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)

Changes over time for: Article 10

Alternative versions:

Changes to legislation:

There are outstanding changes not yet made to Regulation (EU) 2016/425 of the European Parliament and of the Council. Any changes that have already been made to the legislation appear in the content and are referenced with annotations.

Changes to Legislation

Revised legislation carried on this site may not be fully up to date. Changes and effects are recorded by our editorial team in lists which can be found in the ‘Changes to Legislation’ area. Where those effects have yet to be applied to the text of the legislation by the editorial team they are also listed alongside the legislation in the affected provisions. Use the ‘more’ link to open the changes and effects relevant to the provision you are viewing.

View outstanding changes

Changes and effects yet to be applied to the whole legislation item and associated provisions

Art. 3(2) words substituted by S.I. 2019/696 Sch. 35 para. 3(4)(a) (This amendment not applied to legislation.gov.uk. Sch. 35 para. 3(4)(a) substituted immediately before IP completion day by S.I. 2020/1460, reg. 1(4), Sch. 3 para. 24(4))
Art. 3(3) words substituted by S.I. 2019/696 Sch. 35 para. 3(4)(a) (This amendment not applied to legislation.gov.uk. Sch. 35 para. 3(4)(a) substituted immediately before IP completion day by S.I. 2020/1460, reg. 1(4), Sch. 3 para. 24(4))
Art. 3(5) substituted by S.I. 2019/696 Sch. 35 para. 3(4)(b) (This amendment not applied to legislation.gov.uk. Sch. 35 para. 3(4)(b) omitted immediately before IP completion day by virtue of S.I. 2020/1460, reg. 1(4), Sch. 3 para. 3)
Art. 3(5) words substituted in earlier amending provision S.I. 2019/696, Sch. 35 para. 3(4)(b) by S.I. 2020/852 reg. 4(2) Sch. 1 para. 1(u)(ii) (This amendment not applied to legislation.gov.uk. Sch. 1 para. 1(u)(ii) omitted immediately before it comes into force by virtue of S.I. 2020/1460, regs. 1(3), Sch. 4 para. 1(3))
Art. 24(2A) inserted by S.I. 2024/504 reg. 17(b)

Article 10U.K.Obligations of importers

1.Importers shall place only compliant PPE on the market.

2.Before placing PPE on the market, importers shall ensure that the appropriate conformity assessment procedure referred to in Article 19 has been carried out by the manufacturer. They shall ensure that the manufacturer has drawn up the technical documentation, that the PPE bears the [F1UK] marking and is accompanied by the required documents, and that the manufacturer has complied with the requirements set out in Article 8(5) and (6).

Where an importer considers or has reason to believe that PPE is not in conformity with the applicable essential health and safety requirements set out in Annex II, he shall not place it on the market until it has been brought into conformity. Furthermore, where the PPE presents a risk, the importer shall inform the manufacturer and the market surveillance [F2authority] to that effect.

3.Importers shall indicate, on the PPE, their name, registered trade name or registered trade mark and the postal address at which they can be contacted F3.... The contact details shall be in a language easily understood by end-users and market surveillance [F4authority].

[F5The obligation set out in this paragraph 3 to indicate information on the PPE does not apply where—

(a)either—

(i)it is not possible to indicate that information on the PPE, or

(ii)the importer has imported the PPE from an EEA state or Switzerland and places it on the market within the period of [F6seven years] beginning with IP completion day, and

(b)before placing the PPE on the market, the importer sets out the information referred to in this paragraph 3 on the packaging of the PPE or in a document accompanying the PPE.]

4.Importers shall ensure that the PPE is accompanied by the instructions and information set out in point 1.4 of Annex II [F7and that they are clear, legible and in easily understandable English].

5.Importers shall ensure that, while the PPE is under their responsibility, storage or transport conditions do not jeopardise its conformity with the applicable essential health and safety requirements set out in Annex II.

6.When deemed appropriate with regard to the risks presented by PPE, importers shall, to protect the health and safety of consumers and other end-users, carry out sample testing of PPE made available on the market, investigate, and, if necessary, keep a register of complaints, of non-conforming PPE and PPE recalls, and shall keep distributors informed of any such monitoring.

7.Importers who consider or have reason to believe that PPE which they have placed on the market is not in conformity with this Regulation shall immediately take the corrective measures necessary to bring the PPE into conformity, to withdraw it or to recall it, as appropriate. Furthermore, where the PPE presents a risk, importers shall immediately inform the [F8enforcement authority] to that effect, giving details, in particular, of the non-conformity and of any corrective measures taken.

8.Importers shall, for 10 years after the PPE has been placed on the market, keep a copy of the F9... declaration of conformity at the disposal of the market surveillance [F10authority] and ensure that the technical documentation can be made available to [F11that authority], upon request.

9.Importers shall, further to a reasoned request from [F12the enforcement authority], provide it with all the information and documentation, in paper or electronic form, necessary to demonstrate the conformity of PPE in a language which can be easily understood by that authority. They shall cooperate with that authority, at its request, on any action taken to eliminate the risks posed by PPE which they have placed on the market.

Textual Amendments

F1Word in Art. 10(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(10)(a)(i); 2020 c. 1, Sch. 5 para. 1(1)

F2Word in Art. 10(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(10)(a)(ii); 2020 c. 1, Sch. 5 para. 1(1)

F3Words in Art. 10(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(10)(b)(i); 2020 c. 1, Sch. 5 para. 1(1)

F4Word in Art. 10(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(10)(b)(ii); 2020 c. 1, Sch. 5 para. 1(1)

F5Words in Art. 10(3) inserted (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(10)(b)(iii) (as amended by S.I. 2019/1246, regs. 1(3), 5; S.I. 2020/1460, reg. 1(4), Sch. 3 para. 2(1)(n); and S.I. 2020/852, regs. 2(2), 4(2), Sch. 1 para. 1(u)(iv)); 2020 c. 1, Sch. 5 para. 1(1)