Guidance on registration - ECHA - Europa

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72 <strong>Guidance</strong> on registration Version 2.0 May 2012 http://echa.europa.eu/. 5.2.1 General information on the registrant and on the registered substance General information for the identification of the registrant and the substance to be registered must be reported in section 1 of IUCLID 5. This includes: Information regarding the registrant identification (as specified in section 1 of Annex VI) such as: registrant’s name, address, telephone number, fax number and e-mail address, details about the contact person and when appropriate information about location of registrant’s production and own use site(s). If the registrant has appointed a third party representative, the identity and the contact details of this representative should also be included under this section of the technical dossier. Information regarding the role(s) of the registrant, whether he is a manufacturer, importer or only representative. If the registrant is an only representative acting on behalf of a non-EU manufacturer he is advised to attach a document from the non-EU manufacturer appointing him as only representative. Information required for traceability purposes, such as the number of the preregistration or the inquiry preceding the registration (see section 4.1 on data sharing). Information regarding the joint submission if applicable. In case of a joint submission the lead registrant can identify the members of the joint submission in this section. The same applies to the other registrants who can identify the lead registrant that submits the technical information on their behalf. However, this information has only an administrative value in IUCLID 5 and it is not required since the identification of a joint submission and its members has to be carried out in REACH-IT. Information required for the identification of the substance (as specified in section 2 of Annex VI). This includes the name of the substance, its chemical identifiers (EC number, CAS name and number, etc), the molecular and structural formula and its composition (degree of purity, constituents, analytical data, etc.). The identification step is an essential part for REACH registration and the registrant should consult the <strong>Guidance</strong> on substance identification in order to clearly identify and name their substance appropriately. The step of gathering information on the identity of the substance should be done early in the registration process at the level of the pre-registration or inquiry steps (see section 4.1 on data sharing). Therefore the registrant should have all the information required in the technical dossier and should be able to fill all the required fields in IUCLID 5. It is recognised that in the case of import of a mixture, it can be difficult to obtain information on the composition of the mixture from a non-EU supplier. However, also under existing EU legislation (e.g. for classification and labelling of mixtures) importers need to know which substances are present in the mixtures being imported to be sure they are complying with the law. It will be up to companies to improve the communication through their supply chain to ensure their compliance with REACH. In case disclosure of the composition of the mixture may have consequences, the non-EU manufacturer has the possibility to appoint an only representative, as explained in section 2.1.2.6. 5.2.2 Classification and labelling The registrant has to determine the classification and labelling of his substance with respect to physico-chemical properties, environment and human health. Within a joint submission, the lead dossier can propose several classifications depending on the form of the substance, impurities, etc. If a registrant disagrees and wants to propose another classification, then he needs to ‘opt-out’ from this information requirement as discussed in section 3.3.2. The classification and labelling should be documented within section 2 of IUCLID 5 as well as 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 73 the rationale for non classification when this is the case. The rationale for the decision for a classification can be clearly documented in each of the relevant sections of IUCLID. For example the classification for human health should be justified under the relevant section (e.g. acute toxicity, eye irritation, etc.). Registration dossiers submitted from 1 December 2010 onwards must include information on the classification and labelling of the substance according to the CLP criteria. Before 1 December 2010, the classification and labelling information required in the registration dossier had to be developed in accordance with the criteria in Directive 67/548/EEC. 11 All registration dossiers submitted to ECHA before 1 December 2010 will have to be updated without undue delay regarding the information on the classification and labelling, unless this information was already provided according to the CLP Regulation criteria. To ensure that the classification and labelling of hazardous substances are available to all stakeholders and the general public, ECHA will record the classification and labelling proposed in the registration dossier within the classification and labelling inventory established and maintained by ECHA. The classification and labelling inventory will contain the classification of all substances subject to registration as well as of all substances within the scope of the CLP Regulation which meet the criteria for classification as hazardous and are placed on the market. It is recommended that registrants, before classifying their substance, consult Annex VI of the CLP Regulation (where all harmonised classification and labelling of hazardous substances have been listed) as well as the classification and labelling inventory in order to check if their substance is already listed. If already listed in the CLP Regulation (and therefore harmonised at EU level) they should follow this harmonised classification. If already listed in the inventory but not in Annex VI of the CLP Regulation, they should make every effort to harmonise their classification with other registrants, potential registrants having pre-registered and other notifiers of the classification and labelling of the same substance. 5.2.3 Manufacture, use and exposure Information on the manufacture and use(s) of the substance, as specified under section 3 of Annex VI, must be documented in section 3 of IUCLID 5. Although it is up to the registrant to decide on the level of detail to be reported, at least the following data must be provided: Tonnage manufactured, imported or used for article production in tonnes per year, including the tonnage used for own purposes and for intermediates uses (see section 5.2.3.1 below). Brief description of the technological process used in the manufacture of the substance or in the production of articles (not applicable for importers). Information on the form (substance, mixture or article) and the physical state under which the substance is made available in the supply chain. This includes the concentration or concentration range of the substance in mixtures and the quantities of the substance in articles if applicable. Information on waste quantities and composition of waste. Brief description of the identified uses of the substance. Information on the uses advised against and why. 11 The reader is reminded that during the transition period from 1 December 2010 until 1 June 2015 Safety Data Sheets for substances must however include information on the classification of the substance according to both Directive 67/548/EEC and the CLP Regulation (see section 6.1.1). 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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