730. Deputy Sean Fleming asked the Minister for Health the reasoning behind the proposed changes to providing supplements that people require for their health without having to take prescribed drugs (details supplied); and if she will make a statement on the matter. [50958/26]

Thank-you for your query. I note the concerns which you have raised in your submission.

The proposed changes relating to maximum permitted levels of vitamins and mineral in food supplements are being considered at European Union level as part of the implementation of Directive 2002/46/EC on food supplements. The objective of this work is to establish harmonised maximum amounts of vitamins and minerals in food supplements across the Member States, based on best available scientific evidence and ensuring high level consumer protection.

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.

The Tolerable Upper Intake Level (UL) is established through a structured, science-based risk assessment process. It represents the maximum daily intake of a nutrient that is unlikely to cause harmful effects in nearly all individuals in a population. The UL is not a recommended intake level, but rather a safety threshold. Intakes below the UL are unlikely to pose risks, while habitual intake above it increases the likelihood of adverse health effects.

Maximum Amounts (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 (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.

Work resumed at setting MAs by the European Commission in 2021. 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 Department of Health’s position on this matter is not yet finalised, it will be determined based an assessment of evidence from the Commission and EFSA.