On the 27 July 2026, the Digital Omnibus on artificial intelligence (AI) officially entered into force in the European Union as Regulation (EU) 2026/1744. This simplification measure provides, in particular, that for the machinery sector, the main technical requirements relating to high-risk AI systems will be incorporated directly into the Machinery Regulation 2023/1230, rather than being applied under the AI Act. The Machinery Regulation thus becomes the primary framework for the technical compliance of AI systems performing a safety function in a machine.

Addressing the Risk of Regulatory Overlap

A machine may contain an artificial intelligence (AI) device that affects safety, such as an autonomous anti-collision device, a vision system that detects humans, or a control system for a safety component. In this case, two regulations could apply simultaneously:

> The Machinery Regulation 2023/1230, which establishes the health and safety rules that machines, related products, and partly completed machinery must comply with before being placed on the market or put into service in the European Union (EU). In particular, it addresses software, autonomous systems, cybersecurity, and artificial intelligence. Better suited to new technologies, this regulation will take effect on the 20 January 2027, replacing the current Machinery Directive 2006/42/EC.

> The European Regulation on Artificial Intelligence (AI) 2024/1689, often referred to as the “AI Act,” establishes a common framework for the development, marketing, and use of AI systems in the European Union. This horizontal regulation, applicable to many sectors, is specifically designed to enable innovation while protecting health, safety, and fundamental rights. To this end, it regulates certain so-called “high-risk” practices, such as human monitoring, risk management, and cybersecurity.

The European legislator sought to ensure that this situation “do not create overlaps, inconsistent interpretations or divergent enforcement.”[1] To address this type of problem, the European Commission presented, as part of the AI Digital Omnibus, a set of measures aimed at simplifying and making various digital regulations more consistent.

Prioritizing a Sector-Specific Approach to AI

Recital 42 of the AI Omnibus states that: “Given the specific nature of machinery and the machinery sector, and in order to address the need to simplify the regulatory framework for AI-enabled machinery, it is appropriate to move to a sectoral approach by moving Regulation (EU) 2023/1230 from Section A to Section B of Annex I to Regulation (EU) 2024/1689. ”

In practical terms, this change in the section of the Machinery Regulation allows for the exclusion of the technical obligations applicable to high-risk AI as set forth in the AI Act for machinery.

In principle, therefore, a single manufacturer will not have to conduct a separate conformity assessment under the AI Regulation for its safety component (or part of a safety component) and then another conformity assessment under the Machinery Regulation for the complete machine, including the integration of the AI component.

However, this does not mean that the requirements for high-risk AI are being abandoned for machines: they must be incorporated directly into the Machinery Regulation via a delegated act by 2nd August 2028. The text also requires the Commission to ensure, through this act, “shall ensure that the relevant requirements are reflected”[2] in accordance with those of the AI Act.

The stated objective of the European legislator is to reorganize the obligations, not to eliminate them. However, actual effectiveness will depend on the precise content of future delegated acts and on any adaptation of the requirements to the specific characteristics of machines.

Finally, pending the adoption of a delegated act incorporating the technical obligations relating to high-risk AI into the Machinery Regulation, “manufacturers should be free to rely on harmonised standards or common specifications referenced or adopted pursuant to Regulation (EU) 2024/1689 that cover the relevant essential requirements for the presumption of conformity within the meaning of Article 20 of Regulation (EU) 2023/1230 until harmonised standards or common specifications regarding AI are referenced or adopted pursuant to Regulation (EU) 2023/1230.” Although harmonized standards under the Machinery Regulation addressing AI are not yet available, the essential health and safety requirements remain fully applicable in their approach.

Access the AI Omnibus

[1] REGULATION (EU) 2026/1744, Recital 4

[2] REGULATION (EU) 2026/1744, Article 3 Amendments to Regulation (EU) 2023/1230 (1)