Art. 1

02008R1272-20241210 → 02008R1272-20250201

Article 1 Purpose and scope 1. The purpose of this Regulation is to ensure a high level of protection of human health and the environment as well as the free movement of substances, mixtures and articles as referred to in Article 4(8) by: (a) harmonising the criteria for classification of substances and mixtures, and the rules on labelling and packaging for hazardous substances and mixtures; (b) providing an obligation for: (i) manufacturers, importers and downstream users to classify substances and mixtures placed on the market; (ii) suppliers to label and package substances and mixtures placed on the market; (iii) manufacturers, producers of articles and importers to classify those substances not placed on the market that are subject to registration or notification under Regulation (EC) No 1907/2006; (c) providing an obligation for manufacturers and importers of substances to notify the Agency of such classifications and label elements if these have not been submitted to the Agency as part of a registration under Regulation (EC) No 1907/2006; (d) establishing a list of substances with their harmonised classifications and labelling elements at Community level in Part 3 of Annex VI; (e) establishing a classification and labelling inventory of substances, which is made up of all notifications, submissions and harmonised classifications and labelling elements referred to in points (c) and (d); (f) providing an obligation for downstream users, importers and distributors referred to in Article 45(1b) and (1c) to submit information relevant to an adequate emergency health response to appointed bodies in accordance with Annex VIII. (d). 2. This Regulation shall not apply to the following: (a) radioactive substances and mixtures within the scope of Council Directive 96/29/Euratom of 13 May 1996 laying down basic safety standards for the protection of the health of workers and the general public against the danger arising from ionising radiation OJ L 159, 29.6.1996, p. 1.; (b) substances and mixtures which are subject to customs supervision, provided that they do not undergo any treatment or processing, and which are in temporary storage, or in a free zone or free warehouse with a view to re-exportation, or in transit; (c) non-isolated intermediates; (d) substances and mixtures for scientific research and development, which are not placed on the market, provided they are used under controlled conditions in accordance with Community workplace and environmental legislation. 3. Waste as defined in Directive 2006/12/EC of the European Parliament and of the Council of 5 April 2006 on waste OJ L 114, 27.4.2006, p. 9. is not a substance, mixture or article within the meaning of Article 2 of this Regulation. 4. Member States may allow for exemptions from this Regulation in specific cases for certain substances or mixtures, where necessary in the interests of defence. 5. This Regulation shall not apply to substances and mixtures in the following forms, which are in the finished state, intended for the final user: (a) medicinal products as defined in Directive 2001/83/EC; (b) veterinary medicinal products as defined in Directive 2001/82/EC; (c) cosmetic products as defined in Directive 76/768/EEC; (d) medical devices as defined in Directives 90/385/EEC and 93/42/EEC, which are invasive or used in direct physical contact with the human body, and in Directive 98/79/EC; (e) food or feeding stuffs as defined in Regulation (EC) No 178/2002 including when they are used: (i) as a food additive in foodstuffs within the scope of Directive 89/107/EEC; (ii) as a flavouring in foodstuffs within the scope of Directive 88/388/EEC and Decision 1999/217/EC; (iii) as an additive in feeding stuffs within the scope of Regulation (EC) No 1831/2003; (iv) in animal nutrition within the scope of Directive 82/471/EEC. 6. Save where Article 33 applies this Regulation shall not apply to the transport of dangerous goods by air, sea, road, rail or inland waterways.