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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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1.PPE which is in conformity with a designated standard or part thereof shall be presumed to be in conformity with the essential health and safety requirements set out in Annex II covered by that standard or part thereof.
2.The presumption in paragraph 1 is rebuttable.]
Textual Amendments
1.The F3... declaration of conformity shall state that the fulfilment of the applicable essential health and safety requirements set out in Annex II has been demonstrated.
2.The F4... declaration of conformity shall have the model structure set out in Annex IX, shall contain the elements specified in the relevant modules set out in Annexes IV, VI, VII and VIII and shall be continuously updated. It shall be [F5in English].
[F63.Where PPE is subject to more than one enactment requiring a declaration of conformity, the manufacturer must draw up a single declaration of conformity which identifies each enactment by its title.]
4.By drawing up the F7... declaration of conformity, the manufacturer shall assume responsibility for the compliance of the PPE with the requirements laid down in this Regulation.
Textual Amendments
F2Word in Art. 15 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(14)(a); 2020 c. 1, Sch. 5 para. 1(1)
F3Word in Art. 15(1) 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(14)(a); 2020 c. 1, Sch. 5 para. 1(1)
F4Word in Art. 15(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(14)(a); 2020 c. 1, Sch. 5 para. 1(1)
F5Words in Art. 15(2) substituted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 35 para. 3(14)(b); 2020 c. 1, Sch. 5 para. 1(1)
F6Art. 15(3) substituted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 35 para. 3(14)(c); 2020 c. 1, Sch. 5 para. 1(1)
F7Word in Art. 15(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(14)(a); 2020 c. 1, Sch. 5 para. 1(1)
The [F9UK] marking shall be subject to the general principles set out in Article 30 of Regulation (EC) No 765/2008.
Textual Amendments
F8Word in Art. 16 heading substituted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 35 para. 3(15); 2020 c. 1, Sch. 5 para. 1(1)
F9Word in Art. 16 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(15); 2020 c. 1, Sch. 5 para. 1(1)
[F11A1. Paragraph 1 is subject to paragraph 1A.]
1.The [F12UK] marking shall be affixed visibly, legibly and indelibly to the PPE. Where that is not possible or not warranted on account of the nature of the PPE, it shall be affixed to the packaging and to the documents accompanying the PPE.
[F131A.For a period of [F14seven years] months beginning with IP completion day, paragraph 1 does not apply where the UK marking is affixed to—
(a)a label affixed to the PPE; or
(b)a document accompanying the PPE.]
2.The [F12UK] marking shall be affixed before the PPE is placed on the market.
3.For category III PPE, the [F12UK] marking shall be followed by the identification number of the [F15approved] body involved in the procedure set out in Annex VII or VIII.
The identification number of the [F15approved] body shall be affixed by the body itself or, under its instructions, by the manufacturer or his authorised representative.
4.The [F12UK] marking and, where applicable, the identification number of the [F16approved] body may be followed by a pictogram or other marking indicating the risk against which the PPE is intended to protect.
F175.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Textual Amendments
F10Word in Art. 17 heading substituted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 35 para. 3(16)(a); 2020 c. 1, Sch. 5 para. 1(1)
F11Art. 17(A1) inserted (31.12.2020) by S.I. 2019/696, Sch. 35 para. 3(16)(aa) (as inserted by The Product Safety and Metrology etc. (Amendment etc.) (UK(NI) Indication) (EU Exit) Regulations 2020 ( S.I. 2020/1460), reg. 1(4), Sch. 3 para. 24(6)); 2020 c. 1, Sch. 5 para. 1(1)
F12Word in art. 17(1)-(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(16)(a); 2020 c. 1, Sch. 5 para. 1(1)
F13Art. 17(1A) inserted (31.12.2020) by S.I. 2019/696, reg. 1, Sch. 35 para. 3(16)(ab) (as inserted by The Product Safety and Metrology etc. (Amendment etc.) (UK(NI) Indication) (EU Exit) Regulations 2020 (S.I. 2020/1460), reg. 1(4), Sch. 3 para. 24(6)); 2020 c. 1, Sch. 5 para. 1(1)
F14Words in Art. 17(1A) substituted (31.12.2022) by The Product Safety and Metrology (Amendment and Transitional Provisions) Regulations 2022 (S.I. 2022/1393), regs. 1(1), 3, Sch. 2 para. (s)
F15Word in Art. 17(3) substituted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 35 para. 3(16)(b); 2020 c. 1, Sch. 5 para. 1(1)
F16Word in Art. 17(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(16)(c); 2020 c. 1, Sch. 5 para. 1(1)
F17Art. 17(5) 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(16)(d); 2020 c. 1, Sch. 5 para. 1(1)
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