Food Law News - EU - 2003

FSA Letter, 24 March 2003

PARNUTS - Commission's preliminary draft proposal for a Regulation on the addition of vitamins, minerals and of certain other substances to foods. (SANCO/329/03)

For previous news item on this topic, see 17 January 2003. For a copy of the document, see the the pdf file on the FSA web site at Draft Proposal

The letter provides information on the outcome of the discussions in Brussels on 10 March.

All Member States welcomed the proposal, albeit with some concerns on specific issues, though many were only able to express preliminary views at this stage. Some Member States felt that fortification should only be permitted for clear public health reasons and were concerned that voluntary fortification could undermine healthy eating messages. The Commission suggested that this and the Claims proposal could be viewed together and felt that limitations on fortification would be provided by setting of maximum levels, the requirement for vitamins and minerals to be added at a 'significant amount' and the narrow margins between Reference Nutrient Intakes (RNIs) and Safe Upper Levels (SULs) for some nutrients.

There was general consensus that the definitions (Article 2) could be simplified and made more specific. The Commission clarified some of the terminology used and explained that some phrases came from Codex text, which it was reluctant to change, but welcomed other suggestions for improving the definitions. There was some discussion about the intended meaning of 'fresh produce' and suggestions were made that it could be replaced by "unprocessed produce". The Commission agreed to rethink the definition and welcomed suggestions for this. Member States were also asked to provide information on the addition of nutrients to alcoholic drinks, though no objections were raised to the prohibition on fortification of drinks containing more than 1.2% alcohol by volume.

Some suggestions were made for limiting the addition of certain vitamins and minerals to particular foodstuffs and more restrictions, including 'quality criteria' for fortified foods (as in the US). The Commission felt that it would be very difficult to set agreed nutritional profiles and that the text already contains provisions allowing for additional restrictions to be determined under Article 4 (1). However, it indicated that it would be willing to consider prohibiting fortification of sweets, for example, if the majority of Member States were in favour. It also suggested that it might be more appropriate to restrict claims being made on certain products, e.g. sweets, through the Claims Regulation.

The UK queried whether the Regulation was intended to catch foods fortified by virtue of the additions made to animal feed. The Commission had not considered that scenario but suggested it might be more appropriate to control this through animal feed legislation. It was also suggested that the place for the legislative control could be determined on whether the addition was made for the benefit of the animal or of the consumer of the product.

With regard to maximum levels, the Commission envisages that when these are set, decisions may need to be made about which foods may be fortified; if the significant amount required for the addition of nutrients remains at 15% RDA, it will not be practical for some products. In addition, for vitamins or minerals with a narrow margin between the RNI and SUL, it may be necessary only to allow fortification of certain foods in order to ensure that safe intakes are not exceeded. Further, with respect to additives, the maximum level of a vitamin or mineral would cover the total amount of that vitamin or mineral added whatever the purpose.

The UK asked whether the maximum levels, when set, would apply to the quantity of vitamin or mineral in a product at the end of its shelf-life and pointed out that, for some vitamins, manufacturers add more than the declared quantity during production so that the amount present at end of shelf-life is at least equal to the declared quantity. The Commission felt this was an important issue that should be dealt with when we come to deal with tolerances in the review of 90/496/EC. Others were strongly of the opinion that if the maximum level was set on grounds of safety then it must never be exceeded (even at the beginning of shelf-life).

The Commission also said that it did not intend the labelling of foods to which vitamins/minerals had been added to indicate the specific purpose for the addition (i.e. restoration/substitution/fortification). The UK asked whether addition of a mandatorily fortified food (e.g. margarine) to another food (e.g. a cake) as an ingredient would be considered indirect fortification and would then trigger nutrition labelling as in Article7(5). The Commission had not previously thought about this issue but felt that with abolition of the 25% rule the ingredient list would, in this example, automatically include all components of the margarine.

The Commission acknowledged that some substances in Annex 1 currently did not have Recommended Daily Allowances (RDAs) in the Nutrition Labelling Directive 90/496/EC. The Commission said that this would be dealt with in the review of 90/496/EC and pointed out that the SCF has recently adopted a report making recommendations on RDAs for a range of nutrients.

There was general acceptance of Chapter 3 and Annex 3 in principle but questions were raised about the basis for inclusion of substances on the lists, how they would work in practice and whether this text was the most appropriate place to deal with them.

The Commission explained that for some time it has wanted a way of dealing with the use of certain substances in foods and had carefully considered where to include such provisions. The Commission also wanted a way of putting the onus on industry to prove the safety of such products if it wanted to use them.

It was explained that this list was compiled for discussion and as an indicator of the types of substances that could be included. It was recognised that some substances may be regulated elsewhere. Procedurally, if a Member State had a concern about a particular substance, it could raise the issue at Standing Committee and that substance could be added to part A of the Annex. The Commission welcomed suggestions for clarifying procedures and for the movement of substances between the different parts of Annex 3.

The Commission requested that Member States submit remaining comments in writing within two weeks, with a view to progressing this proposal to "catch up with" the Claims proposal. It is envisaged that both proposals could be submitted to the Council/European Parliament before the summer break. The formal proposals will be subject to the normal negotiating process and we will continue to consult and keep you informed of progress during negotiations.

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