698. Deputy Holly Cairns asked the Minister for Health if she has been made aware of upcoming proposals from the European Commission to set maximum levels for vitamins and minerals in fortified food and supplements; whether her Department has engaged with the Commission on the matter; and if so to provide details on these engagements; and if she will make a statement on the matter. [47044/26]

699. Deputy Holly Cairns asked the Minister for Health whether her Department has conducted an impact assessment on the European Commission proposals to set maximum levels for vitamins and minerals in fortified foods and supplements; to provide details of the plans for advice and support for health shops and other affected retailers; and if she will make a statement on the matter. [47045/26]

I propose to take Questions Nos. 698 and 699 together.

I am aware of the ongoing work of the European Commission in relation to the possible setting of maximum amounts for vitamins and minerals in food supplements and fortified foods. This work is provided for under existing EU food law and is intended to support a high level of consumer protection while ensuring a consistent approach across the European Union.

Vitamins and minerals are essential micronutrients required for normal bodily function. However, excessive intake of certain vitamins and minerals may give rise to adverse health effects. For that reason, maximum amounts are generally informed by scientific risk assessment, including tolerable upper intake levels, dietary intake from other sources, and reference intakes for the population.

The legal basis for setting maximum amounts for vitamins and minerals in food supplements is contained in Article 5 of Directive 2002/46/EC on the approximation of the laws of the Member States relating to food supplements. That Directive provides that maximum amounts should take account of upper safe levels established by scientific risk assessment, intake from other dietary sources, and reference intakes for the population.

In relation to fortified foods, Regulation (EC) No. 1925/2006 provides for conditions relating to the addition of vitamins and minerals to foods, including the setting of maximum amounts through the relevant EU procedures. The European Commission has indicated that this work is complex and has been the subject of consultation with Member States and stakeholders over time.

The Department is monitoring developments closely. Officials have engaged with the Food Safety Authority of Ireland (FSAI), which has the relevant scientific and technical expertise in this area, and the FSAI is engaging with industry stakeholders. The Department understands that the European Commission engaged with a number of EU-level industry groups in 2025 and that a call for evidence is expected to provide interested parties with an opportunity to submit views on any proposed approach.

The Department has not finalised a national position on this matter. Any position will be informed by the evidence presented by the European Commission, the scientific advice of the European Food Safety Authority, the views of Member States, and any relevant stakeholder input.

As the Commission’s work is ongoing and no final proposal has been adopted, a formal impact assessment has not been conducted at this stage. The potential implications for consumers, food supplement businesses, health shops and other affected retailers will be considered as the EU process develops and further detail becomes available.

The FSAI will continue to provide advice and technical input, as appropriate, and to engage with stakeholders in line with its statutory role. Interested parties will be encouraged to participate in any Commission call for evidence or consultation process when it opens.