The Personal Protective Equipment (Enforcement) Regulations 2018

[^key-c50a187995771d0b019109dec3146b30]: Words in reg. 1(2) inserted (E.W.S.) (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. 1(2)(a) (as amended by S.I. 2020/676, regs. 1(1), 2, 3); 2020 c. 1, Sch. 5 para. 1(1)

[^key-1eda4815eb612e02891a1ffb353f87fa]: Words in reg. 1(3) inserted (E.W.S.) (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. 1(2)(b)(i) (as amended by S.I. 2020/676, regs. 1(1), 2, 3); 2020 c. 1, Sch. 5 para. 1(1)

[^key-625cc6fcd3d520a0d0bc55c5b9f27283]: Words in reg. 1(3)(a) omitted (E.W.S.) (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. 1(2)(b)(ii) (as amended by S.I. 2020/676, regs. 1(1), 2, 3); 2020 c. 1, Sch. 5 para. 1(1)

[^key-fcaaf792a3b9f180a633c44f856ebdc2]: Word in reg. 1(3)(b) inserted (E.W.S.) (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. 1(2)(b)(iii) (as amended by S.I. 2020/676, regs. 1(1), 2, 3); 2020 c. 1, Sch. 5 para. 1(1)

[^key-4334d78aa446a0850a4e8144b2b46165]: Words in reg. 1(4) inserted (E.W.S.) (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. 1(2)(c) (as amended by S.I. 2020/676, regs. 1(1), 2, 3); 2020 c. 1, Sch. 5 para. 1(1)

[^M_E_1cb0315b-ab9a-4a97-f1d6-11555cab5660]: This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

[^M_E_5d8944c4-13e2-4884-f6e5-2d9974cdf271]: This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

[^key-dff591ad85854ce20b382f334cc682fb]: Words in reg. 12(1) omitted (E.W.S.) (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. 1(7) (as amended by S.I. 2020/676, regs. 1(1), 2, 3); 2020 c. 1, Sch. 5 para. 1(1)

[^key-128125de3141b008b8f9d39d942a65ae]: Words in reg. 12(1)(b) inserted (N.I.) (31.12.2020) by The Product Safety and Metrology etc. (Amendment) (Northern Ireland) (EU Exit) Regulations 2020 (S.I. 2020/1112), reg. 1(b), Sch. 17 para. 1(4)

[^V_NI_3ae848af-b748-a3d7-5232-91cad972237d]: 2015 c.26.

[^M_E_c42c7afd-2368-4a01-86a1-0bea42474dc6]: This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

[^M_E_db64672d-b0ee-46e0-f3c1-a2d427d3087c]: This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

[^key-9c3b29d1f3cf3aaffa0512274d3a83f2]: Word in reg. 18(2) substituted (N.I.) (31.12.2020) by The Product Safety and Metrology etc. (Amendment) (Northern Ireland) (EU Exit) Regulations 2020 (S.I. 2020/1112), reg. 1(b), Sch. 17 para. 1(5)

[^V_EWS_f8408193-cc41-fd54-7f5e-c138f0f77f2c]: Article 47(1) of EU Regulation 2016/425 provides for PPE which is in conformity with Council Directive 89/686/EEC to be placed on the market until 21 April 2019. The 2002 Regulations transposed Council Directive 89/686/EEC.

[^M_E_40364f88-94ec-46a4-e80b-f97e9d7a007b]: This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

[^M_E_9b64ac49-2f39-4958-ecf5-fc55a10732eb]: This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

[^key-9fd9f5c83cfa050748c67aa83bc760a8]: Reg. 2(4)(a) inserted (31.12.2020) by S.I. 2019/696, Sch. 35 para. 1(3)(a) (as substituted by The Product Safety, Metrology and Mutual Recognition Agreement (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1246), regs. 1(3), 9(b)(i); 2020 c. 1, Sch. 5 para. 1(1))

[^M_F_1e221639-5f76-45bd-f95b-6171b371a658]: Reg. 2(4A) inserted (31.12.2020) by S.I. 2019/696, Sch. 35 para. 1(3)(b) (as substituted by The Product Safety, Metrology and Mutual Recognition Agreement (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1246), regs. 1(3), 9(b)(ii); 2020 c. 1, Sch. 5 para. 1(1))

[^key-7b351ba9d4d8ca8264ba5ae24a71a689]: Words in reg. 2(6) substituted (E.W.S.) (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. 1(3)(e) (as amended by S.I. 2020/676, regs. 1(1), 2, 3); 2020 c. 1, Sch. 5 para. 1(1)

[^key-7e5475668267ecb17d43a0e257de4681]: Word in reg. 6 omitted (N.I.) (31.12.2020) by virtue of The Product Safety and Metrology etc. (Amendment) (Northern Ireland) (EU Exit) Regulations 2020 (S.I. 2020/1112), reg. 1(b), Sch. 17 para. 1(2)

[^key-704fc50437d0028719872bdc21b3ea4d]: Words in reg. 6 substituted (E.W.S.) (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. 1(5) (as amended by S.I. 2020/676, regs. 1(1), 2, 3); 2020 c. 1, Sch. 5 para. 1(1)

[^key-1c92c79cc61c3bab82d2a256b777c4df]: Word in reg. 7(1) substituted (E.W.S.) (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. 1(6) (as amended by S.I. 2020/676, regs. 1(1), 2, 3); 2020 c. 1, Sch. 5 para. 1(1)

[^key-00615240097a42b09f2996fb1248b834]: Regs. 2A, 2B inserted (E.W.S.) (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. 1(4) (as amended by S.I. 2020/676, regs. 1(1), 2, 3); 2020 c. 1, Sch. 5 para. 1(1)

[^key-8a9279864b0459b25ddeb61b3dfb46e9]: Regs. 2C, 2D inserted (E.W.S.) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), Sch. 35 para. 1(4) (as amended (31.12.2020) by S.I. 2020/1460, reg. 1(4), Sch. 3 para. 24(2))

[^key-3d57046adc0e3c4d6fc174acb0b0c11d]: Reg. 6A inserted (N.I.) (31.12.2020) by The Product Safety and Metrology etc. (Amendment) (Northern Ireland) (EU Exit) Regulations 2020 (S.I. 2020/1112), reg. 1(b), Sch. 17 para. 1(3)

[^key-80b50b5b2b8661b6f4161f37566f5809]: Pt. 4 inserted (N.I.) (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. 2 para. 15(2)

[^M_E_0a382ca4-3b12-439b-9074-11b7b6a35d46]: This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

[^M_E_037d06b9-3308-4dc0-d3a5-24b1f945a395]: This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

[^M_E_c4548e05-a4ec-4083-cd77-e5b9ea8a0918]: This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

[^M_E_2bbd338b-a9b7-45c0-b239-1d54e1729f1c]: This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

[^key-4eed5976afc58d54269b068b3675ce52]: Reg. 7(3) modified (S.) (1.2.2021) by The Personal Protective Equipment (Temporary Arrangements) (Coronavirus) (Scotland) Regulations 2021 (S.S.I. 2021/50), regs. 1, 4(2)(3) (with reg. 4(4))

[^key-87fe48c8e2f8464fdeb2662c829a51e7]: Reg. 7(1) modified (S.) (1.2.2021) by The Personal Protective Equipment (Temporary Arrangements) (Coronavirus) (Scotland) Regulations 2021 (S.S.I. 2021/50), regs. 1, 4(1) (with reg. 4(4))

[^key-ebfae42d76bdb8ca827c23c390666e51]: Words in reg. 1(2) omitted (E.W.S.) (1.10.2024) by virtue of The Product Safety and Metrology etc. (Amendment) Regulations 2024 (S.I. 2024/696), regs. 1(2), 21(2) (with reg. 23)

[^key-3982002c695df09e1759495b5362a996]: Reg. 2(5) omitted (E.W.S.) (1.10.2024) by virtue of The Product Safety and Metrology etc. (Amendment) Regulations 2024 (S.I. 2024/696), regs. 1(2), 21(3) (with reg. 23)

[^key-b6f78c2be71e37a70c652acce69e8ce6]: Reg. 2C substituted (E.W.S.) (1.10.2024) by The Product Safety and Metrology etc. (Amendment) Regulations 2024 (S.I. 2024/696), regs. 1(2), 21(4) (with reg. 23)

Obligations which are met by complying with obligations in Regulation 2016/425 (pre-exit)

2A

• (1) In this regulation, “harmonised standard” has the meaning in Article 3(10) of Regulation 2016/425 (pre-exit).

• (2) Paragraph (3) applies where before placing PPE on the market, the manufacturer—

• (a) ensures that the PPE has been designed and manufactured in accordance with the applicable essential health and safety requirements set out in Annex II of Regulation 2016/425 (pre-exit);

• (b) carries out the applicable conformity assessment procedure referred to in Article 19 of Regulation 2016/425 (pre-exit), or has it carried out;

• (c) draws up the technical documentation referred to in Annex III of Regulation 2016/425 (pre-exit);

• (d) ensures that the technical documentation and other records and correspondence relating to the conformity assessment procedures are prepared in, or translated into, English;

• (e) affixes a CE marking in accordance with Articles 16 and 17(1) to (4) of Regulation 2016/425 (pre-exit);

• (f) draws up an EU declaration of conformity, in accordance with Article 15 of Regulation 2016/425 (pre-exit); and

• (g) ensures that the EU declaration of conformity is prepared in, or translated into, English.

• (3) Where this paragraph applies—

• (a) the requirements of Articles 8(1) and (2), 15, 16, 17 and 19 are to be treated as being satisfied;

• (b) Articles 8(3), (4), (7) and (8), 9(2) and regulation 7(1) apply, subject to the modifications in paragraph (8);

• (c) Article 41 does not apply.

• (4) Paragraph (5) applies, where before placing PPE on the market, the importer ensures that—

• (a) the applicable conformity assessment procedure referred to in Article 19 of Regulation 2016/425 (pre-exit) has been carried out;

• (b) the manufacturer has drawn up the technical documentation referred to in Annex III of Regulation 2016/425 (pre-exit); and

• (c) the PPE bears the CE marking in accordance with Articles 16 and 17(1) to (4) of Regulation 2016/425 (pre-exit).

• (5) Where this paragraph applies—

• (a) the requirements in Article 10(2), to ensure that—

• (i) the appropriate conformity assessment procedure referred to in Article 19 has been carried out;

• (ii) the manufacturer has drawn up the technical documentation;

• (iii) the PPE bears the UK marking,

are to be treated as being satisfied; and

• (b) the second subparagraph of Article 10(2), Article 10(4), (5) and (8), and regulation 7(1) apply, subject to the modifications in paragraph (8).

• (6) Paragraph (7) applies where, before placing PPE on the market, a distributor ensures that the PPE bears the CE marking in accordance with Articles 16 and 17(1) to (4) of Regulation 2016/425 (pre-exit).

• (7) Where this paragraph applies—

• (a) the requirement for the distributor to verify that the PPE bears the UK marking, referred to in Article 11(2), is to be treated as being satisfied; and

• (b) (excluding the requirement mentioned in sub-paragraph (a)), Article 11(2), 11(3) and regulation 7(1) apply, subject to the modifications in paragraph (8).

• (8) The modifications referred to in subparagraphs (3)(b), (5)(b) and (7)(b) are that—

• (a) any reference to a “declaration of conformity” is to be read as a reference to an EU declaration of conformity, referred to in Article 15 of Regulation 2016/425 (pre-exit);

• (b) any reference to point 1.4 of Annex II is to be read as a reference to point 1.4 of Annex II of Regulation 2016/425 (pre-exit);

• (c) any reference to “essential health and safety requirements” is to be read as a reference to the essential health and safety requirements referred to in Annex II of Regulation 2016/425 (pre-exit);

• (d) any reference to “designated standard” is to be read as a reference to a harmonised standard;

• (e) any reference to “technical documentation” is a reference to the technical documentation referred to in Annex III of Regulation 2016/425 (pre-exit);

• (f) in regulation 7(1), any reference to a numbered Article is to be read as a reference to the equivalent Article of Regulation 2016/425 (pre-exit).

Conformity assessment procedure obligation which is met by complying with Regulation 2016/425 (pre-exit)

2B

• (1) Paragraph (2) applies where—

• (a) PPE is classified under Article 18 of Regulation 2016/425 (pre-exit) as falling within risk category II or risk category III, as set out in Annex I to Regulation 2016/425 (pre-exit); and

• (b) prior to manufacture of that PPE, the manufacturer ensures that the conformity assessment procedure set out in Annex V to Regulation 2016/425 (pre-exit), and referred to in Article 19(b) and (c) of Regulation 2016/425 (pre-exit) as EU type-examination, has been carried out in accordance with Article 19(b) or (c).

• (2) Where this paragraph applies—

• (a) the requirement in Article 19(b) or (c) to follow the conformity assessment procedure referred to in those provisions as type-examination, and set out in Annex V, is to be treated as being satisfied;

• (b) any reference to “conformity assessment procedure” in Articles 8(2) and 10(2) is to be read as including the conformity assessment procedure referred to in Article 19(b) and (c) of Regulation 2016/425 (pre-exit) as EU type-examination;

• (c) any reference to “technical documentation” in Articles 8(2), 8(3), 10(2) and 10(8) is to be read as including the technical documentation relating to the design of the PPE as referred to in Annex V to Regulation 2016/425 (pre-exit).

Expiry of regulations 2A and 2B

2C

• (1) In this regulation “harmonised standard” has the meaning given to it in Article 3(10) of Regulation 2016/425 (pre-exit).

• (2) Paragraph (3) applies where, before placing PPE on the market, the manufacturer—

• (a) ensures that the PPE has been designed and manufactured in accordance with the applicable essential health and safety requirements set out in Annex II of Regulation 2016/425 (pre-exit);

• (b) carries out the applicable conformity assessment procedure referred to in Article 19 of Regulation 2016/425 (pre-exit) or has it carried out;

• (c) draws up the technical documentation referred to in Annex III of Regulation 2016/425 (pre-exit); and

• (d) ensures that the technical documentation and other records and correspondence relating to the conformity assessment procedures are prepared in, or translated into, English.

• (3) Where this paragraph applies—

• (a) Article 8(1) and the first subparagraph of Article 8(2) are to be treated as being satisfied;

• (b) Articles 14, 17(3), 18 and 19 do not apply;

• (c) the following provisions of Article 8 apply subject to the modifications in paragraph (4)—

• (i) Article 8(2), second subparagraph;

• (ii) Article 8(3);

• (iii) Article 8(4);

• (iv) Article 8(7);

• (d) Articles 9, 10(2), (5) and (8), 11(2) and (3), 15, 17 and 41 and Annex IX apply subject to the modifications in paragraph (4).

• (4) The modifications referred to in paragraph (3)(c) and (d) are that—

• (a) any reference to “essential health and safety requirements” is to be read as a reference to the essential health and safety requirements referred to in Annex II of Regulation 2016/425 (pre-exit);

• (b) any reference to “designated standard” is to be read as a reference to a harmonised standard;

• (c) any reference to “technical documentation” is to be read as a reference to the technical documentation referred to in Annex III of Regulation 2016/425 (pre-exit);

• (d) any reference to point 1.4 of Annex II is to be read as a reference to point 1.4 of Annex II of Regulation 2016/425 (pre-exit);

• (e) any reference to “appropriate conformity assessment procedure” or “appropriate procedure” is to be read as a reference to the conformity assessment procedure applicable to the PPE in accordance with Article 19 of Regulation 2016/425 (pre-exit);

• (f) in Article 15 the references to “enactment” are to be read as including Regulation 2016/425 (pre-exit);

• (g) Article 17(4) is to be read as if the words beginning with “and” and ending with “body” were omitted;

• (h) in Annex IX—

• (i) in paragraph 5 the reference to “relevant statutory requirements” is to be read as including Regulation 2016/425 (pre-exit);

• (ii) paragraph 7 is to be read as requiring the manufacturer to include the details set out in paragraph 7 of Annex IX to Regulation 2016/425 (pre-exit).

Qualifying Northern Ireland Goods

2D

• (1) In this regulation—

• “EU Regulation 2016/425 (Northern Ireland)” means Regulation (EU) No. 2016/425 of March 2016 of March 2016 of the European Parliament and of the Council on personal protective equipment, repealing Council Directive 89/686/EEC, as it has effect by virtue of the Protocol on Ireland/Northern Ireland in the EU withdrawal agreement;

• “applicable conformity assessment procedure” means the conformity assessment procedure applicable to the PPE in accordance with Article 19 of EU Regulation 2016/245 (Northern Ireland);

• “CE marking” has the meaning given to it in Article 3(18) of EU Regulation 2016/425 (Northern Ireland);

• “qualifying Northern Ireland goods” has the meaning given to it in regulations made under section 8C(6) of the European Union (Withdrawal) Act 2018;

• “technical documentation” means the documentation referred to in Annex III of Regulation 2016/425 (Northern Ireland).

• (2) Where paragraph (3) applies—

• (a) PPE is to be treated as being in conformity with the essential safety requirements within the meaning given in EU Regulation 2016/425; and

• (b) each relevant economic operator is to be treated as having complied or as complying with the obligations imposed on them under Chapter II of EU Regulation 2016/425.

• (3) This paragraph applies where—

• (a) PPE is—

• (i) in conformity with the essential requirements within the meaning given in EU Regulation 2016/245 (Northern Ireland); and

• (ii) qualifying Northern Ireland goods; and

• (b) each relevant economic operator has complied or is complying with the obligations imposed on them under Chapter II of EU Regulation 2016/425 (Northern Ireland); and

• (c) an importer has complied with the obligations set out in paragraph (4).

• (4) The obligations referred to in paragraph (3)(c) are that, before placing the PPE on the market, the importer—

• (a) complies with Article 10(3) of EU Regulation 2016/425;

• (b) ensures that—

• (i) the applicable conformity assessment procedure has been carried out in relation to the PPE;

• (ii) the manufacturer has drawn up the technical documentation; and

• (iii) the PPE bears the CE marking.

Information obligations

6A

• (1) Nothing in EU Regulation 2016/425 requires any market surveillance authority or the Secretary of State to inform the Commission or member States of any matter in relation to PPE on the market of Great Britain only.

Offences

Penalties

Defence of due diligence

Liability of persons other than the principal offender

Time limit for prosecution of offences

Written notice under Article 38 and service of documents

Appeals against notices

Appropriate court for appeals against notices etc and further appeals

Compensation

Recovery of expenses of enforcement

Action by enforcement authority

PART 4 — Provisions in respect of the UK(NI) indication

Interpretation

20

In this Part “UK(NI) indication” means the marking in the form set out in Schedule 1 to the Product Safety and Metrology etc. (Amendment etc.) (UK(NI) Indication) (EU Exit) Regulations 2020.

UK(NI) indication

21

• (1) Where the CE marking is affixed on the basis of an assessment or a certificate issued by a notified body established in the United Kingdom, a UK(NI) indication must be affixed in relation to the PPE, in accordance with this regulation.

• (2) The UK(NI) indication must be affixed—

• (a) visibly, legibly and indelibly; and

• (b) before PPE is placed on the market in Northern Ireland.

• (3) The UK(NI) indication must accompany the CE marking, wherever that is affixed in accordance with Article 17.

• (4) The UK(NI) indication must be affixed by—

• (a) the manufacturer; or

• (b) the manufacturer's authorised representative.

• (5) When placing PPE on the market in Northern Ireland, an importer must ensure that the manufacturer has complied with their obligations under this regulation.

United Kingdom notified bodies

22

• (1) The reference in Article 28(5) to “objections” does not include objections on the grounds that—

• (a) the conformity assessment body is established in the United Kingdom; or

• (b) the accreditation certificate was issued by the United Kingdom's national accreditation body.

• (2) Where a notified body established in the United Kingdom is involved in a conformity assessment procedure pursuant to Article 19, the notified body identification number referred to in Article 17(3) is the notified body identification number assigned to the notified body pursuant to regulation 23.

Register of notified bodies established in the United Kingdom

23

• (1) The Secretary of State must ensure that—

• (a) each notified body established in the United Kingdom is assigned an identification number; and

• (b) there is a register of—

• (i) notified bodies established in the United Kingdom;

• (ii) their notified body identification number;

• (iii) the activities for which they have been notified;

• (iv) any restrictions on those activities.

• (2) The Secretary of State must ensure that the register referred to in paragraph (1) is maintained and made publicly available.

• (3) The Secretary of State may authorise the United Kingdom Accreditation Service to compile and maintain the register in accordance with paragraph (1)(b).

Offence in relation to the UK(NI) indication

24

• (1) Where an enforcement authority finds that the UK(NI) indication—

• (a) has not been affixed, in contravention of regulation 21; or

• (b) has been affixed otherwise in accordance with regulation 21

it must require a manufacturer to put an end to the non-compliance within such reasonable period as the authority specifies.

• (2) Until the specified period has elapsed, the enforcement authority must not commence proceedings under these Regulations, or take any other enforcement action under these Regulations, against the manufacturer in respect of the non-compliance referred to in paragraph (1).

• (3) Where the non-compliance referred to in paragraph (1) persists beyond the specified period, the enforcement authority must take appropriate measures to—

• (a) restrict or prohibit the PPE being available on the market;

• (b) ensure that the PPE is withdrawn;

• (c) ensure that the PPE is recalled.

• (4) It is an offence for any person to contravene or fail to comply with any requirement of a withdrawal or recall notice that relates to the UK(NI) indication served on that person under these Regulations.

• (5) A person guilty of an offence under paragraph (4) shall be liable on summary conviction to a fine not exceeding level 5 on the standard scale.

• (6) This regulation does not apply where PPE presents a risk.

Further use of UK marking