Regulation of Artificial Intelligence Bill 2026: Committee Stage (Resumed) and Remaining Stages
Seanad Éireann — 2026-07-15
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Niamh Smyth (FF), Cavan-Monaghan

I thank both Senators for speaking to these amendments. I will cover amendments Nos. 55 to 65, inclusive, with the indulgence of the Acting Chairperson. Before addressing individual amendments, it may be helpful to briefly outline the framework that already applies in real world testing of high-risk AI systems. Under Article 60 of the AI Act, real world testing is not unrestricted. It is one of the most heavily regulated aspects of the AI Act. Testing may only take place where permission has been granted under the relevant market surveillance authority and where the detailed conditions set out in Article 60 are satisfied.
Those conditions already require, among other things: a documented testing plan; appropriate risk management measures; human oversight arrangements; safeguards for health, safety and fundamental rights; compliance with applicable union law; regulatory supervision and oversight; record keeping and documentation requirements; and powers for authorities to suspend, modify or terminate testing where concerns arise.
In addition, Articles 61 and 62 provide specific protections for natural persons participating in or affected by real world testing, including informed consent requirements and safeguards for participants. The AI Act therefore embeds risk management, participant protection and fundamental rights safeguards directly into the authorisation and operation of real world testing.
Against that backdrop, I will address the individual amendments.
Amendment No. 55 would require an applicant seeking authorisation for real-world testing to clearly establish how the risk management system referred to in Article 9 will be implemented. I fully agree that effective risk management is a critical element of the AI Act framework. However, Article 60 already establishes a detailed and harmonised set of conditions governing real-world testing of high-risk AI systems. Those conditions must be assessed by relevant market surveillance authorities before authorisation may be granted. The amendment would introduce an additional national authorisation criterion beyond those contained in Article 60. Authorisation decisions must continue to be assessed against the harmonised criteria set out in the AI Act itself. Introducing additional national requirements risks creating uncertainty regarding the relationship between national law and the harmonised framework established by EU law. Accordingly, I cannot accept amendment No. 55.
Amendment No. 56 would require an application for real-world testing to be refused when the applicant has not clearly established how Article 9 risk management systems will be implemented. Again, I fully recognise the importance of risk management. However, Article 60 already sets out the conditions that must be met before testing may be authorised, including safeguards relating to risk management, oversight and participant protection. This amendment would, in effect, create a new mandatory ground for refusal beyond those provided for in the AI Act. Decisions to authorise or refuse testing should continue to be determined by reference to the criteria specified in Article 60. Accordingly, I cannot accept amendment No. 56.
Amendments Nos. 57 and 58 concern fundamental rights considerations. The amendments would require a market surveillance authority to have explicit regard to the impact of testing on fundamental rights and, in the case of amendment No. 58, the rights of vulnerable persons. I fully agree with the protection of fundamental rights as a central objective of the AI Act. However, these considerations are already embedded throughout that Act and specifically within the framework governing real-world testing. Article 60 requires testing to take place under a controlled and supervised framework, with appropriate safeguards in place. Article 60 forms part of a wider framework of safeguards within the AI Act. In particular, the regulation contains extensive provisions relating to risk management, human oversight, informed consent, participant protection and fundamental rights. Real-world testing under Article 60 must operate within the broader regulatory framework. Accordingly, market surveillance authorities are not assessing real-world testing in a legal vacuum. Article 60 already contains detailed safeguards that must be applied in the context of the wider protections contained throughout the AI Act, including those related to participant protection and fundamental rights. Introducing an additional national statutory requirement risks creating overlap and uncertainty as to whether a different threshold is intended to apply in Ireland from that provided for in the AI Act. I am satisfied that the protection of fundamental rights, including the protection of vulnerable persons, is already fully embedded within Article 60 of the framework. Accordingly, I cannot accept amendments Nos. 57 and 58.
Amendment No. 59 would require market surveillance authorities, when deciding whether to authorise real-world testing, to have regard to climate, environmental protection, biodiversity and obligations under the Paris Agreement. I fully recognise the importance of environmental protection, biodiversity and climate action. However, as I outlined earlier, section 48 gives effect to Article 60 of the AI Act, which establishes a harmonised framework for authorising real-world testing. The role of the market surveillance authority is to assess whether the conditions specified within Article 60 have been met. While the AI Act recognises environmental protection as a broader objective, Article 60 does not require separate assessments of climate and biodiversity impacts or compliance with the Paris Agreement when determining whether testing may proceed. This amendment, therefore, would introduce additional national authorisation criteria that do not form part of the harmonised EU framework. That could create uncertainty regarding the basis upon which authorisations should be granted or refused, the scope of the authority's assessment, how such impacts can be measured and how those considerations relate to the conditions already set out in Article 60. For those reasons, I cannot accept amendment No. 59.
Amendment No. 60 would require the Minister to undertake and publish an annual ethical review of the operation of section 48. Real-world testing should be undertaken responsibly and ethically. However, a separate statutory annual ethical review is not necessary. The ethical and fundamental rights considerations identified by the amendment are already integrated directly into the AI Act framework. Article 60 itself contains extensive safeguards, while Articles 61 and 62 provide additional protections relating to informed consent and participant protection. In addition, the AI Act contains formal review and elevation provisions at EU level. Under Article 112, the European Commission is required to assess the operation and effectiveness of the regulation and to report on its implementation. This provides an existing mechanism through which the functioning of the AI Act, including its real-world testing framework, can be reviewed and evaluated over time. The amendment also introduces the concept of ethical review without defining its scope, the standards that should be applied, who should conduct it or how it should interact with the existing regulatory framework. I consider that the existing real-world safeguards and oversight mechanisms provide meaningful protection. Accordingly, I cannot accept amendment No. 60.
Amendments Nos. 61, 62, 64 and 65 would introduce the concept of a proposal taking provisional effect immediately and then no longer coming into full effect. The existing provision sets out a clear statutory process and provides certainty as to when decisions take legal effect. Introducing concepts such as provisional effect and full effect risks creating uncertainty regarding the legal status of testing and the applicable safeguards at various stages of the process. The current framework already provides clarity, certainty and appropriate regulatory oversight. Accordingly, I cannot accept amendments Nos. 61, 62, 64 and 65.
Amendment No. 63 would reduce the current period of 14 working days to a period of no more than seven days. The purpose of section 49 is to balance regulatory intervention with fair procedures. The existing framework allows authorities to suspend, modify or terminate testing where concerns arise, while ensuring affected parties have an opportunity to make representations. The current 14-day period forms part of a coherent procedural framework and provides legal certainty for all parties involved. Replacing it with a shorter and less certain timeframe could reduce the opportunity for affected parties to respond, create uncertainty regarding implementation dates and be particularly challenging where complex, high-risk AI systems are involved. I consider that the 14-day period strikes an appropriate balance between responsiveness and procedural fairness. Therefore, I cannot accept amendment No. 63.

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Retrieved: 2026-08-27T06:52:16+00:00
Sitting date: 2026-07-15