Simplification of the implementation of harmonised rules on artificial intelligence (Digital Omnibus on AI)

2025/0359(COD)

The European Parliament adopted by 569 votes to 45 against and 23 abstentions, amendments to 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).

The issue was sent back to the committee responsible for interinstitutional negotiations.

The main amendments adopted in plenary session are as follows:

Mastering AI

AI system providers should be required to take steps to help improve AI literacy among their staff and others involved in the operation and use of AI systems on their behalf. The Commission and Member States should support AI literacy within society and the wider population, and support the efforts of AI system providers, particularly SMEs, for example by creating public-private partnerships to enable them to fulfil this obligation.

To foster innovation and facilitate the uptake of AI, SMEs, including startups, and SMCs should be provided with priority access to the AI regulatory sandboxes established by the AI Office.

Processing of special categories of personal data for the purposes of detecting and correcting bias

Providers and deployers of other AI systems and models and deployers of high-risk AI systems may exceptionally process special categories of personal data to the extent that processing is necessary to ensure bias detection and correction in view of possible biases that are likely to affect the health and safety of persons, have a negative impact on fundamental rights or lead to discrimination prohibited under Union law. Members have introduced safeguards to ensure that this only occurs where strictly necessary.

Prohibited practices in AI

Members are proposing a ban on the marketing, commissioning, or use of any AI system that modifies, manipulates, or artificially generates realistic images or videos to depict sexually explicit activities or the intimate parts of a person, or that undresses that person, without their consent. This ban will not apply to AI systems equipped with effective safeguards that prevent users from creating such images.

AI Office

The AI Office should ensure that, to the extent innovative AI systems referred to in the directive involve the processing of personal data or otherwise fall under the supervisory remit of other national authorities or competent authorities providing or supporting access to data, the national data protection authorities, the European Data Protection Board and those other national or competent authorities are associated with the operation of the AI regulatory sandbox established at Union level and involved in the supervision of those aspects to the extent that they relate to their respective tasks and powers.

The AI Office should have powers to supervise and enforce the obligations under this Regulation in relation to AI systems that constitute or that are integrated into a designated very large online platform or very large online search engine. Where the Commission has not initiated proceedings for the same infringement, the competent authority of a Member State in which the main establishment of the provider of very large online platform or of very large online search engine is located, or where their legal representative is established, may have the powers to supervise and enforce the obligations under this Regulation.

The supervision and enforcement powers of the AI Office, do not include AI systems placed on the market, put into service or used by Union institutions, bodies, offices or agencies, which are under the supervision of the European Data Protection Supervisor.

Members proposed allocating the AI ​​Office with adequate human, financial and technical resources should be provided, without prejudice to the budgetary procedure and existing financial instruments. In particular, the AI Office should have a sufficient number of personnel whose expertise include an in-depth understanding of AI technologies.

In the implementation and enforcement of this Regulation, the AI Office should promote innovation, competitiveness and the protection of fundamental rights, taking them into consideration in the exercise of their functions.

Flexibility

To prevent overlapping application of sector-specific EU product safety rules and the AI Act, Members argue that obligations under the AI Act can be less stringent for products already regulated under sectoral laws (e.g. medical devices, radio equipment, toy safety, and others).

Additionally, the Commission, the AI Office and Member States’ competent authorities should ensure that supervision, enforcement and monitoring of sectorial and national laws do not create overlaps, inconsistent interpretations or divergent enforcement in order to enable AI innovation in the private and public sector.

Fixed application dates

For high-risk AI systems specifically listed in the regulation (including those involving biometrics, and those used in critical infrastructure, education, employment, essential services, law enforcement, justice and border management), Members proposed 2 December 2027.

For AI systems that are covered by EU sectoral legislation on safety and market surveillance, Members proposed 2 August 2028.

Members also support giving providers until 2 November 2026 to comply with rules on watermarking AI-created audio, image, video or text content to indicate its origin.