{
  "type": "problem",
  "slug": "which-standards",
  "lang": "en",
  "url": "https://www.conphora.com/solutions/problem/which-standards/",
  "markdown": "https://www.conphora.com/solutions/problem/which-standards.md",
  "title": "Which harmonised standards should we test against?",
  "description": "How to find the harmonised standards for a product: the act's requirements, the Commission's published lists, partial application and what standards do.",
  "answer": "Harmonised standards are voluntary European standards whose references the Commission publishes in the Official Journal for a specific act. Applying them gives a presumption of conformity with the requirements they cover. Start from the acts that apply, take the Commission's list for each act, choose the standards that match your product's hazards and functions, and record which parts you applied.",
  "theme": {
    "id": "documentation",
    "label": "Documentation and declarations"
  },
  "roles": [
    {
      "id": "manufacturer",
      "label": "Manufacturer"
    }
  ],
  "regulations": [
    "LVD",
    "EMC",
    "RED",
    "TSD",
    "GPSR"
  ],
  "path": [
    "regulation-library",
    "knowledge-articles"
  ],
  "trigger": "A test lab asks which standards to test against, or a quotation lists standards you cannot judge",
  "keep": null,
  "why": [
    {
      "text": "A standard is a tool, not a rule. Regulation (EU) No 1025/2012 defines a standard as a technical specification adopted by a recognised standardisation body \"with which compliance is not compulsory\", and a harmonised standard as a European standard adopted on the basis of a request made by the Commission for the application of Union harmonisation legislation (Article 2(1)(c)). Where a harmonised standard satisfies the requirements it aims to cover, the Commission publishes its reference in the Official Journal (Article 10(6)). The Commission's harmonised standards pages give access to the latest lists of references, organised per act, and state that the use of these standards remains voluntary.",
      "sources": [
        2,
        6
      ]
    },
    {
      "text": "Publication is what gives a standard its effect. Under the Low Voltage Directive 2014/35/EU, electrical equipment that conforms to harmonised standards, or parts of them, whose references have been published in the Official Journal is presumed to conform to the safety objectives those standards cover (Article 12). Where no harmonised standard has been drawn up and published, the directive gives a role to IEC standards and then to national standards (Articles 13 and 14). The Radio Equipment Directive 2014/53/EU (Article 16) and the toy directive (Directive 2009/48/EC Article 13) contain the same presumption.",
      "sources": [
        1,
        5,
        3
      ]
    },
    {
      "text": "Not applying a standard is allowed, but it has consequences. The low voltage technical file must list the standards applied in full or in part and, where none were applied, describe the solutions adopted to meet the safety objectives (Annex III point 2(d)). For toys, internal production control is only available where the manufacturer has applied harmonised standards covering all relevant safety requirements. Otherwise, or where a standard is published with a restriction, the toy goes to EC-type examination (Directive 2009/48/EC Article 19(2) and (3)). The Toy Safety Regulation (EU) 2025/2509 repeals the directive and applies from 1 August 2030 (Articles 56 and 59); check its procedures for toys placed on the market from that date. Radio equipment has a similar rule for the requirements in Article 3(2) and (3) (Directive 2014/53/EU Article 17(3) and (4)).",
      "sources": [
        1,
        3,
        5
      ]
    },
    {
      "text": "Products without a CE act use standards too. Under the General Product Safety Regulation (EU) 2023/988, a product that conforms to European standards whose references are published under Article 10(7) of Regulation (EU) No 1025/2012 is presumed to meet the general safety requirement for the risks those standards cover (Article 7(1)(a)). Where that presumption does not apply, other European, international and national standards are among the elements taken into account (Article 8(1)). The technical documentation lists the standards applied and identifies parts applied only in part (Article 9(2)).",
      "sources": [
        4
      ]
    }
  ],
  "steps": [
    {
      "name": "Start from the acts, not from the standards",
      "text": "Settle which acts apply to the product first. A standard only gives a presumption of conformity for the act under which its reference is published, and only for the requirements it covers.",
      "item": "regulation-library"
    },
    {
      "name": "Open the Commission's list for each act",
      "text": "The Commission publishes, per act, the references of harmonised standards published in the Official Journal. Use the current list for each act that applies to the product, and note the date you checked it."
    },
    {
      "name": "Match standards to hazards and functions",
      "text": "Most products need more than one standard: a product family standard where one exists, and general standards for hazards it does not cover, such as electromagnetic emissions or radio spectrum. Map each essential requirement of the act to the standard, or the part of it, that covers it.",
      "item": "knowledge-articles"
    },
    {
      "name": "Decide what to do where no standard fits",
      "text": "Where no harmonised standard covers a requirement, describe your own technical solution in the file, or use the international or national standards the act allows. For toys and for some radio requirements, not applying a full harmonised standard means a notified body examination."
    },
    {
      "name": "Write the choice into the technical file",
      "text": "List the standards with their editions, say whether each was applied in full or in part, and name the parts applied. Give the test lab this list, so the report covers exactly the clauses you rely on."
    }
  ],
  "documents": [
    {
      "name": "A requirements-to-standards map per product",
      "from": "The manufacturer",
      "ground": "Directive 2014/35/EU Annex III point 2(d)"
    },
    {
      "name": "The list of standards applied, with edition and the parts applied",
      "from": "The manufacturer",
      "ground": "Directive 2014/35/EU Annex III point 2(d); GPSR Article 9(2)(b)"
    },
    {
      "name": "Test reports against those standards",
      "from": "The test lab",
      "ground": "Directive 2014/35/EU Annex III point 2(f)"
    }
  ],
  "risks": [
    {
      "title": "No presumption outside the published references",
      "text": "Presumption of conformity covers only harmonised standards, or parts of them, whose references have been published in the Official Journal, and only the requirements they cover (Directive 2014/35/EU Article 12; Directive 2014/53/EU Article 16).",
      "source": 1
    },
    {
      "title": "Partial application changes the toy procedure",
      "text": "Where harmonised standards covering all relevant safety requirements do not exist, or the manufacturer has not applied them or has applied them only in part, the toy must undergo EC-type examination by a notified body (Directive 2009/48/EC Article 19(3)).",
      "source": 3
    },
    {
      "title": "A presumption does not stop an authority",
      "text": "Under the GPSR, the presumption of conformity does not prevent market surveillance authorities from taking measures where there is evidence that the product is dangerous (GPSR Article 7(3)).",
      "source": 4
    }
  ],
  "faq": [
    {
      "q": "Are harmonised standards mandatory?",
      "a": "No. A standard is a technical specification with which compliance is not compulsory (Regulation (EU) No 1025/2012 Article 2(1)). Applying a harmonised standard whose reference is published gives a presumption of conformity (Directive 2014/35/EU Article 12)."
    },
    {
      "q": "What is the difference between a European and a harmonised standard?",
      "a": "A harmonised standard is a European standard adopted on the basis of a request made by the Commission for the application of Union harmonisation legislation (Regulation (EU) No 1025/2012 Article 2(1)(c)). Its reference is published in the Official Journal when it meets the requirements it aims to cover (Article 10(6))."
    },
    {
      "q": "Our product has no CE act. Do standards matter?",
      "a": "Yes. Under the GPSR, a product is presumed to meet the general safety requirement where it conforms to European standards whose references are published under Article 10(7) of Regulation (EU) No 1025/2012 (GPSR Article 7(1)(a)). Other standards are taken into account under Article 8(1)."
    },
    {
      "q": "Can we apply only part of a standard?",
      "a": "Yes, but say so. The low voltage file must list the standards applied in full or in part and specify the parts applied (Directive 2014/35/EU Annex III point 2(d)). The GPSR file must identify the parts applied (Article 9(2))."
    },
    {
      "q": "Who decides which standards apply, the test lab or us?",
      "a": "The manufacturer. It draws up the technical documentation and carries out the conformity assessment, or has it carried out (Directive 2014/35/EU Article 6(2)). A lab can advise, but the declaration is issued under the manufacturer's sole responsibility (Annex IV item 3)."
    }
  ],
  "sources": [
    {
      "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"
    },
    {
      "title": "Regulation (EU) No 1025/2012 on European standardisation (consolidated text of 13 December 2024)",
      "publisher": "EUR-Lex",
      "url": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02012R1025-20241213",
      "accessed": "2026-10-04"
    },
    {
      "title": "Directive 2009/48/EC on the safety of toys (consolidated text of 29 August 2026)",
      "publisher": "EUR-Lex",
      "url": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02009L0048-20260829",
      "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"
    },
    {
      "title": "Directive 2014/53/EU on radio equipment (consolidated text of 30 May 2026)",
      "publisher": "EUR-Lex",
      "url": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02014L0053-20260530",
      "accessed": "2026-10-04"
    },
    {
      "title": "Harmonised standards",
      "publisher": "European Commission",
      "url": "https://single-market-economy.ec.europa.eu/single-market/goods/european-standards/harmonised-standards_en",
      "accessed": "2026-10-04"
    }
  ],
  "related": [
    "test-report-outdated",
    "which-regulations-apply",
    "notified-body-needed",
    "needs-ce-marking",
    "first-declaration-of-conformity"
  ],
  "reviewer": "Conphora compliance team",
  "reviewedAt": "2026-10-04",
  "notice": "General information, not legal advice."
}