{
  "type": "problem",
  "slug": "which-regulations-apply",
  "lang": "en",
  "url": "https://www.conphora.com/solutions/problem/which-regulations-apply/",
  "markdown": "https://www.conphora.com/solutions/problem/which-regulations-apply.md",
  "title": "We do not know which regulations apply to our product",
  "description": "How to map the EU rules for one product: GPSR scope and exclusions, the harmonisation acts in Annex I to Regulation 2019/1020, and labelling acts.",
  "answer": "Start with the General Product Safety Regulation, which covers consumer products unless excluded or covered by specific Union safety rules. Then screen the Union harmonisation acts listed in Annex I to Regulation (EU) 2019/1020 against the product's features, add information and labelling acts such as energy, textile or footwear labelling, and note which risks the GPSR still covers. Record the map per product.",
  "theme": {
    "id": "placing-on-market",
    "label": "Placing a product on the market"
  },
  "roles": [
    {
      "id": "manufacturer",
      "label": "Manufacturer"
    },
    {
      "id": "importer",
      "label": "Importer"
    },
    {
      "id": "online-seller",
      "label": "Online seller"
    }
  ],
  "regulations": [
    "GPSR",
    "LVD",
    "ELR",
    "FtLblD",
    "TexR",
    "CosR"
  ],
  "path": [
    "free-compliance-check",
    "product-validation"
  ],
  "trigger": "A new product line, a new supplier or a buyer's questionnaire asks which EU regulations the product complies with",
  "keep": null,
  "why": [
    {
      "text": "The General Product Safety Regulation is the starting point because it is the widest net. It covers any item supplied or made available that is intended for consumers or likely, under reasonably foreseeable conditions, to be used by them even if not intended for them (Article 3(1)), whether new, used, repaired or reconditioned (Article 2(3)). It excludes a fixed list, including medicinal products, food, feed, living plants and animals, plant protection products and antiques (Article 2(2)). It applies from 13 December 2024 (Article 52).",
      "sources": [
        1
      ]
    },
    {
      "text": "The GPSR then steps back where more specific Union rules exist. It applies insofar as there are no specific provisions with the same objective regulating the safety of the products concerned; where specific safety requirements exist, it covers only the aspects and risks they do not (Article 2(1)). For products subject to specific requirements imposed by Union harmonisation legislation, its safety chapter (Chapter II) does not apply to the risks that legislation covers (Article 2(1)(a)), and its Chapter IIa, Chapter III Section 1 (the duties of economic operators in Articles 9 to 18), and Chapters V, VII and IX to XI do not apply at all (Article 2(1)(b), as amended by Regulation (EU) 2024/2748). The online-sales duties of Article 19 sit in Section 2 and are not in that list. REACH and labelling acts such as the footwear and textile rules are also listed in Annex I to Regulation (EU) 2019/1020, to which the GPSR's definition of Union harmonisation legislation refers (Article 3(27)). The Commission nonetheless reads the GPSR as applying fully to everyday goods such as furniture and childcare articles that REACH also restricts (Commission Notice C/2025/6233, section 2.2), and Conphora follows that reading: a product-specific harmonisation act switches Articles 9 to 18 off, while REACH, the POPs rules and labelling-only acts apply alongside them.",
      "sources": [
        1
      ]
    },
    {
      "text": "Union harmonisation legislation has a precise meaning: the acts listed in Annex I to Regulation (EU) 2019/1020 and any other Union legislation harmonising the conditions for marketing products to which that regulation applies (GPSR Article 3(27)). Annex I is a practical checklist. It names, among others, the Low Voltage, EMC and Radio Equipment Directives, the Toy Safety Directive, the Battery and Packaging Regulations, the energy labelling framework, the textile labelling regulation, the footwear labelling directive, the cosmetics regulation and the units of measurement directive. Each act's scope article decides whether it applies: the Low Voltage Directive, for example, covers electrical equipment rated 50 to 1 000 V AC or 75 to 1 500 V DC (Directive 2014/35/EU Article 1).",
      "sources": [
        1,
        2,
        4
      ]
    },
    {
      "text": "Not every act is about safety. The energy labelling framework applies to energy-related products, and its labelling duties bite where a delegated act covers the product group (Regulation (EU) 2017/1369 Articles 1, 3, 4 and 16); it adds labels, a product information sheet and a database entry. Labelling acts like these are easy to miss because they do not change the product's design, yet a product that lacks a required label does not conform to applicable harmonisation legislation, and authorities act on that (Regulation (EU) 2019/1020 Article 16(1)(b)).",
      "sources": [
        2,
        3
      ]
    },
    {
      "text": "The result should be written down. A manufacturer of a product under the GPSR draws up technical documentation before placing it on the market and keeps it up to date (Article 9(2) and (3)); the text does not require a separate record of which acts apply, but keeping one with that documentation is a practical choice. For products under the harmonisation acts listed in Article 4(5) of Regulation (EU) 2019/1020, an economic operator in the EU verifies that the declaration of conformity and technical documentation required by those acts exist (Article 4(1) and (3)).",
      "sources": [
        1,
        2
      ]
    }
  ],
  "steps": [
    {
      "name": "Check that the product is a consumer product and not excluded",
      "text": "The GPSR applies to any item intended for consumers or likely to be used by them under reasonably foreseeable conditions, new, used, repaired or reconditioned. It excludes, among others, medicinal products, food, feed, living plants and animals, plant protection products and antiques. An excluded product follows its own regime.",
      "item": "free-compliance-check"
    },
    {
      "name": "Screen the harmonisation acts in Annex I to Regulation 2019/1020",
      "text": "The GPSR defines Union harmonisation legislation as the acts in Annex I to Regulation (EU) 2019/1020 and other acts harmonising the marketing of products. Go through that list by product feature: mains power, electronics, radio, use by children, pressure, chemicals, batteries, packaging. Read the scope article of each act that might fit."
    },
    {
      "name": "Add the information and labelling acts",
      "text": "Some acts do not concern safety but what the product or its label must say: energy labelling for product groups with a delegated act, textile fibre names, footwear materials, cosmetics labelling and units of measurement. They apply alongside the safety rules and are easy to miss."
    },
    {
      "name": "Work out what the GPSR still covers",
      "text": "For a product with no specific Union safety rules, the GPSR applies in full. Where specific safety rules exist, it covers only the risks they do not. For products under a product-specific harmonisation act, such as a CE act, its safety chapter applies only to uncovered risks, and several chapters, including the operator duties of Chapter III Section 1, do not apply. REACH restrictions, the POPs rules and labelling-only acts do not switch those duties off."
    },
    {
      "name": "Record the result per product and keep it current",
      "text": "Write the acts that apply, the articles that decided it and the date of the check into the technical documentation. Repeat the check when the product, its intended users or the law changes, and for every variant whose features differ.",
      "item": "product-validation"
    }
  ],
  "documents": [
    {
      "name": "A regulation map per product: acts considered, acts that apply and why, date of the check",
      "from": "The manufacturer, or the importer for its own records",
      "ground": "Supporting record for GPSR Article 9(2) and (3) and Regulation (EU) 2019/1020 Annex I; the text does not require a separate map"
    },
    {
      "name": "For each harmonisation act that applies, the documents it prescribes",
      "from": "The manufacturer",
      "ground": "The act's own documentation article; Regulation (EU) 2019/1020 Article 4(3)(a) for the acts listed in its Article 4(5)"
    }
  ],
  "risks": [
    {
      "title": "A missed act means a non-conforming product",
      "text": "Where a product subject to harmonisation legislation does not conform to it, authorities require corrective action within a set period and, if it is not taken, ensure withdrawal, recall or a sales ban (Regulation (EU) 2019/1020 Article 16(1), (2) and (5)).",
      "source": 2
    },
    {
      "title": "Distributors and importers must hold the product back",
      "text": "An importer that has reason to believe a product does not meet the general safety requirement or the documentation and identification duties does not place it on the market; a distributor in the same position does not make it available (GPSR Articles 11(2) and 12(3)).",
      "source": 1
    },
    {
      "title": "Dangerous products trigger immediate action",
      "text": "A manufacturer that has reason to believe its product is dangerous immediately takes corrective measures, informs consumers and notifies the authorities through the Safety Business Gateway (GPSR Article 9(8)).",
      "source": 1
    }
  ],
  "faq": [
    {
      "q": "Is there one official list of all product regulations?",
      "a": "Not of all of them. Annex I to Regulation (EU) 2019/1020 lists the Union harmonisation legislation that regulation applies to, and the GPSR uses it in its definition (GPSR Article 3(27)). National rules for non-harmonised aspects come on top."
    },
    {
      "q": "Our product is for professionals only. Does the GPSR apply?",
      "a": "The GPSR covers items intended for consumers or likely, under reasonably foreseeable conditions, to be used by consumers even if not intended for them (GPSR Article 3(1)). Professional-only products can still fall under harmonisation acts such as the Low Voltage Directive."
    },
    {
      "q": "Does the GPSR apply to second-hand goods?",
      "a": "Yes, to products placed or made available whether new, used, repaired or reconditioned, but not to products clearly marked as needing repair or reconditioning before use (GPSR Article 2(3))."
    },
    {
      "q": "One act applies. Can we stop looking?",
      "a": "No. Several acts often apply together, for example a safety act and a labelling act. Specific safety rules only displace the GPSR for the risks they cover (GPSR Article 2(1))."
    },
    {
      "q": "Which date does the GPSR apply from?",
      "a": "From 13 December 2024 (GPSR Article 52)."
    }
  ],
  "sources": [
    {
      "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"
    },
    {
      "title": "Regulation (EU) 2019/1020 on market surveillance and compliance of products (consolidated text of 12 August 2026)",
      "publisher": "EUR-Lex",
      "url": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02019R1020-20260812",
      "accessed": "2026-10-04"
    },
    {
      "title": "Regulation (EU) 2017/1369 setting a framework for energy labelling (consolidated text of 1 May 2021)",
      "publisher": "EUR-Lex",
      "url": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R1369-20210501",
      "accessed": "2026-10-04"
    },
    {
      "title": "Directive 2014/35/EU on electrical equipment designed for use within certain voltage limits (consolidated text of 30 May 2026)",
      "publisher": "EUR-Lex",
      "url": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02014L0035-20260530",
      "accessed": "2026-10-04"
    }
  ],
  "related": [
    "needs-ce-marking",
    "first-product-launch",
    "new-regulation",
    "sell-in-europe",
    "which-role-are-we"
  ],
  "reviewer": "Conphora compliance team",
  "reviewedAt": "2026-10-05",
  "notice": "General information, not legal advice."
}