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REQUIREMENTS FOR THE COMPILATION OF SAFETY DATA SHEETS PART A 0.1. Introduction 0.1.1. This Annex sets out the requirements that the supplier shall fulfil for the compilation of a safety data sheet that is provided for a substance or a mixture in accordance with Article 31.

0.1.2. The information on substances provided in the safety data sheet shall be consistent with the information in the registration and in the chemical safety report, where required. Where a chemical safety report has been completed, the relevant exposure scenario(s) shall be placed in an annex to the safety data sheet.

0.1.3. The safety data sheet shall mention in each relevant section whether and which different nanoforms it covers and link the relevant safety information to each of those nanoforms. As provided for in Annex VI, the term ‘nanoform’ in this Annex refers to a nanoform or a set of similar nanoforms.

0.2. General requirements for compiling a safety data sheet

0.2.1. The safety data sheet shall enable users to take the necessary measures relating to protection of human health and safety at the workplace, and protection of the environment. The writer of the safety data sheet shall take into account that a safety data sheet must inform its audience of the hazards of a substance or a mixture and provide information on the safe storage, handling and disposal of the substance or the mixture.

0.2.2. The information provided by safety data sheets shall also meet the requirements set out in Directive 98/24/EC. In particular, the safety data sheet shall enable employers to determine whether any hazardous chemical agents are present in the workplace and to assess any risk to the health and safety of workers arising from their use.

0.2.3. The information in the safety data sheet shall be written in a clear and concise manner. The safety data sheet shall be prepared by a competent person who shall take into account the specific needs and knowledge of the user audience, as far as they are known. Suppliers of substances and mixtures shall ensure that such competent persons have received appropriate training, including refresher training.

0.2.4. The language used in the safety data sheet shall be simple, clear and precise, avoiding jargon, acronyms and abbreviations. Statements such as ‘may be dangerous’, ‘no health effects’, ‘safe under most conditions of use’ or ‘harmless’ or any other statements indicating that the substance or mixture is not hazardous or any other statements that are inconsistent with the classification of that substance or mixture shall not be used.

0.2.5. The date of compilation of the safety data sheet shall be given on the first page. When a safety data sheet has been revised and the new, revised version is provided to recipients, the changes shall be brought to the attention of the recipients in Section 16 of the safety data sheet, unless the changes have been indicated elsewhere. For the revised safety data sheets, the date of compilation, identified as ‘Revision: (date)’, shall appear on the first page, as well as one or more indications of which version is replaced, such as version number, revision number, or supersedes date.

0.3. Safety data sheet format

0.3.1. A safety data sheet is not a fixed length document. The length of the safety data sheet shall be commensurate with the hazard of the substance or mixture and the information available.

0.3.2. All pages of a safety data sheet, including any annexes, shall be numbered and shall bear either an indication of the length of the safety data sheet (such as ‘page 1 of 3’) or an indication whether there is a page following (such as ‘Continued on next page’ or ‘End of safety data sheet’).

0.4. Safety data sheet content The information required by this Annex shall be included in the safety data sheet, where applicable and available, in the relevant subsections set out in Part B. The safety data sheet shall not contain blank subsections.

0.5. Other information requirements The inclusion of additional relevant and available information in the relevant subsections may be necessary in some cases in view of the wide range of properties of substances and mixtures.

Additional safety and environmental information is required to address the needs of seafarers and other transport workers in the bulk transport of dangerous goods in sea-going or inland navigation bulk carriers or tank-vessels subject to International Maritime Organisation (IMO) or national regulations. Subsection 14.7 recommends the inclusion of basic classification information when such cargoes are transported in bulk according to the relevant IMO instruments. In addition, ships carrying oil or oil fuel, as defined in Annex I of MARPOL (), in bulk or bunkering oil fuel are required, before loading, to be provided with a ‘material safety data sheet’ in accordance with the IMO’s Maritime Safety Committee (MSC) resolution ‘Recommendations for Material Safety Data Sheets (MSDS) for MARPOL Annex I Oil Cargo and Oil Fuel’ (MSC.286(86)). Therefore, in order to have one harmonised safety data sheet for maritime and non-maritime use, the additional provisions of Resolution MSC.286(86) may be included in the safety data sheets, where appropriate, for marine transport of MARPOL Annex I cargoes and marine fuel oils.

0.6. Units

The units of measurement as set out in Council Directive 80/181/EEC () shall be used.

0.7. Special cases Safety data sheets shall also be required for the special cases listed in paragraph 1.3 of Annex I to Regulation (EC) No 1272/2008 for which there are labelling derogations.

1. SECTION 1: Identification of the substance/mixture and of the company/undertaking This section of the safety data sheet shall prescribe how the substance or mixture shall be identified and how the identified relevant uses, the name of the supplier of the substance or mixture and the contact detail information of the supplier of the substance or mixture, including an emergency contact, shall be provided in the safety data sheet.

1.1. Product identifier The product identifier shall be provided in accordance with Article 18(2) of Regulation (EC) No 1272/2008 in the case of a substance and in accordance with Article 18(3)(a) of Regulation (EC) No 1272/2008 in the case of a mixture, and as provided on the label in the official language(s) of the Member State(s) where the substance or mixture is placed on the market, unless the Member State(s) concerned provide(s) otherwise.

For substances subject to registration, the product identifier shall be consistent with that provided in the registration and the registration number assigned under Article 20(3) of this Regulation shall also be indicated. Additional identifiers may be provided even if they have not been used in the registration. Without affecting the obligations of downstream users laid down in Article 39 of this Regulation, the part of the registration number referring to the individual registrant of a joint submission may be omitted by a supplier who is a distributor or a downstream user provided that:

(a) this supplier assumes the responsibility to provide the full registration number upon request for enforcement purposes or, if the full registration number is not available to him, to forward the request to his supplier, in line with point (b); and

(b) this supplier provides the full registration number to the Member State authority responsible for enforcement (the enforcement authority) within 7 days upon request, received either directly from the enforcement authority or forwarded by his recipient, or, if the full registration number is not available to him, this supplier shall forward the request to his supplier within 7 days upon request and at the same time inform the enforcement authority thereof. A single safety data sheet may be provided to cover more than one substance or mixture where the information in that safety data sheet fulfils the requirements of this Annex for each of those substances or mixtures. Where different forms of a substance are covered by one safety data sheet, relevant information shall be included, clearly indicating which information is related to which form. Alternatively, a separate safety data sheet may be prepared per form or group of forms. If the safety data sheet pertains to one or more nanoforms, or substances that include nanoforms, this shall be indicated by using the word ‘nanoform’. Other means of identification

Other names or synonyms by which the substance or mixture is labelled or commonly known may be provided. Where a mixture has a unique formula identifier (UFI) in accordance with section 5 of Part A of Annex VIII to Regulation (EC) No 1272/2008 and that UFI is indicated in the safety data sheet, then the UFI shall be provided in this subsection.

1.2. Relevant identified uses of the substance or mixture and uses advised against At least a brief description of the identified uses (for example, floor cleaning, or industrial use in polymer production, or professional use in cleaning agents) relevant for the recipient(s) of the substance or mixture shall be indicated. The uses which the supplier advises against and the reasons why shall, where applicable, be stated. This need not be an exhaustive list. Where a chemical safety report is required, the information in this subsection of the safety data sheet shall be consistent with the identified uses in the chemical safety report and the exposure scenarios from the chemical safety report set out in the annex to the safety data sheet.

1.3. Details of the supplier of the safety data sheet

The supplier of the safety data sheet, whether it is the manufacturer, importer, only representative, downstream user or distributor, shall be identified. The full address and telephone number of the supplier shall be given as well as an email address for a competent person responsible for the safety data sheet. In addition, if the supplier is not located in the Member State where the substance or mixture is placed on the market and he has nominated a responsible person for that Member State, a full address and telephone number for that responsible person shall be given. Where an only representative has been appointed, details of the non-Union manufacturer or formulator may also be provided. For registrants, the information on the supplier of the safety data sheet and, if provided, on the supplier of the substance or mixture, shall be consistent with the information on the identity of the manufacturer, importer or only representative provided in the registration.

1.4. Emergency telephone number