2025 EU: Harmonisierte Normen

In the sea of standards, there is a bastion of calm: The harmonized standard (hEN)! However, there are numerous misunderstandings surrounding it. It is often assumed that a standard only becomes a harmonized standard when it is listed in the EU Official Journal. This does not correspond to the legal situation. Although the presumption of conformity arises with the publication of the reference in the Official Journal, the status of a harmonized standard is created by the European Commission's standardization mandate. This is clear from the definitions in the Standardization Regulation.

REGULATION (EU) No 1025/2012 (Standardization Regulation)

Article 2 - Definitions

For the purposes of this Regulation, "standard" means a technical specification adopted by a recognized standardization body for repeated or continuous application, compliance with which is not compulsory and which falls into one of the following categories

Paragraph 1(c) defines

"Harmonized Standard" means a European standard adopted on the basis of a mandate from the Commission for the implementation of Union harmonization legislation.

Thus, there are two conditions for a harmonized standard:

(1) The relevant standardization body must have received a formal mandate from the European Commission to draft a standard.

(2) The standard must cover the essential requirements of the relevant legislation. If it does not cover them completely, this must be explicitly stated.

The presumption of conformity does not arise from the listing itself, but from the fact that the standard meets the essential requirements of the relevant legislation and is based on a Commission mandate. Which essential requirements are covered by the respective harmonized standard is documented in Annex ZA in the case of hEN by CEN and in Annex ZZ in the case of CENELEC and in Annex A in the case of ETSI. Listing in the EU Official Journal is merely the final formal step that triggers the presumption of conformity with legal effect.

With regard to product liability, a manufacturer is nevertheless well advised to always use the latest version of a standard - regardless of whether it is already listed in the Official Journal. If a harmonized standard is not yet listed, it is up to the manufacturer to check whether the standard actually covers the essential requirements relevant to their product. This comparison should always be carried out anyway, as many product areas do not have a current, harmonized standard listed in the Official Journal at the same time.

From a liability law perspective, manufacturers should be guided by the "state of the art", which is regularly defined by the latest published standard. However, in this case, the benefit of the presumption of conformity no longer applies; compliance with the essential requirements must then be demonstrated and documented independently. The Blue Guide 2022 explains this role of harmonized standards in detail in section 4.1.2.2 ("The role of harmonized standards").

The procurement and management of standards in a company or organization brings with it a number of challenges - both strategic and operational:

- Finding the best possible source of supply
- Managing complexity and diversity
- Ensuring up-to-dateness
- Implementation and integration into processes
- Keeping employees' know-how up to date
- Ensuring adequate documentation
- Keeping an eye on ROI

How do you master all these challenges? GLOBALnorm is a comprehensive software solution that helps you to maintain an overview. Say goodbye to confusing spreadsheets and hello to a central platform that includes all relevant standards.

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Harmonized standards:What makes a harmonized standard a harmonized standard?

Harmonized standards:
What makes a harmonized standard a harmonized standard?