{
  "type": "problem",
  "slug": "ppe-or-not",
  "lang": "en",
  "url": "https://www.conphora.com/solutions/problem/ppe-or-not/",
  "markdown": "https://www.conphora.com/solutions/problem/ppe-or-not.md",
  "title": "We are unsure whether our product is protective equipment",
  "description": "When a product is PPE under Regulation (EU) 2016/425: the definition, the private-use exclusions, the three risk categories and their procedures.",
  "answer": "Equipment designed and manufactured to be worn or held by a person for protection against risks to that person's health or safety is personal protective equipment under Regulation (EU) 2016/425, unless Article 2 excludes it. PPE is classified by risk in Annex I. Category I uses internal production control; Categories II and III need a notified body. Consumer products outside it fall under the GPSR.",
  "theme": {
    "id": "placing-on-market",
    "label": "Placing a product on the market"
  },
  "roles": [
    {
      "id": "manufacturer",
      "label": "Manufacturer"
    },
    {
      "id": "importer",
      "label": "Importer"
    }
  ],
  "regulations": [
    "PPE",
    "GPSR"
  ],
  "path": [
    "regulation-library",
    "free-compliance-check"
  ],
  "trigger": "A glove, helmet, pair of glasses, garment, harness or similar product is described as protecting the wearer, and a buyer or marketplace asks whether it needs PPE certification",
  "keep": "Technical documentation and the EU declaration of conformity for 10 years after the PPE is placed on the market (Regulation (EU) 2016/425 Article 8(3))",
  "why": [
    {
      "text": "Whether a product is personal protective equipment (PPE) depends on its design and purpose, not on the product group. Regulation (EU) 2016/425 defines PPE as 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, together with interchangeable components essential for the protective function and connexion systems that link the equipment to an external device or anchorage point (Article 3(1)). The regulation applies from 21 April 2018 (Article 48), and the transitional rules for the old Directive 89/686/EEC have run out: products in conformity with that directive could be placed on the market until 21 April 2019 and still be made available after it (Article 47(1)), and certificates under it stayed valid until 21 April 2023 (Article 47(2)). Regulation (EU) 2024/2748 added internal market emergency rules to the regulation from 29 May 2026.",
      "sources": [
        1
      ]
    },
    {
      "text": "The regulation then excludes some equipment that fits the definition (Article 2(2)). It does not apply to PPE specifically designed for the armed forces or the maintenance of law and order, to PPE for self-defence except for sporting activities, to PPE for private use against atmospheric conditions that are not extreme or against damp and water during dishwashing, to PPE for exclusive use on seagoing vessels or aircraft under international treaties, or to head, face or eye protection covered by UNECE Regulation No 22 for motorcycle and moped riders.",
      "sources": [
        1
      ]
    },
    {
      "text": "For everything inside the scope, the risk category drives the procedure. Annex I sets three categories. Category I includes exclusively minimal risks: superficial mechanical injury, contact with weak cleaning materials or prolonged contact with water, hot surfaces not exceeding 50 °C, eye damage from sunlight, and non-extreme weather. Category III includes exclusively risks with very serious consequences such as death or irreversible damage to health, among them hazardous substances, falls from height, electric shock and live working, drowning, cuts by hand-held chainsaws and harmful noise. Category II covers all other risks.",
      "sources": [
        1
      ]
    },
    {
      "text": "Article 19 attaches a procedure to each category: internal production control for Category I, EU type-examination followed by conformity to type for Category II, and EU type-examination with either supervised product checks or quality assurance of production for Category III. For Category III the CE marking is followed by the identification number of the notified body (Article 17(3)). The manufacturer keeps the technical documentation and declaration for 10 years (Article 8(3)) and accompanies the PPE with instructions in a language easily understood, as determined by the Member State (Article 8(7)), plus the declaration or its internet address (Article 8(8)).",
      "sources": [
        1
      ]
    },
    {
      "text": "A product that falls outside the PPE definition, or inside an exclusion, is not unregulated. If it is a consumer product, it falls under the General Product Safety Regulation, which applies insofar as no specific Union provisions with the same objective regulate its safety (Article 2(1)) and requires an internal risk analysis and technical documentation before it is placed on the market (Article 9(2)).",
      "sources": [
        2
      ]
    }
  ],
  "steps": [
    {
      "name": "Test the PPE definition against the product",
      "text": "Ask two questions: is the product designed and manufactured to be worn or held by a person, and is its purpose to protect that person against one or more risks to health or safety? Interchangeable components essential for the protective function and certain connexion systems are PPE as well.",
      "item": "free-compliance-check"
    },
    {
      "name": "Check the exclusions in Article 2",
      "text": "The regulation does not apply to PPE for the armed forces or law enforcement, for self-defence other than in sport, for private use against non-extreme weather or against damp and water during dishwashing, for exclusive use on seagoing vessels or aircraft, or to motorcycle helmets and visors covered by UNECE Regulation No 22."
    },
    {
      "name": "Classify the risk category",
      "text": "Category I covers only the minimal risks listed in Annex I, such as superficial mechanical injury or hot surfaces up to 50 °C. Category III covers only the listed risks with very serious consequences, such as falls from height, electric shock or harmful noise. Everything else is Category II.",
      "item": "regulation-library"
    },
    {
      "name": "Follow the conformity route for that category",
      "text": "Category I: internal production control. Category II: EU type-examination by a notified body followed by conformity to type. Category III: EU type-examination plus supervised product checks or quality assurance of production; the CE marking is then followed by the notified body's identification number."
    },
    {
      "name": "Prepare the declaration and the instructions",
      "text": "Draw up the technical documentation of Annex III and the EU declaration of conformity, or give its internet address in the instructions. The instructions cover storage, use, cleaning, performance levels or classes, obsolescence where relevant, the risk the PPE protects against and the notified body involved."
    }
  ],
  "documents": [
    {
      "name": "A scope note: definition test, exclusions checked and the risk category chosen",
      "from": "The manufacturer, kept with the technical documentation",
      "ground": "Regulation (EU) 2016/425 Articles 2, 3(1) and Annex I"
    },
    {
      "name": "Technical documentation and the EU declaration of conformity",
      "from": "The manufacturer",
      "ground": "Regulation (EU) 2016/425 Articles 8(2)–(3) and 15"
    },
    {
      "name": "The EU type-examination certificate for Category II and III PPE",
      "from": "The notified body",
      "ground": "Regulation (EU) 2016/425 Article 19(b) and (c)"
    }
  ],
  "risks": [
    {
      "title": "Wrong category, wrong procedure",
      "text": "The conformity assessment procedure is set by the risk category in Annex I (Regulation (EU) 2016/425 Article 19); a Category II or III product assessed with internal production control alone has not been through the procedure the regulation requires.",
      "source": 1
    },
    {
      "title": "Improper use of the CE marking is acted on",
      "text": "Member States build on existing mechanisms to ensure correct application of the CE marking regime and take appropriate action in the event of improper use (Regulation (EU) 2016/425 Article 17(5)).",
      "source": 1
    },
    {
      "title": "Non-conforming PPE must be corrected, withdrawn or recalled",
      "text": "Manufacturers who consider or have reason to believe that PPE they placed on the market is not in conformity must immediately take corrective measures, withdraw or recall it as appropriate, and inform the authorities where it presents a risk (Regulation (EU) 2016/425 Article 8(9)).",
      "source": 1
    }
  ],
  "faq": [
    {
      "q": "Are sunglasses PPE?",
      "a": "Protection against damage to the eyes due to exposure to sunlight, other than during observation of the sun, is listed as a minimal risk in Category I (Regulation (EU) 2016/425 Annex I). Reading that list with the definition in Article 3(1), eyewear designed and manufactured to protect against it is Category I PPE; eyewear without that protective purpose is outside the definition."
    },
    {
      "q": "Are winter gloves or rain jackets PPE?",
      "a": "Not when designed for private use to protect against atmospheric conditions that are not extreme; that equipment is excluded (Regulation (EU) 2016/425 Article 2(2)(c)(i)). Dishwashing gloves for private use are excluded the same way (Article 2(2)(c)(ii))."
    },
    {
      "q": "We sell a fall-arrest harness. Which category is it?",
      "a": "Falling from a height is a Category III risk (Regulation (EU) 2016/425 Annex I), so the harness needs EU type-examination and a production module with a notified body, and the CE marking carries that body's number (Articles 17(3) and 19(c))."
    },
    {
      "q": "Are motorcycle helmets covered?",
      "a": "Head, face or eye protection for users that is covered by UNECE Regulation No 22 on protective helmets and visors for motorcycle and moped riders is excluded from the PPE Regulation (Article 2(2)(e))."
    },
    {
      "q": "What if our product is not PPE?",
      "a": "Then the General Product Safety Regulation applies to it as a consumer product insofar as no specific Union rules with the same objective cover its safety (Article 2(1)), with an internal risk analysis and technical documentation (Article 9(2))."
    }
  ],
  "sources": [
    {
      "title": "Regulation (EU) 2016/425 on personal protective equipment (consolidated text of 29 May 2026)",
      "publisher": "EUR-Lex",
      "url": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02016R0425-20260529",
      "accessed": "2026-10-04"
    },
    {
      "title": "Regulation (EU) 2023/988 on general product safety (consolidated text of 29 May 2026)",
      "publisher": "EUR-Lex",
      "url": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02023R0988-20260529",
      "accessed": "2026-10-04"
    }
  ],
  "related": [
    "needs-ce-marking",
    "which-regulations-apply",
    "first-product-launch",
    "medical-or-wellness",
    "toy-or-not"
  ],
  "reviewer": "Conphora compliance team",
  "reviewedAt": "2026-10-04",
  "notice": "General information, not legal advice."
}