General obligation to register substances on their own or in mixtures. 1. Except as otherwise provided for in this Regulation, any manufacturer or importer of a substance on its own or in one or more mixtures in quantities of 1 tonne or more per year shall submit an application for registration to the Agency. 2. Monomers used as on-site isolated intermediates or transported isolated intermediates shall not be subject to Articles 17 and 18. 3. Any manufacturer or importer of a polymer shall submit a registration application to the Agency for monomeric substances or other substances for which no participant in the supply chain has yet submitted a registration application, provided that both of the following conditions are met: (a) the polymer contains at least 2 % by weight of those monomeric substances or other substances in the form of monomeric units and chemically bonded substances; (b) the total quantity of those monomeric substances or other substances is 1 tonne or more per year. The submission of an application for registration shall be subject to a fee in accordance with Title IX. Each manufacturer or importer of articles shall submit to the Agency an application for registration for each substance contained in those articles if both of the following conditions are met: (a) the substance is present in those articles in a total quantity greater than 1 tonne per manufacturer or importer per year; (b) the substance is expected to be released under normal or reasonably foreseeable conditions of use. Any manufacturer or importer of articles shall submit a notification to the Agency in accordance with paragraph 4 if the substance meets the criteria in Article 57, is identified in accordance with Article 59(1) and both of the following conditions are met: (a) the substance is present in those articles in a total quantity greater than 1 tonne per manufacturer or importer per year; (b) the substance is present in those articles in a concentration greater than 0,1 % by weight. Paragraph 2 shall not apply if the manufacturer or importer can eliminate human or environmental exposure under normal or reasonably foreseeable conditions of use, including disposal. In such cases, the manufacturer or importer shall provide appropriate instructions to the recipient of the article. 4. (a) the identification and contact details of the manufacturer or importer as listed in Section 1 of Annex VI, in addition to their own points of use; (b) the registration numbers referred to in Article 20(1), if available; (c) the identification of the substance as referred to in points 2.(d) the classification of the substance as set out in points 4.1 and 4.2 of Annex VI; (e) a brief description of the uses of the substances contained in the article as set out in point 3.5 of Annex VI and the uses of the articles; (f) the quantity range of the substances, e.g. 1 to 10 tonnes, 10 to 100 tonnes, etc. The Agency may decide that manufacturers or importers of articles must submit an application for registration under this Title for each substance contained in those articles if all of the following conditions are met: (a) the substance is present in those articles in a total quantity greater than 1 tonne per manufacturer or importer per year; (b) the Agency has reason to believe that (i) the substance is being released from those articles; and (ii) the release of the substance from the articles poses a risk to human health or the environment.

Each manufacturer or importer of articles shall submit to the Agency an application for registration for each substance contained in the articles if both of the following conditions are met: (a) the substance is present in the articles in a total quantity greater than 1 tonne per manufacturer or importer per year; (b) the substance is expected to be released under normal or reasonably foreseeable conditions of use. The submission of an application for registration shall be subject to a fee in accordance with Title IX.2. Any manufacturer or importer of articles shall submit a notification to the Agency in accordance with paragraph 4 if the substance meets the criteria in Article 57, is identified in accordance with Article 59(1) and both of the following conditions are met: (a) the substance is present in those articles in a total quantity greater than 1 tonne per manufacturer or importer per year; (b) the substance is present in those articles in a concentration greater than 0,1 % by weight. Paragraph 2 shall not apply if the manufacturer or importer can eliminate human or environmental exposure under normal or reasonably foreseeable conditions of use, including disposal. In such cases, the manufacturer or importer shall provide appropriate instructions to the recipient of the article. 4. (a) the identification and contact details of the manufacturer or importer as listed in Section 1 of Annex VI, in addition to their own points of use; (b) the registration numbers referred to in Article 20(1), if available; (c) the identification of the substance as referred to in points 2.(d) the classification of the substance as set out in points 4.1 and 4.2 of Annex VI; (e) a brief description of the uses of the substances contained in the article as set out in point 3.5 of Annex VI and the uses of the articles; (f) the quantity range of the substances, e.g. 1 to 10 tonnes, 10 to 100 tonnes, etc.

The supplier of a substance or mixture shall provide the recipient of the substance or mixture with a safety data sheet drawn up in accordance with Annex II if (a) the substance meets the criteria for classification as dangerous under Regulation (EC) No .../... 1272/2008 or the mixture meets the criteria for classification as dangerous under Directive 1999/45/EC; or (b) the substance is persistent, bioaccumulative and toxic or highly persistent and highly bioaccumulative according to the criteria set out in Annex XIII; or (c) the substance is included in the list established in accordance with Article 59(1) for reasons other than those referred to in points (a) and (b). 2. Any actor in the supply chain required to carry out a chemical safety assessment of a substance under Articles 14 or 37 shall ensure that the information in the safety data sheet is consistent with the information in that assessment. Where a safety data sheet has been drawn up for a mixture and the supply chain participant has prepared a chemical safety assessment for the mixture, it shall be sufficient if the information in the safety data sheet corresponds to the chemical safety report for the mixture instead of the chemical safety report for each substance contained in the mixture. The supplier shall provide the recipient, at his request, with a safety data sheet drawn up in accordance with Annex II, if the mixture does not meet the criteria for classification as dangerous in accordance with Articles 5, 6 and 7 of Directive 1999/45/EC but contains (a) in an individual concentration of ≥ 1 % by weight for non-gaseous mixtures and ≥ 0,2 % by volume for gaseous mixtures, at least one substance which presents a hazard to human health or the environment, or (b) in an individual concentration of ≥ 0,1 % by weight for non-gaseous mixtures, at least one substance which is persistent, bioaccumulative and toxic or highly persistent and highly bioaccumulative according to the criteria set out in Annex XIII or has been included in the list established under Article 2(1)(a) for reasons other than those referred to in point (a). 59(1); or (c) a substance for which Community occupational exposure limits are set. 4. A safety data sheet need not be supplied where substances classified as dangerous pursuant to Regulation (EC) No 1272/2008 or mixtures classified as dangerous pursuant to Directive 1999/45/EC are offered or sold to the general public together with sufficient information to enable users to take the necessary precautions to protect human health, safety and the environment and where the downstream user or distributor does not require it. 5. Unless the Member State concerned decides otherwise, the safety data sheet shall be supplied in the official language or one of the official languages of each Member State in which the substance or M3 mixture is placed on the market. Identification of the substance of the mixture and the company/undertaking; 2. Hazard identification; 3. Composition/information on ingredients; 4. First aid instructions; 5. Fire-fighting measures; 6. Precautions in case of accidental release; 7. Handling and storage; 8. Exposure limitation/personal protective equipment; 9. Physical and chemical properties; 10. stability and reactivity; 11. toxicological information; 12. environmental information; 13. disposal instructions; 14. information for transport; 15. regulatory information; 16. other information. 7. Any actor in the supply chain required to prepare a chemical safety report in accordance with Article 14 or 37 shall include relevant exposure scenarios (including, where appropriate, use and exposure categories) in an annex to the safety data sheet covering the identified uses and special conditions resulting from the application of Section 3 of Annex XI. Each downstream user shall include the relevant exposure scenarios and use other relevant information from the safety data sheet supplied to him when compiling his own safety data sheet for the identified uses. Each distributor, when compiling his own safety data sheet for uses for which he has submitted information in accordance with Article 37(2), shall submit relevant exposure scenarios and use other relevant information from the safety data sheet supplied to him.

Every manufacturer, importer, downstream user and distributor shall collect and retain all information required to fulfil his obligations under this Regulation for at least 10 years after the last time he manufactured, imported, supplied or used the substance or M3 mixture. That manufacturer, importer, downstream user or distributor shall, without delay, submit that information or make it available to the competent authority of the Member State in which he is established or to the Agency upon request, without prejudice to Titles II and VI. 2. Where a registrant, downstream user or distributor ceases its activities or transfers all or part of its activities to a third party, the person responsible for winding up the undertaking of the registrant, downstream user or distributor or for taking over responsibility for the placing on the market of the substance or on the market shall be bound by the obligation referred to in paragraph 1 instead of the registrant, downstream user or distributor.