Regulation (EC) No 1272/2008 of the European Parliament and of the CouncilShow full title

Article 1 U.K. Purpose and scope

1. The purpose of this Regulation is to ensure a high level of protection of human health and the environment F1 ... by:

(a) [F2 establishing] 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 [F3 mandatory classifications and labelling elements in the GB mandatory classification and labelling list];

(e) establishing a [F4 GB notification database of substances notified to the Agency after IP completion day].

2. This Regulation shall not apply to the following:

(a) radioactive substances and mixtures within the scope of [F5 the Ionising Radiations Regulations 2017] laying down basic safety standards for the protection of the health of workers and the general public against the danger arising from ionising radiation;

(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 F6 ... workplace and environmental legislation.

3. Waste as defined in [F7 Directive 2008/98/EC of the European Parliament and of the Council of 19 November 2008] on waste is not a substance, mixture or article within the meaning of Article 2 of this Regulation.

F8 4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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 [F9 the Human Medicines Regulations 2012];

(b) veterinary medicinal products as defined in [F10 the Veterinary Medicines Regulations 2013];

(c) cosmetic products as defined in [F11 Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products];

[F12 (d) medical devices as defined in the Medical Devices Regulations 2002 which are invasive or used in direct physical contact with the human body, and in vitro diagnostic medical devices, as defined in the same regulations.]

(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 [F13 Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives];

(ii)

as a flavouring in foodstuffs within the scope of [F14 Regulation (EC) No 1334/2008 of the European Parliament and of the Council of 16 December 2008 on flavourings and certain food ingredients with flavouring properties for use in and on foods F15 ...];

(iii)

as an additive in feeding stuffs within the scope of Regulation (EC) No 1831/2003;

(iv)

in animal nutrition within the scope of [F16 Regulation (EC) No 767/2009 of the European Parliament and of the Council of 13 July 2009 on the placing on the market and use of feed].

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.

Textual Amendments

F1 Words in Art. 1(1) omitted (31.12.2020) by virtue of The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720), reg. 1(2), Sch. 2 para. 13(2)(a); 2020 c. 1, Sch. 5 para. 1(1)

F2 Word in Art. 1(1)(a) substituted (31.12.2020) by The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720), reg. 1(2), Sch. 2 para. 13(2)(b); 2020 c. 1, Sch. 5 para. 1(1)

F3 Words in Art. 1(1)(d) substituted (31.12.2020) by The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720), reg. 1(2), Sch. 2 para. 13(2)(c) (as amended by S.I. 2020/1567, reg. 1(2), Sch. 2 para. 3(a)); 2020 c. 1, Sch. 5 para. 1(1)

F4 Words in Art. 1(1)(e) substituted (31.12.2020) by The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720), reg. 1(2), Sch. 2 para. 13(2)(d) (as amended by S.I. 2020/1567, reg. 1(2), Sch. 2 para. 3(b)(i)(ii)); 2020 c. 1, Sch. 5 para. 1(1)

F5 Words in Art. 1(2)(a) substituted (31.12.2020) by The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720), reg. 1(2), Sch. 2 para. 13(3)(a) (as amended by S.I. 2020/1567, reg. 1(2), Sch. 2 para. 3(c)); 2020 c. 1, Sch. 5 para. 1(1)

F6 Word in Art. 1(2)(d) omitted (31.12.2020) by virtue of The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720), reg. 1(2), Sch. 2 para. 13(3)(b); 2020 c. 1, Sch. 5 para. 1(1)

F7 Words in Art. 1(3) substituted (31.12.2020) by The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720), reg. 1(2), Sch. 2 para. 13(4); 2020 c. 1, Sch. 5 para. 1(1)

F8 Art. 1(4) omitted (31.12.2020) by virtue of The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720), reg. 1(2), Sch. 2 para. 13(5); 2020 c. 1, Sch. 5 para. 1(1)

F9 Words in Art. 1(5)(a) substituted (31.12.2020) by The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720), reg. 1(2), Sch. 2 para. 13(6)(a); 2020 c. 1, Sch. 5 para. 1(1)

F10 Words in Art. 1(5)(b) substituted (31.12.2020) by The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720), reg. 1(2), Sch. 2 para. 13(6)(b); 2020 c. 1, Sch. 5 para. 1(1)

F11 Words in Art. 1(5)(c) substituted (31.12.2020) by The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720), reg. 1(2), Sch. 2 para. 13(6)(c); 2020 c. 1, Sch. 5 para. 1(1)

F12 Art. 1(5)(d) substituted (31.12.2020) by The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720), reg. 1(2), Sch. 2 para. 13(6)(d); 2020 c. 1, Sch. 5 para. 1(1)

F13 Words in Art. 1(5)(e)(i) substituted (31.12.2020) by The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720), reg. 1(2), Sch. 2 para. 13(6)(e)(i); 2020 c. 1, Sch. 5 para. 1(1)

F14 Words in Art. 1(5)(e)(ii) substituted (31.12.2020) by The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720), reg. 1(2), Sch. 2 para. 13(6)(e)(ii); 2020 c. 1, Sch. 5 para. 1(1)

F15 Words in Art. 1(5)(e)(ii) omitted (1.4.2025) by virtue of The Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025 (S.I. 2025/361), reg. 1(2), Sch. 9 para. 1(2)

F16 Words in Art. 1(5)(e)(iv) substituted (31.12.2020) by The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720), reg. 1(2), Sch. 2 para. 13(6)(e)(iii); 2020 c. 1, Sch. 5 para. 1(1)