Article 5 / Identification and examination of available information on substances
Article 5
Identification and examination of available information on substances
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:
data generated in accordance with any of the methods referred to in Article 8(3);
epidemiological data and experience on the effects on humans, such as occupational data and data from accident databases;
any other information generated in accordance with section 1 of Annex XI to Regulation (EC) No 1907/2006;
data obtained from new approach methodologies;
any new scientific information;
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.
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:
the information demonstrates germ cell mutagenic, carcinogenic, or toxic to reproduction properties, or endocrine disruption for human health or the environment;
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.
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:
the information demonstrates persistence, mobility and bioaccumulation properties or a lack of degradation.
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.
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.