Addition of vitamins and minerals

What are additives?

A wide range of nutrients and other ingredients are used in food manufacturing, including (but not limited to):

Vitamins
Minerals including trace elements
Amino acids
Essential fatty acids
Fibre
Various plants and herbal extracts

Such nutrients or ingredients are added to food in order to "enrich" or "fortify" the food in question, so as to add or emphasise particular nutritional characteristics.

Regulation (EC) No 1925/2006 harmonises the provisions regarding the addition of vitamins and minerals and of certain other substances to foods. This Regulation ensures the effective functioning of the internal market whilst providing a high level of consumer protection.

Regulation 1925/2006 has been aligned with the new Regulatory Committee procedure with Scrutiny by Regulation (EC) No 108/2008.

What is permitted?

Annex I of the Regulation 1925/2006 is a list of vitamins and minerals which may be added to foods.
Annex II is a list of the sources of vitamins and minerals which may be added to foods.
- Annex I and Annex II have been amended later on by three Commission Regulations to include additional substances:
Annex III is a list of substances other than vitamins or minerals whose use in foods is prohibited, restricted or under Community scrutiny.
Annex III has been amended by Commission Regulation (EU) No 2015/403, prohibiting the use of Ephedra herb and its preparations from Ephedra species and subjecting Yohimbe bark and its preparations originating from Yohimbe (Pausinystalia yohimbe (K. Schum) Pierre ex Beille) to Community scrutiny (see below).

Inclusion of vitamins and minerals in the Annexes

Vitamin and mineral substances may be considered for inclusion in the lists following the evaluation of an appropriate scientific dossier concerning the safety and bioavailability of the individual substance by the European Food Safety Authority (EFSA).

Food business operators should submit requests for the inclusion of vitamins and minerals in the Annexes via the E-submission Food Chain Platform.

- Guidance document for competent authorities, tolerances for the control of compliance of nutrient values declared on a label with EU legislation. (A simplified summary table gives an overview of the different tolerance values included in the guidance document. In case of doubt the guidance document text should be consulted as the official reference)

Conditions for the addition of vitamins and minerals to foods

The Regulation provides for the setting of maximum amounts of vitamins and minerals in these products via the procedure of the Standing Committee on Plants, Animals, Food and Feed (PAFF Committee). Minimum amounts are linked to the notion of significant amount, where this is defined according to Annex XIII to Regulation (EU) No 1169/2011.

The Commission issued a Discussion Paper on the setting of maximum and minimum amounts for vitamins and minerals in foodstuffs , which identified the main issues to be considered in this exercise. The consultation closed on 30 September 2006.

Responses to the Discussion Paper on the setting of maximum and minimum amounts for vitamins and minerals in foodstuffs.

Although the Commission has consulted extensively with Member States and interested stakeholders on the issue, no proposal has yet been presented due to the complex nature of the issue and the divergent views that were expressed.

All the available data on the potential effects on economic operators and consumers of the setting of maximum amounts of vitamins and minerals in foods, including food supplements, will be taken into account. Every effort will be made to ensure that the maximum amounts set will take into account the concerns expressed by all interested parties.

Addition of certain other substances to foods

Is it possible to prohibit, restrict or put under Union scrutiny the use of other substances added to foods (including food supplements)? Yes. The Commission, on its own initiative or at the request of a Member State, may initiate the procedure under Article 8 of the Regulation to prohibit, restrict or put under Union scrutiny a substance other than vitamins or minerals or an ingredient containing such a substance that is added to foods or used in the manufacture of foods.

This could happen where the use of such substances in foods would result in the ingestion of amounts greatly exceeding those reasonably expected to be ingested under normal conditions of consumption of a balanced and varied diet and/or would otherwise represent a potential risk to consumers.

The conditions for use of the procedure may be found in Commission Implementing Regulation (EU) No 307/2012 establishing implementing rules for the application of Article 8 of Regulation (EC) No 1925/2006.

The Commission has received a request from a Member State to initiate the procedure under Article 8 of the Regulation for Ephedra species and for Yohimbe (Pausinystalia yohimbe (K. Schum.) Pierre ex Beille) . The following information was submitted to the European Food Safety Authority (EFSA) for a safety assessment:

EFSA has adopted a scientific opinion on safety evaluation of Ephedra species for use in food and a scientific opinion on the evaluation of the safety in use of Yohimbe (Pausinystalia yohimbe (K. Schum.) Pierre ex Beille).

Commission Regulation (EU) 2015/403 amending Annex III to Regulation (EC) No 1925/2006 of the European Parliament and of the Council as regards Ephedra species and Yohimbe (Pausinystalia yohimbe (K. Schum.) Pierre ex Beille) - places Ephedra herb and its preparations in Part A of Annex III and Yohimbe bark and its preparations originating from Yohimbe (Pausinystalia yohimbe (K. Schum.) Pierre ex Beille) in Part C of Annex III.

Commission Regulation (EU) 2019/650 amending Annex III to Regulation (EC) No 1925/2006 of the European Parliament and of the Council as regards Yohimbe (Pausinystalia yohimbe (K. Schum) Pierre ex Beille) places Yohimbe bark and its preparations originating from Yohimbe (Pausinystalia yohimbe (K. Schum.) Pierre ex Beille) in Part A of Annex III.

The Commission on its own initiative has initiated the procedure under Article 8 of the Regulation for the intake of hydroxyanthracene derivatives from all food sources as concerns have been raised by the Member States regarding a potential risk to consumers linked with the consumption of this substance as outlined in the opinion by the European Food Safety Authority (EFSA) on the scientific substantiation of a health claim related to hydroxyanthracene derivatives and improvement of bowel function (EFSA Journal 2013;11(10):3412 [12 pp.]).

In accordance with Article 8(2) of Regulation (EC) No 1925/2006, the Commission has requested EFSA to provide a scientific opinion on the safety in use of the substance. EFSA has adopted a scientific opinion on the safety of hydroxyanthracene derivatives for use in food.

The Commission, on the basis of a request by certain Member States has initiated the procedure under Article 8 of the Regulation for the intake of green tea catechins, and particularly (-)-epigallocatechin-3-gallate (EGCG), from all food sources as safety concerns have been raised by the Member States regarding a potential risk to consumers linked with the intake of these substances.

These risks are outlined in the scientific opinion on green tea extracts by The National Food Institute of the Technical University of Denmark, and in the safety assessment on levels of (-)- Epigallocatechin-3- gallate (EGCG) in green tea extracts used in food supplements carried out by the Norwegian Institute of Public Health. In accordance with Article 8(2) of Regulation (EC) No 1925/2006, the Commission has requested EFSA to provide a scientific opinion on the safety in use of the substance. EFSA has adopted a scientific opinion on the safety of green tea catechins.

The Commission has initiated, on its own initiative, the procedure under Article 8 of Regulation (EC) No 1925/2006 for the intake of monacolins derived from red yeast rice (i.e. rice fermented with the red yeast Monascus purpurseus) as concerns have been raised by the Member States regarding a potential risk to consumers linked with the consumption of these substances.

This potential risk is outlined in scientific opinions by the European Food Safety Authority (EFSA) on the scientific substantiation of health claims related to monacolin K from red yeast rice and maintenance of normal blood LDL-cholesterol concentrations (EFSA Journal 2011;9(7):2304; EFSA Journal 2013;11(7):3327; EFSA Journal 2013;11(2):3084).

In accordance with Article 8(2) of Regulation (EC) No 1925/2006, the Commission requested EFSA to provide a scientific opinion on the safety in use of these substances. EFSA has adopted a scientific opinion on the safety of monacolins derived from red yeast rice.

The Commission, on the basis of a request by a Member State, has initiated the procedure under Article 8 of Regulation (EC) No 1925/2006 on the addition of vitamins and minerals and of certain other substances to foods for the intake of alpha-lipoic acid in food supplements because of the potential risk to health associated with the intake of this substance.

Safety concerns associated with the use of alpha-lipoic acid in food supplements have been outlined in a scientific opinion by the Danish National Food Institute (DTU) on the safety of alpha-lipoic acid use in food supplements, and in an expert opinion on the safety of placing dietary supplements with alpha-lipoic acid on the market for the general population by the Belgian Superior Health Council.

In accordance with Article 8(2) of Regulation (EC) No 1925/2006, the Commission has requested EFSA to provide a scientific opinion on the safety of the substance when intentionally added to foods.

Evaluation

Article 16 of the Regulation provides for the submission of a report - by the Commission to the European Parliament and the Council - that evaluates the effects of implementation of the Regulation. Commission Implementing Regulation (EU) No 489/2012 establishes implementing rules for the application of Article 16 of Regulation (EC) No 1925/2006. The Commission’s work on the report is still on-going.

Register

As required by Article 9 of the Regulation, the Commission establishes and maintains a Community Register on the addition of vitamins and minerals and of certain other substances to foods.

Monitoring of fortified food products

Member States may request notification to their competent authority of the placing on the market in their territory of foods to which vitamins and minerals have been added and of foods containing substances listed in Annex III, Parts B and C in accordance with Article 15 of the Regulation. The list of competent authorities may be found here:

Information on the relevant contact points has been provided by some EU countries.