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Regulation (EU) 2016/425 of the European Parliament and of the CouncilDangos y teitl llawn
Regulation (EU) 2016/425 of the European Parliament and of the Council of 9 March 2016 on personal protective equipment and repealing Council Directive 89/686/EEC (Text with EEA relevance)
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Changes over time for: Article 38
Changes to legislation:
Regulation (EU) 2016/425 of the European Parliament and of the Council, Article 38 is up to date with all changes known to be in force on or before 01 August 2026. There are changes that may be brought into force at a future date. Changes that have been made appear in the content and are referenced with annotations.
Changes to Legislation
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Changes and effects yet to be applied to Article 38:
- Art. 24(2)(c) and word inserted by S.I. 2026/40 reg. 12(b)
Newidiadau ac effeithiau heb eu gweithredu eto ar yr eitem ddeddfwriaeth gyfan a’r darpariaethau cysylltiedig.
- Art. 24(2)(c) and word inserted by S.I. 2026/40 reg. 12(b)
Article 38U.K.Procedure F1... for dealing with PPE presenting a risk
1.Where the market surveillance [F2authority has] sufficient reason to believe that PPE covered by this Regulation presents a risk to the health or safety of persons, [F3the authority] shall carry out an evaluation in relation to the PPE concerned covering all relevant requirements laid down in this Regulation. The relevant economic operators shall cooperate as necessary with the market surveillance [F4authority] for that purpose.
Where, in the course of the evaluation referred to in the first subparagraph, the market surveillance [F5authority finds] that the PPE does not comply with the requirements laid down in this Regulation, [F6the authority] shall without delay require the relevant economic operator to take all appropriate corrective action to bring the PPE into compliance with those requirements, to withdraw the PPE from the market, or to recall it within a reasonable period, commensurate with the nature of the risk, as [F6the authority] may prescribe.
The market surveillance [F7authority] shall inform the relevant [F8approved] body accordingly.
Article 21 of Regulation (EC) No 765/2008 shall apply to the measures referred to in the second subparagraph of this paragraph.
F92.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
3.The economic operator shall ensure that all appropriate corrective action is taken in respect of all the PPE concerned that it has made available on the market F10....
4.Where the relevant economic operator does not take adequate corrective action within the period referred to in the second subparagraph of paragraph 1, the market surveillance [F11authority] shall take all appropriate F12... measures to prohibit or restrict the PPE being made available on [F13the market], to withdraw the PPE from that market or to recall it.
F14...
F155.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
F156.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
F157.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
F158.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Textual Amendments
F1Words in Art. 38 heading omitted (31.12.2020) by virtue of The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 35 para. 3(36)(a); 2020 c. 1, Sch. 5 para. 1(1)
F2Words in Art. 38(1) substituted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 35 para. 3(36)(b)(i)(aa); 2020 c. 1, Sch. 5 para. 1(1)
F3Words in Art. 38(1) substituted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 35 para. 3(36)(b)(i)(bb); 2020 c. 1, Sch. 5 para. 1(1)
F4Word in Art. 38(1) substituted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 35 para. 3(36)(b)(i)(cc); 2020 c. 1, Sch. 5 para. 1(1)
F5Words in Art. 38(1) substituted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 35 para. 3(36)(b)(ii)(aa); 2020 c. 1, Sch. 5 para. 1(1)
F6Words in Art. 38(1) substituted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 35 para. 3(36)(b)(ii)(bb); 2020 c. 1, Sch. 5 para. 1(1)
F7Word in Art. 38(1) substituted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 35 para. 3(36)(b)(iii)(aa); 2020 c. 1, Sch. 5 para. 1(1)
F8Word in Art. 38(1) substituted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 35 para. 3(36)(b)(iii)(bb); 2020 c. 1, Sch. 5 para. 1(1)
F9Art. 38(2) omitted (31.12.2020) by virtue of The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 35 para. 3(36)(c); 2020 c. 1, Sch. 5 para. 1(1)
F10Words in Art. 38(3) omitted (31.12.2020) by virtue of The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 35 para. 3(36)(d); 2020 c. 1, Sch. 5 para. 1(1)
F11Word in Art. 38(4) substituted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 35 para. 3(36)(e)(i)(aa); 2020 c. 1, Sch. 5 para. 1(1)
F12Word in Art. 38(4) omitted (31.12.2020) by virtue of The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 35 para. 3(36)(e)(i)(bb); 2020 c. 1, Sch. 5 para. 1(1)
F13Words in Art. 38(4) substituted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 35 para. 3(36)(e)(i)(cc); 2020 c. 1, Sch. 5 para. 1(1)
F14Words in Art. 38(4) omitted (31.12.2020) by virtue of The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 35 para. 3(36)(e)(ii); 2020 c. 1, Sch. 5 para. 1(1)
F15Art. 38(5)-(8) omitted (31.12.2020) by virtue of The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 35 para. 3(36)(f); 2020 c. 1, Sch. 5 para. 1(1)
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