Regulation (EU) 2016/425 of the European Parliament and of the CouncilDangos y teitl llawn

CHAPTER III U.K. CONFORMITY OF THE PPE

[F1 Article 14 U.K. Presumption of conformity of PPE

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

F1 Art. 14 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(13); 2020 c. 1, Sch. 5 para. 1(1)

Article 15 U.K. F2 ... Declaration of conformity

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 [F5 in English].

[F6 3. 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

F2 Word 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)

F3 Word 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)

F4 Word 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)

F5 Words 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)

F6 Art. 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)

F7 Word 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)

Article 16 U.K. General principles of the [F8 UK] marking

The [F9 UK] marking shall be subject to the general principles set out in Article 30 of Regulation (EC) No 765/2008.

Textual Amendments

F8 Word 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)

F9 Word 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)

Article 17 U.K. Rules and conditions for affixing the [F10 UK] marking

[F11 A1. Paragraph 1 is subject to paragraph 1A.]

1. The [F12 UK] 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.

[F13 1A. For a period of [F14 seven 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 [F12 UK] marking shall be affixed before the PPE is placed on the market.

3. For category III PPE, the [F12 UK] marking shall be followed by the identification number of the [F15 approved] body involved in the procedure set out in Annex VII or VIII.

The identification number of the [F15 approved] body shall be affixed by the body itself or, under its instructions, by the manufacturer or his authorised representative.

4. The [F12 UK] marking and, where applicable, the identification number of the [F16 approved] body may be followed by a pictogram or other marking indicating the risk against which the PPE is intended to protect.

F17 5. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F10 Word 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)

F11 Art. 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)

F12 Word 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)

F13 Art. 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)

F14 Words 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)

F15 Word 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)

F16 Word 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)

F17 Art. 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)