Art.57

Article 57 – AI Regulatory Sandboxes

SME Key SME Relevant ~2 min read · 492 words

Article 57 is one of the most SME-friendly articles in the entire EU AI Act. It requires every member state to establish at least one AI regulatory sandbox — a controlled environment where AI systems can be developed, tested, and validated before market placement, under regulatory supervision and with relaxed compliance obligations. Sandboxes are specifically designed to help startups and SMEs innovate without the full weight of pre-market compliance.

✓ Low compliance impact for SMEs

WHAT THE ARTICLE IS ABOUT

Safe spaces for AI innovation under regulatory supervision

Article 57 mandates the creation of AI regulatory sandboxes across the EU — controlled environments established and managed by national competent authorities where businesses can develop, train, test and validate AI systems before they go to market. The sandbox concept balances innovation with oversight, giving companies — especially smaller ones — access to regulatory guidance while working on AI systems that may be subject to the Act’s requirements.

WHAT IT SAYS

At least one per member state, prioritising SMEs and startups

Each member state must establish at least one AI regulatory sandbox at national level by 2 August 2026 — before the Act’s main high-risk AI requirements apply
The AI Office may establish a Union-level AI regulatory sandbox in addition to national sandboxes
Sandboxes must be accessible to any provider or prospective provider of an AI system, with priority given to SMEs and startups
Participation in a sandbox does not exempt participants from their obligations under other applicable EU or national law
Participants benefit from direct engagement with national competent authorities and can receive guidance on compliance without that guidance being used against them in enforcement proceedings
Sandbox participants must meet eligibility criteria and sign a sandbox plan setting out objectives, duration, and oversight arrangements
Information exchanged in sandbox proceedings is subject to confidentiality protections

WHO IS AFFECTED

AI developers and startups — with SMEs given explicit priority

SMEs and startups developing AI systems — explicitly prioritised for sandbox access
Any provider or prospective provider of an AI system wanting pre-market regulatory guidance
National competent authorities responsible for establishing and managing sandboxes
The AI Office potentially managing a Union-level sandbox
Research institutions and public bodies developing AI in regulated areas

WHAT IT MEANS FOR SMES

The most directly beneficial provision in the Act for small AI innovators

If you are building an AI system that may be high-risk and you are concerned about compliance costs and regulatory uncertainty, sandboxes are your entry point — they let you develop under regulatory supervision without full pre-market compliance costs
The priority access for SMEs and startups is written directly into the article — regulators are required to prioritise you, not treat you equally with large corporations
Sandbox participation gives you access to regulatory guidance that is specifically designed not to be used against you in enforcement — you can ask hard questions without fear
Monitor your national competent authority’s sandbox programme — as of August 2026 these must exist in every member state, and several countries have already established them ahead of the deadline
Spain was an early mover with its national AI sandbox — check the AI Office website for an up-to-date map of available sandboxes across member states

Article 58 — Sandbox functioning (the detailed rules for how sandboxes operate)
Article 59 — Personal data processing in sandboxes (special data rules for sandbox participants)
Article 60 — Real world testing outside sandboxes (the alternative testing pathway)
Article 62 — Measures for SMEs (Article 57 is part of the broader SME support framework)

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