CHAPTER I

GENERAL PROVISIONS

Subject matter
Article 1
This Regulation lays down requirements for the design and manufacture of personal protective equipment (PPE) which is to be made available on the market, in order to ensure protection of the health and safety of users and establish rules concerning PPE in the United Kingdom.

Scope
Article 2
1
This Regulation applies to PPE.
2
This Regulation does not apply to PPE:
a
specifically designed for use by the armed forces or in the maintenance of law and order;
b
designed to be used for self-defence, with the exception of PPE intended for sporting activities;
c
designed for private use to protect against:
1. atmospheric conditions that are not of an extreme nature,
2. damp and water during dishwashing;
d
for exclusive use on seagoing vessels or aircraft that are subject to the relevant international treaties applicable in the United Kingdom;
e
for head, face or eye protection of users, that is covered by Regulation No 22 of the United Nations Economic Commission for Europe on uniform provisions concerning the approval of protective helmets and their visors for drivers and passengers of motorcycles and mopeds.

Definitions
Article 3
For the purposes of this Regulation, the following definitions apply:
1. ‘personal protective equipment’ (PPE) means:
  1. 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;
  2. interchangeable components for equipment referred to in point (a) which are essential for its protective function;
  3. 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 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 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 United Kingdom who has received a written mandate from a manufacturer to act on his behalf in relation to specified tasks;
6. importer” means a person who—
  1. is established in the United Kingdom and places PPE from a country outside of the United Kingdom on the market; or
  2. 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;
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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;
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
19. ‘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.

Making available on the market
Article 4
PPE shall only be made available on the market if, where properly maintained and used for its intended purpose, it complies with this Regulation and does not endanger the health or safety of persons, domestic animals or property.

Essential health and safety requirements
Article 5
PPE shall meet the essential health and safety requirements set out in Annex II which apply to it.

Provisions concerning the use of PPE
Article 6. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Making available, putting into service and exhibition at trade fairs, etc
Article 7
1
Nothing in this Regulation impedes, for the aspects covered by this Regulation, the making available on the market of PPE which complies with this Regulation.
2
At trade fairs, exhibitions and demonstrations or similar events, nothing in this Regulation prevents the showing of PPE which does not comply with this Regulation, provided that a visible sign clearly indicates that the PPE does not comply with this Regulation and is not available on the market until it has been brought into conformity.
During demonstrations, adequate measures shall be taken to ensure the protection of persons.

Designated standard
Article 7A
1.
Subject to paragraphs 6 and 7, in this Regulation, a “
designated standard
” means a technical specification which is—
a
adopted by a recognised standardisation body
or an international standardising body
, for repeated or continuous application, with which compliance is not compulsory; and
b
designated by the Secretary of State, by publishing the reference to the standard and maintaining that publication in a manner the Secretary of State considers appropriate.
2.
For the purposes of paragraph 1, “
technical specification
” means a document that prescribes technical requirements to be fulfilled by a product, process, service or system and which lays down one or more of the following—
a
the characteristics required of a product, including—
i
levels of quality, performance, interoperability, environmental protection, health, safety or dimensions; and
ii
the requirements applicable to the product as regards the name under which the product is sold, terminology, symbols, testing and test methods, packaging, marking or labelling and conformity assessment procedures;
b
production methods and processes relating to the product, where these have an effect on the characteristics of the product.
3.
For the purposes of this Article, a “
recognised standardisation body
” means any one of the following organisations—
a
the European Committee for Standardisation (CEN);
b
the European Committee for Electrotechnical Standardisation (Cenelec);
c
the European Telecommunications Standards Institute (ETSI);
d
the British Standards Institution (BSI).
3A.
In this Article “
international standardising body
” has the same meaning as it has for the purposes of the Agreement on Technical Barriers to Trade, part of Annex 1A to the agreement establishing the World Trade Organisation signed at Marrakesh on 15 April 1994 (as modified from time to time).
4.
When considering whether the manner of publication of a reference is appropriate in accordance with paragraph 1(b), the Secretary of State must have regard to whether the publication will draw the standard to the attention of any person who may have an interest in the standard.
5.
Before publishing the reference to a technical specification adopted by the British Standards Institution, the Secretary of State must have regard to whether the technical specification is consistent with
such
technical specifications adopted by the other recognised standardisation bodies
or by international standardising bodies as the Secretary of State considers to be relevant
.
6.
The Secretary of State may remove from publication the reference to a standard which has been published in accordance with paragraph 1(b).
7.
Where the Secretary of State removes the reference to a standard from publication, that standard is no longer a designated standard.
8.
In this Article, a reference to a “
product
” is a reference to PPE to which this Regulation applies.
9.
The Secretary of State may, by regulations, amend paragraph 3 to reflect any changes in the name or structure of the recognised standardisation bodies.
10.
Regulations made under paragraph 9 must be made by statutory instrument, subject to annulment in pursuance of a resolution of either House of Parliament.
Art. 7A 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(7); 2020 c. 1, Sch. 5 para. 1(1)
Word in Art. 1 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(2)(a); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 1 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(2)(b); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 2(2)(d) 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(3); 2020 c. 1, Sch. 5 para. 1(1)
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)
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)
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)
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)
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)
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)
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)
Art. 6 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(5); 2020 c. 1, Sch. 5 para. 1(1)
Art. 7 heading 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(6)(a); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 7(1) 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(6)(b); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 7(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(6)(c); 2020 c. 1, Sch. 5 para. 1(1)
Art. 7A(3A) inserted (31.12.2020) by European Union (Future Relationship) Act 2020 (c. 29), s. 40(7), Sch. 4 para. 23(b); S.I. 2020/1662, reg. 2(ee)
Words in Art. 7A(1)(a) inserted (31.12.2020) by European Union (Future Relationship) Act 2020 (c. 29), s. 40(7), Sch. 4 para. 23(a); S.I. 2020/1662, reg. 2(ee)
Word in Art. 7A(5) inserted (31.12.2020) by European Union (Future Relationship) Act 2020 (c. 29), s. 40(7), Sch. 4 para. 23(c)(i); S.I. 2020/1662, reg. 2(ee)
Words in Art. 7A(5) inserted (31.12.2020) by European Union (Future Relationship) Act 2020 (c. 29), s. 40(7), Sch. 4 para. 23(c)(ii); S.I. 2020/1662, reg. 2(ee)