EU Machinery Regulation 2023/1230 (AI provisions)

What it is

Regulation (EU) 2023/1230 of 14 June 2023 is the Union regulation on machinery, repealing Directive 2006/42/EC. Recital 12 says this Regulation should cover the safety risks stemming from new digital technologies, after noting that current product-safety legislation, including the Machinery Directive, contains a number of gaps for AI, IoT and robotics.

Recital 55 limits third-party conformity assessment of software ensuring safety functions to systems with a fully or partially self-evolving behaviour using machine learning approaches ensuring safety functions. Those provisions should not apply to software incapable of learning or evolving, and programmed only to execute certain automated functions of machinery or related products.

The consolidated text empowers the Commission to amend Annex III … by adding health and safety requirements in respect of Artificial Intelligence (AI) systems that are classified as high-risk pursuant to Article 6(1) of Regulation (EU) 2024/1689 because they are a safety component in a product covered by this Regulation, or they are themselves a product covered by this Regulation. Those delegated acts shall apply by 2 August 2028.

The AI Act Service Desk lists the same regulation as Annex I Section B item 21.

What it is not

The regulation is not IEC 61508 and not ISO 10218. Recital 55 is explicit that the extra third-party assessment for safety-function software does not apply to non-learning, fixed automation. We have not found an official sentence that the 2 August 2028 delegated acts have already been adopted.

How it relates to other frameworks

• EU AI Act. Machinery is Annex I Section B item 21 on the Service Desk page we cite. Section B systems have a narrower AI Act application already explained on the EU AI Act explainer.
• ISO 10218. Industrial-robot safety standard. Different issuer; ISO 10218-1 excludes medical, military and airborne robots on the catalog page.

Primary sources

Read Regulation (EU) 2023/1230 and Annex I.