Harmonised Standards Under GPSR: What They Mean

You're preparing technical documentation for an educational toy imported from China. In the risk assessment you hit a question: "is the product compliant with the relevant standards?". Your supplier sent a certificate with a mysterious number, "EN 71-1", that means nothing to you. You start searching online and drown in abbreviations: EN, IEC, PN-EN, harmonised standards, presumption of conformity. This is where many sellers get lost. Which is a shame, because harmonised standards are the strongest tool in your GPSR (EU) 2023/988 documentation — if you know how to use them, they make proving safety significantly easier.

What harmonised standards are

Harmonised standards are technical standards developed by European standardisation organisations on behalf of the European Commission, whose reference numbers are published in the Official Journal of the EU. The key feature: applying a harmonised standard gives a presumption of conformity with the relevant safety requirements. In other words — if a product meets the applicable harmonised standard, it is presumed to be safe within the scope covered by that standard.

This is a huge help. Instead of proving safety from scratch, you rely on a recognised European benchmark. That's why the list of applied standards is one of the pillars of technical documentation.

Harmonised standards versus other standards

Not every EN standard is harmonised under GPSR. It's worth distinguishing three levels:

Type	Significance for GPSR
Harmonised standard (published in the EU Official Journal)	Gives a presumption of conformity with safety requirements
Non-harmonised national/European standard	Can serve as evidence of due diligence, but without an automatic presumption
International standard (e.g. IEC, ISO)	Technically useful, but does not by itself give a presumption in the EU

In your documentation, a reference to a harmonised standard "carries" the most weight. Other standards can support the assessment, but they don't give the same legal effect.

How to find the right standard for your product

You don't need to know every standard — you need to find the ones relevant to your category. Practical steps:

1. Classify the product — what it is, what it's for, who it's for (toy, electrical equipment, textiles).
2. Look for the standard family for the category — e.g. EN 71 for toys, electrical safety standards for electronics.
3. Check what the supplier declares — which standards they cite in certificates and test reports.
4. Verify currency — whether the standard is still in force and harmonised.

The "EN 71-1" certificate from the example is part of the standard family for toy safety — a good starting point, but it needs checking against your specific product.

How to use standards in your risk assessment

Standards and risk assessment complement each other. A harmonised standard often describes specific hazards and the required measures for a given category (e.g. maximum size of small parts, permissible temperatures, electrical requirements). In your risk assessment, you state that for a given hazard you applied a solution compliant with the standard. This strengthens your reasoning and shows you're not working "by feel".

Watch out for supplier test reports

Suppliers from China often provide test reports that cite EN standards. Before you accept them, check three things: whether the report covers exactly your model (not a similar one), whether the standard is current, and whether the laboratory is credible. A report covering a different version of the product doesn't protect you — and this is a common problem with imports. Photos of markings help verify compliance — more on that in our article on photos and the technical description.

What if there's no harmonised standard

For some products, no dedicated harmonised standard exists. GPSR doesn't block this — in that case, you demonstrate safety based on risk assessment, good engineering practice, non-harmonised standards, and the current state of technical knowledge. Documentation then needs to be more thorough, because you don't have a "ready-made" presumption of conformity. It's worth keeping all sources and justifications — and then storing them for 10 years, which we cover in our article on document archiving.

Frequently asked questions

Is applying a harmonised standard mandatory?

No, it's voluntary. But applying it gives a presumption of conformity, so it makes proving safety much easier. If you don't use one, you have to demonstrate safety by other means — which is harder.

How do I know a standard is harmonised?

Reference numbers of harmonised standards are published in the Official Journal of the European Union for specific pieces of legislation. An EN standard itself doesn't have to be harmonised — you need to check this for the specific number and regulation.

Is a supplier's certificate enough as proof of conformity with a standard?

A certificate or test report helps, but you must verify that it covers your model and the current standard. Responsibility for product conformity rests with the importer, not the supplier.

Do I need to list standards in the technical documentation?

Yes. The list of applied standards is an element of the technical documentation. In it, you state which standards you're relying on to demonstrate the product's safety.