Guidance on registration - ECHA - Europa

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84 <strong>Guidance</strong> on registration Version 2.0 May 2012 67/548/EEC and Regulation (EC) 1272/2008 or in Directive 1999/45/EC. The relevant exposure limit values will be also identified in the SDS. The final ES developed for identified uses as part of the CSA has to be communicated to the registrant’s customers as an annex to the SDS, as this provides instructions of risk management measures that should be in place in order to ensure control of risks. It is the responsibility of the supplier to keep the SDS updated. Please, note that with the entry into force of the CLP Regulation on 20 January 2009, the following transition period applies regarding the classification of substances to be included in the SDS: From 1 December 2010 until 1 June 2015, the SDS for substances shall contain the classification according to both Directive 67/548/EEC and the CLP Regulation. On 1 June 2015 the transition period ends and from then onwards the SDS must include only the classification according to the CLP Regulation and need no longer make reference to the classification according to 67/548/EEC. The following transition period applies to the classification of mixtures in the SDS: From the entry into force of the CLP Regulation on 20 January 2009 until 1 June 2015, the classification of a mixture in accordance to the CLP Regulation may be added on a voluntary basis together with the classification in accordance to Directive 1999/45/EC in the SDS. However, where a mixture is both classified and labelled according to the CLP Regulation, that classification shall be provided in the SDS together with the classification for the mixture and its constituents in accordance to Directive 1999/45/EC and Directive 67/548/EEC respectively. From 1 June 2015 onwards, the transition period ends and mixtures and their constituents will be classified exclusively according to the CLP Regulation. Further information is available in the <strong>Guidance</strong> on the compilation of safety data sheets. Legal reference: Article 31, Annex II 6.1.2 Provide other information to customers When supplying a substance or a mixture for which an SDS is not required (see section above), the supplier still has to provide to all downstream users and distributors he supplies the following information: if the substance is subject to authorisation 16 and the details of the granted authorisation or appropriate information if authorisation has been denied; the details of any restriction 17 imposed; any available and relevant information about the substance that is necessary to enable appropriate risk management; the registration number if available for any substances for which information is communicated under the points above. This information shall be communicated at the latest at the time of the first delivery of the 16 For further information on the authorisation process, refer to the <strong>Guidance</strong> on authorisation application 17 For further information on the restriction process, refer to the <strong>Guidance</strong> on Annex XV on restrictions 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 85 substance on its own or in a mixture after 1 June 2007. Legal reference: Article 32 6.2 Classification and Labelling notification If the substance is subject to registration, but has not yet been registered, or if the substance is within the scope of the CLP Regulation, meets the criteria for classification as hazardous and is placed on the market either on its own or contained in a hazardous mixture above specified concentration limits, the registrant must notify to ECHA the information related to its classification and labelling. This has to be done within one month after placing the substance on the market or within one month after 1 December 2010 for substances already on the market at that date. For substances registered before 1 December 2010 the classification and labelling will be reported in the registration dossier and no separate notification is required. Note that the obligation to classify and label a substance according to the CLP Regulation applies from 1 December 2010. This means that in cases where a registration was submitted earlier than 1 December 2010 the registration dossier may contain only the classification and labelling information according to Directive 67/548/EEC. In this case the registrant needs to update his registration dossier without undue delay by including the new classification and labelling according to the CLP Regulation. Further information on how to update a registration dossier is provided in section 7. The classification and labelling notification can be prepared using any of the following tools: IUCLID 5: a classification and notification dossier can be created in IUCLID, in a similar way to a registration dossier. This is the only option if confidentiality of the IUPAC name of the substance is to be claimed. Bulk: this option allows the notifier to submit notifications for several substances defined by their EC or CAS number in a single file. Online: the information can be entered manually in REACH-IT. This can be the preferred option if only a few substances are to be notified and the notifier is not currently using IUCLID 5. Submission of the classification and labelling notification must be done electronically via the REACH -IT portal on the ECHA website (https://reach-it.echa.europa.eu/). ECHA has compiled all the information submitted on classification and labelling and established a classification and labelling inventory as required by the CLP Regulation. The inventory is publicly accessible through the ECHA website (http://echa.europa.eu/web/guest/informationon-chemicals/cl-inventory-database) and allows free access to most of the information provided, in particular to the classification and labelling of the substance. Access to part of the information is however restricted to notifiers and registrants who have submitted information on the same substance. If the classifications submitted for the same substance by different registrants or notifiers differ, the registrants and notifiers are required to make every effort to come to an agreed classification, and update their registrations/notifications as appropriate. Additional information is provided in the Introductory <strong>Guidance</strong> on the CLP Regulation, the <strong>Guidance</strong> on the application of the CLP criteria and the Practical Guide 7: How to notify substances in the Classification and Labelling Inventory. Legal reference: Article 40 and 41 of the CLP Regulation 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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