{
  "url": "https://openlegislation.uk/eu-regulation-2016-425/article-3",
  "json_url": "https://openlegislation.uk/eu-regulation-2016-425/article-3.json",
  "legislation": "eur/2016/425",
  "legislation_title": "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)",
  "legislation_url": "https://openlegislation.uk/eu-regulation-2016-425",
  "path": "article/3",
  "kind": "article",
  "number": "3",
  "heading": "Definitions",
  "text": "For the purposes of this Regulation, the following definitions apply:\n(1)‘personal protective equipment’ (PPE) means:\n(a)equipment designed and manufactured to be worn or held by a person for protection against one or more risks to that person's health or safety;\n(b)interchangeable components for equipment referred to in point (a) which are essential for its protective function;\n(c)connexion systems for equipment referred to in point (a) that are not held or worn by a person, that are designed to connect that equipment to an external device or to a reliable anchorage point, that are not designed to be permanently fixed and that do not require fastening works before use;\n(2)‘making available on the market’ means any supply of PPE for distribution or use on the market of Great Britain in the course of a commercial activity, whether in return for payment or free of charge;\n(3)‘placing on the market’ means the first making available of PPE on the market of Great Britain;\n(4)‘manufacturer’ means any natural or legal person who manufactures PPE or has it designed or manufactured, and markets it under his name or trademark;\n(5)‘authorised representative’ means any natural or legal person established within the United Kingdom who has received a written mandate from a manufacturer to act on his behalf in relation to specified tasks;\n(6)importer” means a person who—\n(a)is established in the United Kingdom and places PPE from a country outside of the United Kingdom on the market; or\n(b)is established in Northern Ireland and places PPE on the market that has been supplied to them for distribution, consumption or use in the course of a commercial activity, whether in return for payment or free of charge, from an EEA state;\n(7)‘distributor’ means any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes PPE available on the market;\n(8)‘economic operators’ means the manufacturer, the authorised representative, the importer and the distributor;\n(9)‘technical specification’ means a document that prescribes technical requirements to be fulfilled by PPE;\n(10). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .\n(11). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .\n(12). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .\n(13)‘conformity assessment’ means the process demonstrating whether the essential health and safety requirements of this Regulation relating to PPE have been fulfilled;\n(14)‘conformity assessment body’ means a body that performs conformity assessment activities including calibration, testing, certification and inspection;\n(15)‘recall’ means any measure aimed at achieving the return of PPE that has already been made available to the end-user;\n(16)‘withdrawal’ means any measure aimed at preventing PPE in the supply chain from being made available on the market;\n(17). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .\n(18). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .\n(19)‘approved body’ has the meaning given in Article 20;\n(20)‘designated standard’ has the meaning given in Article 7A;\n(21)‘enforcement authority’ means a person enforcing this Regulation under regulation 4 of the Personal Protective Equipment (Enforcement) Regulations 2018 (S.I. 2018/390);\n(22)‘UK Marking’ means the marking in the form set out in Annex 2 of Regulation (EC) 765/2008 of the European Parliament and of the Council setting out the requirements for accreditation and market surveillance relating to the marketing of products, and repealing Regulation (EEC) 339/93;\n(23)‘UK national accreditation body’ means the body appointed by the Secretary of State in accordance with Article 4 of Regulation (EC) 765/2008 of the European Parliament and of the Council setting out the requirements for accreditation and market surveillance relating to the marketing of products, and repealing Regulation (EEC) 339/93;\n(24)‘Regulation 2016/425 (pre-exit)’ means Regulation (EU) 2016/425 of the European Parliament and of the Council on personal protective equipment and repealing Council Directive 89/686/EEC, as it had effect immediately before IP completion day;\n(25)In this Regulation, references to “the market surveillance authority” are to be construed in accordance with regulation 3 of the Personal Protective Equipment (Enforcement) Regulations 2018.",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Words in Art. 3(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(4)(a) (as substituted by S.I. 2020/1460, reg. 1(4), Sch. 3 para. 24(4)); 2020 c. 1, Sch. 5 para. 1(1)"
    },
    {
      "type": "F",
      "label": "F2",
      "text": "Words in Art. 3(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(4)(a) (as substituted by S.I. 2020/1460, reg. 1(4), Sch. 3 para. 24(4)); 2020 c. 1, Sch. 5 para. 1(1)"
    },
    {
      "type": "F",
      "label": "F3",
      "text": "Words in Art. 3(5) substituted (E.W.S.) (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (UK(NI) Indication) (EU Exit) Regulations 2020 (S.I. 2020/1460), reg. 1(2), Sch. 5 para. 1(6)(a)"
    },
    {
      "type": "F",
      "label": "F4",
      "text": "Art. 3(6) 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(4)(c) (as amended by S.I. 2020/1460, reg. 1(4), Sch. 3 para. 24(5)); 2020 c. 1, Sch. 5 para. 1(1)"
    },
    {
      "type": "F",
      "label": "F5",
      "text": "Art. 3(10)-(12) 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(4)(d); 2020 c. 1, Sch. 5 para. 1(1)"
    },
    {
      "type": "F",
      "label": "F6",
      "text": "Art. 3(17)(18) 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(4)(d); 2020 c. 1, Sch. 5 para. 1(1)"
    },
    {
      "type": "F",
      "label": "F7",
      "text": "Art. 3(19)-(25) 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(4)(e) (as amended by S.I. 2020/852, regs. 2(2), 4(2), Sch. 1 para. 1(u)(iii)); 2020 c. 1, Sch. 5 para. 1(1)"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eur/2016/425/article/3",
    "retrieved_at": "2026-11-01T14:45:58.157392+00:00"
  },
  "licence": "Open Government Licence v3.0",
  "licence_url": "https://www.nationalarchives.gov.uk/doc/open-government-licence/version/3/",
  "attribution": "Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives."
}