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substances

PREAMBLE: REACH - Registration, Evaluation, Authorisation and Restriction of Chemicals [go to this PREAMBLE]

... (1) This Regulation should ensure a high level of protection of human health and the environment as well as the free movement of substances, on their own, in preparations and in articles, while enhancing competitiveness and innovation. This Regulation should also promote the development of alternative methods for the assessment of hazards of substances. ...

... (2) The efficient functioning of the internal market for substances can be achieved only if requirements for substances do not differ significantly from Member State to Member State. ...

... (3) A high level of human health and environmental protection should be ensured in the approximation of legislation on substances, with the goal of achieving sustainable development. That legislation should be applied in a non-discriminatory manner whether substances are traded on the internal market or internationally in accordance with the Community's international commitments. ...

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

... (9) The assessment of the operation of the four main legal instruments governing chemicals in the Community, i.e. Council Directive 67/548/EEC of 27 June 1967 on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances ⁽⁴⁾, Council Directive 76/769/EEC of 27 July 1976 on the approximation of the laws, regulations and administrative provisions of the Member States relating to restrictions on the marketing and use of certain dangerous substances and preparations ⁽⁵⁾, Directive 1999/45/EC of the European Parliament and of the Council of 31 May 1999 concerning the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations ⁽⁶⁾ and Council Regulation (EEC) No 793/93 of 23 March 1993 on the evaluation and control of the risks of existing substances ⁽⁷⁾, identified a number of problems in the functioning of Community legislation on chemicals, resulting in disparities between the laws, regulations and administrative provisions in Member States directly affecting the functioning of the internal market in this field, and the need to do more to protect public health and the environment in accordance with the precautionary principle. ...

... (10) Substances under customs supervision which are in temporary storage, in free zones or free warehouses with a view to re-exportation or in transit are not used within the meaning of this Regulation and should therefore be excluded from its scope. The carriage of dangerous substances and of dangerous preparations by rail, road, inland waterways, sea or air should also be excluded from its scope as specific legislation already applies to such carriage. ...

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

... (12) An important objective of the new system to be established by this Regulation is to encourage and in certain cases to ensure that substances of high concern are eventually replaced by less dangerous substances or technologies where suitable economically and technically viable alternatives are available. This Regulation does not affect the application of Directives on worker protection and the environment, especially Directive 2004/37/EC of the European Parliament and of the Council of 29 April 2004 on the protection of workers from the risks related to exposure to carcinogens or mutagens at work (Sixth individual Directive within the meaning of Article 16(1) of Council Directive 89/391/EEC) ⁽⁸⁾ and Council Directive 98/24/EC of 7 April 1998 on the protection of the health and safety of workers from the risks related to chemical agents at work (fourteenth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC) ⁽⁹⁾ under which employers are required to eliminate dangerous substances, wherever technically possible, or to substitute dangerous substances with less dangerous substances. ...

... (13) This Regulation should apply without prejudice to the prohibitions and restrictions laid down in Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products ⁽¹⁰⁾ in so far as substances are used and marketed as cosmetic ingredients and are within the scope of this Regulation. A phase-out of testing on vertebrate animals for the purpose of protecting human health as specified in Directive 76/768/EEC should take place with regard to the uses of those substances in cosmetics. ...

... (14) This Regulation will generate information on substances and their uses. Available information, including that generated by this Regulation, should be used by the relevant actors in the application and implementation of appropriate Community legislation, for example that covering products, and Community voluntary instruments, such as the eco-labelling scheme. The Commission should consider in the review and development of relevant Community legislation and voluntary instruments how information generated by this Regulation should be used, and examine possibilities for establishing a European quality mark. ...

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

... (17) All available and relevant information on substances on their own, in preparations and in articles should be collected to assist in identifying hazardous properties, and recommendations about risk management measures should systematically be conveyed through supply chains, as reasonably necessary, to prevent adverse effects on human health and the environment. In addition, communication of technical advice to support risk management should be encouraged in the supply chain, where appropriate. ...

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

... (19) Therefore, the registration provisions should require manufacturers and importers to generate data on the substances they manufacture or import, to use these data to assess the risks related to these substances and to develop and recommend appropriate risk management measures. To ensure that they actually meet these obligations, as well as for transparency reasons, registration should require them to submit a dossier containing all this information to the Agency. Registered substances should be allowed to circulate on the internal market. ...

... (20) The evaluation provisions should provide for follow-up to registration, by allowing for checks on whether registrations are in compliance with the requirements of this Regulation and if necessary by allowing for generation of more information on the properties of substances. If the Agency in cooperation with the Member States considers that there are grounds for considering that a substance constitutes a risk to human health or the environment, the Agency should, after having included the substance in the Community rolling action plan for substance evaluation, relying on the competent authorities of Member States, ensure that this substance is evaluated. ...

... (21) 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 also be used to initiate the authorisation or restrictions procedures under this Regulation or risk management procedures under other Community legislation. Therefore it should be ensured that this information is available to the competent authorities and may be used by them for the purpose of such procedures. ...

... (22) The authorisation provisions should ensure the good functioning of the internal market while assuring that the risks from substances of very high concern are properly controlled. Authorisations for the placing on the market and use should be granted by the Commission only if the risks arising from their use are adequately controlled, where this is possible, or the use can be justified for socio-economic reasons and no suitable alternatives are available, which are economically and technically viable. ...

... (23) The restriction provisions should allow the manufacturing, placing on the market and use of substances presenting risks that need to be addressed, to be made subject to total or partial bans or other restrictions, based on an assessment of those risks. ...

... (24) In preparation for this Regulation, the Commission has launched REACH Implementation Projects (RIPs), involving relevant experts from stakeholder groups. Some of those projects aim at developing draft guidelines and tools which should help the Commission, the Agency, Member States, manufacturers, importers and downstream users of substances to fulfil, in concrete terms, their obligations under this Regulation. This work should enable the Commission and the Agency to make available appropriate technical guidance, in due time, with regard to the deadlines introduced by this Regulation. ...

... (25) The responsibility to assess the risks and hazards of substances should be given, in the first place, to the natural or legal persons that manufacture or import substances, but only when they do so in quantities exceeding a certain volume, to enable them to carry the associated burden. Natural or legal persons handling chemicals should take the necessary risk management measures in accordance with the assessment of the risks of substances and pass on relevant recommendations along the supply chain. This should include describing, documenting and notifying in an appropriate and transparent fashion the risks stemming from the production, use and disposal of each substance. ...

... (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 normally be submitted to authorities. ...

... (28) Scientific research and development normally takes place in quantities below one tonne per year. There is no need to exempt such research and development because substances in those quantities do not have to be registered in any case. However, in order to encourage innovation, product and process oriented research and development should be exempted from the obligation to register for a certain time period where a substance is not yet intended to be placed on the market to an indefinite number of customers because its application in preparations or articles still requires further research and development performed by the potential registrant himself or in cooperation with a limited number of known customers. In addition, it is appropriate to provide for a similar exemption to downstream users using the substance for the purposes of product and process oriented research and development, provided that the risks to human health and the environment are adequately controlled in accordance with the requirements of legislation for the protection of workers and the environment. ...

... (29) Since producers and importers of articles should be responsible for their articles, it is appropriate to impose a registration requirement on substances which are intended to be released from articles and have not been registered for that use. In the case of substances of very high concern which are present in articles above tonnage and concentration thresholds, where exposure to the substance cannot be excluded and where the substance has not been registered by any person for this use, the Agency should be notified. The Agency should also be empowered to request that a registration be submitted if it has grounds for suspecting that the release of a substance from the article may present a risk to human health or the environment and the substance is present in those articles in quantities totalling over one tonne per producer or importer per year. The Agency should consider the need for a proposal for a restriction where it considers that the use of such substances in articles poses a risk to human health or the environment that is not adequately controlled. ...

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

... (31) The Commission, in close cooperation with industry, Member States and other relevant stakeholders, should develop guidance to fulfil the requirements under this Regulation related to preparations (in particular with regard to safety data sheets incorporating exposure scenarios) including assessment of substances incorporated into special preparations — such as metals incorporated in alloys. In doing so, the Commission should take full account of the work that will have been carried out within the framework of the RIPs and should include the necessary guidance on this matter in the overall REACH guidance package. This guidance should be available before the application of this Regulation. ...

... (32) A chemical safety assessment should not need to be performed for substances in preparations in certain very small concentrations which are considered as not giving rise to concern. Substances in preparations in such low concentrations should also be exempt from authorisation. These provisions should apply equally to preparations that are solid mixtures of substances until a specific shape is given to such a preparation that transforms it into an article. ...

... (33) Joint submission and the sharing of information on substances should be provided for in order to increase the efficiency of the registration system, to reduce costs and to reduce testing on vertebrate animals. One of a group of multiple registrants should submit information on behalf of the others according to rules which ensure that all the required information is submitted, while allowing sharing of the costs burden. A registrant should be able to submit information directly to the Agency in certain specified cases. ...

... (34) Requirements for generation of information on substances should be tiered according to the volumes of manufacture or importation of a substance, because these provide an indication of the potential for exposure of man and the environment to the substances, and should be described in detail. To reduce the possible impact on low volume substances, new toxicological and ecotoxicological information should only be required for priority substances between 1 and 10 tonnes. For other substances in that quantity range there should be incentives to encourage manufacturers and importers to provide this information. ...

... (35) The Member States, the Agency and all interested parties should take full account of the results of the RIPs, in particular with regard to the registration of substances which occur in nature. ...

... (36) It is necessary to consider the application of Article 2(7)(a) and (b) and Annex XI to substances derived from mineralogical processes and the review of Annexes IV and V should fully take this into account. ...

... (37) If tests are performed, they should comply with the relevant requirements of protection of laboratory animals, set out in Council Directive 86/609/EEC of 24 November 1986 on the approximation of laws, regulations and administrative provisions of the Member States regarding the protection of animals used for experimental and other scientific purposes ⁽¹¹⁾, and, in the case of ecotoxicological and toxicological tests, good laboratory practice, set out in Directive 2004/10/EC of the European Parliament and of the Council of 11 February 2004 on the harmonisation of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their application for tests on chemical substances ⁽¹²⁾. ...

... (38) The generation of information by alternative means offering equivalence to prescribed tests and test methods should also be allowed, for example when this information comes from valid qualitative or quantitative structure activity models or from structurally related substances. To this end the Agency, in cooperation with Member States and interested parties, should develop appropriate guidance. It should also be possible not to submit certain information if appropriate justification can be provided. Based on experience gained through RIPs, criteria should be developed defining what constitutes such justification. ...

... (42) To avoid overloading authorities and natural or legal persons with the work arising from the registration of phase-in substances already on the internal market, that registration should be spread over an appropriate period of time, without introducing undue delay. Deadlines for the registration of these substances should therefore be set. ...

... (43) Data for substances already notified in accordance with Directive 67/548/EEC should be eased into the system and should be upgraded when the next tonnage quantity threshold is reached. ...

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

... (50) It is in the public interest to ensure the quickest possible circulation of test results on human health or environmental hazards of certain substances to those natural or legal persons which use them, in order to limit any risks associated with their use. Sharing of information should occur where this is requested by any registrant, in particular in the case of information involving tests on vertebrate animals, under conditions that ensure a fair compensation for the company that has undertaken the tests. ...

... (53) In order to allow a potential registrant of a phase-in substance to proceed with his registration, even if he cannot reach agreement with a previous registrant, the Agency, on request, should allow use of any summary or robust study summary of tests already submitted. The registrant who receives these data should be obliged to pay a contribution to the costs to the owner of the data. For non-phase-in substances, the Agency may ask for evidence that a potential registrant has paid the owner of a study before the Agency gives permission for the potential registrant to use that information in his registration. ...

... (54) In order to avoid duplication of work, and in particular to avoid duplication of testing, registrants of phase-in substances should pre-register as early as possible with a database managed by the Agency. A system should be established in order to provide for the establishment of Substance Information Exchange Forums (SIEF) to help exchange of information on the substances that have been registered. SIEF participants should include all relevant actors submitting information to the Agency on the same phase-in substance. They should include both potential registrants, who must provide and be supplied with any information relevant to the registration of their substances, and other participants, who may receive financial compensation for studies they hold but are not entitled to request information. In order to ensure the smooth functioning of that system they should fulfil certain obligations. If a member of a SIEF does not fulfil his obligations, he should be penalised accordingly but other members should be enabled to continue preparing their own registration. In cases where a substance has not been pre-registered, measures should be taken to help downstream users find alternative sources of supply. ...

... (56) Part of the responsibility of manufacturers or importers for the management of the risks of substances is the communication of information on these substances to other professionals such as downstream users or distributors. In addition, producers or importers of articles should supply information on the safe use of articles to industrial and professional users, and consumers on request. This important responsibility should also apply throughout the supply chain to enable all actors to meet their responsibility in relation to management of risks arising from the use of substances. ...

... (57) As the existing safety data sheet is already being used as a communication tool within the supply chain of substances and preparations, it is appropriate to develop it further and make it an integral part of the system established by this Regulation. ...

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

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

... (63) It is also necessary to ensure that generation of information is tailored to real information needs. To this end evaluation should require the Agency to decide on the programmes of testing proposed by manufacturers and importers. In cooperation with Member States, the Agency should give priority to certain substances, for instance those which may be of very high concern. ...

... (66) The Agency should also be empowered to require further information from manufacturers, importers or downstream users on substances suspected of posing a risk to human health or the environment, including by reason of their presence on the internal market in high volumes, on the basis of evaluations performed. Based on the criteria for prioritising substances developed by the Agency in cooperation with the Member States a Community rolling action plan for substance evaluation should be established, relying on Member State competent authorities to evaluate substances included therein. If a risk equivalent to the level of concern arising from the use of substances subject to authorisation arises from the use of isolated intermediates on site, the competent authorities of the Member States should also be allowed to require further information, when justified. ...

... (69) To ensure a sufficiently high level of protection for human health, including having regard to relevant human population groups and possibly to certain vulnerable sub-populations, and the environment, substances of very high concern should, in accordance with the precautionary principle, be subject to careful attention. Authorisation should be granted where natural or legal persons applying for an authorisation demonstrate to the granting authority that the risks to human health and the environment arising from the use of the substance are adequately controlled. Otherwise, uses may still be authorised if it can be shown that the socio-economic benefits from the use of the substance outweigh the risks connected with its use and there are no suitable alternative substances or technologies that are economically and technically viable. Taking into account the good functioning of the internal market it is appropriate that the Commission should be the granting authority. ...

... (70) Adverse effects on human health and the environment from substances of very high concern should be prevented through the application of appropriate risk management measures to ensure that any risks from the uses of a substance are adequately controlled, and with a view to progressively substituting these substances with a suitable safer substance. Risk management measures should be applied to ensure, when substances are manufactured, placed on the market and used, that exposure to these substances including discharges, emissions and losses, throughout the whole life-cycle is below the threshold level beyond which adverse effects may occur. For any substance for which authorisation has been granted, and for any other substance for which it is not possible to establish a safe level of exposure, measures should always be taken to minimise, as far as technically and practically possible, exposure and emissions with a view to minimising the likelihood of adverse effects. Measures to ensure adequate control should be identified in any Chemical Safety Report. These measures should be applied and, where appropriate, recommended to other actors down the supply chain. ...

... (71) Methodologies to establish thresholds for carcinogenic and mutagenic substances may be developed taking into account the outcomes of RIPs. The relevant Annex may be amended on the basis of these methodologies to allow thresholds where appropriate to be used while ensuring a high level of protection of human health and the environment. ...

... (72) To support the aim of eventual replacement of substances of very high concern by suitable alternative substances or technologies, all applicants for authorisation should provide an analysis of alternatives considering their risks and the technical and economic feasibility of substitution, including information on any research and development the applicant is undertaking or intends to undertake. Furthermore, authorisations should be subject to time-limited review whose periods would be determined on a case-by-case basis and normally be subject to conditions, including monitoring. ...

... (73) Substitution of a substance on its own, in a preparation or in an article should be required when manufacture, use or placing on the market of that substance causes an unacceptable risk to human health or to the environment, taking into account the availability of suitable safer alternative substances and technologies, and the socio-economic benefits from the uses of the substance posing an unacceptable risk. ...

... (74) Substitution of a substance of very high concern by suitable safer alternative substances or technologies should be considered by all those applying for authorisations of uses of such substances on their own, in preparations or for incorporation of substances into articles by making an analysis of alternatives, the risks involved in using any alternative and the technical and economic feasibility of substitution. ...

... (75) The possibility of introducing restrictions on the manufacturing, placing on the market and use of dangerous substances, preparations and articles applies to all substances falling within the scope of this Regulation, with minor exemptions. Restrictions on the placing on the market and the use of substances which are carcinogenic, mutagenic or toxic to reproduction, category 1 or 2, for their use by consumers on their own or in preparations should continue to be introduced. ...

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

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

... (78) The Agency should provide advice on the prioritisation of substances to be made subject to the authorisation procedure, to ensure that decisions reflect the needs of society as well as scientific knowledge and developments. ...

... (79) A total ban on a substance would mean that none of its uses could be authorised. It would therefore be pointless to allow the submission of applications for authorisation. In such cases the substance should be removed from the list of substances for which applications can be submitted and added to the list of restricted substances. ...

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

... (81) In order to provide a harmonised approach to the authorisation of the uses of particular substances, the Agency should issue opinions on the risks arising from those uses, including whether or not the substance is adequately controlled and on any socio-economic analysis submitted to it by third parties. These opinions should be taken into account by the Commission when considering whether or not to grant an authorisation. ...

... (85) In relation to Annex XVII Member States should be allowed to maintain for a transitional period more stringent restrictions, provided that these restrictions have been notified according to the Treaty. This should concern substances on their own, substances in preparations and substances in articles, the manufacturing, the placing on the market and the use of which is restricted. The Commission should compile and publish an inventory of these restrictions. This would provide an opportunity for the Commission to review the measures concerned with a view to possible harmonisation. ...

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

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

... (114) To ensure a harmonised protection for the general public, and, in particular, for persons who come into contact with certain substances, and the proper functioning of other Community legislation relying on the classification and labelling, an inventory should record the classification in accordance with Directive 67/548/EEC and Directive 1999/45/EC agreed by manufacturers and importers of the same substance, if possible, as well as decisions taken at Community level to harmonise the classification and labelling of some substances. This should take full account of the work and experience accumulated in connection with the activities under Directive 67/548/EEC, including the classification and labelling of specific substances or groups of substances listed in Annex I of Directive 67/548/EEC. ...

... (115) Resources should be focused on substances of the highest concern. A substance should therefore be added to Annex I of Directive 67/548/EEC if it meets the criteria for classification as carcinogenic, mutagenic or toxic for reproduction categories 1, 2 or 3, as a respiratory sensitiser, or in respect of other effects on a case-by-case basis. Provision should be made to enable competent authorities to submit proposals to the Agency. The Agency should give its opinion on the proposal while interested parties should have an opportunity to comment. The Commission should take a decision subsequently. ...

... (119) Apart from their participation in the implementation of Community legislation, Member State competent authorities should, because of their closeness to stakeholders in the Member States, play a role in the exchange of information on risks of substances and on the obligations of natural or legal persons under chemicals legislation. At the same time, close cooperation between the Agency, the Commission and the competent authorities of the Member States is necessary to ensure the coherence and efficiency of the global communication process. ...

... (130) Since the objectives of this Regulation, namely laying down rules for substances and establishing a European Chemicals Agency, cannot be sufficiently achieved by the Member States and can therefore be better achieved at Community level, the Community may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve those objectives. ...

ARTICLE-1: Aim and scope [go to this ARTICLE]

... 1. The purpose of this Regulation is to ensure a high level of protection of human health and the environment, including the promotion of alternative methods for assessment of hazards of substances, as well as the free circulation of substances on the internal market while enhancing competitiveness and innovation. ...

... 2. This Regulation lays down provisions on substances and preparations within the meaning of Article 3. These provisions shall apply to the manufacture, placing on the market or use of such substances on their own, in preparations or in articles and to the placing on the market of preparations. ...

... 3. This Regulation is based on the principle that it is for manufacturers, importers and downstream users to ensure that they manufacture, place on the market or use such substances that do not adversely affect human health or the environment. Its provisions are underpinned by the precautionary principle. ...

ARTICLE-2: Application [go to this ARTICLE]

... (a) radioactive substances within the scope of Council Directive 96/29/Euratom of 13 May 1996 laying down basic safety standards for the protection of the health of workers and the general public against the dangers arising from ionising radiation ⁽²⁶⁾; ...

... (b) substances, on their own, in a preparation or in an article, which are subject to customs supervision, provided that they do not undergo any treatment or processing, and which are in temporary storage, or in a free zone or free warehouse with a view to re-exportation, or in transit; ...

... (d) the carriage of dangerous substances and dangerous substances in dangerous preparations by rail, road, inland waterway, sea or air. ...

... 3. Member States may allow for exemptions from this Regulation in specific cases for certain substances, on their own, in a preparation or in an article, where necessary in the interests of defence. ...

... (ii) as a flavouring in foodstuffs within the scope of Council Directive 88/388/EEC of 22 June 1988 on the approximation of the laws of the Member States relating to flavourings for use in foodstuffs and to source materials for their production ⁽³⁴⁾ and Commission Decision 1999/217/EC of 23 February 1999 adopting a register of flavouring substances used in or on foodstuffs drawn up in application of Regulation (EC) No 2232/96 of the European Parliament and of the Council ⁽³⁵⁾; ...

... (c) medical devices which are invasive or used in direct physical contact with the human body in so far as Community measures lay down provisions for the classification and labelling of dangerous substances and preparations which ensure the same level of information provision and protection as Directive 1999/45/EC; ...

... (a) substances included in Annex IV, as sufficient information is known about these substances that they are considered to cause minimum risk because of their intrinsic properties; ...

... (b) substances covered by Annex V, as registration is deemed inappropriate or unnecessary for these substances and their exemption from these Titles does not prejudice the objectives of this Regulation; ...

... (c) substances on their own or in preparations, registered in accordance with Title II, exported from the Community by an actor in the supply chain and re-imported into the Community by the same or another actor in the same supply chain who shows that: ...

... (d) substances, on their own, in preparations or in articles, which have been registered in accordance with Title II and which are recovered in the Community if: ...

ARTICLE-3: Definitions [go to this ARTICLE]

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

... 8. manufacturing: means production or extraction of substances in the natural state; ...

... (a) it is listed in the European Inventory of Existing Commercial Chemical Substances (EINECS); ...

... 30. per year: means per calendar year, unless stated otherwise, for phase-in substances that have been imported or manufactured for at least three consecutive years, quantities per year shall be calculated on the basis of the average production or import volumes for the three preceding calendar years; ...

... 39. substances which occur in nature: means a naturally occurring substance as such, unprocessed or processed only by manual, mechanical or gravitational means, by dissolution in water, by flotation, by extraction with water, by steam distillation or by heating solely to remove water, or which is extracted from air by any means; ...

ARTICLE-5: No data, no market [go to this ARTICLE]

... Subject to Articles 6, 7, 21 and 23, substances on their own, in preparations or in articles shall not be manufactured in the Community or placed on the market unless they have been registered in accordance with the relevant provisions of this Title where this is required. ...

ARTICLE-6: General obligation to register substances on their own or in preparations [go to this ARTICLE]

... General obligation to register substances on their own or in preparations ...

ARTICLE-7: Registration and notification of substances in articles [go to this ARTICLE]

... Registration and notification of substances in articles ...

... 6. Paragraphs 1 to 5 shall not apply to substances that have already been registered for that use. ...

ARTICLE-8: Only representative of a non-Community manufacturer [go to this ARTICLE]

... 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 36, 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 referred to in Article 31. ...

ARTICLE-9: Exemption from the general obligation to register for product and process orientated research and development (PPORD) [go to this ARTICLE]

... 7. The Agency may decide to extend the five-year exemption period by a further maximum of five years or, in the case of substances to be used exclusively in the development of medicinal products for human or veterinary use, or for substances that are not placed on the market, for a further maximum of ten years, upon request if the manufacturer or importer or producer of articles can demonstrate that such an extension is justified by the research and development programme. ...

ARTICLE-10: Information to be submitted for general registration purposes [go to this ARTICLE]

... (x) for substances in quantities of 1 to 10 tonnes, exposure information as specified in section 6 of Annex VI; ...

ARTICLE-12: Information to be submitted depending on tonnage [go to this ARTICLE]

... (a) the information specified in Annex VII for non-phase-in substances, and for phase-in substances meeting one or both of the criteria specified in Annex III, manufactured or imported in quantities of one tonne or more per year per manufacturer or importer; ...

... (b) the information on physicochemical properties specified in Annex VII, section 7 for phase-in substances manufactured or imported in quantities of one tonne or more per year per manufacturer or importer which do not meet either of the criteria specified in Annex III; ...

... (c) the information specified in Annexes VII and VIII for substances manufactured or imported in quantities of 10 tonnes or more per year per manufacturer or importer; ...

... (d) the information specified in Annexes VII and VIII and testing proposals for the provision of the information specified in Annex IX for substances manufactured or imported in quantities of 100 tonnes or more per year per manufacturer or importer; ...

... (e) the information specified in Annexes VII and VIII and testing proposals for the provision of the information specified in Annexes IX and X for substances manufactured or imported in quantities of 1000 tonnes or more per year per manufacturer or importer. ...

ARTICLE-13: General requirements for generation of information on intrinsic properties of substances [go to this ARTICLE]

... General requirements for generation of information on intrinsic properties of substances ...

... 1. Information on intrinsic properties of substances may be generated by means other than tests, provided that the conditions set out in Annex XI are met. In particular for human toxicity, information shall be generated whenever possible by means other than vertebrate animal tests, through the use of alternative methods, for example, in vitro methods or qualitative or quantitative structure-activity relationship models or from information from structurally related substances (grouping or read-across). Testing in accordance with Annex VIII, Sections 8.6 and 8.7, Annex IX and Annex X may be omitted where justified by information on exposure and implemented risk management measures as specified in Annex XI, section 3. ...

... 3. 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 a Commission Regulation or in accordance with other international test methods recognised by the Commission or the Agency as being appropriate. The Commission shall adopt that Regulation, designed to amend the non-essential elements of this Regulation by supplementing it, in accordance with the procedure referred to in Article 133(4). ...

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

ARTICLE-14: Chemical safety report and duty to apply and recommend risk reduction measures [go to this ARTICLE]

... 1. Without prejudice to Article 4 of Directive 98/24/EC, a chemical safety assessment shall be performed and a chemical safety report completed for all substances subject to registration in accordance with this Chapter in quantities of 10 tonnes or more per year per registrant. ...

... The chemical safety report shall document the chemical safety assessment which shall be conducted in accordance with paragraphs 2 to 7 and with Annex I for either each substance on its own or in a preparation or in an article or a group of substances. ...

ARTICLE-15: Substances in plant protection and biocidal products [go to this ARTICLE]

... Substances in plant protection and biocidal products ...

... 1. Active substances and co-formulants manufactured or imported for use in plant protection products only and included either in Annex I to Council Directive 91/414/EEC ⁽⁴⁰⁾ or in Commission Regulation (EEC) No 3600/92 ⁽⁴¹⁾, Commission Regulation (EC) No 703/2001 ⁽⁴²⁾, Commission Regulation (EC) No 1490/2002 ⁽⁴³⁾, or Commission Decision 2003/565/EC ⁽⁴⁴⁾ and for any substance for which a Commission Decision on the completeness of the dossier has been taken pursuant to Article 6 of Directive 91/414/EEC shall be regarded as being registered and the registration as completed for manufacture or import for the use as a plant protection product and therefore as fulfilling the requirements of Chapters 1 and 5 of this Title. ...

... 2. Active substances manufactured or imported for use in biocidal products only and included either in Annexes I, IA or IB to Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market ⁽⁴⁵⁾ or in Commission Regulation (EC) No 2032/2003 ⁽⁴⁶⁾on the second phase of the 10-year work programme referred to in Article 16(2) of Directive 98/8/EC, until the date of the decision referred to in the second subparagraph of Article 16(2) of Directive 98/8/EC, shall be regarded as being registered and the registration as completed for manufacture or import for the use in a biocidal product and therefore as fulfilling the requirements of Chapters 1 and 5 of this Title. ...

ARTICLE-16: Duties of the Commission, the Agency and registrants of substances regarded as being registered [go to this ARTICLE]

... Duties of the Commission, the Agency and registrants of substances regarded as being registered ...

... 1. The Commission or the relevant Community body shall make information equivalent to that required by Article 10 available to the Agency for substances regarded as registered according to Article 15. The Agency shall include this information or a reference thereto in its databases and notify the competent authorities thereof by 1 December 2008. ...

... 2. Articles 21, 22 and 25 to 28 shall not apply to uses of substances regarded as registered according to Article 15. ...

ARTICLE-20: Duties of the Agency [go to this ARTICLE]

... The Agency shall undertake the completeness check within three weeks of the submission date, or within three months of the relevant deadline of Article 23, as regards registrations of phase-in substances submitted in the course of the two-month period immediately preceding that deadline. ...

ARTICLE-21: Manufacturing and import of substances [go to this ARTICLE]

... Manufacturing and import of substances ...

... In the case of registrations of phase-in substances, such a registrant may continue the manufacture or import of the substance or production or import of an article, if there is no indication to the contrary from the Agency in accordance with Article 20(2) within the three weeks after the submission date or, if submitted within the two-month period before the relevant deadline of Article 23, if there is no indication to the contrary from the Agency in accordance with Article 20(2) within the three months from that deadline, without prejudice to Article 27(8). ...

ARTICLE-22: Further duties of registrants [go to this ARTICLE]

... (c) changes in the annual or total quantities manufactured or imported by him or in the quantities of substances present in articles produced or imported by him if these result in a change of tonnage band, including cessation of manufacture or import; ...

ARTICLE-23: Specific provisions for phase-in substances [go to this ARTICLE]

... Specific provisions for phase-in substances ...

... 1. Article 5, Article 6, Article 7(1), Article 17, Article 18 and Article 21 shall not apply until 1 December 2010 to the following substances: ...

... (a) phase-in substances classified as carcinogenic, mutagenic or toxic to reproduction, category 1 or 2, in accordance with Directive 67/548/EEC and manufactured in the Community or imported, in quantities reaching one tonne or more per year per manufacturer or per importer, at least once after 1 June 2007; ...

... (b) phase-in substances classified as very toxic to aquatic organisms which may cause long-term adverse effects in the aquatic environment (R50/53) in accordance with Directive 67/548/EEC, and manufactured in the Community or imported in quantities reaching 100 tonnes or more per year per manufacturer or per importer, at least once after 1 June 2007; ...

... (c) phase-in substances manufactured in the Community or imported, in quantities reaching 1000 tonnes or more per year per manufacturer or per importer, at least once after 1 June 2007. ...

... 2. Article 5, Article 6, Article 7(1), Article 17, Article 18 and Article 21 shall not apply until 1 June 2013 to phase-in substances manufactured in the Community or imported, in quantities reaching 100 tonnes or more per year per manufacturer or per importer, at least once after 1 June 2007. ...

... 3. Article 5, Article 6, Article 7(1), Article 17, Article 18 and Article 21 shall not apply until 1 June 2018 to phase-in substances manufactured in the Community or imported, in quantities reaching one tonne or more per year per manufacturer or per importer, at least once after 1 June 2007. ...

... 5. This Article shall also apply to substances registered under Article 7 adapted as necessary. ...

ARTICLE-24: Notified substances [go to this ARTICLE]

... Notified substances ...

ARTICLE-25: Objectives and general rules [go to this ARTICLE]

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

ARTICLE-27: Sharing of existing data in the case of registered substances [go to this ARTICLE]

... Sharing of existing data in the case of registered substances ...

ARTICLE-28: Duty to pre-register for phase-in substances [go to this ARTICLE]

... Duty to pre-register for phase-in substances ...

... 4. The Agency shall by 1 January 2009 publish on its website a list of the substances referred to in paragraph 1(a) and (d). That list shall comprise only the names of the substances, including their EINECS and CAS number if available and other identity codes, and the first envisaged registration deadline. ...

... 7. Manufacturers or importers of phase-in substances in quantities of less than one tonne per year that appear on the list published by the Agency in accordance with paragraph 4 of this Article, as well as downstream users of those substances and third parties holding information on those substances, may submit the information referred to in paragraph 1 of this Article or any other relevant information to the Agency for those substances, with the intention of being part of the substance information exchange forum as referred to in Article 29. ...

ARTICLE-31: Requirements for safety data sheets [go to this ARTICLE]

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

ARTICLE-32: Duty to communicate information down the supply chain for substances on their own or in preparations for which a safety data sheet is not required [go to this ARTICLE]

... Duty to communicate information down the supply chain for substances on their own or in preparations for which a safety data sheet is not required ...

... (a) the registration number(s) referred to in Article 20(3), if available, for any substances for which information is communicated under points (b), (c) or (d) of this paragraph; ...

ARTICLE-33: Duty to communicate information on substances in articles [go to this ARTICLE]

... Duty to communicate information on substances in articles ...

ARTICLE-34: Duty to communicate information on substances and preparations up the supply chain [go to this ARTICLE]

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

ARTICLE-35: Access to information for workers [go to this ARTICLE]

... Workers and their representatives shall be granted access by their employer to the information provided in accordance with Articles 31 and 32 in relation to substances or preparations that they use or may be exposed to in the course of their work. ...

ARTICLE-37: Downstream user chemical safety assessments and duty to identify, apply and recommend risk reduction measures [go to this ARTICLE]

... 3. For registered substances, the manufacturer, importer or downstream user shall comply with the obligations laid down in Article 14 either before he next supplies the substance on its own or in a preparation to the downstream user making the request referred to in paragraph 2 of this Article, provided that the request was made at least one month before the supply, or within one month after the request, whichever is the later. ...

... For phase-in substances, the manufacturer, importer or downstream user shall comply with this request and with the obligations laid down in Article 14 before the relevant deadline in Article 23 has expired, provided that the downstream user makes his request at least 12 months before the deadline in question. ...

ARTICLE-40: Examination of testing proposals [go to this ARTICLE]

... 1. The Agency shall examine any testing proposal set out in a registration or a downstream user report for provision of the information specified in Annexes IX and X for a substance. Priority shall be given to registrations of substances which have or may have PBT, vPvB, sensitising and/or carcinogenic, mutagenic or toxic for reproduction (CMR) properties, or substances classified as dangerous according to Directive 67/548/EEC above 100 tonnes per year with uses resulting in widespread and diffuse exposure. ...

ARTICLE-41: Compliance check of registrations [go to this ARTICLE]

... 6. Any third party may electronically submit information to the Agency relating to substances that appear on the list referred to in Article 28(4). The Agency shall consider this information together with the information submitted according to Article 124 when checking and selecting dossiers. ...

ARTICLE-43: Procedure and time periods for examination of testing proposals [go to this ARTICLE]

... 1. In the case of non phase-in substances, the Agency shall prepare a draft decision in accordance with Article 40(3) within 180 days of receiving a registration or downstream user report containing a testing proposal. ...

... 2. In the case of phase-in substances, the Agency shall prepare the draft decisions in accordance with Article 40(3): ...

ARTICLE-44: Criteria for substance evaluation [go to this ARTICLE]

... 1. In order to ensure a harmonised approach, the Agency shall in cooperation with the Member States develop criteria for prioritising substances with a view to further evaluation. Prioritisation shall be on a risk-based approach. The criteria shall consider: ...

... (a) hazard information, for instance 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; ...

... 2. The Agency shall use the criteria in paragraph 1 for the purpose of compiling a draft Community rolling action plan which shall cover a period of three years and shall specify substances to be evaluated each year. Substances shall be included if there are grounds for considering (either on the basis of a dossier evaluation carried out by the Agency or on the basis of any other appropriate source, including information in the registration dossier) that a given substance constitutes a risk to human health or the environment. The Agency shall submit the first draft rolling action plan to the Member States by 1 December 2011. The Agency shall submit draft annual updates to the rolling action plan to the Member States by 28 February each year. ...

... The Agency shall adopt the final Community rolling action plan on the basis of an opinion from the Member State Committee set up under Article 76(1)(e) (hereinafter referred to as the Member State Committee) and shall publish the plan on its website, identifying the Member State who will carry out the evaluation of the substances listed therein as determined according to Article 45. ...

ARTICLE-45: Competent authority [go to this ARTICLE]

... 1. The Agency shall be responsible for coordinating the substance evaluation process and ensuring that substances on the Community rolling action plan are evaluated. In doing so, the Agency shall rely on the competent authorities of Member States. In carrying out an evaluation of a substance, the competent authorities may appoint another body to act on their behalf. ...

... The Agency shall refer the matter to the Member State Committee, in order to agree which authority shall be the competent authority, taking into account the Member State in which the manufacturer(s) or importer(s) is located, the respective proportions of total Community gross domestic product, the number of substances already being evaluated by a Member State and the expertise available. ...

... If, within 60 days of the referral, the Member State Committee reaches unanimous agreement, the Member States concerned shall adopt substances for evaluation accordingly. ...

... If the Member State Committee fails to reach a unanimous agreement, the Agency shall submit the conflicting opinions to the Commission, which shall decide which authority shall be the competent authority, in accordance with the procedure referred to in Article 133(3), and the Member States concerned shall adopt substances for evaluation accordingly. ...

... 4. The competent authority identified in accordance with paragraphs 2 and 3 shall evaluate the allocated substances in accordance with this Chapter. ...

ARTICLE-46: Requests for further information and check of information submitted [go to this ARTICLE]

... 1. If the competent authority considers that further information is required, including, if appropriate, information not required in Annexes VII to X, it shall prepare a draft decision, stating reasons, requiring the registrant(s) to submit the further information and setting a deadline for its submission. A draft decision shall be prepared within 12 months of the publication of the Community rolling action plan on the Agency's website for substances to be evaluated that year. The decision shall be taken in accordance with the procedure laid down in Articles 50 and 52. ...

ARTICLE-47: Coherence with other activities [go to this ARTICLE]

... 1. An evaluation of a substance shall be based on all relevant information submitted on that particular substance and on any previous evaluation under this Title. Where information on intrinsic properties of a substance has been generated by reference to structurally related substance(s), the evaluation may also cover these related substances. In cases where a decision on an evaluation has been previously taken in accordance with Article 51 or Article 52, any draft decision requiring further information under Article 46 may be justified only by a change of circumstances or acquired knowledge. ...

ARTICLE-49: Further information on on-site isolated intermediates [go to this ARTICLE]

... For on-site isolated intermediates that are used in strictly controlled conditions, neither dossier nor substance evaluation shall apply. However, where the competent authority of the Member State in whose territory the site is located considers that a risk to human health or the environment, equivalent to the level of concern arising from the use of substances meeting the criteria in Article 57, arises from the use of an on-site isolated intermediate and that risk is not properly controlled, it may: ...

ARTICLE-55: Aim of authorisation and considerations for substitution [go to this ARTICLE]

... The aim of this Title is to ensure the good functioning of the internal market while assuring that the risks from substances of very high concern are properly controlled and that these substances are progressively replaced by suitable alternative substances or technologies where these are economically and technically viable. To this end all manufacturers, importers and downstream users applying for authorisations shall analyse the availability of alternatives and consider their risks, and the technical and economic feasibility of substitution. ...

ARTICLE-56: General provisions [go to this ARTICLE]

... 3. Paragraphs 1 and 2 shall not apply to the use of substances in scientific research and development. Annex XIV shall specify if paragraphs 1 and 2 apply to product and process orientated research and development as well as the maximum quantity exempted. ...

... 4. Paragraphs 1 and 2 shall not apply to the following uses of substances: ...

... 5. In the case of substances that are subject to authorisation only because they meet the criteria in Article 57(a), (b) or (c) or because they are identified in accordance with Article 57(f) only because of hazards to human health, paragraphs 1 and 2 of this Article shall not apply to the following uses: ...

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

... (a) for substances referred to in Article 57(d), (e) and (f), below a concentration limit of 0,1 % weight by weight (w/w); ...

... (b) for all other substances, below the lowest of the concentration limits specified in Directive 1999/45/EC or in Annex I to Directive 67/548/EEC which result in the classification of the preparation as dangerous. ...

ARTICLE-57: Substances to be included in Annex XIV [go to this ARTICLE]

... Substances to be included in Annex XIV ...

... The following substances may be included in Annex XIV in accordance with the procedure laid down in Article 58: ...

... (a) substances meeting the criteria for classification as 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 XIII of this Regulation; ...

... (e) substances which are very persistent and very bioaccumulative in accordance with the criteria set out in Annex XIII of this Regulation; ...

... (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) or (e) — for which there is scientific evidence of probable serious effects to human health or the environment which give rise to an equivalent level of concern to those of other substances listed in points (a) to (e) and which are identified on a case-by-case basis in accordance with the procedure set out in Article 59. ...

ARTICLE-58: Inclusion of substances in Annex XIV [go to this ARTICLE]

... Inclusion of substances in Annex XIV ...

... 1. Whenever a decision is taken to include in Annex XIV substances referred to in Article 57, such a decision shall be taken in accordance with the procedure referred to in Article 133(4). It shall specify for each substance: ...

... 3. Prior to a decision to include substances in Annex XIV, the Agency shall, taking into account the opinion of the Member State Committee, recommend priority substances to be included specifying for each substance the items set out in paragraph 1. Priority shall normally be given to substances with: ...

... The number of substances included in Annex XIV and the dates specified under paragraph 1 shall also take account of the Agency's capacity to handle applications in the time provided for. The Agency shall make its first recommendation of priority substances to be included in Annex XIV by 1 June 2009. The Agency shall make further recommendations at least every second year with a view to including further substances in Annex XIV. ...

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

... 8. Substances which as a result of new information no longer meet the criteria of Article 57 shall be removed from Annex XIV in accordance with the procedure referred to in Article 133(4). ...

ARTICLE-59: Identification of substances referred to in Article 57 [go to this ARTICLE]

... Identification of substances referred to in Article 57 ...

... 1. The procedure set out in paragraphs 2 to 10 of this Article shall apply for the purpose of identifying substances meeting the criteria referred to in Article 57 and establishing a candidate list for eventual inclusion in Annex XIV. The Agency shall indicate, within this list, the substances that are on its work programme according to Article 83(3)(e). ...

... 2. The Commission may ask the Agency to prepare a dossier in accordance with relevant Sections of Annex XV for substances which in its opinion meet the criteria set out in Article 57. The dossier may be limited, if appropriate, to a reference to an entry in Annex I of Directive 67/548/EEC. The Agency shall make this dossier available to the Member States. ...

... 3. Any Member State may prepare a dossier in accordance with Annex XV for substances which in its opinion meet the criteria set out in Article 57 and forward it to the Agency. The dossier may be limited, if appropriate, to a reference to an entry in Annex I of Directive 67/548/EEC. The Agency shall make this dossier available within 30 days of receipt to the other Member States. ...

ARTICLE-60: Granting of authorisations [go to this ARTICLE]

... (a) substances meeting the criteria in Article 57(a), (b), (c) or (f) for which it is not possible to determine a threshold in accordance with Section 6.4 of Annex I; ...

... (b) substances meeting the criteria in Article 57(d) or (e); ...

... (c) substances identified under Article 57(f) having persistent, bioaccumulative and toxic properties or very persistent and very bioaccumulative properties. ...

... 4. If an authorisation cannot be granted under paragraph 2 or for substances listed in paragraph 3, an authorisation may only be granted if it is shown that socio-economic benefits outweigh the risk to human health or the environment arising from the use of the substance and if there are no suitable alternative substances or technologies. This decision shall be taken after consideration of all of the following elements and taking into account the opinions of the Committee for Risk Assessment and the Committee for Socio-economic Analysis referred to in Article 64(4)(a) and (b): ...

... (d) available information on the risks to human health or the environment of any alternative substances or technologies. ...

... 5. When assessing whether suitable alternative substances or technologies are available, all relevant aspects shall be taken into account by the Commission, including: ...

ARTICLE-62: Applications for authorisations [go to this ARTICLE]

... 3. Applications may be made for one or several substances, that meet the definition of a group of substances in Section 1.5 of Annex XI, and for one or several uses. Applications may be made for the applicant's own use(s) and/or for uses for which he intends to place the substance on the market. ...

ARTICLE-64: Procedure for authorisation decisions [go to this ARTICLE]

... 2. The Agency shall make available on its web-site broad information on uses, taking into account Articles 118 and 119 on access to information, for which applications have been received and for reviews of authorisations, with a deadline by which information on alternative substances or technologies may be submitted by interested third parties. ...

... 3. In preparing its opinion, each Committee referred to in paragraph 1 shall first check that the application includes all the information specified in Article 62 that is relevant to its remit. If necessary, the Committees shall, in consultation with each other, make a joint request to the applicant for additional information to bring the application into conformity with the requirements of Article 62. The Committee for Socio-economic Analysis may, if it deems it necessary, require the applicant or request third parties to submit, within a specified time period, additional information on possible alternative substances or technologies. Each Committee shall also take into account any information submitted by third parties. ...

ARTICLE-65: Obligation of holders of authorisations [go to this ARTICLE]

... Holders of an authorisation, as well as downstream users referred to in Article 56(2) including the substances in a preparation, shall include the authorisation number on the label before they place the substance or a preparation containing the substance on the market for an authorised use without prejudice to Directive 67/548/EEC and Directive 1999/45/EC. This shall be done without delay once the authorisation number has been made publicly available in accordance with Article 64(9). ...

ARTICLE-67: General provisions [go to this ARTICLE]

... 2. Paragraph 1 shall not apply to the use of substances in cosmetic products, as defined by Directive 76/768/EEC, with regard to restrictions addressing the risks to human health within the scope of that Directive. ...

ARTICLE-68: Introducing new and amending current restrictions [go to this ARTICLE]

... 1. When there is an unacceptable risk to human health or the environment, arising from the manufacture, use or placing on the market of substances, which needs to be addressed on a Community-wide basis, Annex XVII shall be amended in accordance with the procedure referred to in Article 133(4) by adopting new restrictions, or amending current restrictions in Annex XVII, for the manufacture, use or placing on the market of substances on their own, in preparations or in articles, pursuant to the procedure set out in Articles 69 to 73. Any such decision shall take into account the socio-economic impact of the restriction, including the availability of alternatives. ...

ARTICLE-69: Preparation of a proposal [go to this ARTICLE]

... 5. The Agency shall maintain a list of substances for which a dossier conforming to the requirements of Annex XV is planned or underway by either the Agency or a Member State for the purposes of a proposed restriction. If a substance is on the list, no other such dossier shall be prepared. If it is proposed by either a Member State or the Agency that an existing restriction listed in Annex XVII should be re-examined a decision on whether to do so shall be taken in accordance with the procedure referred to in Article 133(2) based on evidence presented by the Member State or the Agency. ...

ARTICLE-72: Submission of an opinion to the Commission [go to this ARTICLE]

... 1. The Agency shall submit to the Commission without delay the opinions of the Committees for Risk Assessment and 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 Article 70 and Article 71(1) the Agency shall inform the Commission accordingly, stating the reasons. ...

ARTICLE-76: Composition [go to this ARTICLE]

... (d) a Committee for Socio-economic Analysis, which shall be responsible for preparing the opinion of the Agency on applications for authorisation, proposals for restrictions, and any other questions that arise from the operation of this Regulation relating to the socio-economic impact of possible legislative action on substances; ...

... (e) a Member State Committee, which shall be responsible for resolving potential divergences of opinions on draft decisions proposed by the Agency or the Member States under Title VI and proposals for identification of substances of very high concern to be subjected to the authorisation procedure under Title VII; ...

ARTICLE-77: Tasks [go to this ARTICLE]

... (a) performing 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; ...

... (e) establishing and maintaining database(s) with information on all registered substances, the classification and labelling inventory and the harmonised classification and labelling list. It shall make the information identified in Article 119(1) and (2) in the database(s) publicly available, free of charge, over the Internet, except where a request made under Article 10(a)(xi) is considered justified. The Agency shall make other information in the databases available on request in accordance with Article 118; ...

... (f) making publicly available information as to which substances are being, and have been evaluated within 90 days of receipt of the information at the Agency, in accordance with Article 119(1); ...

... (i) providing guidance to stakeholders including Member State competent authorities on communication to the public of information on the risks and safe use of substances, on their own, in preparations or in articles; ...

... (l) at the Commission's request, providing 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; ...

... (b) at the Executive Director's request, providing 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; ...

... (c) at the Executive Director's request, drawing up an opinion on any other aspects concerning the safety of substances on their own, in preparations or in articles. ...

ARTICLE-83: Duties and powers of the Executive Director [go to this ARTICLE]

... (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; an overview of the activities of the Forum; ...

ARTICLE-109: Rules on transparency [go to this ARTICLE]

... To ensure transparency, the Management Board shall, on the basis of a proposal by the Executive Director and in agreement with the Commission, adopt rules to ensure the availability to the public of regulatory, scientific or technical information concerning the safety of substances on their own, in preparations or in articles which is not of a confidential nature. ...

ARTICLE-110: Relations with relevant Community bodies [go to this ARTICLE]

... 2. The Executive Director, having consulted the Committee on Risk Assessment and the European Food Safety Authority, shall establish rules of procedure concerning substances for which an opinion has been sought in a food safety context. These rules of procedure shall be adopted by the Management Board, in agreement with the Commission. ...

ARTICLE-111: Formats and software for submission of information to the Agency [go to this ARTICLE]

... The Agency shall specify formats and make them available free of charge, and software packages and make them available on its website for any submissions to the Agency. Member States, manufactures, importers, distributors or downstream users shall use these formats and packages in their submissions to the Agency pursuant to this Regulation. In particular, the Agency shall make available software tools to facilitate the submission of all information relating to substances registered in accordance with Article 12(1). ...

ARTICLE-112: Scope [go to this ARTICLE]

... (a) substances subject to registration; ...

... (b) substances within the scope of Article 1 of Directive 67/548/EEC, which meet the criteria for classification as dangerous in accordance with that Directive, and which are placed on the market either on their own, or in a preparation above the concentration limits specified in Directive 1999/45/EC, where relevant, which results in the classification of the preparation as dangerous. ...

ARTICLE-119: Electronic public access [go to this ARTICLE]

... 1. The following information held by the Agency on substances whether on their own, in preparations or in articles, shall be made publicly available, free of charge, over the Internet in accordance with Article 77(2)(e): ...

... (a) the name in the IUPAC Nomenclature, for dangerous substances within the meaning of Directive 67/548/EEC, without prejudice to paragraph 2(f) and (g); ...

... 2. The following information on substances whether on their own, in preparations or in articles, shall be made publicly available, free of charge, over the Internet in accordance with Article 77(2)(e) except where a party submitting the information submits a justification in accordance with Article 10(a)(xi), accepted as valid by the Agency, as to why such publication is potentially harmful for the commercial interests of the registrant or any other party concerned: ...

... (f) the name in the IUPAC Nomenclature for non-phase-in substances which are dangerous within the meaning of Directive 67/548/EEC for a period of six years; ...

... (g) the name in the IUPAC Nomenclature for dangerous substances within the meaning of Directive 67/548/EEC that are only used as one or more of the following: ...

ARTICLE-123: Communication to the public of information on risks of substances [go to this ARTICLE]

... Communication to the public of information on risks of substances ...

... The competent authorities of the Member States shall inform the general public about the risks arising from substances where this is considered necessary for the protection of human health or the environment. The Agency, in consultation with competent authorities and stakeholders and drawing as appropriate on relevant best practice, shall provide guidance for the communication of information on the risks and safe use of chemical substances, on their own, in preparations or in articles, with a view to coordinating Member States in these activities. ...

ARTICLE-124: Other responsibilities [go to this ARTICLE]

... Competent authorities shall submit electronically to the Agency any available information that they hold on substances registered in accordance with Article 12(1) whose dossiers do not contain the full information referred to in Annex VII, in particular whether enforcement or monitoring activities have identified suspicions of risk. The competent authority shall update this information as appropriate. ...

... Member States shall establish national helpdesks to provide advice to manufacturers, importers, downstream users and any other interested parties on their respective responsibilities and obligations under this Regulation, in particular in relation to the registration of substances in accordance with Article 12(1), in addition to the operational guidance documents provided by the Agency under Article 77(2)(g). ...

ARTICLE-135: Transitional measures regarding notified substances [go to this ARTICLE]

... Transitional measures regarding notified substances ...

ARTICLE-136: Transitional measures regarding existing substances [go to this ARTICLE]

... Transitional measures regarding existing substances ...

ARTICLE-138: Review [go to this ARTICLE]

... 1. By 1 June 2019, the Commission shall carry out a review to assess whether or not to extend 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 or subject to registration but manufactured or imported in quantities of less than 10 tonnes per year. However, for substances meeting the criteria for classification as carcinogenic, mutagenic or toxic for reproduction, category 1 or 2, in accordance with Directive 67/548/EEC, the review shall be carried out by 1 June 2014. When carrying out the review the Commission shall take into account all relevant factors, including: ...

... (a) the risks posed by polymers in comparison with other substances; ...

... 3. The report, referred to in Article 117(4), on the experience acquired with the operation of this Regulation shall include a review of the requirements relating to registration of substances manufactured or imported only in quantities starting at one tonne but less than 10 tonnes per year per manufacturer or importer. On the basis of that review, the Commission may present legislative proposals to modify the information requirements for substances manufactured or imported in quantities of one tonne or more up to 10 tonnes per year per manufacturer or importer, taking into account the latest developments, for example in relation to alternative testing and (quantitative) structure-activity relationships ((Q)SARs). ...

... 5. The Commission shall carry out a review of Annex XIII by 1 December 2008, to assess the adequacy of the criteria for identifying substances which are persistent, bioaccumulative and toxic or very persistent and very bioaccumulative, with a view to proposing an amendment to it, if appropriate, in accordance with the procedure referred to in Article 133(4). ...

... 7. By 1 June 2013 the Commission shall carry out a review to assess whether or not, taking into account latest developments in scientific knowledge, to extend the scope of Article 60(3) to substances identified under Article 57(f) as having endocrine disrupting properties. On the basis of that review the Commission may, if appropriate, present legislative proposals. ...

... 8. By 1 June 2019, the Commission shall carry out a review to assess whether or not to extend the scope of Article 33 to cover other dangerous substances, taking into account the practical experience in implementing that Article. On the basis of that review, the Commission may, if appropriate, present legislative proposals to extend that obligation. ...

ARTICLE-I: GENERAL PROVISIONS FOR ASSESSING SUBSTANCES AND PREPARING CHEMICAL SAFETY REPORTS [go to this ARTICLE]

... GENERAL PROVISIONS FOR ASSESSING SUBSTANCES AND PREPARING CHEMICAL SAFETY REPORTS ...

... 0.4. Substances whose physicochemical, toxicological and ecotoxicological properties are likely to be similar or follow a regular pattern as a result of structural similarity may be considered as a group, or "category "of substances. If the manufacturer or importer considers that the chemical safety assessment carried out for one substance is sufficient to assess and document that the risks arising from another substance or from a group or "category "of substances are adequately controlled then he can use that chemical safety assessment for the other substance or group or "category "of substances. The manufacturer or importer shall provide a justification for this. ...

... 0.11. When assessing the risk of the use of one or more substances incorporated into a special preparation (for instance alloys), the way the constituent substances are bonded in the chemical matrix shall be taken into account. ...

... 3.1.5. If one study is available then a robust study summary should be prepared for that study. Where there is more than one study addressing the same effect, then the study or studies giving rise to the highest concern shall be used to draw a conclusion and a robust study summary shall be prepared for that study or studies and included as part of the technical dossier. Robust summaries will be required of all key data used in the hazard assessment. If the study or studies giving rise to the highest concern are not used, then this shall be fully justified and included as part of the technical dossier, not only for the study being used but also for all studies 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. ...

... 4.0.1. The objective of the PBT and vPvB assessment shall be to determine if the substance fulfils the criteria given in Annex XIII and if so, to characterise the potential emissions of the substance. A hazard assessment in accordance with Sections 1 and 3 of this Annex addressing all the long-term effects and the estimation of the long-term 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 in Annex XIII. Therefore, a separate PBT and vPvB assessment is required. ...

... 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. ...

... For substances satisfying the PBT and vPvB criteria, the manufacturer or importer shall use the information as obtained in Section 5, Step 2 when implementing on its site, and recommending for downstream users, risk management measures which minimise exposures and emissions to humans and the environment, throughout the lifecycle of the substance that results from manufacture or identified uses. ...

ARTICLE-II: GUIDE TO THE COMPILATION OF SAFETY DATA SHEETS [go to this ARTICLE]

... This Annex sets out the requirements for a Safety Data Sheet that is provided for a substance or a preparation in accordance with Article 31. The Safety Data Sheet provides a mechanism for transmitting appropriate safety information on classified substances and preparations, including information from the relevant Chemical Safety Report(s) down the supply chain to the immediate downstream user(s). The information provided in the Safety Data Sheet shall be consistent with the information in the Chemical Safety Report, where one is required. Where a Chemical Safety Report has been performed, the relevant exposure scenario(s) shall be placed into an annex of the Safety Data Sheet, to make reference to them under the relevant headings of the Safety Data Sheet easier. ...

... The 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. ...

... 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. ...

... 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. ...

... 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. ...

... 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 in the preparation: ...

... (a) substances presenting a health or environmental hazard within the meaning of Directive 67/548/EEC, if they are present in concentrations equal to or greater than the lowest of: ...

... (b) substances for which there are Community workplace exposure limits, which are not already included under point (a); ...

... (c) substances that are persistent, bioaccumulative and toxic or very persistent and very bioaccumulative in accordance with the criteria set out in Annex XIII, if the concentration of an individual substance is equal to or greater than 0,1 %. ...

... 3.3. For a preparation not classified as dangerous according to Directive 1999/45/EC, the substances shall be indicated, together with their concentration or concentration range, if they are present in an individual concentration of either: ...

... - the substances present a health or environmental hazard within the meaning of Directive 67/548/EEC [58], or ...

... - the substances are assigned Community workplace exposure limits, or ...

... (b) ≥ 0,1 % by weight and the substances are persistent, bioaccumulative and toxic or very persistent and very bioaccumulative in accordance with the criteria set out in Annex XIII. ...

... 3.4. The classification (derived either from Articles 4 and 6 of Directive 67/548/EEC, from Annex I to Directive 67/548/EEC or from an agreed entry in the classification and labelling inventory established under Title XI of this Regulation) of the above substances shall be given, including the symbol letters and R phrases which are assigned in accordance with their physicochemical, human health and environmental hazards. The R phrases do not need to be written out in full here: reference shall be made to heading 16, where the full text of each relevant R phrase shall be listed. If the substance does not meet the classification criteria, the reason for indicating the substance in section 3 shall be described, such as "PBT-substance "or "substance with a Community workplace exposure limit". ...

... 3.5. The name and the Registration number, assigned under Article 20(1) of this Regulation, EINECS or ELINCs number, if available, of the above substances shall be given in accordance with Directive 67/548/EEC. The CAS number and IUPAC name (if available) may also be helpful. For substances listed by a generic name, according to Article 15 of Directive 1999/45/EC or the footnote to Section 3.3 of this Annex, a precise chemical identifier is not necessary. ...

... 3.6. If, in accordance with the provisions of Article 15 of Directive 1999/45/EC or the footnote to Section 3.3 of this Annex, the identity of certain substances is to be kept confidential, their chemical nature shall be described in order to ensure safe handling. The name used shall be the same as that which derives from the above procedures. ...

... 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. ...

... 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. ...

... 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. ...

... For substances subject to registration, summaries of the information derived from the application of Annexes VII to XI of this Regulation shall be given. The information shall also include the result of the comparison of the 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 of this Regulation. ...

... 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: ...

... For substances subject to registration, summaries of the information derived from the application of Annexes VII to XI shall be included. ...

ARTICLE-III: CRITERIA FOR SUBSTANCES REGISTERED IN QUANTITIES BETWEEN 1 AND 10 TONNES [go to this ARTICLE]

... CRITERIA FOR SUBSTANCES REGISTERED IN QUANTITIES BETWEEN 1 AND 10 TONNES ...

... Criteria for substances registered between 1 and 10 tonnes, with reference to Article 12(1)(a) and (b): ...

... (a) substances for which it is predicted (ie by the application of (Q)SARs or other evidence) that they are likely to meet the criteria for category 1 or 2 classification for carcinogenicity, mutagenicity or reproductive toxicity or the criteria in Annex XIII; ...

... (b) substances: ...

... (i) with dispersive or diffuse use(s) particularly where such substances are used in consumer preparations or incorporated into consumer articles; and ...

ARTICLE-V: EXEMPTIONS FROM THE OBLIGATION TO REGISTER IN ACCORDANCE WITH ARTICLE 2(7)(b) [go to this ARTICLE]

... 1. Substances which result from a chemical reaction that occurs incidental to exposure of another substance or article to environmental factors such as air, moisture, microbial organisms or sunlight. ...

... 2. Substances which result from a chemical reaction that occurs incidental to storage of another substance, preparation or article. ...

... 3. Substances which result from a chemical reaction occurring upon end use of other substances, preparations or articles and which are not themselves manufactured, imported or placed on the market. ...

... 4. Substances which are not themselves manufactured, imported or placed on the market and which result from a chemical reaction that occurs when: ...

... 7. The following substances which occur in nature, if they are not chemically modified: ...

... 8. Substances occurring in nature other than those listed under paragraph 7, if they are not chemically modified, unless they meet the criteria for classification as dangerous according to Directive 67/548/EEC. ...

... 9. Basic elemental substances for which hazards and risks are already well known: ...

ARTICLE-VI: INFORMATION REQUIREMENTS REFERRED TO IN ARTICLE 10 [go to this ARTICLE]

... The registrant should gather all existing available test data on the substance to be registered, this would include a literature search for relevant information on the substance. Wherever practicable, registrations should be submitted jointly, in accordance with Articles 11 or 19. This will enable test data to be shared, thereby avoiding unnecessary testing and reducing costs. The registrant should also collect all other available and relevant information on the substance regardless whether testing for a given endpoint is required or not at the specific tonnage level. This should include information from alternative sources (e.g. from (Q)SARs, read-across from other substances, in vivo and in vitro testing, epidemiological data) which may assist in identifying the presence or absence of hazardous properties of the substance and which can in certain cases replace the results of animal tests. ...

... 6. INFORMATION ON EXPOSURE FOR SUBSTANCES REGISTERED IN QUANTITIES BETWEEN 1 AND 10 TONNES PER YEAR PER MANUFATCURER OR IMPORTER ...

ARTICLE-VII: STANDARD INFORMATION REQUIREMENTS FOR SUBSTANCES MANUFACTURED OR IMPORTED IN QUANTITIES OF ONE TONNE OR MORE [64] [go to this ARTICLE]

... STANDARD INFORMATION REQUIREMENTS FOR SUBSTANCES MANUFACTURED OR IMPORTED IN QUANTITIES OF ONE TONNE OR MORE [64] ...

... (a) non-phase-in substances manufactured or imported in quantities of 1 to 10 tonnes; ...

... (b) phase-in substances manufactured or imported in quantities of 1 to 10 tonnes and meeting the criteria in Annex III in accordance with Article 12(1)(a) and (b); and ...

... (c) substances manufactured or imported in quantities of 10 tonnes or more. ...

... Any other relevant physicochemical, toxicological and ecotoxicological information that is available shall be provided. For substances not meeting the criteria in Annex III only the physicochemical requirements as set out in section 7 of this Annex are required. ...

... Before new tests are carried out to determine the properties listed in this Annex, all available in vitro data, in vivo data, historical human data, data from valid (Q)SARs and data from structurally related substances (read-across approach) shall be assessed first. In vivo testing with corrosive substances at concentration/dose levels causing corrosivity shall be avoided. Prior to testing, further guidance on testing strategies should be consulted in addition to this Annex. ...

... 7.3.Boiling point | 7.3.The study does not need to be conducted:for gases, orfor solids which either melt above 300 °C or decompose before boiling. In such cases the boiling point under reduced pressure may be estimated or measured, orfor substances which decompose before boiling (e.g. auto-oxidation, rearrangement, degradation, decomposition, etc.). | ...

... 7.10.Flammability | 7.10.The study does not need to be conducted:if the substance is a solid which possesses explosive or pyrophoric properties. These properties should always be considered before considering flammability, orfor 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, orfor substances which spontaneously ignite when in contact with air. | ...

... 7.11.Explosive properties | 7.11.The study does not need to be conducted if:there are no chemical groups associated with explosive properties present in the molecule, orthe substance contains chemical groups associated with explosive properties which include oxygen and the calculated oxygen balance is less than -200, orthe organic substance or a homogenous mixture of organic substances contains chemical groups associated with explosive properties, but the exothermic decomposition energy is less than 500 J/g and the onset of exothermic decomposition is below 500 °C, orfor 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. | ...

... 7.13.Oxidising properties | 7.13.The study does not need to be conducted if:the substance is explosive, orthe substance is highly flammable, orthe substance is an organic peroxide, orthe 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. | ...

ARTICLE-VIII: STANDARD INFORMATION REQUIREMENTS FOR SUBSTANCES MANUFACTURED OR IMPORTED IN QUANTITIES OF 10 TONNES OR MORE [66] [go to this ARTICLE]

... STANDARD INFORMATION REQUIREMENTS FOR SUBSTANCES MANUFACTURED OR IMPORTED IN QUANTITIES OF 10 TONNES OR MORE [66] ...

... 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 12(1)(c). Accordingly, the information required in column 1 of this Annex is additional to that required in column 1 of Annex VII. Any other relevant physicochemical, toxicological and ecotoxicological information that is available shall be provided. Column 2 of this Annex lists specific rules according to which the required standard information may be omitted, replaced by other information, provided at a different stage or adapted in another way. If the conditions are met under which column 2 of this Annex allows adaptations, the registrant shall clearly state this fact and the reasons for each adaptation under the appropriate headings in the registration dossier. ...

... 8.5.Acute toxicity | 8.5.The study/ies do(es) not generally need to be conducted if:the substance is classified as corrosive to the skin.In addition to the oral route (8.5.1), for substances other than gases, the information mentioned under 8.5.2 to 8.5.3 shall be provided for at least one other route. The choice for the second route will depend on the nature of the substance and the likely route of human exposure. If there is only one route of exposure, information for only that route need be provided. | ...

... 8.6.1.Short-term repeated dose toxicity study (28 days), one species, male and female, most appropriate route of administration, having regard to the likely route of human exposure. | 8.6.1.The short-term toxicity study (28 days) does not need to be conducted if:a reliable sub-chronic (90 days) or chronic toxicity study is available, provided that an appropriate species, dosage, solvent and route of administration were used, orwhere a substance undergoes immediate disintegration and there are sufficient data on the cleavage products, orrelevant human exposure can be excluded in accordance with Annex XI Section 3.The appropriate route shall be chosen on the following basis:Testing by the dermal route is appropriate if:(1)inhalation of the substance is unlikely; and(2)skin contact in production and/or use is likely; and(3)the physicochemical and toxicological properties suggest potential for a significant rate of absorption through the skin.Testing by the inhalation route is appropriate if exposure of humans via inhalation is likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size.The sub-chronic toxicity study (90 days) (Annex IX, Section 8.6.2) shall be proposed by the registrant if: the frequency and duration of human exposure indicates that a longer term study is appropriate;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, orappropriately designed toxicokinetic studies reveal accumulation of the substance or its metabolites in certain tissues or organs which would possibly remain undetected in a short-term toxicity study but which are liable to result in adverse effects after prolonged exposure.Further studies shall be proposed by the registrant or may be required by the Agency in accordance with Article 40 or 41 in case of:failure to identify a NOAEL in the 28 or the 90 days study, unless the reason for the failure to identify a NOAEL is absence of adverse toxic effects, ortoxicity of particular concern (e.g. serious/severe effects), orindications 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), orthe 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, orparticular 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), oreffects shown in substances with a clear relationship in molecular structure with the substance being studied, were not detected in the 28 or the 90 days study. | ...

... 8.7.1.Screening for reproductive/developmental toxicity, one species (OECD 421 or 422), if there is no evidence from available information on structurally related substances, from (Q)SAR estimates or from in vitro methods that the substance may be a developmental toxicant | 8.7.1.This study does not need to be conducted if:the substance is known to be a genotoxic carcinogen and appropriate risk management measures are implemented, orthe substance is known to be a germ cell mutagen and appropriate risk management measures are implemented, orrelevant human exposure can be excluded in accordance with Annex XI section 3, ora pre-natal developmental toxicity study (Annex IX, 8.7.2) or a two-generation reproductive toxicity study (Annex IX, Section 8.7.3) is available.If a substance is known to have an adverse effect on fertility, meeting the criteria for classification as Repr Cat 1 or 2: R60, and the available data are adequate to support a robust risk assessment, then no further testing for fertility will be necessary. However, testing for development toxicity must be considered.If a substance is known to cause developmental toxicity, meeting the criteria for classification as Repr Cat 1 or 2: R61, and the available data are adequate to support a robust risk assessment, then no further testing for developmental toxicity will be necessary. However, testing for effects on fertility must be considered.In cases where there are serious concerns about the potential for adverse effects on fertility or development, either a pre-natal developmental toxicity study (Annex IX, Section 8.7.2) or a two-generation reproductive toxicity study (Annex IX, Section 8.7.3) may be proposed by the registrant instead of the screening study. | ...

ARTICLE-IX: STANDARD INFORMATION REQUIREMENTS FOR SUBSTANCES MANUFACTURED OR IMPORTED IN QUANTITIES OF 100 TONNES OR MORE [68] [go to this ARTICLE]

... STANDARD INFORMATION REQUIREMENTS FOR SUBSTANCES MANUFACTURED OR IMPORTED IN QUANTITIES OF 100 TONNES OR MORE [68] ...

... Column 1 of this Annex establishes the standard information required for all substances manufactured or imported in quantities of 100 tonnes or more in accordance with Article 12(1)(d). Accordingly, the information required in column 1 of this Annex is additional to that required in column 1 of Annexes VII and VIII. Any other relevant physicochemical, toxicological and ecotoxicological information that is available shall be provided. Column 2 of this Annex lists specific rules according to which the registrant may propose to omit the required standard information, replace it by other 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. ...

... 8.6.2.Sub-chronic toxicity study (90-day), one species, rodent, male and female, most appropriate route of administration, having regard to the likely route of human exposure. | 8.6.2.The sub-chronic toxicity study (90 days) does not need to be conducted if:a reliable short-term toxicity study (28 days) is available showing severe toxicity effects according to the criteria for classifying the substance as R48, for which the observed NOAEL-28 days, with the application of an appropriate uncertainty factor, allows the extrapolation towards the NOAEL-90 days for the same route of exposure, ora reliable chronic toxicity study is available, provided that an appropriate species and route of administration were used, ora substance undergoes immediate disintegration and there are sufficient data on the cleavage products (both for systemic effects and effects at the site of uptake), orthe 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, orsystemic effects or other evidence of absorption is observed in skin and/or eye irritation studies, orin vitro tests indicate significant dermal absorption, orsignificant dermal toxicity or dermal penetration is recognised for structurally-related substances.Testing by the inhalation route is appropriate if:exposure of humans via inhalation is likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size.Further studies shall be proposed by the registrant or may be required by the Agency in accordance with Articles 40 or 41 in case of:failure to identify a NOAEL in the 90 days study unless the reason for the failure to identify a NOAEL is absence of adverse toxic effects, ortoxicity of particular concern (e.g. serious/severe effects), orindications 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), orparticular 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). | ...

... 9.2.1.2.Simulation testing on ultimate degradation in surface water | 9.2.1.2.The study need not be conducted if:the substances is highly insoluble in water, orthe substance is readily biodegradable. | ...

... 9.2.1.3.Soil simulation testing (for substances with a high potential for adsorption to soil) | 9.2.1.3.The study need not be conducted:if the substance is readily biodegradable, orif direct and indirect exposure of soil is unlikely. | ...

... 9.2.1.4.Sediment simulation testing (for substances with a high potential for adsorption to sediment) | 9.2.1.4.The study need not be conducted:if the substance is readily biodegradable, orif direct and indirect exposure of sediment is unlikely. | ...

... 9.4.Effects on terrestrial organisms | 9.4.These studies do not need to be conducted if direct and indirect exposure of the soil compartment is unlikely.In the absence of toxicity data for soil organisms, the equilibrium partitioning method may be applied to assess the hazard to soil organisms. The choice of the appropriate tests depends on the outcome of the chemical safety assessment.In particular for substances that have a high potential to adsorb to soil or that are very persistent, the registrant shall consider long-term toxicity testing instead of short-term. | ...

ARTICLE-X: STANDARD INFORMATION REQUIREMENTS FOR SUBSTANCES MANUFACTURED OR IMPORTED IN QUANTITIES OF 1000 TONNES OR MORE [70] [go to this ARTICLE]

... STANDARD INFORMATION REQUIREMENTS FOR SUBSTANCES MANUFACTURED OR IMPORTED IN QUANTITIES OF 1000 TONNES OR MORE [70] ...

... 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 12(1)(e). Accordingly, the information required in column 1 of this Annex is additional to that required in column 1 of Annexes VII, VIII and IX. Any other relevant physicochemical, toxicological and ecotoxicological information that is available shall be provided. Column 2 of this Annex lists specific rules according to which the registrant may propose to omit the required standard information, replace it by other 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. ...

... | 8.6.3.A long-term repeated toxicity study (≥ 12 months) may be proposed by the registrant or required by the Agency in accordance with Articles 40 or 41 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-day or 90-day study for which the available evidence is inadequate for toxicological evaluation or risk characterisation, oreffects shown in substances with a clear relationship in molecular structure with the substance being studied were not detected in the 28-day or 90-day study, orthe substance may have a dangerous property that cannot be detected in a 90-day study. | ...

... 8.9.1.Carcinogenicity study | 8.9.1.A carcinogenicity study may be proposed by the registrant or may be required by the Agency in accordance with Articles 40 or 41 if:the substance has a widespread dispersive use or there is evidence of frequent or long-term human exposure, andthe substance is classified as mutagen 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.If the substances is classified as mutagen category 1 or 2, the default presumption would be that a genotoxic mechanism for carcinogenicity is likely. In these cases, a carcinogenicity test will normally not be required. | ...

ARTICLE-XI: GENERAL RULES FOR ADAPTATION OF THE STANDARD TESTING REGIME SET OUT IN ANNEXES VII TO X [go to this ARTICLE]

... Annexes VII to X set out the information requirements for all substances manufactured or imported in quantities of: ...

... 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 reference substance(s) 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 Agency, after consulting with relevant stakeholders and other interested parties, shall issue guidance on technically and scientifically justified methodology for the grouping of substances sufficiently in advance of the first registration deadline for phase-in substances. ...

... If the group concept is applied, substances shall be classified and labelled on this basis. ...

... 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 methods referred to in Article 13(3), more specifically on the technical limitations of a specific method, shall always be respected. ...

ARTICLE-XII: GENERAL PROVISIONS FOR DOWNSTREAM USERS TO ASSESS SUBSTANCES AND PREPARE CHEMICAL SAFETY REPORTS [go to this ARTICLE]

... GENERAL PROVISIONS FOR DOWNSTREAM USERS TO ASSESS SUBSTANCES AND PREPARE CHEMICAL SAFETY REPORTS ...

ARTICLE-XIII: CRITERIA FOR THE IDENTIFICATION OF PERSISTENT, BIOACCUMULATIVE AND TOXIC SUBSTANCES, AND VERY PERSISTENT AND VERY BIOACCUMULATIVE SUBSTANCES [go to this ARTICLE]

... CRITERIA FOR THE IDENTIFICATION OF PERSISTENT, BIOACCUMULATIVE AND TOXIC SUBSTANCES, AND VERY PERSISTENT AND VERY BIOACCUMULATIVE SUBSTANCES ...

... (i) persistent, bioaccumulative and toxic substances (PBT-substances), and ...

... (ii) very persistent and very bioaccumulative substances (vPvB-substances). ...

... A substance is identified as a PBT substance if it fulfils the criteria in Sections 1.1, 1.2 and 1.3. A substance is identified as a vPvB substance if it fulfils the criteria in Sections 2.1 and 2.2. This annex shall not apply to inorganic substances, but shall apply to organo-metals. ...

... 1. PBT-SUBSTANCES ...

... 2. vPvB-SUBSTANCES ...

ARTICLE-XIV: LIST OF SUBSTANCES SUBJECT TO AUTHORISATION [go to this ARTICLE]

... LIST OF SUBSTANCES SUBJECT TO AUTHORISATION ...

ARTICLE-XV: DOSSIERS [go to this ARTICLE]

... Information on exposures, alternative substances and risks ...

... The available use and exposure information and information on alternative substances and techniques shall be provided. ...

... Available information on alternative substances and techniques shall be provided, including: ...

ARTICLE-XVI: SOCIO-ECONOMIC ANALYSIS [go to this ARTICLE]

... - availability, suitability, and technical feasibility of alternative substances and/or technologies, and economic consequences thereof, and information on the rates of, and potential for, technological change in the sector(s) concerned. In the case of an application for authorisation, the social and/or economic impacts of using any available alternatives, ...

ARTICLE-XVII: RESTRICTIONS ON THE MANUFACTURE, PLACING ON THE MARKET AND USE OF CERTAIN DANGEROUS SUBSTANCES, PREPARATIONS AND ARTICLES [go to this ARTICLE]

... RESTRICTIONS ON THE MANUFACTURE, PLACING ON THE MARKET AND USE OF CERTAIN DANGEROUS SUBSTANCES, PREPARATIONS AND ARTICLES ...

... Designation of the substance, of the groups of substances or of the preparation | Conditions of restriction | ...

... 1.Polychlorinated terphenyls (PCTs)Preparations, including waste oils, with a PCT content higher than 0,005 % by weight. | 1.Shall not be used. However, the following use of equipment, installations and fluids which were in service on 30 June 1986 shall continue to be permitted until they are disposed of or reach the end of their service life:(a)closed-system electrical equipment transformers, resistors and inductors;(b)large condensers (≥ 1 kg total weight);(c)small condensers;(d)heat-transmitting fluids in closed-circuit heat-transfer installations;(e)hydraulic fluids for underground mining equipment.2.The Member State may, for reasons of protection of human health and the environment, prohibit the use of equipment, installations and fluids covered by paragraph 1 before they are disposed of or reach the end of their service life.3.The placing on the second-hand market of equipment, plant and fluids covered by paragraph 1 which are not intended for disposal shall be prohibited.4.Where the Member State considers that it is not possible for technical reasons to use substitute articles, it may permit the use of PCTs and preparations thereof where the latter are solely intended, in the normal conditions of maintenance of equipment, to supplement the level of liquids containing PCTs in properly functioning existing installations purchased before 1 October 1985.5.The Member State may, provided prior notification stating the reasons is sent to the Commission, grant derogations from the ban on the placing on the market and use of primary and intermediate substances or preparations, in so far as they consider that these derogations have no deleterious effects on human health and the environment.6.Without prejudice to the implementation of other Community provisions relating to the labelling of dangerous substances and preparations, equipment and installations containing PCTs must also display instructions concerning the disposal of PCTs and the maintenance and use of equipment and installations containing them. These instructions must be capable of being read horizontally when the object containing the PCTs is installed in the normal way. The inscription must stand out clearly from its background and shall be in a language which is understood in the territory where it is being used. | ...

... 3.Liquid substances or preparations, which are regarded as dangerous according to the definitions in Council Directive 67/548/EEC and Directive 1999/45/EC. | 1.Shall not be used in:ornamental objects, intended to produce light or colour effects by means of different phases, for example in ornamental lamps and ashtrays,tricks and jokes,games for one or more participants, or any object intended to be used as such, even with ornamental aspects.2.Without prejudice to paragraph 1, substances and preparations which:present an aspiration hazard and are labelled with R65, andcan be used as fuel in decorative lamps, andare placed on the market in packaging of a capacity of 15 litres or less,shall not contain a colouring agent, unless required for fiscal reasons, or perfume or both.3.Without prejudice to the implementation of other Community provisions relating to the classification, packaging and labelling of dangerous substances and preparations, the packaging of substances and preparations covered by paragraph 2, where intended for use in lamps, must be marked legibly and indelibly as follows:"Keep lamps filled with this liquid out of the reach of children". | ...

... 5.BenzeneCAS No 71-43-2EINECS No 200-753-785 | 1.Not permitted in toys or parts of toys as placed on the market where the concentration of benzene in the free state is in excess of 5 mg/kg of the weight of the toy or part of toy.2.Shall not be used in concentrations equal to, or greater than, 0,1 % by mass in substances or preparations placed on the market.3.However, paragraph 2 shall not apply to:(a)motor fuels which are covered by Directive 98/70/EC;(b)substances and preparations for use in industrial processes not allowing for the emission of benzene in quantities in excess of those laid down in existing legislation;(c)waste covered by Council Directive 91/689/EEC of 12 December 1991 on hazardous waste [72]and Directive 2006/12/EC. | ...

... 6.Asbestos fibres(a)CrocidoliteCAS No 12001-28-4(b)AmositeCAS No 12172-73-5(c)AnthophylliteCAS No 77536-67-5(d)ActinoliteCAS No 77536-66-4(e)TremoliteCAS No 77536-68-6(f)Chrysotile [73]CAS No 12001-29-5CAS No 132207-32-0 | 1.The placing on the market and use of these fibres and of articles containing these fibres added intentionally shall be prohibited.However, Member States may except the placing on the market and use of diaphragms containing chrysotile (point (f)) for existing electrolysis installations until they reach the end of their service life, or until suitable asbestos-free substitutes become available, whichever is the sooner. The Commission will review this derogation before 1 January 2008.2.The use of articles containing asbestos fibres referred to in paragraph 1 which were already installed and/or in service before 1 January 2005 shall continue to be permitted until they are disposed of or reach the end of their service life. However, Member States may, for reasons of protection of human health, prohibit the use of such articles before they are disposed of or reach the end of their service life.Member States shall not permit the introduction of new applications for chrysotile asbestos on their territories.3.Without prejudice to the application of other Community provisions on the classification, packaging and labelling of dangerous substances and preparations, the placing on the market and use of these fibres and of articles containing these fibres, as permitted according to the preceding derogations, shall be permitted only if the articles bear a label in accordance with the provisions of Appendix 7 to this Annex. | ...

... 12.2-NaphthylamineCAS No 91-59-8EINECS No 202-080-4and its salts13.BenzidineCAS No 92-87-5EINECS No 202-199-1and its salts14.4-NitrobiphenylCAS No 92-93-3EINECS No 202-204-715.4-Aminobiphenyl xenylamineCAS No 92-67-1EINECS No 202-177-1and its salts | 1.Shall not be used in concentrations equal to or greater than 0,1 % by weight in substances and preparations placed on the market.However, this provision shall not apply to waste containing one or more of these substances and covered by Directives 91/689/EEC and 2006/12/EC.2.Such substances and preparations shall not be sold to the general public.3Without prejudice to the application of other Community provisions on the classification, packaging and labelling of dangerous substances and preparations, the packaging of such preparations shall be legible and indelibly marked as follows:"Restricted to professional users". | ...

... 16.Lead carbons:(a)Neutral anhydrous carbonate (PbCO3)CAS No 598-63-0EINECS No 209-943-4(b)Trilead-bis(carbonate)-dihydroxide 2 Pb CO3-Pb(OH)2CAS No 1319-46-6EINECS No 215-290-6 | Shall not be used as substances and a constituent of preparations intended for use as paints, except for the restoration and maintenance of works of art and historic buildings and their interiors, where Member States wish to permit this on their territory, in accordance with the provisions of ILO Convention 13 on the use of white lead and sulphates of lead in paint. | ...

... 18.Mercury compounds | 1.Shall not be used as substances and constituents of preparations intended for use:(a)to prevent the fouling by micro-organisms, plants or animals of:the hulls of boats,cages, floats, nets and any other appliances or equipment used for fish or shellfish farming,any totally or partly submerged appliances or equipment;(b)in the preservation of wood;(c)in the impregnation of heavy-duty industrial textiles and yarn intended for their manufacture;(d)in the treatment of industrial waters, irrespective of their use.2.The placing on the market of batteries and accumulators, containing more than 0,0005 % of mercury by weight, including in those cases where these batteries and accumulators are incorporated into appliances shall be prohibited. Button cells and batteries composed of button cells with a mercury content of no more than 2 % by weight shall be exempted from this prohibition. | ...

... 19.Arsenic compounds | 1.Shall not be used as substances and constituents of preparations intended for use:(a)to prevent the fouling by micro-organisms, plants or animals of:the hulls of boats,cages, floats, nets and any other appliances or equipment used for fish or shellfish farming,any totally or partly submerged appliances or equipment;(b)in the preservation of wood. Furthermore, wood so treated shall not be placed on the market;(c)however, by way of derogation:(i)Relating to the substances and preparations in the preservation of wood: these may only be used in industrial installations using vacuum or pressure to impregnate wood if they are solutions of inorganic compounds of the copper, chromium, arsenic (CCA) type C. Wood so treated shall not be placed on the market before fixation of the preservative is completed.(ii)Relating to wood treated with CCA solutions in industrial installations according to point (i): this may be placed on the market for professional and industrial use provided that the structural integrity of the wood is required for human or livestock safety and skin contact by the general public during its service life is unlikely:as structural timber in public and agricultural buildings, office buildings, and industrial premises,in bridges and bridgework,as constructional timber in freshwater areas and brackish waters e.g. jetties and bridges,as noise barriers,in avalanche control,in highway safety fencing and barriers,as debarked round conifer livestock fence posts,in earth retaining structures,as electric power transmission and telecommunications poles,as underground railway sleepers.Without prejudice to the application of other Community provisions on the classification, packaging and labelling of dangerous substances and preparations, all treated wood placed on the market shall be individually labelled "For professional and industrial installation and use only, contains arsenic". In addition, all wood placed on the market in packs shall also bear a label stating "Wear gloves when handling this wood. Wear a dust mask and eye protection when cutting or otherwise crafting this wood. Waste from this wood shall be treated as hazardous by an authorised undertaking".(iii)Treated wood referred to under points (i) and (ii) shall not be used:in residential or domestic constructions, whatever the purpose,in any application where there is a risk of repeated skin contact,in marine waters,for agricultural purposes other than for livestock fence posts and structural uses in accordance with point (ii),in any application where the treated wood may come into contact with intermediate or finished products intended for human and/or animal consumption.2.Shall not be used as substances and constituents of preparations intended for use in the treatment of industrial waters, irrespective of their use. | ...

... 20.Organostannic compounds | 1.Shall not be placed on the market for use as substances and constituents of preparations when acting as biocides in free association paint.2.Shall not be placed on the market or used as substances and constituents of preparations which act as biocides to prevent the fouling by micro-organisms, plants or animals of:(a)all craft irrespective of their length intended for use in marine, coastal, estuarine and inland waterways and lakes;(b)cages, floats, nets and any other appliances or equipment used for fish or shellfish farming;(c)any totally or partly submerged appliance or equipment.3.Shall not be used as substances and constituents of preparations intended for use in the treatment of industrial waters. | ...

... 21.Di-μ-oxo-di-n-butylstanniohydroxyborane dibutyltin hydrogen borate C8H19BO3Sn (DBB)CAS No 75113-37-0ELINCS No 401-040-5 | Shall be prohibited in a concentration equal to or greater than 0,1 % in substances and constituents of preparations placed on the market. However, this provision shall not apply to this substance (DBB) or preparations containing it if these are intended solely for conversion into finished articles, among which this substance will no longer feature in a concentration equal to or greater than 0,1 %. | ...

... 22.PentachlorophenolCAS No 87-86-5EINECS No 201-778-6and its salts and esters | 1.Shall not be used in a concentration equal to or greater than 0,1 % by mass in substances or preparations placed on the market.2.Transitional provisions:By way of derogation until 31 December 2008 France, Ireland, Portugal, Spain and the United Kingdom may chose not to apply this provision to substances and preparations intended for use in industrial installations not permitting the emission and/or discharge of pentachlorophenol (PCP) in quantities greater than those prescribed by existing legislation:(a)in the treatment of wood.However, treated wood shall not be used:inside buildings whether for decorative purposes or not, whatever their purpose (residence, employment, leisure),for the manufacture and re-treatment of:(i)containers intended for growing purposes;(ii)packaging that may come into contact with raw materials, intermediate or finished products destined for human and/or animal consumption;(iii)other materials that may contaminate the products mentioned in (i) and (ii);(b)in the impregnation of fibres and heavy-duty textiles not intended in any case for clothing or for decorative furnishings;(c)by way of special exception, Member States may on a case-by-case basis, permit on their territory specialised professionals to carry out in situ and for buildings of cultural, artistic and historical interest, or in emergencies, a remedial treatment of timber and masonry infected by dry rot fungus (Serpula lacrymans) and cubic rot fungi.In any case:(a)Pentachlorophenol used alone or as a component of preparations employed within the framework of the above exceptions must have a total hexachlorodibenzoparadioxin (HCDD) content of not more than two parts per million (ppm);(b)these substances and preparations shall not:be placed on the market except in packages of 20 litres or more;be sold to the general public.3.Without prejudice to the implementation of other Community provisions concerning the classification, packaging and labelling of dangerous substances and preparations, the packaging of substances and preparations covered by paragraphs 1 and 2 shall be marked clearly and indelibly:"Reserved for industrial and professional use".This provision shall not apply to waste covered by Directives 91/689/EEC and 2006/12/EC. | ...

... 23.CadmiumCAS No 7440-43-9EINECS No 231-152-8and its compounds | 1.Shall not be used to give colour to finished articles manufactured from the substances and preparations listed below:(a)polyvinyl chloride (PVC) [3904 10] [3904 21] [3904 22] [74],polyurethane (PUR) [3909 50] [74],low-density polyethylene (ld PE), with the exception of low-density polyethylene used for the production of coloured masterbatch [3901 10] [74],cellulose acetate (CA) [3912 11] [3912 12] [74],cellulose acetate butyrate (CAB) [3912 11] [3912 12] [74],epoxy resins [3907 30] [74],melamine — formaldehyde (MF) resins [3909 20] [74],urea — formaldehyde (UF) resins [3909 10] [74],unsaturated polyesters (UP) [3907 91] [74],polyethylene terephthalate (PET) [3907 60] [74],polybutylene terephthalate (PBT) [74],transparent/general-purpose polystyrene [3903 11] [3903 19] [74],acrylonitrile methylmethacrylate (AMMA) [74],cross-linked polyethylene (VPE) [74],high-impact polystyrene [74],polypropylene (PP) [3902 10] [74];(b)paints [3208] [3209] [74].However, if the paints have a high zinc content, their residual concentration of cadmium shall be as low as possible and shall at all events not exceed 0,1 % by mass.In any case, whatever their use or intended final purpose, finished articles or components of articles manufactured from the substances and preparations listed above coloured with cadmium shall not be placed on the market if their cadmium content (expressed as Cd metal) exceeds 0,01 % by mass of the plastic material.2.However, paragraph 1 does not apply to articles to be coloured for safety reasons.3.Shall not be used to stabilise the finished articles listed below manufactured from polymers or copolymers of vinyl chloride:packaging materials (bags, containers, bottles, lids) [3923 29 10] [3920 41] [3920 42] [74],office or school supplies [3926 10] [74],fittings for furniture, coachwork or the like [3926 30] [74],articles of apparel and clothing accessories (including gloves) [3926 20] [74],floor and wall coverings [3918 10] [74],impregnated, coated, covered or laminated textile fabrics [5903 10] [74],imitation leather [4202] [74],gramophone records [8524 10] [74],tubes and pipes and their fittings [3917 23] [74],swing doors [74],vehicles for road transport (interior, exterior, underbody) [74],coating of steel sheet used in construction or in industry [74],insulation for electrical wiring [74].In any case, whatever their use or intended final purpose, the placing on the market of the above finished articles or components of articles manufactured from polymers or copolymers of vinyl chloride, stabilised by substances containing cadmium shall be prohibited, if their cadmium content (expressed as Cd metal) exceeds 0,01 % by mass of the polymer.4.However, paragraph 3 does not apply to finished articles using cadmium-based stabilisers for safety reasons.5.Within the meaning of this Regulation, "cadmium plating "means any deposit or coating of metallic cadmium on a metallic surface.Shall not be used for cadmium plating metallic articles or components of the articles used in the sectors/applications listed below:(a)equipment and machinery for:food production [8210] [8417 20] [8419 81] [8421 11] [8421 22] [8422] [8435] [8437] [8438] [8476 11] [74],agriculture [8419 31] [8424 81] [8432] [8433] [8434] [8436] [74],cooling and freezing [8418] [74],printing and book-binding [8440] [8442] [8443] [74];(b)equipment and machinery for the production of:household goods [7321] [8421 12] [8450] [8509] [8516] [74],furniture [8465] [8466] [9401] [9402] [9403] [9404] [74],sanitary ware [7324] [74],central heating and air conditioning plant [7322] [8403] [8404] [8415] [74].In any case, whatever their use or intended final purpose, the placing on the market of cadmium-plated articles or components of such articles used in the sectors/applications listed in points (a) and (b) above and of articles manufactured in the sectors listed in point (b) above shall be prohibited.6.The provisions referred to in paragraph 5 are also applicable to cadmium-plated articles or components of such articles when used in the sectors/applications listed in points (a) and (b) below and to articles manufactured in the sectors listed in (b) below:(a)equipment and machinery for the production of:paper and board [8419 32] [8439] [8441] [74],textiles and clothing [8444] [8445] [8447] [8448] [8449] [8451] [8452] [74];(b)equipment and machinery for the production of:industrial handling equipment and machinery [8425] [8426] [8427] [8428] [8429] [8430] [8431] [74],road and agricultural vehicles [chapter 87] [74],rolling stock [chapter 86] [74],vessels [chapter 89] [74].7.However, the restrictions in paragraphs 5 and 6 do not apply to:articles and components of the articles used in the aeronautical, aerospace, mining, offshore and nuclear sectors whose applications require high safety standards and in safety devices in road and agricultural vehicles, rolling stock and vessels,electrical contacts in any sector of use, on account of the reliability required of the apparatus on which they are installed.Owing to the development of knowledge and techniques in respect of substitutes less dangerous than cadmium and its compounds, the Commission shall, in consultation with the Member States, assess the situation at regular intervals in accordance with the procedure laid down in Article 133(3) of this Regulation. | ...

... 28.Substances which appear in Annex I to Directive 67/548/EEC classified as carcinogen category 1 or carcinogen category 2 and labelled at least as "Toxic (T) "with risk phrase R 45: "May cause cancer "or risk phrase R49: "May cause cancer by inhalation", and listed as follows:Carcinogen category 1 listed in Appendix 1.Carcinogen category 2 listed in Appendix 2. | Without prejudice to the other parts of this Annex the following shall apply to entries 28 to 30: 1.Shall not be used in substances and preparations placed on the market for sale to the general public in individual concentration equal to or greater than:either the relevant concentration specified in Annex I to Directive 67/548/EEC, orthe relevant concentration specified in Directive 1999/45/EC. | ...

... 29.Substances which appear in Annex I to Directive 67/548/EEC classified as mutagen category 1 or mutagen category 2 and labelled with risk phrase R46: "May cause heritable genetic damage", and listed as follows:Mutagen category 1 listed in Appendix 3.Mutagen category 2 listed in Appendix 4. | Without prejudice to the implementation of other Community provisions relating to the classification, packaging and labelling of dangerous substances and preparations, the packaging of such substances and preparations must be marked legibly and indelibly as follows: "Restricted to professional users". | ...

... 30.Substances which appear in Annex I to Directive 67/548/EEC classified as toxic to reproduction category 1 or toxic to reproduction category 2 and labelled with risk phrase R60: "May impair fertility "and/or R61: "May cause harm to the unborn child", and listed as follows:Toxic to reproduction category 1 listed in Appendix 5.Toxic to reproduction category 2 listed in Appendix 6. | 2.By way of derogation, paragraph 1 shall not apply to:(a)medicinal or veterinary products as defined by Directive 2001/82/EC and Directive 2001/83/EC;(b)cosmetic products as defined by Council Directive 76/768/EEC;(c)motor fuels which are covered by Directive 98/70/EC,mineral oil products intended for use as fuel in mobile or fixed combustion plants,fuels sold in closed systems (e.g. liquid gas bottles);(d)artists' paints covered by Directive 1999/45/EC. | ...

... 31.(a)creosote; wash oilCAS No 8001-58-9EINECS No 232-287-5(b)creosote oil; wash oilCAS No 61789-28-4EINECS No 263-047-8(c)distillates (coal tar), naphthalene oils; naphthalene oilCAS No 84650-04-4EINECS No 283-484-8(d)creosote oil, acenaphthene fraction; wash oilCAS No 90640-84-9EINECS No 292-605-3(e)distillates (coal tar), upper; heavy anthracene oilCAS No 65996-91-0EINECS No 266-026-1(f)anthracene oilCAS No 90640-80-5EINECS No 292-602-7(g)tar acids, coal, crude; crude phenolsCAS No 65996-85-2EINECS No 266-019-3(h)creosote, woodCAS No 8021-39-4EINECS No 232-419-1(i)low temperature tar oil, alkaline; extract residues (coal), low temperature coal tar alkalineCAS No 122384-78-5EINECS No 310-191-5 | 1.Shall not be used as substances or in preparations in the treatment of wood. Furthermore, wood so treated shall not be placed on the market.2.However by way of derogation:(a)relating to the substances and preparations: these may be used for wood treatment in industrial installations or by professionals covered by Community legislation on the protection of workers for in situ retreatment only if they contain:(i)benzo[a]pyrene at a concentration of less than 0,005 % by mass;(ii)and water extractable phenols at a concentration of less than 3 % by mass.Such substances and preparations for use in wood treatment in industrial installations or by professionals:may be placed on the market only in packaging of a capacity equal to or greater than 20 litres,shall not be sold to consumers.Without prejudice to the application of other Community provisions on the classification, packaging and labelling of dangerous substances and preparations, the packaging of such substances and preparations shall be legibly and indelibly marked as follows:"For use in industrial installations or professional treatment only".(b)relating to wood treated in industrial installations or by professionals according to point (a) which is placed on the market for the first time or retreated in situ: this is permitted for professional and industrial use only, e.g. on railways, in electric power transmission and telecommunications, for fencing, for agricultural purposes (e.g. stakes for tree support) and in harbours and waterways;(c)the prohibition in paragraph 1 on the placing on the market shall not apply to wood which has been treated with substances listed in entry 31(a) to (i) before 31 December 2002 and is placed on the second-hand market for re-use.3.However, treated wood referred to under paragraph 2(b) and (c) shall not be used:inside buildings, whatever their purpose,in toys,in playgrounds,in parks, gardens, and outdoor recreational and leisure facilities where there is a risk of frequent skin contact,in the manufacture of garden furniture such as picnic tables,for the manufacture and use and any re-treatment of:containers intended for growing purposes,packaging that may come into contact with raw materials, intermediate or finished products destined for human and/or animal consumption,other materials which may contaminate the articles mentioned above. | ...

... 32.ChloroformCAS No 67-66-3EINECS No 200-663-833.Carbon tetrachloride-tetrachloromethaneCAS No 56-23-5EINECS No 200-262-834.1,1,2 TrichloroethaneCAS No 79-00-5EINECS No 201-166-935.1,1,2,2 TetrachloroethaneCAS No 79-34-5EINECS No 201-197-836.1,1,1,2 TetrachloroethaneCAS No 630-20-637.PentachloroethaneCAS No 76-01-7EINECS No 200-925-138.1,1 DichloroethyleneCAS No 75-35-4EINECS No 200-864-039.1,1,1 Trichloroethane, methyl chloroformCAS No 71-55-6EINECS No 200-756-3 | 1.Shall not be used in concentrations equal to or greater than 0,1 % by weight in substances and preparations placed on the market for sale to the general public and/or in diffusive applications such as in surface cleaning and cleaning of fabrics.2.Without prejudice to the application of other Community provisions on the classification, packaging and labelling of dangerous substances and preparations, the packaging of such substances and preparations containing them in concentrations equal to or greater than 0,1 % shall be legible and indelibly marked as follows:"For use in industrial installations only".By way of derogation this provision shall not apply to:(a)medicinal or veterinary products as defined by Directive 2001/82/EC and Directive 2001/83/EC;(b)cosmetic products as defined by Directive 76/768/EEC. | ...

... 40.Substances meeting the criteria of flammability in Directive 67/548/EEC and classified as flammable, highly flammable or extremely flammable regardless of whether they appear in Annex I to that Directive or not. | 1Shall not be used on their own or in the form of preparations in aerosol generators that are placed on the market for the general public for entertainment and decorative purposes such as the following:metallic glitter intended mainly for decoration,artificial snow and frost,"whoopee "cushions,silly string aerosols,imitation excrement,horn for parties,decorative flakes and foams,artificial cobwebs,stink bombs,etc.2.Without prejudice to the application of other Community provisions on the classification, packaging and labelling of dangerous substances, the following words must appear legibly and indelibly on the packaging of aerosol generators referred to above:"For professional users only".3.By way of derogation, paragraphs 1 and 2 shall not apply to the aerosol generators referred to in Article 9a of Council Directive 75/324/EEC of 20 May 1975 on the approximation of the laws of the Member States relating to aerosol dispensers [75].4.The articles referred to in paragraphs 1 and 2 shall not be placed on the market unless they conform to the requirements indicated. | ...

... 42.Alkanes, C10-C13, chloro (short-chain chlorinated paraffins) (SCCPs)EINECS No 287-476-5 | Shall not be placed on the market for use as substances or as constituents of other substances or preparations in concentrations higher than 1 %: in metalworking,for fat liquoring of leather. | ...

... 45.Diphenylether, octabromo derivative C12H2Br8O | 1.Shall not be placed on the market or used as a substance or as a constituent of substances or of preparations in concentrations higher than 0,1 % by mass.2.Articles may not be placed on the market if they, or flame-retardant parts thereof, contain this substance in concentrations higher than 0,1 % by mass. | ...

... 47.Cement | 1.Cement and cement-containing preparations shall not be used or placed on the market, if they contain, when hydrated, more than 0,0002 % soluble chromium VI of the total dry weight of the cement.2.If reducing agents are used, then without prejudice to the application of other Community provisions on the classification, packaging and labelling of dangerous substances and preparations, the packaging of cement or cement-containing preparations shall be legibly and indelibly marked with information on the packing date, as well as on the storage conditions and the storage period appropriate to maintaining the activity of the reducing agent and to keeping the content of soluble chromium VI below the limit indicated in paragraph 1.3.By way of derogation, paragraphs 1 and 2 shall not apply to the placing on the market for, and use in, controlled closed and totally automated processes in which cement and cement-containing preparations are handled solely by machines and in which there is no possibility of contact with the skin. | ...

... 51.The following phthalates (or other CAS- and EINECS numbers covering the substance):bis (2-ethylhexyl) phthalate (DEHP)CAS No 117-81-7Einecs No 204-211-0dibutyl phthalate (DBP)CAS No 84-74-2Einecs No 201-557-4benzyl butyl phthalate (BBP)CAS No 85-68-7Einecs No 201-622-7 | Shall not be used as substances or as constituents of preparations, at concentrations higher than 0,1 % by mass of the plasticised material, in toys and childcare articles [76]. Toys and childcare articles containing these phthalates in a concentration higher than 0,1 % by mass of the plasticised material shall not be placed on the market. The Commission shall re-evaluate, by 16 January 2010, the measures provided for in relation to this point in the light of new scientific information on such substances and their substitutes, and if justified, these measures shall be modified accordingly. | ...

... 52.The following phthalates (or other CAS- and EINECS numbers covering the substance):di-"isononyl "phthalate (DINP)CAS No 28553-12-0 and 68515-48-0Einecs No 249-079-5 and 271-090-9di-"isodecyl "phthalate (DIDP)CAS No 26761-40-0 and 68515-49-1Einecs No 247-977-1 and 271-091-4di-n-octyl phthalate (DNOP)CAS No 117-84-0Einecs No 204-214-7 | Shall not be used as substances or as constituents of preparations, at concentrations higher than 0,1 % by mass of the plasticised material, in toys and childcare articles [76]which can be placed in the mouth by children. Toys and childcare articles containing these phthalates in a concentration higher than 0,1 % by mass of the plasticised material shall not be placed on the market. The Commission shall re-evaluate, by 16 January 2010, the measures provided for in relation to this point in the light of new scientific information on such substances and their substitutes, and if justified, these measures shall be modified accordingly. | ...

... Substances: ...

... The name is the same as that used for the substance in Annex I to Directive 67/548/EEC. Whenever possible dangerous substances are designated by their EINECS (European Inventory of Existing Commercial Chemical Substances) or ELINCS (European List of Notified Chemical Substances) names. These are referred to as EC numbers in the table. Other entries not listed in EINECS or ELINCS are designated using an internationally recognised chemical name (e.g. ISO, IUPAC). An additional common name is included in some cases. ...

... The index number is the identification code given to the substance in Annex I of Directive 67/548/EEC. Substances are listed in the Appendix according to this index number. ...

... Chemical Abstracts Service (CAS) numbers have been defined for substances to help in their identification. ...

... For substances belonging to one particular group of substances included in Annex I to Directive 67/548/EEC, the symbols, indications of danger, R- and S-phrases to be used for each substance shall be those shown in the appropriate entry in that Annex. ...

... For substances belonging to more than one group of substances included in Annex I to Directive 67/548/EEC, the symbols, indications of danger, R- and S-phrases to be used for each substance shall be those shown in both the appropriate entries given in that Annex. In cases where two different classifications are given in the two entries for the same hazard, the classification reflecting the more severe hazard classification shall be used. ...

... Some organic substances may be marketed either in a specific isomeric form or as a mixture of several isomers. ...

... Certain substances which are susceptible to spontaneous polymerisation or decomposition are generally placed on the market in a stabilised form. It is in this form that they are listed in Annex I to Directive 67/548/EEC. ...

... However, such substances are sometimes placed on the market in a non-stabilised form. In this case, the manufacturer or any person who places such a substance on the market must state on the label the name of the substance followed by the words "non-stabilised". ...

... Substances with specific effects on human health (see chapter 4 of Annex VI of Directive 67/548/EEC) that are classified as carcinogenic, mutagenic and/or toxic for reproduction in categories 1 or 2 are ascribed Note E if they are also classified as very toxic (T+), toxic (T) or harmful (Xn). For these substances, the risk phrases R20, R21, R22, R23, R24, R25, R26, R27, R28, R39, R68 (harmful), R48 and R65 and all combinations of these risk phrases shall be preceded by the word "Also". ...

... This note applies to certain coal- and oil-derived substances and to certain entries for groups of substances in Annex I to Directive 67/548/EEC. ...

... The classification as a carcinogen or mutagen need not apply if it can be shown that the substance contains less than 0,1 % w/w 1,3-butadiene (EINECS No 203-450-8). If the substance is not classified as a carcinogen or mutagen, at least the S-phrases (2-)9-16 should apply. This note applies to certain complex oil-derived substances in Annex I to Directive 67/548/EC ...

... Tar, coal, high-temperature, residues; Coal tar solids residue (Solids formed during the coking of bituminous coal to produce crude bituminous coal high temperature tar. Composed primarily of coke and coal particles, highly aromatised compounds and mineral substances.) | 648-061-00-8 | 309-726-5 | 100684-51-3 | M | ...

ARTICLE-FOOTNOTES: List of Footnotes [go to this ARTICLE]

... [21] Commission Directive 93/67/EEC of 20 July 1993 laying down the principles for assessment of risks to man and the environment of substances notified in accordance with Council Directive 67/548/EEC (OJ L 227, 8.9.1993, p. 9). ...

... [24] Commission Regulation (EC) No 1488/94 of 28 June 1994 laying down the principles for the assessment of risks to man and the environment of existing substances in accordance with Council Regulation (EEC) No 793/93 (OJ L 161, 29.6.1994, p. 3). ...

... [42] Commission Regulation (EC) No 703/2001 of 6 April 2001 laying down the active substances of plant protection products to be assessed in the second stage of the work programme referred to in Article 8(2) of Council Directive 91/414/EEC and revising the list of Member States designated as rapporteurs for those substances (OJ L 98, 7.4.2001, p. 6). ...

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