The Italian Ministry of health has given both producers and consumers of supplements a welcome respite, allowing a host of nutrient sources to remain on the market, which otherwise would have become illegal in July accordance with new European rules for supplements.

The European food supplements directive, which was recently challenged before the EU Court of justice, lists permitted vitamins and minerals, as well as sources 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 be taken off the market. Campaigners say the lists are also 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

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;
Decrees:

Article 1.

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.

Article 2.

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

Annex I
List of minerals permitted in food supplements in addition to those listed in annex I of legislative decree number 169/2004

Vanadium
Boron
Nickel
Tin
Silica

Annex II
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:
thiamin monophosphate
Vitamin C and niacin:
nicotinamide ascorbate
Vitamin B 6:
pyridoxine dipalitate
Vitamin E:
succinate of d-alpha-tocopherol poliethylene glycole 1000

Boron:
boric acid
sodium borate

Calcium:
aminoacid chelate
calcium pidolate
calcium sulphate
calcium phosphate
calcium fluoride
calcium acetate
calcium piruvate
calcium chelate
calcium aspartate
calcium lysinate
calcium methionate
calcium orotate
[calcium] on yeast
calcium folinate
[calcium] from dolomite (carbonate of Ca and Mg)

Fluoride:
sodium monofluoride phosphate
Chromium:
aminoacid chelate
chromium picolinate
chromium polycholinate
[chromium] on yeast
chromium orotate
chromium nitrate
chromium pidolate
chromium ascorbate

Copper:
aminoacid chelate
copper oxide
copper orotate
[copper] on yeast
copper glycinate
copper pidolate
copper aspartate
copper glycirinate

Nickel:
nickel sulphate

Iron:
ferrous hydroxide
ferrous pidolate
aminoacid chelate
iron glycerophosphate
iron orthophosphate
[iron] on yeast
iron orotate
iron aspartate
iron picolinate
iron ascorbate
[iron] oxides

Selenium:
[selenium] on yeast
selenium aspartate
selenomethionine
aminoacid chelate
selenium proteinate
selenium ascorbate

Sodium:
sodium ascorbate
sodium silicate
sodium metasilicate
sodium vanadiate
sodium metavanadiate
sodium molybdate
sodium molybdate dihydrate
sodium sulphate
sodium borate
sodium tetraborate decahydrate
sodium tetraborate anhydro
sodium pyruvate
sodium pidolate
sodium aspartate

Magnesium:
aminoacid chelate
magnesium pidolate
magnesium piruvate
magnesium DL-aspartate
magnesium L-aspartate
magnesium orotate
magnesium pidolate
magnesium lysinate
magnesium methionate
[magnesium] on yeast
[magnesium] from dolomite (carbonate of Ca and Mg)
magnesium succinate
magnesium hypophosphate
magnesium aspartate

Manganese:
aminoacid chelate
manganese aspartate
[manganese] on yeast
manganese pidolate
manganese orotate
manganese ascorbate

Zinc:
aminoacid chelate
zinc methionine
zinc orotate
zinc pidolate
zinc stearate
[zinc] on yeast
zinc aspartate
zinc phosphate
zinc picolinate
zinc ascorbate

Potassium:
potassium aspartate
potassium phosphate (dibase and monobase)
potassium DL-aspartate
potassium glutamate
potassium L-aspartate
potassium sulphate
[potassium] on yeast
potassium pidolate
potassium molybdate
potassium orotate
aminoacid chelate
potassium piruvate
potassium caseinate
[potassium] monopersulphate

Silica:
silica dioxide

Tin:
tin chloride

Vanadium:
vanadyl chelate
vanadyl sulphate

Molybdenum:
[molybdenum] on yeast
aminoacid chelate
molybdenum aspartate
molybdenum ascorbate

Iodine
on yeast

Phosphorus:
aminoacid chelate
phosphorus proteinate
[phosphorus] on yeast

08.03.2005 - Government Printing Office and Mint - 09:45:21