Law-ref.org REACH - Registration, Evaluation and Authorisation of Chemicals
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PREAMBLE     [go to this PREAMBLE]
... 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. ...
... 28. Scientific research and development normally takes place in quantities below 1 tonne per year. There is no need to exempt such research and development because substances in those quantities do not have to be registered in any case. However, in order to encourage innovation, 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. ...
... 28. Scientific research and development normally takes place in quantities below 1 tonne per year. There is no need to exempt such research and development because substances in those quantities do not have to be registered in any case. However, in order to encourage innovation, 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 1 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. ...
... 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. ...
... 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. ...
... 59. The requirements for undertaking chemical safety assessments by downstream users should also be prescribed in detail to allow them to meet their obligations. These requirements should only apply above a total quantity of 1 tonne of substance or preparation. In any case, however, the downstream users should consider the use and identify and apply appropriate risk management measures. Downstream users should report certain basic information on use to the Agency. ...
... 61. For reasons of workability and proportionality, it is appropriate to exempt downstream users using low quantities of a substance from such reporting. ...


ARTICLE-3: Definitions     [go to this ARTICLE]
... 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; ...


ARTICLE-6: General obligation to register substances on their own or in preparations     [go to this ARTICLE]
... 1. Save where this Regulation provides otherwise, any manufacturer or importer of a substance, either on its own or in one or more preparation(s), in quantities of 1 tonne or more per year shall submit a registration to the Agency. ...
... (b) the total quantity of such monomer substance(s) or other substance(s) makes up 1 tonne or more per year. ...


ARTICLE-7: Registration and notification of substances in articles     [go to this ARTICLE]
... (a) the substance is present in those articles in quantities totalling over 1 tonne per producer or importer per year; ...
... (a) the substance is present in those articles in quantities totalling over 1 tonne per producer or importer per year; ...
... (a) the substance is present in those articles in quantities totalling over 1 tonne per producer or importer per year; ...


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]
... 1. Articles 5, 6, 7, 17, 18 and 21 shall not apply for a period of five years to a substance manufactured in the Community or imported for the purposes of product and process orientated research and development by a manufacturer or importer or producer of articles, by himself or in cooperation with listed customers and in a quantity which is limited to the purpose of product and process orientated research and development. ...
... (d) the estimated quantity as specified in section 3.1 of Annex VI; ...
... 4. The Agency may decide to impose conditions with the aim of ensuring that the substance or the preparation or article in which the substance is incorporated will be handled only by staff of listed customers as referred to in paragraph 2(e) in reasonably controlled conditions, in accordance with the requirements of legislation for the protection of workers and the environment, and will not be made available to the general public at any time either on its own or in a preparation or article and that remaining quantities will be re-collected for disposal after the exemption period. In such cases, the Agency may ask the notifier to provide additional necessary information. ...


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 1 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 1 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 1 000 tonnes or more per year per manufacturer or importer. ...
... 2. As soon as the quantity of a substance per manufacturer or importer that has already been registered reaches the next tonnage threshold, the manufacturer or importer shall inform the Agency immediately of the additional information he would require under paragraph 1. Article 26(3) and (4) shall apply adapted as necessary. ...


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-17: Registration of on-site isolated intermediates     [go to this ARTICLE]
... 1. Any manufacturer of an on-site isolated intermediate in quantities of 1 tonne or more per year shall submit a registration to the Agency for the on-site isolated intermediate. ...


ARTICLE-18: Registration of transported isolated intermediates     [go to this ARTICLE]
... 1. Any manufacturer or importer of a transported isolated intermediate in quantities of 1 tonne or more per year shall submit a registration to the Agency for the transported isolated intermediate. ...
... 3. A registration for a transported isolated intermediate in quantities of more than 1 000 tonnes per year per manufacturer or importer shall include the information specified in Annex VII in addition to the information required under paragraph 2. For the generation of this information, Article 13 shall apply. ...


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; ...
... (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]
... (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 1 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 1 000 tonnes or more per year per manufacturer or per importer, at least once after 1 June 2007. ...
... 2. Article 5, Article 6, Article 7(1), Article 17, Article 18 and Article 21 shall not apply until 1 June 2013 to phase-in substances manufactured in the Community or imported, in quantities reaching 100 tonnes or more per year per 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 1 tonne or more per year per manufacturer or per importer, at least once after 1 June 2007. ...


ARTICLE-24: Notified substances     [go to this ARTICLE]
... 2. If the quantity of a notified substance manufactured or imported per manufacturer or importer reaches the next tonnage threshold under Article 12, the additional required information corresponding to that tonnage threshold, as well as to all the lower tonnage thresholds, shall be submitted in accordance with Articles 10 and 12, unless it has already been submitted in accordance with those Articles. ...


ARTICLE-28: Duty to pre-register for phase-in substances     [go to this ARTICLE]
... 1. In order to benefit from the transitional regime provided for in Article 23 each potential registrant of a phase-in substance in quantities of 1 tonne or more per year, including without limitation intermediates, shall submit all the following information to the Agency: ...
... 6. Potential registrants who manufacture or import for the first time a phase-in substance in quantities of 1 tonne or more per year or use for the first time a phase-in substance in the context of production of articles or import for the first time an article containing a phase-in substance that would require registration, after 1 December 2008, shall be entitled to rely on Article 23 provided that they submit the information referred to in paragraph 1 of this Article to the Agency within six months of first manufacturing, importing or using the substance in quantities of 1 tonne or more per year and no later than 12 months before the relevant deadline in Article 23. ...
... 6. Potential registrants who manufacture or import for the first time a phase-in substance in quantities of 1 tonne or more per year or use for the first time a phase-in substance in the context of production of articles or import for the first time an article containing a phase-in substance that would require registration, after 1 December 2008, shall be entitled to rely on Article 23 provided that they submit the information referred to in paragraph 1 of this Article to the Agency within six months of first manufacturing, importing or using the substance in quantities of 1 tonne or more per year and no later than 12 months before the relevant deadline in Article 23. ...
... 7. Manufacturers or importers of phase-in substances in quantities of less than 1 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-37: Downstream user chemical safety assessments and duty to identify, apply and recommend risk reduction measures     [go to this ARTICLE]
... (c) the downstream user uses the substance or preparation in a total quantity of less than 1 tonne per year; ...


ARTICLE-38: Obligation for downstream users to report information     [go to this ARTICLE]
... 5. Except where a downstream user is relying on the exemption in Article 37(4)(c), reporting in accordance with paragraphs 1 to 4 of this Article shall not be required in respect of a substance, on its own or in a preparation, used by the downstream user in quantities of less than 1 tonne per year for that particular use. ...


ARTICLE-41: Compliance check of registrations     [go to this ARTICLE]
... (b) the dossier is for a substance manufactured or imported in quantities of 1 tonne or more per year and does not meet the requirements of Annex VII applying under either Article 12(1)(a) or (b), as the case may be; or ...


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. ...


ARTICLE-67: General provisions     [go to this ARTICLE]
... 1. A substance on its own, in a preparation or in an article, for which Annex XVII contains a restriction shall not be manufactured, placed on the market or used unless it complies with the conditions of that restriction. This shall not apply to the manufacture, placing on the market or use of a substance in scientific research and development. Annex XVII shall specify if the restriction shall not apply to product and process orientated research and development, as well as the maximum quantity exempted. ...


ARTICLE-74: Fees and charges     [go to this ARTICLE]
... 2. A fee need not be paid for a registration of a substance in a quantity of between 1 and 10 tonnes where the registration dossier contains the full information in Annex VII. ...


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 ...
... 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 1 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 1 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). ...
... 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 1 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 1 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). ...