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manufacturers


PREAMBLE: REACH - Registration, Evaluation, Authorisation and Restriction of Chemicals     [go to this PREAMBLE]
... (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. ...
... (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. ...
... (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. ...
... (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. ...
... (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. ...
... (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. ...
... (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. ...
... (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. ...
... (55) Manufacturers and importers of a substance on its own or in a preparation should be encouraged to communicate with the downstream users of the substance with regard to whether they intend to register the substance. Such information should be provided to a downstream user sufficiently in advance of the relevant registration deadline if the manufacturer or importer does not intend to register the substance, in order to enable the downstream user to look for alternative sources of supply. ...
... (56) Part of the responsibility of manufacturers 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. ...
... (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. ...
... (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. ...


ARTICLE-1: Aim and scope     [go to this ARTICLE]
... 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-3: Definitions     [go to this ARTICLE]
... 17. actors in the supply chain: means all manufacturers and/or importers and/or downstream users in a supply chain; ...


ARTICLE-4: General provision     [go to this ARTICLE]
... Any manufacturer, importer, or where relevant downstream user, may, whilst retaining full responsibility for complying with his obligations under this Regulation, appoint a third party representative for all proceedings under Article 11, Article 19, Title III and Article 53 involving discussions with other manufacturers, importers, or where relevant downstream users. In these cases, the identity of a manufacturer or importer or downstream user who has appointed a representative shall not normally be disclosed by the Agency to other manufacturers, importers, or, where relevant, downstream users. ...
... Any manufacturer, importer, or where relevant downstream user, may, whilst retaining full responsibility for complying with his obligations under this Regulation, appoint a third party representative for all proceedings under Article 11, Article 19, Title III and Article 53 involving discussions with other manufacturers, importers, or where relevant downstream users. In these cases, the identity of a manufacturer or importer or downstream user who has appointed a representative shall not normally be disclosed by the Agency to other manufacturers, importers, or, where relevant, downstream users. ...


ARTICLE-11: Joint submission of data by multiple registrants     [go to this ARTICLE]
... 1. When a substance is intended to be manufactured in the Community by one or more manufacturers and/or imported by one or more importers, and/or is subject to registration under Article 7, the following shall apply. ...


ARTICLE-19: Joint submission of data on isolated intermediates by multiple registrants     [go to this ARTICLE]
... 1. When an on-site isolated intermediate or transported isolated intermediate is intended to be manufactured in the Community by one or more manufacturers and/or imported by one or more importers, the following shall apply. ...


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


... (j) providing advice and assistance to manufacturers and importers registering a substance in accordance with Article 12(1); ...


ARTICLE-113: Obligation to notify the Agency     [go to this ARTICLE]
... 1. Any manufacturer, producer of articles or importer, or group of manufacturers or producers of articles or importers, who place on the market a substance within the scope of Article 112, shall notify to the Agency the following information in order for it to be included in the inventory in accordance with Article 114, unless submitted as part of the registration: ...


ARTICLE-124: Other responsibilities     [go to this ARTICLE]
... 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-136: Transitional measures regarding existing substances     [go to this ARTICLE]
... 1. The requests to manufacturers and importers to submit information to the Commission made by a Commission Regulation in application of Article 10(2) of Regulation (EEC) No 793/93, shall be considered as decisions adopted in accordance with Article 52 of this Regulation. ...
... 2. The requests to manufacturers and importers to submit information to the Commission made by a Commission Regulation in application of Article 12(2) of Regulation (EEC) No 793/93, shall be considered as decisions adopted in accordance with Article 52 of this Regulation. The Agency shall identify the competent authority for the substance to carry out the tasks of Article 46(3) and Article 48 of this Regulation. ...


... (a) the costs for manufacturers and importers of drawing up the chemical safety reports; ...


ARTICLE-I: GENERAL PROVISIONS FOR ASSESSING SUBSTANCES AND PREPARING CHEMICAL SAFETY REPORTS     [go to this ARTICLE]
... 0.1. The purpose of this Annex is to set out how manufacturers and importers are to assess and document that the risks arising from the substance they manufacture or import are adequately controlled during manufacture and their own use(s) and that others further down the supply chain can adequately control the risks. This Annex shall also apply adapted as necessary to producers and importers of articles required to make a chemical safety assessment as part of a registration. ...
... 0.5. The chemical safety assessment shall be based on the information on the substance contained in the technical dossier and on other available and relevant information. Manufacturers or importers submitting a proposal for testing in accordance with Annexes IX and X shall record this under the relevant heading of the chemical safety report. Available information from assessments carried out under other international and national programmes shall be included. Where available and appropriate, an assessment carried out under Community legislation (e.g. risk assessments completed under Regulation (EEC) No 793/93) shall be taken into account in the development of, and reflected in, the chemical safety report. Deviations from such assessments shall be justified. ...


ARTICLE-XV: DOSSIERS     [go to this ARTICLE]
... The socio-economic impacts of the proposed restriction may be analysed with reference to Annex XVI. To this end, the net benefits to human health and the environment of the proposed restriction may be compared to its net costs to manufacturers, importers, downstream users, distributors, consumers and society as a whole. ...


ARTICLE-XVI: SOCIO-ECONOMIC ANALYSIS     [go to this ARTICLE]
... - impact of a granted or refused authorisation on the applicant(s), or, in the case of a proposed restriction, the impact on industry (e.g. manufacturers and importers). The impact on all other actors in the supply chain, downstream users and associated businesses in terms of commercial consequences such as impact on investment, research and development, innovation, one-off and operating costs (e.g. compliance, transitional arrangements, changes to existing processes, reporting and monitoring systems, installation of new technology, etc.) taking into account general trends in the market and technology, ...


ARTICLE-XVII: RESTRICTIONS ON THE MANUFACTURE, PLACING ON THE MARKET AND USE OF CERTAIN DANGEROUS SUBSTANCES, PREPARATIONS AND ARTICLES     [go to this ARTICLE]
... The classification and label shown for this substance applies to the dangerous property(ies) indicated by the risk phrase(s) in combination with the category(ies) of danger shown. The requirements of Article 6 of Directive 67/548/EEC on manufacturers, distributors, and importers of this substance apply to all other aspects of classification and labelling. The final label shall follow the requirements of section 7 of Annex VI to Directive 67/548/EEC. ...