Italian Health Minister Sirchia has given both producers and consumers of supplements a welcome break by allowing a long list of vitamin and mineral sources to remain on the market which otherwise would have become illegal in July, in accordance with new European rules for supplements.
The European food supplements directive, which has been challenged before the EU Court of Justice, lists permitted vitamins and minerals, as well as sources or chemical forms of these vitamins and minerals which may be used in the formulation of food supplements. The lists are exclusive, meaning that any substance not on the list will either have to be "proven safe" by extensive (and expensive) scientific documentation or products containing it will have to be taken off the market. According to the Alliance for Natural Health, which has initiated the legal challenge against the prohibition clause of the directive, the lists are very restrictive, typically only listing the isolated chemical substances and inorganic mineral salts which have been used by pharmaceutical manufacturers for decades, making the more natural "food-like" substances illegal to sell or buy.
According to the EU supplements directive, individual countries in the EU have the possibility to grant extension for nutrients and their sources currently used on the market, until the year 2009. In accordance with the provisions of the directive, the Italian Ministry of Health has published a list of additional nutrients and nutrient sources that will be acceptable on the Italian market until proven safe or until the extension runs out in December of 2009.
The list contains five additional minerals - vanadium, boron, nickel, tin and silica - as well as a great number of vitamin and mineral sources that were on the Italian market on 31 July 2003, when the Food Supplements directive was first published. The Italian industry association Federsalus worked closely with ministry officials in drafting the list.
An unofficial translation of the Italian ministerial decree follows here:
MINISTRY OF HEALTH
Decree of 17 February 2005
List of minerals and of vitamin-mineral sources permitted in food supplements in addition to those listed in annexes I and II of the legislative decree of 21 May 2004, number 169, in application of article 3, 3rd paragraph, of that same legislative decree.
THE MINISTER OF HEALTH
Having examined community directive 46/2002/EC of the European Parliament and the Council, of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements;
Having examined the legislative decree of 21 May 2004, number 169, which has implemented the aforesaid directive and in particular its article 3, 3rd paragraph;
Considering that in the past, food supplements were put on the market under the procedure of article 7 of legislative decree of 27 January 1992, number 111, on products destined for particular nutritional uses;
Having taken stock of the minerals and the vitamin-mineral sources used in food supplements put on the market at or before 31 July 2003 following the notification procedure of article 7 of the legislative decree number 111/1992;
Considering it necessary to publish the list of substances as per article 3, 2nd paragraph of legislative decree number 169/2004;
Having obtained the opinion of the competent consultative commission as per article 11 of legislative decree number 169/2004 on 17 December 1004;
1. Until 31 December 2009, the annex I of legislative decree 169/2004 is extended to include the minerals listed in annex I of the present decree.
2. In case of a negative opinion of the European Agency for Food Safety about the use of minerals included in annex I to this decree, the Ministry of Health will update the annex without delay to eliminate any minerals that have received a negative evaluation.
1. Until 31 December 2009, the annex II of legislative decree 169/2004 is extended to include the vitamin-mineral sources listed in annex II of the present decree.
2. In the case of a negative opinion of the European Agency for Food Safety about the use of vitamin-mineral sources included in annex II to this decree, the Minister of Health will update the annex without delay to eliminate any vitamin-mineral sources that have been negatively evaluated.
Rome, 17 February 2005 The Minister: Sirchia
List of minerals permitted in food supplements in addition to those listed in annex I of legislative decree number 169/2004:
List of vitamin-mineral sources permitted in food supplements in addition to those listed in annex II of legislative decree number 169/2004
Vitamin B 1:
Vitamin C and niacin:
Vitamin B 6:
succinate of d-alpha-tocopherol poliethylene glycole 1000
[calcium] on yeast
[calcium] from dolomite (carbonate of Ca and Mg)
sodium monofluoride phosphate
[chromium] on yeast
[copper] on yeast
[iron] on yeast
[selenium] on yeast
sodium molybdate dihydrate
sodium tetraborate decahydrate
sodium tetraborate anhydro
[magnesium] on yeast
[magnesium] from dolomite (carbonate of Ca and Mg)
[manganese] on yeast
[zinc] on yeast
potassium phosphate (dibase and monobase)
[potassium] on yeast
[molybdenum] on yeast
[phosphorus] on yeast
08.03.2005 - Government Printing Office and Mint - 09:45:21