On the proposal for a regulation of the European Parliament and of the Council amending Regulations (EU) 2024/1689 and (EU) 2018/1139 as regards the simplification of the implementation of harmonised rules on artificial intelligence (Digital Omnibus on AI)
A-10-2026-0073
Committee on the Internal Market and Consumer Protection Committee on Civil Liberties, Justice and Home Affairs · Rapporteur: Arba Kokalari, Michael McNamara
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- Full procedure 2025/0359
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Parliament's amended version of the proposed regulation simplifies the AI Act by adjusting rules on AI literacy, bias detection, prohibited practices, high-risk classification, and supervision, and postpones application dates for high-risk AI obligations.¶¶¶ It extends certain SME measures to small mid-cap enterprises, adds a ban on non-consensual deepfake sexual content, and clarifies that AI systems integrated into products are not automatically high-risk unless they perform safety functions.¶¶ The AI Office gains powers to supervise general-purpose AI models and conduct pre-market assessments, while the Commission must issue guidance and templates for post-market monitoring by February 2027.¶¶¶ Application of high-risk AI obligations is set for 2 December 2027 for Annex III systems and 2 August 2028 for Annex I systems, replacing the Commission's proposed conditional mechanism.¶¶¶
Committee position. The committees propose to amend the Commission proposal, notably by setting fixed application dates for high-risk AI obligations and adding targeted adjustments on AI literacy, bias detection, and supervision.¶¶¶
Key points
- Extends measures for SMEs to small mid-cap enterprises (SMCs) and introduces definitions for SMEs and SMCs, while safeguarding the AI Act's objectives.¶
- Amends AI literacy obligations: providers and deployers must support AI literacy, but no specific level is guaranteed; the Commission issues guidance and encourages literacy in society.¶¶¶
- Allows exceptional processing of special categories of personal data for bias detection and correction in high-risk AI, subject to strict conditions and safeguards.¶¶¶
- Adds a prohibited practice: placing on the market or using AI that generates realistic non-consensual sexual deepfakes, with exceptions for safety measures and development.¶¶
- Clarifies that an AI system is high-risk only if it is a safety component necessary for product safety; user assistance or quality control functions are not safety functions.¶¶¶
- Deletes provisions on single application for notified bodies and removes related amendments, simplifying designation procedures.¶¶¶
- Presumes compliance with AI cybersecurity requirements if high-risk AI systems meet essential cybersecurity requirements under Regulation (EU) 2024/2847.¶¶
- Extends AI regulatory sandboxes and real-world testing to high-risk AI systems in Annex I, with voluntary agreements for Section B products, and allows the AI Office to establish a Union-level sandbox.¶¶¶
- Requires the AI Office to have adequate resources and personnel, and clarifies its supervision over general-purpose AI models, excluding certain systems.¶¶¶
- Strengthens cooperation between market surveillance authorities and fundamental rights bodies, ensuring access to information without undue delay and mutual assistance.¶¶¶
- Sets a 3-month transitional period for providers of generative AI systems already on the market to comply with marking obligations by 2 November 2026.¶¶
- Moves Union harmonisation legislation from Annex I Section A to Section B, and requires the Commission to adopt delegated acts for essential health and safety requirements.¶¶¶
Who is affected
- Providers and deployers of AI systems, especially SMEs and SMCs, face simplified obligations and extended deadlines.¶¶¶
- National competent authorities and market surveillance authorities must cooperate more closely and respond to requests without undue delay.¶¶¶
- The AI Office gains new supervisory powers and must be adequately resourced.¶¶¶
- Providers of generative AI systems must comply with marking obligations by 2 November 2026.¶¶
Figures and deadlines
- 99.8% of all Union companies are small and medium-sized enterprises.¶
- Transitional period of 3 months for providers of generative AI systems already on the market before 2 August 2026.¶
- Deadline of 2 February 2027 for the Commission to adopt guidance on the post-market monitoring plan.¶
- Application dates: 2 December 2027 for Annex III systems and 2 August 2028 for Annex I systems.¶
Legal basis: Article 294(2) and Article 114 of the Treaty on the Functioning of the European Union¶