Italy
Allows More Nutrient Sources by Sepp Hasslberger
www.newmediaexplorer.org
March 14, 2005
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;
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)
ferrous hydroxide
ferrous pidolate
aminoacid chelate
iron glycerophosphate
iron orthophosphate
[iron] on yeast
iron orotate
iron aspartate
iron picolinate
iron ascorbate
[iron] oxides
