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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 11
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Article 11U.K.Obligations of distributors
1.When making PPE available on the market, distributors shall act with due care in relation to the requirements of this Regulation.
2.Before making PPE available on the market, distributors shall verify that it bears the [F1UK] marking, is accompanied by the required documents and by the instructions and information set out in point 1.4 of Annex II [F2and that they are clear, legible and in easily understandable English] and that the manufacturer and the importer have complied with the requirements set out in Article 8(5) and (6) and Article 10(3) respectively.
Where a distributor 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 make the PPE available on the market until it has been brought into conformity. Furthermore, where the PPE presents a risk, the distributor shall inform the manufacturer or the importer to that effect as well as the market surveillance [F3authority].
3.Distributors shall ensure that, while PPE is under their responsibility, its storage or transport conditions do not jeopardise its conformity with the applicable essential health and safety requirements set out in Annex II.
4.Distributors who consider or have reason to believe that PPE which they have made available on the market is not in conformity with this Regulation shall make sure that the corrective measures necessary to bring it into conformity, to withdraw it or to recall it, as appropriate, are taken. Furthermore, where the PPE presents a risk, distributors shall immediately inform the [F4enforcement authority] to that effect, giving details, in particular, of the non-conformity and of any corrective measures taken.
5.Distributors shall, further to a reasoned request from [F5the enforcement authority], provide it with all the information and documentation, in paper or electronic form, necessary to demonstrate the conformity of the PPE. They shall cooperate with that authority, at its request, on any action taken to eliminate the risks posed by PPE which they have made available on the market.
Textual Amendments
F1Word in Art. 11(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(11)(a)(i)(aa); 2020 c. 1, Sch. 5 para. 1(1)
F2Words in Art. 11(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(11)(a)(i)(bb); 2020 c. 1, Sch. 5 para. 1(1)
F3Word in Art. 11(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(11)(a)(ii); 2020 c. 1, Sch. 5 para. 1(1)
F4Words in Art. 11(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(11)(b); 2020 c. 1, Sch. 5 para. 1(1)
F5Words in Art. 11(5) 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(11)(c); 2020 c. 1, Sch. 5 para. 1(1)
Modifications etc. (not altering text)
C1Art. 11(2) restricted (E.) (31.12.2020) by The Personal Protective Equipment (Temporary Arrangements) (Coronavirus) (England) Regulations 2020 (S.I. 2020/1484), regs. 1(1), 2, 3
C2Art. 11(2) restricted (W.) (31.12.2020) by The Personal Protective Equipment (Temporary Arrangements) (Coronavirus) (Wales) Regulations 2020 (S.I. 2020/1489), regs. 1(1), 2, 3
C3Art. 11(2) restricted (S.) (1.2.2021) by The Personal Protective Equipment (Temporary Arrangements) (Coronavirus) (Scotland) Regulations 2021 (S.S.I. 2021/50), regs. 1, 2, 3 (with reg. 4(4))
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