Delegated Acts

Legal Framework

The primary procedural framework for adopting delegated acts under the AI Act is established by Article 106. This article grants the European Commission the power to adopt delegated acts to supplement or amend certain non-essential elements of the Regulation. A critical substantive rule within this framework is found in Article 106(12), which imposes a specific obligation when adopting such acts for AI systems that are safety components under the new Machinery Regulation (Regulation (EU) 2024/1689). The law requires that the requirements set out in Chapter III, Section 2, of that Machinery Regulation must be taken into account during the adoption process.

Practical Application

This provision ensures a coherent regulatory interface between the AI Act and sectoral product safety legislation. The requirement to "take into account" the Machinery Regulation's safety requirements means the Commission cannot adopt a delegated act for an AI safety component in isolation. The procedural and substantive safety rules from the sectoral regulation, which govern conformity assessment, risk assessment, and technical documentation for machinery, must inform and shape the content of the AI Act's delegated act. This interpretation, supported by the principle of legislative coherence, aims to prevent conflicts and ensure that AI systems integrated into machinery comply with a unified safety standard. There is no case law on this specific provision yet, as the AI Act is newly applicable.

Key Considerations

• Sector-Specific Scrutiny: When the Commission proposes a delegated act related to AI safety components, stakeholders must scrutinize it for alignment with the essential health and safety requirements of the Machinery Regulation.
• Compliance Interlock: Providers of AI systems that are safety components of machinery must prepare for a dual compliance checkpoint, where delegated acts under the AI Act will explicitly reference or incorporate safeguards mandated by the Machinery Regulation.