528. Deputy Cathal Crowe asked the Minister for Health if she will address concerns raised by health store owners (details supplied) regarding the proposed EU maximum amounts for vitamins and minerals in food supplements; if she will outline her position on the matter; and if she will make a statement on the matter. [46717/26]

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

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 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 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.

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 legal basis for the setting of Maximum Amounts (MAs) for food supplements is covered under Article 5 of the Directive, this provision sets the criteria to be taken into account when establishing maximum amounts.

Article 5

1. Maximum amounts of vitamins and minerals present in food supplements per daily portion of consumption as recommended by the manufacturer shall be set, taking the following into account:

(a) upper safe levels of vitamins and minerals established by scientific risk assessment based on generally accepted scientific data, taking into account, as appropriate, the varying degrees of sensitivity of different consumer groups;

(b) intake of vitamins and minerals from other dietary sources.

2. When the maximum levels referred to in paragraph 1 are set, due account should also be taken of reference intakes of vitamins and minerals for the population.

These provisions have to be interpreted in light of the respective recitals (13), (14) and (16) in the legal act.

13) Excessive intake of vitamins and minerals may result in adverse effects and therefore necessitate the setting of maximum safe levels for them in food supplements, as appropriate. Those levels must ensure that the normal use of the products under the instructions of use provided by the manufacturer will be safe for the consumer.

(14) When maximum levels are set, therefore, account should be taken of the upper safe levels of the vitamins and minerals, as established by scientific risk assessment based on generally acceptable scientific data, and of intakes of those nutrients from the normal diet. Due account should also be taken of reference intake amounts when setting maximum levels.

(15) Food supplements are purchased by consumers for supplementing intakes from the diet. In order to ensure that this aim is achieved, if vitamins and minerals are declared on the label of food supplements, they should be present in the product in a significant amount.

The European Food Safety Authority (EFSA) was formally mandated by the European Commission to update the Tolerable Upper Intake Levels (ULs) for use in assessing potential risks for consumers via dietary intake, considering recent scientific developments and evidence.