New Machinery Regulation: Status of harmonised standards

Draft standardisation request to CEN/CENELEC

On 4 July 2024, the European Commission published a draft standardisation mandate. This decision, addressed to CEN/CENELEC, is intended to cover future mandates for the creation of harmonised standards (hEN) in accordance with Machinery Regulation (EU) 2023/1230.

The overriding aim of the standardisation mandate is to build on the previous mandate to create harmonised standards in accordance with the Machinery Directive. In future, such standards should also ensure a high level of health and safety protection in accordance with the Machinery Regulation. The standardisation mandate also explicitly addresses interfaces with other regulations:

• The planned Cyber Resilience Act (CRA) sets out horizontal requirements for the cyber security of products with digital elements. According to the standardisation mandate, harmonised standards that serve the basic requirements of the CRA are also to be adapted to the requirements of the Machinery Regulation.
• The new regulation on artificial intelligence (AI) defines, among other things, requirements for the placing on the market and commissioning of AI systems with a high risk potential. In relation to machinery, these are systems that guarantee safety functions and whose behaviour develops itself in whole or in part through machine learning. The horizontal requirements of the AI Act should also be taken into account when developing these harmonised standards.

In order to fulfil the standardisation mandate, CEN and CENELEC should draw up harmonised standards in accordance with the requirements of the MVO to be covered. As described above, the extent to which these standards should fulfil the new EHSRs introduced by the Machinery Directive or the requirements already laid down in the Machinery Directive must be taken into account.

The detailed annex to the standardisation mandate, which lists all the safety requirements to be met by the Machinery Directive, is therefore divided into two groups:

Annex I focuses on the new product categories or technology fields added by the MVO, whose safety objectives are to be covered by NEW harmonised standards. These standards must essentially fulfil the following criteria and have been adopted by CEN or CENELEC by 20 January 2026 at the latest:

• Standards on horizontal issues of risk reduction and the safety of machinery, specifically for risks of emerging technologies and innovative product categories not covered by existing harmonised standards
• Standards for machinery with fully or partially self-evolving behaviour or whose safety functions are controlled by safety components or systems that are fully or partially self-evolving
• Standards for safety functions that are based, inter alia, on external connections, software or based, inter alia, on external connections, software or data and providing protection against corruption
• Standards for autonomous mobile machinery, with or without a monitoring function

Annex II lists the product categories or fields of technology that have existed since the MD and whose safety objectives are achieved by revising EXISTING harmonised standards that already fulfil the presumption of conformity under the MD within the framework of Implementing Decision 2023/1586. By 20 January 2026 at the latest, CEN and CENELEC should also confirm applicable standards or adopt successor standards intended to cover these existing and future requirements.
 

Outlook

At present, this draft has neither been adopted nor approved by the European Commission - the content may therefore still change before final publication. 6 months after the final publication of this mandate, CEN and CENELEC must submit the draft joint work programme to the EU Commission, which should then already contain initial details of the new or revised standards. In any case, the specification of a time frame is interesting: If the hENs  are adopted by CEN/CENELEC at the beginning of 2026, the standards would probably be published by mid-2026, after which users can purchase the standards from the national institutes. After that, there will still be 6 months until the standards are published in the EU Official Journal in accordance with the MVO, which is scheduled for the end of 2026 at the latest.

In addition, the draft addresses the ruling handed down on 5 March 2024 in the "Malamud" case, according to which access to harmonised standards as part of EU law must be free of charge. Accordingly, the hENs can be the subject of requests for access to documents in accordance with Regulation (EU) 1049/2001. In this case, access to these standards must be granted. Public access in the context of such so-called "readability platforms" has not yet been submitted. Further information on the ruling can be found in our technical article "ECJ ruling: harmonised standards in the EU Official Journal"
 

Download the standardisation mandate

You can open and download the full text of the draft standardisation request via the following link:

Draft standardisation request machinery regulation
 

Product information

Footnote:
¹ See CEN/CENELEC webinar on the new MVO
² See KAN Brief 03/2023 of the Commission for Occupational Health and Safety and Standardisation
³ See CEN/CENELEC Webinar "Gap analysis"

Posted on: 2024-07-12 (last amendment)

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