in force 2026-07-01 MODIFIED+4,318 −0§
Amended by Regulation (EU) 2024/2865 32024R2865
applies from: unchanged
A new point (ca) is added to paragraph 1, listing data obtained from new approach methodologies among the relevant available information to be identified on a substance.
New paragraphs 3 to 8 are added, setting out how substances containing more than one constituent are to be evaluated using information on individual constituents versus the substance itself, including specific rules for mutagenicity, carcinogenicity, reproductive toxicity and endocrine disruption hazard classes, for biodegradation, persistence, mobility and bioaccumulation hazard classes, an exclusion for unmodified plant- or fungus-derived substances, a definition of plants for that exclusion, and a mechanism for the Commission to request Agency evaluation and adopt delegated acts creating derogations from these rules.
Paragraph 2 remains unchanged in wording between the two versions.
Cited: Art. 5, v2 · Art. 5, v1
text before / after
texts differ too much for an inline diff; shown separately
before (02008R1272-20260501)
Article 5 Identification and examination of available information on substances 1. Manufacturers, importers and downstream users of a substance shall identify the relevant available information for the purposes of determining whether the substance 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); (b) epidemiological data and experience on the effects on humans, such as occupational data and data from accident databases; (c) any other information generated in accordance with section 1 of Annex XI to Regulation (EC) No 1907/2006; (d) any new scientific information; (e) any other information generated under internationally recognised chemical programmes. The information shall relate to the forms or physical states in which the substance is placed on the market and in which it can reasonably be expected to be used. 2. Manufacturers, importers and downstream users shall examine the information referred to in paragraph 1 to ascertain whether it is adequate, reliable and scientifically valid for the purpose of the evaluation pursuant to Chapter 2 of this Title.
after (02008R1272-20260701)
Article 5 Identification and examination of available information on substances 1. Manufacturers, importers and downstream users of a substance shall identify the relevant available information for the purposes of determining whether the substance 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); (b) epidemiological data and experience on the effects on humans, such as occupational data and data from accident databases; (c) any other information generated in accordance with section 1 of Annex XI to Regulation (EC) No 1907/2006; (ca) data obtained from new approach methodologies; (d) any new scientific information; (e) any other information generated under internationally recognised chemical programmes. The information shall relate to the forms or physical states in which the substance is placed on the market and in which it can reasonably be expected to be used. 2. Manufacturers, importers and downstream users shall examine the information referred to in paragraph 1 to ascertain whether it is adequate, reliable and scientifically valid for the purpose of the evaluation pursuant to Chapter 2 of this Title. 3. A substance containing more than one constituent, in the form of an individual constituent, an identified impurity or an additive, for which relevant information referred to in paragraph 1 is available, shall be evaluated using the available information on those known constituents as well as on the substance itself. 4. For the evaluation of a substance containing more than one constituent pursuant to Chapter 2 in relation to the germ cell mutagenicity, carcinogenicity, reproductive toxicity, endocrine disruption for human health and endocrine disruption for the environment hazard classes referred to in sections 3.5, 3.6, 3.7, 3.11 and 4.2 of Annex I, the manufacturer, importer and downstream user shall use the relevant available information referred to in paragraph 1 for each of the known constituents. Relevant available information on a substance containing more than one constituent itself shall be taken into account where one of the following conditions is met: (a) the information demonstrates germ cell mutagenic, carcinogenic, or toxic to reproduction properties, or endocrine disruption for human health or the environment; (b) the information supports the conclusions based on the relevant available information on the constituents in the substance. Relevant available information on the substance containing more than one constituent itself demonstrating an absence of the properties referred to in point (a) or less severe properties shall not override the relevant available information on the constituents in the substance. 5. For the evaluation of a substance containing more than one constituent pursuant to Chapter 2 of this Title in relation to the biodegradation, persistence, mobility and bioaccumulation properties within the hazardous to the aquatic environment, persistent, bioaccumulative and toxic or very persistent, very bioaccumulative properties and persistent, mobile and toxic or very persistent, very mobile properties hazard classes referred to in sections 4.1.2.8, 4.1.2.9, 4.3.2.3.1, 4.3.2.3.2, 4.4.2.3.1 and 4.4.2.3.2 of Annex I, the manufacturer, importer and downstream user shall use the relevant available information referred to in paragraph 1 for each of the known constituents in the substance. Relevant available information on a substance containing more than one constituent itself shall be taken into account where one of the following conditions is met: (a) the information demonstrates persistence, mobility and bioaccumulation properties or a lack of degradation. (b) the information supports the conclusions based on the relevant available information on the constituents in the substance. Relevant available information on the substance containing more than one constituent itself demonstrating an absence of the properties referred to in point (a) or less severe properties shall not override the relevant available information on the constituents in the substance. 6. Paragraphs 4 and 5 shall not apply to substances containing more than one constituent which are extracted from plants or plant parts and which are not chemically modified as defined in Article 3, point (40), of Regulation (EC) No 1907/2006. 7. For the purpose of paragraph 6, plants refers to living or dead organisms from the kingdoms Plantae and Fungi, and includes algae, lichens and yeasts. 8. For certain substances containing more than one constituent that are not covered by paragraph 6, where the Commission receives evidence that the rules set out in paragraphs 4 or 5 might not be suitable for certain substances containing more than one constituent, the Commission may request the Agency to evaluate the available data. The Commission is empowered to adopt delegated acts in accordance with Article 53a to amend Annex I by creating a new section and by including and modifying, in that section, the derogations from paragraph 4 or 5 on classification of substances containing more than one constituent. For those delegated acts, the Commission shall take into account scientific evidence, advances in knowledge, and the opinion of the Agency when available, to appropriately classify substances containing more than one constituent provided that a high level of protection of human health and the environment is ensured.