Guidance on registration - ECHA - Europa

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28 <strong>Guidance</strong> on registration Version 2.0 May 2012 measure, in accordance with its national legal system, to exempt in specific cases certain substances from REACH. The exemption will, naturally, only apply within the territory of the Member State having fixed the exemption. It can be expected that Member States who decide on such an exemption will inform the suppliers concerned; however, if in doubt, manufacturers, importers and producers of mixtures or articles which are used by Member State military forces or authorities in a defence context, are advised to contact those forces or authorities to check if an exemption has been granted which may cover their substance, mixture or article. More information on national exemptions in the interest of defence in individual Member States is available on the European Defence Agency website (http://www.eda.europa.eu/reach). Legal reference: Article 2 (3) 2.2.2.4 Waste Waste is defined in the Waste Framework Directive 2008/98/EC 5 as any substance or object which the holder discards or intends or is required to discard. This may be waste from households (e.g. newspapers or clothes, food, cans or bottles) or from professionals or from industry (e.g. tyres, slag, window frames that are discarded). The requirements of the REACH Regulation for substances, mixtures and articles do not apply to waste; and waste operations are not downstream uses under REACH. This however does not mean that substances in their waste stage are totally exempted from REACH. When a chemical safety assessment is required (see section 3.2.1) it must cover the whole life cycle of the substance in the exposure assessment, including the waste stage. Additional information on this can be found in the <strong>Guidance</strong> on waste and recovered substances. It is important to remark that once waste is recovered and in this recovery process another substance, mixture or article is produced, the REACH requirements will apply to the recovered material in the same way as to any other substance, mixture or article manufactured, produced or imported in the EU. In specific cases, where a substance recovered in the EU is the same as a substance which has already been registered, an exemption from the registration obligation may apply. More guidance on recovery is available in section 0. Legal reference: Article 2 (2) 2.2.2.5 Non-isolated intermediates Intermediates are a class of substances for which specific provisions have been laid down under REACH for reasons of workability and because of their special nature. An intermediate is defined as a substance that is manufactured for and consumed in or used for chemical processing to be transformed into another substance (Article 3 (15)). REACH distinguishes between non-isolated intermediates and isolated intermediates. Nonisolated intermediates are not covered by REACH. REACH applies however to isolated intermediates, although they may benefit from reduced registration requirements under specific conditions. Isolated intermediates are discussed further in section 2.2.5 of this document. A non-isolated intermediate is defined as an intermediate that during synthesis is not intentionally removed (except for sampling) from the equipment in which the synthesis takes place. Such equipment includes the reaction vessel, its ancillary equipment, and any 5 Directive 2008/98/EC repeals and replaces Directive 2006/12/EC which is mentioned in Article 2(2) of the REACH Regulation. Annankatu 18, P.O. Box 400, FI-00121 Helsinki, Finland | Tel. +358 9 686180 | Fax +358 9 68618210 | echa.europa.eu
<strong>Guidance</strong> on registration Version 2.0 May 2012 29 equipment through which the substance(s) pass(es) during a continuous flow or batch process as well as the pipe work for transfer from one vessel to another for the purpose of the next reaction step, but it excludes tanks or other vessels in which the substance(s) are stored after the manufacture (Article 3 (15) (a)). Intermediates falling within the above definition are therefore exempted from REACH. Note however that quantities of the same substance may be used in other operations or under other conditions, which implies that those quantities cannot be regarded as non-isolated intermediates. Only the quantities of the substance used under the conditions qualifying it as a non-isolated intermediate are exempted from REACH. For the remaining quantities, the relevant requirements under REACH must be fulfilled. Additional information on intermediates can be found in the <strong>Guidance</strong> on intermediates. Legal references: Article 2 (1) (c), Article 3 (15) (a) 2.2.2.6 Transported substances The REACH Regulation exempts from its provisions the carriage of dangerous substances and dangerous substances in dangerous mixtures by rail, road, inland waterway, sea or air. Please note that for all activities (manufacture, import, use) related to the concerned substances other than its transport, the REACH requirements apply (unless covered by another exemption). EU transport legislation (for example, Directive 2008/68/EC on the inland transport of dangerous goods) already regulates the safety conditions of transport of dangerous substances by various means of transport and thus such transport is exempted from the provisions of the REACH Regulation. Legal reference: Article 2 (1) (d) 2.2.3 Substances exempted from registration Substances that present minimum risk because of their intrinsic properties (like water, nitrogen, etc.) and substances for which registration is deemed inappropiate or unnecessary (such as substances occuring in nature like minerals, ores and ores concentrates if they are not chemically modified) are exempted from registration. Polymers are exempted from the requirement to register while the monomer substances or any other substances they consist of must be registered provided certain conditions are fulfilled. REACH also exempts from registration certain substances that are adequately regulated under other legislations, like substances used in food or feedingstuffs or in medicinal products, where the relevant criteria are met. Additional exemptions from registration apply to substances that are already registered and are either exported and re-imported into the EU or recovered through a recovery process in the EU. Note that substances exempted from the obligation to register may still be subject to authorisation or restriction provisions under REACH. The specific conditions under which the exemptions from registration under REACH apply are described in detail below. Annankatu 18, P.O. Box 400, FI-00121 Helsinki, Finland | Tel. +358 9 686180 | Fax +358 9 68618210 | echa.europa.eu
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Guidance on registration - ECHA - Europa

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