Lead dossier

Hazard categories

2.1 to 2.4, 2.6 and 2.7, 2.8 types A and B, 2.9, 2.10, 2.12, 2.13 categories 1 and 2, 2.14 categories 1 and 2, 2.15 types A to F; 73  if applicable, the name of the substance as given in EINECS;  the classification and labelling of the substance;  physicochemical data concerning the substance and on pathways and environmental fate;  the result of each toxicological and ecotoxicological study;  any derived no-effect level (DNEL) or predicted no-effect concentration (PNEC) established in accordance with Annex I;  the guidance on safe use provided in accordance with section 4 and 5 of Annex VI;  the analytical methods if requested in accordance with Annexes IX or X which make it possible to detect a dangerous substance when discharged into the environment as well as to determine the direct exposure of humans. Legal references: Article 118, Article 119 – 3.1 to 3.6, 3.7 adverse effects on sexual function and fertility or on development, 3.8 effects other than narcotic effects, 3.9 and 3.10; – 4.1; – 5.1; 74 5 Preparation of the registration dossier Aim: The aim of this chapter is to describe how to prepare a registration dossier. It offers an overview on the information the registrant has to submit as part of his registration dossier and explains how this information has to be reported. It does not, however, provide specific practical instructions on how to successfully submit a registration dossier to ECHA. For this latter information, the reader is advised to consult the ECHA manual ‘How to prepare registration and PPORD dossiers’ accessible at: http://echa.europa.eu/manuals. This document is also available via the help system built into IUCLID. Structure: The structure of this chapter is as follows: PREPARATION OF THE REGISTRATION DOSSIER INTRODUCTION TECHNICAL DOSSIER CHEMICAL SAFETY REPORT Section 5.1 Section 5.2 Section 5.3 General information Steps of the Section 5.2.1 Chemical Safety Assessment Section 5.3.1 Classification and labelling Chesar tool Section 5.2.2 Section 5.3.2 Manufacture, use and exposure Section 5.2.3 Information requirements Section 5.2.4 Guidance on safe use Section 5.2.5 Review by an assesor Section 5.2.6 Confidential information Section 5.2.7 75 5.1 Introduction All relevant and available information has to be documented in both the technical dossier and (for substances manufactured or imported in quantities of 10 tonnes or more per year per registrant) in the chemical safety report (CSR). The information needs to be reported in IUCLID format, and submitted to ECHA via REACH-IT, as shown in Figure 5. Members of the joint submission have also the possibility to create their registration dossiers online in REACH- IT, instead of installing and using IUCLID21. This is however not possible for the lead registrant. For further technical details, see ECHA manual ‘How to prepare registration and PPORD dossiers’ ( http://echa.europa.eu/manuals). Article 10 (a), in combination with Annexes VI to X defines the information to be documented in the technical dossier. Annex XI establishes the rules for the adaptation of the information defined in Annexes VI to X and has to be considered in combination with these annexes. Similarly, Article 10 (b), Article 14 and Annex I set out the general requirements for the CSA and the CSR applicable for substances subject to registration in quantities of ten tonnes or more per year. The relation between the information to be submitted for registration, as defined in REACH, and the IUCLID sections where it has to be reported is shown in Table 4 below. Table 4: Relation between the information requirements in Article10 and the corresponding sections in a IUCLID file Information requirements Article 10 IUCLID (a) Technical dossier Article 10 (a) Annex VI section 1 (i) identity of the manufacturer or importer Legal entity & Section 1 (ii) identity of the substance Annex VI section 2 (iii) manufacture and uses of the substance and if Annex VI section 3 relevant use and exposure categories (iv) classification and labelling Annex VI section 4 (v) guidance on safe use Annex VI section 5 (vi) study summaries of information derived from Annex VII to XI Sections 4, 5, 6 and 7 the application of Annexes VII to XI (vii) robust study summaries of the information Annex I, Annex VII Sections 4, 5, 6 and 7 derived from the application of Annexes VII to to XI XI if required under Annex I (viii) indication regarding the review by an assessor Dossier header22 of information submitted under (iii), (iv), (vi), (vii) and (b) (ix) proposals for testing Sections 4, 5, 6, 7 (x) exposure information for substances in Annex VI section 6 quantities of 1 to 10 tonnes 21 Please note that only those dossiers created online in REACH-IT can be updated via REACH-IT. 22 The dossier header consists of information which is going to be used for administrative purposes and it is completed by the applicant when preparing his dossier from the substance data set. 76 (xi) request as to which information in Article All relevant sub 119(2) should not be made available on the sections Internet (b) Chemical safety report Article 10 (b) Attachment in section 13 Article 14, Annex 1 In order to generate his registration dossier, the registrant will have to undertake the following tasks:  Document the technical dossier with all relevant and available information  Carry out the chemical safety assessment (CSA) for substances manufactured or imported in quantities of 10 tonnes or more per year per registrant  Record the results of the CSA in the CSR. These tasks are described in detail in the following sections for an individual registration. Note that in case of a joint submission the information to be provided by the lead registrant and the members of the joint submission will not be the same as explained previously in section 4.3. Figure 5: Structure and format of the registration dossier 77 5.2 Generation of the technical dossier All relevant and available information on the substance, from its identification and intrinsic properties to the classification and evaluation of its hazards needs to be reported in the technical dossier. The information requirements depend on the three-year average tonnage calculated in the year of the registration for substances manufactured/imported during the three consecutive years. For substances which has not been manufactured/imported during the three consecutive years the information requirements depend on the tonnage estimated during the calendar year of registration. The data will be reported in IUCLID which is the reporting format for the technical dossier. In some cases more than one hazard profile would be relevant for a substance (for example if various compositions of the registered substance exist with different hazard profiles or if a substance transforms during the use and both parent and transformation products play a role in a safety assessment). To ensure a transparent organisation of the dataset for such substances, so-called “assessment entities” can be defined in IUCLID. For more information about this concept please refer to chapter D.2 of the Guidance on information requirements and chemical safety assessment, Part D: Framework for exposure assessment available at: http://echa.europa.eu/guidance-documents/guidance-on-information-requirements-and- chemical-safety-assessment. The technical dossier will also include the administrative data required for the identification of the registration and its further processing by ECHA (registrant’s identity, tonnage band, etc.). The following sections of this guidance describe in a general way the content and level of detail needed in the registration dossier. Before the preparation of a registration dossier registrants are advised to consult the ECHA manual ‘How to prepare registration and PPORD dossiers’ accessible at: http://echa.europa.eu/manuals. This document is also available via the help system built into IUCLID. 5.2.1 General information on the registrant and on the registered substance General information for the identification of the registrant and the substance that need to be reported in the registration dossier include:  registrant identification (as specified in section 1 of Annex VI), i.e. 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 sites.  role of the registrant (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 pre- registration or the inquiry preceding the registration.  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 ‘one substance, one registration’ principle requires multiple registrants of the same substance to be part of the same, joint submission for that substance. This means that 78 registrants of the same substance agree to submit a joint registration covering the substances manufactured/imported by them individually. Such an agreement on the data submitted must be relevant for the scope of the substance as jointly registered by the registrants. In this respect, the joint registration is expected to include specification of the boundaries of the substance covered by the registration, in terms of its chemical composition. The specifications of the boundary of the substance covered by the registration are commonly known as the substance identity profile (SIP). The SIP concept has been developed by Cefic to aid preparation of SIEFs document sameness criteria for the joint submission23. It is the responsibility of the registrant to identify the substance. Information on the principles of substance identification can be found in the Guidance on identification and naming of substances under REACH and CLP ( http://echa.europa.eu/guidance- documents/guidance-on-reach). 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 of this guidance. 5.2.2 Classification and labelling Registration dossiers must include information on the classification and labelling of the substance according to the CLP criteria. 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 report several classifications in case several compositions of the registered substance (having different percentage of constituents, impurities and/or differing in their form) have different hazard profiles. In such case classification records in IUCLID have to be clearly linked to the relevant compositions. If a member registrant disagrees and wants to propose another classification, then he needs to ‘opt-out’ from this information requirement (see section 4.3.2 of this guidance). Different classifications for the same substance may be reported and justified jointly in the lead dossier. However, in case of disagreement a member registrant will need to opt-out from this information requirement in his own dossier. The rationale for the decision for a classification (as well as the rationale for non classification when this is the case) should be clearly documented. A reason for non classification can be due to  a lack of data,  inconclusive data, or  data which is conclusive for non classification. 23 Cefic guidance documents, for example Guidance for Lead Registrants ( http://www.cefic.org/Industry- support/Implementing-reach/Guidances-and-Tools1/) outline the advantages of having a documented SIP available for transparency on cost sharing for joint submission. 79 The classification and labelling proposed in registration dossiers are reported within the Classification and Labelling Inventory (C&L Inventory) established and maintained by ECHA, see http://echa.europa.eu/web/guest/information-on-chemicals/cl-inventory-database. The C&L Inventory contains 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 to the CLP Regulation (containing all harmonised classification and labelling of hazardous substances) as well as the C&L Inventory to check if their substance is already included. If the substance is included in Annex VI to the CLP Regulation (and therefore harmonised at EU level) the registrant must follow this harmonised classification. If the substance needs to be classified for additional endpoints to those covered by the harmonised classification, the registrant should report these next to the harmonised endpoints in his registration dossier. If the substance is already listed in the C&L Inventory but not in Annex VI to the CLP Regulation, the registrants should make every effort to agree their classification with other registrants, potential registrants having pre-registered and other notifiers of the classification and labelling of the same substance. For further information on harmonised classification and labelling please consult Questions and answers on Annex VI to CLP http://echa.europa.eu/support/qas-support/browse/- /qa/70Qx/view/scope/clp/annex+vi+to+clp. It may be also useful to view ‘Harmonised classification and labelling’ section on the ECHA website http://echa.europa.eu/regulations/clp/harmonised-classification-and-labelling. 5.2.3 Manufacture, use and exposure 5.2.3.1 Information on manufacture and uses of the substance (section 3 of Annex VI) Information on the manufacture and uses of the substance is to be provided as part of a registration dossier. This information plays an important role in many different REACH processes including the generation of CSR when one is needed, dissemination of (non- confidential) information on where substances are used as well as input to the prioritisation/deprioritisation of substances for further regulatory processes. Substances that are not used in a wide-dispersive manner (e.g. no uses by consumers of the substance as such, in mixtures or in articles, no widespread uses by professional workers and no industrial uses with potential for exposure) may be deprioritised from REACH/CLP regulatory actions. To reflect the absence of the types of uses above, the use description should:  not include entries in sections 3.5.4 to 3.5.6 of IUCLID (as there are no registered professional, consumer or service life uses),  indicate that uses at industrial sites are limited to a few sites only (for example < 5),  claim that uses at industrial sites take place under closed (rigorously contained) conditions leading to insignificant exposure to humans and insignificant release to the environment on the various routes. Note: These conditions need to be described in the exposure assessment (for substances > 10 t/a) or in the exposure information according to Annex VI (6) (substances < 10 ta). Please note: Registrants may be aware that one or more uses of their substances are to be considered wide dispersive (and thus qualify for being of priority concern for authorities). 80 However in the context of the overall use pattern of the substance the extent of such uses may be minor, which would be a key information for authorities in priority setting. Therefore, registrants are advised to provide specific information on the tonnage for such uses. Members of a joint submission also have to report their own uses and cannot simply refer to the dossier of the lead registrant, even if the chemical safety report (CSR) has been submitted jointly. In order to provide the use information, use maps developed under the CSR/ES roadmap can be helpful ( http://www.echa.europa.eu/en/web/guest/csr-es-roadmap/use- maps). Use maps include the description of use and its contributing activities as well as the references to the corresponding inputs to the exposure assessment of workers, environment or consumers. For more detailed guidance on use description, including advice on how to source and report the information please consult the Guidance on information requirements and chemical safety assessment, Chapter R12: Use description available at http://echa.europa.eu/guidance- documents/guidance-on-information-requirements-and-chemical-safety-assessment. 5.2.3.2 Information on exposure for substances > 10 t If according to Article 14 (4) the registrant is required to perform an exposure assessment as defined in section 5 of Annex I, then all identified uses of the registrant should be assessed (see section 5.3 of this guidance). This can be reported either in a joint or an individual chemical safety report (CSR). The exposure assessment includes a description of the conditions of use and an estimation of the exposure resulting from these conditions. The outcome of the exposure assessment is compared with the hazard characteristics of the substance for demonstrating control of risk (risk characterisation according to section 6 of Annex I). Registrants wishing to demonstrate that a substance is of low priority for the REACH/CLP regulatory processes may describe in their exposure assessment the condition ensuring absence/insignificance of exposure to humans and release to the environment on the various routes, e.g. how the substance is used under closed (rigorously contained) conditions. Such information may also be relevant for justifying that a certain information or test is not needed (exposure based waiving). REACH Annexes VIII to X establish in column 2 the specific rules for adaptation of standard information requirements and Annex XI establishes general rules for adaptation of those requirements (see also section 4.1.1 of this guidance). 5.2.3.3 Information on exposure for substances < 10 tonnes (section 6 of Annex VI) For substances manufactured or imported between 1 and 10 tonnes per year, the registrant must provide information on exposure as specified under section 6 of Annex VI. Information regarding point 6.1.1 – industrial use and 6.1.2 (b) – use resulting in inclusion into or onto matrix will be satisfied when describing the use according to Guidance on information requirements and chemical safety assessment, Chapter R12: Use description (corresponding section 3.5 of IUCLID – Life cycle description). The extent of exposure information expected depends on what the registrant intends to demonstrate. Registrants claiming that Article 12(1) (b) does not apply for a substance due to absence of dispersive or diffuse uses (claim to be made in section 14 of IUCLID) should provide the following information in the technical dossier:  absence of consumer uses, wide-spread uses by professional workers and service life. Registrants indicate such absence by not including the above-mentioned uses into their technical dossier (sections 3.5.4 to 3.5.6 of IUCLID empty) and advising against such uses in their safety data sheet (if a safety data sheet is required) and in section 3.6 of IUCLID; 81  description of the condition ensuring absence/insignificance of exposure to humans and release to the environment on the various routes, e.g. how the substance is used under closed (rigorously contained) conditions. The same information will also be relevant if registrants intend to demonstrate that the substance is of low priority for the REACH/CLP regulatory processes. 5.2.4 Information requirements on intrinsic properties (Annexes VII to X) All relevant available information on the physicochemical, toxicological and ecotoxicological properties of the substance as specified under Annexes VII to X (and its adaptations according to Annex XI) have to be provided in the technical dossier. For substances manufactured/imported below 10 tonnes per year, Annex III sets the criteria triggering information requirements set out in Annex VII. Special considerations for 1-10 tonnes dossiers For the lowest tonnage level (1-10 tonnes per year) the standard information requirements are defined in Annex VII and divided into two types: 1. Information on physicochemical properties required for all substances in this tonnage band (Annex VII, section 7); 2. Information on toxicological and ecotoxicological properties required for substances predicted to be hazardous (Annex VII, sections 8-9). According to Article 12(1)(a), the information in section 8-9 of Annex VII is only required when existing information suggests that a substance meets the criteria of Annex III. Registrants can claim in their technical dossier (section 14 of IUCLID) that Annex III criteria are not fulfilled (and thus information according to section 8 and 9 of Annex VII is not required). For this purpose registrants should review and subsequently verify available information, including:  data from submitted REACH registrations (i.e. ECHA’s dissemination website: http://echa.europa.eu/en/information-on-chemicals) or C&L notifications (i.e. ECHA’s C&L Inventory: http://echa.europa.eu/information-on-chemicals/cl-inventory-database) or any other relevant databases, for example OECD eChemPortal ( http://www.echemportal.org);  regulatory data (e.g. Annex VI of CLP);  experimental data, e.g. in QSAR Toolbox ( http://www.qsartoolbox.org/), ECHA’s inventory of substances likely to meet the Annex III criteria ( http://echa.europa.eu/information-on- chemicals/annex-iii-inventory);  alternatives to test data (e.g. QSAR, read-across, in-vitro);  in-house marketing information and information provided by customers or downstream sector organisations for characterising the uses of the substance (see also chapter 5.2.3 of this guidance). Information on how to fill in section 14 – Annex III criteria in IUCLID is given in the ECHA manual ‘How to prepare registration and PPORD dossiers’ accessible at: http://echa.europa.eu/manuals. This document is also available via the help system built-in IUCLID. The reader is also advised to consult Practical guide 3: ‘How to report robust study summaries’ if in need of more specific information on the level of detail to be reported for each individual 82 endpoint. The document is available at http://echa.europa.eu/practical-guides. For more information please visit the Annex III inventory the ECHA website ( http://echa.europa.eu/information-on-chemicals/annex-iii-inventory). 5.2.5 Guidance on safe use The registrant will have to report the following information (as required under section 5 of Annex VI): 