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

Article 2 U.K. Definitions

For the purpose of this Regulation, the following definitions shall apply:

1.

‘hazard class’ means the nature of the physical, health or environmental hazard;

2.

‘hazard category’ means the division of criteria within each hazard class, specifying hazard severity;

3.

‘hazard pictogram’ means a graphical composition that includes a symbol plus other graphic elements, such as a border, background pattern or colour that is intended to convey specific information on the hazard concerned;

4.

‘signal word’ means a word that indicates the relative level of severity of hazards to alert the reader to a potential hazard; the following two levels are distinguished:

(a)

‘Danger’ means a signal word indicating the more severe hazard categories;

(b)

‘Warning’ means a signal word indicating the less severe hazard categories;

5.

‘hazard statement’ means a phrase assigned to a hazard class and category that describes the nature of the hazards of a hazardous substance or mixture, including, where appropriate, the degree of hazard;

6.

‘precautionary statement’ means a phrase that describes recommended measure(s) to minimise or prevent adverse effects resulting from exposure to a hazardous substance or mixture due to its use or disposal;

7.

‘substance’ means a chemical element and its compounds in the natural state or obtained by any manufacturing process, including any additive necessary to preserve its stability and any impurity deriving from the process used, but excluding any solvent which may be separated without affecting the stability of the substance or changing its composition;

8.

‘mixture’ means a mixture or solution composed of two or more substances;

9.

‘article’ means an object which during production is given a special shape, surface or design which determines its function to a greater degree than does its chemical composition;

10.

[F1 “producer of an article” means any natural or legal person—

(a)

who makes or assembles an article within Great Britain;

(b)

who makes or assembles an article within Northern Ireland which is a qualifying Northern Ireland good and which is placed directly on the market in Great Britain;]

11.

‘polymer’ means a substance consisting of molecules characterised by the sequence of one or more types of monomer units. Such molecules must be distributed over a range of molecular weights wherein differences in the molecular weight are primarily attributable to differences in the number of monomer units. A polymer comprises the following:

(a)

a simple weight majority of molecules containing at least three monomer units which are covalently bound to at least one other monomer unit or other reactant;

(b)

less than a simple weight majority of molecules of the same molecular weight.

In the context of this definition a ‘monomer unit’ means the reacted form of a monomer substance in a polymer;

12.

‘monomer’ means a substance which is capable of forming covalent bonds with a sequence of additional like or unlike molecules under the conditions of the relevant polymer-forming reaction used for the particular process;

13.

‘registrant’ means the manufacturer or the importer of a substance or the producer or importer of an article submitting a registration for a substance under Regulation (EC) No 1907/2006;

14.

‘manufacturing’ means production or extraction of substances in the natural state;

15.

[F2 “manufacturer” means any natural or legal person—

(a)

established in Great Britain, who manufactures a substance within Great Britain;

(b)

established in Northern Ireland, who manufactures a substance which is a qualifying Northern Ireland good and which is placed directly on the market in Great Britain;]

16.

[F3 “import” means the physical introduction into Great Britain, except where the goods are qualifying Northern Ireland goods;]

17.

[F4 “importer” means any natural or legal person established within Great Britain who is responsible for import;]

18.

‘placing on the market’ means supplying or making available, whether in return for payment or free of charge, to a third party. Import shall be deemed to be placing on the market;

19.

‘downstream user’ means any natural or legal person established [F5 within Great Britain, or within Northern Ireland in the case of qualifying Northern Ireland goods which are placed directly on the market in Great Britain], other than the manufacturer or the importer, who uses a substance, either on its own or in a mixture, in the course of his industrial or professional activities. A distributor or a consumer is not a downstream user. A re-importer exempted pursuant to Article 2(7)(c) of Regulation (EC) No 1907/2006 shall be regarded as a downstream user;

20.

‘distributor’ means any natural or legal person established [F6 within Great Britain, or within Northern Ireland in the case of qualifying Northern Ireland goods which are placed directly on the market in Great Britain], including a retailer, who only stores and places on the market a substance, on its own or in a mixture, for third parties;

21.

‘intermediate’ means a substance that is manufactured for and consumed in or used for chemical processing in order to be transformed into another substance (hereinafter referred to as ‘synthesis’);

22.

‘non-isolated intermediate’ means an intermediate that during synthesis is not intentionally removed (except for sampling) from the equipment in which the synthesis takes place. Such equipment includes the reaction vessel, its ancillary equipment, and any equipment through which the substance(s) pass(es) during a continuous flow or batch process as well as the pipework for transfer from one vessel to another for the purpose of the next reaction step, but it excludes tanks or other vessels in which the substance(s) are stored after the manufacture;

23.

‘the Agency’ means the [F7 Health and Safety Executive];

24.

‘competent authority’ means the authority or authorities or bodies [F8 appointed to carry out the obligations arising from this Regulation by the Biocidal Products and Chemicals (Appointment of Authorities and Enforcement) Regulations 2013];

25.

‘use’ means any processing, formulation, consumption, storage, keeping, treatment, filling into containers, transfer from one container to another, mixing, production of an article or any other utilisation;

26.

‘supplier’ means any manufacturer, importer, downstream user or distributor placing on the market a substance, on its own or in a mixture, or a mixture;

27.

‘alloy’ means a metallic material, homogeneous on a macroscopic scale, consisting of two or more elements so combined that they cannot be readily separated by mechanical means; alloys are considered to be mixtures for the purposes of this Regulation;

28.

‘UN RTDG’ means the United Nations Recommendations on the Transport of Dangerous Goods;

29.

‘notifier’ means the manufacturer or the importer, or group of manufacturers or importers notifying to the Agency;

30.

‘scientific research and development’ means any scientific experimentation, analysis or chemical research carried out under controlled conditions;

31.

‘cut-off value’ means a threshold of any classified impurity, additive or individual constituent in a substance or in a mixture, above which threshold these shall be taken into account for determining if the substance or the mixture, respectively, shall be classified;

32.

‘concentration limit’ means a threshold of any classified impurity, additive or individual constituent in a substance or in a mixture that may trigger classification of the substance or the mixture, respectively;

33.

‘differentiation’ means distinction within hazard classes depending on the route of exposure or the nature of the effects;

34.

‘M-factor’ means a multiplying factor. It is applied to the concentration of a substance classified as hazardous to the aquatic environment acute category 1 or chronic category 1, and is used to derive by the summation method the classification of a mixture in which the substance is present;

35.

‘package’ means the complete product of the packing operation, consisting of the packaging and its contents;

36.

‘packaging’ means one or more receptacles and any other components or materials necessary for the receptacles to perform their containment and other safety functions;

37.

‘intermediate packaging’ means packaging placed between inner packaging, or articles, and outer packaging.

38.

[F9 “GB mandatory classification and labelling list” means the list of mandatory classification and labelling requirements of substances and groups of substances established and maintained in accordance with Article 38A;

39.

F10 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

40.

“European Chemicals Agency” means the Agency established by Article 75 of Regulation (EC) No 1907/2006 as it has effect in EU law;

41.

“EU CLP Regulation” means Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EEC, and amending Regulation (EC) No 1907/2006, as it has effect in EU law;

42.

“Devolved Authority” means—

(a)

the Scottish Ministers, or

(b)

the Welsh Ministers;

43.

“qualifying Northern Ireland goods” has the meaning given by regulations made under section 8C(6) of the European Union (Withdrawal) Act 2018.]

Textual Amendments

F1 Art. 2(10) substituted (31.12.2020) by S.I. 2019/720, Sch. 2 para. 14(a) (as substituted by The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1567), reg. 1(2), Sch. 2 para. 4)

F2 Art. 2(15) substituted (31.12.2020) by S.I. 2019/720, Sch. 2 para. 14(b) (as substituted by The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1567), reg. 1(2), Sch. 2 para. 4)

F3 Art. 2(16) substituted (31.12.2020) by S.I. 2019/720, Sch. 2 para. 14(c) (as substituted by The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1567), reg. 1(2), Sch. 2 para. 4)

F4 Art. 2(17) substituted (31.12.2020) by S.I. 2019/720, Sch. 2 para. 14(d) (as substituted by The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1567), reg. 1(2), Sch. 2 para. 4)

F5 Words in Art. 2(19) substituted (31.12.2020) by S.I. 2019/720, Sch. 2 para. 14(e) (as substituted by The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1567), reg. 1(2), Sch. 2 para. 4)

F6 Words in Art. 2(20) substituted (31.12.2020) by S.I. 2019/720, Sch. 2 para. 14(f) (as substituted by The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1567), reg. 1(2), Sch. 2 para. 4)

F7 Words in Art. 2(23) substituted (31.12.2020) by S.I. 2019/720, Sch. 2 para. 14(g) (as substituted by The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1567), reg. 1(2), Sch. 2 para. 4)

F8 Words in Art. 2(24) substituted (31.12.2020) by S.I. 2019/720, Sch. 2 para. 14(h) (as substituted by The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1567), reg. 1(2), Sch. 2 para. 4)

F9 Art. 2(38)-(43) inserted by S.I. 2019/720, Sch. 2 para. 14(i) (as substituted) by The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1567), reg. 1(2), Sch. 2 para. 4)

F10 Art. 2(39) omitted (21.5.2026) by virtue of The Chemicals (Health and Safety) (Amendment, Consequential and Transitional Provision) Regulations 2026 (S.I. 2026/484), reg. 1(1), Sch. para. 1(3)