Guidance on registration - ECHA - Europa

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48 <strong>Guidance</strong> on registration Version 2.0 May 2012 ‘existing substances’. The full and exhaustive list is accessible at http://esis.jrc.ec.europa.eu/. Note that the list has been ‘frozen’ and no more substances can be added to it or removed from it. The substance was manufactured at least once in any of the current Member States of the EU, without being placed on the EU market by the manufacturer or importer after 31 May 1992 (15 years before entering into force of REACH), provided that the manufacturer or importer has documentary evidence of this. Such documentary evidence can be, for example, order sheets, stock lists, or any other documents which can be undoubtedly traced back to a date after 31 May 1992. If the substance would have been placed on the market by the manufacturer or importer, it would normally have been notified under Directive 67/548/EEC and in that case it will be considered as registered. The substance was placed on the market in any of the current Member States of the EU before 1 June 2007 by the manufacturer or importer, and is a so-called ‘no-longer polymer’ (NLP). A NLP is a substance which was considered as having been notified in accordance with the first indent of Article 8 (1) of Directive 67/548/EEC in the version resulting from the amendment effected by Directive 79/831/EEC (and hence did not have to be notified under that Directive), but which does not meet the REACH definition of a polymer. Also in this case, the manufacturer or importer must have documentary evidence that he placed the substance on the market and that it was a NLP and that the substance was placed on the market by any manufacturer or importer between 18 September 1981 and 31 October 1993 inclusive. Such documentary evidence can be, for example, order sheets, stock lists, labels, safety data sheets, or any other documents which can be undoubtedly traced back to a date between 18 September 1981 and 31 October 1993 inclusive. A non-exhaustive list of NLPs is accessible at http://esis.jrc.ec.europa.eu/. Note that it only serves information purposes. Please note that the transitional regime for phase-in substances also applies to on-site and transported isolated intermediates as well as to substances in articles which need to be registered. Legal references: Article 3 (20) 2.3.1.2 Non phase-in substance All substances that do not fulfil any of the criteria for phase-in substances as presented in the previous section are considered to be non phase-in substances. Non phase-in substances do not benefit from the transitional regime provided for phase-in substances and need to be registered before they can be manufactured, imported or placed on the market in the EU, unless they have already been notified under Directive 67/548/EEC (see section 2.2.4.3). It is important to stress that registration of non phase-in substances will first require the submission of an inquiry dossier to determine whether a registration or another inquiry has already been submitted for the same substance so that data sharing mechanisms can apply. For more information on inquiry and data sharing processes see section 4.4. 2.3.2 Deadlines for registration Substances falling under the scope of the REACH Regulation and not exempted from the registration obligation must be registered before they can be manufactured, imported or placed on the market. Phase-in substances and non-phase-in substances have different timelines for registration. Non phase-in substances and phase-in substances which have not been pre-registered, must be registered before manufacture or import starting 12 months after entry into force of the legislation, i.e. by 1 June 2008. 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 49 For phase-in substances, which are manufactured or imported in a quantity of one tonne or more per year and which have been pre-registered between 1 June 2008 and 1 December 2008 (inclusive), the registration provisions are applied in a stepwise way to facilitate the transition to REACH. The transitional arrangements introduce different deadlines for registration, without the need to interrupt the manufacture or import of these substances. The deadlines set for the registration of phase-in substances have been based on the tonnage manufactured or imported per manufacturer or importer or producer of articles. This follows from the assumption that chemicals manufactured in high volumes will in many cases be more likely to present a greater risk to humans and the environment. A greater priority has also been given to substances of higher concern, such as carcinogenic, mutagenic and reprotoxic substances (CMR) and substances which are very toxic to aquatic organisms and may cause long-terms effects in the aquatic environment (classified as R50/53). The 'phase-in' deadlines after entry into force of the Regulation are presented in the following Table (applicable only if the substance has been pre-registered). Table 1: Deadlines for the registration of phase-in substances Deadline to submit registration dossier to ECHA 30 November 2010 at 23:59:59 (GMT) (at the latest) 30 November 2010 at 23:59:59 (GMT) (at the latest) 30 November 2010 at 23:59:59 (GMT) (at the latest) 31 May 2013 at 23:59:59 (GMT) (at the latest) 31 May 2018 at 23:59:59 (GMT) (at the latest) Criteria for substances Phase-in substances manufactured in the EU or imported in quantities of 1000 tonnes or more per year per manufacturer or per importer, at least once after 1 June 2007; Phase-in substances classified 8 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; 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 tonne or more per year per manufacturer or per importer at least once after 1 June 2007; Phase-in substances manufactured or imported in quantities of 100 tonnes or more per year per manufacturer in the Community or per importer at least once after 1 June 2007; Phase-in substances manufactured in the Community or imported in quantities of 1 tonne or more per year per manufacturer or per importer at least once after 1 June 2007. 8 ‘Classified in accordance with Directive 67/548/EEC’ refers to substances listed in Annex VI of the CLP Regulation with a harmonised classification and labelling and substances self-classified by the registrant. 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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