3352. Deputy John Lahart asked the Minister for Health the rationale behind the EU vitamin harmonisation rules; the reason for the proposals; the evidence base for same; and if she will make a statement on the matter. [60111/26]

Thank-you for your query.

I am aware of the current work of the European Commission on setting Maximum Amounts (MAs) for vitamins and minerals in food supplements and fortified foods.

Vitamins and essential minerals are micronutrients required for the body to function properly. While they are vital for health, consuming them in excessive amounts can cause harmful effects. To address this risk, the concept of a tolerable upper intake level (UL) was developed. This science-based reference value helps policymakers and other stakeholders assess and manage the potential dangers of excessive nutrient intake.

MAs are limits set on the amount of each vitamin and mineral in food supplements and fortified foods, they are derived using the UL as a key reference point. The purpose of setting MAs is to ensure the safety of consumers. The Food Safety Authority of Ireland (FSAI) Scientific Committee previously gave advice with regards to setting maximum amounts The Safety of Vitamins and Minerals in Food Supplements | Food Safety Authority of Ireland. https://www.fsai.ie/publications/the-safety-of-vitamins-and-minerals-in-food-supple

The approach proposed by the European Commission is in line with this advice. The values will be set on the most up-to-date scientific data, standard model of calculation and on a case-by-case basis.

In 2025, the Commission met with several EU level industry groups and next steps include a call for evidence by the Commission. All interested parties are encouraged to submit any commentary on the MAs once this call is launched. The FSAI is engaging with industry stakeholders on this and is encouraging them to submit feedback when the Commission opens the call for evidence.

The legal basis for the setting of Maximum Amounts (MAs) for food supplements is covered under Article 5 of Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements.

Directive 2002/46/EC on the approximation of the laws of the Member States relating to food supplements establishes the legal framework governing food supplements marketed as foodstuffs within the European Union.

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.

Kind regards