Art. 14

02006R1907-20160714 → 02006R1907-20161011

Article 14 Chemical safety report and duty to apply and recommend risk reduction measures 1. Without prejudice to Article 4 of Directive 98/24/EC, a chemical safety assessment shall be performed and a chemical safety report completed for all substances subject to registration in accordance with this Chapter in quantities of 10 tonnes or more per year per registrant. The chemical safety report shall document the chemical safety assessment which shall be conducted in accordance with paragraphs 2 to 7 and with Annex I for either each substance on its own or in a mixture or in an article or a group of substances. 2. A chemical safety assessment in accordance with paragraph 1 need not be performed for a substance which is present in a mixture if the concentration of the substance in the mixture is less than the lowest of any of the following: than: (a) the applicable concentrations defined in the table of Article 3(3) of Directive 1999/45/EC; (b) the specific concentration limits that have been set in Part 3 of Annex VI to Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures OJ L 353, 31.12.2008, p. 1;; (ba) for substances classified as hazardous to the aquatic environment, if a multiplying factor (hereinafter referred to as M-factor) has been set in Part 3 of Annex VI to Regulation (EC) No 1272/2008, the cut-off value in Table 1.1 of Annex I to that Regulation adjusted using the calculation set out in section 4.1 of Annex I to that Regulation; (c) the concentration limits given in Part B of Annex II to Directive 1999/45/EC; (d) the concentration limits given in Part B of Annex III to Directive 1999/45/EC; (e) the specific concentration limits given in an agreed entry in the classification and labelling inventory referred to in Article 42 11, paragraph 3 of Regulation (EC) No 1272/2008; (ea) for substances classified as hazardous to the aquatic environment, if an M-factor has been set in an agreed entry in the classification and labelling inventory referred to in Article 42 of Regulation (EC) No 1272/2008, the cut-off value in Table 1.1 of Annex I to that Regulation adjusted using the calculation set out in section 4.1 of Annex I to that Regulation; (f) (b) 0,1 % weight by weight (w/w), if the substance meets the criteria in Annex XIII of to this Regulation. 3. A chemical safety assessment of a substance shall include the following steps: (a) human health hazard assessment; (b) physicochemical hazard assessment; (c) environmental hazard assessment; (d) persistent, bioaccumulative and toxic (PBT) and very persistent and very bioaccumulative (vPvB) assessment. 4. If, as a result of carrying out steps (a) to (d) of paragraph 3, the registrant concludes that the substance fulfils the criteria for any of the following hazard classes or categories set out in Annex I to Regulation (EC) No 1272/2008: (a) hazard classes 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; (b) 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; (c) hazard class 4.1; (d) hazard class 5.1, or is assessed to be a PBT or vPvB, the chemical safety assessment shall include the following additional steps: (a) exposure assessment including the generation of exposure scenario(s) (or the identification of relevant use and exposure categories if appropriate) and exposure estimation; (b) risk characterisation. The exposure scenarios (where appropriate the use and exposure categories), exposure assessment and risk characterisation shall address all identified uses of the registrant. 5. The chemical safety report need not include consideration of the risks to human health from the following end uses: (a) in food contact materials within the scope of Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on materials and articles intended to come into contact with food OJ L 338, 13.11.2004, p. 4.; (b) in cosmetic products within the scope of Directive 76/768/EEC. 6. Any registrant shall identify and apply the appropriate measures to adequately control the risks identified in the chemical safety assessment, and where suitable, recommend them in the safety data sheets which he supplies in accordance with Article 31. 7. Any registrant required to conduct a chemical safety assessment shall keep his chemical safety report available and up to date.