Which harmonised standards should we test against?

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.^[2][6]

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.^[1][5][3]

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)).^[1][3][5]

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)).^[4]