What are harmonised standards under GPSR and how do I find the right one for my product?
Harmonised standards are European standards that, when cited in the Official Journal of the European Union (OJEU), can help you demonstrate that your product meets relevant EU safety requirements under the GPSR and related product legislation. The most practical way to find the right standard is to first confirm which EU act applies to your product, then consult the OJEU list for that act and match the listed standards to your product’s hazards and features. This guide explains how.
What are harmonised standards under the GPSR, and what do they prove?
Harmonised standards are European standards developed by CEN, CENELEC, or ETSI following a request from the European Commission. They become “harmonised” when their references are published in the OJEU. Under the General Product Safety Regulation (EU) 2023/988 (GPSR), conformity with relevant cited European standards supports a presumption of safety for the risks those standards cover.
This presumption is not absolute. Market surveillance authorities can still act if they have evidence that a product is dangerous, even if testing shows compliance with a standard. Also, standards only cover what they cover, so you still need to address any hazards outside a standard’s scope through risk assessment, warnings, instructions, and design controls.
Harmonised standards differ from other specifications (industry standards, internal specifications, or certification-scheme rules) because only OJEU-cited standards provide the EU “presumption” concept. The GPSR is a horizontal safety regulation, so the relevant harmonised standards may be listed under other EU harmonisation legislation (for example, electrical, radio, machinery-related, or toy rules), depending on the product and the risks.
How do I find the right harmonised standard for my product?
The fastest reliable method is to start with the applicable EU legislation, then confirm the OJEU-cited standards under that act, and finally check which standard matches your product’s hazards and intended users. The GPSR applies in full when no sector legislation covers the same safety objective, and it applies only to risks not covered when sector legislation does apply.
- Identify the applicable EU act(s). Decide whether your product is mainly covered by the GPSR, or by a sector-specific EU harmonisation law, with the GPSR covering the remaining risks.
- Define the product and foreseeable use. Document variants, accessories, age groups, and reasonably foreseeable misuse.
- Map hazards. Typical categories include mechanical, chemical, electrical, thermal, fire, choking, hygiene, and cybersecurity or functional safety for connected or software-driven products.
- Search the OJEU for harmonised standards under the relevant act. Use the Commission’s OJEU references list, then filter by product family and hazard type.
- Confirm the exact standard version. Check the EN number, title, edition date, and any amendments or corrigenda cited in the OJEU.
- Record your rationale. Keep a short justification for why each standard applies, and why others do not, in your technical file.
- If no harmonised standard fits, use other evidence. Use non-harmonised EN, ISO/IEC, and national standards, along with a documented risk assessment, to show how you meet the GPSR’s general safety requirement.
What is the difference between harmonised standards, EN standards, and ISO/IEC standards?
An EN standard is a European standard adopted by CEN, CENELEC, or ETSI. A harmonised standard is an EN standard whose reference is published in the OJEU under a specific EU act, which is what triggers the presumption of conformity or safety for the covered requirements. ISO/IEC standards are international standards, and they only become EN standards when adopted in Europe, often shown as EN ISO or EN IEC.
| Type | Who publishes it | How to tell | What it means for GPSR evidence |
|---|---|---|---|
| Harmonised standard | CEN/CENELEC/ETSI | Cited in the OJEU under an EU act | Supports the presumption for covered risks |
| EN standard (not harmonised) | CEN/CENELEC/ETSI | EN number, but not OJEU-cited | Useful evidence, but no automatic presumption |
| ISO/IEC | ISO/IEC | ISO or IEC number; may be adopted as EN ISO/EN IEC | Useful evidence; presumption applies only if OJEU-cited as harmonised |
EN standards are typically implemented nationally (for example, as national standards with identical text), but national publication does not make a standard harmonised. The only reliable check is the OJEU citation for the relevant EU act and the exact version referenced.
How does EARP help with harmonised standards under the GPSR and product compliance?
At EARP, we help you select and document the right standards strategy for the GPSR and related EU product rules, and we support your EU market-access obligations with independent regulatory services.
- Identify applicable EU legislation, then map the right OJEU-cited harmonised standards to your product and hazards.
- Check standard editions, amendments, and scope limitations, and document a clear applicability rationale for your technical file.
- Review your product safety documentation for completeness and consistency for authority requests and marketplace checks.
- Provide EU Responsible Person and EU Authorised Representative support aligned with the GPSR and the Market Surveillance Regulation (EU) 2019/1020 (MSR) role requirements, including risk-communication duties to the manufacturer under MSR Article 4.
See our services, or contact us to discuss your product category and the standards path that fits your EU selling model.
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