New harmonized PPE standards 2026: what manufacturers and importers must review

Key data

If your company manufactures, imports or distributes personal protective equipment in the EU, you have an urgent task: review the EN standards that support your certifications. The Commission Implementing Decision (EU) 2026/1279, published on 16 June 2026, completely replaces the previous list of harmonized standards for PPE and repeals Decision 2023/941. Applying a standard that has already been repealed can invalidate the presumption of conformity and compromise the CE marking of your products.

The reference legal framework remains Regulation (EU) 2016/425, which regulates the essential safety requirements for PPE. What is changing now is the catalogue of technical standards whose application automatically grants that presumption of conformity.

What does this regulation establish?

European harmonized standards (EN standards) are technical standards developed by European standardization bodies (such as CEN or CENELEC) under a mandate from the Commission. When a manufacturer applies an EN standard included in the official list, it is presumed that their product complies with the essential safety requirements of Regulation (EU) 2016/425, which greatly facilitates the CE marking process.

This Implementing Decision updates that official list. The specific changes it introduces are:

• The EN standards currently valid for PPE in accordance with Regulation (EU) 2016/425 are published.
• The standards that have been updated or replaced compared to the previous list (Decision 2023/941) are identified.
• Commission Implementing Decision (EU) 2023/941 is completely repealed, which was the reference in force until now.
• Notified bodies that carry out conformity assessments must operate in accordance with the new versions of standards.

Economic and operational impact

The impact is not a direct fine, but the consequences of inaction can be equally costly. If a company continues to apply an EN standard that has been replaced and no longer appears on the current list, it loses the automatic presumption of conformity. This implies:

• Commercial blockade: Products without valid CE marking cannot be legally marketed in the European market.
• Recertification cost: If the standard has changed substantially, it may be necessary to repeat technical tests and obtain new certificates from notified bodies, with associated costs.
• Product withdrawal: Market surveillance authorities may require the withdrawal of products that do not comply with current standards.
• Impact on the supply chain: Distributors and importers that market products from manufacturers that have not updated their certifications also assume responsibility.

The cost of a preventive review (audit of applied standards, consultation with the notified body) is significantly lower than the cost of a market withdrawal or urgent recertification.

Who does it affect?

• PPE manufacturers established in the EU that use harmonized EN standards to demonstrate compliance with Regulation (EU) 2016/425.
• PPE importers that introduce products into the European market and are responsible for verifying that manufacturers of origin comply with current regulations.
• PPE distributors that market products in the EU and must ensure that the products they distribute have valid and up-to-date certifications.
• Notified bodies that carry out conformity assessments of PPE: must update their assessment procedures in accordance with the new versions of standards.
• Procurement and OHS managers in companies that acquire PPE for their workers: must verify that acquired products maintain valid CE marking.

Practical example

A Spanish company manufacturing chemical protection gloves applies the EN 374 standard in its previous version to obtain CE marking for its product range. With the publication of Decision 2026/1279, it must verify whether that specific version of EN 374 standard continues to appear on the new official list or has been replaced by an updated version.

If the standard has been updated and the previous version no longer grants presumption of conformity, the company has two options: adapt its product to the requirements of the new version of the standard (with corresponding technical tests) or request its notified body to conduct an assessment under the new standard. In both cases, until it has the new certificate, it cannot market the product with CE marking based on the repealed standard.

The same scenario applies to an importer bringing PPE from an Asian manufacturer: if that manufacturer's certificate references a standard no longer included on the current list, the importer is responsible to European authorities.

What should companies do now?

1. Audit the EN standards currently applied: Create an inventory of all harmonized standards that support the CE marking certificates of your PPE products.
2. Compare with the new official list: Verify in the text of Decision 2026/1279 whether the versions of standards you apply remain valid or have been updated or replaced.
3. Contact your notified body: Consult whether your current certificates are affected by changes to the list and what steps are necessary to maintain their validity.
4. Review supplier and manufacturer certificates: If you are an importer or distributor, require your suppliers to provide written confirmation that their certifications are up-to-date in accordance with Decision 2026/1279.
5. Update technical documentation: If any standard has changed, update the EU declaration of conformity and the technical file of the affected products.
6. Establish a regulatory monitoring process: Lists of harmonized standards are updated periodically. Implement an alert system to detect future changes before they affect your certifications.

Official source

Consult complete regulation on official source

Disclaimer: This article is for informational purposes only and does not constitute legal advice. For specific decisions, consult a qualified professional. Source: https://eur-lex.europa.eu/./legal-content/AUTO/?uri=OJ:L_202601279