What Are Harmonised Standards Under GPSR and What Is the Presumption of Conformity?

On 27 April 2026, the European Commission published Implementing Decision (EU) 2026/901, updating the official list of harmonised standards that support the General Product Safety Regulation. For manufacturers outside the EU, this kind of publication tends to go unnoticed. Understanding what it means and why it matters is the purpose of this article.

What the GPSR Is and Who It Applies To

The General Product Safety Regulation (EU) 2023/988 is the EU’s baseline safety framework for consumer products. It applies to all products placed on the EU market that are intended for consumers, or that consumers are likely to use, regardless of whether a sector-specific regulation also applies.

For non-EU manufacturers, this means that selling a consumer product in Europe triggers GPSR obligations before anything else is considered. The regulation covers product safety requirements, technical documentation, labelling, and the designation of an EU Responsible Person. 

What a Harmonised Standard Actually Is

A harmonised standard is a technical standard developed by one of the three European standardisation bodies — CEN, CENELEC, or ETSI — in response to a mandate from the European Commission. Once developed and validated, its reference is published in the Official Journal of the European Union.

That publication step is what makes it “harmonised” in the legal sense. A standard can be technically excellent and widely used in industry without being harmonised. The reference publication in the Official Journal is what creates the legal effect.

Harmonised standards exist under many EU regulations: CE marking directives, the GPSR, ecodesign legislation, and others. Each regulation maintains its own list. The list updated by Decision (EU) 2026/901 is specifically the list of harmonised standards supporting the GPSR.

The Presumption of Conformity: What It Means in Practice

Article 7 of the GPSR establishes that a product is presumed safe when it conforms to a relevant harmonised standard whose reference has been published in the Official Journal. This is called the presumption of conformity.

In practical terms, this means the following. If your product falls within the scope of a harmonised standard on the GPSR list, and your product meets the requirements of that standard, you benefit from a legal presumption that the product satisfies the GPSR’s general safety requirement. You do not need to build a safety justification from scratch. The standard provides the framework, and conformity with it provides the presumption.

This is significant for two reasons.

First, it simplifies the compliance process considerably. Rather than conducting an open-ended safety analysis, the manufacturer applies a defined set of test methods and performance criteria, documents the results, and references the standard in the technical documentation.

Second, it does not make compliance with the standard mandatory. The GPSR does not require manufacturers to use harmonised standards. A manufacturer can place a product on the EU market without following any harmonised standard, provided the product is genuinely safe and that safety can be demonstrated by other means. The presumption of conformity is a benefit, not an obligation.

What Just Changed: The April 2026 Update

Decision (EU) 2026/901, published on 27 April 2026, replaces the previous list established by Implementing Decision (EU) 2019/1698. It introduces four revised standards that now replace earlier versions, and it sets a withdrawal date of 27 October 2027 for those earlier versions.

The four standards with updated references are:

EN 915:2024 (gymnastic equipment, asymmetric bars) replaces EN 915:2008. EN 12196:2023 (gymnastic equipment, horses and bucks) replaces EN 12196:2003. EN 14988:2017+A2:2024 (children’s high chairs) replaces EN 14988:2017+A1:2020. EN 16156:2024 (cigarettes, ignition propensity) replaces EN 16156:2010.

Until 27 October 2027, both the new and the previous versions remain on the list. Manufacturers may apply either version during this coexistence period. From 28 October 2027, only the new versions will carry the presumption of conformity.

The full updated list now contains 76 standard references across a broad range of consumer product categories. These include children’s furniture and care articles, gymnastic and fitness equipment, bicycles and cycling accessories, floating leisure articles, internal blinds, lighters, laser products, and audio and IT equipment. The complete list is published in Annex I of Decision (EU) 2026/901 in the Official Journal of the European Union.

What If Your Product Has No Harmonised Standard?

A large number of consumer products subject to the GPSR are not covered by any harmonised standard on the official list. Furniture, decorative items, sports accessories, kitchen utensils, textile products, and many other categories have no harmonised standard under the GPSR.

For these products, the presumption of conformity is not available.

The manufacturer must demonstrate product safety through other means. Article 7 of the GPSR establishes a hierarchy of criteria for this purpose, in descending order of weight:

1. National standards of EU member states that transpose international standards not yet harmonised at EU level are the first reference point.
2. International standards from ISO or IEC that have not been harmonised at EU level come next.
3. European Commission recommendations on product safety assessment provide further guidance.
4. Codes of good practice established at sector or member state level are also relevant.
5. Finally, the state of the art and the reasonable safety expectations of consumers provide the baseline.

In practice, this means the manufacturer must build the safety case from available technical references rather than from a single harmonised standard. The risk assessment becomes more demanding because the manufacturer must justify the choice of methodology and criteria, not just apply a defined standard.

This situation is more common than many manufacturers expect, particularly for products that fall directly under GPSR without any sector-specific regulation applying. The article Your Product Has No CE Marking: Does That Mean It Is Free from EU Regulation? partly covers this scenario.

How the List Gets Updated and Why You Need to Monitor It

The list of harmonised standards under the GPSR is not static. The European Commission issues new implementing decisions when CEN, CENELEC, or ETSI revise existing standards or develop new ones in response to Commission mandates. Each update can add new references, confirm existing ones, or set withdrawal dates for superseded versions.

When a new version of a standard is added and a withdrawal date is set for the previous version, manufacturers have a defined transition window. During this coexistence period, both versions carry the presumption of conformity. Using a standard whose reference has been withdrawn from the Official Journal no longer provides the presumption of conformity, even if the standard itself still exists technically and is still available for purchase.

This creates a monitoring obligation for manufacturers. A product placed on the market in conformity with a standard that is subsequently withdrawn needs to be reassessed against the current version.

If the product has not changed but the standard has, the documentation must be updated to reflect the applicable current reference.

For manufacturers outside the EU who manage compliance for multiple product lines, tracking updates to multiple lists across multiple regulations is a non-trivial task.

A Practical Checklist for Non-EU Manufacturers

Before placing a consumer product on the EU market under the GPSR, three questions need answers:

• Does a harmonised standard exist for my product under the GPSR? Check the current list published in the Official Journal. If yes, conformity with that standard provides the presumption of conformity.
• Is the standard current, or is it in a withdrawal period? If a withdrawal date has been set, identify the replacement standard and assess whether your product meets its requirements.
• If no harmonised standard exists, what is my safety demonstration strategy? Identify the applicable international standards, sector codes of practice, or Commission recommendations that will form the basis of the risk assessment, and document the methodology explicitly.

How GetReady Compliance Can Help

Determining whether a harmonised standard applies to your product, identifying the current applicable version, and building a compliant risk assessment when no standard exists are tasks that benefit from structured regulatory support.

GetReady Compliance supports non-EU manufacturers in mapping their GPSR obligations, preparing technical documentation, and developing safety demonstration strategies for products in and outside the harmonised standards framework. If you would like to assess the GPSR compliance requirements for a specific product, request a quote.