Proposed Regulation on the Addition of Vitamins and Minerals to Foods - Latest Developments

Originally published August 2005

In November 2003, the European Commission issued a proposal for a Regulation on the addition of vitamins and minerals to foods (the "proposed Regulation")¹. The aim of the proposed Regulation is to regulate the voluntary addition of vitamins and minerals to foods in order to promote the free circulation of such foods in the EU and at the same time to provide a high level of protection for consumers.

Under the proposed Regulation, only those vitamins and minerals listed in Annex I may be added to foods, and then only in the forms set out in Annex II. Maximum and minimum amounts of vitamins and minerals that can be added to foods will also be set, with their addition to foods also being subject to the vitamin or mineral meeting certain purity criteria. The proposed Regulation also allows for the possibility of establishing restrictions or prohibitions on the addition of specific vitamins or minerals to a particular food or category of food.

The proposed Regulation also prohibits the addition of vitamins and minerals to certain foods. As currently drafted, these are alcoholic drinks containing more than 1.2% by volume of alcohol (subject to a limited derogation for tonic wines) and unprocessed foods such as fruits, vegetables, meat, poultry and fish. There is also the opportunity for the list of prohibited foods to be extended in the future under the comitology procedure. The proposed Regulation also provides a basis for restricting or prohibiting the addition of "certain other substances" (other than vitamins and minerals) to foods. These substances will be included in Annex III, however no such substances are currently listed in the proposed Regulation.

The proposed Regulation will be adopted jointly by the European Parliament and the Council of Ministers (which consists of representatives from Member States) under the co-decision procedure. The Council considered the amendments to the proposed Regulation put forward by the Parliament at the end of May this year. However there are still a number of areas where the two bodies are in disagreement. Set out below are the key areas of disagreement.

The Commission's original proposal provided that (amongst other things) the "nutrient profile"² of a product should be taken into account when setting the maximum levels for vitamins and minerals and any conditions restricting or prohibiting the addition of specific vitamins or minerals to a food where the "reference intake" of the population for the vitamin or mineral in question was close to upper safe levels. The Parliament removed this reference to "nutrient profiles" but it has been re-inserted by the Council.

The factors to be taken into account when determining whether any other foods or categories of foods should be added to the list of "prohibited foods" (that is, those to which vitamins or minerals may not be added) is also a contentious issue between the Parliament and the Council. Parliament has suggested that decision-makers should only be able to prohibit the addition of particular vitamins and minerals to foods or categories of foods and then only in cases where the addition of such vitamins and minerals would result in a danger to public health. However, the Council has proposed that the nutritional value of a food or category of food should be taken into account when considering whether any additional foods should be added to the prohibited foods list. The Council's proposal is potentially more far-reaching as it could allow, for example, prohibiting the addition of vitamins or minerals to foods that are high in fat or sugar such as chocolate or confectionery products.

The Parliament proposed that the Commission establish Recommended Daily Allowances ("RDAs") for all of the vitamins and minerals listed in Annex I and II, taking into account the latest scientific knowledge and international recommendations. The Parliament also recommends that "upper safe levels" and RDAs be set for the "other substances" included in Annex III. The Council is opposed to this amendment.

The original Commission proposal included certain labelling obligations where vitamins or minerals had been added to foods, including a compulsory declaration of total amounts of the vitamins and minerals added to the food expressed per 100g (or per 100ml) in line with the current nutritional labelling requirements set out in Directive 90/496. However, the Parliament wants manufacturers to provide information on vitamins and minerals expressed per 100g (or per 100ml), and per serving size in absolute numbers and as a percentage of the RDA for the respective vitamins/minerals. The Parliament has also indicated that manufacturers should state the manufacturers' recommended daily intake ("RDI") of the product together with a warning not to exceed the stated RDA. The Parliament also wants similar labelling obligations where certain other substances listed in Annex III have been added to a food.

The original Commission proposal contained certain transitional measures, including a derogation permitting Member States to allow the use of vitamins and minerals not listed in Annex I or in forms not listed in Annex II in their territory for a period of seven years. The Parliament wants to shorten this transitional period to three years. However the Council has rejected the Parliament's suggestion and re-inserted a transitional period of seven years.

Under the original proposal, vitamins and minerals could be added to foods for one or more of three stated purposes:

1. restoration of vitamins and minerals lost in the manufacturing, storage or handling process;
2. creating nutritional equivalence in substitute foods (for example adding vitamins to margarine so that it has a similar vitamin content to butter); and
3. fortification or enrichment of foods in order to improve its nutritional value in certain circumstances (for example taking into account deficiencies in the population).

While the Parliament made no substantial changes on this point, the Council appears to be taking a more liberal view with the amendments it has proposed. In brief, the Council has not included an exhaustive list of the circumstances in which vitamins or minerals may be added to foods. Further, while it has kept in the conditions in which vitamins and minerals can be added for fortification or enrichment purposes, it has deleted the references to restoration and nutritional equivalence from the main body of the proposed Regulation and instead intends to insert a provision in the recitals indicating that vitamins and minerals may be added to foods for these two purposes. It will be interesting to see where this issue ends up, especially if it results in the Regulation containing a non-exhaustive list of the purposes for which vitamins and minerals may be added to foods.

The Council is not currently expected to send its common position on the proposed Regulation back to the Parliament for a second reading until at least November or December of this year. Although the Council has reached a political agreement and therefore has agreed the content of its common position, it is currently undertaking legal and linguistic editing of the text. Once the Parliament receives the Council's common position, it will have, generally, three months to either approve the Council's common position and adopt the Regulation or forward further amendments to the proposal to the Council and the Commission.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.