http://www.legislation.gov.uk/uksi/2018/390The Personal Protective Equipment (Enforcement) Regulations 2018texttext/xmlenCONSUMER PROTECTIONHEALTH AND SAFETYStatute Law Database2024-10-04Expert Participation2024-10-01 These Regulations provide for the enforcement of Regulation (EU) 2016/425 of the European Parliament and of the Council of 9 March 2016 on personal protective equipment (OJ No L81, 31.3.2016, p51) (“EU Regulation 2016/425”). The Personal Protective Equipment (Enforcement) Regulations 2018reg. 2(4)The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019Sch. 35 para. 1(3)(a)reg. 1The Personal Protective Equipment (Enforcement) Regulations 2018reg. 2(4A)The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019Sch. 35 para. 1(3)(b)reg. 1The Personal Protective Equipment (Enforcement) Regulations 2018reg. 2(5)The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019Sch. 35 para. 1(3)(c)(i)reg. 1The Personal Protective Equipment (Enforcement) Regulations 2018reg. 2(5)The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019Sch. 35 para. 1(3)(c)(ii)reg. 1The Personal Protective Equipment (Enforcement) Regulations 2018reg. 2(5A)The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019Sch. 35 para. 1(3)(d)reg. 1The Personal Protective Equipment (Enforcement) Regulations 2018reg. 20The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019Sch. 35 para. 1(8)reg. 1The Personal Protective Equipment (Enforcement) Regulations 2018Sch. 6The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019Sch. 35 para. 1(9)reg. 1 2018 No. 390Consumer ProtectionHealth And SafetyThe Personal Protective Equipment (Enforcement) Regulations 2018Made20th March 2018Laid before Parliament21st March 2018Coming into force21st April 2018The Secretary of State is a Minister designated for the purposes of section 2(2) of the European Communities Act 1972 (“the 1972 Act”) in relation to measures relating to safety as regards personal protective equipment.These Regulations make provision for a purpose mentioned in section 2(2) of the 1972 Act and it appears to the Secretary of State that it is expedient for certain references to provisions of EU instruments to be construed as references to those provisions as amended from time to time.The Secretary of State makes the following Regulations in exercise of the powers conferred by section 2(2) of, and paragraph 1A of Schedule 2 to, the 1972 Act.PART 1PreliminaryCitation, commencement and interpretation11These Regulations may be cited as the Personal Protective Equipment (Enforcement) Regulations 2018 and come into force on 21st April 2018.2In these Regulations—“the 1974 Act” means the Health and Safety at Work etc. Act 1974 ;“the 1978 Order” means the Health and Safety at Work (Northern Ireland) Order 1978 ;“the 1987 Act” means the Consumer Protection Act 1987 ;“the 2002 Regulations” means the Personal Protective Equipment Regulations 2002 ;“district council” means a district council within the meaning of the Local Government Act (Northern Ireland) 1972 ;“EU Regulation 2016/425” means Regulation (EU) No 2016/425 of the European Parliament and of the Council on personal protective equipment, repealing Council Directive 89/686/EEC , as amended from time to time;“RAMS” means Regulation (EC) No 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) No 339/93 , as amended from time to time;“risk” means a risk which may result in harm to the health or safety of persons, domestic animals or property, if personal protective equipment (“PPE”) is used in a normal and predictable manner; and“weights and measures authority” means a local weights and measures authority within the meaning set out in section 69 of the Weights and Measures Act 1985 .3In these Regulations a reference to—aa numbered regulation, paragraph or Schedule is a reference to the regulation, paragraph or Schedule as numbered in these Regulations unless otherwise stated;ban Article, paragraph of an Article or Annex is a reference to the Article, paragraph of an Article or Annex as numbered in EU Regulation 2016/425;ca “relevant economic operator” in relation to PPE means an economic operator with obligations in respect of PPE under EU Regulation 2016/425; anddan “enforcement authority” is to be construed in accordance with regulation 4.4Expressions and words used in these Regulations which are used in EU Regulation 2016/425 have the same meaning as in EU Regulation 2016/425.Application, transitional provisions, savings and revocation21These Regulations apply to PPE placed on the market on or after 21st April 2018.2These Regulations do not apply to PPE—adesigned for the uses specified in Article 2(2)(a) to (d); orbthat falls within Article 2(2)(e).3Nothing in these Regulations prevents the showing of PPE at trade fairs, exhibitions, demonstrations or the like, which is not in compliance with the provisions of EU Regulation 2016/425, provided that a visible sign clearly indicates that such PPE does not comply with those provisions and that it is not for sale until it is made compliant.4The 2002 Regulations continue to apply, as if they had not been revoked, to PPE placed on the market before 21st April 2019 , and in any such case the consequential amendments made by Schedule 5 do not apply.5If, before 21st April 2019—aan EC type-examination certificate is issued by an approved body under the 2002 Regulations, pursuant to the EC type-examination procedure set out in Schedule 7 to those Regulations, orban approval decision is made under, and in accordance with, Part B of Schedule 8 (system for ensuring EC quality of production by means of monitoring) to the 2002 Regulations,that certificate or decision remains valid until 21st April 2023 , or until its' expiry date if earlier, for the purpose of satisfying the requirements of an EU declaration of conformity set out in paragraphs 7 or 8 of Annex IX.6The 2002 Regulations are revoked save to the extent required to give effect to paragraphs (4) and (5).<Addition ChangeId="key-00615240097a42b09f2996fb1248b834-1661337582524" CommentaryRef="key-00615240097a42b09f2996fb1248b834" Extent="E+W+S">Obligations which are met by complying with obligations in Regulation 2016/425 (pre-exit)</Addition>2A1In this regulation, “harmonised standard” has the meaning in Article 3(10) of Regulation 2016/425 (pre-exit).2Paragraph (3) applies where before placing PPE on the market, the manufacturer—aensures 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);bcarries out the applicable conformity assessment procedure referred to in Article 19 of Regulation 2016/425 (pre-exit), or has it carried out;cdraws up the technical documentation referred to in Annex III of Regulation 2016/425 (pre-exit);densures that the technical documentation and other records and correspondence relating to the conformity assessment procedures are prepared in, or translated into, English;eaffixes a CE marking in accordance with Articles 16 and 17(1) to (4) of Regulation 2016/425 (pre-exit);fdraws up an EU declaration of conformity, in accordance with Article 15 of Regulation 2016/425 (pre-exit); andgensures that the EU declaration of conformity is prepared in, or translated into, English.3Where this paragraph applies—athe requirements of Articles 8(1) and (2), 15, 16, 17 and 19 are to be treated as being satisfied;bArticles 8(3), (4), (7) and (8), 9(2) and regulation 7(1) apply, subject to the modifications in paragraph (8);cArticle 41 does not apply.4Paragraph (5) applies, where before placing PPE on the market, the importer ensures that—athe applicable conformity assessment procedure referred to in Article 19 of Regulation 2016/425 (pre-exit) has been carried out;bthe manufacturer has drawn up the technical documentation referred to in Annex III of Regulation 2016/425 (pre-exit); andcthe PPE bears the CE marking in accordance with Articles 16 and 17(1) to (4) of Regulation 2016/425 (pre-exit).5Where this paragraph applies—athe requirements in Article 10(2), to ensure that—ithe appropriate conformity assessment procedure referred to in Article 19 has been carried out;iithe manufacturer has drawn up the technical documentation;iiithe PPE bears the UK marking,are to be treated as being satisfied; andbthe second subparagraph of Article 10(2), Article 10(4), (5) and (8), and regulation 7(1) apply, subject to the modifications in paragraph (8).6Paragraph (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).7Where this paragraph applies—athe 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; andb(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).8The modifications referred to in subparagraphs (3)(b), (5)(b) and (7)(b) are that—aany 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);bany 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);cany 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);dany reference to “designated standard” is to be read as a reference to a harmonised standard;eany reference to “technical documentation” is a reference to the technical documentation referred to in Annex III of Regulation 2016/425 (pre-exit);fin 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).<Addition ChangeId="key-00615240097a42b09f2996fb1248b834-1661337582524" CommentaryRef="key-00615240097a42b09f2996fb1248b834" Extent="E+W+S">Conformity assessment procedure obligation which is met by complying with Regulation 2016/425 (pre-exit)</Addition>2B1Paragraph (2) applies where—aPPE 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); andbprior 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).2Where this paragraph applies—athe 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;bany 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;cany 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). <Addition ChangeId="key-8a9279864b0459b25ddeb61b3dfb46e9-1661337675780" CommentaryRef="key-8a9279864b0459b25ddeb61b3dfb46e9" Extent="E+W+S"><Substitution ChangeId="key-b6f78c2be71e37a70c652acce69e8ce6-1728056979141" CommentaryRef="key-b6f78c2be71e37a70c652acce69e8ce6">Further use of UK marking</Substitution></Addition>2C1In this regulation “harmonised standard” has the meaning given to it in Article 3(10) of Regulation 2016/425 (pre-exit).2Paragraph (3) applies where, before placing PPE on the market, the manufacturer—aensures 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);bcarries out the applicable conformity assessment procedure referred to in Article 19 of Regulation 2016/425 (pre-exit) or has it carried out;cdraws up the technical documentation referred to in Annex III of Regulation 2016/425 (pre-exit); anddensures that the technical documentation and other records and correspondence relating to the conformity assessment procedures are prepared in, or translated into, English.3Where this paragraph applies—aArticle 8(1) and the first subparagraph of Article 8(2) are to be treated as being satisfied;bArticles 14, 17(3), 18 and 19 do not apply;cthe following provisions of Article 8 apply subject to the modifications in paragraph (4)—iArticle 8(2), second subparagraph;iiArticle 8(3);iiiArticle 8(4);ivArticle 8(7);dArticles 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).4The modifications referred to in paragraph (3)(c) and (d) are that—aany 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);bany reference to “designated standard” is to be read as a reference to a harmonised standard;cany 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);dany 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);eany 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);fin Article 15 the references to “enactment” are to be read as including Regulation 2016/425 (pre-exit);gArticle 17(4) is to be read as if the words beginning with “and” and ending with “body” were omitted;hin Annex IX—iin paragraph 5 the reference to “relevant statutory requirements” is to be read as including Regulation 2016/425 (pre-exit);iiparagraph 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).<Addition ChangeId="key-8a9279864b0459b25ddeb61b3dfb46e9-1661337675780" CommentaryRef="key-8a9279864b0459b25ddeb61b3dfb46e9" Extent="E+W+S">Qualifying Northern Ireland Goods</Addition>2D1In 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).2Where paragraph (3) applies—aPPE is to be treated as being in conformity with the essential safety requirements within the meaning given in EU Regulation 2016/425; andbeach 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 2016/425.3This paragraph applies where—aPPE is—iin conformity with the essential requirements within the meaning given in EU Regulation 2016/245 (Northern Ireland); andiiqualifying Northern Ireland goods; andbeach relevant economic operator has complied or is complying with the obligations imposed on them under Chapter II of EU Regulation 2016/425 (Northern Ireland); andcan importer has complied with the obligations set out in paragraph (4).4The obligations referred to in paragraph (3)(c) are that, before placing the PPE on the market, the importer—acomplies with Article 10(3) of EU Regulation 2016/425;bensures that—ithe applicable conformity assessment procedure has been carried out in relation to the PPE;iithe manufacturer has drawn up the technical documentation; andiiithe PPE bears the CE marking.PART 2Market Surveillance and EnforcementDesignation of market surveillance authorities31The market surveillance authority is—ain the case of PPE for private use or consumption (other than that referred to in paragraph (2)(b))—iin Great Britain, within its area, a weights and measures authority; andiiin Northern Ireland, within its area, a district council;bin the case of PPE for use or operation in the circumstances set out in paragraph (2)—isubject to paragraph (3), in Great Britain, the Health and Safety Executive; andiiin Northern Ireland, the Health and Safety Executive for Northern Ireland.2The circumstances referred to in paragraphs (1)(b) are where the PPE is designed—afor use or operation, whether exclusively or not, by persons at work; orbfor use, otherwise than at work, in non-domestic premises made available to persons at a place where they may use the PPE provided for their own use there.3In so far as these Regulations apply to PPE intended exclusively or primarily for use on relevant nuclear sites, the market surveillance authority is the Office for Nuclear Regulation.4In paragraph (3) “relevant nuclear site” means a site which is—aa GB nuclear site (within the meaning given in section 68 of the Energy Act 2013 );ban authorised defence site (within the meaning given in regulation 2(1) of the Health and Safety (Enforcing Authority) Regulations 1998 ); orca new nuclear build site (within the meaning given in regulation 2A of those Regulations ).Enforcement Authorities41Subject to paragraph (2), EU Regulation 2016/425, these Regulations and RAMS (in its application to PPE) must be enforced by the market surveillance authority.2Notwithstanding paragraph (1), the Secretary of State may enforce EU Regulation 2016/425, these Regulations and RAMS (in its application to PPE).3In Scotland only the Lord Advocate may commence proceedings for an offence under these Regulations.Enforcement Powers51Schedule 1 makes provision for enforcement powers under the 1987 Act where the enforcement authority is—aa weights and measures authority;ba district council; orcthe Secretary of State.2Schedule 2 makes provision for enforcement powers under the 1974 Act where the enforcement authority is the Health and Safety Executive or the Office for Nuclear Regulation.3Schedule 3 makes provision for enforcement powers under the 1978 Order where the enforcement authority is the Health and Safety Executive for Northern Ireland.4In addition to the powers available to an enforcement authority by virtue of paragraph (1), (2) or (3), as appropriate, the enforcement authority may use the powers in Schedule 4 (compliance, withdrawal and recall notices).Notification to the Secretary of State of enforcement action etc6A market surveillance authority must immediately notify the Secretary of State of any action taken by it, evaluation made or other opinion formed by it, in accordance with Chapter 6.<Addition ChangeId="key-3d57046adc0e3c4d6fc174acb0b0c11d-1661337782917" CommentaryRef="key-3d57046adc0e3c4d6fc174acb0b0c11d" Extent="N.I.">Information obligations</Addition>6A1Nothing 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.Offences71It is an offence for an economic operator to contravene the requirements and obligations set out in—aArticle 8 (obligations of manufacturers);bArticle 10 (obligations of importers);cArticle 11 (obligations of distributors);dArticle 13 (identification of economic operators);eArticle 16 (general principles of UK marking); andfArticle 17 (rules and conditions for affixing the UK marking).2It is an offence for an economic operator to fail to—acooperate with;bprovide information to; andccomply with any of the requirements of,the market surveillance authority acting under Article 38.3It is an offence for an economic operator to fail to take the action required under—aArticle 40 (compliant PPE which presents a risk); orbArticle 41 (formal non-compliance).4It is an offence for a person—ato intentionally obstruct an enforcement authority acting in the execution or enforcement of EU Regulation 2016/425;bwithout reasonable cause, to fail to give such an enforcement authority any assistance or information which that person may reasonably require for those purposes;cto knowingly or recklessly furnish to such an enforcement authority any information knowing it to be false or misleading in a material particular; ordto fail to produce a document or record for such an enforcement authority when required to do so.5Proceedings must not be commenced against an economic operator under paragraph (1), (2) or (3) if the economic operator has been given a time period within which to comply or take action, and that time period has not expired.Penalties8A person guilty of an offence under these Regulations is liable on summary conviction—ain England and Wales, to a fine or imprisonment for a term not exceeding three months, or to both;bin Scotland and Northern Ireland, to a fine not exceeding level 5 on the standard scale or imprisonment for a term not exceeding three months, or to both;Defence of due diligence91In proceedings for an offence under these Regulations, it is a defence for a person (“P”) to show that P took all reasonable steps and exercised all due diligence to avoid committing the offence.2P may not rely on a defence under paragraph (1) which involves a third party allegation unless P has—aserved notice in accordance with paragraph (3); orbobtained leave of the court.3The notice must—agive any information in the possession of P which identifies or assists in identifying the person who—iis alleged to have committed the act or default; oriisupplied the information on which P relies; andbbe served on the person bringing the proceedings not less than seven clear days before—ithe hearing of the proceedings in England, Wales and Northern Ireland;iithe trial date in Scotland.4P may not rely on a defence under paragraph (1) which involves an allegation that the commission of the offence was due to reliance on information supplied by another person unless it was reasonable in all the circumstances to have relied on the information, having regard in particular to—athe steps that P took, and those which might reasonably have been taken, for the purpose of verifying the information; andbwhether P had any reason to disbelieve the information.5In this regulation, “third party allegation” means an allegation that the commission of the offence was due to—athe act or default of another person; orbreliance on information supplied by another person.Liability of persons other than the principal offender101Where the commission by a person (“P”) of an offence under these Regulations is due to anything which another person (“S”) did or failed to do in the course of business, S is guilty of that offence and may be proceeded against and punished, whether or not proceedings are taken against P.2Where a body corporate commits an offence under these Regulations, a relevant person is also guilty of the offence where the offence was committed by the body corporate—awith the consent or connivance of a relevant person; orbas a result of the negligence of a relevant person.3In paragraph (2) a “relevant person” means—aa director, manager, secretary or other similar officer of the body corporate;bin relation to a body corporate managed by its members, a member of that body performing managerial functions;ca partner in relation to a Scottish partnership; orda person purporting to act as a person described in subparagraphs (a), (b) or (c).Time limit for prosecution of offences111In England and Wales an information relating to an offence under these Regulations that is triable by a magistrates' court may be so tried if it is laid within 12 months after the date on which evidence sufficient in the opinion of the prosecutor to justify the proceedings comes to the knowledge of the prosecutor.2In Scotland—asummary proceedings for an offence may only be commenced within 12 months after the date on which evidence sufficient in the Lord Advocate's opinion to justify the proceedings came to the Lord Advocate's knowledge, andbsection 136(3) of the Criminal Procedure (Scotland) Act 1995 (time limit for certain offences) applies for the purpose of this paragraph as it applies for the purpose of that section.3In Northern Ireland summary proceedings for an offence may be instituted within 12 months after the date on which evidence sufficient in the opinion of the prosecutor to justify proceedings comes to the knowledge of the prosecutor.4No proceedings are to be brought more than three years after the commission of the offence.5For the purposes of this regulation a certificate of the prosecutor (or in Scotland, the Lord Advocate) as to the date on which such evidence as is referred to above came to their notice is conclusive evidence of that fact.6This regulation has effect subject to paragraph (1)(n) of Schedule 2 (enforcement powers of the Health and Safety Executive and the Office for Nuclear Regulation under the 1974 Act) and to paragraph (1)(n) of Schedule 3 (enforcement powers of the Health and Safety Executive for Northern Ireland under the 1978 Order).Written notice under Article 38 and service of documents121In a case falling within Article 38 (procedure at national level for dealing with PPE presenting a risk), a market surveillance authority must provide notice when requiring the economic operator to, within a reasonable period—atake appropriate corrective action;bwithdraw the PPE from the market in Northern Ireland ; orcrecall the PPE.2The notice given under paragraph (1) must—agive reasons for the action required;bprovide a time limit for compliance; andcbe served in accordance with paragraphs (3) to (6).3Any document required or authorised by EU Regulation 2016/425 or these Regulations to be served on a person may be served by—idelivering it to that person in person;iileaving it at the person's proper address; oriiisending it by post or electronic means to that person's proper address.4In the case of a body corporate, a document may be served on a director of that body.5In the case of a partnership, a document may be served on a partner or person having control or management of the partnership business.6If a person has specified an address in the United Kingdom (other than that person's proper address) at which that person or someone on that person's behalf will accept service, that address must also be treated as that person's proper address.7For the purposes of this regulation “proper address” means—ain the case of a body corporate or its director—ithe registered or principal office of that body; oriithe email address of the secretary or clerk of that body;bin the case of a partnership, a partner or person having control or management of the partnership business—ithe principal office of the partnership; oriithe email address of a partner or a person having that control or management;cin any other case, a person's last known address, which includes an email address.8In this regulation, “partnership” includes a Scottish partnership.Appeals against notices131An application for an order to vary the terms of, or set aside, a notice served under regulation 5 (enforcement powers) or 12 (Article 38 notices) may be made—aby the economic operator on whom the notice has been served; andbin the case of a notice other than a recall notice, by a person having an interest in the PPE in respect of which the notice has been served.2An application must be made before the end of the period of 21 days beginning with the day on which the notice was served.3The appropriate court may only make an order setting aside a notice served under regulation 5 or 12 if satisfied—athat no contravention of EU Regulation 2016/425 or these Regulations has occurred; orbthat the enforcement authority failed to comply with Article 14 (presumption of conformity of PPE) when serving the notice.4On an application to vary the terms of the notice, the appropriate court may vary the terms of the notice as it considers appropriate.5In this regulation—a“the appropriate court” is to be determined in accordance with regulation 14; andb“notice” means—ia notice served under regulation 12;iia prohibition notice, a notice to warn or a suspension notice served in accordance with Schedule 1; oriiia compliance notice, a withdrawal notice, or a recall notice served in accordance with Schedule 4.Appropriate court for appeals against notices etc and further appeals141In England and Wales, or Northern Ireland, the appropriate court for the purposes of regulation 13 is—athe court in which proceedings have been brought for an offence under regulation 7 (offences);ban employment tribunal seized of appeal proceedings against a notice which relates to PPE which has been served under or by virtue of paragraph 1 of Schedule 2;can industrial tribunal seized of appeal proceedings against a notice which relates to PPE which has been served under or by virtue of paragraph 1 of Schedule 3 (enforcement powers of the Health and Safety Executive for Northern Ireland under the 1978 Order); ordin any other case, a magistrates' court in England and Wales, or Northern Ireland.2In Scotland the appropriate court for the purposes of regulation 13 is—athe sheriff of a sheriffdom in which the person making the appeal resides or, as the case may be, has a registered or principal office; orban employment tribunal seized of appeal proceedings against a notice which relates to PPE which has been served under or by virtue of paragraph 1 of Schedule 2.3A person aggrieved by an order made by a magistrates' court in England and Wales, or Northern Ireland, pursuant to an application under regulation 13, or by a decision of such a court not to make such an order, may appeal against that order or decision—ain England and Wales, to the Crown Court;bin Northern Ireland, to the county court.Compensation151Where an enforcement authority other than the Health and Safety Executive, the Health and Safety Executive of Northern Ireland or the Office for Nuclear Regulation, serves a relevant notice in respect of PPE, that authority is liable to pay compensation to a person having an interest in the PPE in respect of any loss or damage caused by reason of the notice if both conditions mentioned in paragraph (2) are met.2The conditions are that—athe PPE in respect of which the relevant notice was served neither—ipresents a risk; noriicontravenes any requirement of EU regulation 2016/425; andbany neglect or default on the part of the economic operator was not the reason for service of the relevant notice.3In this regulation, “relevant notice” means a suspension, withdrawal or recall notice as referred to in regulation 13(5)(b).Recovery of expenses of enforcement161This regulation applies where a person commits an offence under regulation 7 (offences).2The court may (in addition to any other order it may make as to costs or expenses) order the person to reimburse the enforcement authority for any expenditure which the authority has reasonably incurred in investigating the offence.Action by enforcement authority171An enforcement authority may itself take any action which an economic operator could have been required to take by a notice served under regulation 5 (enforcement powers) where the conditions for serving such a notice are met and either—athe enforcement authority has been unable to identify any economic operator on whom to serve such a notice; orbthe economic operator on whom such a notice has been served has failed to comply with it.2If the enforcement authority has taken action under paragraph (1) following the failure of an economic operator to comply with a notice, the authority may recover from that person as a civil debt any costs or expenses incurred by the enforcement authority in taking the action.3A civil debt recoverable under paragraph (2) may be recovered summarily—ain England and Wales, by way of a complaint pursuant to section 58 of the Magistrates' Courts Act 1980;bin Northern Ireland, in proceedings under Article 62 of the Magistrates' Court (Northern Ireland) Order 1981.PART 3MiscellaneousReview and consequential amendments181The Secretary of State must—acarry out a review of the regulatory provision contained in these Regulations; andbpublish a report setting out the conclusions of that review.2In carrying out the review the Secretary of State must, so far as is reasonable, have regard to how EU Regulation 2016/425 (which is enforced and supplemented by means of these Regulations) is executed and enforced in other member States.3The first report must be published before the end of the period of five years beginning with the day on which these Regulations come into force.4Subsequent reports under this regulation are to be published at intervals not exceeding five years.5Section 30(4) of Small Business, Enterprise and Employment Act 2015 requires that the reports published under this regulation must, in particular—aset out the objectives intended to be achieved by the regulatory provision referred to in paragraph (1)(a),bassess the extent to which those objectives are achieved,cassess whether those objectives remain appropriate, anddif those objectives remain appropriate, assess the extent to which they could be achieved in another way which involves less onerous regulatory provision.6In this regulation, “regulatory provision” has the same meaning as in sections 28 to 32 of the 2015 Act (see section 32 of that Act).<P1 DocumentURI="http://www.legislation.gov.uk/uksi/2018/390/regulation/19" IdURI="http://www.legislation.gov.uk/id/uksi/2018/390/regulation/19" id="regulation-19"><Pnumber>19</Pnumber><P1para><Text>Schedule 5 (consequential amendments) makes amendments to legislation which are consequential to these Regulations (subject to regulation 2(4)).</Text></P1para></P1></P1group></Part><Part DocumentURI="http://www.legislation.gov.uk/uksi/2018/390/part/4" IdURI="http://www.legislation.gov.uk/id/uksi/2018/390/part/4" NumberOfProvisions="5" id="part-4" RestrictExtent="N.I." RestrictStartDate="2020-12-31"><Number><Strong><Addition ChangeId="key-80b50b5b2b8661b6f4161f37566f5809-1661337878741" CommentaryRef="key-80b50b5b2b8661b6f4161f37566f5809" Extent="N.I.">PART 4</Addition></Strong></Number><Title><Addition ChangeId="key-80b50b5b2b8661b6f4161f37566f5809-1661337878741" CommentaryRef="key-80b50b5b2b8661b6f4161f37566f5809" Extent="N.I.">Provisions in respect of the UK(NI) indication</Addition><Addition ChangeId="key-80b50b5b2b8661b6f4161f37566f5809-1661337878741" CommentaryRef="key-80b50b5b2b8661b6f4161f37566f5809" Extent="N.I.">Interpretation</Addition>20In 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.<Addition ChangeId="key-80b50b5b2b8661b6f4161f37566f5809-1661337878741" CommentaryRef="key-80b50b5b2b8661b6f4161f37566f5809" Extent="N.I.">UK(NI) indication</Addition>211Where 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.2The UK(NI) indication must be affixed—avisibly, legibly and indelibly; andbbefore PPE is placed on the market in Northern Ireland.3The UK(NI) indication must accompany the CE marking, wherever that is affixed in accordance with Article 17.4The UK(NI) indication must be affixed by—athe manufacturer; orbthe manufacturer's authorised representative.5When placing PPE on the market in Northern Ireland, an importer must ensure that the manufacturer has complied with their obligations under this regulation.<Addition ChangeId="key-80b50b5b2b8661b6f4161f37566f5809-1661337878741" CommentaryRef="key-80b50b5b2b8661b6f4161f37566f5809" Extent="N.I.">United Kingdom notified bodies</Addition>221The reference in Article 28(5) to “objections” does not include objections on the grounds that—athe conformity assessment body is established in the United Kingdom; orbthe accreditation certificate was issued by the United Kingdom's national accreditation body.2Where 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.<Addition ChangeId="key-80b50b5b2b8661b6f4161f37566f5809-1661337878741" CommentaryRef="key-80b50b5b2b8661b6f4161f37566f5809" Extent="N.I.">Register of notified bodies established in the United Kingdom</Addition>231The Secretary of State must ensure that—aeach notified body established in the United Kingdom is assigned an identification number; andbthere is a register of—inotified bodies established in the United Kingdom;iitheir notified body identification number;iiithe activities for which they have been notified;ivany restrictions on those activities.2The Secretary of State must ensure that the register referred to in paragraph (1) is maintained and made publicly available.3The Secretary of State may authorise the United Kingdom Accreditation Service to compile and maintain the register in accordance with paragraph (1)(b).<Addition ChangeId="key-80b50b5b2b8661b6f4161f37566f5809-1661337878741" CommentaryRef="key-80b50b5b2b8661b6f4161f37566f5809" Extent="N.I.">Offence in relation to the UK(NI) indication</Addition>241Where an enforcement authority finds that the UK(NI) indication—ahas not been affixed, in contravention of regulation 21; orbhas been affixed otherwise in accordance with regulation 21it must require a manufacturer to put an end to the non-compliance within such reasonable period as the authority specifies.2Until 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).3Where the non-compliance referred to in paragraph (1) persists beyond the specified period, the enforcement authority must take appropriate measures to—arestrict or prohibit the PPE being available on the market;bensure that the PPE is withdrawn;censure that the PPE is recalled.4It 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.5A 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.6This regulation does not apply where PPE presents a risk.Andrew Griffiths Minister for Small Business, Consumer and Corporate Responsibility
Department for Business, Energy and Industrial Strategy
SCHEDULE 1Enforcement Powers of Weights and Measures Authorities, District Councils and the Secretary of State under the 1987 Act Regulation 5Enforcement powers under the 1987 Act1For the purposes of enforcing EU Regulation 2016/425 and these Regulations, the following sections of the 1987 Act apply subject to the modifications in paragraph 2—asection 13 (prohibition notices and notices to warn);bsection 14 (suspension notices);csection 16 (forfeiture: England and Wales and Northern Ireland);dsection 17 (forfeiture Scotland);esection 18 (power to obtain information);fsection 19 (interpretation of Part 2);gsection 29 (powers of search etc);hsection 30 (provisions supplemental to section 29);isection 31 (powers of customs officer to detain goods);jsection 33 (appeals against detention of goods);ksection 34 (compensation for seizure and detention);lsection 35 (recovery of expenses of enforcement);msection 37 (power of Commissioners for Revenue and Customs);nsection 45 (interpretation);osection 46(1) (meaning of “supply”);pSchedule 2 (prohibition notices and notices to warn).Modifications to the 1987 Act2The sections of the 1987 Act referred to in paragraph 1 apply as if—ain section 13—iin subsection (1), for “unsafe” on each occasion that it appears, there were substituted “ non-compliant ”;iiin subsection (1), “relevant” were omitted each time it appears;iiiin subsection (2), the words from “; and the Secretary of State may” to the end were omitted;ivsubsections (4) to (7) were omitted;bin section 14—iin subsection (1), after “any safety provision has been contravened in relation to the goods”, there were inserted “ or that such goods present a risk ”;iiin subsection (2)(b), after “any safety provision has been contravened in relation to the goods”, there were inserted “ or that such goods present a risk ”;iiiin subsection (2)(c), “under section 15 below” were omitted;ivsubsections (6) to (8) were omitted;cin section 16—iin subsection (1), after “a contravention in relation to the goods of a safety provision”, there were inserted “ or that such goods present a risk ”;iifor subsection (2)(b) there were substituted—bwhere an application with respect to some or all of the goods has been made to a magistrates court under regulation 13 (appeals against notices) of the 2018 PPE Regulations, or section 33, to that court; and;iiiin subsection (3) after “a contravention in relation to the goods of a safety provision” there were inserted “ or that such goods present a risk ”;ivafter subsection (4) there were inserted—4AA court may infer for the purposes of this section that any goods present a risk, if it is satisfied that such a risk is presented by goods which are representative of those goods (whether by reason of being of the same design or part of the same consignment or batch or otherwise).;din section 17—iin subsection (1), after “a contravention of a safety provision”, there were inserted “ or where the goods present a risk ”;iiin subsection (6), after “a contravention in relation to the goods of a safety provision”, there were inserted “ or that those goods present a risk ”;iiiafter subsection (7), there were inserted—7AThe sheriff may infer for the purposes of this section that any goods present a risk, if satisfied that such a risk is presented by goods which are representative of those goods (whether by reason of being of the same design or part of the same consignment or batch or otherwise).;ein section 18, subsections (3) and (4) were omitted;fin section 29—iin subsection (4)(a), after “any contravention of any safety provision in relation to the goods” there were inserted “ or whether the goods present a risk ”;iiin subsection (4)(b), after “any such contravention” there were inserted “ or whether the goods present a risk ”;gin section 30—iat the end of subsection (2)(a)(ii), for “and” there were substituted “ or ”;iiafter subsection (2)(a)(ii), there were inserted—iiithat any goods which any officer has power to inspect under section 29(4) are on any premises and their inspection is likely to demonstrate that they present a risk; and; andiiisubsections (5), (7) and (8) were omitted;hin section 31(1), for “Part II of this Act”, there were substituted “ the 2018 PPE Regulations ”;iin section 34—ithe word “and” at the end of subsection (1)(a) were omitted; andiiafter that subsection, there were inserted—aathe goods do not present a risk; and;jin section 37(1), for “Part II of this Act”, there were substituted “ the 2018 PPE Regulations ”;kin section 45(1)—ithe definitions of “conditional sale agreement”, “gas”, “motor vehicle”, “personal injury”, “subordinate legislation” and “substance” were omitted;iibefore the definition of “aircraft”, there were inserted —“the 2018 PPE Regulations” means the Personal Protective Equipment (Enforcement) Regulations 2018;;iiibefore the definition of enforcement authority there were inserted—“economic operator” has the same meaning as in EU Regulation 2016/425;;ivfor the definition of “enforcement authority” there were substituted—“enforcement authority” means an enforcement authority as defined in regulation 4 of the 2018 PPE Regulations;;vafter the definition of enforcement authority there were inserted—“EU Regulation 2016/425” means Regulation (EU) No 2016/425 of the European Parliament and of the Council on personal protective equipment, repealing Council Directive 89/68/EEC, as amended from time to time;;vifor the definition of “goods” there were substituted—“goods” means personal protective equipment within the scope of EU Regulation 2016/425;;viiafter the definition of “modifications” there were inserted—“non-compliant” in relation to any goods means that—aa safety provision has been contravened in relation to the goods, orbthe goods present a riskand “compliant” shall be construed accordingly;;;viiiafter the definition of “premises”, there were inserted—“present a risk” means a risk within the meaning set out in regulation 1(2) of the 2018 PPE Regulations;;ixfor the definition of “safety provision” there were substituted—“safety provision” means any provision imposing an obligation on an economic operator in EU Regulation 2016/425;; andxfor the definition of “safety regulations” there were substituted—“safety regulations” means EU Regulation 2016/425 and the 2018 PPE Regulations;;lin section 46(1), the words “and, in relation to gas or water, those references shall be construed as including references to providing the service by which the gas or water is made available for use” were omitted, andmin Schedule 2—ifor “unsafe”, on each occasion that it appears, there were substituted “ non-compliant ”; andiifor “safe” on each occasion that it appears, there were substituted “ compliant ”.SCHEDULE 2Enforcement Powers of the Health and Safety Executive and the Office for Nuclear Regulation under the 1974 Act Regulation 5Enforcement powers under the 1974 Act1For the purposes of enforcing EU Regulation 2016/425 and these Regulations, the following sections of the 1974 Act apply subject to the modifications in paragraph 2—asection 19 (appointment of inspectors);bsection 20 (powers of inspectors);csection 21 (improvement notices);dsection 22 (prohibition notices);esection 23 (provisions supplementary to sections 21 and 22);fsection 24 (appeal against improvement or prohibition notice);gsection 25 (power to deal with cause of imminent danger);hsection 25A (power of customs office to detain articles and substances);isection 26 (power of enforcing authorities to indemnify inspectors);jsection 27 (obtaining of information by the Executive, enforcing authorities etc);ksection 27A (information communicated by Commissioners for Revenue and Customs);lsection 28 (restrictions on disclosure of information);msection 33 (offences);nsection 34 (extension of time for bringing summary proceedings);osection 35 (venue);psection 39 (prosecution by inspectors);qsection 41 (evidence); andrsection 42 (power of court to order cause of offence to be remedied, or in certain cases, forfeiture).Modifications to the 1974 Act2The sections of the 1974 Act referred to in paragraph 1 apply as if—areferences to “relevant statutory provisions” were references to—ithe provisions of the 1974 Act set out in paragraph 1, as modified by this paragraph; andiithese Regulations;breferences to “risk” were references to “risk” as defined in regulation 1(2) of these Regulations;cin section 19—iin subsection (1)—aafor “Every enforcing authority” there were substituted “ The Health and Safety Executive and the Office for Nuclear Regulation ”;bbfor references to “it” there were substituted “ they ”;ccfor “thinks” there were substituted “ think ”;dd“within its field of responsibility” were omitted;iiin subsection (2), paragraph (b) were omitted;iiiin subsection (3), for “enforcing authority which appointed him” there were substituted “ Health and Safety Executive or the Office for Nuclear Regulation as the case may be ”;din section 20—iin subsection (1), “within the field of responsibility of the enforcing authority which appointed him” were omitted;iiin subsection (2)(c)(i), for “his (the inspector's) enforcing authority” there were substituted “ the Health and Safety Executive or the Office for Nuclear Regulation as the case may be ”;iiiin subsection (2)(h), for “him to have caused or to be likely to cause danger to health and safety”, there were substituted “ contravene the relevant statutory provisions or present a risk ”; andivsubsection (3) were omitted;ein section 21—ibefore paragraph (a), there were inserted—zais making available on the market personal protective equipment which presents a risk;;iiafter “specifying the”, there were inserted “ risk, or ”; andiiiafter “requiring that person to”, there were inserted “ address the risk or ”;ffor section 22(2) there were substituted—2An inspector may serve a notice (in this Part referred to as “a prohibition notice”) on a person if, as regards any activities to which this section applies, the inspector is of the opinion that, as carried on or likely to be carried on by or under the control of the person in question, the activities involve or, as the case may be, will involve—aa risk; orba contravention of a relevant statutory provision.;gin section 23, subsections (3), (4) and (6) were omitted;hfor section 25A(1) there were substituted—1A customs officer may, for the purposes of facilitating the exercise or performance by the Health and Safety Executive, the Office for Nuclear Regulation or an inspector (as the case may be), of any of their powers and duties under any of the relevant statutory provisions, seize any imported article or imported substance and retain it for not more than two working days.;ifor the heading to section 26, there were substituted “ Power to indemnify inspectors ”;jin section 26, there were substituted “ the body ” for each of the following references—i“the enforcing authority”;ii“that authority”; andiii“the authority”;kin section 27—ifor “Executive”, on each occasion it appears, there were substituted “ Health and Safety Executive or the Office for Nuclear Regulation as the case may be ”;iiin subsection (1), paragraph (b) were omitted; andiiiin subsection (1), “or, as the case may be to the enforcing authority in question” were omitted;lfor section 27A(2) there were substituted—2This subsection applies to the Health and Safety Executive, the Office for Nuclear Regulation and to an inspector.;min section 28—ifor “Executive”, on each occasion that it appears, there were substituted “ Health and Safety Executive ”;iiin subsection (1)(a), “, other than the Office for Nuclear Regulation (or an inspector appointed by it,” and “, by virtue of section 43A(6) below” were omitted;iiiin subsection (3)(a), “or any enforcing authority” were omitted;ivin subsection (4), “or an enforcing authority” and “or authority (including, in the case of an enforcing authority, any inspector appointed by it)” were omitted;vin subsection (5)(a), “or the purposes of the enforcing authority in question in connection with the relevant statutory provisions” were omitted;viin subsection (7), “14(4)(a) or” were omitted;viifor subsection (7)(b), there were substituted—bfor the purposes of any legal proceedings or for the purposes of a report of any such proceedings,; andviiisubsection (9B) were omitted;nin section 33—iin subsection (1), paragraphs (a) to (i) and (k) to (m) were omitted;iifor subsection (2), there were substituted—2A person guilty of an offence under this section is liable—aon summary conviction—iin England and Wales, to a fine or imprisonment for a term not exceeding three months, or to both;iiin Scotland, to a fine not exceeding the statutory maximum or imprisonment for a term not exceeding three months, or to both;bon conviction on indictment to a fine or imprisonment for a term not exceeding two years , or to both.; andosection 33(3) were omitted;pin section 34—iin subsection (1), paragraphs (a) and (b) were omitted; andiiin subsection (1), for the words from “and it appears” to the end, there were substituted—and it appears from the investigation or, in a case falling within paragraph (d), from the proceedings at the inquiry, that any of the relevant statutory provisions was contravened at a time which is material in relation to the subject-matter of the investigation or inquiry, summary proceedings against any person liable to be proceeded against in respect of the contravention may be commenced at any time within three months of the conclusion of the investigation or inquiry.; andiiisubsections (3) to (6) were omitted;qin section 35, for “any enforcing authority”, there were substituted “ the Health and Safety Executive or the Office for Nuclear Regulation as the case may be ”;rin section 39(1), for enforcing authority” there were substituted “ Health and Safety Executive or the Office for Nuclear Regulation as the case may be ”; andsin section 42 , subsections (3A), (4) and (5) were omitted.SCHEDULE 3Enforcement Powers of the Health and Safety Executive for Northern Ireland under the 1978 Order Regulation 5Enforcement Powers under the 1978 Order1For the purposes of enforcing EU regulation 2016/425, these Regulations and RAMs (in its application to PPE) the following Articles of the 1978 Order apply subject to the modifications in paragraph 2—aArticle 21 (appointment of inspectors);bArticle 22 (powers of inspectors);cArticle 23 (improvement notices);dArticle 24 (prohibition notices);eArticle 25 (provisions supplementary to Articles 23 and 24);fArticle 26 (appeal against improvement or prohibition notice);gArticle 27 (power to deal with cause of imminent danger);hArticle 27A (power of customs officer to detain articles and substances);iArticle 28 (power of enforcing authorities to indemnify inspectors);jArticle 29 (obtaining of information by the Executive, enforcing authorities etc);kArticle 29A (information communicated by Commissioners for Revenue and Customs);lArticle 30 (restrictions on disclosure of information);mArticle 31 (offences);nArticle 32 (extension of time for bringing summary proceedings);oArticle 33 (venue);pArticle 36 (prosecution by inspectors);qArticle 38 (evidence);rArticle 39 (power of court to order cause of offence to be remedied or, in certain cases, forfeiture).Modifications to the 1978 Order2The Articles of the 1978 Order referred to in paragraph apply as if—areferences to “relevant statutory provisions” were references to—ithe provisions of the 1978 Order set out in paragraph 1, as modified by this paragraph; andiithese Regulations;breferences to “risk” were references to “risk within the meaning of regulation 1(2) of these Regulations;cin Article 21—iin paragraph (1), for “Every enforcing authority” there were substituted “ The Health and Safety Executive for Northern Ireland ”;iiin paragraph (1) “within its field of responsibility” were omitted;iiiin paragraph (2), sub-paragraph (b) were omitted;ivin paragraph (3), for “enforcing authority which appointed him” there were substituted “ Health and Safety Executive for Northern Ireland ”;din Article 22—iin paragraph (1), “within the field of responsibility of the enforcing authority which appointed him” were omitted;iiin paragraph 2(c)(i), for “his (the inspector's) enforcing authority” there were substituted “ the Health and Safety Executive for Northern Ireland ”;iiiin paragraph 2(2)(h), for “him to have caused or to be likely to cause danger to health and safety”, there were substituted “ contravene the relevant statutory provisions or present a risk ”; andivparagraph (3) were omitted;ein Article 23—ibefore paragraph (a), there were inserted—zais making available on the market personal protective equipment which presents a risk;;iiafter “specifying the”, there were inserted “ risk or ”; andiiiafter “requiring that person to”, there were inserted “ address the risk or ”;ffor Article 24(2) and (3) there were substituted—2An inspector may serve a notice (in this Part referred to as a prohibition notice”) on a person if, as regards any activities to which this paragraph applies, the inspector is of the opinion that, as carried on or likely to be carried on by or under the control of the person in question, the activities involve or, as the case may be, will involve—aa risk; orbthe contravention of a relevant statutory provision.3A prohibition notice must—astate that the inspector is of the said opinion;bspecify the matters which in his opinion give, or as they case may be, will give rise to the said risk;cwhere in his opinion any of those matters involves or, as the case may be, will involve a contravention of any of the relevant statutory provisions, state that he is of the opinion, specify the provision or provisions as to which he is of that opinion, and give particulars of the reasons why he is of that opinion; andddirect that the activities to which the notice relates must not be carried on by or under the control of the person on whom the notice is served unless the matters specified in pursuance of sub-paragraph (b) and any associated contraventions of provisions so specified in pursuance of sub-paragraph (c) have been remedied.;gin Article 25, paragraphs (3), (4) and (5) were omitted;hin Articles 27A(1), for “any enforcing authority” and “the authority” there were substituted “ the Health and Safety Executive for Northern Ireland ”;ifor the heading to Article 28, there were substituted “ Power to indemnify inspectors ”;jin Article 28, for “the enforcing authority which appointed him”, “that authority” and “the authority” there were, in each case, substituted “ the Health and Safety Executive for Northern Ireland ”;kin Article 29—iin paragraph (1)(b), for “an enforcing authority” there were substituted “ the Health and Safety Executive for Northern Ireland ” and for “the Authority's functions” there were substituted “ its functions ”;ii“the department concerned, or” were omitted;iiifor “the Executive”, in each case it appears, there were substituted “ the Health and Safety Executive for Northern Ireland ”;iv“or, as the case may be, to the enforcing authority in question” were omitted;lin Article 29A(2) for “an enforcing authority” there were substituted “ the Health and Safety Executive for Northern Ireland ”;min Article 30 —ifor “Executive”, on each occasion that it appears, there were substituted “ Health and Safety Executive for Northern Ireland ”;iiin paragraph (3), “or any enforcing authority” were omitted;iiiin paragraph (4), “or any enforcing authority” and “or authority (including in the case of an enforcing authority, any inspector appointed by it)” were omitted;ivin paragraph (5), “or the purposes of the enforcing authority in question in connection with the relevant statutory provisions” were omitted;vin paragraph (6), “16(4)(a) or” were omitted;vifor paragraph (6)(b), there were substituted—bfor the purposes of any legal proceedings or for the purposes of a report of any such proceedings;; andnin Article 31—iin paragraph (1), sub-paragraphs (a) to (i) and (k) to (m) were omitted;iifor paragraph (2), there were substituted—2A person guilty of an offence under this Article is liable—aon summary conviction, to a fine not exceeding the statutory maximum or imprisonment for a term not exceeding three months, or to both;bon conviction on indictment, to a fine or imprisonment for a term not exceeding two years or to both.; andiiiArticle 31(3) were omitted;oin Article 32—iin paragraph (1), sub-paragraphs (a) and (b) were omitted;iiin paragraph (1), for the words from “and it appears” to the end, there were substituted “ and it appears from the proceedings at the inquest that any of the relevant statutory provisions was contravened at a time which is material in relation to the subject-matter of the inquest, summary proceedings against any person liable to be proceeded against in respect of the contravention may be commenced at any time within three months of the conclusion of the inquest. ”; andiiiparagraphs (3) and (4) were omitted;pin Article 33, for “any enforcing authority” there were substituted “ Health and Safety Executive for Northern Ireland ”;qin Article 36, for “ enforcing authority” there were substituted “ Health and Safety Executive for Northern Ireland ”; andrin Article 39, paragraphs (3A), (4) and (5) were omitted.SCHEDULE 4Compliance, Withdrawal and Recall Notices Regulation 5Compliance notice11An enforcement authority may serve a compliance notice on a relevant economic operator in respect of PPE if the authority has reasonable grounds for believing that there is non-compliance with the requirements or obligations of EU Regulation 2016/425.2A compliance notice must—arequire the relevant economic operator on which it is served to—iend the non-compliance within such period as may be specified in the notice; oriiprovide evidence, within such period as may be specified in the notice, demonstrating to the satisfaction of the enforcement authority that the non-compliance has not in fact occurred;bwarn the relevant economic operator that, if the non-compliance persists or if satisfactory evidence has not been produced under paragraph (a) within the period specified in the notice, further action may be taken in respect of the PPE or any such equipment of the same type made available on the market by that economic operator.3A compliance notice may include directions as to the measures to be taken by the relevant economic operator to secure compliance, including different ways of securing compliance.4Subject to sub-paragraph (5), an enforcement authority may revoke or vary a compliance notice by serving a notification on the relevant economic operator.5An enforcement authority may not vary a compliance notice so as to make it more restrictive for the relevant economic operator or more onerous for the economic operator to comply.Withdrawal notice21An enforcement authority may serve a withdrawal notice on a relevant economic operator in respect of PPE if the authority has reasonable grounds for believing that—athe PPE has been made available on the market; andbeither of the following conditions are met—ithe PPE presents a risk; oriithe PPE is not in conformity with the requirements of EU Regulation 2016/425 or RAMS (in its application to PPE);2A withdrawal notice must prohibit the relevant economic operator from making the PPE available on the market without the consent of the enforcement authority.3A withdrawal notice may require the relevant economic operator to take action to alert end-users to any risk presented by the PPE.4A withdrawal notice may require the relevant economic operator to keep the enforcement authority informed of the whereabouts of any PPE referred to in the notice.5A consent given by the enforcement authority pursuant to a withdrawal notice may impose such conditions on the making available on the market as the authority considers appropriate.Recall notice31The enforcement authority may serve a recall notice on a relevant economic operator in respect of PPE if the authority has reasonable grounds for believing that—athe PPE has been made available to end-users; andbeither of the following conditions is met—ithe PPE presents a risk;iithe PPE is not in conformity with the requirements of EU Regulation 2016/425 or RAMS (in its application to PPE).2A recall notice must require the relevant economic operator to use reasonable endeavours to organise the return of the PPE from end-users to the economic operator or another person specified in the notice.3A recall notice may—arequire the recall to be effected in accordance with a code of practice;brequire the relevant economic operator to—icontact end-users in order to inform them of the recall, to the extent that it is practicable to do so;iipublish a notice in such form and such manner as is likely to bring to attention of end-users any risk the PPE poses and the fact of recall;iiimake arrangements for the collection or return of the PPE from end-users or its disposal;ivimpose such additional requirements on the relevant economic operator as are reasonable and practicable with a view to achieving the return of the PPE.4In determining what requirements to include in a recall notice, the enforcement authority must take into consideration the need to encourage distributors and end-users to contribute to its implementation.5A recall notice may only be issued by the enforcement authority where—aother action which it may require under these Regulations would not suffice to address the non-compliance;bthe action being undertaken by the relevant economic operator in fulfilment of the requirements of EU Regulation 2016/425 is unsatisfactory or insufficient to address the non-compliance;cthe enforcement authority has given not less than ten days' notice to the economic operator of its intention to serve such a notice; anddthe enforcement authority has taken account of any advice obtained under sub-paragraph (6).6A relevant economic operator which has received notice from the enforcement authority of an intention to serve a recall notice may at any time prior to the service of the recall notice require the authority to seek the advice of such person as the Institute determines on questions of—awhether there is non-compliance; andbwhether the issue of a recall notice would be proportionate.7Sub-paragraph (5)(b), (c) and (d) do not apply in the case of PPE presenting a serious risk requiring, in the view of the enforcement authority, urgent action.8Where a relevant economic operator requires the enforcement authority to seek advice under sub-paragraph (6), that economic operator is to be responsible for the fees, costs and expenses of the Institute and of the person appointed by the Institute to advise the enforcement authority.9A recall notice served by the enforcement authority may require the relevant economic operator to keep the authority informed of the whereabouts of the PPE to which the recall notice relates, so far as the economic operator is able to do so.10In this paragraph, “Institute” means the charitable organisation with registered number 803725 and known as the Chartered Institute of Arbitrators.Interpretation4In this Schedule “non-compliance” means that PPE—apresents a risk; orbis not in conformity with the requirements of EU regulation 2016/425 or RAMS (in its application to PPE).SCHEDULE 5Consequential Amendments Regulation 19Amendment of the Personal Protective Equipment at Work Regulations 19921Regulation 4 (provision of personal protective equipment) of the Personal Protective Equipment at Work Regulations 1992 is amended as follows—afor paragraph (3)(e) substitute the following—eit complies with any legal requirement which is applicable to that item of personal protective equipment.; andbafter paragraph (4) insert—5In paragraph (3)(e), “any legal requirement” means any requirement of—aan enactment (whether in an Act or instrument) which implements in Great Britain any provision on design or manufacture with respect to health or safety in any relevant Community Directive listed in Schedule 1; orbRegulation (EU) 2016/425 of the European Parliament and of the Council on personal protective equipment and repealing Council Directive 89/686/EEC (OJ No L81, 31.3.2016, p51)..Amendment of the Control of Lead at Work Regulations 20022Regulation 6 (prevention or control of exposure to lead) of the Control of Lead at Work Regulations 2002 is amended as follows—ain paragraph (7)(a) for “provision in the Personal Protective Equipment Regulations 2002” substitute “ legal requirement ”; andbafter paragraph (10) insert—11In paragraph (7)(a) “legal requirement” means any requirement of the Personal Protective Equipment Regulations 2002 or Regulation (EU) 2016/425 of the European Parliament and of the Council on personal protective equipment and repealing Council Directive 89/686/EEC (OJ No L81, 31.3.2016, p51)..Amendment of the Control of Substances Hazardous to Health 20023Regulation 7 (prevention or control of exposure to substances hazardous to health) of the Control of Substances Hazardous to Health 2002 is amended as follows—ain paragraph (9)(a) for “provision in the Personal Protective Equipment Regulations 2002” substitute “ legal requirement ”; andbafter paragraph (11) insert—12In paragraph (9)(a), “legal requirement” means any requirement of the Personal Protective Equipment Regulations 2002 or Regulation (EU) 2016/425 of the European Parliament and of the Council on personal protective equipment and repealing Council Directive 89/686/EEC (OJ No L81, 31.3.2016, p51)..Amendment of the Control of Lead at Work Regulations (Northern Ireland) 20034Regulation 6 (prevention or control of exposure to lead) of the Control of Lead at Work Regulations (Northern Ireland) 2003 is amended as follows—ain paragraph (7)(a) for “provision in the Personal Protective Equipment Regulations 2002” substitute “ legal requirement ”; andbafter paragraph (10) insert—11In paragraph (7)(a), “legal requirement” means any requirement of the Personal Protective Equipment Regulations 2002 or Regulation (EU) 2016/425 of the European Parliament and of the Council on personal protective equipment and repealing Council Directive 89/686/EEC (OJ No L81, 31.3.2016, p51)..Amendment of the Control of Substances Hazardous to Health Regulations (Northern Ireland) 20035Regulation 7 of the Control of Substances Hazardous to Health Regulations 2003 is amended as follows—ain paragraph (9)(a) for “provision in the Personal Protective Equipment Regulations 2002” substitute “ legal requirement ”; andbafter paragraph (11) insert—12In paragraph (9)(a), “legal requirement” means any requirement of the Personal Protective Equipment Regulations 2002 or Regulation (EU) 2016/425 of the European Parliament and of the Council on personal protective equipment and repealing Council Directive 89/686/EEC (OJ No L81, 31.3.2016, p51)..Amendment of the Enterprise Act 2002 (Part 9 Restrictions of Disclosure of Information) (Specification) Order 20046In Schedule 1 (specified subordinate legislation) to the Enterprise Act 2002 (Part 9 Restrictions of Disclosure of Information) (Specification) Order 2004 for “Personal Protective Equipment Regulations 2002” substitute “ Personal Protective Equipment (Enforcement) Regulations 2018 ”.Amendment of the Control of Noise at Work Regulations 20057Regulation 7 (hearing protection) of the Control of Noise at Work Regulations 2005 is amended as follows—ain paragraph (4) for “requirement of the Personal Protective Equipment Regulations 2002” substitute “ legal requirement ”; andbafter paragraph (4) insert—5In paragraph (4), “legal requirement” means any requirement of the Personal Protective Equipment Regulations 2002 or Regulation (EU) 2016/425 of the European Parliament and of the Council on personal protective equipment and repealing Council Directive 89/686/EEC (OJ No L81, 31.3.2016, p51)..Amendment of the Control of Noise at Work Regulations (Northern Ireland) 20068Regulation 7 (hearing protection) of the Control of Noise at Work Regulations (Northern Ireland) 2006 is amended as follows—ain paragraph (4) for “requirement of the Personal Protective Equipment Regulations 2002” substitute “ legal requirement ”; andbafter paragraph (4) insert—5In paragraph (4), “legal requirement” means any requirement of the Personal Protective Equipment Regulations 2002 or Regulation (EU) 2016/425 of the European Parliament and of the Council on personal protective equipment and repealing Council Directive 89/686/EEC (OJ No L81, 31.3.2016, p51)..Amendment of the Legislative and Regulatory Reform (Regulatory Functions) Order 20079The Schedule to the Legislative and Regulatory Reform (Regulatory Functions) Order 2007 is amended as follows—ain Part 3, under the heading “Public health and safety”, omit “Personal Protective Equipment Regulations 2002” and at the end insert “ Personal Protective Equipment (Enforcement) Regulations 2018 ”;bin Part 8, omit “Personal Protective Equipment Regulations 2002” and in the appropriate place insert “ Personal Protective Equipment (Enforcement) Regulations 2018 ”; andcin Part 13, omit “Personal Protective Equipment Regulations 2002” and in the appropriate place insert “ Personal Protective Equipment (Enforcement) Regulations 2018 ”.Amendment of the REACH Enforcement Regulations 200810Schedule 5B (placing on the market and use of paint stripper containing dichloromethane) to the REACH Enforcement Regulations 2008 is amended as follows—ain paragraphs 2(b) and 3(a)(ii) for “the Personal Protective Equipment Regulations 2002” substitute “ any legal requirement applicable to that equipment ”; andbafter paragraph 4 insert—5In this Schedule “legal requirement” means any requirement of the Personal Protective Equipment Regulations 2002 or Regulation (EU) 2016/425 of the European Parliament and of the Council on personal protective equipment and repealing Council Directive 89/686/EEC (OJ No L81, 31.3.2016, p51)..Amendment of the Co-ordination of Regulatory Enforcement (Regulatory Functions in Scotland and Northern Ireland) Order 200911The Co-ordination of Regulatory Enforcement (Regulatory Functions in Scotland and Northern Ireland) Order 2009 is amended as follows—ain Part 4 of Schedule 1, omit “Personal Protective Equipment Regulations 2002” and at the end insert “ Personal Protective Equipment (Enforcement) Regulations 2018 ”; andbin Part 2 of Schedule 2, omit “Personal Protective Equipment Regulations 2002” and in the appropriate place insert “ Personal Protective Equipment (Enforcement) Regulations 2018 ”.Amendment of the Control of Asbestos Regulations 201212Regulation 11 (prevention or reduction of exposure to asbestos) of the Control of Asbestos Regulations 2012 is amended as follows—ain paragraph (4)(a) for “provision of the Personal Protective Equipment Regulations 2002” substitute “ legal requirement ”; andbafter paragraph (5) insert—6In paragraph (4)(a), “legal requirement” means any requirement of the Personal Protective Equipment Regulations 2002 or Regulation (EU) 2016/425 of the European Parliament and of the Council on personal protective equipment and repealing Council Directive 89/686/EEC (OJ No L81, 31.3.2016, p51)..Amendment of the Control of Asbestos Regulations (Northern Ireland) 201213Regulation 11 (prevention or reduction of exposure to asbestos) of the Control of Asbestos Regulations (Northern Ireland) 2012 is amended as follows—ain paragraph (4)(a) for “provision of the Personal Protective Equipment Regulations 2002” substitute “ legal requirement ”; andbafter paragraph (5) insert—6In paragraph (4)(a), “legal requirement” means any requirement of the Personal Protective Equipment Regulations 2002 or Regulation (EU) 2016/425 of the European Parliament and of the Council on personal protective equipment and repealing Council Directive 89/686/EEC (OJ No L81, 31.3.2016, p51)..Amendment of the Ionising Radiations Regulations 201714Regulation 10 (personal protective equipment) of the Ionising Radiations Regulations 2017 is amended as follows—ain paragraph (1)(a) for “provision of the Personal Protective Equipment Regulations 2002” substitute “ legal requirement ”; andbafter paragraph (2) insert—3In paragraph (1)(a), “legal requirement” means any requirement of the Personal Protective Equipment Regulations 2002 or Regulation (EU) 2016/425 of the European Parliament and of the Council on personal protective equipment and repealing Council Directive 89/686/EEC (OJ No L81, 31.3.2016, p51)..Amendment of the Ionising Radiations Regulations (Northern Ireland) 201715Regulation 10 (personal protective equipment) of the Ionising Radiations Regulations (northern Ireland) 2017 is amended as follows—ain paragraph (1)(a) for “provision of the Personal Protective Equipment Regulations 2002” substitute “ legal requirement ”; andbafter paragraph (2) insert—3In paragraph (1)(a), “legal requirement” means any requirement of the Personal Protective Equipment Regulations 2002 or Regulation (EU) 2016/425 of the European Parliament and of the Council on personal protective equipment and repealing Council Directive 89/686/EEC (OJ No L81, 31.3.2016, p51)..

(This note is not part of the Regulations)

These Regulations provide for the enforcement of Regulation (EU) 2016/425 of the European Parliament and of the Council of 9 March 2016 on personal protective equipment (OJ No L81, 31.3.2016, p51) (“EU Regulation 2016/425”).

EU Regulation 2016/425 repeals and replaces Council Directive 89/686/EEC of 21 December 1989 on the approximation of the laws of the Member States relating to personal protective equipment (OJ No L399, 30.12.1989, p18); which was implemented in the United Kingdom by the Personal Protective Equipment Regulations 2002 (S.I. 2002/1144) (as amended). These Regulations revoke S.I. 2002/1144 with savings (see regulation 2).

Regulation 3 designates market surveillance authorities for the purpose of EU Regulation 2016/425 and these Regulations.

Regulations 4, 5 and Schedules 1 to 4 provide for enforcement authorities and their powers of enforcement. Offences and penalties are set out in regulations 7 and 8. The remainder of Part 2 provisions deal with related enforcement and procedural issues such as defences, liability of third parties, time limits, service of documents, appeals and compensation, etc.

Regulation 18 sets out a process for the Secretary of State to review the regulatory provision contained within these Regulations and publish a report setting out the conclusions of that review. The first such report must be published within five years after the coming into force date of this instrument and subsequent reviews must be carried out every five years after that.

Schedule 5 contains amendments to other legislation which are consequential to these Regulations.

A Transposition Note is published with the Explanatory Memorandum alongside these Regulations on www.legislation.gov.uk.

The EU Regulations referred to above are published at http://eur-lex.europa.eu.

Citation, commencement and interpretation11These Regulations may be cited as the Personal Protective Equipment (Enforcement) Regulations 2018 and come into force on 21st April 2018.2In these Regulations—“the 1974 Act” means the Health and Safety at Work etc. Act 1974 ;“the 1978 Order” means the Health and Safety at Work (Northern Ireland) Order 1978 ;“the 1987 Act” means the Consumer Protection Act 1987 ;“the 2002 Regulations” means the Personal Protective Equipment Regulations 2002 ;“district council” means a district council within the meaning of the Local Government Act (Northern Ireland) 1972 ;“EU Regulation 2016/425” means Regulation (EU) No 2016/425 of the European Parliament and of the Council on personal protective equipment, repealing Council Directive 89/686/EEC , as amended from time to time; “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 ...; “RAMS” means Regulation (EC) No 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) No 339/93 , as amended from time to time;“risk” means a risk which may result in harm to the health or safety of persons, domestic animals or property, if personal protective equipment (“PPE”) is used in a normal and predictable manner; and“weights and measures authority” means a local weights and measures authority within the meaning set out in section 69 of the Weights and Measures Act 1985 .3In these Regulations (unless otherwise stated) a reference to—aa numbered regulation, paragraph or Schedule is a reference to the regulation, paragraph or Schedule as numbered in these Regulations ...;ban Article, paragraph of an Article , Chapter or Annex is a reference to the Article, paragraph of an Article , Chapter or Annex as numbered in EU Regulation 2016/425;ca “relevant economic operator” in relation to PPE means an economic operator with obligations in respect of PPE under EU Regulation 2016/425; anddan “enforcement authority” is to be construed in accordance with regulation 4.4Expressions and words used in these Regulations which are used in EU Regulation 2016/425 have the same meaning as in EU Regulation 2016/425 unless otherwise stated.Application, transitional provisions, savings and revocation21These Regulations apply to PPE placed on the market on or after 21st April 2018.2These Regulations do not apply to PPE—adesigned for the uses specified in Article 2(2)(a) to (d); orbthat falls within Article 2(2)(e).3Nothing in these Regulations prevents the showing of PPE at trade fairs, exhibitions, demonstrations or the like, which is not in compliance with the provisions of EU Regulation 2016/425, provided that a visible sign clearly indicates that such PPE does not comply with those provisions and that it is not for sale until it is made compliant.4Subject to the modifications made in paragraph (4A), the 2002 Regulations continue to apply, as if they had not been revoked, to PPE placed on the market before 21st April 2019 , and in any such case the consequential amendments made by Schedule 5 do not apply.4AThe modifications referred to in paragraph (4) are as follows—aany reference to “Community” is to be read as including the United Kingdom;bany reference to “Member State” is to be read as including the United Kingdom;cin Schedule 7—iin paragraph 5—aaomit from “The Commission” to “conducted”;bbbefore “file shall be held” insert “ manufacturer's technical ”;iiin paragraph 6, omit from “An inspection body” to the end;din Schedule 10, in paragraph 2, omit from “with a view” to “the Commission5. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6The 2002 Regulations are revoked save to the extent required to give effect to paragraphs (4) to (5). Notification to the Secretary of State of enforcement action etc6A market surveillance authority must immediately notify the Secretary of State of any action taken by it, evaluation made or other opinion formed by it, or other matter within its knowledge which is required by Article 38 to be communicated to the Commission or the ... member States.Offences71It is an offence for an economic operator to contravene the requirements and obligations set out in—aArticle 8 (obligations of manufacturers);bArticle 10 (obligations of importers);cArticle 11 (obligations of distributors);dArticle 13 (identification of economic operators);eArticle 16 (general principles of CE marking); andfArticle 17 (rules and conditions for affixing the CE marking).2It is an offence for an economic operator to fail to—acooperate with;bprovide information to; andccomply with any of the requirements of,the market surveillance authority acting under Article 38.3It is an offence for an economic operator to fail to take the action required under—aArticle 40 (compliant PPE which presents a risk); orbArticle 41 (formal non-compliance).4It is an offence for a person—ato intentionally obstruct an enforcement authority acting in the execution or enforcement of EU Regulation 2016/425;bwithout reasonable cause, to fail to give such an enforcement authority any assistance or information which that person may reasonably require for those purposes;cto knowingly or recklessly furnish to such an enforcement authority any information knowing it to be false or misleading in a material particular; ordto fail to produce a document or record for such an enforcement authority when required to do so.5Proceedings must not be commenced against an economic operator under paragraph (1), (2) or (3) if the economic operator has been given a time period within which to comply or take action, and that time period has not expired.Written notice under Article 38 and service of documents121In a case falling within Article 38 (procedure ... for dealing with PPE presenting a risk), a market surveillance authority must provide notice when requiring the economic operator to, within a reasonable period—atake appropriate corrective action;bwithdraw the PPE from the market; orcrecall the PPE.2The notice given under paragraph (1) must—agive reasons for the action required;bprovide a time limit for compliance; andcbe served in accordance with paragraphs (3) to (6).3Any document required or authorised by EU Regulation 2016/425 or these Regulations to be served on a person may be served by—idelivering it to that person in person;iileaving it at the person's proper address; oriiisending it by post or electronic means to that person's proper address.4In the case of a body corporate, a document may be served on a director of that body.5In the case of a partnership, a document may be served on a partner or person having control or management of the partnership business.6If a person has specified an address in the United Kingdom (other than that person's proper address) at which that person or someone on that person's behalf will accept service, that address must also be treated as that person's proper address.7For the purposes of this regulation “proper address” means—ain the case of a body corporate or its director—ithe registered or principal office of that body; oriithe email address of the secretary or clerk of that body;bin the case of a partnership, a partner or person having control or management of the partnership business—ithe principal office of the partnership; oriithe email address of a partner or a person having that control or management;cin any other case, a person's last known address, which includes an email address.8In this regulation, “partnership” includes a Scottish partnership.Review and consequential amendments181The Secretary of State must—acarry out a review of the regulatory provision contained in these Regulations; andbpublish a report setting out the conclusions of that review.2In carrying out the review the Secretary of State must, so far as is reasonable, have regard to how EU Regulation 2016/425 (which is enforced and supplemented by means of these Regulations) is executed and enforced in any member States.3The first report must be published before the end of the period of five years beginning with the day on which these Regulations come into force.4Subsequent reports under this regulation are to be published at intervals not exceeding five years.5Section 30(4) of Small Business, Enterprise and Employment Act 2015 requires that the reports published under this regulation must, in particular—aset out the objectives intended to be achieved by the regulatory provision referred to in paragraph (1)(a),bassess the extent to which those objectives are achieved,cassess whether those objectives remain appropriate, anddif those objectives remain appropriate, assess the extent to which they could be achieved in another way which involves less onerous regulatory provision.6In this regulation, “regulatory provision” has the same meaning as in sections 28 to 32 of the 2015 Act (see section 32 of that Act).S.I. 1990/1304. See article 2 of, and the Schedule to this Order.1972 c.68. Section 2(2) was amended by section 27(1)(a) of the Legislative and Regulatory Reform Act 2006 (c.51) and by Part 1 of the Schedule to the European Union (Amendment) Act 2008 (c.7). The enabling powers of section 2(2) were extended by virtue of the amendment of section 1(2) by section 1 of the European Economic Area Act 1993 (c.51).Paragraph 1A of Schedule 2 was inserted by section 28 of the Legislative and Regulatory Reform Act 2006 and amended by Part 1 of the Schedule to the European Union (Amendment) Act 2008.1974 c.37.S.I. 1978/1039 (N.I. 9).1987 c.43.S.I. 2002/1144 as amended by S.I. 2004/693, 2012/1848 and 2015/1630.1972 Chapter 9.OJ No L81, 31.3.2016, p.51.OJ No L399, 30.12.1989, p.18.OJ No L 218, 13.8.2008, p.30.1985 c.72; section 69 was amended by the Local Government (Wales) Act 1994 (c.19), section 66 and Schedule 16, paragraph 75; the Local Government etc. (Scotland) Act 1994 (c.39), section 180 and Schedule 13, paragraph 144; and the Statute Law (Repeals) Act 1989 (c.43) Schedule 1, Part 1.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.Article 47(2) of the EU Regulation 2016/425 provides for EC type-examination certificates and approval decisions issued under Council Directive 89/686/EEC to remain valid until 21 April 2023 unless they expire before that date.2013 c.32.S.I. 1998/494 amended by S.I. 2014/469. There are other amendments not relevant to these Regulations.Regulation 2A was inserted by S.I. 2014/469 and amended by S.I. 2015/51 (regulation 38, Schedule 5).1995 c.46.2015 c.26.S.I. 1992/2966. There are amendments not relevant to this instrument.S.I. 2002/2676. There are amendments not relevant to this instrument.S.I. 2002/2677. There are amendments not relevant to this instrument.S.R. 2003/35. There are amendments not relevant to this instrument.S.R. 2003/34. There are amendments not relevant to this instrument.S.I. 2004/693. There are amendments not relevant to this instrument.S.I. 2005/1643. There are amendments not relevant to this instrument.S.R. 2006/1. Paragraph (4) was amended by the Health and Safety (Miscellaneous Amendments and Revocation) Regulations (Northern Ireland) 2009 (S.R. 2009/227).S.I. 2007/3544. There are amendments not relevant to this instrument.S.I. 2008/2852. There are amendments not relevant to this instrument.S.I. 2009/669. There are amendments not relevant to this instrument.S.I. 2012/632. There are amendments not relevant to this instrument.S.R. 2012/179. There are amendments not relevant to this instrument.S.I. 2017/1075. There are amendments not relevant to this instrument.S.R. 2017/229. There are amendments not relevant to this instrument.Reg. 7(1) modified (W.) (31.12.2020) by The Personal Protective Equipment (Temporary Arrangements) (Coronavirus) (Wales) Regulations 2020 (S.I. 2020/1489), regs. 1(1), 4(1) (with reg. 4(4))Reg. 7(1) modified (E.) (31.12.2020) by The Personal Protective Equipment (Temporary Arrangements) (Coronavirus) (England) Regulations 2020 (S.I. 2020/1484), regs. 1(1), 4(1) (with reg. 4(4))Reg. 7(3) modified (E.) (31.12.2020) by The Personal Protective Equipment (Temporary Arrangements) (Coronavirus) (England) Regulations 2020 (S.I. 2020/1484), regs. 1(1), 4(2)(3) (with reg. 4(4))Reg. 7(3) modified (W.) (31.12.2020) by The Personal Protective Equipment (Temporary Arrangements) (Coronavirus) (Wales) Regulations 2020 (S.I. 2020/1489), regs. 1(1), 4(2)(3) (with reg. 4(4))1974 c.37.S.I. 1978/1039 (N.I. 9).1987 c.43.S.I. 2002/1144 as amended by S.I. 2004/693, 2012/1848 and 2015/1630.1972 Chapter 9.OJ No L81, 31.3.2016, p.51.OJ No L399, 30.12.1989, p.18.OJ No L 218, 13.8.2008, p.30.1985 c.72; section 69 was amended by the Local Government (Wales) Act 1994 (c.19), section 66 and Schedule 16, paragraph 75; the Local Government etc. (Scotland) Act 1994 (c.39), section 180 and Schedule 13, paragraph 144; and the Statute Law (Repeals) Act 1989 (c.43) Schedule 1, Part 1.This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland onlyThis version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland onlyWords 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)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)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)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)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)This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland onlyThis version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland onlyWords 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)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)2015 c.26.This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland onlyThis version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland onlyWord 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)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.This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland onlyThis version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland onlyReg. 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))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))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)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)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)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)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)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))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)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)This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland onlyThis version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland onlyThis version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland onlyThis version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland onlyReg. 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))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))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)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)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)