# Delegated Acts — legal context bundle > Curated from overview.legal on 2026-08-22. Canonical page: https://overview.legal/topics/delegated-acts-adoption-procedures > Sources are cited per item. Verify against the official texts before relying on them. This content specifically addresses the procedural framework for adopting delegated acts under the AI Act, including how they apply to safety components and sectoral regulations. This is a distinct procedural topic not adequately covered by existing topics. ## Overview ## Legal Framework The AI Act establishes a cross-sectoral procedural bridge between its own high-risk requirements and pre-existing product safety legislation. Articles 103, 106, and 107 of the AI Act amend Regulation (EU) No 167/2013 (agricultural machinery), Directive (EU) 2016/797 (railway interoperability), and Regulation (EU) 2018/858 (motor vehicle type-approval), respectively. Each amendment inserts a new paragraph requiring that, when the European Commission adopts delegated acts under the base regulation concerning AI systems that qualify as safety components within the meaning of the AI Act, the requirements set out in Chapter III, Section 2 of the AI Act must be taken into account. Chapter III, Section 2 covers the substantive obligations for high-risk AI systems, including risk management, data governance, technical documentation, record-keeping, transparency, human oversight, accuracy, and robustness. Additionally, Article 92 of the AI Act confers a specific delegated-act power on the Commission to determine the information that standardized icons must display and the procedures for their establishment. ## Key Developments No case law or enforcement decisions yet interpret these delegated-act provisions, as the AI Act's application dates for high-risk obligations have not arrived. The amendments to the sectoral regulations signal that the Commission's exercise of its pre-existing delegated-act powers is now legally conditioned by AI Act requirements. Where the Commission previously enjoyed broad discretion to set technical specifications for safety components under sectoral frameworks, it must now demonstrably integrate the Chapter III, Section 2 criteria into its delegated-act drafting. This creates a justiciable obligation: delegated acts adopted under the amended sectoral instruments that fail to account for AI Act high-risk requirements may be vulnerable to annulment under Article 263 TFEU. ## Practical Guidance - **Map your AI system's regulatory footprint across sectors.** If your AI system functions as a safety component in a regulated product (e.g., railway signaling, vehicle braking, agricultural machinery), identify which sectoral regulation applies and whether the Commission has adopted or is developing delegated acts under that instrument affecting your component. - **Track delegated-act consultations.** The Commission must consult stakeholders when preparing delegated acts. Monitor the Commission's Better Regulation portal for initiatives under Regulations 167/2013, 2018/858, and Directive 2016/797 that touch on AI safety components, and submit position papers arguing for alignment with Chapter III, Section 2 requirements. - **Build compliance on dual tracks.** Ensure your AI safety component satisfies both the sectoral technical requirements (as specified in delegated acts) and the AI Act's Chapter III, Section 2 obligations, since delegated acts must take the latter into account. - **Prepare for challenge opportunities.** If a delegated act under a sectoral regulation affects your AI safety component and does not adequately address Chapter III, Section 2 requirements, consider supporting or initiating annulment proceedings before the General Court. - **Monitor Article 92 icon standardization.** If your AI system requires user-facing transparency icons, follow the Commission's delegated-act process under Article 92, which will define mandatory icon content and establishment procedures. ## Legislation (full text of key provisions) ### Amendment to Regulation (EU) No 167/2013 *Source: AI Act, aiact-art-103-en, 2024-06-12 — https://overview.legal/posts/93609* In Article 17(5) of Regulation (EU) No 167/2013, the following subparagraph is added:‘When adopting delegated acts pursuant to the first subparagraph concerning artificial intelligence systems which are safety components within the meaning of Regulation (EU) 2024/1689 of the European Parliament and of the Council (*), the requirements set out in Chapter III, Section 2, of that Regulation shall be taken into account. ### Amendment to Directive (EU) 2016/797 *Source: AI Act, aiact-art-106-en, 2024-06-12 — https://overview.legal/posts/93615* In Article 5 of Directive (EU) 2016/797, the following paragraph is added:‘12. When adopting delegated acts pursuant to paragraph 1 and implementing acts pursuant to paragraph 11 concerning Artificial Intelligence systems which are safety components within the meaning of Regulation (EU) 2024/1689 of the European Parliament and of the Council (*), the requirements set out in Chapter III, Section 2, of that Regulation shall be taken into account. ### Amendment to Regulation (EU) 2018/858 *Source: AI Act, aiact-art-107-en, 2024-06-12 — https://overview.legal/posts/93617* In Article 5 of Regulation (EU) 2018/858 the following paragraph is added:‘4. When adopting delegated acts pursuant to paragraph 3 concerning Artificial Intelligence systems which are safety components within the meaning of Regulation (EU) 2024/1689 of the European Parliament and of the Council (*), the requirements set out in Chapter III, Section 2, of that Regulation shall be taken into account. ### Amendment to Regulation (EU) No 168/2013 *Source: AI Act, aiact-art-104-en, 2024-06-12 — https://overview.legal/posts/93611* In Article 22(5) of Regulation (EU) No 168/2013, the following subparagraph is added:‘When adopting delegated acts pursuant to the first subparagraph concerning Artificial Intelligence systems which are safety components within the meaning of Regulation (EU) 2024/1689 of the European Parliament and of the Council (*), the requirements set out in Chapter III, Section 2, of that Regulation shall be taken into account. ### Recital 173 — Commission delegated powers to adapt AI rules *Source: AI Act, aiact-rec-173-en, 2024-06-12 — https://overview.legal/posts/94028* In order to ensure that the regulatory framework can be adapted where necessary, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission to amend the conditions under which an AI system is not to be considered to be high-risk, the list of high-risk AI systems, the provisions regarding technical documentation, the content of the EU declaration of conformity the provisions regarding the conformity assessment procedures, the provisions establishing the high-risk AI systems to which the conformity assessment procedure based on assessment of the quality management system and assessment of the technical documentation should apply, the threshold, benchmarks and indicators, including by supplementing those benchmarks and indicators, in the rules for the classification of general-purpose AI models with systemic risk, the criteria for the designation of general-purpose AI models with systemic risk, the technical documentation for providers of general-purpose AI models and the transparency information for providers of general-purpose AI models. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making (55). In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States’ experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts. ### Recital 52 — classification of standalone high-risk AI systems *Source: AI Act, aiact-rec-52-en, 2024-06-12 — https://overview.legal/posts/93786* As regards stand-alone AI systems, namely high-risk AI systems other than those that are safety components of products, or that are themselves products, it is appropriate to classify them as high-risk if, in light of their intended purpose, they pose a high risk of harm to the health and safety or the fundamental rights of persons, taking into account both the severity of the possible harm and its probability of occurrence and they are used in a number of specifically pre-defined areas specified in this Regulation. The identification of those systems is based on the same methodology and criteria envisaged also for any future amendments of the list of high-risk AI systems that the Commission should be empowered to adopt, via delegated acts, to take into account the rapid pace of technological development, as well as the potential changes in the use of AI systems. ### Recital 101 — General-purpose AI model provider transparency obligations *Source: AI Act, aiact-rec-101-en, 2024-06-12 — https://overview.legal/posts/93884* Providers of general-purpose AI models have a particular role and responsibility along the AI value chain, as the models they provide may form the basis for a range of downstream systems, often provided by downstream providers that necessitate a good understanding of the models and their capabilities, both to enable the integration of such models into their products, and to fulfil their obligations under this or other regulations. Therefore, proportionate transparency measures should be laid down, including the drawing up and keeping up to date of documentation, and the provision of information on the general-purpose AI model for its usage by the downstream providers. Technical documentation should be prepared and kept up to date by the general-purpose AI model provider for the purpose of making it available, upon request, to the AI Office and the national competent authorities. The minimal set of elements to be included in such documentation should be set out in specific annexes to this Regulation. The Commission should be empowered to amend those annexes by means of delegated acts in light of evolving technological developments. ## Guidance ### EDPB-EDPS Joint Opinion 03/2022 on the Proposal for a Regulation on the European Health Data Space *Source: EDPB, edpb-edps-joint-opinion-032022-on-the-proposal-for-a-regulation-on-en, 2022-07-12 — https://overview.legal/posts/125922 — original: https://www.edpb.europa.eu/documents/legislative-opinion/edpb-edps-joint-opinion-032022-on-the-proposal-for-a-regulation-on_en* Adopted 1 EDPB - EDPS Joint Opinion 03 /2022 on the Proposal for a Regulation on the European Health Data Space Adopted on 12 July 2022 Adopted 2 Adopted 3 Executive Summary With this Joint Opinion, the EDPB and the EDPS aim to draw attention to a number of overarching concerns on the Proposal on the European Health Data Space and urge the co - legislature to take decisive action. The EDPB and the EDPS note that the Proposal ai ms at supporting individuals to take control of their own health… ## Related topics - **Delegation of Powers** — https://overview.legal/topics/delegation-of-powers-procedures The content specifically addresses 'Exercise of the delegation' which is a distinct procedural topic covering how delegated powers are exercised, implemented, a - **Committee Procedure under AI Act** — https://overview.legal/topics/committee-procedure-ai-act The content specifically addresses 'Committee procedure' as a distinct procedural mechanism under the AI Act. This topic is not adequately covered by existing t - **Annex III Classification Changes and Updates** — https://overview.legal/topics/annex-iii-classification-changes The content specifically addresses amendments to Annex III, which represents a distinct regulatory mechanism for updating high-risk AI system classifications. T - **High-Risk AI Classification** — https://overview.legal/topics/high-risk-ai-classification The content specifically addresses classification rules for high-risk AI systems under the AI Act, which is a distinct regulatory concept requiring its own dedi - **Provider Obligations for AI Systems** — https://overview.legal/topics/provider-obligations-ai The content specifically addresses obligations imposed on providers of high-risk AI systems, which is a distinct and important category of requirements that des - **Conformity Assessment for AI Systems** — https://overview.legal/topics/conformity-assessment-ai Provider obligations typically include conformity assessment procedures and documentation requirements, which is a specific compliance mechanism under the AI Ac --- Generated by overview.legal · https://overview.legal/topics/delegated-acts-adoption-procedures · 2026-08-22