not least in the event of several Member States proposing different bodies for the evaluation of the same substance, the Agency shall submit the rolling plan to the Commission, which shall adopt it in accordance with the procedure referred to in Article 141(3).

6.  The Agency shall publish the definitive rolling plans on its website .

7.  A Member State may notify the Agency at any time of a new substance, whenever it is in possession of information which suggests that there is a danger to the environment or to human health. The Agency shall, if justified, add that substance to the list of substances to be evaluated under the rolling plan.

Article 52

Requests for further information

1.  If the Agency considers that further information is required for the purposes of clarifying the suspicion referred to in Article 51(1) , including, if appropriate, information not required in Annexes V to VIII, it shall prepare a draft decision, stating reasons, requiring the registrant(s) to submit the further information. The decision shall be taken in accordance with the procedure laid down in Articles 56 and 57 .

2.  The registrant shall submit the information required to the Agency.

3.  A draft decision requiring further information from registrant(s) shall be prepared within 12 months of the publication of the rolling plan on the Agency's website.

4.  When the Agency finishes its evaluation activities under paragraphs 1, 2 and 3, it shall notify the Member States accordingly within 12 months of the start of the evaluation of the substance. If this deadline is exceeded, the evaluation shall be deemed to be finished.

Article 53

Coherence with other activities

1.  The Agency or the national body in charge of an evaluation shall base its evaluation of a substance on any previous evaluation under this Title. Any draft decision requiring further information under Article 52 may be justified only by a change of circumstances or acquired knowledge.

2.  Where appropriate, implementing measures shall be adopted in accordance with the procedure referred to in Article 141(3) .

Article 54

Check of information submitted and follow-up to substance evaluation

1.  The Agency shall examine any information submitted in consequence of a decision taken under Article 52 , and shall draft any appropriate decisions in accordance with Article 52 , if necessary.

2.  Once the substance evaluation has been completed, the Agency shall use the information obtained from this evaluation for the purposes of Articles 65(4) and 75(2) and shall transmit the information obtained to the Commission and the Member States. The Agency shall inform the Commission, the registrant and the Member States of its conclusions as to whether or how to use the information obtained.

EVALUATION OF INTERMEDIATES

Article 55

Further information on on-site isolated intermediates

For on-site isolated intermediates, neither dossier nor substance evaluation shall apply. However, where a risk equivalent to the level of concern arising from the use of substances to be included in Annex XIII(a) under Article 63 can be demonstrated arising from the use of an on-site isolated intermediate, the Agency may:

   a) require the registrant to submit further information directly related to the risk identified. This request shall be accompanied by a written justification;
   b) examine any information submitted and, if necessary, take any appropriate risk reduction measures to address the risks identified in relation to the site in question.

The procedure provided for in the first paragraph may be undertaken only by the Agency .

COMMON PROVISIONS

Article 56

Registrants" rights

1.  The Agency shall communicate any draft decision under Articles 45, 46 or 52 to the registrant(s) or downstream user(s) concerned, informing them of their right to comment within 30 days of receipt. The Agency shall take any comments received into account and may amend the draft decision accordingly.

2.  If a registrant has definitively ceased the manufacture or import of the substance, he shall inform the Agency of this fact with the consequence that his registration shall no longer be valid, and no further information may be requested with respect to that substance, unless he submits a new registration.

3.  The registrant may definitively cease the manufacture or import of the substance upon receipt of the draft decision. In such cases, he shall inform the Agency of this fact with the consequence that his registration shall no longer be valid, and no further information may be requested with respect to that substance, unless he submits a new registration.

4.  Notwithstanding paragraphs 2 and 3, further information may be required in accordance with Article 52 in either or both of the following cases:

   a) where the Agency prepares a dossier in accordance with Annex XIV concluding that there is a potential long-term risk to man or the environment justifying the need for further information;
   b) where the exposure to the substance manufactured or imported by the registrant(s) concerned contributes significantly to that risk.

The procedure in Articles 75 to 79 shall apply mutatis mutandis.

Article 57

Adoption of decisions under evaluation

1.  The Agency shall circulate its draft decision, or the one drawn up by the national body in charge of the evaluation (rapporteur body), in accordance with Article 45, 46 or 52, together with any comments by stakeholders, ECVAM and the registrant or downstream user, and specifying to the Member States how these comments have been taken into account .

2.  Within 30 days of circulation, the Member States may propose amendments to the draft decision to the Agency .

3.  If the Agency does not receive any proposals within 30 days, it shall take the decision in the version notified under paragraph 1.

4.  If the Agency receives a proposal for amendment, it may modify the draft decision. The Agency shall refer a draft decision, together with any amendments proposed, to the Member State Committee within 15 days of the end of the 30-day period referred to in paragraph 2 .

5.  The Agency shall forthwith communicate any proposal for amendment to any registrants or downstream users concerned and allow them to comment within 30 days. The Member State Committee shall take any comments received into account.

6.  If, within 60 days of the referral, the Member State Committee reaches a unanimous agreement on the draft decision, the Agency shall take the decision accordingly.

If the Member State Committee fails to reach a unanimous agreement, it shall adopt an opinion in accordance with Article 92(7) within 60 days of the referral. The Agency shall transmit that opinion to the Commission.

7.  Within 60 days of receipt of the opinion, the Commission shall prepare a draft decision to be taken in accordance with the procedure referred to in Article  141(2) .

8.  An appeal may be brought, in accordance with Articles 98, 99 and 100 , against Agency decisions under paragraphs 3 and 6.

Article 58

Cost sharing for tests involving vertebrate animals without an agreement between registrants

1.  If a registrant or downstream user performs a test on behalf of others, they shall all share the cost of that study equally.

2.  If there is a failure to reach such an agreement and the study involves tests on vertebrate animals, the Agency shall designate one of the registrants or downstream users to carry out the study. The registrant or downstream user that has carried out the study shall make available to the Agency the study and proof of the cost of that study. The Agency shall make available to the other registrants and/or downstream users a copy of the study concerned, on receipt of proof that the other registrants and/or downstream users have paid the registrant or downstream user that has carried out the study a share of the cost shown by the latter.

3.  If any of the other registrants and/or downstream users fail to pay their share of the cost, they shall not be able to register their substance.

4.   In the case referred to in paragraph 1, the registrant or downstream user who performs the test shall provide each of the others concerned with a copy of the test.

5.  The person performing and submitting the study shall have a claim against the others accordingly. The others shall have a claim for a copy of the study. Any person concerned shall be able to make a claim in order to prohibit another person from manufacturing, importing or placing the substance on the market if that other person either fails to pay his share of the cost or to provide security for that amount or fails to hand over a copy of the study performed. All claims shall be enforceable in the national courts. Any person may choose to submit their claims for remuneration to an arbitration board and accept the arbitration order.

Article 59

Publication of information on the evaluation

By 28 February of each year, the Agency shall publish on its website a report on the progress made over the previous calendar year towards discharging the obligations incumbent upon it in relation to the examination of testing proposals .

AUTHORISATION REQUIREMENT

Article 60

Aim of authorisation

The aim of this Title is to ensure that substances of very high concern are replaced by safer alternative substances or technologies, where available. Where no such alternatives are available, and where the benefits to society outweigh the risks connected with the use of such substances, the aim of this Title is to ensure that the use of substances of very high concern is properly controlled and that alternatives are encouraged. Its provisions are underpinned by the precautionary principle.

Article 61

General provisions

1.  A manufacturer, importer or downstream user shall not place on the market a substance for a use or use it himself if that substance is included in Annex XIII, unless:

   a) the use(s) of that substance on its own, in a preparation or the incorporation of the substance into an article for which the substance is placed on the market or for which he uses the substance himself has been authorised in accordance with Articles 66 to 70 ; or
   b) the use(s) of that substance on its own, in a preparation or the incorporation of the substance into an article for which the substance is placed on the market or for which he uses the substance himself has been exempted from the authorisation requirement in Annex XIII itself in accordance with Article 64(2) ; or
   c) the date referred to in Article 64(1)(d)(i) has not been reached; or
   d) the date referred to in Article 64(1)(d)(i) has been reached and he made an application 18 months before that date but a decision on the application for authorisation has not yet been taken; or
   e) in cases where the substance is placed on the market, authorisation for that use has been granted to his immediate downstream user.

2.  A downstream user may use a substance meeting the criteria set out in paragraph 1 provided that the use is in accordance with the conditions of an authorisation granted to an actor up his supply chain for that use .

3.  Paragraphs  1 and 2 shall not apply to the use of substances in scientific research and development or in product and process orientated research and development in quantities not exceeding 1 tonne per year .

4.  Paragraphs  1 and 2 shall not apply to the use of substances when they are present in preparations:

   a) for substances referred to in Article 63(d), (e) and (f), below a concentration limit of 0,1 %;
   b) for all other substances, below the concentration limits specified in Directive 1999/45/EC which result in the classification of the preparation as dangerous.

Article 62

List of substances subject to authorisation

Substances that are known to fulfil the criteria of Article 63 shall be listed in Annex XIII(a) pending the procedure for authorisation. Once the authorisation procedure has been initiated, the substances shall be listed in Annex XIII(b), in accordance with the procedure laid down in Article 64(1).

Article 63

Substances to be included in Annex XIII(a)

Without prejudice to existing or future restrictions the following substances shall be included in Annex XIII(a) in accordance with the procedure laid down in Article 65 :

   a) substances meeting the criteria for classification as carcinogenic category 1 or 2 in accordance with Directive 67/548/EEC;
   b) substances meeting the criteria for classification as mutagenic category 1 or 2 in accordance with Directive 67/548/EEC;
   c) substances meeting the criteria for classification as toxic for reproduction category 1 or 2 in accordance with Directive 67/548/EEC;
   d) substances which are persistent, bioaccumulative and toxic in accordance with the criteria set out in Annex XII;
   e) substances which are very persistent and very bioaccumulative in accordance with the criteria set out in Annex XII;
   f) substances, such as those having endocrine disrupting properties or those having persistent, bioaccumulative and toxic properties or very persistent and very bioaccumulative properties, which do not fulfil the criteria of points (d) and (e) and which are identified as giving rise to a similar level of concern as substances listed in points (a) to (e) on a case-by-case basis in accordance with the procedure set out in Article 65 ;
   g) substances which are ingredients added to tobacco products within the meaning of Article 2(1) and (5) of Directive 2001/37/EC.

Article 64

Inclusion of substances in Annex XIII(b)

1.  Whenever a decision is taken to include in Annex XIII(b) substances referred to in Article 63 , such a decision shall be taken in accordance with the procedure referred to in Article 141(3) . It shall specify for each substance:

   a) the identity of the substance;
   b) the intrinsic property (properties) of the substance referred to in Article 63 ;
   c) any restrictions, in accordance with Article 74;
  d) transitional arrangements:
   i) the date(s) from which the placing on the market and the use of the substance shall be prohibited unless an authorisation is granted, hereinafter "the sunset date";
   ii) a date or dates at least 18 months before the sunset date(s) by which applications must be received if the applicant wishes to continue to use the substance or place it on the market for certain uses after the sunset date(s); these continued uses shall be allowed after the sunset date until a decision on the application for authorisation is taken;
   e) review periods, which must not exceed 5 years, for all uses;
   f) uses or categories of uses exempted from the authorisation requirement, if any, and conditions for such exemptions, if any.

2.  Uses or categories of uses may be exempted from the authorisation requirement. In the establishment of such exemptions, account shall be taken, in particular, of the following:

   a) existing specific Community legislation imposing minimum requirements relating to the protection of health or the environment for the use of the substance, such as binding occupational exposure limits, emission limits and so forth;
   b) existing legal obligations to take appropriate technical and management measures to ensure compliance with any relevant health, safety and environmental standards in relation to the use of the substance.

Exemptions may be subject to conditions.

Such exemptions shall not be granted to uses or categories of uses for substances referred to in Article 63 which are ingredients added to tobacco products within the meaning of Article 2(1) and (5) of Directive 2001/37/EC, notwithstanding Article 12 of that Directive.

3.  The Agency shall recommend that priority substances be transferred from Annex XIII(a) to Annex XIII(b), specifying for each substance the items set out in paragraph 1. Priority shall normally be given to :

   a) substances with PBT or vPvB properties;
   b) substances with wide dispersive use;
   c) substances with high volumes; or
   d) substances which are ingredients added to tobacco products within the meaning of Article 2(1) and (5) of Directive 2001/37/EC.

The number of substances included in Annex XIII and the dates specified under paragraph 1 shall also take account of the Agency's capacity to handle applications in the time provided for.

4.  Before the Agency sends its recommendation to the Commission it shall make it publicly available on its website, clearly indicating the date of publication. The Agency shall invite all interested parties to submit comments within three months of the date of publication, in particular on the following:

   a) fulfilment of the criteria in Article 63(d), (e) and (f);
   b) uses which should be exempt from the authorisation requirement.

The Agency shall update its recommendation, taking into account the comments received.

5.  After inclusion of a substance in Annex XIII, this substance shall not be subject to new restrictions under the procedure outlined in Title VIII covering the risks to human health or the environment from the use of the substance arising from the intrinsic properties specified in Annex XIII except where scientific information is presented to the Agency that demonstrates the need for urgent measures to further restrict the substance.

6.  Substances for which all uses have been prohibited under Title VIII or by other Community legislation shall not be included in Annex XIII or shall be removed from it.

Article 65

Identification and inclusion in Annex XIII(a) of substances referred to in Article 63

1.   Substances referred to in Article 63(a), (b) and (c) shall be included in Annex XIII(a).

2.  To identify substances referred to in Article 63(d) , (e) and (f) the procedure set out in paragraphs 3 to 8 of this Article shall apply prior to any recommendations under Article 64(3) .

3.  The Commission may ask the Agency to prepare a dossier in accordance with Annex XIV for substances which in its opinion meet the criteria set out in Article 63 (d) , (e) and (f). The Agency shall circulate this dossier to the Member States.

4.  Any Member State may prepare a dossier in accordance with Annex XIV for substances which in its opinion meet the criteria set out in Article 63(d) , (e) and (f) and forward it to the Agency. The Agency shall circulate this dossier to the other Member States.

5.  Within 30 days of circulation, the other Member States or the Agency may comment on the identification of the substance in the dossier to the Agency.

6.  If the Agency does not receive any comments, it may include this substance in its recommendations under Article 64(3) .

7.  Upon receipt of comments from another Member State or on its own initiative, the Agency shall refer the dossier to the Member State Committee within 15 days of the end of the 30-day period referred to in paragraph 5 .

8.  If, within 30 days of the referral, the Member State Committee reaches a qualified majority agreement that the substance satisfies the criteria for authorisation and should be included in Annex XIII(b), the Agency shall, within 15 working days, recommend to the Commission that the substance be included in Annex XIII(b), as provided for in Article 64(3) . If the Member State Committee fails to reach a qualified majority agreement, it shall adopt an opinion within 30 days of the referral. The Agency shall transmit that opinion to the Commission within 15 working days , including information on any minority view within the Committee, in order for the Commission to take a decision .

9.  Substances that are newly classified as fulfilling the criteria of Article 63(a), (b) and (c) and substances identified as fulfilling the criteria of Article 63(d), (e) and (f) shall be included in Annex XIII(a) within three months.

THE GRANTING OF AUTHORISATIONS

Article 66

The granting of authorisations

1.  The Commission shall be responsible for taking decisions on applications for authorisations in accordance with this Title. The precautionary principle shall apply when such decisions are taken.

2.  An authorisation shall be granted only if :

   a) suitable alternative substances or technologies do not exist, and measures are in place to minimise exposure; and
   b) it is demonstrated that the social and economic advantages outweigh the risks to human health or the environment which arise from the use of the substance; and
   c) the risk to human health or the environment from the use of a substance arising from the intrinsic properties specified in Annex XIII(a) is adequately controlled in accordance with section 6 of Annex I, and as documented in the applicant's chemical safety report.

3.  The decision to grant authorisation pursuant to paragraph 2 shall be taken after consideration of all of the following elements:

   a) the risk posed by the uses of the substance;
   b) the socio-economic benefits arising from its use and the socio-economic implications of a refusal to authorise as demonstrated by the applicant or other interested parties;
   c) the analysis of the alternatives submitted by the applicant under Article 68(4)(e) and (f) and any third party contributions submitted under Article 70(2) ;
   d) available information on the health or environmental risks of any alternative substances or technologies.

4.  In granting authorisation pursuant to paragraph 2 the Commission shall not consider the following:

   a) the risks to human health and the environment of emissions of the substance from an installation for which a permit was granted in accordance with Council Directive 96/61/EC (55) ;
   b) the risks to and via the aquatic environment of discharges of the substance from a point source governed by the requirement for prior regulation referred to in Article 11(3) of Directive 2000/60/EC of the European Parliament and of the Council (56) and legislation adopted under Article 16 thereof;
   c) the risks to human health arising from the use of a substance in a medical device regulated by Directives 90/385/EEC, 93/42/EEC or 98/79/EC.

5.  A use shall not be authorised if this would constitute a relaxation of a restriction set out in Annex XVI.

6.  An authorisation shall be granted only if the application is made in conformity with the requirements of Article 68 .

7.  Authorisations shall be subject to review periods and to the presentation of substitution plans, and may be subject to other conditions, including monitoring. Authorisations shall be subject to a time-limit not exceeding 5 years .

8.  The authorisation shall specify:

   a) the person(s) to whom the authorisation is granted;
   b) the identity of the substance(s);
   c) the use(s) for which the authorisation is granted;
   d) the conditions under which the authorisation is granted;
   e) the review period;
   f) any monitoring arrangement.

9.  Notwithstanding any conditions of an authorisation, the holder shall ensure that the level of exposure is reduced to as low as is technically possible.

Article 67

Review of authorisations

1.  Authorisations shall be regarded as valid until the Commission decides on a new application, provided that the holder of the authorisation submits a new application at least 18 months before the expiry of the time-limit. Rather than re-submitting all elements of the original application for the current authorisation, the applicant may submit only:

   a) the number of the current authorisation ;
   b) an update of the socio-economic analysis, analysis of alternatives and substitution plan contained in the original application;
   c) an update of the chemical safety report.

If any other elements of the original application have changed, he shall also submit updates of these element(s).

2.  Authorisations shall be reviewed at any time if the circumstances of the original authorisation have changed so as to affect the risk to human health or the environment, or the socio-economic impact.

In such cases, the Commission shall set a reasonable deadline by which the holder(s) of the authorisation may submit further information necessary for the review and indicate by when it will take a decision in accordance with Article 70 .

3.  In its review decision the Commission may, taking into account proportionality, amend the authorisation or withdraw the authorisation from the time of the decision, if under the changed circumstances it would not have been granted.

In cases where there is a risk for human health or the environment, the Commission may suspend the authorisation pending the review, taking into account proportionality.

4.  If an environmental quality standard referred to in Directive 96/61/EC is not met, the authorisations granted for the use of the substance concerned shall be reviewed.

5.  If the environmental objectives as referred to in Article 4(1) of Directive 2000/60/EC are not met, the authorisations granted for the use of the substance concerned in the relevant river basin may be reviewed.

6.  If a use of a substance is subsequently restricted or prohibited under Regulation (EC) No 850/2004 of the European Parliament and of the Council (57) , the Commission shall withdraw the authorisation for that use .

Article 68

Applications for authorisations

1.  An application for an authorisation shall be made to the Agency.

2.  Applications for authorisation may be made by the manufacturer(s), importer(s) and/or downstream user(s) of the substance. Applications may be made by one or several persons.

3.  Applications may be made for one or several substances, and for one or several uses. Applications may be made for the applicant's own use(s) and/or for uses for which he intends to place the substance on the market.

4.  An application for authorisation shall include the following information:

   a) the identity of the substance(s), as referred to in section  2 of Annex IV;
   b) the name and contact details of the person or persons making the application;
   c) a request for authorisation, specifying for which use(s) the authorisation is sought and covering the use of the substance in preparations and/or the incorporation of the substance in articles, where this is relevant;
   d) unless already submitted as part of the registration, a chemical safety report in accordance with Annex I covering the risks to human health and/or the environment from the use of the substance(s) arising from the intrinsic properties specified in Annex XIII ;
   e) a socio-economic analysis conducted in accordance with Annex XV;
(f) an analysis of the alternatives considering their risks and the technical and economic feasibility of substitution, where appropriate accompanied by a substitution plan, including research and development and a timetable for proposed actions by the applicant.

5.  The application shall not include any of the following:

   a) the risks to human health and the environment of emissions of the substance from an installation for which a permit has been granted in accordance with Directive 96/61/EC;
   b) the risks to and via the aquatic environment of discharges of the substance from a point source governed by the requirement for prior regulation referred to in Article 11(3) of Directive 2000/60/EC and legislation adopted under Article 16 thereof;
   c) the risks to human health arising from the use of a substance in a medical device regulated by Directives 90/385/EEC, 93/42/EEC or 98/79/EC.

6.   An application for an authorisation shall be accompanied by the fee as set by the Agency.

Article 69

Subsequent applications for authorisation

1.  If an application has been made for a use of a substance, a subsequent applicant may refer, by means of a letter of access granted by the previous applicant, to the parts of the previous application submitted in accordance with Article 68(4)(d), (e) and (f) .

2.  If an authorisation has been granted for a use of a substance, a subsequent applicant may refer, by means of a letter of access granted by the holder of the authorisation, to the parts of the holder's application submitted in accordance with Article 68(4)(d), (e) and (f) .

Article 70

Procedure for authorisation decisions

1.  The Agency shall acknowledge the date of receipt of the application. The Agency's Committees for Risk and Alternative Assessment and for Socio-economic Analysis shall give their draft opinions within ten months of the date of receipt of the application.

2.  The Agency shall make available on its web-site broad information on uses, taking confidentiality into account in accordance with Article 127 , for which applications have been received, with a deadline by which information on alternative substances or technologies may be submitted by interested third parties.

3.  In preparing its opinion, each Committee referred to in paragraph 1 shall first check that the application includes all the information specified in Article 68 that is relevant to its remit. If necessary, a Committee shall ask the applicant for additional information to bring the application into conformity with the requirements of Article 68 . Each Committee shall also take into account any information submitted by third parties, and may ask these third parties for further information, if required.

If either or both committees decide that additional information is needed on alternative substances or technologies, then they may commission a consultant or Member State authority to carry out a time-limited investigation into available alternatives. Such investigations shall be funded by the authorisation fee set by the Agency pursuant to Article 68(6).

4.  The draft opinions shall include the following elements:

   (a) Risk and Alternative Assessment Committee: a check on the assessment (carried out by the applicant for authorisation) of the risk to health and/or the environment arising from the use(s) of the substance as described in the application;
   (b) Socio-economic Analysis Committee: a check on the assessment (carried out by the applicant for authorisation) of the socio-economic factors associated with the use(s) of the substance as described in the application, when an application is made in accordance with Article 68(4)(e) and (f) .

5.  The Agency shall send these draft opinions to the applicant by the end of the deadline set out in paragraph 1. Within 1 month of receipt of the draft opinion, the applicant may provide written notice that he wishes to comment. The draft opinion shall be deemed to have been received 7 days after the Agency has sent it.

If the applicant does not wish to comment, the Agency shall send these opinions to the Commission, the Member States and the applicant, within 15 days of the end of the period within which the applicant may comment or within 15 days of receipt of notice from the applicant that he does not intend to comment.

If the applicant wishes to comment, he shall send his written argumentation to the Agency within 2 months of the receipt of the draft opinion. The Committees shall consider the comments and adopt their final opinions within 2 months of receipt of the written argumentation, taking this argumentation into account where appropriate. Within a further 15 days the Agency shall send the opinions, with the written argumentation attached, to the Commission, the Member States and the applicant.

6.  The Agency shall, at the same time as it communicates these to the applicant, make the non-confidential parts of its opinions and any attachments thereto publicly available on its website, in accordance with Article 127 .

7.  In cases covered by Article 69(1) , the Agency shall treat the applications together, provided the deadlines for the first application can be met.

8.  The Commission shall prepare a draft authorisation decision within 3 months of receipt of the opinions from the Agency. A final decision granting or refusing the authorisation shall be taken in accordance with the procedure referred to in Article 141(2) .

9.  Summaries of the Commission decisions, including the authorisation number, shall be published in the Official Journal of the European Union and shall be made publicly available in a database established and kept up to date by the Agency.

10.  In cases covered by Article 69(2) , the deadline set out in paragraph 1 of this Article shall be shortened to 5 months.

AUTHORISATIONS IN THE SUPPLY CHAIN

Article 71

Obligation of information on substances subject to authorisations

All substances, for use on their own, in preparations or in articles, that fulfil the conditions set out in Article 63 shall be labelled and accompanied, at all times, by a safety data sheet. The label shall include:

   a) the name of the substance;
   b) attestation that the substance is included in Annex XIII; and
   c) each specific use for which the substance has been authorised.

Article 72

Downstream Users

1.  Downstream users using a substance in accordance with Article 62(2) shall notify the Agency within 3 months of the first supply of the substance. They shall use only the format specified by the Agency in accordance with Article 119 .

2.  The Agency shall establish and keep up to date a register of downstream users who have made a notification in accordance with paragraph 1. The Agency shall grant access to this register to the competent authorities of the Member States.

GENERAL ISSUES

Article 73

General provisions

1.  A substance on its own, in a preparation or in an article, for which Annex XVI contains a restriction shall not be manufactured, placed on the market or used unless it complies with the conditions of that restriction. This shall not apply to the manufacture, placing on the market or use of a substance in scientific research and development, or product and process orientated research and development in the quantities required for the purposes of product and process orientated research and development .

2.  Paragraph 1 shall not apply to the use of substances which are waste and are treated in a waste treatment installation within the conditions of a permit under Directives 75/442/EEC or 91/689/EEC , without prejudice to Regulation (EC) No 850/2004 .

THE RESTRICTIONS PROCESS

Article 74

Introducing new and amending current restrictions

1.  When there is an unacceptable risk to the environment or human health, including that of vulnerable populations and citizens exposed early in life or continuously to mixtures of pollutants, arising from the manufacture, use or placing on the market of substances, which needs to be addressed on a Community-wide basis, Annex XVI shall be amended in accordance with the procedure referred to in Article 141(3) by adopting new restrictions, or amending current restrictions in Annex XVI, for the manufacture, use or placing on the market of substances on their own, in preparations or in articles, pursuant to the procedure set out in Articles 75 to 79 .

The first subparagraph shall not apply to the use of a substance as an on-site isolated intermediate.

2.  For substances which meet the criteria for classification as carcinogenic, mutagenic or toxic to reproduction, categories 1 and 2, and for which restrictions to consumer use are proposed by the Commission, Annex XVI shall be amended in accordance with the procedure referred to in Article 141(3) . Articles 75 to 79 shall not apply .

3.  Restrictions addressing only the risks to human health of the use of a substance in cosmetics products within the scope of Directive 76/768/EEC shall not be included in Annex XVI .

Article 75

Preparation of a proposal

1.  If the Commission considers that the manufacture, placing on the market or use of a substance on its own, in a preparation or in an article poses a risk to human health or the environment that is not adequately controlled and needs to be addressed at Community level, it shall ask the Agency to prepare a dossier which conforms to the requirements of Annex XIV. If this dossier demonstrates that action on a Community-wide basis is necessary, beyond any measures already in place, the Agency shall suggest restrictions, in order to initiate the restrictions process.

The Agency shall refer to any Member State dossier, chemical safety report or risk assessment submitted to it under this Regulation. It shall also refer to any relevant risk assessment submitted by third persons for the purposes of other Community Regulations or Directives. To this end other bodies, such as agencies, established under Community law and carrying out a similar task shall provide information to the Agency on request.

2.  If a Member State considers that the manufacture, placing on the market or use of a substance on its own, in a preparation or in an article poses a risk to human health or the environment that is not adequately controlled and needs to be addressed at Community level, it shall prepare a dossier which conforms to the requirements of Annex XIV. If this dossier demonstrates that action on a Community-wide basis is necessary, beyond any measures already in place, the Member State shall submit it to the Agency in the format outlined in Annex XIV, in order to initiate the restrictions process.

Member States shall refer to any dossier, chemical safety report or risk assessment submitted to the Agency under this Regulation. Member States shall also refer to any relevant risk assessment submitted for the purposes of other Community Regulations or Directives. To this end other bodies, such as agencies, established under Community law and carrying out a similar task shall provide information to the Member State concerned on request.

The Committee for Risk and Alternative Assessment and the Committee for Socio-economic Analysis shall check whether the dossier submitted conforms to the requirements of Annex XIV. Within 30 days of receipt, the Agency shall inform the Member State suggesting restrictions, as to whether the Committees find that the dossier conforms. If the dossier does not conform, the reasons shall be given to the Member State in writing within 45 days of receipt. The Member State shall bring the dossier into conformity within 30 days of the date of receipt of the reasons from the Agency, otherwise the procedure under this Chapter shall be terminated.

3.  The Agency shall announce immediately/without delay/post on its website that a Member State or the Commission intends to initiate a restrictions process, and shall inform those who are registering the substance concerned.

4.  The Agency shall make publicly available on its website all dossiers conforming with Annex XIV including the restrictions suggested pursuant to paragraphs 1 and 2 without delay, clearly indicating the date of publication. The Agency shall invite all interested parties to submit individually or jointly within 3 months of the date of publication:

   a) comments on dossiers and the suggested restrictions;
   b) a socio-economic analysis, or information which can contribute to one, of the suggested restrictions, examining the advantages and drawbacks of the proposed restrictions. It shall conform to the requirements in Annex XV.

Article 76

Agency opinion: Committee for Risk and Alternative Assessment

Within 9 months of the date of publication referred to in Article 75(4) , the Committee for Risk and Alternative Assessment shall formulate an opinion on the suggested restrictions based on its consideration of the relevant parts of the dossier. This opinion shall take account of the Member State dossier and the views of interested parties referred to in point (a) of Article 75(4) .

Article 77

Agency opinion: Committee for Socio -economic Analysis

1.  Within 12 months of the date of publication referred to in Article 75(4) , the Committee for Socio-economic Analysis shall formulate an opinion on the suggested restrictions, based on its consideration of the relevant parts of the dossier and the socio-economic impact. It shall prepare a draft opinion on the suggested restrictions and on the related socio-economic impact, taking account of the analyses or information according to point (b) of Article 75(4) , if there are any. The Agency shall publish the draft opinion on its website without delay. The Agency shall invite interested parties to give their comments on the draft opinion by a deadline set by the Agency.

2.  The Committee for Socio-economic Analysis shall without delay adopt its opinion, taking into account where appropriate further comments received by the deadline set. This opinion shall take account of the comments and socio-economic analyses of interested parties submitted under point (b) of Article 75(4) and under paragraph 1 of this Article .

3.  Where the opinion of the Committee for Risk and Alternative Assessment diverges significantly from the restrictions suggested by a Member State or the Commission, the Agency may postpone the deadline for the opinion of the Committee for Socio-economic Analysis by a maximum of 90 days.

Article 78

Submission of an opinion to the Commission

1.  The Agency shall submit to the Commission the opinions of the Committees for Risk and Alternative Assessment and for Socio-economic Analysis on restrictions suggested for substances on their own, in preparations or in articles. If one or both of the Committees do not formulate an opinion by the deadline set in Articles 76(1) and 77(1) the Agency shall inform the Commission accordingly, stating the reasons.

2.  The Agency shall publish the opinions of the two Committees on its website without delay.

3.  The Agency shall provide the Commission on request with all documents and evidence submitted to or considered by it.

Article 79

Commission decision

1.  If the conditions laid down in Article 74 are fulfilled, the Commission shall prepare a draft amendment to Annex XVI, within 3 months of receipt of the opinion of the Committee for Socio-economic Analysis or the end of the deadline established under Article 77  if that Committee does not form an opinion, whichever is the earlier.

Where the draft amendment is not in accordance with any of the opinions of the Agency, the Commission shall annex a detailed explanation of the reasons for the differences.

2.  A final decision shall be taken in accordance with the procedure referred to in Article 141(3) .

3.  Where a substance is already regulated in Annex XVI, and the conditions laid down in Article 74 are fulfilled, the Commission shall prepare a draft amendment to Annex XVI, within 3 months of receipt of the opinion of the Committee for Socio-economic Analysis or by the deadline established under Article 77 if that Committee does not form an opinion, whichever is the earlier.

Where the draft amendment is not in accordance with any of the opinions of the Agency, the Commission shall annex a detailed explanation of the reasons for the differences.

Where a substance has not been regulated before in Annex XVI, the Commission shall, within the time limit specified in the first subparagraph, submit a proposal to the European Parliament and the Council to amend Annex XVI.

AGENCY

Article 80

Establishment

A European Chemicals Agency is established. The host Member State shall facilitate and financially contribute to the setting up and running of the Agency.

Article 81

Mission of the Agency

The Agency shall be in charge of the overall management of the REACH process.

Article 82

International responsibilities

The Agency shall make every possible effort to promote the international acceptability of REACH standards, and shall also take full account of existing standards established by other international institutions provided it is convinced of those standards" capacity to safeguard the environment and health.

Article 83

Tasks

1.  The Agency shall provide the Member States and the institutions of the Community with the best possible scientific and technical advice on questions relating to chemicals which fall within its remit and which are referred to it in accordance with the provisions of this Regulation. In the cases covered by this Regulation, the Agency shall take legally binding decisions.

2.  The Agency shall, in particular through its committees :

   a) develop criteria for prioritising substances for evaluation and compile a list of priority substances for evaluation, pursuant to Title VI ;
   b) draw up opinions on applications for authorisation, pursuant to Title VII ;
   c) take part in the procedure for adopting restrictions in respect of certain dangerous substances and preparations by preparing dossiers and drawing up opinions, pursuant to Title VIII ;
   d) perform the tasks allotted to it under Title VI;
   e) draw up proposals with a view to harmonising classifications and labelling at Community level, pursuant to Title X ;
   f) at the request of the Commission, provide technical and scientific support for steps to improve cooperation between the Community, its Member States, international organisations and third countries on scientific and technical issues relating to the safety of substances, as well as active participation in technical assistance and capacity-building activities on sound management of chemicals in developing countries ;
   g) at the request of the Commission or the European Parliament, draw up an opinion on any other aspects concerning the safety of substances on their own, in preparations or in articles ;
   h) at the request of the Commission, draw up opinions relating to the revision of the criteria laid down in Articles 5, 6, 17 and 18 concerning the selection of substances for registration purposes with a view to including, inter alia, data relating to exposure risks and scenarios;
   i) provide advice to the Secretariat regarding its technical assistance and capacity building activities on sound management of chemicals and compliance with chemical safety standards in developing countries.

3.  The Agency shall, in particular through the Forum :

   a) spread good practice and highlight problems at Community level ;
   b) propose, coordinate and evaluate harmonised enforcement projects and joint inspections ;
   c) coordinate exchanges of inspectors ;
   d) identify enforcement strategies and minimum enforcement criteria, taking particular account of the specific problems for SMEs ;
   e) develop working methods and tools of use to local inspectors ;
   f) develop an electronic information-exchange procedure;
   g) liaise with industry and other stakeholders, including those in third countries and relevant international organisations as necessary;
   h) cooperate with the Commission and the Member States with a view to promoting voluntary agreements between industry and other interested parties.

4.  In addition, the Agency shall :

   a) perform the tasks allotted to it under Title II, including facilitating the efficient registration of imported substances, in a way consistent with the Community's international trading obligations towards third countries ;
   b) perform the tasks allotted to it as regards the sharing of data and preventing superfluous experiments from being carried out, pursuant to Title III ;
   c) perform the tasks allotted to it as regards information in the supply chain, pursuant to Title VI ;
   d) establish and maintain database(s) with information on all registered substances, the classification and labelling inventory and the harmonised classification and labelling list, make the information identified in Article 127(1) in the data base(s) publicly available within 15 working days, and make other information in the databases available on request in accordance with Article 126(3) ;
   e) make publicly available information as to which substances are being, and have been, evaluated within 15 working days of receipt of the information at the Agency, in accordance with Article 127(1) ;
   f) prepare detailed information for interested parties, including those in third countries, on the possibility of public participation, particularly as regards information on substances;
   g) provide technical and scientific guidance and tools, including a dedicated help-desk and a website for the operation of this Regulation, in particular in order to assist the development of chemical safety reports by industry and especially by SMEs ;
   h) provide technical and scientific guidance on the operation of this Regulation for Member State competent authorities and provide support to the competent authorities" help desks established under Title XII;
   i) prepare explanatory information on this Regulation for other stakeholders ;
   j) establish and maintain a centre of excellence for risk communication; provide centralised, coordinated resources in the area of information on the safe use of chemical substances, preparations and articles; facilitate the sharing of best practice in the risk communication sector;
   k) make information available based on the REACH data base for the use of authorised substances in articles;
   l) publish on its website, by ... (58) , a list of substances that have been identified as fulfilling the criteria referred to in Article 63 . This list shall be updated periodically;
   m) at the request of developing countries, grant them, on mutually agreed terms and conditions, technical assistance and capacity building activities on sound management of chemicals and compliance with chemical safety standards in order to meet requirements referred to in this Regulation;
   n) monitor technical assistance and capacity building activities by the Community and its Member States on sound management of chemicals and compliance with chemical safety standards in developing countries, and contribute to co-ordination between the Community, Member States and international organisations in the aforementioned area;
   o) promote, in cooperation with the Commission, mutual recognition between the European Union and third countries of the results of the tests carried out in application of and in conformity with this Regulation.

Article 84

Composition

1.  The Agency shall comprise:

   a) a Management Board, which shall exercise the responsibilities set out in Article 86 ;
   b) an Executive Director, who shall exercise the responsibilities set out in Article 90 ;
   c) a Committee for Risk and Alternative Assessment, which shall be responsible for preparing the opinion of the Agency on evaluations, applications for authorisation and proposals for restrictions, for evaluating the availability of alternatives and for any other questions that arise from the operation of this Regulation relating to risks to human health or the environment;
   d) a Committee for Socio-economic Analysis, which shall be responsible for preparing the opinion of the Agency on evaluations, applications for authorisation, proposals for restrictions, and any other questions that arise from the operation of the present Regulation including the socio-economic analysis of the effect of possible legislative action on substances;
   e) a Committee for Alternative Test Methods, which shall be responsible for developing and implementing an integrated strategy to speed up the development, validation and legal acceptance of non-animal test methods, and to ensure their use in intelligent stepwise risk assessment to meet the requirements of this Regulation. The Committee shall be responsible for allocating funding for alternative test methods provided through the registration fee. The Committee shall consist of experts from ECVAM, animal welfare organisations and other relevant stakeholders.

Every year the Committee shall produce a report to be presented by the Agency to the European Parliament and the Council on the progress made on the development, validation and legal acceptance of non-animal test methods, the use of such methods in intelligent stepwise risk assessment to meet the requirements of this Regulation, and the amount and distribution of funding for alternative test methods;

   f) a Member State Committee, which shall be responsible for resolving potential divergences of opinions between Member States on draft decisions proposed by the Agency under Title VI and preparing the opinion of the Agency on proposals for classification and labelling under Title X and proposals for identification of substances of very high concern to be subjected to the authorisation procedure under Title VII;
   g) a Forum for Exchange of Information on Enforcement, hereinafter "the Forum", which shall co-ordinate a network of Member States authorities responsible for enforcement of this Regulation;
   h) a Secretariat, which shall provide technical, scientific and administrative support for the Committees and the Forum and ensure appropriate co-ordination between them. It shall also undertake the work required of the Agency under the procedures for pre-registration, registration and evaluation as well as preparation of guidance, database maintenance and information provision;
   i) a Board of Appeal, which shall decide on appeals against decisions taken by the Agency.

2.  The Committees referred to in points (c), (d), (e) and (f) of paragraph 1, hereinafter "the Committees", and the Forum may each establish working groups. For this purpose they shall adopt, in accordance with their rules of procedure, precise arrangements for delegating certain tasks to these working groups.

3.  The Committees and the Forum may, if they consider it appropriate, seek advice on important questions of a general scientific or ethical nature from appropriate sources of expertise.

Article 85

Composition of the Management Board

1.  The Management Board shall be composed of nine representatives from Member States nominated by the Council, one representative nominated by the Commission and two representatives nominated by the European Parliament.

In addition, four representatives of interested parties (industry and consumer, worker and environmental protection organisations) shall be nominated by the Commission as members of the Management Board without voting rights.

The members of the Management Board shall be nominated in such a way as to ensure the highest levels of competence, a wide range of relevant specialist knowledge and (without prejudice to such characteristics) the broadest possible geographical distribution within the European Union.

2.  Members shall be appointed on the basis of their relevant experience and expertise in the field of chemicals safety or the regulation of chemicals.

3.  The duration of the term of office shall be four years. The term of office may be renewed once. However, for the first mandate, the Council and the European Parliament shall each identify half of their nominees for whom this period shall be six years.

4.  The list of interested party representatives drawn up by the Commission shall be forwarded to the European Parliament, together with the relevant backgound documents. Within three months of notification the European Parliament may submit its view for consideration to the Council, which shall then appoint the Management Board .

Article 86

Powers of the Management Board

The Management Board shall appoint the Executive Director pursuant to Article 91 and an accounting officer in accordance with Article 43 of Regulation (EC, Euratom) No 2343/2002.

It shall adopt:

   a) by 30 April each year, the general report of the Agency for the previous year and forward it by 15 June at the latest to the Member States, the European Parliament, the Council, the Commission, the European Economic and Social Committee and the Court of Auditors;
   b) by 31 October each year the work programme of the Agency for the coming year and forward it to the Member States, the European Parliament, the Council and the Commission;
   c) the final budget of the Agency before the beginning of the financial year, adjusting it, where necessary, according to the Community contribution and any other revenue of the Agency;
   d) the fee structure of the Agency in a transparent way;
   e) a multiannual programme for substance evaluations.

It shall establish and adopt the internal rules and procedures of the Agency.

It shall perform its duties in relation to the Agency's budget pursuant to Articles 104, 105 and 112 .

It shall exercise disciplinary authority over the Executive Director.

It shall establish its rules of procedure.

It shall appoint the Chairman, the members and alternates of the Board of Appeal.

It shall forward annually to the budgetary authority any information relevant to the outcome of the evaluation procedures.

Article 87

Chairmanship of the Management Board

1.  The Management Board shall elect a Chairman and a Deputy-Chairman from among its members. The Deputy-Chairman shall automatically take the place of the Chairman if he is prevented from attending to his duties.

2.  The terms of the office of the Chairman and the Deputy-Chairman shall be two years and shall expire when they cease to be members of the Management Board. The term of office shall be renewable once.

3.  The elected Chairman shall introduce himself to the European Parliament.

Article 88

Meetings

1.  The Management Board shall meet when convened by the Chairman or at the request of at least one-third of its members .

2.  The Executive Director shall take part in the meetings of the Management Board, without voting rights.

3.  The Management Board may invite the Chairmen of the Committees or the Chairman of the Forum, as referred to in Article 84(1)(c) to (g) , to attend its meetings without voting rights.

Article 89

Voting

The Management Board shall establish rules of procedure for voting, including the conditions for a member to vote on behalf of another member. Unless otherwise provided, the Management Board shall act by a majority of its members with the right to vote.

Article 90

Duties and powers of the Executive Director

1.  The Agency shall be managed by its Executive Director.

2.  The Executive Director shall be the legal representative of the Agency. He shall be responsible for:

   a) the day-to-day administration of the Agency;
   b) managing all the Agency resources necessary for carrying out its tasks;
   c) ensuring that the time-limits laid down in Community legislation for the adoption of opinions by the Agency are complied with;
   d) ensuring appropriate and timely co-ordination between the Committees and the Forum;
   e) concluding and managing necessary contracts with service providers and the bodies referred to in Article 94 ;
   f) the preparation of the statement of revenue and expenditure and the execution of the budget of the Agency;
   g) all staff matters;
   h) providing the secretariat for the Management Board;
   i) preparing draft opinions of the Management Board concerning the proposed rules of procedure of the Committees and of the Forum;
   j) making arrangements for the execution of any further function(s) allotted to the Agency by delegation from the Commission;
   k) adopting the draft and definitive rolling plans of evaluation of substances and their updates pursuant to Title VI, if there are no proposals for amendments;
   l) establishing and maintaining contact with the European Parliament and ensuring that a regular dialogue is held with that body's relevant committees.

3.  Each year, the Executive Director shall submit the following to the Management Board for approval:

   a) a draft report covering the activities of the Agency in the previous year, including information about the number of registration dossiers received, the number of substances evaluated, the number of applications for authorisation received, the number of proposals for restriction received by the Agency and opined upon, the time taken for completion of the associated procedures, and the substances authorised, dossiers rejected, substances restricted; complaints received and the action taken; the technical assistance and capacity building activities carried out in developing countries; an overview of the activities of the Forum;
   b) a draft programme of work for the coming year;
   c) the draft annual accounts;
   d) the draft forecast budget for the coming year.

4.  Once the general report and the programmes have been adopted by the Management Board, the Executive Director shall forward them to the European Parliament, the Council, the Commission and the Member States, and shall arrange for them to be published.

Article 91

Appointment of the Executive Director

1.  The Executive Director of the Agency shall be appointed by the Management Board from among a list of candidates proposed by the Commission following a public-selection procedure advertised by means of a call for expressions of interest published in the Official Journal of the European Union and in other periodicals or on Internet sites. Prior to nomination the candidate designated by the Management Board shall be asked as soon as possible to make a statement before the European Parliament and to answer questions from Parliament's Members.

The Executive Director shall be nominated on the grounds of merit and documented administrative and management skills, as well as his relevant experience in the fields of chemical safety or regulation. The Management Board shall take its decision by a two-thirds majority of all members with a right to vote.

Power to dismiss the Executive Director shall lie with the Management Board, in accordance with the same procedure.

2.  The term of the office of the Executive Director shall be 5 years. It may be prolonged by the Management Board once for another period of up to 5 years.

Article 92

Establishment of the Committees

1.  Each Member State shall appoint one member to the Risk and Alternative Assessment Committee. Members shall be appointed for their role and experience in the regulation of chemicals and/or for their technical and scientific expertise in reviewing risk assessments of substances.

2.  Each Member State shall appoint one member to the Socio-economic Analysis Committee. Members shall be appointed for their role and experience in the regulation of chemicals and/or for their expertise in socio-economic analysis.

3.  Each Member State shall appoint one member to the Member State Committee. The chairman of the Member State Committee shall be an employee of the Agency, nominated by the Executive Director.

4.  The Committees should aim to have a broad range of relevant expertise among their members. To this end the Committees may co-opt a maximum of five additional members chosen on the basis of their specific competence.

Members of the Committees shall be appointed for a term of three years which shall be renewable.

The members of each Committee may be accompanied by advisers on scientific, technical or regulatory matters.

The Executive Director or his representative and representatives of the Commission shall be entitled to attend all the meetings of the Committees and working groups convened by the Agency or its committees. Stakeholders may also attend meetings as observers .

5.  The members of each Committee shall ensure that there is appropriate co-ordination between the tasks of the Agency and the work of their Member State competent authority.

6.  The members of the Committees shall be supported by the scientific and technical resources available to the Member States. To this end, Member States shall provide adequate scientific and technical resources to the members of the Committees that they have nominated. Each Member State competent authority shall facilitate the activities of the Committees and their working groups .

7.  When preparing an opinion, each Committee shall use its best endeavours to reach a consensus. If such a consensus cannot be reached, the opinion shall consist of the position of the majority of members and the minority position(s), with their grounds.

8 .  Each Committee shall establish its own rules of procedure.

These rules shall in particular lay down the procedures for appointing and replacing the Chairman, replacing members, the procedures for delegating certain tasks to working groups, the creation of working groups and the establishment of a procedure for the urgent adoption of opinions .

These rules shall enter into force after receiving a favourable opinion from the Commission and the Management Board.

Article 93

Establishment of the Forum

1.  Each Member State shall appoint, for a three-year term, which shall be renewable, one member to the Forum. Members shall be chosen for their role and experience in enforcement of chemicals legislation and shall maintain relevant contacts with the Member State competent authorities.

The Forum should aim to have a broad range of relevant expertise among its members. To this end the Forum may co-opt a maximum of five additional members chosen on the basis of their specific competence. These members shall be appointed for a term of three years, which shall be renewable.

The members of the Forum may be accompanied by scientific and technical advisers.

The Executive Director of the Agency or his representative and representatives of the Commission shall be entitled to attend all the meetings of the Forum and its working groups. Stakeholders may also attend meetings as observers .

Members of the Forum may not be members of the Management Board.

2.  The members of the Forum appointed by a Member State shall ensure that there is appropriate co-ordination between the tasks of the Forum and the work of their Member State competent authority.

3.  The members of the Forum shall be supported by the scientific and technical resources available to the competent authorities of the Member States. Each Member State competent authority shall facilitate the activities of the Forum and its working groups .

4.  The Forum shall establish its own rules of procedure.

These rules shall in particular lay down the procedures for appointing and replacing the Chairman, replacing members and the procedures for delegating certain tasks to working groups.

These rules shall enter into force after receiving a favourable opinion from the Commission and the Management Board.

Article 94

Rapporteurs of Committees and use of experts

1.  Where, in accordance with Article 83 , a Committee is required to provide an opinion or consider whether a Member State dossier conforms with the requirements of Annex XIV, it shall appoint one of its members as a rapporteur. The Committee concerned may appoint a second member to act as co-rapporteur. A member of a Committee shall not be appointed rapporteur for a particular case if he indicates any interest that might be prejudicial to the independent consideration of that case. The Committee concerned may replace the rapporteur or co-rapporteur by another one of its members at any time, if, for example, they are unable to fulfil their duties within the prescribed time limits, or if a potentially prejudicial interest comes to light.

2.  Member States shall transmit to the Agency the names of independent experts with proven experience in reviewing chemical risk assessments and/or socio-economic analyses or other relevant scientific expertise, who would be available to serve on working groups of the Committees, together with an indication of their qualifications and specific areas of expertise.

The Agency shall keep an up-to-date list of experts. The list shall include the experts referred to in the first subparagraph and other experts identified directly by the Secretariat.

3.  On a proposal from the Executive Director, the Management Board shall draw up and make public a list of the competent bodies appointed by the Member States which, either individually, or as part of a network, may assist the Agency in the performance of its tasks, in particular those conferred on it by Title VI. The Agency may confer certain tasks on these bodies, in particular the evaluation of testing proposals, dossiers and substances.

4.  The provision of services by Member State bodies on the public list referred to in paragraph 3, Committee members or any expert serving on a working group of the Committees or Forum, or performing any other task for the Agency, shall be governed by a written contract between the Agency and the body concerned, the Agency and the person concerned, or where appropriate between the Agency and the employer of the person concerned.

The body or the person concerned, or his employer, shall be remunerated in accordance with a scale of fees to be included in the financial arrangements established by the Management Board. Where the body or person concerned fails to fulfil his duties, the Executive Director has the right to terminate or suspend the contract or withhold remuneration.

5.  The performance of services for which there are several potential providers may result in a call for an expression of interest, if the scientific and technical context allows, and if it is compatible with the duties of the Agency, in particular the need to provide a high level of protection of human health and the environment.

The Management Board shall adopt the appropriate procedures on a proposal from the Executive Director.

6.  The Agency may use the services of experts for the discharge of other specific tasks for which it is responsible.

Article 95

Independence

1.  The membership of the Committees and of the Forum shall be made public. When each appointment is published, the professional qualifications of each member shall be specified.

2.  Members of the Management Board, the Executive Director, members of the Committees, members of the Forum, members of the Board of Appeal, experts and scientific and technical advisers shall not have economic or other interests in the chemical sector which may prejudice their impartiality. They shall undertake to act independently and in the public interest and shall each year make a declaration of their financial interests. Any indirect interests relating to the chemical industry shall be declared in a register held by the Agency and accessible to the public on request at the Agency's offices .

Member States shall refrain from giving the members of the Risk and Alternative Assessment Committee, of the Socio-economic Analysis Committee, of the Forum or of the Board of Appeal, or their scientific and technical advisers and experts, any instruction which is incompatible with the individual tasks of those persons or with the tasks, responsibilities and independence of the Agency.

The Agency's code of practice shall specify measures relating to the application of this article.

3.  At each of their meetings, members of the Management Board, the Executive Director, members of the Committees, the members of the Forum and any experts and scientific and technical advisers participating in the meeting shall declare any interests which could be considered to be prejudicial to their independence with respect to any points on the agenda. Anyone declaring such interests shall participate neither in the discussion of the relevant agenda points nor in any voting thereupon. Such declarations shall be made publicly accessible.

Article 96

Establishment of the Board of Appeal

1.  The Board of Appeal shall consist of a Chairman and two other members.

2.  The Chairman and the two members shall have alternates who shall represent them in their absence.

3.  The Chairman, the other members and the alternates shall be appointed by the Management Board from among a list of qualified candidates proposed by the Commission following a public-selection procedure advertised by means of a call for expressions of interest published in the Official Journal of the European Union and in other periodicals or on Internet sites. The members of the Board of Appeal shall be selected on the basis of their relevant experience and expertise in the field of chemical safety, natural sciences or regulatory and judicial procedures .

4.  The qualifications required for the members of the Board of Appeal shall be determined by the Commission in accordance with the procedure referred to in Article 141(2) .

5.  The Chairman and the members shall have equal voting rights.

Article 97

Members of the Board of Appeal

1.  The term of office of the members of the Board of Appeal, including the Chairman and the alternates shall be 5 years. It may be prolonged once .

2.  The members of the Board of Appeal may not perform any other duties in the Agency .

3.  The members of the Board of Appeal may not be removed either from office or from the list during their respective terms, unless there are serious grounds for such removal and the Commission, after obtaining the opinion of the Management Board, takes a decision to this effect.

4.  Members of the Board of Appeal may not take part in any appeal proceedings if they have any personal interest therein, or if they have previously been involved as representatives of one of the parties to the proceedings, or if they participated in the decision under appeal.

5.  If a member of the Board of Appeal considers for reasons mentioned in paragraph 4 that he must not take part in any appeal proceedings, he shall inform the Board of Appeal accordingly. Members of the Board may be objected to by any party to the appeal proceedings on any of the grounds mentioned in paragraph 4 , or if suspected of partiality. No objection may be based on the nationality of members.

6.  The Board of Appeal shall decide as to the action to be taken in the cases specified in paragraphs 4 and 5 without the participation of the member concerned. For the purposes of taking this decision, the member concerned shall be replaced on the Board of Appeal by an alternate.

Article 98

Decisions subject to appeal

1.  An appeal may be brought against decisions of the Agency or the Commission taken pursuant to Article 10, Article 20 , the second subparagraph of Article 26(1), Article 28(5) and (8) , Article 32(6) , Article 57, Article 66, Article 126(5) or Article 127 .

2.  An appeal lodged pursuant to paragraph 1 shall have suspensive effect.

Article 99

Persons entitled to appeal, time-limits and form

1.  Any natural or legal person may appeal against a decision addressed to that person.

2.  The appeal, together with the statements of the grounds thereof, shall be filed in writing to the Agency within 1 month of the notification of the decision to the person concerned, or in the absence thereof, of the day on which it became known to the latter, unless otherwise provided in this Regulation.

Article 100

Examination and decisions on appeal

1.  The Board of Appeal shall examine whether the appeal is well-founded within 30 days of the appeal being filed in accordance with Article 99(2) . Parties to the appeal proceedings shall be entitled to make oral presentation during this procedure.

2.  The Board of Appeal may exercise any power which lies within the competence of the Agency.

Article 101

Actions before the Court of Justice of the European Communities

1.  An action may be brought before the Court of Justice of the European Communities, in accordance with Article 230 of the Treaty, contesting a decision taken by the Board of Appeal or, in cases where no right of appeal lies before the Board, by the Agency.

2.  Should the Agency fail to take a decision, proceedings for failure to act may be brought before the Court of Justice of the European Communities in accordance with Article 232 of the Treaty.

3.  The Agency shall be required to take the necessary measures to comply with the judgment of the Court of Justice of the European Communities.

Article 102

Complaints to the Ombudsman

Any citizen of the Union or any natural or legal person residing or having its registered office in a Member State shall have the right to submit to the Ombudsman complaints concerning alleged instances of maladministration in the activities of the Agency in accordance with Article 195 of the Treaty.

Article 103

Conflicts of opinion with other bodies

1.  The Agency shall take care to ensure early identification of potential sources of conflict between its opinions and those of other bodies established under Community law, including Community Agencies, such as the European Food Safety Authority and the European Medicines Agency , and Scientific Committees, such as the Scientific Committee for Toxicology, Ecotoxicology and the Environment (CSTEE), and the Scientific Committee on Cosmetic Products and Non-food Products intended for the Consumer (SCCNFP), carrying out a similar task in relation to issues of common concern.

2.  Where the Agency identifies a potential source of conflict, it shall contact the body concerned in order to ensure that any relevant scientific or technical information is shared and to identify the scientific or technical points which are potentially contentious.

3.  Where there is a fundamental conflict over scientific or technical points and the body concerned is a Community Agency or a scientific committee, the Agency and the body concerned shall work together either to solve the conflict or to submit a joint document to the Commission clarifying the scientific and/or technical points of conflict.

Article 104

The budget of the Agency

1.  The revenues of the Agency shall consist of:

   a) a subsidy from the Community, entered in the general budget of the European Communities (Commission Section);
   b) the fees paid by undertakings;
   c) any voluntary contribution from the Member States.

2.  The expenditure of the Agency shall include the staff, administrative, infrastructure and operational expenses.

3.  By 15 February of each year at the latest, the Executive Director shall draw up a preliminary draft budget covering the operational expenditure and the programme of work anticipated for the following financial year, and shall forward this preliminary draft to the Management Board together with an establishment plan.

4.  Revenue and expenditure shall be in balance.

5.  Each year the Management Board, on the basis of a draft drawn up by the Executive Director, shall produce an estimate of revenue and expenditure for the Agency for the following financial year. This estimate, which shall include a draft establishment plan, shall be forwarded by the Management Board to the Commission by 31 March at the latest.

6.  The estimate shall be forwarded by the Commission to the European Parliament and the Council, hereinafter "the budgetary authority", together with the preliminary draft budget of the European Communities.

7.  On the basis of the estimate, the Commission shall enter in the preliminary draft budget of the European Communities the estimates it considers necessary for the establishment plan and the amount of the subsidy to be charged to the general budget, which it shall place before the budgetary authority in accordance with Article 272 of the Treaty.

8.  The budgetary authority shall authorise the appropriations for the subsidy to the Agency.

The budgetary authority shall adopt the establishment plan for the Agency.

9.  The budget of the Agency shall be adopted by the Management Board. It shall become final following final adoption of the general budget of the European Communities. Where appropriate, it shall be adjusted accordingly.

10.  Any modification to the budget, including the establishment plan, shall follow the procedure referred to in paragraph 5.

11.  The Management Board shall, as soon as possible, notify the budgetary authority of its intention to implement any project which may have significant financial implications for the funding of its budget, in particular any projects relating to property such as the rental or purchase of buildings. It shall inform the Commission thereof.

Where a branch of the budgetary authority has notified its intention to deliver an opinion, it shall forward its opinion to the Management Board within a period of 6 weeks from the date of notification of the project.

Article 105

Implementation of the Agency's budget

1.  The Executive Director shall perform the duties of the authorising officer and shall implement the Agency's budget.

2.  Monitoring of the commitment and payment of all the Agency's expenditure and of the establishment and recovery of all the Agency's revenue shall be carried out by the Accounting Officer of the Agency.

3.  By 1 March at the latest following each financial year, the Agency's accounting officer shall communicate the provisional accounts to the Commission's accounting officer together with a report on the budgetary and financial management for that financial year. The Commission's accounting officer shall consolidate the provisional accounts of the institutions and decentralised bodies in accordance with Article 128 of Regulation (EC, Euratom) No 1605/2002 .

4.  By 31 March at the latest following each financial year, the Commission's accounting officer shall forward the Agency's provisional accounts to the Court of Auditors, together with a report on the budgetary and financial management for that financial year. The report on the budgetary and financial management for that financial year shall also be forwarded to the European Parliament and the Council.

5.  On receipt of the Court of Auditors' observations on the Agency's provisional accounts, pursuant to Article 129 of Regulation (EC, Euratom) No 1605/2002, the Executive Director shall draw up the Agency's final accounts under his own responsibility and forward them to the Management Board for an opinion.

6.  The Management Board shall deliver an opinion on the Agency's final accounts.

7.  By 1 July of the following year at the latest, the Executive Director shall send the final accounts, together with the opinion of the Management Board, to the European Parliament, the Council, the Commission and the Court of Auditors.

8.  The final accounts shall be published.

9.  The Executive Director shall send the Court of Auditors a reply to its observations by 30 September at the latest. He shall also send this reply to the Management Board.

10.  The European Parliament, upon a recommendation from the Council, shall, before 30 April of year N + 2, give a discharge to the Executive Director in respect of the implementation of the budget for year N.

Article 106

Fees

The structure and amount of the fees referred to in Article 104(1)(b) shall be set by the Management Board and shall be made public.

Part of the fee shall be allocated to the development of non-animal test methods.

Article 107

Combating fraud

1.  In order to combat fraud, corruption and other unlawful activities, the provisions of Regulation (EC) No 1073/1999 of the European Parliament and of the Council(59) shall apply without restrictions to the Agency.

2.  The Agency shall be bound by Interinstitutional Agreement 1999/1074/Euratom(60) concerning internal investigations by the European Anti-Fraud Office (Olaf) and shall issue, without delay, the appropriate provisions applicable to all of its staff.

3.  The decisions concerning funding and the implementing agreements and instruments resulting from them shall explicitly stipulate that the Court of Auditors and Olaf may carry out, if necessary, on-the-spot checks of the recipients of the Agency's funding and the agents responsible for allocating it.

Article 108

Financial regulation

The financial rules applicable to the Agency shall be adopted by the Management Board after the Commission has been consulted. They may not depart from Regulation (EC, Euratom) No 2343/2002 unless specifically necessary for the Agency's operation and with the Commission's prior consent. The budgetary authority shall approve such derogations.

Article 109

Legal personality and seat of the Agency

1.  The Agency shall be a body of the Community and shall have legal personality. In each Member State it shall enjoy the most extensive legal capacity accorded to legal persons under their laws. In particular it may acquire and dispose of movable and immovable property and may be a party to legal proceedings.

2.  The Agency shall be represented by its Executive Director.

3.  The Agency shall be located at Helsinki, Finland.

Article 110

Liability of the Agency

1.  The contractual liability of the Agency shall be governed by the law applicable to the contract in question. The Court of Justice of the European Communities shall have jurisdiction pursuant to any arbitration clause contained in a contract concluded by the Agency.

2.  In the case of non-contractual liability, the Agency shall, in accordance with the general principles common to the laws of the Member States, make good any damage caused by it or by its servants in the performance of their duties.

The Court of Justice of the European Communities shall have jurisdiction in any dispute relating to compensation for such damages.

3.  The personal financial and disciplinary liability of its servants towards the Agency shall be governed by the relevant rules applying to the staff of the Agency.

Article 111

Privileges and immunities of the Agency

The Protocol on the Privileges and Immunities of the European Communities shall apply to the Agency.

Article 112

Staff rules and regulations

1.  The staff of the Agency shall be subject to the Staff Regulations of Officials of the European Communities and the Conditions of employment of other servants of the European Communities laid down by Council Regulation (EEC, Euratom, ECSC) No 259/68 (61) . In respect of its staff, the Agency shall exercise the powers which have been devolved to the appointing authority.

2.  The Management Board shall, in agreement with the Commission, adopt the necessary implementing provisions.

3.  The Agency's staff shall consist of officials assigned or seconded by the Commission or Member States on a temporary basis and of other servants recruited by the Agency as necessary to carry out its tasks.

Article 113

Duty of confidentiality

Members of the Management Board, members of the Committees and of the Forum, experts and officials and other servants of the Agency, shall be required, even after their duties have ceased, not to disclose information of the kind covered by the duty of professional secrecy.

Article 114

Participation of third countries

The Management Board may, in agreement with the relevant Committee or the Forum, invite representatives of third countries to participate in the work of the Agency. The conditions for participation shall be determined beforehand by the Commission.

Article 115

International harmonisation of regulations

The Management Board may, in agreement with the relevant Committee or the Forum, invite representatives of international organisations with interests in the field of chemicals regulation to participate as observers in the work of the Agency. The conditions for participation shall be determined beforehand by the Commission.

Article 116

Contacts with stakeholder organisations

The Management Board shall, in agreement with the Commission, develop appropriate contacts between the Agency and the representatives of industry and workers and of consumer protection, environmental protection and animal protection organisations. These contacts may include the participation of observers in certain aspects of the Agency's work, under conditions determined beforehand by the Management Board, in agreement with the Commission.

Article 117

Rules on transparency

To ensure maximum transparency, the Management Board shall, on the basis of a proposal by the Executive Director and in agreement with the Commission, adopt rules and set up a registry to ensure the availability to the public of regulatory, scientific or technical information concerning the safety of chemicals, pursuant to Regulation (EC) No 1049/2001.

The internal rules of procedure of the Agency and of the Committees and working groups thereof shall be made available to the public via the Agency and on the Internet.

The applications for authorisation submitted, the stage reached in the procedure, interim decisions, authorisations and any other condition or restriction imposed shall be published on the Internet in a comprehensible form.

Article 118

Relations with relevant Community Bodies

1.  The Agency shall co-operate with other Community bodies to ensure mutual support in the accomplishment of their respective tasks in particular to avoid duplication of work.

2.  The Executive Director, having consulted the Committee for Risk and Alternative Assessment and the European Food Safety Authority, shall establish rules of procedure concerning substances used in plant protection products. These rules of procedure shall be adopted by the Management Board, in agreement with the Commission.

This Title shall not otherwise affect the competences vested in the European Food Safety Authority.

3.  This Title shall not affect the competences vested in the European Medicines Agency .

4.  The Executive Director, having consulted the Committee for Risk and Alternative Assessment, the Committee for Socio-economic Analysis and the Advisory Committee on Safety, Hygiene and Health Protection at Work, shall establish rules of procedure concerning worker protection issues. These rules of procedure shall be adopted by the Management Board, in agreement with the Commission.

This Title shall not affect the competences vested in the Advisory Committee on Safety, Hygiene and Health Protection at Work.

Article 119

Formats and software for submission of information to the Agency

The Agency shall specify special formats and make them available free of charge, and software packages and make them available on its website for any submissions to the Agency by Member States, manufactures, importers or downstream users.

CLASSIFICATION AND LABELLING INVENTORY

Article 120

Obligation to notify the Agency

1.  Any importer or manufacturer, or group of importers or manufacturers, who place on the market a substance which meets the criteria for classification as a dangerous substance in accordance with Directive 67/548/EEC, on its own, or in a preparation above the concentration limits specified in Directive 1999/45/EC which results in the classification of the preparation as dangerous , shall notify to the Agency the following information in order for it to be included in the inventory in accordance with Article 121 , unless submitted as part of the registration:

   a) the identity of the manufacturer or importer responsible for placing the substance(s) on the market;
   b) the identity of the substance(s) as specified in part 2 of Annex IV;
   c) the hazard classification of the substance(s), resulting from the application of Articles 4 and 6 of Directive 67/548/EEC;
   d) the resulting hazard label for the substance(s), resulting from application of Articles 23, 24 and 25 of Directive 67/548/EEC;
   e) specific concentration limits, where applicable, resulting from the application of Article 4(4) of Directive 67/548/EEC and Articles 4 to 7 of Directive 1999/45/EC.

2.  In submitting this information, the manufacturer or importer shall use the format specified pursuant to Article 119 .

3.  Where the obligation under paragraph 1 results in different entries on the inventory for the same substance, the Agency shall establish the entry to be included in the inventory.

4.  The information listed in paragraph 1 shall be updated by the notifier(s) whenever:

   a) any new scientific or technical information is generated which results in a change to the classification and labelling of the substance;
   b) notifiers and registrants of differing entries for a single substance come to an agreed entry in accordance with paragraph 3.

Article 121

The classification and labelling inventory

1.  A classification and labelling inventory, listing the information referred to in Article 120(1) , both for information notified under Article 120(1) as well as for information submitted as part of a registration, shall be established and maintained by the Agency in the form of a database. The non-confidential information in this database identified in Article 127(1) shall be publicly accessible. The Agency shall grant access to the other data on each substance in the inventory to the notifiers and registrants who have submitted information on that substance.

The Agency shall update the inventory when it receives updated information in accordance with Article 120(4) .

2.  In addition to the information referred to in paragraph 1, the Agency shall record the following information, where appropriate, against each entry:

   a) whether, in respect of the entry, there is a harmonised classification and labelling at Community level by inclusion in Annex I of Directive 67/548/EEC;
   b) whether it is an agreed entry of two or more notifiers or registrants;
   c) the relevant registration number(s), if available.

Article 122

Harmonisation of classification and labelling

1.  Harmonised classification and labelling at Community level shall, from the entry into force of this Regulation, only be added to Annex I of Directive 67/548/EEC for classification of a substance as carcinogenic, mutagenic or toxic for reproduction categories 1, 2 or 3, or as a respiratory sensitiser. To this end:

   (a) Member State competent authorities may submit proposals to the Agency for harmonised classification and labelling in accordance with Annex XIV;
   b) the Agency may prepare harmonised classification and labelling proposals, in accordance with Annex XIV.

2.  The Member State Committee shall formulate an opinion on the proposal, giving parties concerned the opportunity to comment. The Agency shall forward this opinion and any comments to the Commission, which shall take a decision in accordance with Article 4(3) of Directive 67/548/EEC.

Article 123

Transitional arrangements

The obligations set out in Article 120 shall apply from the deadline established under Article 23(1) .

INFORMATION

Article 124

Reporting

1.  Every five years , Member States shall submit to the Commission a report on the operation of this Regulation in their respective territories, including sections on evaluation and enforcement in the format specified by the Agency in accordance with Article 119 .

However, the first report shall be submitted by ... (62) .

The report shall record the experience acquired as regards application of the Regulation. It shall contain, inter alia, information on monitoring and checking measures carried out, any infringements established and the penalties imposed.

2.  Every five years , the Agency shall submit to the Commission a report on the operation of this Regulation.

The first report shall be submitted by … (63) *.

3.  Every five years , the Commission shall publish and forward to the European Parliament and to the Council a general report on the experience acquired with the operation of this Regulation, including the information referred to in paragraphs 1 and 2.

However, the first report shall be published by … (64) **.

Article 125

Special provisions for information to the general public

1.  In order to help consumers to make safe and sustainable use of substances and preparations, manufacturers shall make available risk-based information, via an on-pack label on each unit placed on the market for sale to the consumer, that identifies risks associated with recommended use or foreseeable misuse situations. Furthermore, on-pack labelling shall be complemented, when appropriate, by the use of other channels of communication, such as websites, for the provision of more detailed safety and use information in relation to the substance or preparation.

2.  Directives 1999/45/EC and 67/548/EEC shall be amended accordingly.

Article 126

Access to information

1.  Access to information submitted in accordance with this Regulation shall be granted for documents held by the Agency in accordance with Regulation (EC) No 1049/2001. The Agency shall publish such information on its website and shall make it available on request, in accordance with Article 83(4)(d) .

2.  This information shall be made available in each of the official languages of the European Union.

3.  Whenever a request for access to documents, not including the information referred to in Article 127(1), for which the applicant has requested confidentiality is made under Regulation (EC) No 1049/2001 to the Agency, the Agency shall perform the consultation of the third party provided for in Article 4(4) of Regulation (EC) No 1049/2001 in accordance with the second and third subparagraphs.

The Agency shall inform the registrant and, where appropriate, the potential registrant, downstream user or other party concerned of this request .

The Agency shall inform the applicant, as well as the registrant, the potential registrant, the downstream user or other party concerned of its decision with regard to the application for access to the documents. Any of these may, in accordance with Articles 98, 99 and 100 , appeal to the Board of Appeal against that decision within 15 days of the decision. Such an appeal shall have suspensive effect. The Board of Appeal shall decide on the appeal within 30 days.

4.  Access to non-confidential information submitted in accordance with this Regulation shall be granted for documents held by competent authorities of the Member States in accordance with Directive 2003/4/EC . Member States shall ensure that a system is established under which any party concerned may appeal with suspensive effect against decisions taken in relation to access to documents.

5.  While an appeal is pending or while an appeal may yet be introduced, the Agency and any competent authority of a Member State shall continue to keep the information in question confidential.

6.  The Agency and any competent authority of a Member State shall apply Article 127 of this Regulation when taking a decision under Article 4 of Regulation (EC) No 1049/2001 and Article 4 of Directive 2003/4/EC, respectively. However, where Member States have received information through the Agency, the Agency shall take the decision whether to grant or refuse access in accordance with Article 4(4) and (5) of Regulation (EC) No 1049/2001.

7.  Any total or partial refusal by the Agency of access to documents under Article 8 of Regulation (EC) No 1049/2001 may be appealed by means of a complaint to the Ombudsman or to the Board of Appeal in accordance with Articles 98, 99 and 100 .

8.  The Management Board shall adopt the arrangements for implementing Regulation (EC) No 1049/2001 not later than ... (65) .

Article 127

Confidentiality

1.  The following information shall not be considered as confidential :

   a) the name in the IUPAC Nomenclature, for dangerous substances within the meaning of Directive 67/548/EEC ;
   b) if applicable, the name of the substance as given in Einecs;
   c) physicochemical data concerning the substance and on pathways and environmental fate;
   d) the result of each toxicological and ecotoxicological study;
   e) any derived no-effect level (Dnel) or predicted no-effect concentration (Pnec) established in accordance with Annex I;
   f) if essential to classification and labelling, the degree of purity of the substance and the identity of impurities and/or additives which are known to be dangerous;
   g) the guidance on safe use provided in accordance with section 4 of Annex IV;
   h) the information contained in the safety data sheet, except for the name of the company/undertaking or where the information is considered confidential by application of paragraph 2;
   i) analytical methods if requested in accordance with Annex VII or VIII which make it possible to detect a dangerous substance when discharged into the environment as well as to determine the direct exposure of humans;
   j) the fact that testing on vertebrate animals has been carried out.

2.  The following information shall be considered as confidential:

   a) details of the full composition of a preparation;
   b) the precise use, function or application of a substance or preparation ;
   c) links between a manufacturer or importer and his downstream users, in both directions of the supply chain and including all actors involved in it.

In exceptional cases, where there are immediate risks to human health, safety or the environment, such as emergency situations, the Agency may disclose the information referred to in this paragraph.

3.  All other information shall be accessible in accordance with Article 126 .

Article 128

Cooperation with third countries and international organisations

Notwithstanding Articles 126 and 127 , information received by the Agency under this Regulation may be disclosed to any government or body of a third country or an international organisation in accordance with an agreement concluded between the Community and the third party concerned under Regulation (EC) No 304/2003 of the European Parliament and of the Council(66) or under Article 181a (3) of the Treaty, provided that both the following conditions are met:

   a) the purpose of the agreement is cooperation on the implementation or management of legislation concerning chemicals covered by this Regulation;
   b) the third party protects the confidential information as mutually agreed.

COMPETENT AUTHORITIES

Article 129

Appointment

Member States shall appoint the competent authority or competent authorities responsible for performing the tasks allotted to competent authorities under this Regulation and for co-operating with the Commission and the Agency in the implementation of this Regulation. Member States shall place adequate resources at the disposal of the competent authorities to enable them to fulfil their tasks under this Regulation in a timely manner.

Article 130

Co-operation between competent authorities

The competent authorities shall co-operate with each other in the performance of their tasks under this Regulation and shall give the competent authorities of other Member States all the necessary and useful support to this end.

Article 131

Communication to the public of information on risks of substances

In accordance with the guidelines to be drawn up by the Agency, the competent authorities of the Member States shall inform the general public about the risks arising from substances where this is considered necessary for the protection of human health or the environment.

Article 132

Other responsibilities of the competent authorities

The competent authorities shall provide advice to manufacturers, importers, downstream users and any other interested parties on their respective responsibilities and obligations under this Regulation, in addition to the operational guidance documents provided by the Agency under Article 83(4)(g) . This shall include in particular, but not be limited to, advice to SMEs on how to meet their obligations under this Regulation.

ENFORCEMENT

Article 133

Tasks of the Member States

Member States shall maintain a system of official controls and other activities as appropriate to the circumstances in accordance with the guidelines to be drawn up by the Agency .

Member States shall take measures to support enterprises – especially SMEs and downstream users – for the implementation of this Regulation.

The Agency shall be authorised by the Member States to initiate controls and activities and shall establish guidelines for the control system's harmonisation and effectiveness.

Article 134

Sanctions for non-compliance

1.  The Member States shall, on the basis of a set of guidelines drawn up by the Agency, lay down the provisions on penalties applicable for infringement of the provisions of this Regulation and shall take all measures necessary to ensure that they are implemented. The penalties provided for must be effective, proportionate and dissuasive. The Member States shall notify those provisions to the Commission and the Agency not later than ... (67) and shall notify it without delay of any subsequent amendment affecting them.

2.  In cases where the provisions of the Member States require a fine, the amount of the fine shall be determined according to the gravity and duration of the infringement, the extent of damage to the environment and human health and any aggravating or attenuating circumstances, such as consideration of animal welfare, as appropriate. It shall be set at a level which ensures that it has a deterrent effect.

Article 135

Report

Member States shall submit a report to the Agency by 1 July each year on the results of the official checks, the monitoring carried out, fines set and the other measures taken pursuant to Articles 133 and 134 during the previous calendar year. The Agency shall make these reports available to the Commission.

TRANSITIONAL AND FINAL PROVISIONS

Article 136

Free movement clause

1.   Member States shall not prohibit, restrict or impede the manufacturing, import, placing on the market or use of a substance, on its own, in a preparation or in an article, falling within the scope of this Regulation, which complies with this Regulation and, where appropriate, with Community acts adopted in implementation of this Regulation.

2.  Paragraph 1 shall not affect the right of Member States to maintain or introduce more stringent protective measures in accordance with Community legislation on worker protection, if a chemical safety assessment has not been carried out in accordance with this Regulation for a use of a substance.

Article 137

Safeguard Clause

1.  Where a Member State has justifiable grounds for believing that a substance, on its own, in a preparation or in an article, although satisfying the requirements of this Regulation, constitutes a risk to human health or the environment, it may take appropriate provisional measures. The Member State shall immediately inform the Commission, the Agency and the other Member States thereof, giving reasons for its decision and submitting the scientific or technical information on which the provisional measure is based.

2.  The Commission shall take a decision in accordance with the procedure referred to in Article  141(2) within 90 days of receipt of the information from the Member State. This decision shall either:

   a) authorise the provisional measure for a time period defined in the decision; or
   b) require the Member State to revoke the provisional measure.

3.  If, in the case of a decision as referred to in point (a) of paragraph 2, the provisional measure taken by the Member State consists in a restriction on the placing on the market or use of a substance, the Member State concerned shall initiate a Community restrictions procedure by submitting to the Agency a dossier, in accordance with Annex XIV, within 3 months of the date of the Commission decision.

4.  In the case of a decision as referred to in point (a) of paragraph 2, the Commission shall consider whether this Regulation needs to be adapted.

Article 138

Statement of reasons for decisions

The Competent Authorities, the Agency and the Commission shall state the reasons for all decisions they take under this Regulation.

Article 139

Amendments to the Annexes

The Annexes may be amended in accordance with the procedure referred to in Article 141(3) .

Not later than ... (68) , a section shall be inserted at the beginning of Annex II which lays down objective criteria for the exemption of substances and/or groups of substances.

Article 140

Implementing legislation

The measures necessary for the efficient implementation of this Regulation shall be adopted in accordance with the procedure referred to in Article 141(3) .

Article 141

Committee procedure

1.  The Commission shall be assisted by a Committee composed of representatives of the Member States and chaired by the representative of the Commission.

2.  Where reference is made to this paragraph, Articles 3 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.

3.  Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.

4.  The period laid down in Article 5(6) of Decision 1999/468/EC shall be three months.

Article 142

Preparation of establishment of the Agency

The Commission shall afford the necessary support towards the establishment of the Agency .

For that purpose, until such time as the Executive Director assumes his duties following his appointment by the Management Board of the Agency in accordance with Article 91, the Commission, on behalf of the Agency, and using the budget provided for the latter, may:

   a) appoint personnel, including a person who shall fulfil the functions of the Executive Director on an interim basis; and
   b) conclude other contracts.

Article 143

Transitional measures regarding restrictions

Not later than ... (69) , the Commission shall, if necessary, prepare a draft amendment to Annex XVI in accordance with either of the following:

   a) any risk evaluation and recommended strategy for limiting risks that has been adopted at Community level in accordance with Article 11 of Regulation (EEC) No 793/93 but for which Community measures to limit those risks have not yet been taken;
   b) any proposal, which has been submitted to the relevant institutions but has not yet been adopted, concerning the introduction of restrictions under Directive 76/769/EEC.

Article 144

Intermediary ex post impact assessment

1.  Five years after the entry into force of this Regulation, without prejudice to the provisions of Article 145, the Commission shall carry out an intermediary ex post impact assessment of the Regulation. The impact assessment shall analyse the state of play as regards implementation of the Regulation, shall confront the achieved results with the previous expectations, and shall evaluate the impact of the Regulation on the functioning of, and competition within, the internal market.

2.  The Commission shall submit the ex post impact assessment to the European Parliament and the Council by ... (70) at the latest. The Commission shall introduce a proposal for any amendments to the Regulation that appear necessary on the basis of the ex post impact assessment.

Article 145

Review

1.  Six years after entry into force of this Regulation, the Commission shall carry out a review with a view to the application of the obligation to perform a chemical safety assessment and to document it in a chemical safety report to substances not covered by this obligation because they are not subject to registration. On the basis of this review, the Commission may, in accordance with the procedure referred to in Article 141(3) , extend this obligation.

2.  The Commission shall adapt Articles 16 and 43 , in accordance with the procedure referred to in Article 141(3) , as soon as a practicable and cost-efficient way of selecting polymers for registration on the basis of sound technical and valid scientific criteria can be established, but not later than ... * , and after publishing a report on the following:

   a) the risks posed by polymers in comparison with other substances;
   b) the need, if any, of registering certain types of polymer, taking account of competitiveness and innovation on the one hand and the protection of health and the environment on the other.

3.  The report, referred to in Article 124 (3) , on the experience acquired with the operation of this Regulation shall include a review of the information requirements relating to registration of substances .

On the basis of that review, the Commission may, in accordance with the procedure referred to in Article 141(3) , modify the information requirements specified in Annexes V to VIII , with the purpose of taking into account the latest developments, in particular in relation to alternative testing and (quantitative) structure-activity relationships ((Q)SARs).

4.  The report referred to in the second subparagraph of Article 124(3) shall be accompanied, where justified, by a legislative proposal for reviewing the criteria laid down in Articles 5, 6, 17 and 18 relating to the selection of substances for registration purposes with a view to including, inter alia, data relating to exposure risks and scenarios.

5.  Not later than ... (71) , the Commission shall carry out a review of the functioning of Article 6, taking into account the scope and the role of the guidance and notification, with a view to including substances classified as dangerous according to Directive 67/548/EEC.

Article 146

Repeal

Directives 76/769/EEC, 91/155/EEC , 93/67/EEC, 93/105/EC and 2000/21/EC, and Regulations (EEC) No 793/93 and (EC) No 1488/94 are repealed.

References to the repealed acts shall be construed as references to this Regulation.

Article 147

Amendment of Directive 1999/45/EC

Article 14 of Directive 1999/45/EC is deleted. Directive 1999/45/EC shall be amended to ensure consumers are provided with the information needed to take appropriate measures for the safe use of substances and preparations.

Article 148

Entry into force and application

1.  This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

2.  Titles II and XII shall apply from ... (72) .

3.  Articles 92 and 93 shall apply from ... (73) * .

4.  Articles 75 to 79 shall apply from ... (74) ** .

5.  Articles 52, 53 and 54 shall apply from ... (75) ***.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at

For the European Parliament For the Council

The President The President

ANNEX I

GENERAL PROVISIONS FOR ASSESSING SUBSTANCES AND PREPARING CHEMICAL SAFETY REPORTS

0.  INTRODUCTION

0.1.  The purpose of this Annex is to set out how manufacturers and importers are to assess and document that the risks arising from the substance they manufacture or import are adequately controlled during manufacture and their own use(s) and that others further down the supply chain can adequately control the risks.

0.2.  The chemical safety assessment shall address all the identified uses. It shall consider the use of the substance on its own (including any major impurities and additives), in a preparation or in an article. The assessment shall consider all stages of the life-cycle (including the waste phase, notwithstanding Article 2(1)(d) of this Regulation) of the substance as defined by the identified uses. The chemical safety assessment shall be based on a comparison of the potential adverse effects of a substance with the known or reasonably foreseeable exposure of man and/or the environment to that substance.

0.3.  If the manufacturer or importer considers that the chemical safety assessment carried out for one substance is sufficient to assess and document that the risks arising from another substance or from a group of substances are adequately controlled then he can use that chemical safety assessment for the other substance or group of substances. The manufacturer or importer shall provide a justification for this.

0.4.  The chemical safety assessment shall be based on the information on the substance contained in the technical dossier and on other available and relevant information. Available information from assessments carried out under other international and national programmes shall be included. Where available and appropriate, an assessment carried out under Community legislation (e.g. risk assessments completed under Regulation (EEC) No 793/93) shall be taken into account in the development of, and reflected in, the chemical safety report. Deviations from such assessments shall be justified.

Thus the information to be considered includes information related to the hazard of the substance, the exposure arising from the manufacture or import and the identified uses of the substance.

In accordance with Annex IX, Section 3, in some cases, it may not be necessary to generate missing information, because risk management measures which are necessary to control a well-characterised risk may also be sufficient to control other potential risks, which will not therefore need to be characterised precisely.

If the manufacturer or importer considers that further information is necessary for producing his chemical safety report and that this information can only be obtained by performing tests in accordance with Annex VI, VII or VIII using vertebrate animals, he shall submit a proposal for a testing strategy, explaining why he considers that additional information is necessary and record this in the chemical safety report under the appropriate heading. While waiting for results of further testing, he shall record the risk management measures he has put in place in his chemical safety report.

0.5.  A chemical safety assessment performed by a manufacturer or an importer for a substance shall include the following steps in accordance with the respective sections of this Annex:

   1. Human health hazard assessment
   2. Human health hazard assessment of physicochemical properties
   3. Environmental hazard assessment
   4. PBT and vPvB assessment

If as a result of steps 1 to 4 the manufacturer or importer concludes that the substance or the preparation meets the criteria for classification as dangerous according to Directives  67/548/EEC or 1999/45/EC or is assessed to be a PBT or vPvB, the chemical safety assessment shall also consider the following steps:

   5. Exposure assessment
   6. Risk characterisation

A summary of all the relevant information used in addressing the points above, shall be presented under the relevant heading of the chemical safety report (Section 7).

0.6.  The main element of the exposure part of the chemical safety report is the description of the manufacturer's or importer's exposure scenario(s) and the exposure scenario(s) recommended by the manufacturer or importer to be implemented for the identified use(s). The exposure scenarios contain a description of the risk management measures which the manufacturer or importer has implemented and recommends to be implemented by downstream users. If the substance is placed on the market, these exposure scenarios including the risk management measures shall be summarised in an annex to the safety data sheet in accordance with Annex IA.

0.7.  The level of detail required in describing an exposure scenario will vary substantially from case to case, depending on the use of a substance, its hazardous properties and the amount of information available to the manufacturer or importer. Exposure scenarios can describe the appropriate risk management measures for several individual uses of a substance. Single exposure scenarios may thereby cover large ranges of uses.

0.8.  The process which the manufacturer or importer goes through, in carrying out their chemical safety assessment and developing their chemical safety reports, may be iterative. Iterations may consider on the one hand developing and revising the exposure scenario(s), which may include developing and implementing or recommending risk management measures, and on the other hand the need to generate further information. The purpose of generating further information is to establish a more precise risk characterisation, based on a refined hazard assessment or exposure assessment. This will allow appropriate information to be communicated down the supply chain in the safety data sheet.

0.9.  Where information is not necessary in accordance with Annex IX , this fact shall be stated under the appropriate heading of the chemical safety report and a reference shall be made to the justification in the technical dossier. This fact that no information is required shall also be stated in the safety data sheet.

0.10.  In relation to particular effects, such as ozone depletion, for which the procedures set out in Sections 1 to 6 are impracticable, the risks associated with such effects shall be assessed on a case-by-case basis and the manufacturer or importer shall include a full description and justification of such assessments in the chemical safety report and summarised in the safety data sheet.

0.11.  Where the methodology described in this Annex is not appropriate, details of alternative methodology used shall be explained and justified in the chemical safety report.

0.12.  Part A of the chemical safety report shall include a declaration that the risk management measures outlined in the relevant exposure scenarios for the manufacturer's or importer's own use(s) are implemented by the manufacturer or importer and that those exposure scenarios for the identified uses are communicated to all known users further down the supply chain in the safety data sheet.

1.  HUMAN HEALTH HAZARD ASSESSMENT

1.0.  Introduction

1.0.1.  The objective of the human health hazard assessment shall be:

   to determine the classification and labelling of a substance in accordance with Directive 67/548/EEC ; and
   to derive levels of exposure to the substance above which humans should not be exposed. This level of exposure is known as the Derived No-Effect Level (Dnel).

1.0.2.  The human health hazard assessment shall consider the following groups of potential effects: (1) toxicokinetics, metabolism and distribution, (2) acute effects (acute toxicity, irritation and corrosivity), (3) sensitisation, (4) repeated dose toxicity and (5) CMR effects (carcinogenity, mutagenicity and toxicity for reproduction). Based on all the available information, other effects shall be considered when necessary.

1.0.3.  The hazard assessment shall comprise the following four steps:

Step 1. Evaluation of non-human data

Step 2. Evaluation of human data

Step 3. Classification and Labelling

Step 4. Derivation of Derived No-Effect Levels (Dnels)

1.0.4.  The first three steps shall be undertaken for every effect for which information is available and shall be recorded under the relevant section of the Chemical Safety Report and where required and in accordance with Article 33 , summarised in the Safety Data Sheet under headings 2 and 11.

1.0.5.  For any effect for which no relevant information is available, the relevant section shall contain the sentence "This information is not required by this regulation. See the justification at …".

1.0.6.  Step 4 of the human health hazard assessment shall be undertaken by integrating the results from the first three steps and shall be included under the relevant heading of the Chemical Safety Report and summarised in the Safety Data Sheet under heading 8.1.

1.1.  Step 1: Evaluation of non-human data

1.1.1.  The evaluation of non-human data shall comprise:

   the hazard identification for the effect based on all available non-human data;
   the establishment of the quantitative dose (concentration) – response (effect) relationship.

1.1.2.  When it is not possible to establish the quantitative dose (concentration) – response (effect) relationship, then this should be justified and a semi-quantitative or qualitative analysis shall be included. For acute effects it is usually not possible to establish the quantitative dose (concentration) – response (effect) relationship on the basis of the results of a test conducted in accordance with Annex X. In such cases it suffices to determine whether and to which degree the substance has an inherent capacity to cause the effect.

1.1.3.  All non-human data used to assess a particular effect on humans and to establish the dose (concentration) – response (effect) relationship, shall be briefly presented, if possible in the form of a table or tables, distinguishing between in vitro, in vivo and other data. The relevant test results (e.g., LD50, NO(A)EL or LO(A)EL) and test conditions (e.g., test duration, route of administration) and other relevant information shall be presented, in internationally recognised units of measurement for that effect.

1.1.4  If there are several studies addressing the same effect, then normally the study or studies giving rise to the highest concern shall be used to establish the Derived No-Effect Levels and a robust study summary shall be prepared for that study or studies and included as part of the technical dossier. If the study or studies giving rise to the highest concern are not used, then this shall be fully justified and robust study summaries shall be prepared and included as part of the technical dossier, not only for the study being used but also for all studies demonstrating a higher concern than the study being used. For substances where all available studies indicate no hazards an overall assessment of the validity of all studies should be performed.

1.2.  Step 2: Evaluation of human data

If no human data are available, this part shall contain the statement "No human data are available". However, if human data is available, it shall be presented, if possible in the form of a table.

1.3.  Step 3: Classification and Labelling

1.3.1.  The appropriate classification and labelling developed in accordance with the criteria in Directive 67/548/EEC shall be presented and justified. A comparison of the available data with the criteria given in Directive 67/548/EEC for CMR, categories 1 and 2, shall always be performed and a statement presented of whether the substance fulfils or does not fulfil those criteria.

1.3.2.  If the data are inadequate to decide whether a substance should be classified for a particular end-point, the registrant shall indicate and justify the action or decision he has taken as a result.

1.4.  Step 4: Identification of Derived No-Effect Level(s) (DNEL(s))

1.4.1.  Based on the outcomes of steps 1 to 3, a Derived No-Effect Level(s) shall be established for the substance, reflecting the likely route(s), duration and frequency of exposure. If justified by the exposure scenario(s), a single Dnel may be sufficient. However, taking into account the available data and the exposure scenario(s) in Section 5 of the Chemical Safety Report it may be necessary to identify different DNELs for each relevant human population (e.g., workers, consumers and humans liable to exposure indirectly via the environment) and for vulnerable populations and for different routes of exposure. A full justification shall be given specifying, inter alia, the choice of the data used, the route of exposure (oral, dermal, inhalation) and the duration and frequency of exposure to the substance for which the Dnel is valid. If more than one route of exposure is likely to occur, then a Dnel shall be estgablished for each route of exposure and for the exposure from all routes combined. When established the Dnel, the following factors shall, inter alia, be taken into account:

   i) the uncertainty arising, among other factors, from the variability in the experimental data and from intra- and inter-species variation;
   ii) the nature and severity of the effect;
   iii) the human population to which the quantitative and/or qualitative information on exposure applies;
   iv) particular susceptibilities of vulnerable populations;
   v) any indication of non-standard effects, especially where the mode of action remains unknown or insufficiently characterised;
   vi) possible co-exposure to other chemicals.

1.4.2.  If it is not possible to identify a Dnel, then this shall be clearly stated and fully justified.

2.  PHYSICOCHEMICAL HAZARD ASSESSMENT

2.1.  The objective of the hazard assessment for physicochemical properties shall be to determine the classification and labelling of a substance in accordance with Directive 67/548/EEC .

2.2.  The potential effects to human health shall be assessed for at least the following physicochemical properties:

   explosivity,
   flammability,
   oxidizing potential.

If the data are inadequate to decide whether a substance should be classified for a particular end-point, the registrant shall indicate and justify the action or decision he has taken as a result.

2.3.  The assessment of each effect shall be presented under the relevant heading of the Chemical Safety Report (Section 7) and where required and in accordance with Article 33 , summarised in the Safety Data Sheet under headings 2 and 9.

2.4.  For every physicochemical property, the assessment shall entail an evaluation of the inherent capacity of the substance to cause the effect.

2.5.  The appropriate classification and labelling developed in accordance with the criteria in Directive 67/548/EEC shall be presented and justified.

3.  ENVIRONMENTAL HAZARD ASSESSMENT

3.0.  Introduction

3.0.1.  The objective of the environmental hazard assessment shall be to determine the classification and labelling of a substance in accordance with Directive 67/548/EEC and to identify the concentration of the substance below which adverse effects in the environmental sphere of concern are not expected to occur. This concentration is known as the Predicted No-Effect Concentration (Pnec).

3.0.2.  The environmental hazard assessment shall consider the potential effects on the environment, comprising the (1) aquatic (including sediment), (2) terrestrial and (3) atmospheric compartments, including the potential effects that may occur (4) via food-chain accumulation. In addition, the potential effects on the (5) microbiological activity of sewage treatment systems shall be considered. The assessment of the effects on each of these five environmental spheres shall be presented under the relevant heading of the Chemical Safety Report (Section 7) and where required and in accordance with Article 33, summarised in the Safety Data Sheet under headings 2 and 12.

3.0.3.  For any environmental sphere, for which no effect information is available, the relevant section shall contain the sentence "This information is not required by this regulation. See the justification at …". For any environmental sphere for which information is available, but the manufacturer or importer believes that it is not necessary to conduct the hazard assessment, the manufacturer or importer shall present a justification under the relevant heading of the Chemical Safety Report (Section 7) and where required and in accordance with Article 33 , summarised in the Safety Data Sheet under heading 12.

3.0.4.  The hazard assessment shall comprise the following three steps, which shall be clearly identified as such in the Chemical Safety Report:

Step 1. Evaluation of data

Step 2. Classification and Labelling

Step 3. Derivation of the Predicted No-Effect Concentration (Pnec)

3.1.  Step 1: Evaluation of data

3.1.1.  The evaluation of all available data shall comprise:

   the hazard identification based on all available data;
   the establishment of the quantitative dose (concentration) – response (effect) relationship.

3.1.2.  When it is not possible to establish the quantitative dose (concentration) – response (effect) relationship, then this should be justified and a semi-quantitative or qualitative analysis shall be included.

3.1.3.  All data used to assess the effects on a specific environmental sphere shall be briefly presented, if possible in the form of a table or tables. The relevant test results (e.g. LC50 or NOEC) and test conditions (e.g. test duration, route of administration) and other relevant information shall be presented, in internationally recognised units of measurement for that effect.

3.1.4.  All data used to assess the environmental fate of the substance shall be briefly presented, if possible in the form of a table or tables. The relevant test results and test conditions and other relevant information shall be presented, in internationally recognised units of measurement for that effect.

3.1.5.  If there are several studies addressing the same effect, then the study or studies giving rise to the highest concern shall be used to draw a conclusion and a robust study summary shall be prepared for that study or studies and included as part of the technical dossier. If the study or studies giving rise to the highest concern are not used, then this shall be fully justified and robust study summaries shall be prepared and included as part of the technical dossier, not only for the study being used but also for all studies reaching a higher concern than the study being used. For substances where all available studies indicate no hazards an overall assessment of the validity of all studies should be performed.

3.2.  Step 2: Classification and Labelling

3.2.1.  The appropriate classification and labelling developed in accordance with the criteria in Directive 67/548/EEC shall be presented and justified.

3.2.2.  If the data are inadequate to decide whether a substance should be classified for a particular end-point, the registrant shall indicate and justify the action or decision he has taken as a result.

3.3.  Step 3: Identification of the Predicted No-Effect Concentration

3.3.1.  Based on the available data, the Pnec for each environmental sphere shall be established. The Pnec may be calculated by applying an appropriate assessment factor to the effect values (e.g. LC50 or NOEC) derived from tests on organisms. An assessment factor expresses the difference between effects values derived for a limited number of species from laboratory tests and the Pnec for the environmental sphere(76) .

3.3.2.  If it is not possible to derive the Pnec, then this shall be clearly stated and fully justified.

4.  PBT AND VPVB ASSESSMENT

4.0.  Introduction

4.0.1.  The objective of the PBT and vPvB assessment shall be to determine if the substance fulfils the criteria given in Annex XII and if so, to characterise the potential emissions of the substance. A hazard assessment in accordance with Sections 1 and 3 of this Annex addressing all the long-term effects and the estimation of the long-term exposure of humans and the environment as carried out in accordance with Section 5 (Exposure Assessment), step 2 (Exposure Estimation), cannot be carried out with sufficient reliability for substances satisfying the PBT and vPvB criteria, which necessitates the need for a separate PBT and vPvB assessment.

4.0.2.  The PBT and vPvB assessment shall be based on all the information submitted as part of the technical dossier. If the technical dossier contains for one or more endpoints only information as required in Annexes V and VI, the registrant shall consider whether further information needs to be generated to fulfil the objective of the PBT and vPvB assessment.

4.0.3.  The PBT and vPvB assessment shall comprise the following two steps, which shall be clearly identified as such in Part C, Section 7 of the Chemical Safety Report:

Step 1. Comparison with the Criteria

Step 2. Emission Characterisation

The assessment shall also be summarised in the Safety Data Sheet under heading 12.

4.1.  Step 1: Comparison with the Criteria

This part of the PBT and vPvB assessment shall entail the comparison of the available data with the criteria given in Annex XII and a statement of whether the substance fulfils or does not fulfil the criteria. If the available data are not sufficient to decide whether the substance fulfils the criteria in Annex XII, then other evidence giving rise to an equivalent level of concern shall be considered on a case-by-case basis.

4.2.  Step 2: Emission Characterisation

If the substance fulfils the criteria an emission characterisation shall be conducted comprising the relevant parts of the exposure assessment as described in Section 5. In particular it shall contain an estimation of the amounts of the substance released to the different environmental compartments during all activities carried out by the manufacturer or importer and all identified uses, and an identification of the likely routes by which humans and the environment are exposed to the substance.

5.  EXPOSURE ASSESSMENT

5.0.  Introduction

The objective of the exposure assessment shall be to make a quantitative or qualitative estimate of the dose/concentration of the substance to which humans and the environment are or may be exposed. The exposure assessment shall entail the following two steps, which shall be clearly identified as such in the chemical safety report:

Step 1. Development of exposure scenarios

Step 2. Exposure Estimation

Where required and in accordance with Article 33 , the assessment shall also be summarised in an annex to the safety data sheet.

5.1.  Step 1: Development of exposure scenarios

5.1.1.  Exposure scenarios shall be developed for manufacture in the Community, manufacturer's and importer's own use, and all identified uses. An exposure scenario is the set of conditions that describe how the substance is manufactured or used during its life-cycle and how the manufacturer or importer controls, or recommends downstream users to control, exposures of humans and the environment. These exposure scenarios may be as wide-ranging or specific as necessary. The exposure scenario shall be presented under the relevant heading of the chemical safety report, and summarised in an annex to the safety data sheet, using an appropriate short title giving a brief general description of the use. In particular, an exposure scenario includes, where relevant, a description of:

   the processes involved in the production by the manufacturer and, if relevant, the further processing and use by the manufacturer or importer, including the physical form in which the substance is manufactured, processed and/or used;
   the processes involved in the identified use of the substance foreseen by the manufacturer or importer, including the physical form in which the substance is processed and/or used;
   the risk management measures implemented by the manufacturer or importer to reduce or avoid exposure of humans (including workers and consumers) and the environment to the substance;
   the risk management measures which the manufacturer or importer recommends to be implemented by the downstream users to reduce or avoid exposure of humans (including workers and consumers) and the environment to the substance;
   the waste management measures implemented by the manufacturer or importer and those recommended to be implemented by the downstream user or consumer to reduce or avoid exposure of humans and the environment to the substance during waste, disposal and/or recycling;
   the activities of workers related to the processes and the duration and frequency of their exposure to the substance;
   the activities of consumers and the duration and frequency of their exposure to the substance;
   the duration and frequency of emissions of the substance to the different environmental compartments and sewage treatment systems and the dilution in the receiving environmental compartment.

5.1.2.  When the assessment is identified to be used for an application for an authorisation for a specific use, exposure scenarios need only be developed for those uses and the subsequent life-cycle steps.

5.2.  Step 2: Exposure Estimation

5.2.1.  The exposure shall be estimated for each exposure scenario developed and shall be presented under the relevant heading of the chemical safety report and where required and in accordance with Article 33, summarised in an annex to the safety data sheet. The exposure estimation entails three elements: (1) emission estimation; (2) chemical fate and pathways; and (3) estimation of exposure levels.

5.2.2.  The emission estimation shall consider the emissions during all relevant parts of the life-cycle of the substance under the assumption that the risk management measures described in the exposure scenario have been implemented.

5.2.3.  A characterisation of possible degradation, transformation, or reaction processes and an estimation of environmental distribution and fate shall be performed.

5.2.4  An estimation of the exposure levels shall be performed for all human populations (workers, consumers and humans liable to exposure indirectly via the environment) and environmental spheres for which exposure to the substance is known or reasonably foreseeable. Each relevant route of human exposure (inhalation, oral, dermal and combined through all relevant routes of exposure) shall be addressed. Such estimations shall take account of spatial and temporal variations in the exposure pattern. In particular, the exposure estimation shall take account of:

   adequately measured, representative exposure data,
   any major impurities and additives in the substance,
   the quantity in which the substance is produced and/or imported,
   the quantity for each identified use,
   the degree of containment,
   the physicochemical properties of the substance,
   transformation and/or degradation products,
   the likely routes of exposure of and potential for absorption in humans,
   the likely pathways to the environment and environmental distribution and degradation and/or transformation (see also Section 3 Step 1).

5.2.5  Where adequately measured representative exposure data are available, special consideration shall be given to them when conducting the exposure assessment. Appropriate models can be used for the estimation of exposure levels. Relevant monitoring data from substances with analogous use and exposure patterns or analogous properties can also be considered.

6.  RISK CHARACTERISATION

6.1  The risk characterisation shall be carried out for each exposure scenario and shall be presented under the relevant heading of the Chemical Safety Report.

6.2  The risk characterisation shall consider the human populations (exposed as workers, consumers or indirectly via the environment and if relevant a combination thereof) and the environmental spheres for which exposure to the substance is known or reasonably foreseeable, under the assumption that the risk management measures described in the exposure scenarios in the previous Section have been implemented. In addition, the overall environmental risk caused by the substance shall be reviewed by integrating the results for all relevant spheres and all relevant emission/release sources of the substance.

6.3  The risk characterisation consists of:

   a comparison of the exposure of each human population known to be or likely to be exposed with the appropriate Derived No-Effect Levels;
   a comparison of the predicted environmental concentrations in each environmental sphere with the Pnecs; and
   an assessment of the likelihood and severity of an event occurring due to the physicochemical properties of the substance.

6.4  For any exposure scenario, the exposures of humans and the environment can be considered to be adequately controlled, if:

   the exposure levels estimated in Section 6.2 do not exceed the appropriate Dnel or the Pnec, as determined in Sections 1 and 3, respectively, and;
   the likelihood and severity of an event occurring due to the physicochemical properties of the substance as determined in Section 2 is negligible.

6.5  For those human effects and those environmental spheres for which it was not possible to determine a Dnel or a Pnec, a qualitative assessment of the likelihood that effects are avoided when implementing the exposure scenario shall be carried out.

For substances satisfying the PBT and vPvB criteria, the manufacturer or importer shall use the information as obtained in Section 5, Step 2 when implementing on its site, and recommending for downstream users, risk management measures which minimise exposures to humans and the environment.

7.  CHEMICAL SAFETY REPORT FORMAT

The Chemical Safety Report shall include the following headings:

CHEMICAL SAFETY REPORT FORMAT

PART A

1. SUMMARY OF RISK MANAGEMENT MEASURES

2. DECLARATION THAT RISK MANAGEMENT MEASURES ARE IMPLEMENTED

3. DECLARATION THAT RISK MANAGEMENT MEASURES ARE COMMUNICATED

PART B

1. IDENTIFICATION OF THE SUBSTANCE AND PHYSICOCHEMICAL PROPERTIES

2. CLASSIFICATION AND LABELLING

3. ENVIRONMENTAL FATE PROPERTIES

3.1. Degradation

3.2. Environmental distribution

3.3. Bioaccumulation

PART C

1. HUMAN HEALTH HAZARD ASSESSMENT

1.1. Toxicokinetics metabolism and distribution

1.2. Acute toxicity

1.3. Irritation

1.3.1. Skin

1.3.2. Eye

1.3.3. Respiratory Tract

1.4. Corrosivity

1.5. Sensitisation

1.5.1. Skin

1.5.2. Respiratory system

1.6. Repeated dose toxicity

1.7. Mutagenicity

1.8. Carcinogenicity

1.9. Toxicity for reproduction

1.9.1. Effects on fertility

1.9.2. Developmental Toxicity

1.10 Other effects

2. HUMAN HEALTH ASSESSMENT OF PHYSICOCHEMICAL PROPERTIES

2.1. Explosivity

2.2. Flammability

2.3. Oxidising potential

3. ENVIRONMENTAL HAZARD ASSESSMENT

3.1. Aquatic Compartment (including sediment)

3.2. Terrestrial Compartment

3.3. Atmospheric Compartment

3.4. Microbiological Activity in Sewage Treatment Systems

4. PBT AND VPVB ASSESSMENT

5. EXPOSURE ASSESSMENT

5.1. [Title of Exposure Scenario 1]

5.1.1. Exposure Scenario

5.1.2. Exposure Assessment

5.2. [Title of Exposure Scenario 2]

5.2.1. Exposure Scenario

5.2.2. Exposure Assessment

[etc.]

6. RISK CHARACTERISATION

6.1. [Title of Exposure Scenario 1]

6.1.1. Human Health

6.1.1.1. Workers

6.1.1.2. Consumers

6.1.1.3. Humans liable to indirect exposure via the environment

6.1.2. Environment

6.1.2.1. Aquatic Compartment (incl. Sediment)

6.1.2.2. Terrestrial Compartment

6.1.2.3. Atmospheric Compartment

6.1.2.4. Microbiological Activity in Sewage Treatment Systems

6.2. [Title of Exposure Scenario 2]

6.2.1. Human Health

6.2.1.1. Workers

6.2.1.2. Consumers

6.2.1.3. Humans liable to indirect exposure via the environment

6.2.2. Environment

6.2.2.1. Aquatic Compartment (incl. Sediment)

6.2.2.2. Terrestrial Compartment

6.2.2.3. Atmospheric Compartment

6.2.2.4. Microbiological Activity in Sewage Treatment Systems

[etc.]

6.x. Overall exposure (combined for all relevant emission/release sources)

6.x.1 Human health (combined for all exposure routes)

6.x.1.1

6.x.2 Environment (combined for all emission sources)

6.x.2.1

ANNEX IA

GUIDE TO THE COMPILATION OF SAFETY DATA SHEETS

This Annex sets out the requirements for a Safety Data Sheet that is provided for a substance or a preparation in accordance with Article 33 . The Safety Data Sheet provides a mechanism for transmitting appropriate information from the relevant Chemical Safety Report(s) down the supply chain to the immediate downstream user(s). The information provided in the Safety Data Sheet shall be consistent with the information in the chemical safety report, where one is required. Where a chemical safety report has been performed, the relevant exposure scenario(s) shall be placed into an annex of the safety data sheet, to make reference to them under the relevant headings of the safety data sheet easier.

The purpose of this Annex is to ensure consistency and accuracy in the content of each of the mandatory headings listed in Article 33 , so that the resulting safety data sheets will enable users to take the necessary measures relating to protection of health and safety at the workplace, and protection of the environment.

The information provided by safety data sheets shall also meet the requirements set out in Council Directive 98/24/EC. In particular, the safety data sheet shall enable the employer to determine whether any hazardous chemical agents are present in the workplace, and to assess any risk to the health and safety of workers arising from their use.

The information in the Safety Data Sheet shall be written in a clear and concise manner. The safety data sheet shall be prepared by a competent person who shall take into account the specific needs of the user audience, as far as it is known. Persons placing substances and preparations on the market shall ensure that competent persons have received appropriate training, including refresher training.

For preparations not classified as dangerous, but for which a safety data sheet is required according to Article 34 , proportionate information shall be provided under each heading.

Additional information may be necessary in some cases in view of the wide range of properties of the substances and preparations. If in other cases it emerges that information on certain properties is of no significance or that it is technically impossible to provide, the reasons for this shall be clearly stated under each heading. Information shall be provided for each hazardous property. If it is stated that a particular hazard does not apply, clearly differentiate between cases where no information is available to the classifier, and cases where negative test results are available.

Give the date of issue of the safety data sheet on the first page. When a safety data sheet has been revised, the changes shall be brought to the attention of the recipient.

Note

Safety data sheets are also required for certain special substances and preparations (e.g. metals in massive form, alloys, compressed gases etc.) listed in chapters 8 and 9 of Annex VI to Directive 67/548/EEC, for which there are labelling derogations.

1.  IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND OF THE COMPANY/UNDERTAKING

1.1.  Identification of the substance or preparation

The term used for identification shall be identical to that provided on the label as set out in Annex VI to Directive 67/548/EEC.

For substances subject to registration, the term shall be consistent with that provided under registration and the registration number assigned under Article 20(1 ) of this Regulation shall also be indicated.

Other means of identification available may also be indicated.

1.2.  Use of the substance/preparation

Indicate the uses of the substance or preparation as far as they are known. Where there are many possible uses, only the most important or common uses need be listed. This shall include a brief description of what it actually does, e.g. flame retardant, anti-oxidant, etc.

Where a chemical safety report is required, the safety data sheet shall contain information on all the identified uses relevant to the recipient of the safety data sheet. This information shall be consistent with the identified uses and exposure scenarios set out in the annex to the safety data sheet.

1.3.  Company/undertaking identification

Identify the person responsible for placing the substance or preparation on the market within the Community, whether it be the manufacturer, importer or distributor. Give the full address and telephone number of this person.

In addition, where this person is not located in the Member State where the substance or preparation is placed on the market, give a full address and telephone number for the person responsible in that Member State, if possible.

For registrants, the person identified shall be consistent with the information on the identity of the manufacturer or importer provided in the registration.

1.4.  Emergency telephone

In addition to the above mentioned information, supply the emergency telephone number of the company and/or relevant official advisory body (this may be the body responsible for receiving information relating to health, which is referred to in Article 17 of Directive 1999/45/EC).

2.  HAZARDS IDENTIFICATION

Give here the classification of the substance or preparation which arises from application of the classification rules in Directives 67/548/EEC or 1999/45/EC. Indicate clearly and briefly the hazards the substance or preparation presents to man and the environment.

Distinguish clearly between preparations which are classified as dangerous and preparations which are not classified as dangerous according to Directive 1999/45/EC.

Describe the most important adverse physicochemical, human health and environmental effects and symptoms relating to the uses and possible misuses of the substance or preparation that can reasonably be foreseen.

It may be necessary to mention other hazards, such as dustiness, suffocation, freezing or environmental effects such as hazards to soil-dwelling organisms, etc., which do not result in classification but which may contribute to the overall hazards of the material.

The information shown on the label shall be given under heading 15.

The classification of the substance shall be consistent with the classification provided to the classification and labelling inventory according to Title X.

3.  COMPOSITION/INFORMATION ON INGREDIENTS

The information given shall enable the recipient to identify readily the hazards of the components of the preparation. The hazards of the preparation itself shall be given under heading 3.

3.1.  It is not necessary to give the full composition (nature of the ingredients and their concentration), although a general description of the components and their concentrations can be helpful.

3.2.  For a preparation classified as dangerous according to Directive 1999/45/EC, the following substances shall be indicated, together with their concentration or concentration range:

  i) substances presenting a health or environmental hazard within the meaning of Directive 67/548/EEC, if they are present in concentrations equal to or greater than the lowest of:
   the applicable concentrations defined in the table of Article 3 (3) of Directive  1999/45/EC, or
   the concentration limits given in Annex I to Directive  67/548/EEC, or
   the concentration limits given in Part B of Annex II to Directive  1999/45/EC, or
   the concentration limits given in Part B of Annex III to Directive  1999/45/EC, or
   the concentration limits given in an agreed entry in the classification and labelling inventory established under Title X,
   ii) and substances for which there are Community workplace exposure limits, which are not already included under (i).

3.3.  For a preparation not classified as dangerous according to Directive 1999/45/EC, the following substances shall be indicated, together with their concentration or concentration range, if they are present in an individual concentration of ≥ 1% by weight for non-gaseous preparations and ≥ 0,2% by volume for gaseous preparations:

   substances presenting a health or environmental hazard within the meaning of Directive 67/548/EEC((77) );
   and substances for which there are Community workplace exposure limits.

3.4.  For preparations not fulfilling the requirements of points 3.2 and 3.3 and for which the PNEC of the used substances is lower than 500 µg/litre, the quantity, biodegradation (eliminability) and logPOW shall be communicated to the downstream user in accordance with the requirements of Articles 39 and 40.

3.5.  The classification (derived either from Articles 4 and 6 of Directive 67/548/EEC or from Annex I to Directive 67/548/EEC) of the above substances shall be given, including the symbol letters and R phrases which are assigned in accordance with their physicochemical, health and environmental hazards. The R phrases do not need to be written out in full here: reference shall be made to heading 16, where the full text of each relevant R phrase shall be listed.

3.6.  The name and the Einecs or Elincs number of the above substances shall be given in accordance with Directive 67/548/EEC. The CAS number and Iupac name (if available) may also be helpful. For substances listed by a generic name, according to Article 15 of Directive 1999/45/EC or the footnote to point 3.3 of this Annex, a precise chemical identifier is not necessary. The registration number assigned under Article 20(1) of this Regulation shall also be given for each substance that is subject to registration.

3.7.  If, in accordance with the provisions of Article 15 of Directive 1999/45/EC or the footnote to point 3.3 of this Annex, the identity of certain substances is to be kept confidential, their chemical nature shall be described in order to ensure safe handling. The name used shall be the same as that which derives from the above procedures.

4.  FIRST AID MEASURES

Describe the first-aid measures.

Specify first whether immediate medical attention is required.

The information on first aid shall be brief and easy to understand by the victim, bystanders and first-aiders. The symptoms and effects shall be briefly summarised. The instructions shall indicate what is to be done on the spot in the case of an accident and whether delayed effects can be expected after exposure.

Subdivide the information according to the different routes of exposure, i.e. inhalation, skin and eye contact and ingestion, under different subheadings.

Indicate whether professional assistance by a doctor is needed or advisable.

For some substances or preparations it may be important to emphasise that special means to provide specific and immediate treatment shall be available at the workplace.

5.  FIRE-FIGHTING MEASURES

Refer to requirements for fighting a fire caused by the substance or preparation, or arising in its vicinity by indicating:

   suitable extinguishing media,
   extinguishing media which shall not be used for safety reasons,
   special exposure hazards arising from the substance or preparation itself, combustion products, resulting gases,
   special protective equipment for fire-fighters.

6.  ACCIDENTAL RELEASE MEASURES

Depending on the substance or preparation involved, information may be needed on:

   personal precautions such as:
removal of ignition sources, provision for sufficient ventilation/respiratory protection, control of dust, prevention of skin and eye contact,
   environmental precautions such as:
keeping away from drains, surface- and ground-water and soil, possible need to alert the neighbourhood,
   methods for cleaning up such as:
use of absorbent material (e.g. sand, diatomaceous earth, acid binder, universal binder, sawdust, etc.), reduction of gases/fumes with water, dilution.

Also consider the need for indications such as: "never use, neutralise with ...".

Note

If appropriate refer to headings 8 and 13.

7.  HANDLING AND STORAGE

Note

Information in this section shall relate to the protection of health, safety and the environment. It shall assist the employer in devising suitable working procedures and organisational measures according to Article 5 of Directive 98/24/EC.

Where a chemical safety report or a registration is required, the information in this section shall be consistent with the information given, for the identified uses and exposure scenarios set out in the annex to the safety data sheet.

7.1.  Handling

Specify precautions for safe handling including advice on technical measures such as: containment, local and general ventilation, measures to prevent aerosol and dust generation and fire, measures required to protect the environment (e.g. use of filters or scrubbers on exhaust ventilation, use in a bounded area, measures for collection and disposal of spillages, etc.) and any specific requirements or rules relating to the substance or preparation (e.g. procedures or equipment which are prohibited or recommended) and if possible give a brief description.

7.2.  Storage

Specify the conditions for safe storage such as: specific design for storage rooms or vessels (including retention walls and ventilation), incompatible materials, conditions of storage (temperature and humidity limit/range, light, inert gas, etc.) special electrical equipment and prevention of static electricity.

Give advice if relevant on quantity limits under storage conditions. In particular indicate any special requirements such as the type of material used in the packaging/containers of the substance or preparation.

7.3.  Specific use(s)

For end products designed for specific use(s), recommendations shall refer to the identified use(s) and be detailed and operational. If possible, reference shall be made to industry - or sector - specific approved guidance.

8.  EXPOSURE CONTROLS/PERSONAL PROTECTION

8.1.  Exposure limit values

Specify currently applicable specific control parameters including occupational exposure limit values and/or biological limit values. Values shall be given for the Member State where the substance or preparation is placed on the market. Give information on currently recommended monitoring procedures.

Where a chemical safety report is required, the relevant Dnels and Pnecs for the substance shall be given for the exposure scenarios set out in the annex to the safety data sheet.

For preparations, it is useful to provide values for those constituent substances which are required to be listed in the safety data sheet according to heading 3.

8.2.  Exposure controls

For the purposes of this document exposure control means the full range of specific protection and prevention measures to be taken during use in order to minimise worker and environmental exposure.

8.2.1.  Occupational exposure controls

This information will be taken into account by the employer in carrying out an assessment of risk to the health and safety of workers for the substance or preparation under Article 4 of Directive 98/24/EC, which requires the design of appropriate work processes and engineering controls, the use of adequate equipment and materials, the application of collective protection measures at source, and finally the use of individual protection measures, such as personal protection equipment. Therefore provide suitable and adequate information on these measures to enable a proper risk assessment to be carried out under Article 4 of Directive 98/24/EC. This information shall complement that already given under heading 7.1.

Where personal protection is needed, specify in detail which equipment will provide adequate and suitable protection. Take into account Council Directive 89/686/EEC(78) ) and make reference to the appropriate CEN standards.

Where a chemical safety report is required, a summary of the risk management measures that adequately control exposure of workers to the substance shall be given for the exposure scenarios set out in the annex to the safety data sheet.

8.2.1.1.  Respiratory protection

For dangerous gases, vapours or dust, specify the type of protective equipment to be used, such as self contained breathing apparatus, adequate masks and filters.

8.2.1.2.  Hand protection

Specify clearly the type of gloves to be worn when handling the substance or preparation, including:

   the type of material,
   the breakthrough time of the glove material, with regard to the amount and duration of dermal exposure.

If necessary indicate any additional hand protection measures.

8.2.1.3.  Eye protection

Specify the type of eye protection equipment required such as: safety glasses, safety goggles, face shield.

8.2.1.4.  Skin protection

If it is necessary to protect a part of the body other than the hands, specify the type and quality of protection equipment required, such as: apron, boots and full protective suit. If necessary, indicate any additional skin protection measures and specific hygiene measures.

8.2.2.  Environmental exposure controls

Specify the information required by the employer to fulfil his commitments under Community environmental protection legislation.

Where a chemical safety report is required, a summary of the risk management measures that adequately control exposure of the environment to the substance shall be given for the exposure scenarios set out in the annex to the safety data sheet.

9.  PHYSICOCHEMICAL PROPERTIES

To enable proper control measures to be taken, provide all relevant information on the substance or preparation, particularly the information listed under heading 9.2. The information in this section shall be consistent with the information provided in a registration where one is required.

9.1.  General information

Appearance

Indicate the physical state (solid, liquid, gas) and the colour of the substance or preparation as supplied.

Odour

If odour is perceptible, give a brief description of it.

9.2.  Important health, safety and environmental information

pH

Indicate the pH of the substance or preparation as supplied or of an aqueous solution; in the latter case, indicate the concentration.

Boiling point/boiling range:

Flash point:

Flammability (solid, gas):

Explosive properties:

Oxidising properties:

Vapour pressure:

Relative density:

Solubility:

Water solubility:

Fat solubility (solvent – oil to be specified) :

Partition coefficient: n-octanol/water:

Viscosity:

Vapour density:

Evaporation rate:

9.3.  Other information

Indicate other important safety parameters, such as, miscibility, conductivity, melting point/melting range, gas group (useful for European Parliament and Council Directive 94/9/EC)(79) ), auto-ignition temperature etc.

Note 1

The above properties shall be determined in accordance with the specifications of Part A of Annex X or any other comparable method.

Note 2

For preparations, information shall normally be given on the properties of the preparation itself. However, if it is stated that a particular hazard does not apply, clearly differentiate between cases where no information is available to the classifier, and cases where negative test results are available. If it is considered necessary to give information about the properties of individual components, please indicate clearly what the data refers to.

10.  STABILITY AND REACTIVITY

State the stability of the substance or preparation and the possibility of hazardous reactions occurring under certain conditions of use and also if released into the environment.

10.1.  Conditions to avoid

List those conditions such as temperature, pressure, light, shock, etc., which may cause a dangerous reaction and if possible give a brief description.

10.2.  Materials to avoid

List materials such as water, air, acids, bases, oxidising agents or any other specific substance which may cause a dangerous reaction and if possible give a brief description.

10.3.  Hazardous decomposition products

List hazardous materials produced in dangerous amounts upon decomposition.

Note

Address specifically:

   the need for and the presence of stabilisers,
   the possibility of a hazardous exothermic reaction,
   safety significance, if any, of a change in physical appearance of the substance or preparation,
   hazardous decomposition products, if any, formed upon contact with water,
   possibility of degradation to unstable products.

11.  TOXICOLOGICAL INFORMATION

This section deals with the need for a concise but complete and comprehensible description of the various toxicological (health) effects, which can arise if the user comes into contact with the substance or preparation.

The information shall include dangerous-to-health effects from exposure to the substance or preparation, based on, for example, test data and experience. The information shall also include, where appropriate, delayed, immediate and chronic effects from short- and long-term exposure: for example sensitisation, narcosis, carcinogenicity, mutagenicity and reproductive toxicity (developmental toxicity and fertility). It shall also include information on the different routes of exposure (inhalation, ingestion, skin and eye contact), and describe the symptoms related to the physical, chemical and toxicological characteristics.

Taking account of the information already provided under heading 3, composition/information on ingredients, it may be necessary to make reference to specific health effects of certain substances in the preparation.

The information in this section shall be consistent with the information provided for in a registration where required and/or in a chemical safety report where required and shall give information on the following groups of potential effects:

   toxicokinetics, metabolism and distribution,
   acute effects (acute toxicity, irritation and corrosivity),
   sensitisation,
   repeated dose toxicity, and
   CMR effects (carcinogenity, mutagenicity and toxicity for reproduction).

For substances subject to registration, summaries of the information derived from the application of Annexes V to IX of this Regulation shall be given. The information shall also include the result of the comparison of the available data with the criteria given in Directive 67/548/EEC for CMR, categories 1 and 2, following Paragraph 1.3.1 of Annex I.

12.  ECOLOGICAL INFORMATION

Describe the possible effects, behaviour and environmental fate of the substance or preparation in air, water and/or soil. Where available, give relevant test data (e.g. LC50 fish ≤ 1 mg/l).

The information in this section shall be consistent with the information provided for in a registration where required and/or in a chemical safety report where required.

Describe the most important characteristics likely to have an effect on the environment owing to the nature of the substance or preparation and likely methods of use. Information of the same kind shall be supplied for dangerous products arising from the degradation of substances and preparations. This may include the following:

12.1.  Ecotoxicity

This shall include relevant available data on aquatic toxicity, both acute and chronic for fish, crustaceans, algae and other aquatic plants. In addition, toxicity data on soil micro- and macro-organisms and other environmentally relevant organisms, such as birds, bees and plants, shall be included when available. Where the substance or preparation has inhibitory effects on the activity of micro-organisms, the possible impact on sewage treatment plants shall be mentioned.

For substances subject to registration, summaries of the information derived from the application of Annexes V to IX of this Regulation shall be included.

12.2.  Mobility

The potential of the substance or the appropriate constituents of a preparation(80) ), if released to the environment, to transport to groundwater or far from the site of release.

Relevant data might include:

   known or predicted distribution to environmental compartments,
   surface tension,
   absorption/desorption.

For other physicochemical properties see heading 9.

12.3.  Persistence and degradability

The potential of the substance or the appropriate constituents of a preparation to degrade in relevant environmental media, either through biodegradation or other processes such as oxidation or hydrolysis. Degradation half lives shall be quoted where available. The potential of the substance or appropriate constituents of a preparation to degrade in sewage treatment plants shall also be mentioned.

12.4.  Bioaccumulative potential

The potential of the substance or the appropriate constituents of a preparation to accumulate in biota and, eventually, to pass through the food chain, with reference to the octanol-water partition coefficient (Kow) and bioconcentration factor (BCF), if available.

12.5.  Results of PBT assessment

Where a chemical safety report is required, the results of the PBT assessment as set in the Chemical Safety Report shall be given.

12.6.  Other adverse effects

If available, include information on any other adverse effects on the environment, e.g. ozone depletion potential, photochemical ozone creation potential, endocrine disrupting potential and/or global warming potential.

Remarks

Ensure that information relevant to the environment is provided under other headings of the safety data sheet, especially advice for controlled release, accidental release measures, transport and disposal considerations under headings 6, 7, 13, 14 and 15.

13.  DISPOSAL CONSIDERATIONS

If the disposal of the substance or preparation (surplus or waste resulting from the foreseeable use) presents a danger, a description of these residues and information on their safe handling shall be given.

Specify the appropriate methods of disposal of both the substance or preparation and any contaminated packaging (incineration, recycling, landfilling, etc.).

Where a chemical safety report is required, the information on the waste management measures that adequately control exposure of humans and the environment to the substance shall be consistent with the exposure scenarios set out in the annex to the safety data sheet.

Note

Refer to any relevant Community provisions relating to waste. In their absence, it is useful to remind the user that national or regional provisions may be in force.

14.  TRANSPORT INFORMATION

Indicate any special precautions which a user needs to be aware of or needs to comply with in connection with transport or conveyance either within or outside his premises. Where relevant, provide information on the transport classification for each of the modal regulations: IMDG (sea), ADR (road, Directive 94/55/EC), RID (rail, Council Directive 96/49/EC (1) ), ICAO/IATA (air). This might include inter alia:

   UN number,
   class,
   proper shipping name,
   packing group,
   marine pollutant,
   other applicable information.

15.  REGULATORY INFORMATION

Give the health, safety and environmental information shown on the label according to Directives 67/548/EEC and 1999/45/EC.

If the substance or preparation covered by this safety data sheet is the subject of specific provisions in relation to protection of man or the environment at Community level (e.g. authorisations given under Title VII or restrictions under Title VIII) these provisions shall, as far as is possible, be stated.

Also mention, where possible, the national laws which implement these provisions and any other national measures that may be relevant.

16.  OTHER INFORMATION

Indicate any other information which the supplier assesses as being of importance for the health and safety of the user and for the protection of the environment, for example:

   list of relevant R phrases. Write out the full text of any R phrases referred to under headings  2 and 3 of the safety data sheet,
   training advice,
   recommended restrictions on use (i.e. non-statutory recommendations by supplier),
   further information (written references and/or technical contact point),
   sources of key data used to compile the data sheet,

For a revised safety data sheet, indicate clearly the information, which has been added, deleted or revised (unless this has been indicated elsewhere).

ANNEX IB

CHEMICAL SAFETY ASSESSMENTS FOR PREPARATIONS

A chemical safety assessment for a preparation shall be conducted in accordance with Annex I with the following modifications:

1.  INFORMATION BASE

The chemical safety assessment for a preparation shall be based on the information on the individual substances in the preparation contained in the technical dossier and/or the information communicated by the supplier in the safety data sheet. It shall also be based on the information available on the preparation itself.

2.  HAZARD ASSESSMENTS

The hazard assessments (human health, human health for physicochemical properties and environmental) shall be carried out in accordance with Sections 1, 2 and 3 with the following alterations:

(a)  For the evaluation of data step(s), any relevant data for the preparation, the classification for each substance in the preparation and any specific concentration limits for each substance in the preparation shall be presented.

(b)  For the classification and labelling step, the classification and labelling for the preparation in accordance with Directive  1999/45/EC shall be presented and justified.

(c)  For the derivation of derived no-effect levels (Dnels), the Dnel for each substance in the preparation with an appropriate reference to the safety data sheet of the supplier shall be listed, as well as the Dnel derived for the preparation, with a justification on their derivation. In lack of any information to the contrary, then additivity of effects shall be assumed. The Dnels for the preparation can then be calculated for each route of exposure and each exposure scenario as a weighted average of the Dnels for each substance in the preparation, with the weights being the fraction of the exposure to the substance in the preparation to the total exposure to all substances in the preparation.

(d)  For the derivation of the predicted no-effect concentrations (Pnecs), the Pnec for each substance in the preparation with an appropriate reference to the safety data sheet of the supplier shall be listed, as well as the Pnecs derived for the preparation, with a justification on their derivation. In lack of any information to the contrary, then additivity of effects shall be assumed. The Pnecs for the preparation can then be calculated for each environmental sphere and each exposure scenario as a weighted average of the Pnecs for each substance in the preparation, with the weights being the fraction of the exposure to the substance in the preparation to the total exposure to all substances in the preparation.

3.  PBT ASSESSMENT

If the preparation contains a substance fulfilling the criteria given in Annex XII, then this shall be stated in the chemical safety report.

4.  EXPOSURE ASSESSMENT

4.1  The objective of the exposure assessment shall be to make a quantitative or qualitative estimate of the dose/concentration of the preparation to which humans and the environment are or may be exposed.

4.2  Exposure scenarios shall be developed in accordance with Section 5.1 of Annex I. Exposure shall be estimated for each exposure scenario developed and for each substance in the preparation in accordance with Section 5.2 of Annex I.

4.3  Assuming additivity of effects, then for each route of human exposure and each human population and for each environmental sphere, the estimation of the exposure level to the preparation is the sum of the estimates of the exposure level to each substance in the preparation.

ANNEX IC

CRITERIA FOR PHASE-IN SUBSTANCES REGISTERED IN QUANTITIES BETWEEN 1 AND 10 TONNES PER YEAR PER MANUFACTURER OR IMPORTER FOR WHICH THE FULL INFORMATION SPECIFIED IN ANNEX V IS REQUIRED

The technical dossier referred to in Article 11(a) shall include the full information specified in Annex V where the registrant considers that either:

  a) there is an indication on the basis of available data or on the basis of available and valid (quantitative) structure – activity relationship (Q)SARs) that the substance may meet:
   - the criteria for classification as carcinogenic, mutagenic or toxic for reproduction; or
   - the criteria in Annex XII (PBT, vPvB); or
   b) the substance is likely to fulfil the criteria for classification on the basis of available information as dangerous with regard to human health or the environment and
   - the substance is used as such or in preparations intended for consumer use or professional use; or
   - the substance is incorporated into an article intended for consumer use and is intended to be released from an article during normal or foreseeable use conditions of use.

The Agency shall provide an electronic tool for QSAR on its website which provides reliable results and is easy for SMEs to apply.

ANNEX II

EXEMPTIONS FROM OBLIGATION TO REGISTER

IN ACCORDANCE WITH ARTICLE 4 (1) (A)

EINECS no

Name/Group

CAS no

200-061-5

D-glucitol C 6 H 14 O 6

50-70-4

200-066-2

Ascorbic acid C 6 H 8 O 6

50-81-7

200-075-1

Glucose C 6 H 12 O 6

50-99-7

200-294-2

L-lysine C 6 H 14 N 2 O 2

56-87-1

200-312-9

Palmitic acid, pure C 16 H 32 O 2

57-10-3

200-313-4

Stearic acid, pure C 18 H 36 O 2

57-11-4

200-334-9

Sucrose, pure C 12 H 22 O 11

57-50-1

200-405-4

α-tocopheryl acetate C 31 H 52 O 3

58-95-7

200-432-1

DL-methionine C 5 H 11 NO 2 S

59-51-8

200-578-6

Ethanol

64-17-5

200-711-8

D-mannitol C 6 H 14 O 6

69-65-8

200-812-7

Methane CH 4

78-82-8

201-771-8

1-sorbose C 6 H 12 O 6

87-79-6

204-007-1

Oleic acid, pure C 18 H 34 O 2

112-80-1

204-664-4

Glycerol stearate, pure C 21 H 42 O 4

123-94-4

204-696-9

Carbon dioxide CO 2

124-38-9

205-278-9

Calcium pantothenate, D-form C 9 H 17 NO 5 .1/2Ca

137-08-6

EINECS no

Name/Group

CAS no

205-582-1

Lauric acid, pure C 12 H 24 O 2

143-07-7

205-590-5

Potassium oleate C 18 H 34 O 2 K

143-18-0

205-756-7

DL-phenylalanine C 9 H 11 NO 2

150-30-1

208-407-7

Sodium gluconate C 6 H 12 O 7 .Na

527-07-1

212-490-5

Sodium stearate, pure C 18 H 36 O 2 .Na

822-16-2

215-171-9

Magnesia

1309-48-4

215-279-6

Limestone

A noncombustible solid characteristic of sedimentary rock. It consists primarily of calcium carbonate

1317-65-3

215-665-4

Sorbitan oleate C 24 H 44 O 6

1338-43-8

216-472-8

Calcium distearate, pure C 18 H 36 O 2 .1/2Ca

1592-23-0

231-096-4

Iron

7439-89-6

231-098-5

Krypton Kr

7439-90-9

231-110-9

Neon Ne

7440-01-9

231-147-0

Argon Ar

7440-37-1

231-153-3

Carbon C

7440-44-0

231-168-5

Helium He

7440-59-7

231-172-7

Xenon Xe

7440-63-3

231-783-9

Nitrogen N2

7727-37-9

EINECS no

Name/Group

CAS no

231-791-2

Water, distilled, conductivity or of similar purity H 2 O

7732-18-5

231-955-3

Graphite C

7782-42-5

231-959-9

Oxygen O 2

7782-44-7

232-50-59

Na - lignosulphonate

8061-51-6

232-50-64

Ca lignosulphonate

8061-52-7

232-50-85

NH 4 - lignosulphonate

8061-53-8

232-51-06

Lignosulphonic acid

8062-15-5

232-273-9

Sunflower oil

Extractives and their physically modified derivatives. It consists primarily of the glycerides of the fatty acids linoleic, and oleic. (Helianthus annuus, Compositae).

8001-21-6

232-274-4

Soybean oil

Extractives and their physically modified derivatives. It consists primarily of the glycerides of the fatty acids linoleic, oleic, palmitic and stearic (Soja hispida, Leguminosae).

8001-22-7

EINECS no

Name/Group

CAS no

232-276-5

Safflower oil

Extractives and their physically modified derivatives. It consists primarily of the glycerides of the fatty acid linoleic (Carthamus tinctorius, Compositae).

8001-23-8

232-278-6

Linseed oil

Extractives and their physically modified derivatives. It consists primarily of the glycerides of the fatty acids linoleic, linolenic and oleic (Linum usitatissimum, Linaceae).

8001-26-1

232-281-2

Corn oil

Extractives and their physically modified derivatives. It consists primarily of the glycerides of the fatty acids linoleic, oleic, palmitic and stearic. (Zea mays, Gramineae).

8001-30-7

232-282-8

Coconut oil

Extractives and their physically modified derivatives.

8002-31-8

232-293-8

Castor Oil

Extractives and their physically modified derivatives. It consists primarily of the glycerides of the fatty acid ricinoleic (Ricinus communis, Euphorbiaceae).

8001-79-4

EINECS no

Name/Group

CAS no

232-296-4

Peanut oil

Extractives and their physically modified derivatives.

8002-03-7

232-299-0

Rape oil

Extractives and their physically modified derivatives. It consists primarily of the glycerides of the fatty acids erucic, linoleic and oleic (Brassica napus, Cruciferae).

8002-13-9

232-304-6

Crude Tall Oil

8002-26-4

232-307-2

Lecithins

The complex combination of diglycerides of fatty acids linked to the choline ester of phosphoric acid.

8002-43-5

232-316-1

Palm oil

Extractives and their physically modified derivatives.

8002-75-3

232-350-7

Turpentine oil/wood turpentine

8006-64-2

232-370-6

Sesame seed oil

Extractives and their physically modified derivatives.

8008-74-0

232-425-4

Palmkernel oil

Extractives and their physically modified derivatives.

8023-79-8

EINECS no

Name/Group

CAS no

232-436-4

Syrups, hydrolyzed starch

A complex combination obtained by the hydrolysis of cornstarch by the action of acids or enzymes. It consists primarily of d-glucose, maltose and maltodextrins.

8029-43-4

232-442-7

Tallow, hydrogenated

8030-12-4

232-675-4

Dextrin

9004-53-9

232-679-6

Starch

High-polymeric carbohydrate material usually derived form cereal grains such as corn, wheat and sorghum, and from roots and tubers such as potatoes and tapioca. Includes starch which has been pregelatinised by heating in the presence of water.

9005-25-8

232-940-4

Maltodextrin

9050-36-6

234-328-2

Vitamin A

11103-57-4

238-976-7

Sodium D-gluconate C 6 H 12 O 7 .xNa

14906-97-9

248-027-9

D-glucitol monostearate C 24 H 48 O 7

26836-47-5

262-988-1

Fatty acids, coco, Me esters

61788-59-8

262-989-7

Fatty acids, tallow, Me esters

61788-61-2

263-060-9

Fatty acids, castor-oil

61789-44-4

263-129-3

Fatty acids, tallow

61790-37-2

265-995-8

Cellulose pulp

65996-61-4

266-9-484

Shea butter

Extractives and their physically modified derivatives.

EINECS no

Name/Group

CAS no

266-046-0

Glass, oxide

65997-17-3

266-925-9

Fatty acids, C12-18

This substance is identified by SDA Substance Name: C12-C18 alkyl carboxylic acid and SDA Reporting Number: 16-005-00.

67701-01-3

266-928-5

Fatty acids C16-18

This substance is identified by SDA Substance Name: C16-C18 alkyl carboxylic acid and SDA Reporting Number: 19-005-00.

67701-03-5

266-929-0

Fatty acids, C8-18 and C18-unsatd.

This substance is identified by SDA Substance Name: C8-C18 and C18 unsaturated alkyl carboxylic acid and SDA Reporting Number: 01-005-00.

67701-05-7

266-930-6

Fatty acids, C14-18 and C16-18-unsatd.

This substance is identified by SDA Substance Name: C14-C18 and C16-C18 unsaturated alkyl carboxylic acid and SDA Reporting Number: 04-005-00

67701-06-8

266-932-7

Fatty acids, C16-C18 and C18-unsatd.

This substance is identified by SDA Substance Name: C16-C18 and C18 unsaturated alkyl carboxylic acid and SDA Reporting Number: 11-005-00

67701-08-0

EINECS no

Name/Group

CAS no

266-948-4

Glycerides, C16-18 and C18-unsatd.

This substance is identified by SDA Substance Name: C16-C18 and C18 unsaturated trialkyl glyceride and SDA Reporting Number: 11-001-00.

67701-30-8

267-007-0

Fatty acids, C14-18 and C16-18-unsatd., Me esters

This substance is identified by SDA Substance Name: C14-C18 and C16-C18 unsaturated alkyl carboxylic acid methyl ester and SDA Reporting Number: 04-010-00.

67762-26-9

267-013-3

Fatty acids, C6-12

This substance is identified by SDA Substance Name: C6-C12 alkyl carboxylic acid and SDA Reporting Number: 13-005-00.

67762-36-1

268-099-5

Fatty acids, C14-22 and C16-22 unsatd.

This substance is identified by SDA Substance Name: C14-C22 and C16-C22 unsaturated alkyl carboxylic acid and SDA Reporting Number: 07-005-00

68002-85-7

268-616-4

Syrups, corn, dehydrated

68131-37-3

269-657-0

Fatty acids, soya

68308-53-2

269-658-6

Glycerides, tallow mono- , di- and tri-, hydrogenated

68308-54-3

270-298-7

Fatty acids, C14-22

68424-37-3

EINECS no

Name/Group

CAS no

270-304-8

Fatty acids, linseed-oil

68424-45-3

270-312-1

Glycerides, C16-18 and C18-unsatd. mono- and di-

This substance is identified by SDA Substance Name: C16-C18 and C18 unsaturated alkyl and C16-C18 and C18 unsaturated dialkyl glyceride and SDA Reporting Number: 11-002-00.

68424-61-3

288-123-8

Glycerides, C10-18

85665-33-4

292-771-7

Fatty acids, C12-14

90990-10-6

292-776-4

Fatty acids, C12-18 and C18-unsatd.

90990-15-1

294-851-7

Illipe fat

Extractives and their physically modified derivatives.

Sal oil

Extractives and their physically modified derivatives.

Almond oil

Extractives and their physically modified derivatives.

8007-69-0

Hazelnut oil

Extractives and their physically modified derivatives.

EINECS no

Name/Group

CAS no

Walnut oil

Extractives and their physically modified derivatives.

8024-09-7

Cashew nut oil

Extractives and their physically modified derivatives.

8007-24-7

Brazil nut oil

Extractives and their physically modified derivatives.

Pistachio nut oil

Extractives and their physically modified derivatives.

Macadamia nut oil

Extractives and their physically modified derivatives.

Hydrogenated, interesterified and fractionated soybean oil

Extractives and their physically modified derivatives.

Hydrogenated, interesterified and fractionated rapeseed oil

Extractives and their physically modified derivatives.

EINECS no

Name/Group

CAS no

Hydrogenated, interesterified and fractionated sunflower oil

Extractives and their physically modified derivatives.

Hydrogenated, interesterified and fractionated palm oil

Extractives and their physically modified derivatives.

Hydrogenated, interesterified and fractionated coconut oil

Extractives and their physically modified derivatives.

Hydrogenated, interesterified and fractionated palmkernel oil

Extractives and their physically modified derivatives.

Soybeans, hulls and meals

Extractives and their physically modified derivatives.

Rapeseed, hulls and meals

Extractives and their physically modified derivatives

Sunflower seeds, hulls and meals

Extractives and their physically modified derivatives.

EINECS no

Name/Group

CAS no

Natural gas, crude oil, coal

295-731-7

Non-oxide glass

92128-37-5

296-916-5

Fatty acids, rape-oil, erucic acid-low

93165-31-2

305-415-3

Glass, oxide

94551-67-4

305-416-9

Glass, oxide

94551-68-5

Noble gases

Substances commonly found in foodstuffs, such as citric acid, sugar, oils, fatty acids, etc.

Industrial gases such as hydrogen, methane, oxygen and biogas

Inorganic substances that are common, or the risks of which are well known, e.g. sodium chloride, soda, potash, calcium oxide, gold, silver, aluminium, magnesium, silicates, glass, frit

ANNEX III

EXEMPTIONS FROM THE OBLIGATION TO REGISTER

IN ACCORDANCE WITH ARTICLE 4 (1) (B)

1.  Substances rendered radioactive by either natural or artificial nuclear transformation;

2.  Substances which result from a chemical reaction that occurs incidental to exposure of another substance or article to environmental factors such as air, moisture, microbial organisms or sunlight;

3.  Substances which result from a chemical reaction that occurs incidental to storage of another substance, preparation or article;

4.  Substances which result from a chemical reaction occurring upon end use of other substances, preparations or articles and which are not themselves manufactured, imported or placed on the market;

5.  Substances which result from a chemical reaction that occurs when:

   i) a stabiliser, colorant, flavouring agent, antioxidant, filler, solvent, carrier, surfactant, plasticiser, corrosion inhibitor, antifoamer or defoamer, dispersant, precipitation inhibitor, desiccant, binder, emulsifier, de-emulsifier, dewatering agent, agglomerating agent, adhesion promoter, flow modifier, pH neutraliser, sequesterant, coagulant, flocculant, fire retardant, lubricant, chelating agent, or quality control reagent functions as intended, or
   ii) a substance solely intended to provide a specific physicochemical characteristic functions as intended;

6.  By-products, unless they are imported or placed on the market themselves;

7.  Hydrates of a substance or hydrated ions, formed by association of a substance with water, provided that the substance has been registered by the manufacturer or importer using this exemption;

8.  Substances occurring in nature if they are not chemically modified during their manufacturing, unless they meet the criteria for classification as dangerous according to Directive 67/548/EEC ;

9.  Ores and concentrates derived from them, if they are not chemically modified during their manufacturing;

Natural gas, liquefied petroleum gas (LPG), crude oil, coal;

11.  Minerals, ores and concentrates and other materials derived from them by mineralogical or physical transformation processes;

12.  Process gases such as coke oven gas, blast furnace gas and fuel gas in oil refineries and components thereof.

ANNEX IV

INFORMATION REQUIREMENTS REFERRED TO IN ARTICLE 11

GUIDANCE NOTE

ON FULFILLING THE REQUIREMENTS OF ANNEXES IV TO IX

Annexes IV to IX specify the information that shall be submitted for registration and evaluation purposes according to Articles 11, 13 and 14, 45, 46 and 52 . For the lowest tonnage level, the standard requirements are in Annex V, and every time a new tonnage level is reached, the requirements of the corresponding Annex have to be added. For each registration the precise information requirements will differ, according to tonnage, use and exposure. The Annexes shall thus be considered as a whole, and in conjunction with the overall requirements of registration, evaluation and the duty of care.

STEP 1 – GATHER AND SHARE EXISTING INFORMATION NEEDS

The registrant(s) should gather all existing available test data on the substance to be registered. Potential registrants should share test data, thereby avoiding unnecessary testing and reducing costs. The registrant(s) should also collect all other available information on the substance. This should include alternative data (e.g. from (Q)SARs, read-across from other substances, in-vitro testing, epidemiological data) which may assist in identifying the presence or absence of hazardous properties of the substance and which can in certain cases replace the results of animal tests. In addition, information on exposure, use and risk management measures in accordance with Article 11 and Annex V should be collected. Considering all this information together, the registrant(s) will be able to determine the need to generate further information.

STEP 2 – CONSIDER INFORMATION NEEDS

The registrant shall identify what information is required for the registration. First, the relevant Annex or Annexes to be followed shall be identified, according to tonnage. These Annexes set out the standard information requirements, but shall be considered in conjunction with Annex IX, which allows variation from the standard approach, where it can be justified. In particular, information on exposure, use and risk management measures shall be considered at this stage in order to determine the information needs for the substance.

STEP 3 – IDENTIFY INFORMATION GAPS

The registrant shall then compare the information needs for the substance with the information already available and identify where there are gaps. It is important at this stage to ensure that the available data is relevant and sufficient to fulfil requirements.

STEP 4 – GENERATE NEW DATA/PROPOSE TESTING STRATEGY

In some cases it will not be necessary to generate new data. However, where there is an information gap that needs to be filled, new data shall be generated (Annexes V and VI), or a testing strategy shall be proposed (Annexes VII and VIII), depending on the tonnage. New tests on vertebrate animals shall only be conducted or proposed as a last resort when all other data sources have been exhausted.

In some cases, the rules set out in Annex V to IX may require certain tests to be undertaken earlier than or in addition to the standard requirements.

NOTES

Note 1: If it is not technically possible, or if it does not appear scientifically necessary to give information, the reasons shall be clearly stated, in accordance with the relevant provisions.

Note 2: The registrant may wish to declare that certain information submitted in the registration dossier is confidential. If this is the case, he shall list the items and provide a justification in accordance with Article 126.

INFORMATION REFERRED TO IN ARTICLE 11 (A) (I) TO (V)

1.  GENERAL REGISTRANT INFORMATION

1.1.  Registrant

1.1.1.  Name, address, telephone number, fax number and e-mail address

1.1.2.  Contact person

1.1.3.  Location of the registrant's production and own use site(s), as appropriate

1.2.  Joint submission of data by consortia: other consortia members

Articles 12 or 19 foresee that parts of the registration may be submitted by one manufacturer or importer on behalf of other members of the consortium.

In this case, that manufacturer or importer shall identify the other members of the consortium specifying:

   their name, address, telephone number, fax number and e-mail address,
   parts of the present registration which apply to other members of the consortium.

Mention the number(s) given in Annex IV, V, VI, VII or VIII, as appropriate.

Any other consortium members shall identify the manufacturer/importer submitting on his behalf specifying:

   his name, address, telephone number, fax number and e-mail address,
   parts of the registration which are submitted by those manufacturer(s) or importer(s).

Mention the number(s) given in Annex IV, V, VI, VII or VIII, as appropriate.

2.  IDENTITIFICATION OF THE SUBSTANCE

For each substance, the information given in this section shall be sufficient to enable each substance to be identified. If it is not technically possible or if it does not appear scientifically necessary to give information on one or more of the items below, the reasons shall be clearly stated.

2.1.  Name or other identifier of each substance

2.1.1.  Name(s) in the Iupac nomenclature or other international chemical name(s)

2.1.2.  Other names (usual name, trade name, abbreviation)

2.1.3.  Einecs or Elincs number (if available and appropriate)

2.1.4.  CAS name and CAS number (if available)

2.1.5.  Other identity code (if available)

2.2.  Information related to molecular and structural formula of each substance

2.2.1.  Molecular and structural formula (including Smiles notation, if available)

2.2.2  Information on optical activity (if applicable and appropriate)

2.2.3.  Molecular weight or molecular weight range

2.3.  Composition of each substance

2.3.1.  Degree of purity (%)

2.3.2.  Nature of impurities, including isomers and by-products

2.3.3.  Percentage of (significant) main impurities

2.3.4.  Nature and order of magnitude (......ppm, ......%) of any additives (e.g. stabilising agents or inhibitors)

2.3.5.  Spectral data (ultra-violet, infra-red, nuclear magnetic resonance or mass spectrum)

2.3.6.  High-pressure liquid chromatogram, gas chromatogram

2.3.7.  Description of the analytical methods or the appropriate bibliographical references for the identification of the substance and, where appropriate, for the identification of impurities and additives. This information shall be sufficient to allow the methods to be reproduced.

3.  INFORMATION ON MANUFACTURE AND USE(S) OF THE SUBSTANCE(S)

3.1.  Overall manufacture and/or imports in tonnes per manufacturer or importer per year in:

3.1.1.  The calendar year of the registration (estimated quantity)

3.2.  In case of a manufacturer: Brief description of the technological process used in manufacture

Precise details of the process, particularly those of a commercially sensitive nature, are not required.

3.3.  An indication of the tonnage used for his own use(s)

3.4.  Form (substance, preparation or article) and/or physical state under which the substance is made available to downstream users and/or consumers . Concentration or concentration range of the substance in preparations made available to downstream users and quantities of the substance in articles made available to downstream users.

3.5.  Brief general description of the identified use(s)

3.6.  Waste quantities and composition of waste resulting from production and identified uses (where known)

3.7.  Uses advised against (see safety data sheet heading 16)

Where applicable, an indication of the uses, which the registrant advises against and why (i.e. non-statutory recommendations by supplier). This need not be an exhaustive list.

4.  CLASSIFICATION AND LABELLING

4.1.  The hazard classification of the substance(s), resulting from the application of Articles 4 and 6 of Directive 67/548/EEC;

In addition, for each entry, the reasons why no classification is given for an endpoint should be provided (i.e. if data are lacking, inconclusive, or conclusive but not sufficient for classification);

4.2.  The resulting hazard label for the substance(s), resulting from the application of Articles 23 to 25 of Directive 67/548/EEC;

4.3.  Specific concentration limits, where applicable, resulting from the application of Article 4 (4) of Directive 67/548/EEC and Articles 4 to 7 of Directive 1999/45/EC.

5.  GUIDANCE ON SAFE USE CONCERNING:

This information shall be consistent with that in the Safety Data Sheet, where such a Safety Data Sheet is required according to Article 33 of this Regulation.

5.1.  First-aid measures (safety data sheet heading 4)

5.2.  Fire-fighting measures (safety data sheet heading 5)

5.3.  Accidental release measures (safety data sheet heading 6)

5.4.  Handling and Storage (safety data sheet heading 7)

5.5.  Transport information (safety data sheet heading 14)

Where a chemical safety report is not required, the following additional information is required:

5.6.  Exposure Controls/Personal Protection (safety data sheet heading 8)

5.7.  Stability and Reactivity (safety data sheet heading 10)

5.8.  Disposal considerations

5.8.1.  Disposal considerations (safety data sheet heading 13)

5.8.2.  Information on recycling and methods of disposal for industry

5.8.3  Information on recycling and methods of disposal for the public

6.  USE AND EXPOSURE CATEGORIES

6.1.  Main use category

   a) industrial use and/or
   b) professional use and/or
   c) consumer use.

6.1.1.  Specification for industrial and professional use:

   a) used in closed system and/or
   b) use resulting in inclusion into or onto matrix and/or
   c) non-dispersive use and/or
   d) dispersive use.

6.2.  Significant route(s) of exposure:

6.2.1.  Human exposure:

   a) oral and/or
   b) dermal and/or
   c) inhalatory.

6.2.2.  Environmental exposure:

   a) water and/or
   b) air and/or
   c) solid waste and/or
   d) soil.

6.3.  Pattern of exposure:

   a) accidental/infrequent and/or
   b) occasional and/or
   c) continuous /frequent.

ANNEX V

STANDARD INFORMATION REQUIREMENTS FOR SUBSTANCES MANUFACTURED OR IMPORTED IN QUANTITIES OF 1 TONNE OR MORE

Column 1 of this Annex establishes the standard information required for all substances manufactured or imported in quantities of 1 tonne or more in accordance with Article 13 (1)(a). Column 2 of this Annex lists specific rules according to which the required standard information may be omitted, replaced by other information, provided at a different stage or adapted in another way. If the conditions are met under which column 2 of this Annex allows adaptations, the registrant shall clearly state this fact and the reasons for each adaptation under the appropriate headings in the registration dossier.

At the level of this Annex, the registrant must submit a proposal and a time schedule for fulfilling the information requirements of this Annex in accordance with Article 13(1)(a) where this involves tests on vertebrate animals.

In addition to these specific rules, a registrant may adapt the required standard information set out in column 1 of this Annex according to the general rules contained in Annex IX. In this case as well, he shall clearly state the reasons for any decision to adapt the standard information under the appropriate headings in the registration dossier referring to the appropriate specific rule(s) in column 2 or in Annexes IX or X(81) .

Before new tests are carried out to determine the properties listed in this Annex, all available in vitro data, in vivo data, historical data, data from valid (Q)SARs and data from structurally related substances (read-across approach) shall be assessed first.

When, for certain endpoints, information is not provided for other reasons than those mentioned in column 2 of this Annex or in Annex IX, this fact and the reasons shall also be clearly stated.

5.   information on the physicochemical properties of the substance

Column 1

Standard information required

Column 2

Specific rules for adaptation from Column 1

5.1. State of the substance at 20o C and 101,3 kPa

5.2. Melting/freezing point

5.2. The study does not need to be conducted for solids and liquids with a melting/freezing point below 0 °C.

5.3. Boiling point

5.3. The study does not need to be conducted:

– for gases; or

– for solids which either melt above 360 °C or decompose before boiling. In such cases the boiling point under reduced pressure may be estimated or measured; or

– for substances which decompose before boiling (e.g. auto-oxidation, rearrangement, degradation, decomposition, etc.).

5.4. Relative density

5.4. The study does not need to be conducted if:

– the substance is only stable in solution in a particular solvent and the solution density is similar to that of the solvent. In such cases, an indication of whether the solution density is higher or lower than the solvent density is sufficient; or

– the substance is a gas. In this case, an estimation based on calculation shall be made from its molecular weight and the Ideal Gas Laws.

5.5. Vapour pressure

5.5. The study does not need to be conducted if:

– a transition (change of physical state or decomposition) is observed. The following information should then be included: nature of the transition, temperature at which the transition occurs at atmospheric pressure, vapour pressure at 10 and 20 °C above this temperature (unless the transition is from solid to gas); or

– the melting point is above 300 °C.

If the melting point is between 200 °C and 300 °C, a limit value based on measurement or a recognised calculation method is sufficient.

5.6. Surface tension

5.6. The study does not need to be conducted if:

– the water solubility is below 1 mg/l at 20 °C or

– the substance forms micelles in the relevant concentration range for testing.

5.7. Water solubility

5.7. The study does not need to be conducted if:

– the substance is hydrolytically unstable (half-life less than 12 hours); or

– the substance is readily oxidisable in water.

If the substance appears "insoluble" in water, a limit test up to the detection limit of the analytical method shall be performed.

5.8. Partition coefficient n-octanol/water

5.8. The study does not need to be conducted if the substance is inorganic. If the test cannot be performed (e.g. the substance decomposes, has a high surface activity, reacts violently during the performance of the test or does not dissolve in water or in octanol, or it is not possible to obtain a sufficiently pure substance), a calculated value for log P as well as details of the calculation method shall be provided.

5.9. Flash-point

5.9. The study does not need to be conducted if:

the substance is inorganic; or

the substance only contains volatile organic components with flash-points above 100 °C for aqueous solutions; or

the estimated flash-point is above 200 °C; or

the flash-point can be accurately predicted by interpolation from existing characterised materials.

5.10. Flammability

5.10. The study does not need to be conducted:

if the substance is a solid which possesses explosive or pyrophoric properties. These properties should always be considered before considering flammability; or

for gases, if the concentration of the flammable gas in a mixture with inert gases is so low that, when mixed with air, the concentration is all time below the lower limit; or

for substances which spontaneously ignite when in contact with air.

5.11. Explosive properties

5.11 . The study does not need to be conducted if:

there are no chemical groups associated with explosive properties present in the molecule; or

the substance contains chemical groups associated with explosive properties which include oxygen and the calculated oxygen balance is less than –200; or

the organic substance or a homogenous mixture of organic substances contains chemical groups associated with explosive properties, but the exothermic decomposition energy is less than 500 J/g and the onset of exothermic decomposition is below 500 ºC; or

for mixtures of inorganic oxidising substances (UN Division 5.1) with organic materials, the concentration of the inorganic oxidising substance is:

less than 15%, by mass, if assigned to UN Packaging Group I (high hazard) or II (medium hazard)

less than 30%, by mass, if assigned to UN Packaging Group III (low hazard).

Note: Neither a test for propagation of detonation nor a test for sensitivity to detonative shock is required if the exothermic decomposition energy of organic materials is less than 800 J/g.

5.12. Self-ignition temperature

5.12 . The study does not need to be conducted:

if the substance is explosive or ignites spontaneously with air at room temperature; or

for liquids non flammable in air, e.g. no flash point up to 200 °C; or

for gases having no flammable range; or

for solids, if the substance has a melting point < 160 °C, or if preliminary results exclude self-heating of the substance up to 400 °C.

5.13. Oxidising properties

5.13 . The study does not need to be conducted if:

the substance is explosive; or

the substance is highly flammable; or

the substance is an organic peroxide; or

the substance is incapable of reacting exothermically with combustible materials, for example on the basis of the chemical structure (e.g. organic substances not containing oxygen or halogen atoms and these elements are not chemically bonded to nitrogen or oxygen, or inorganic substances not containing oxygen or halogen atoms).

The full test does not need to be conducted for solids if the preliminary test clearly indicates that the test substance has oxidising properties.

Note that as there is no test method to determine the oxidising properties of gaseous mixtures, the evaluation of these properties must be realised by an estimation method based on the comparison of the oxidising potential of gases in a mixture with that of the oxidising potential of oxygen in air.

5.14. Granulometry

5.14 . The study does not need to be conducted if the substance is marketed or used in a non solid or granular form.

6.   toxicological information

In vivo testing with corrosive substances at concentration/dose levels causing corrosivity shall be avoided.

Column 1

Standard information required

Column 2

Specific rules for adaptation from Column 1

6.1. Skin irritation or skin corrosion

6.1. Steps 3 and 4 do not need to be conducted if:

The assessment of this endpoint shall comprise the following consecutive steps:

(1) an assessment of the available human and animal data,

(2) an assessment of the acid or alkaline reserve ,

(3) in vitro study for skin corrosion,

(4) in vitro study for skin irritation.

the available information indicates that the criteria are met for classification as corrosive to the skin or irritating to eyes ; or

the substance is flammable in air at room temperature; or

– the substance is classified as very toxic in contact with skin; or

an acute toxicity study by the dermal route does not indicate skin irritation up to the limit dose level (2000 mg/kg body weight).

6.2. Eye irritation

6.2. Step 3 does not need to be conducted if:

The assessment of this endpoint shall comprise the following consecutive steps:

(1) an assessment of the available human and animal data,

the available information indicates that the criteria are met for classification as corrosive to the skin or irritating to eyes ; or

the substance is flammable in air at room temperature .

(2) an assessment of the acid or alkaline reserve ,

(3) in vitro study for eye irritation.

6.3. Skin sensitisation

6.3. Step 2 does not need to be conducted if:

The assessment of this endpoint shall comprise the following consecutive steps:

(1) an assessment of the available human, animal and alternative data,

(2) In vivo testing.

the available information indicates that the substance should be classified for skin sensitisation or corrosivity ; or

– the substance is a strong acid (pH < 2.0) or base (pH > 11.5); or

– the substance is flammable in air at room temperature .

The Murine Local Lymph Node Assay ( LLNA) is the first-choice method for in vivo testing. Only in exceptional circumstances should another test be used. Justification for the use of another test shall be provided .

6.4. Mutagenicity

6.4. Further mutagenicity studies shall be considered in case of a positive result.

6.4.1. In vitro gene mutation study in bacteria

6.4.1. A study does not usually need to be conducted if the substance is known to be carcinogenic category 1 or 2 or mutagenic category 1, 2 or 3.

If the screening criteria in point (a) of Annex Ic are fulfilled for carcinogenicity and mutagenicity and the company does not introduce and recommend appropriate risk management then suitable further mutagenicity testing shall be performed by the registrant.

6.5. Acute toxicity

6.5. The study/ies do(es) not generally need to be conducted if:

the substance is corrosive; or

precise dosage of the substance cannot be administered due to the chemical or physical properties of the substance; or

the substance is flammable in air at room temperature.

The study need not be conducted if a study on acute toxicity by the inhalation route (6.5.2) or dermal route (6.5.3) is available.

6.5.1. By oral route

7.   ecotoxicological information

Column 1

Standard information required

Column 2

Specific rules for adaptation from Column 1

7.1. Aquatic toxicity

7.1.1. Short-term toxicity testing on invertebrates (preferred species Daphnia)

The registrant may consider long-term toxicity testing instead of short-term.

7.1.1. The study does not need to be conducted if:

there are mitigating factors indicating that aquatic toxicity is unlikely to occur, for instance if the substance is highly insoluble in water or the substance is unlikely to cross biological membranes; or

a short-term or long-term study on fish is available; or

– a long-term aquatic toxicity study on invertebrates is available; or

adequate information for environmental classification and labelling is available.

The long-term aquatic toxicity study on Daphnia (Annex VII, 7.1.5) shall be conducted if the comparison of the (predicted) environmental exposure with the results from the short-term aquatic toxicity data indicates the need to investigate further the effects on aquatic organisms;

The long-term aquatic toxicity study on Daphnia (Annex VII, 7.1.5) shall be considered if the substance is poorly water soluble .

If the screening criteria in Annex Ic (a) are fulfilled for PBT or vPvB or Annex Ic(b) for environmental concerns and the company does not introduce and recommend appropriate risk management then suitable further environmental testing shall be performed by the registrant.

7.2. Degradation

7.2.1. Biotic

7.2.1.1. Ready biodegradability

7.2.1.1. .The study does not need to be conducted if the substance is inorganic.

8.  OTHER AVAILABLE PHYSICOCHEMICAL, TOXICOLOGICAL AND ECOTOXICOLOGICAL INFORMATION

Any other relevant physicochemical, toxicological and ecotoxicological information that is available shall be provided.

ANNEX VI

Additional standard information requirements for substances manufactured or imported in quantities of 10 tonnes or more

Column 1 of this Annex establishes the standard information required for all substances manufactured or imported in quantities of 10 tonnes or more in accordance with Article 13  (1) (b). Accordingly, the information required in column 1 of this Annex is additional to that required in column 1 of Annex V. Column 2 of this Annex lists specific rules according to which the required standard information may be omitted, replaced by other information, provided at a different stage or adapted in another way. If the conditions are met under which column 2 of this Annex allows adaptations, the registrant shall clearly state this fact and the reasons for each adaptation under the appropriate headings in the registration dossier.

In addition to these specific rules, a registrant may adapt the required standard information set out in column 1 of this Annex according to the general rules contained in Annex IX. In this case as well, he shall clearly state the reasons for any decision to adapt the standard information under the appropriate headings in the registration dossier referring to the appropriate specific rule(s) in column 2 or in Annexes IX or X(82) .

At the level of this Annex, the registrant must submit a proposal and a time schedule for fulfilling the information requirements of this Annex in accordance with Article 13(1) (b) where this involves tests on vertebrate animals.

Before new tests are carried out to determine the properties listed in this Annex, all available in vitro data, in vivo data, historical data, data from valid (Q)SARs and data from structurally related substances (read-across approach) shall be assessed first.

When, for certain endpoints, information is not provided for other reasons than those mentioned in column 2 of this Annex or in Annex IX, this fact and the reasons shall also be clearly stated.

6.  TOXICOLOGICAL INFORMATION

In vivo testing with corrosive substances at concentration/dose levels causing corrosivity shall be avoided.

Column 1

Standard information required

Column 2

Specific rules for adaptation from Column 1

6.1. Skin irritation

6.1.1. In vivo skin irritation

6.1.1. The study does not need to be conducted if:

– the substance is classified as corrosive to the skin/irritant on the basis of the assessment of the endpoint according to Annex V ; or

– the substance is a strong acid (pH < 2.0) or base (pH > 11.5); or

– the substance is flammable in air at room temperature; or

– the substance is classified as very toxic in contact with skin; or

– the acute toxicity study by the dermal route does not indicate skin irritation up to the limit dose level (2000 mg/kg body weight).

6.2. Eye irritation

6.2.1. In vivo eye irritation

6.2.1. The study does not need to be conducted if:

the substance is classified as irritating to eyes with risk of serious damage to eyes on the basis of the assessment of the endpoint according to Annex V; or

– the substance is classified as corrosive to the skin, provided that the registrant has classified the substance as eye irritant ; or

– the substance is a strong acid (pH < 2.0) or base (pH > 11.5); or

– the substance is flammable in air at room temperature .

6.4. Mutagenicity

6.4.2. In vitro cytogenicity study in mammalian cells or in vitro micronucleus study

6.4.2 These studies (6.4.2 and 6.4.3) do not usually need to be conducted if:

adequate data from an in vivo test are available; or

– the substance is known to be carcinogenic category 1 or 2 or mutagenic category 1, 2 or 3, or the registrant implements and, where necessary, recommends risk management measure as if this were the case; or

the chemical safety assessment pursuant to Annex I indicates that the risk to health/environment with regard to exposure for the identified uses is not relevant or is adequately controlled, taking into account risk management measures. Section 3 of Annex IX shall apply.

6.4.3. In vitro gene mutation study in mammalian cells, if a negative result in Annex V, 6.4.1. and Annex VI, 6.4.2.

6.4.3. The study does not need to be conducted if adequate data from a reliable in vivo mammalian gene mutation test are available.

6.4. Appropriate in vivo mutagenicity studies shall be considered in case of a positive result in any of the mutagenicity studies in Annex V or VI.

6.5. Acute toxicity

The route of application shall be based on the intended use of the substance or the prepration containing the substance and the related exposure.

The second route for acute toxicity shall only be tested if the information cannot be derived from the other available information.

For gases and volatile liquids (vapour pressure above 10-2 Pa at 20°C ) the information shall be provided for the inhalation route (6.5.2).

6.5. The study/ies do(es) not need to be conducted if:

– precise doses of the substance cannot be administered due to the chemical or physical properties of the substance; or

– the substance is classified as corrosive to the skin ; or

– the substance is flammable in air at room temperature.

For substances other than gases, the information mentioned under 6.5.1. to 6.5.3. shall be provided for at least two routes, one of which the oral route. The choice for the second route will depend on the nature of the substance and the likely route of human exposure. If there is only one route of exposure, information for only that route need be provided.

The appropriate second route shall be chosen on the following basis:

6.5.1. By oral route

6.5.1. If not provided for in Annex V

6.5.2. By inhalation

6.5.2. Testing by the inhalation route is appropriate if exposure of humans via inhalation is likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size .

6.5.3. By dermal route

6.5.3. Testing by the dermal route is appropriate if:

(1) inhalation of the substance is unlikely; and

(2) skin contact in production and/or use is likely; and

(3) the physicochemical and toxicological properties suggest potential for a significant rate of absorption through the skin .

6.6. Repeated dose toxicity

6.6.1. Short-term repeated dose toxicity study (28 days), one species, male and female, most appropriate route of administration, having regard to the likely route of human exposure.

6.6.1. The short-term toxicity study (28 days) does not need to be conducted if:

– a reliable sub-chronic (90 days) or chronic toxicity study is available, provided that an appropriate species, dosage, solvent and route of administration were used; or

– where a substance undergoes immediate disintegration and there are sufficient data on the cleavage products; or

the chemical safety assessment pursuant to Annex I indicates that the risk to health/environment with regard to repeated exposure for the identified uses is not relevant or is adequately controlled taking into account risk management measures. Section 3 of Annex IX shall apply; or

for substances below 100 t/a per manufacturer and importer; or

no repeated consumer or professional exposure occurs (i.e. the criteria in Annex Ic (b) first paragraph are not fulfilled) and no repeated industrial worker exposure occurs; or

the registrant implements and, where necessary, recommends appropriate risk management measures to mitigate the risks of repeated exposure.

The appropriate route shall be chosen on the following basis:

Testing by the dermal route is appropriate if:

(1) inhalation of the substance is unlikely; and

(2) skin contact in production and/or use is likely; and

(3) the physicochemical and toxicological properties suggest potential for a significant rate of absorption through the skin.

Testing by the inhalation route is appropriate if exposure of humans via inhalation is likely, taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size.

The sub-chronic toxicity study (90 days) (Annex VII, 6.6.2) shall be proposed by the registrant if:

– the frequency and duration of human exposure indicates that a longer term study is appropriate; and one of the following conditions is met:

– other available data indicate that the substance may have a dangerous property that cannot be detected in a short-term toxicity study; or

– appropriately designed toxicokinetic studies reveal accumulation of the substance or its metabolites in certain tissues or organs which would possibly remain undetected in a short-term toxicity study but which are liable to result in adverse effects after prolonged exposure.

Further studies shall be proposed by the registrant or may be required by the competent authority of the evaluating Member State in accordance with Article 45 or 46 in case of:

– failure to identify a NOAEL in the 28 or the 90 days study, unless the reason for the failure to identify a NOAEL is absence of adverse toxic effects; or

– toxicity of particular concern (e.g., serious/severe effects); or

– indications of an effect for which the available evidence is inadequate for toxicological and/or risk characterisation; In such cases it may also be more appropriate to perform specific toxicological studies that are designed to investigate these effects (e.g., immunotoxicity, neurotoxicity); or

– the route of exposure used in the initial repeated dose study was inappropriate in relation to the expected route of human exposure and route-to-route extrapolation cannot be made; or

– particular concern regarding exposure (e.g. use in consumer products leading to exposure levels which are close to the dose levels at which toxicity to humans may be expected ); or

– effects shown in substances with a clear relationship in molecular structure with the substance being studied, were not detected in the 28 or the 90 days study.

6.7. Reproductive toxicity

An initial assessment of this endpoint shall take into consideration all available toxicological information (e.g. from the 28-day or 90-day study), in particular information on structurally related substances, from (Q)SAR estimates or from in vitro methods.

6.7. If the initial assessment shows that there is evidence that the substance may be a developmental or reproductive toxicant and the company does not introduce and recommend appropriate risk management measures as if it were classified as reprotoxic category 1 or 2, then suitable further reprotoxicity testing shall be performed by the registrant.

The conditions stated for these studies in Annex VII shall apply.

6.8 Toxicokinetics

6.8.1. Assessment of the toxicokinetic behaviour of the substance to the extent that can be derived from the relevant available information

7.   ecotoxicological information

Column 1

Standard information required

Column 2

Specific rules for adaptation from Column 1

7.1. Aquatic toxicity

7.1.2. Growth inhibition study on aquatic plants ( algae preferred)

7.1.2. The study does not need to be conducted if there are mitigating factors indicating that aquatic toxicity is unlikely to occur for instance if the substance is highly insoluble in water or the substance is unlikely to cross biological membranes .

7.1.3. Short-term toxicity testing on fish: The registrant may consider long-term toxicity testing instead of short-term.

7.1.3. The study does not need to be conducted if:

there are mitigating factors indicating that aquatic toxicity is unlikely to occur, for instance if the substance is highly insoluble in water; or

– the substance is unlikely to cross biological membranes; or

– a long-term aquatic toxicity study on fish is available.

Long -term aquatic toxicity testing as described in Annex VII shall be considered if the chemical safety assessment according to Annex I indicates the need to investigate further effects on aquatic organisms. The choice of the appropriate test(s) will depend on the results of the chemical safety assessment.

The long-term aquatic toxicity study on fish (Annex VII, 7.1.6) shall be considered if the substance is poorly water soluble .

7.1.4. Activated sludge respiration inhibition testing

7.1.4. The study does not need to be conducted if:

there is no emission to a sewage treatment plant; or

there are mitigating factors indicating that microbial toxicity is unlikely to occur, for instance the substance is highly insoluble in water; or

– the substance is found to be readily biodegradable and the applied test concentrations are in the range of concentrations that can be expected in the influent of a sewage treatment plant.

The study may be replaced by a nitrification inhibition test if available data show that the substance is likely to be an inhibitor of microbial growth or function, in particular nitrifying bacteria .

7.2. Degradation

7.2. Further degradation testing shall be considered if the chemical safety assessment according to Annex I indicates the need to investigate further the degradation of the substance. The choice of the appropriate test(s) will depend on the results of the chemical safety assessment.

7.2.1. Biotic

7.2.1.1. Ready biodegradability

7.2.1.1. The study does not need to be conducted if the substance is inorganic.

7.2.2. Abiotic

7.2.2.1. Hydrolysis as a function of pH.

7.2.2.1. The study does not need to be conducted if:

– the substance is readily biodegradable; or

the substance is highly insoluble in water .

7.3. Fate and behaviour in the environment

7.3.1. Adsorption/desorption screening

7.3.1. The study does not need to be conducted if:

– based on the physicochemical properties the substance can be expected to have a low potential for adsorption (e.g. the substance has a low octanol water partition coefficient); or

– the substance and its relevant degradation products decompose rapidly.

ANNEX VII

ADDITIONAL STANDARD INFORMATION REQUIREMENTS

FOR SUBSTANCES MANUFACTURED OR IMPORTED IN QUANTITIES OF 100 TONNES OR MORE

At the level of this Annex, the registrant must submit a proposal and a time schedule for fulfilling the information requirements of this Annex in accordance with Article 13  (1) (c).

Column 1 of this Annex establishes the standard information required for all substances manufactured or imported in quantities of 100 tonnes or more in accordance with Article 13  (1) (c). Accordingly, the information required in column 1 of this Annex is additional to that required in column 1 of Annexes V and VI. Column 2 of this Annex lists specific rules according to which the registrant may propose to omit the required standard information, replace it by other information, provide it at a later stage or adapt it in another way. If the conditions are met under which column 2 of this Annex allows an adaptation to be proposed, the registrant shall clearly state this fact and the reasons for proposing each adaptation under the appropriate headings in the registration dossier.

In addition to these specific rules, a registrant may propose to adapt the required standard information set out in column 1 of this Annex according to the general rules contained in Annex IX. In this case as well, he shall clearly state the reasons for any decision to propose adaptations to the standard information under the appropriate headings in the registration dossier referring to the appropriate specific rule(s) in column 2 or in Annexes IX or X(83) .

Before new tests are carried out to determine the properties listed in this Annex, all available in vitro data, in vivo data, historical data, data from valid (Q)SARs and data from structurally related substances (read-across approach) shall be assessed first.

When, for certain endpoints, it is proposed not to provide information for other reasons than those mentioned in column 2 of this Annex or in Annex IX, this fact and the reasons shall also be clearly stated.

5.  INFORMATION ON THE PHYSICOCHEMICAL PROPERTIES OF THE SUBSTANCE

Column 1

Standard information required

Column 2

Specific rules for adaptation from Column 1

5.18. Stability in organic solvents and identity of relevant degradation products

Only required if stability of the substance is considered to be critical.

5.18. The study does not need to be conducted if the substance is inorganic.

5.19. Dissociation constant

5.19. The study does not need to be conducted if:

– the substance is hydrolytically unstable (half-life less than 12 hours) or is readily oxidisable in water; or

– the substance is not soluble in water or does not contain any ionic structure.

5.20. Viscosity

6.   toxicological information

In vivo testing with corrosive substances at concentration/dose levels causing corrosivity shall be avoided.

Column 1

Standard information required

Column 2

Specific rules for adaptation from Column 1

6.4. If there is a positive result in any of the mutagenicity studies in Annex V or VI and there are no results available from an in vivo study, an appropriate in vivo mutagenicity study shall be proposed by the registrant.

If there is a positive result from any in vivo study available, further appropriate in vivo studies shall be proposed.

6.6. Repeated dose toxicity

6.6.1. Short-term repeated dose toxicity study (28 days), one species, male and female, most appropriate route of administration, having regard to the likely route of human exposure, unless already provided as part of Annex VI requirements or if tests according to 6.6.2 is proposed. In this case, Section 3 of Annex IX shall not apply.

6.6.2. Sub-chronic toxicity study (90-day), one species, rodent, male and female, most appropriate route of administration, having regard to the likely route of human exposure.

6.6.2. The sub-chronic toxicity study (90 days) does not need to be conducted if:

– a reliable short-term toxicity study (28 days) is available showing severe toxicity effects according to the criteria for classifying the substance as R48, for which the observed NOAEL-28 days, with the application of an appropriate uncertainty factor, allows the extrapolation towards the NOAEL-90 days for the same route of exposure; or

– a reliable chronic toxicity study is available, provided that an appropriate species and route of administration were used; or

– the substance is unreactive, insoluble and not inhalable and there is no evidence of absorption and no evidence of toxicity in a 28-day "limit test", particularly if such a pattern is coupled with limited human exposure.

The appropriate route shall be chosen on the following basis:

Testing by the dermal route is appropriate if:

(1) skin contact in production and/or use is likely; and

(2) the physicochemical properties suggest a significant rate of absorption through the skin; and

(3) one of the following conditions is met:

– toxicity is observed in the acute dermal toxicity test at lower doses than in the oral toxicity test; or

– systemic effects or other evidence of absorption is observed in skin and/or eye irritation studies; or

– in vitro tests indicate significant dermal absorption; or

– significant dermal toxicity or dermal penetration is recognised for structurally-related substances.

Testing by the dermal route is inappropriate if the absorption by the skin is unlikely as indicated by molecular weight (MW > 800 or molecular diameter > 15 Å) and low liposolubility (log Kow < -1 or > 4).

Testing by the inhalation route is appropriate if:

(1) exposure of humans via inhalation is likely; and

(2) one of the following conditions is met:

– the substance has a vapour pressure above 10-2 Pa at 20 °C; or

– the substance is a powder containing more than 1% particles on a w/w basis, with a particle size MMAD less than 100 μm; or

the substance will be used in a manner which generates aerosols, particles or droplets in an inhalable size range (> 1% on a w/w basis of particles with MMAD < 100 μm). In the absence of contra-indications, the oral route shall be the preferred one.

Further studies shall be proposed by the registrant or may be required by the competent authority of the evaluating Member State in accordance with Articles 45, 46 or 52 in case of:

– failure to identify a NOAEL in the 90 days study unless the reason for the failure to identify a NOAEL is absence of adverse toxic effects; or

– toxicity of particular concern (e.g. serious/severe effects); or

– indications of an effect for which the available evidence is inadequate for toxicological and/or risk characterisation; In such cases it may also be more appropriate to perform specific toxicological studies that are designed to investigate these effects (e.g. immunotoxicity, neurotoxicity); or

– particular concern regarding exposure (e.g. use in consumer products leading to exposure levels which are high relative to the dose levels at which toxicity to humans may be expected).

6.7. Reproductive toxicity

6.7. The studies do not need to be conducted if:

– the substance is known to be a genotoxic carcinogen and appropriate risk management measures are implemented; or

– the substance is known to be a germ cell mutagen and appropriate risk management measures are implemented; or

the chemical safety assessment according to Annex I indicates that the risk to health/environment with regard to repeated exposure for the identified uses is not relevant or is adequately controlled taking into account risk management measures. Section 3 of Annex IX shall apply.

6.7.1. Developmental toxicity study, one species, most appropriate route of administration, having regard to the likely route of human exposure (Annex X B.31 or OECD 414).

6.7.1 The study shall be initially performed on one species. A decision on the need to perform a study at this tonnage level or the next on a second species should be based on the outcome of the first test and all other relevant available data .

6.7.2 . Two-generation reproductive toxicity study, one species, male and female, most appropriate route of administration, having regard to the likely route of human exposure.

6.7.2. The two-generation reproductive toxicity study shall be proposed by the registrant if there are indications of potential reproductive toxicity from a repeated dose toxicity study (90 days) (e.g. histopathological effects on the gonads) or the substance has a close structural relationship with a known reproductive toxicant.

The study shall be initially performed on one species. A decision on the need to perform a study at this tonnage level or the next on a second species should be based on the outcome of the first test and all other relevant available data.

7.   ecotoxicological information

Column 1

Standard information required

Column 2

Specific rules for adaptation from Column 1

7.1. Aquatic toxicity

7.1. Long-term toxicity testing shall be proposed by the registrant if the chemicals safety assessment according to Annex I indicates the need to investigate further the effects on aquatic organisms. The choice of the appropriate test(s) depends on the results of the safety assessment.

7.1.5. Long-term toxicity testing on Daphnia, (unless already provided as part of Annex V requirements)

7.1.5. The study does not need to be conducted if:

– the substance is unlikely to cross biological membranes (MW > 800 or molecular diameter > 15 Å); or

– direct or indirect exposure of the aquatic compartment is unlikely.

7.1.6. Long-term toxicity testing on fish, (unless already provided as part of Annex VI requirements)

7.1.6. The study does not need to be conducted if:

– the substance is unlikely to cross biological membranes (MW > 800 or molecular diameter > 15 Å); or

– direct or indirect exposure of the aquatic compartment is unlikely.

The information shall be provided for one of the following 7.1.6.1, 7.1.6.2 or 7.1.6.3.

7.1.6.1 Fish early-life stage (FELS) toxicity test (OECD 210)

7.1.6.2 Fish short-term toxicity test on embryo and sac-fry stages (Annex X C.15 or OECD 212)

7.1.6.3 Fish, juvenile growth test (Annex X C.14 or OECD 215)

7.1.6.1. The FELS toxicity test shall be proposed by the registrant or may be required by the competent authority of the evaluating Member State in accordance with Articles 45, 46 or 52 if the substance has a potential to bioaccumulate.

7.2. Degradation

7.2. Further degradation testing shall be proposed by the registrant if the chemical safety assessment according to Annex I indicates the need to investigate further the degradation of the substance. The choice of the appropriate test(s) depends on the results of the safety assessment.

7.2.1. Biotic

The information mentioned under 7.2.1.3 and 7.2.1.4 shall also be proposed by the registrant or may be required by the competent authority of the evaluating Member State in accordance with Articles 45, 46 or 52 in the cases defined below.

7.2.1.2. Simulation testing on ultimate degradation in surface water

7.2.1.2. The study need not be conducted if:

– the water solubility of the substance is below 10 μg/l;

– the substance is readily biodegradable.

7.2.1.3. Soil simulation testing (for substances with a high potential for adsorption to soil)

7.2.1.3. The study need not be conducted:

– if the substance is readily biodegradable; or

– if direct or indirect exposure of soil is unlikely.

7.2.1.4. Sediment simulation testing (for substances with a high potential for adsorption to sediment)

7.2.1.4. The study need not be conducted:

– if the substance is readily biodegradable; or

– if direct or indirect exposure of soil is unlikely.

7.2.3. Identification of degradation products

7.2.3. Unless the substance is readily biodegradable

Further testing shall be proposed by the registrant if the chemical safety assessment according to Annex I indicates the need to investigate further the fate and behaviour of the substance. The choice of the appropriate test(s) depends on the results of the safety assessment.

7.3. Fate and behaviour in the environment

7.3.2. Bioconcentration in (one) aquatic species, preferably fish

7.3.2. The study need not be conducted if:

– the substance has a low potential for bioaccumulation (ie log Kow < 3); or

– the substance is unlikely to cross biological membranes (MW > 800 or molecular diameter > 15 Å); or

– direct or indirect exposure of the aquatic compartment is unlikely.

7.3.3. Further studies on adsorption/desorption depending on the results of the study required in Annex VI

7.3.3. The study need not be conducted if:

– based on the physicochemical properties the substance can be expected to have a low potential for adsorption (e.g. the substance has a low octanol water partition coefficient); or

– the substance decomposes rapidly.

7.4. Effects on terrestrial organisms

7.4. These studies do not need to be conducted if direct or indirect exposure of the soil compartment is unlikely.

In the absence of toxicity data for soil organisms, the equilibrium partitioning method may be applied to assess the exposure to soil organisms. In the case of a significant exposure a selection out of the following tests shall be proposed by the registrant.

In particular for substances that have a high potential to adsorb to soil, the registrant shall consider long-term toxicity testing instead of short-term.

7.4.1. Short-term toxicity to earthworms

7.4.2. Effects on soil micro-organisms

7.4.3. Short-term toxicity to plants

9.   methods of detection and analysis

Description of the analytical methods shall be provided on request, for the relevant compartments for which studies were performed using the analytical method concerned. If the analytical methods are not available this shall be justified.

ANNEX VIII

Additional standard information requirements for substances manufactured or imported in quantities of 1000 tonnes or more

At the level of this Annex, the registrant must submit a proposal and a time schedule for fulfilling the information requirements of this Annex that involve vertebrate animal tests in accordance with Article 13  (1) (d).

Column 1 of this Annex establishes the standard information required for all substances manufactured or imported in quantities of 1000 tonnes or more in accordance with Article 13  (1) (d). Accordingly, the information required in column 1 of this Annex is additional to that required in column 1 of Annexes V, VI and VII. Column 2 of this Annex lists specific rules according to which the registrant may propose to omit the required standard information, replace it by other information, provide it at a later stage or adapt it in another way. If the conditions are met under which column 2 of this Annex allows an adaptation to be proposed, the registrant shall clearly state this fact and the reasons for proposing each adaptation under the appropriate headings in the registration dossier.

In addition to these specific rules, a registrant may propose to adapt the required standard information set out in column 1 of this Annex according to the general rules contained in Annex IX. In this case as well, he shall clearly state the reasons for any decision to propose adaptations to the standard information under the appropriate headings in the registration dossier referring to the appropriate specific rule(s) in column 2 or in Annexes IX or X(84) .

Before new tests are carried out to determine the properties listed in this Annex, all available in vitro data, in vivo data, historical data, data from valid (Q)SARs and data from structurally related substances (read-across approach) shall be assessed first.

When, for certain endpoints, it is proposed not to provide information for other reasons than those mentioned in column 2 of this Annex or in Annex IX, this fact and the reasons shall also be clearly stated.

6.   toxicological information

Column 1

Standard information required

Column 2

Specific rules for adaptation from Column 1

6.4. If appropriate, in case of a positive result in any previous mutagenicity study further mutagenicity studies shall be proposed by the registrant.

6.6.3. A long-term repeated toxicity study (≥ 12 months) may be proposed by the registrant or required by the competent authority of the evaluating Member State in accordance with Articles 45, 46 or 52 if the frequency and duration of human exposure indicates that a longer term study is appropriate and one of the following conditions is met:

– serious or severe toxicity effects of particular concern were observed in the 28 days or 90 days study for which the available evidence is inadequate for toxicological or risk characterisation; or

– effects shown in substances with a clear relationship in molecular structure with the substance being studied were not detected in the 28 days or 90 days study; or

– the substance may have a dangerous property that cannot be detected in a 90 days study.

6.6. Further studies shall be proposed by the registrant or may be required by the competent authority of the evaluating Member State in accordance with Articles 45, 46 or 52 in case of:

– toxicity of particular concern (e.g. serious/severe effects); or

– indications of an effect for which the available evidence is inadequate for toxicological and/or risk characterisation; In such cases it may also be more appropriate to perform specific toxicological studies that are designed to investigate these effects (e.g. immunotoxicity, neurotoxicity); or

– particular concern regarding exposure (e.g. use in consumer products leading to exposure levels which are close to the dose levels at which toxicity is observed).

6.7. Reproductive toxicity

6.7.4. Two-generation reproductive toxicity study, one species, male and female, most appropriate route of administration, having regard to the likely route of human exposure, unless already provided as part of Annex VII requirements

6.7.4. The study need not be conducted if:

– the substance is known to be a genotoxic carcinogen and appropriate risk management measures are implemented; or

– the substance is known to be a germ cell mutagen and appropriate risk management measures are implemented; or

– the substance is of low toxicological activity (no evidence of toxicity seen in any of the tests available), it can be proven from toxicokinetic data that no systemic absorption occurs via relevant routes of exposure (e.g. plasma/blood concentrations below detection limit using a sensitive method and absence of the substance and of metabolites of the substance in urine, bile or exhaled air) and there is no or no significant human exposure.

6.9. A carcinogenicity study may be proposed or may be required by the competent authority of the evaluating Member State in accordance with Articles 45, 46 or 52 if:

– the substance has a widespread dispersive use or there is evidence of frequent or long-term human exposure; and

– the substance is classified as mutagenic category 3 or there is evidence from the repeated dose study(ies) that the substance is able to induce hyperplasia and/or pre-neoplastic lesions.

7.   ecotoxicological information

Column 1

Standard information required

Column 2

Specific rules for adaptation from Column 1

7.2. Degradation

7.2. Further degradation testing shall be proposed of the chemical safety assessment according to Annex I indicates the need to investigate further the degradation of the substance. The choice of the appropriate test(s) depends on the results of the safety assessment.

7.2.1. Biotic

7.2.1.5. Further confirmatory testing on rates of biodegradation (aerobic and/or anaerobic) in environmental compartments (water, sediment, soil) with specific emphasis on the identification of the most relevant degradation products.

7.3. Fate and behaviour in the environment

7.3. Further testing shall be proposed by the registrant if the chemical safety assessment according to Annex I indicates the need to investigate further the fate and behaviour of the substance. The choice of the appropriate test(s) depends on the results of the safety assessment.

7.3.4. Further environmental fate and behaviour studies

7.4. Effects on terrestrial organisms

7.4. Long-term toxicity testing shall be proposed by the registrant when the comparison of the (predicted) environmental exposure with the results from the short-term toxicity test(s) indicates the need to investigate further the effects on terrestrial organisms. The choice of the appropriate test(s) depends on the outcome of this comparison.

These studies do not need to be conducted if direct or indirect exposure of the soil compartment is unlikely.

7.4.4. Long-term toxicity testing on earthworms, unless already provided as part of Annex VII requirements.

7.4.5. Long-term toxicity testing on soil invertebrates other than earthworms, unless already provided as part of Annex VII requirements.

7.4.6. Long-term toxicity testing on plants, unless already provided as part of Annex VII requirements.

7.5. Long-term toxicity to sediment organisms

7.5. Long-term toxicity testing shall be proposed by the registrant when the comparison of the (predicted) environmental exposure with the results from the short-term toxicity test(s) indicates the need to investigate further the effects on sediment organisms. The choice of the appropriate test(s) depends on the results of the safety assessment.

7.6. Long-term or reproductive toxicity to birds

7.6. The study need not be conducted if direct or indirect exposure of birds is unlikely.

9.   methods of detection and analysis

Description of the analytical methods shall be provided on request, for the relevant compartments for which studies were performed using the analytical method concerned. If the analytical methods are not available this shall be justified.

ANNEX IX

GENERAL RULES FOR ADAPTATION OF THE STANDARD TESTING REGIME SET OUT IN ANNEXES V TO VIII

Annexes V to VIII set out the standard testing regime required for all substances manufactured or imported in quantities of:

   1 tonne or more in accordance with Article 13  (1) (a),
   10 tonnes or more in accordance with Article 13  (1) (b),
   100 tonnes or more in accordance with Article 13  (1) (c), and
   1000 tonnes or more in accordance with Article 13  (1) (d).

In addition to the specific rules set out in Column 2 of Annexes V to VIII, a registrant may adapt the standard testing regime in accordance with the general rules set out in Section 1 of this Annex. Under evaluation competent authorities of evaluating Member States may assess these adaptations to the standard testing regime.

1.  TESTING DOES NOT APPEAR SCIENTIFICALLY NECESSARY

1.1.  Use of existing data

1.1.1.  Data on physical-chemical properties from experiments not carried out according to GLP or Annex X

Data shall be considered to be equivalent to data generated by the corresponding test in Annex X if the following conditions are met:

   1) adequacy for the purpose of classification and labelling and risk assessment, and
   2) adequate and reliable documentation of the study is provided.

1.1.2.  Data from animal experiments not carried out according to GLP or Annex X

Data shall be considered to be equivalent to data generated by the corresponding test in Annex X if the following conditions are met:

   1) adequacy for the purpose of classification and labelling and risk assessment,
   2) adequate and reliable coverage of the key parameters foreseen to be investigated in the corresponding test in Annex X,
   3) exposure duration comparable to or longer than the corresponding test in Annex X if exposure duration is a relevant parameter, and
   4) adequate and reliable documentation of the study is provided.

1.1.3.  Historical human data

Historical human data, such as epidemiological studies on exposed populations, accidental or occupational exposure data and clinical studies, shall be considered.

The strength of the data for a specific health effect depends, among other things, on the type of analysis and on the parameters covered and on the magnitude and specificity of the response and consequently the predictability of the effect. Criteria for assessing the adequacy of the data include:

   1) the proper selection and characterisation of the exposed and control groups,
   2) adequate characterisation of exposure,
   3) sufficient length of follow-up for disease occurrence,
   4) valid method for observing an effect,
   5) proper consideration of bias and confounding factors, and
   6) a reasonable statistical reliability to justify the conclusion.

In all cases adequate and reliable documentation shall be provided.

1.2.  Weight of evidence

There may be sufficient weight of evidence from several independent sources of information leading to the assumption/conclusion that a substance has or has not a particular dangerous property, while the information from each single source alone is regarded insufficient to support this notion.

There may be sufficient weight of evidence from the use of newly developed test methods, not yet included in Annex X, leading to the conclusion that a substance has or has not a particular dangerous property.

Where sufficient weight of evidence for the presence or absence of a particular dangerous property is available:

   further testing on vertebrate animals for that property shall be omitted,
   further testing not involving vertebrate animals may be omitted.

In all cases adequate and reliable documentation shall be provided.

1.3.  Structure-activity relationship (SAR)

Results obtained from valid qualitative or quantitative structure-activity relationship models ((Q)SARs) may indicate the presence or absence of a certain dangerous property. Results of (Q)SARs may be used instead of testing when the following conditions are met:

   results are derived from a (Q)SAR model whose scientific validity has been established,
   results are adequate for the purpose of classification and labelling and risk assessment, and
   adequate and reliable documentation of the applied method is provided.

The Agency in collaboration with the Commission, Member States and interested parties shall develop and provide guidance in assessing which (Q)SARs will meet these conditions and provide examples.

1.4.  In vitro methods

Results obtained from suitable in vitro methods may indicate the presence of a certain dangerous property. In this context, "suitable' means sufficiently well developed according to internationally agreed test development criteria (e.g. the ECVAM criteria for the entry of a test into the prevalidation process). Depending on the potential risk, immediate confirmation requiring testing beyond the information foreseen in Annex V or VI or proposed confirmation requiring testing beyond the information foreseen in Annex VII or VIII for the respective tonnage level may be necessary.

If the results obtained from the use of such in vitro methods do not indicate a certain dangerous property, the relevant test shall nevertheless be carried out at the appropriate tonnage level to confirm the negative result, unless testing is not required in accordance with Annexes V to VIII or the other rules in Annex IX.

Such confirmation may be waived, if the following conditions are met:

   1) results are derived from an in vitro method whose scientific validity has been established by a validation study, according to internationally agreed validation principles,
   2) results are adequate for the purpose of classification and labelling and risk assessment, and
   3) adequate and reliable documentation of the applied method is provided.

1.5.  Grouping of substances and read-across approach

Substances whose physicochemical, toxicological and ecotoxicological properties are likely to be similar or follow a regular pattern as a result of structural similarity may be considered as a group, or "category" of substances. Application of the group concept requires that physicochemical properties, human health effects and environmental effects or environmental fate may be predicted from data for a reference substance within the group by interpolation to other substances in the group (read-across approach). This avoids the need to test every substance for every endpoint.

The similarities may be based on:

   1) a common functional group,
   2) the common precursors and/or the likelihood of common breakdown products via physical and biological processes, which result in structurally similar chemicals, or
   3) a constant pattern in the changing of the potency of the properties across the category.

If the group concept is applied, substances shall be classified and labelled on this basis.

In all cases adequate and reliable documentation shall be provided.

2.  TESTING IS TECHNICALLY NOT POSSIBLE

Testing for a specific endpoint may be omitted, if it is technically not possible to conduct the study as a consequence of the properties of the substance: e.g. very volatile, highly reactive or unstable substances cannot be used, mixing of the substance with water may cause danger of fire or explosion or the radio-labelling of the substance required in certain studies may not be possible. The guidance given in the test guidelines of Annex X, more specifically on the technical limitations of a specific method, shall always be respected.

3.  SUBSTANCE-TAILORED EXPOSURE-DRIVEN TESTING

3.1.  Testing in accordance with Annexes VII and VIII, and where specified in Annex VI, may be omitted, based on the exposure scenario(s) developed in the Chemical Safety Report.

3.2.   Adequate justification and documentation shall be provided in the Chemical Safety Assessment for exposure-based waiving for Annexes VII and VIII, and for specified tests in Annex VI consistent with these conditions, including the following:

   i) the types of environmental compartments;
   ii) the human populations exposed;
   iii) the risk management measures;
   iv) the routes of exposure;
   v) the duration and frequency of exposure;
   vi) protection of animal lives.

Not later than ... (85) , the Commission shall adopt criteria defining what constitutes adequate justification for exposure-based waiving for Annexes VII and VIII, and for specified tests in Annex VI, in accordance with Article 141(3). Waiving shall take place in a harmonised manner in accordance with these conditions.

ANNEX X

Annex unamended. See Commission proposal COM(2003)0644.

ANNEX XI

GENERAL PROVISIONS FOR DOWNSTREAM USERS TO ASSESS SUBSTANCES AND PREPARE CHEMICAL SAFETY REPORTS

INTRODUCTION

The purpose of this Annex is to set out how downstream users are to assess and document that the risks arising from the substance(s) they use are adequately controlled during their use for a use not covered by the safety data sheet supplied to them and that other users further down the supply chain can adequately control the risks. The assessment shall cover the life-cycle of the substance, from its receipt by the downstream user, for his own uses and for his identified uses in quantities of 1 tonne or more per year further down the supply chain. The assessment shall consider the use of the substance on its own, in a preparation or in an article.

In carrying out the chemical safety assessment and producing the Chemical Safety Report, the downstream user shall take account of information received in the Safety Data Sheet from the supplier of the chemical in accordance with Article 33 of this Regulation. Where available and appropriate, an assessment carried out under Community legislation, (e.g. risk assessments completed under Regulation (EEC) No  793/93) shall be taken into account in the chemical safety assessment and be reflected in the Chemical Safety Report. Deviations from such assessments shall be justified. Assessments carried out under other international and national programmes may also be taken into account.

The process which the downstream user goes through in carrying out the chemical safety assessment and in producing his Chemical Safety Report, involves three steps:

Step 1: Development of exposure scenario(s)

The downstream user shall develop exposure scenarios for uses not covered in a safety data sheet supplied to him in accordance with Section 5 of Annex I.

Step 2: If necessary, a refinement of the hazard assessment by the supplier;

If the downstream user considers the assessments reported in the Safety Data Sheet supplied to him to be appropriate, then no further hazard assessment or PBT and vPvB assessment is necessary. In this case he shall use the relevant information reported by the supplier for the risk characterisation. This shall be stated in the chemical safety report.

If the downstream user considers the assessments reported in the Safety Data Sheet supplied to him to be inappropriate, then he shall carry out the relevant assessments in accordance with Annex I, sections 1 through 4 as appropriate to him.

In those cases where the downstream user considers that information in addition to that provided by the supplier is necessary for producing his Chemical Safety Report the downstream user shall gather this information. Where this information can only be obtained by testing on vertebrate animals, he shall submit a proposal for a testing strategy to the Agency in accordance with Article 40 . He shall explain why he considers that additional information is necessary. While waiting for results of further testing, he shall record the risk management measures he has put in place.

On completion of any additional testing, the downstream user shall revise the Chemical Safety Report, and his Safety Data Sheet, as appropriate.

Step 3: Risk characterisation.

A risk characterisation shall be carried out for each new exposure scenario as prescribed in section 6 of Annex I. The risk characterisation shall be presented under the relevant heading of the Chemical Safety Report and summarised in the Safety Data Sheet under the relevant heading(s).

In these steps, iterations may be made between on the one hand developing new exposure scenario, which entails developing and implementing or recommending risk management measures, and on the other hand generating further information. The purpose of generating further information is to establish a more precise risk characterisation, based on a refined hazard assessment and/or exposure assessment.

The downstream user shall produce a Chemical Safety Report detailing his chemical safety assessment using part C, sections 5 and 6, of the format set out in Section 7 of Annex I and the other sections of this format, if appropriate.

Part A of the Chemical Safety Report shall include a declaration that the risk management measures outlined in the relevant exposure scenarios are implemented by the downstream user for his own uses and that the risk management measures outlined in the exposure scenarios for the identified uses are communicated down the supply chain.

ANNEXES XII TO XVI

Annexes unamended. See Commission proposal COM(2003)0644

ANNEX XVII

PERSISTENT ORGANIC POLLUTANTS (POPS)

Annex deleted

(1) OJ C 112, 30.4.2004, p. 92.
(2) Position of the European Parliament of 17 November 2005 (not yet published in the Official Journal).
(3) Commission Working Document SEC(1998) 1986 final, referred to in White paper Strategy for a future Chemicals Policy, COM(2001) 88 final, 27.2.2001.
(4) 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 ).
(5) OJ L 187, 16.7.1988, p. 14.
(6) OJ L 200, 30.7.1999, p. 1. Directive as last amended by Council Directive 2004/66/EC (OJ L 168, 1.5.2004, p. 35 ).
(7) 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).
(8) OJ L 262, 27.9.1976, p. 201. Directive as last amended by Commission Directive 2004/98/EC (OJ L 305, 1.10.2004, p. 63 ).
(9) OJ L 158, 30.4.2004, p. 50. Corrected in OJ L 229, 29.6.2004, p. 23.
(10) OJ L 124, 20.5.2003, p. 36.
(11) 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).
(12) OJ L 50, 20.2.2004, p. 44.
(13) OJ L 357, 31.12.2002, p. 72.
(14) OJ L 136, 30.4.2004, p. 1.
(15) OJ L 31, 1.2.2002, p . 1. Regulation as amended by Regulation (EC) No 1642/2003 (OJ L 245, 29.9.2003, p. 4).
(16) OJ C 218, 13.9.2003, p. 1.
(17) OJ L 41, 14.2.2003, p. 26.
(18) OJ L 145, 31.5.2001, p. 43.
(19) OJ L 184, 17.7.1999, p. 23.
(20) OJ L 78, 26.3.1991, p. 38. Directive as amended by Commission Directive 98/101/EC (OJ L 1, 5.1.1999, p. 1).
(21) OJ L 227, 8.9.1993, p. 9.
(22) OJ L 294, 30.11.1993, p. 21.
(23) OJ L 103, 28.4.2000, p. 70.
(24) OJ L 161, 29.6.1994, p. 3.
(25) OJ L 348, 28.11.1992, p. 1.
(26) OJ L 131, 5.5.1998, p. 11.
(27) OJ C 364, 18.12.2000, p. 1.
(28) As set out in the Communication from the Commission on the precautionary principle, COM(2000)0001 final .
(29) OJ L 159, 29.6.1996, p. 1.
(30) OJ L 194, 25.7.1975, p. 39. Directive as last amended by Regulation (EC) No 1882/2003.
(31) OJ L 184, 15.7.1988, p. 61. Directive as last amended by Regulation (EC) No 1882/2003.
(32) OJ L 194, 18.7.2001, p. 26.
(33) OJ L 262, 27.9.1976, p. 169. Directive as last amended by Commission Directive 2005/52/EC (OJ L 234, 10.9.2005, p. 9).
(34) OJ L 136, 30.4.2004, p. 1.
(35) OJ L 40, 11.2.1989, p. 27. Directive as last amended by Regulation (EC) No 1882/2003.
(36) OJ L 268, 18.10.2003, p. 29. Regulation as amended by Commission Regulation (EC) No 378/2005 (OJ L 59, 5.3.2005, p. 8).
(37) OJ L 213, 21.7.1982, p. 8. Directive as last amended by Commission Directive 2004/116/EC (OJ L 379, 24.12.2004, p. 81).
(38) OJ L 338, 13.11.2004, p. 4.
(39) OJ L 189, 20.7.1990, p. 17. Directive as last amended by Regulation (EC) No 1882/2003.
(40) OJ L 169, 12.7.1993, p. 1. Directive as last amended by Regulation (EC) No 1882/2003.
(41) OJ L 331, 7.12.1998, p. 1. Directive as last amended by Regulation (EC) No 1882/2003.
(42) OJ L 230, 19.8.1991, p. 1. Directive as last amended by Regulation (EC) No 396/2005 of the European Parliament and of the Council (OJ L 70, 16.3.2005, p. 1).
(43) OJ L 123, 24.4.1998, p. 1. Directive as amended by Regulation (EC) No 1882/2003.
(44) OJ L 350, 28.12.1998, p. 58. Directive as last amended by Regulation (EC) No 1882/2003.
(45) OJ L 259, 15.10.1979, p. 10.
(46) OJ L 154, 5.6.1992, p. 1.
(47)* Two years after the date of entry into force of this Regulation.
(48)* Three years after the date of entry into force of this Regulation.
(49)* Six years after the date of entry into force of this Regulation.
(50)** 11 years after the date of entry into force of this Regulation.
(51)* One year after the date of entry into force of this Regulation
(52)* 18 months after the date of entry into force of this Regulation.
(53)* Five years after the date of entry into force of this Regulation.
(54)** Nine years after the date of entry into force of this Regulation.
(55) OJ L 257, 10.10.1996, p. 26. Directive as last amended by Regulation (EC) No 166/2006 of the European Parliament and of the Council (OJ L 33, 4.2.2006, p. 1).
(56) OJ L 327, 22.12.2000, p. 1. Directive as amended by Decision No 2455/2001/EC (OJ L 331, 15.12.2001, p. 1).
(57) OJ L 158, 30.4.2004, p. 7.
(58)* One year after the date of entry into force of this Regulation.
(59) OJ L 136, 31.5.1999, p. 1
(60) OJ L 136, 31.5.1999, p. 15.
(61) OJ L 329, 25.11.1982, p. 31.
(62)* Four years after the date of entry into force of this Regulation.
(63)** Five years after the date of entry into force of this Regulation.
(64)*** Six years after the date of entry into force of this Regulation.
(65)* Six months after the date of entry into force of this Regulation.
(66) OJ L 63, 6.3.2003, p. 1.
(67)* 18 months after the date of entry into force of this Regulation.
(68)* 18 months after the date of entry into force of this Regulation.
(69)* 18 months after the date of entry into force of this Regulation.
(70)* Six years after the date of entry into force of this Regulation.
(71)* Seven years after the date of entry into force of this Regulation.
(72)* 60 days after the date of entry into force of this Regulation .
(73)** One year after the date of entry into force of this Regulation .
(74)*** 18 months after the date of entry into force of this Regulation.
(75)**** Two years after the date of entry into force of this Regulation.
(76) In general, the more extensive the data and the longer the duration of the tests, the smaller is the degree of uncertainty and the size of the assessment factor. An assessment factor of 1000 is typically applied to the lowest of three short term L(E)C50 values derived from species representing different trophic levels and a factor of 10 to the lowest of three long-term NOEC values derived from species representing different trophic levels.
(77) Where the person responsible for placing the preparation on the market can demonstrate that the disclosure in the safety data sheet of the chemical identity of a substance which is exclusively classified as: - irritant with the exception of those assigned R41 or irritant in combination with one or more of the properties mentioned in point 2.3.4 of Article 10 of Directive 1999/45/EC; or - harmful in combination with one or more of the properties mentioned in point 2.3.4 of Article 10 of Directive 1999/45/EC presenting acute lethal effects alone; will put at risk the confidential nature of his intellectual property, he may, in accordance with the provisions of Part B of Annex VI to Directive 1999/45/EC, refer to that substance either by means of a name that identifies the most important functional chemical groups, or by means of an alternative name.
(78) OJ L 399, 30.12.1989, p. 18.
(79) OJ L 100, 19.4.1994, p. 1.
(80) This information cannot be given for the preparation because it is substance specific. It should therefore be given, where available and appropriate, for each constituent substance in the preparation which is required to be listed in the safety data sheet according to the rules under heading 2 of this Annex.
(81) Note: conditions for not requiring a specific test that are set out in the appropriate test methods in Annex X itself that are not repeated in column 2, also apply.
(82) Note: conditions for not requiring a specific test that are set out in the appropriate test methods in Annex X itself that are not repeated in column 2, also apply.
(83) Note: conditions for not requiring a specific test that are set out in the appropriate test methods in Annex X itself that are not repeated in column 2, also apply.
(84) Note: conditions for not requiring a specific test that are set out in the appropriate test methods in Annex X itself that are not repeated in column 2, also apply.
(85)* 18 months after the date of entry into force of this Regulation.

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