Digital Package on Simplification: a pragmatic adjustment of the AI Act for a realistic and innovation-friendly implementation‍

Digital Package on Simplification: a pragmatic adjustment of the AI Act for a realistic and innovation-friendly implementation

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1. A project made public in early November 2025, in a context of high expectations

In early November 2025, the European Commission made public the Digital Package on Simplification, as part of its “A Simpler and Faster Europe” programme.

This initiative aims to streamline the implementation of Regulation (EU) 2024/1689, known as the Artificial Intelligence Act (AI Act), adopted on 13 June 2024 and in force since 1 August 2024.

Its ambition is to reduce administrative burdens while maintaining the ethical and legal safeguards that underpin the European framework for trustworthy artificial intelligence.

Access the draft European text: European Commission - Digital Package on Simplification.

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2. A pragmatic turning point in the European strategy for AI regulation

The Digital Package on Simplification represents a pragmatic evolution of the European regulatory model.

Faced with practical challenges in implementing the AI Act , delays in the designation of competent authorities, lack of harmonised standards, excessive documentation for SMEs, and high compliance costs, the Commission has chosen to adjust the regulatory mechanics rather than reopen the legislative debate.

This recalibration takes place amid strong industrial and geopolitical pressures, as several major US AI players have advocated for a more flexible framework, arguing that excessive rigidity could hinder innovation.

It is difficult to deny that US lobbying has had a tangible influence, yet this orientation remains consistent with the European objective of efficiency and credibility.

Far from constituting a setback, this evolution reflects institutional maturity. The European Union now seeks to combine legal certainty, innovation and competitiveness, transforming the AI Act from a prescriptive instrument into a living regulatory framework, capable of adapting to a rapidly evolving technological environment.

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3. The main simplification measures proposed

The Digital Package on Simplification introduces targeted technical amendments without altering the core structure or objectives of the AI Act:

• Transitional grace period for the watermarking obligation applicable to AI systems already placed on the market;
• Extension of existing regulatory privileges granted to SMEs to include small mid-caps, with simplified technical documentation and proportionate penalties;
• Removal of the requirement for a harmonised post-market monitoring plan, giving providers greater flexibility;
• Clarification of the interplay between the AI Act and the Cyber Resilience Act;
• Reduced registration burden for AI systems used in high-risk areas but performing only procedural or preparatory tasks;
• New legal basis allowing the processing of special categories of personal data for bias detection and correction, under appropriate safeguards;
• Broader use of AI regulatory sandboxes, including an EU-level sandbox under the supervision of the AI Office;
• Centralisation of oversight of certain AI systems within the Commission, notably those embedded in very large online platforms and search engines.

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4. Legal basis and institutional scope

The proposal is based on Article 114 of the Treaty on the Functioning of the European Union (TFEU), which provides the legal foundation for internal market harmonisation.

The proposed amendments are proportionate and strictly limited to what is necessary to ensure consistency and facilitate the effective implementation of the Regulation.

They form part of a broader Digital Omnibus and Simplification Package, designed to make the EU’s digital regulatory framework, including the AI Act, Cyber Resilience Act and Data Act, clearer, more coherent and economically sustainable, while preserving the Union’s high level of protection for health, safety and fundamental rights.