Art. 6

02008R1272-20260501 → 02008R1272-20260701

Article 6 Identification and examination of available information on mixtures 1. Manufacturers, importers and downstream users of a mixture shall identify the relevant available information on the mixture itself or the substances contained in it for the purposes of determining whether the mixture entails a physical, health or environmental hazard as set out in Annex I, and, in particular, the following: (a) data generated in accordance with any of the methods referred to in Article 8(3) on the mixture itself or the substances contained in it; (b) epidemiological data and experience on the effects on humans for the mixture itself or the substances contained in it, such as occupational data or data from accident databases; (c) any other information generated in accordance with section 1 of Annex XI to Regulation (EC) No 1907/2006 for the mixture itself or the substances contained in it; (ca) data obtained from new approach methodologies; (d) any other information generated under internationally recognised chemical programmes for the mixture itself or the substances contained in it. The information shall relate to the forms or physical states in which the mixture is placed on the market and, when relevant, in which it can reasonably be expected to be used. 2. Subject to paragraphs 3 and 4, where the information referred to in paragraph 1 is available for the mixture itself, and the manufacturer, importer or downstream user has ascertained that information to be adequate and reliable and where applicable, scientifically valid, that manufacturer, importer or downstream user shall use that information for the purposes of the evaluation pursuant to Chapter 2 of this Title. 3. For the evaluation of mixtures pursuant to Chapter chapter 2 of this Title in relation to the germ cell mutagenicity, carcinogenicity carcinogenicity, reproductive toxicity, endocrine disruption for human health and reproductive toxicity endocrine disruption for the environment hazard classes referred to in sections 3.5.3.1, 3.6.3.1 3.6.3.1, 3.7.3.1, 3.11.3.1 and 3.7.3.1 4.2.3.1 of Annex I, the manufacturer, importer or and downstream user shall only use the relevant available information referred to in paragraph 1 for the substances in the mixture. Further, in cases where mixture and not for the mixture itself. Where the available test data on the mixture itself demonstrate germ cell mutagenic, carcinogenic or toxic to reproduction effects properties, or endocrine disruption for human health or the environment which have not been identified from the relevant available information on the individual substances, substance referred to in the first subparagraph, those data shall also be taken into account. account for the purposes of the evaluation of the mixture referred to in the first subparagraph. 4. For the evaluation of mixtures pursuant to Chapter 2 of this Title in relation to the biodegradation biodegradation, persistency, mobility and bioaccumulation properties within the hazardous to the aquatic environment environment, persistent, bioaccumulative and toxic or very persistent, very bioaccumulative properties and persistent, mobile and toxic or very persistent, very mobile properties hazard class classes referred to in sections 4.1.2.8 4.1.2.8, 4.1.2.9, 4.3.2.3.1, 4.3.2.3.2, 4.4.2.3.1 and 4.1.2.9 4.4.2.3.2 of Annex I, the manufacturer, importer or and downstream user shall only use the relevant available information referred to in paragraph 1 for the substances in the mixture. mixture and not for the mixture itself. 5. Where no or inadequate test data on the mixture itself of the kind referred to in paragraph 1 are available, the manufacturer, importer or downstream user shall use other available information on individual substances and similar tested mixtures which may also be considered relevant for the purposes of determining whether the mixture is hazardous, provided that that manufacturer, importer or downstream user has ascertained that information to be adequate and reliable for the purpose of the evaluation pursuant to Article 9(4).