Regulation (EU) 2016/425 of the European Parliament and of the CouncilShow full title

Article 3 U.K. Definitions

For the purposes of this Regulation, the following definitions apply:

(1)

‘personal protective equipment’ (PPE) means:

(a)

equipment designed and manufactured to be worn or held by a person for protection against one or more risks to that person's health or safety;

(b)

interchangeable components for equipment referred to in point (a) which are essential for its protective function;

(c)

connexion systems for equipment referred to in point (a) that are not held or worn by a person, that are designed to connect that equipment to an external device or to a reliable anchorage point, that are not designed to be permanently fixed and that do not require fastening works before use;

(2)

‘making available on the market’ means any supply of PPE for distribution or use on the [F1 market of Great Britain] in the course of a commercial activity, whether in return for payment or free of charge;

(3)

‘placing on the market’ means the first making available of PPE on the [F2 market of Great Britain];

(4)

‘manufacturer’ means any natural or legal person who manufactures PPE or has it designed or manufactured, and markets it under his name or trademark;

(5)

‘authorised representative’ means any natural or legal person established within the [F3 United Kingdom] who has received a written mandate from a manufacturer to act on his behalf in relation to specified tasks;

(6)

[F4 importer” means a person who—

(a)

is established in the United Kingdom and places PPE from a country outside of the United Kingdom on the market; or

(b)

is established in Northern Ireland and places PPE on the market that has been supplied to them for distribution, consumption or use in the course of a commercial activity, whether in return for payment or free of charge, from an EEA state;]

(7)

‘distributor’ means any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes PPE available on the market;

(8)

‘economic operators’ means the manufacturer, the authorised representative, the importer and the distributor;

(9)

‘technical specification’ means a document that prescribes technical requirements to be fulfilled by PPE;

(10)

F5 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(11)

F5 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(12)

F5 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(13)

‘conformity assessment’ means the process demonstrating whether the essential health and safety requirements of this Regulation relating to PPE have been fulfilled;

(14)

‘conformity assessment body’ means a body that performs conformity assessment activities including calibration, testing, certification and inspection;

(15)

‘recall’ means any measure aimed at achieving the return of PPE that has already been made available to the end-user;

(16)

‘withdrawal’ means any measure aimed at preventing PPE in the supply chain from being made available on the market;

(17)

F6 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(18)

F6 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(19)

[F7 ‘approved body’ has the meaning given in Article 20;

(20)

‘designated standard’ has the meaning given in Article 7A;

(21)

‘enforcement authority’ means a person enforcing this Regulation under regulation 4 of the Personal Protective Equipment (Enforcement) Regulations 2018 (S.I. 2018/390);

(22)

‘UK Marking’ means the marking in the form set out in Annex 2 of Regulation (EC) 765/2008 of the European Parliament and of the Council setting out the requirements for accreditation and market surveillance relating to the marketing of products, and repealing Regulation (EEC) 339/93;

(23)

‘UK national accreditation body’ means the body appointed by the Secretary of State in accordance with Article 4 of Regulation (EC) 765/2008 of the European Parliament and of the Council setting out the requirements for accreditation and market surveillance relating to the marketing of products, and repealing Regulation (EEC) 339/93;

(24)

‘Regulation 2016/425 (pre-exit)’ means Regulation (EU) 2016/425 of the European Parliament and of the Council on personal protective equipment and repealing Council Directive 89/686/EEC, as it had effect immediately before IP completion day;

(25)

In this Regulation, references to “the market surveillance authority” are to be construed in accordance with regulation 3 of the Personal Protective Equipment (Enforcement) Regulations 2018.]

Textual Amendments

F1 Words in Art. 3(2) substituted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 35 para. 3(4)(a) (as substituted by S.I. 2020/1460, reg. 1(4), Sch. 3 para. 24(4)); 2020 c. 1, Sch. 5 para. 1(1)

F2 Words in Art. 3(3) substituted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 35 para. 3(4)(a) (as substituted by S.I. 2020/1460, reg. 1(4), Sch. 3 para. 24(4)); 2020 c. 1, Sch. 5 para. 1(1)

F3 Words in Art. 3(5) substituted (E.W.S.) (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (UK(NI) Indication) (EU Exit) Regulations 2020 (S.I. 2020/1460), reg. 1(2), Sch. 5 para. 1(6)(a)

F4 Art. 3(6) substituted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 35 para. 3(4)(c) (as amended by S.I. 2020/1460, reg. 1(4), Sch. 3 para. 24(5)); 2020 c. 1, Sch. 5 para. 1(1)

F5 Art. 3(10)-(12) omitted (31.12.2020) by virtue of The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 35 para. 3(4)(d); 2020 c. 1, Sch. 5 para. 1(1)

F6 Art. 3(17)(18) omitted (31.12.2020) by virtue of The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 35 para. 3(4)(d); 2020 c. 1, Sch. 5 para. 1(1)

F7 Art. 3(19)-(25) inserted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 35 para. 3(4)(e) (as amended by S.I. 2020/852, regs. 2(2), 4(2), Sch. 1 para. 1(u)(iii)); 2020 c. 1, Sch. 5 para. 1(1)