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; hazard classes 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; hazard class 4.1; hazard class 5.1; Guidance on registration 63 Version 4.0 - August 2021 d) certain information contained in the safety data sheet as defined in Article 119(2); e) the trade name(s) of the substance; f) the name in the IUPAC Nomenclature can be claimed confidential for a substance that fulfils the criteria for any of the hazard classes set out in Article 58(1) of Regulation (EC) No 1272/2008, but only for a period of six years and if the substance is not one of the substance defined in Article 3(20) of REACH, e.g. substances listed in the European Inventory of Existing Commercial Chemical Substances (‘EINECS’);20 g) the name in the IUPAC Nomenclature can also be claimed confidential for a substance that fulfils the criteria for any of the hazard classes set out in Article 58(1) of Regulation (EC) No 1272/2008, if the substance is only used as one or more of the following21: (i) as an intermediate; (ii) in scientific research and development; (iii) in product and process orientated research and development. • In addition, Article 118(2) lists the information whose disclosure is normally deemed to undermine the commercial interests of the concerned person, and will hence not be made available to the public, unless urgent action is essential to protect human health, safety or the environment: o details of the full composition of a mixture; o without prejudice to Article 7(6) and Article 64(2), the precise use, function or application of a substance or mixture, including information about its precise use as an intermediate; o the precise tonnage of the substance or mixture manufactured or placed on the market; o the links between a manufacturer or importer and their distributors or downstream users. Practical instructions for requesting confidentiality in a registration are available in the ECHA manual Dissemination and confidentiality under the REACH Regulation accessible at: http://echa.europa.eu/manuals. The manual is also available via the help system built into IUCLID. Legal references: Article 118, Article 119 4.5 Access to documents Access to documents held by ECHA may be granted on the basis of a case-by-case assessment as it is foreseen in Regulation (EC) No 1049/2001 on public access to documents, (the ‘ATD Regulation’). The ATD Regulation provides for exceptions under which disclosure of the requested documents, regardless of their medium, may be denied partly or in their entirety, for instance because their disclosure would undermine the protection of commercial interests of a natural or legal person, and in the absence of an overriding public interest in the 20 For this reason, when requesting confidentiality on the IUPAC name of a non phase-in substance, the registrant must set the ‘Phase-in status’ field in the IUCLID dossier header as ‘non phase-in’ for the claim to be considered for assessment. 21 In these cases, the ‘phase-in’ status does not need to be indicated in the IUCLID dossier. 64 Guidance on registration Version 4.0 – August 2021 disclosure. Where it is not clear whether a document may or may not be disclosed, the ATD Regulation requires ECHA to consult the author of the document with a view to assessing whether it should or should not be disclosed, e.g. registration dossiers and Chemical Safety Reports are considered documents. Guidance on registration 65 Version 4.0 - August 2021 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 must submit as part of their registration dossier and explains how this information must be reported. It does not provide specific practical instructions on how to successfully submit a registration dossier to ECHA. For this consult the ECHA manual How to prepare registration and PPORD dossiers at: http://echa.europa.eu/manuals. The manual is also available via the help system built into IUCLID. Structure: The structure of this chapter is as follows: PREPARATION OF THE REGISTRATION DOSSIER PREPARATION OF THE INTRODUCTION CHEMICAL SAFETY REPORT TECHNICAL DOSSIER Section 5.1 Section 5.3 Section 5.2 Steps of the General information Chemical Safety Assessment Section 5.2.1 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 66 Guidance on registration Version 4.0 – August 2021 5.1 Introduction Article 10(a) in combination with Annexes VI to X of REACH define the information to be documented in the technical dossier. Annex XI establishes the rules for adapting the information required in Annexes VII to X. All Annexes must be considered in combination. 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. All information of the registration dossier must be reported in IUCLID format. The relation between the information to be submitted for registration (under REACH) and the IUCLID sections where it must be reported, is detailed in Table 2 below. Table 2: Relation between the information requirements in Article 10 and the corresponding sections in a IUCLID file Information requirements Article 10 IUCLID (a) Technical dossier Article 10(a) (i) identity of the manufacturer or importer Annex VI section 1 Legal entity & Section 1 (ii) identity of the substance Annex VI section 2 (iii) manufacture and uses of the substance Annex VI section 3 and if 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 Annex VII to XI Sections 4, 5, 6 and 7 from the application of Annexes VII to XI (vii) robust study summaries of the Annex I, Annex VII Sections 4, 5, 6 and 7 information derived from the application of to XI Annexes VII to XI if required under Annex I (viii) indication regarding the review by an Dossier header22 assessor of information submitted under (iii), (iv), (vi), (vii) and (b) (ix) proposals for testing Annex IX and X Sections 4, 5, 6, 7 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 their dossier from the substance data set. Guidance on registration 67 Version 4.0 - August 2021 (x) exposure information for substances in Annex VI section 6 quantities of 1 to 10 tonnes (xi) request as to which information in All relevant sub sections Article 119(2) should not be made available on the Internet (b) Chemical safety report (CSR) Article 10(b) Attachment in section 13 Article 14, Annex 1 The creation of the registration dossier consists of the following tasks: • Preparation of the technical dossier • Carrying out the chemical safety assessment (when relevant), and • Recording the results of the chemical safety assessment (when carried out) in the chemical safety report These tasks are described in detail in the following paragraphs. The registration dossier must be submitted to ECHA via REACH-IT, as shown in. Figure 4. Figure 4: Structure and format of the registration dossier 5.2 Preparation 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, exposure and risks, must be reported in the technical dossier. The information requirements depend on the intended tonnage band to be manufactured or imported within a calendar year (see section 2.2.6 Calculation of the volume to be registered). 68 Guidance on registration Version 4.0 – August 2021 The technical dossier will also include the administrative data required for the identification of the registration and for its further processing by ECHA (registrant’s identity, tonnage band, etc.). The following sections of this guidance describe 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. The manual is also available via the help system built into IUCLID. 5.2.1 General information on the registrant and on the registered substance The registration dossier must include general information for the identification of the registrant and the substance. This information includes: • identity of the registrant (as specified in section 1 of Annex VI of REACH), i.e. registrant’s name, address, telephone number and e-mail address, details of the contact person, and as appropriate, information about the 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’ they are advised to attach a document from the ‘non-EU manufacturer’ appointing them as only representative. • information required for traceability purposes, such as the number of the inquiry preceding the registration. • identification of the substance (as specified in section 2 of Annex VI of REACH). This includes the name of the substance, its chemical identifiers (EC number, CAS name and CAS number, etc.), the molecular and structural formula and its composition (degree of purity, constituents, analytical data, etc.). The ‘one substance, one registration’ principle requires registrants of the same substance to register it jointly within the same joint submission. The jointly submitted data must be representative for all the compositions of the substance covered in the joint registration dossier. The so-called boundary composition of substance provided in the lead dossier describes the scope of the compositions covered by the jointly submitted data. Several boundary compositions can be reported if different sets of hazard information are representative for different compositions of the same substance. It is the responsibility of each registrant to identify their 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 the other 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 obligations applicable to substances. It will be up to these registrants to guarantee sufficient communication through their supply chain to ensure their compliance with their REACH obligations. In case the disclosure of the composition of the mixture to the importers may have consequences, the ‘non-EU manufacturer’ of the substance has the possibility to appoint an only representative, as explained in section 2.1.2.5 Only representative of a ‘non-EU manufacturer’. Guidance on registration 69 Version 4.0 - August 2021 5.2.2 Classification and labelling Registration dossiers must include information on the classification and labelling of the substance according to the criteria established by Regulation (EC) No 1272/2008. The registrant must determine the classification and labelling of their substance with respect to physical, health and environmental hazards. Guidance on the Application of the CLP Criteria, is available at https://echa.europa.eu/guidance-documents/guidance-on-clp. Within a joint submission, the lead dossier may contain several classifications in case different 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 must be linked to the relevant compositions. If a member registrant disagrees and wants to propose another classification they will need to opt out from this information requirement in their own dossier (see section 4.3.3 Conditions for opting out from the jointly submitted data). 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 but not sufficient for classification. The classification and labelling proposed in registration dossiers are reported within the Classification and Labelling Inventory (C&L Inventory) established and maintained by ECHA, available at https://echa.europa.eu/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 verify if their substance has already been classified. If the substance is included in Annex VI to the CLP Regulation (and therefore harmonised at EU level for specific hazard classes) the registrant must follow this harmonised classification. If there are reasons to classify the substance for additional hazards than those already covered in Annex VI, the registrant should report them together with the harmonised endpoints in their 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 inquired and other notifiers of the classification and labelling of the same substance. For further information on harmonised classification and labelling the reader is advised to consult the 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 the Harmonised classification and labelling section at: http://echa.europa.eu/regulations/clp/harmonised-classification-and-labelling. If the substance is within the scope of the CLP Regulation, has not been registered under REACH (e.g. the substance is manufactured/imported in quantities below 1 tonne/year), 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 manufacturer/importer must notify to ECHA the information related to its classification and labelling. This must be done within one month after placing the substance on the market (Article 40(3) of the CLP Regulation). 70 Guidance on registration Version 4.0 – August 2021 For technical instructions on C&L notifications please consult the ECHA manual How to prepare a classification and labelling notification available at: http://echa.europa.eu/manuals. It is also advised to view the Notification to the C&L Inventory section accessible at: http://echa.europa.eu/regulations/clp/cl-inventory/notification-to-the-cl-inventory. Additional information is provided in the Introductory Guidance on the CLP Regulation and the Guidance on the application of the CLP criteria available at: https://echa.europa.eu/guidance- documents/guidance-on-clp. 5.2.3 Manufacture, use and exposure 5.2.3.1 Information on manufacture and uses of the substance (section 3 of Annex VI of REACH) 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. These conditions need to be described in the exposure assessment (for substances > 10 tonnes per year) or in the exposure information according to Annex VI (6) (substances < 10 tonnes per year). 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). 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. Each registrant must always report their own uses. They cannot refer to the dossier jointly submitted by the lead registrant, even if the chemical safety report (CSR) has been submitted jointly. If the CSR is provided jointly by the lead registrant, the lead registrant must report, in addition to their own uses, all the uses that are covered by the joint CSR. In order to provide the use information, use maps developed under the CSR/ES roadmap can be helpful ( https://echa.europa.eu/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 https://echa.europa.eu/guidance- Guidance on registration 71 Version 4.0 - August 2021 documents/guidance-on-reach. 5.2.3.2 Information on exposure for substances > 10 tonnes If, according to Article 14(4) the registrant is required to perform an exposure assessment as defined in section 5 of Annex I of REACH, then all identified uses of the registrant should be assessed (see section 5.374 Chemical Safety Report). This can be reported either in a joint or in 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 of REACH). 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 Fulfilling the information requirements). 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 of REACH. 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 the 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; • 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) must be provided in the technical dossier (see section 4.1 Information requirements for details). Special considerations for 1-10 tonnes dossiers (Annex VII) Certain substances benefit from reduced information requirements when being registered at 72 Guidance on registration Version 4.0 – August 2021 the lowest tonnage band, as clarified in Article 2 of the Commission Implementing Regulation 2019/169223. These are substances defined in Article 3(20) of REACH as phase-in substances, i.e. substances listed in the European Inventory of Existing Commercial Chemical Substances (‘EINECS’)24, the so-called ‘no-longer polymer’ (NLP)25 and substances that were 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 199226. When such a substance does not meet the Annex III criteria: • The registrant can register the substance with reduced information requirements (i.e. only the information on physicochemical properties specified in Annex VII, section 7 of REACH) at the lowest tonnage band (1-10 tonnes per year), as clarified by the implementing regulation on the end of phase-in27 (Article 12(1)(b)); or • The registrant can register the substance with the standard information requirements at the lowest tonnage band (1-10 tonnes per year) and claim a fee waiver (Articles 12(1)(b) and 74, recital 34). Not fulfilling the Annex III criteria means that: • there is no indication that the substance has carcinogenic, mutagenic or toxic to reproduction (CMR, category 1A or 1B), persistent, bioaccumulative and toxic (PBT) or very persistent, very bioaccumulative (vPvB) properties, and • there is no indication that a substance with dispersive or diffuse uses would be classified as hazardous for human health or as an environmental hazard under the CLP Regulation. For more information, see the Annex III inventory available at: http://echa.europa.eu/information-on-chemicals/annex-iii-inventory 23 Commission Implementing Regulation (EU) 2019/1692 of 9 October 2019 on the application of certain registration and data-sharing provisions of Regulation (EC) No 1907/2006 of the European Parliament and of the Council after the expiry of the final registration deadline for phase-in substances 24 The EINECS list contains, in principle, all substances on the Community market on 18 September 1981. The full and exhaustive list is part of the EC Inventory accessible on the ECHA website: http://echa.europa.eu/information-on-chemicals/ec-inventory. The list has been ‘frozen’ and more substances cannot be added to it or removed from it. 25 These are substances that were placed on the market in any of the current Member States of the EU before 1 June 2007 by the manufacturer or importer and were 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 they placed the substance on the market, 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, that only serves for information purposes, is accessible at http://echa.europa.eu/information-on-chemicals/ec-inventory. 26 The manufacturer or importer must have 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. 27 Commission Implementing Regulation (EU) 2019/1692 of 9 October 2019 on the application of certain registration and data-sharing provisions of Regulation (EC) No 1907/2006 of the European Parliament and of the Council after the expiry of the final registration deadline for phase-in substances Guidance on registration 73 Version 4.0 - August 2021 Before registrants can claim in their technical dossier (section 14 of IUCLID) that Annex III criteria are not fulfilled, they should review and subsequently verify all available information, including: • data from submitted REACH registrations (see ECHA’s dissemination website: http://echa.europa.eu/en/information-on-chemicals) or C&L notifications (see ECHA’s C&L Inventory: http://echa.europa.eu/information-on-chemicals/cl-inventory-database) or any other relevant databases, e.g. the 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 section 5.2.3 Manufacture, use and exposure). Information on how to fill in section 14 in IUCLID, regarding the Annex III criteria is detailed in the ECHA manual How to prepare registration and PPORD dossiers accessible at: http://echa.europa.eu/manuals. The manual is also available via the help system built-in IUCLID. Additional information on more specific information on the level of detail to be reported for each individual endpoint, can also be found in our practical guides for example Practical guide for SME managers and REACH coordinators - How to fulfil your information requirements at tonnages 1-10 and 10-100 tonnes per year’ accessible at: http://echa.europa.eu/practical- guides,. 5.2.5 Guidance on safe use The registrant must report the following information (as required under section 5 of Annex VI of REACH): •