Protection of human health: addition of nutrients to food

The Council's common position, adopted by qualified majority, conforms to the objectives of the Commission proposal while introducing a limited number of modifications. These include:

- removing the definitions in Article 2 on the purposes of the addition of vitamins and minerals to food in favour of explaining the circumstances in which vitamins and minerals may be added to food in Article 3 (Requirements);

- a more precise description of derogations applicable to Article 4 (outlining the cases where the addition of vitamins and minerals may not take place) in relation to alcoholic beverages;

- streamlining the provisions applicable to substances other than vitamins and minerals (merging Articles 10 and 11 of the original proposal);

- clarifying the procedures for notification of existing and new national provisions (new Article 11 and deletion of Article 9 of the original text).

The common position reflects the spirit of all or part of 17 of the 23 amendments which were acceptable by the Commission in full, in part, in principle or subject to drafting changes and of 3 amendments which the Commission had originally indicated it was unable to accept. The amendments refer to :

- Restriction on the addition of vitamins and minerals : the common position has introduced a derogation for the addition of vitamins and minerals to well specified traditional beverages containing more than 1.2% by volume of alcohol;

- Other substances : the common position has merged Articles 10 and 11 of the original Commission proposal on the addition of certain other substances to foods into Article 8 simplifying the text and specifying the procedure for evaluation of these substances;

- Annex II : the common position has added to annex II of the Regulation, as an allowed mineral source, calcium sulphate. Moreover, it has maintained in the same Annex the sodium and the potassium salts of ortophosphoric acid and pyridoxine dipalmitate as a source of vitamin B6.

- Other : modifications have been made to Annexes I and II so that the opinion of the Authority shall be taken into account; allowing Member States, during an initial transition period, to authorise on to their territory vitamins and minerals not listed in the annexes of the Regulation provided a dossier is submitted to the Commission. The list of these substances will then be published in the Community register which will be available to the public; the publication in the Community Register of information on national provisions on the mandatory addition of vitamins and minerals; the notification of national prohibitions or restrictions on the use of certain other substances.

It should be noted that the Council has not incorporated the amendments concerning : the bio-availability of added vitamins and minerals; the necessity that labelling, presentation and advertising

should not mislead consumers; proposing to take into consideration the intakes of vitamins and minerals from food supplements when setting maximum levels; making compulsory the consultation of the Standing Committee on the Food Chain and Animal Health when Member States notify the Commission on the adoption of new provisions and proposing the communication to the Commission and the publication of the notifications of the placing on the market of foods covered by the Regulation.

Other innovations introduced in the common position include:

- the grouping of all the applicable transitional measures in a new Article 17, with the deletion of Article 4 of the original proposal;

- a revision of Articles 6 (on conditions on the addition of vitamins and minerals) and 7 (on labelling, presentation and advertising) following the deletion of the definitions in Article 2;

- a modification of Article 15 on monitoring, so that when a notification of placing on the market is required, information on the withdrawal of the product from the market can also be required;

- a reference to implementation rules for the application of Article 16;

- the deletion of sodium chloride from Annex II and with a corresponding modification of Recital 11 explaining this change.