Official Report: Minutes of Evidence

The Chairperson (Ms Ferguson): I welcome David Wilson, senior principal officer, Department of Health; Caroline Barry, head of chemical and industrial pollution policy branch, Department of Agriculture, Environment and Rural Affairs; and Aoibhinn Corrigan, deputy principal, Department of Agriculture, Environment and Rural Affairs. Happy new year to you all. I invite you to brief the Committee when you are ready.

Ms Caroline Barry (Department of Agriculture, Environment and Rural Affairs): Thank you, Madam Chair and members for giving me the opportunity today to speak to you on regulation (EU) 2025/2457 of the European Parliament and of the Council of 26 November 2025 on the reattribution of scientific and technical tasks and improving cooperation among Union agencies in the area of chemicals.

The Act came into force on 1 January this year. It forms part of the European Union's "One-substance, one assessment" package under the EU's chemical strategy for sustainability, which was published in October 2020. The overarching goal of the package is to streamline the EU's chemical risk assessment framework by reducing duplication; ensuring transparency and consistency; and fully utilising scientific expertise and resources across EU legislation. The purpose of regulation 2025/2457 is to facilitate the reallocation of scientific and technical tasks and improve inter-agency cooperation. It aims to simplify the current framework; improve the quality and coherence of safety assessment across Union legal Acts; and ensure that existing resources are used more efficiently. It does so by making amendments to a number of EU regulations.

It amends regulation 178/2002, which establishes the general principles and requirements for food law in the EU, ensuring food safety and the establishment of the European Food Safety Authority (EFSA). It also makes changes to regulation 401/2009, which establishes the European Environment Agency and the European Information and Observation Network. Furthermore, it makes changes to regulation 2017/745 — known as the "medical device regulation" — which establishes a comprehensive framework for the regulation of medical devices in the EU, ensuring high standards of safety and health. The fourth regulation that it makes changes to is regulation 2019/1021, which aims to protect human life and the environment by prohibiting and restricting the production and use of persistent organic pollutants (POPs).

Regulation 401/2009 is not covered by the Windsor framework, and thus the changes do not apply in Northern Ireland. Regulation 2019/1021 is covered by the Windsor framework and falls within DAERA's remit. Furthermore, DAERA is the competent authority responsible for enforcing POPs in Northern Ireland. The amendment of the EU POPs regulation expands the tasks, workload and remit of scientific committees in the European Chemicals Agency (ECHA) and the European Commission concerning persistent organic pollutants in waste. The primarily administrative changes therefore result in no new burden for DAERA. Therefore, DAERA does not envisage any significant impacts on the public or businesses in Northern Ireland stemming from the Act in relation to POPs.

There is likely to be a very modest increase in the EU-level resources needed to support ECHA's new responsibilities, but those costs are at an EU level and are not directly assigned to any individual member state or Northern Ireland. There is the potential for some Northern Ireland-based stakeholders to experience indirect costs or, more likely, benefits, depending on how the new procedures affect compliance, transparency and efficiency with the EU's new system. Overall, it is expected that the changes introduced by the regulations will make ECHA's work more effective and coherent.

I will now pass over to my colleague David Wilson from the Department of Health.

Mr David Wilson (Department of Health): Good morning, members. The Department of Health's interest in the regulations is limited to the amendments to the medical device regulation EU 2017/745 and its application. The regulation applies in Northern Ireland under the Windsor framework annex 2 on medical devices. The Department for the Economy also has an interest in the regulation, as Northern Ireland medical device manufacturers will follow its provisions. We liaised with DFE colleagues and agreed that DOH would lead in the Committee today to present on the anticipated impact.

The amendment to regulation (EU) 2017/745 tasks the European Chemicals Agency with updating existing guidelines on conducting risk-benefit assessment and scientific advice and guidance on specific substances. Article 3 of the proposed EU regulation amends annex 1 of regulation 2017/745 to task the ECHA to provide risk assessment, scientific advice and guidance on specific substances that are carcinogenic, mutagenic or toxic to reproduction and substances that are classified as endocrine disruptors for human health. Furthermore, it tasks the ECHA with updating existing guidelines and conducting a risk-benefit assessment on the presence of phthalates in those substances. It also aligns a hazard class description of endocrine disruptors.

The regulation on medical devices allocates tasks to the ECHA, such as the provision of expert advice and guidance. The EU's assessment is that the impact on the ECHA is low.

From a Health and Economy perspective, the overall impact is negligible with no increase in burden in the delivery of health or on Northern Ireland manufacturers. There are amendments that affect the EU internal mechanisms for management, with specialised committees to provide relevant advice. There are no practical implications.

On behalf of our Food Standards Agency colleagues, I will report on the amendments to regulation 178/2002 on general food law. The Food Standards Agency has considered the amendments insofar as they relate to the work of the European Food Safety Authority. The EFSA is not a decision-making body; its primary role is to provide independent scientific advice on the safety of food and feed. Any scientific advice or safety opinion produced by the EFSA is used by the European Commission and EU member states to formulate risk management decisions to safeguard public health. As the changes brought forward to the regulation are tightly focused on the way in which the EFSA engages and cooperates with other risk assessment bodies, the EFSA does not expect the changes to result in any impact on outcomes for consumers, industry or regulators in Northern Ireland. The changes are internal to the EFSA's ways of working.

The Chairperson (Ms Ferguson): Thank you. Do any members have questions for the officials?

Dr Aiken: This seems to be similar to the evidence that we had from DAERA in the previous session. It is about tidying up.

The Chairperson (Ms Ferguson): I thank you all for your presentation this morning.