Harmonised Standard
Definition
A harmonised standard is a European standard adopted by a European standardisation organisation on the basis of a request from the European Commission in support of Union harmonisation legislation, and whose reference has been published in the Official Journal of the European Union.
Expanded Explanation
Three conditions matter. The standard must be produced by CEN, CENELEC or ETSI; it must respond to a formal standardisation request from the Commission; and its reference must be cited in the Official Journal. A European standard that fails any of these is a useful technical document but not a harmonised standard, and it carries no special legal effect.
Applying a harmonised standard is voluntary. Its value is that conformity with it confers a presumption of conformity with the requirements it covers, which shifts the burden of argument when an authority asks how a requirement was met.
For Digital Product Passports, standardisation work is being carried out under a Commission request to CEN-CENELEC, including through Joint Technical Committee 24. Until references are cited in the Official Journal, that work informs practice but does not yet confer presumption of conformity.
Why It Matters
Standards decide how much a compliance argument has to be constructed from first principles. Knowing which standards are cited, and which are merely published, is the difference between a short justification and a long one.
Legal and Regulatory Context
Regulation (EU) No 1025/2012 on European standardisation defines harmonised standards. Regulation (EU) 2024/1781 attaches the presumption of conformity to them for ecodesign requirements.
Relationship to Adjacent Concepts
Harmonised standards are the usual route to presumption of conformity; common specifications are the fallback the Commission may adopt where suitable standards are unavailable.
Common Misconceptions
Only standards whose references are published in the Official Journal under the relevant legislation are harmonised. Most EN standards are not.
Related Terms
Related Knowledge Base Articles
- How Conformity Assessment Works for Digital Product Passports
- How Will Digital Product Passports Change Product Compliance?
Related Articles
- Presumption of Conformity
- Conformity Assessment
- EU Declaration of Conformity
- Notified Body
- Technical Documentation
- Authorised Representative
- Corrective Action
- Market Surveillance
See Also
References
- Regulation (EU) No 1025/2012 on European standardisation: https://eur-lex.europa.eu/eli/reg/2012/1025/oj
- Regulation (EU) 2024/1781 establishing a framework for ecodesign requirements: https://eur-lex.europa.eu/eli/reg/2024/1781/oj
- CEN-CENELEC, Joint Technical Committee 24 Digital Product Passport: https://www.cencenelec.eu/areas-of-work/cen-cenelec-topics/digital-product-passport/
About This Article
tieback Knowledge is a continuously maintained reference library covering Digital Product Passports, product traceability, product compliance and related regulations. Articles are reviewed regularly as legislation, standards and implementation guidance evolve.