Health Supreme by Sepp Hasslberger

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March 14, 2005

Food Supplements: Italy Allows More Nutrient Sources

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:


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.


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;

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


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

boric acid
sodium borate

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)

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

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

nickel sulphate

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

[selenium] on yeast
selenium aspartate
aminoacid chelate
selenium proteinate
selenium ascorbate

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

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

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

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

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 dioxide

tin chloride

vanadyl chelate
vanadyl sulphate

[molybdenum] on yeast
aminoacid chelate
molybdenum aspartate
molybdenum ascorbate

on yeast

aminoacid chelate
phosphorus proteinate
[phosphorus] on yeast

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

See also:

A list of the nutrients and sources missing from the Food Supplements Directive's positive lists has just gone up on the site of CHC - Consumers for Health Choice, in the UK. Ingredients that have already obtained derogation (in the UK) areĀ marked with ** whilst those that CHC believe are likely to obtain derogation in the near future are marked ++.


posted by Sepp Hasslberger on Monday March 14 2005
updated on Tuesday December 21 2010

URL of this article:


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" Let thy food be thy medicine and thy medicine be thy food." Hippocrates (460-377 BC) We might say that the debate of what is food and what is medicine goes back more than two thousand years, to Hippocrates, the Greek physician who is also known as the father of modern scientific medicine. In the early 1960s, pharmaceutical medicines were in the headlines with a tragic development. Mothers who had... [read more]
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Readers' Comments

Will anyone be able to let me have some information about permissible Limits of Silica & Nikel in food of Medicinal supplement
answers for this will be greatly appretiated
thanking you
Dr Vijay

Posted by: Dr. Vijaykumar on March 3, 2006 04:59 AM


Dr. Vijay,

if you are inquiring about limits in Italy (since your comment is on an article about the Italian situation), your best bet would be the Italian health products producers association, Federsalus.

Their website:

Posted by: Sepp on March 3, 2006 11:04 AM


I would like information about permissible Limits of calcium (Ca)& sodium (Na) in food or Rice or any tomato or gravy items for example
answers for this will be greatly appretiated
thanking you
Chef Tony

Posted by: TONY ANDREW LESLIE on April 20, 2006 03:04 PM


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These articles are brought to you strictly for educational and informational purposes. Be sure to consult your health practitioner of choice before utilizing any of the information to cure or mitigate disease. Any copyrighted material cited is used strictly in a non commercial way and in accordance with the "fair use" doctrine.



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