Join a discussion series on the Digital Omnibus package and its important modifications to several EU Regulations in the digital sector. In this first Digital Omnibus Talk, we will discuss the impact of this legislative package on the AI Act.
The rapid pace and increasing complexity of technological development have compelled the European Union to adopt a comprehensive set of rules aimed at regulating various aspects of the digital economy, infrastructure, and society. The increasing size of the EU regulatory framework in the digital sector, however, has also raised several questions. In particular, some commentators have criticised the complexity of the regulatory framework, which causes overlaps and duplications, and potentially weakens legal certainty for economic operators subject to the framework, as well as posing challenges to the regulatory authorities responsible for its enforcement. In addition, as noted in the 2024 Draghi report, the complexity of the regulatory framework may also hinder innovation in Europe.
To address these concerns, on 18 November 2025, the European Commission published the Digital Omnibus package. The proposal, which will need to be approved by the Council and the European Parliament in the coming months to become a binding legislation, introduces substantial amendments to several key EU Regulations, including the AI Act. Key changes include aligning the application timelines for high-risk AI rules with the availability of harmonised standards and guidance, adding a six-month transition period for generative AI output marking obligations, and replacing the mandatory AI literacy requirement for companies with a non-binding encouragement by the Commission and Member States. It extends existing SME privileges to small and mid-caps companies, removes the obligation to register exempted AI systems in the EU database, and allows greater flexibility in post-market monitoring. Governance is streamlined by reinforcing the AI Office’s supervisory powers over systems based on general-purpose AI models and enabling an EU-level regulatory sandbox. Additionally, the proposal broadens the legal basis for processing sensitive data for bias detection to all AI systems and introduces operational adjustments to reduce duplication and improve conformity assessment procedures.
Through an informed discussion among academics, representatives of regulatory authorities, firms, and civil society, the Talk aims to unpack the impact of the Digital Omnibus proposal on the AI Act.
Key questions discussed during the webinar:
- Are the modifications introduced by the Digital Omnibus package only ‘technical’, as argued by the European Commission, or do they introduce substantial modifications to the AI Act?
- Does the legislative package effectively simplify the AI Act, thus improving legal certainty and reducing compliance costs for public authorities and private firms?
- Will the Digital Omnibus effectively support innovation in the AI sector in Europe, as argued by the Draghi Report?
- What is the impact of the Digital Omnibus on AI users’ rights in the digital sphere?
The Digital Omnibus Talks are organised by the EUI Centre for a Digital Society and the Centre for Media Pluralism and Freedom in cooperation with the Department of Legal Studies of the University of Florence. The initiative takes place in the context of the Florence Forum on Digital Regulation (FLODIR).
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