Harmonised standards: providing clarification

published on 10 October 2024 | reading time approx. 4 minutes

Harmonised standards are a key element in ensuring the free movement of products within the EU market. They offer technical standards which, if replicated, guarantee uniformity in the application of product legislation. Furthermore, when expressly referred to by a regulation, the burden of proof of a possible non-conformity of a product, process or service shifts to the competent authority.

This contribution not only clarifies their difference from other quasi-homonymous regulatory instruments, but also outlines the legal effects of their adoption.

What is a harmonised standard?

Article 2(1) of Regulation (EU) 1025/2012 defines it as a document issued by a recognised standardisation body dictating the technical requirements that a particular product, process, service or system may satisfy (a document also known as a ‘technical specification’)¹. The use of the term ‘standard’ could be more easily understood if replaced by the term ‘standard’.

Standards are also ‘harmonised’ when they are adopted at the request of the European Commission for the application of Union legislation (Art. 2(1)(c), Reg. (EU) 1025/2012) and their references are published in the Official Journal of the European Union.

Harmonised standards and harmonised legislation: what are the differences?

The term ‘harmonised standard’, an unfortunate translation of ‘harmonised standard’, could be confused with ‘harmonised legislation’. However, ‘harmonised standard’ and ‘harmonised legislation’ are not synonymous: in fact, whereas ‘harmonised standard’ refers to technical specifications that are issued by European standardisation bodies at the request of the Commission, the expression ‘harmonised legislation’ means provisions (such as regulations and directives) that are adopted by the EU that lay down essential requirements for placing certain products on the European market, aimed primarily at protecting the health and safety of consumers (e.g. EU Reg. 2017/745 on medical devices or Reg. 1223/2009 on cosmetic products, Dir. 2009/48/EC on toy safety, etc.). Harmonised standards provide the technical specifications to demonstrate compliance with these requirements. In other words, harmonised legislation defines the ‘end’, while harmonised standards detail the ‘how’.

Not only that. Harmonised standards are of voluntary application, unlike harmonised legislation, which is mandatory.

What are the advantages for companies adopting harmonised standards?

The adoption of harmonised standards is not compulsory: an enterprise can freely decide whether or not to comply with them. Nevertheless, their use is advisable because the adoption of harmonised standards demonstrates that a product or service for which a technical specification exists achieves a certain level of quality, safety and reliability.

Furthermore, products that comply with the technical specifications contained in a harmonised standard are presumed to comply with harmonised European Union legislation. This is provided that the harmonised legislation explicitly states that the harmonised standards confer a presumption of conformity with the essential requirements to which they refer.

The presumption of conformity is useful in the event of challenges to the conformity of products by market surveillance authorities: in fact, when a company adopts a harmonised standard, the burden of proving the non-compliance of the product lies with the competent authority and not with the company. Where, on the other hand, the disputed good has not been produced in conformity with a harmonised standard, the onus is on the producing company to prove that the product complies with the safety and performance requirements dictated by European legislation.

One example in the cosmetics sector

Article 8 of Regulation (EC) 1223/2009 (Cosmetics Regulation) requires that, in order to ensure the proper functioning of the internal market and a high level of protection of human health, good manufacturing practices shall be respected in the manufacture of cosmetic products. The second paragraph of this article then clarifies that ‘where manufacturing takes place in accordance with the relevant harmonised standards, the references of which have been published in the Official Journal of the European Union, compliance with good manufacturing practice shall be presumed’.

The harmonised standard EN ISO 22716:2007 was published in the Official Journal of the European Union and prescribes how cosmetic products should be manufactured, controlled, stored and shipped. It does not, however, cover the safety aspects of personnel working in the establishment, nor does it cover environmental protection aspects.

Therefore, in the case of the adoption of EN ISO 22716:2007, the aspects relating to the production, control, storage and dispatch of cosmetic products are presumed to comply with the provisions of Article 8 of Regulation (EC) 1223/2009. Thus, in the event of a challenge by the competent authority (e.g. Ministry of Health), the latter will have to prove that the manufacturer has nonetheless violated the Cosmetics Regulation despite the adoption of harmonised standards. If, on the other hand, such standards had not been adopted, the burden of proof on the conformity of the cosmetics would be on the manufacturer.

Conclusions

Harmonised standards are a key tool for ensuring the quality, safety and conformity of products within the European single market. Companies that choose to comply with such standards can benefit from a presumption of conformity that reduces the risk of disputes with both competent authorities and other economic operators.

[1] Standardisation bodies can be international (ISO and IEC), European (CEN, Cenelec and ETSI) or national (in Italy: UNI and CEI).