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Food supplements
are concentrated sources of nutrients or
other substances with a nutritional or
physiological effect whose purpose is to
supplement the normal diet. They are marketed
'in dose' form i.e. as pills, tablets,
capsules, liquids in measured doses etc.
The
Directive
2002/46/EC of the European Parliament and
Council of 10 June 2002 on the approximation
of the laws of Member States relating to food
supplements establishes harmonised rules for the
labelling of food supplements and introduces
specific rules on vitamins and minerals in
food supplements. The aim is to harmonise the
legislation and to ensure that these products
are safe and appropriately labelled so that
consumers can make informed choices.
Annex II of
Directive 2002/46/EC is a list of permitted
vitamin or mineral preparations that may be
added for specific nutritional purposes in
food supplements. It has been amended by
Commission
Directive 2006/37/EC and Commission Regulation (EC) 1170/2009 to
include additional substances. The trade of
products containing vitamins and minerals not
listed in Annex II has been prohibited from
the 1st of August 2005.
Directive 2002/46/EC has been aligned with the Regulatory Procedure with Scrutiny by Regulation (EC) 1137/2008.
Inclusion of substances in the Annexes
Vitamin and mineral substances may be
considered for inclusion in the lists
following the evaluation of an appropriate
scientific dossier concerning the safety and
bioavailability of the individual substance
by the European Food Safety Agency
(EFSA). For more information, view EFSA’s activities on food supplements.
Guidance for submission
The document
Administrative
guidance on submissions for safety evaluation
of substances added for specific nutritional
purposes in the manufacture of foods 
provides detailed information on the
procedure that should be followed for the
submission of requests for substances to be
considered for inclusion in the permitted
list.
Updated
15/09/2009
Derogations
There is a wide range of vitamin
preparations and minerals substances used in
the manufacture of food supplements that are
currently marketed in Member States and which
have not undergone a scientific safety
evaluation. In order to allow the necessary
time for this safety evaluation, Member
States may provide derogations until 31
December 2009, for vitamins and minerals and
their forms not included in the Directive, in
view of the future addition to the Annexes of
the Directive, as long as the following
conditions are fulfilled:
(a) the substance in question was used
in food supplements marketed in the Community
prior to 12 July 2002
(b) the European Food Safety Authority
has not given an unfavourable opinion in
respect of the use of the substance, or its
use in that form, in the manufacture of food
supplements, on the basis of a dossier
supporting use of the substance that has to
be submitted to the Commission by the Member
State by 12 July 2005.
Petitioners should contact the
competent authorities in the individual
Member States if they wish to obtain such
derogations.
List of competent authorities of
the Member States within the meaning of
Article 4(6) of Directive 2002/46 on food
supplements
Updated
22-06-2010
Dossiers submitted to the
European Commission under art. 4(6) of Directive
2002/46/EC on food supplements.
Updated
02-02-2010
Levels of vitamins and minerals in food
supplements
Directive 2002/46/EC on food
supplements provides for the setting of
maximum and minimum amounts of vitamins and
minerals in these products via the Standing
Committee procedure.
Directorate General Health and Consumer Protection has issued a
Discussion Paper on the setting of maximum and minimum amounts for vitamins and minerals in foodstuffs, which identified the main issues to be considered in this exercise.
Responses to the Discussion Paper on the setting of maximum and minimum amounts for vitamins and minerals in foodstuffs.
In the frame of the exercise on the establishment of maximum and minimum amounts of vitamins and minerals in foodstuffs and in particular in food supplements, several letters have been addressed to Commissioner Kyprianou.
Directorate General Health and Consumer Protection has prepared a collective answer.
Report to the Council and the European Parliament on the use of substances other than vitamins and minerals in food supplements
Directorate General Health and Consumers has commissioned a study on the use of substances with nutritional or physiological effects other than vitamins and minerals in food supplements.
Taking into account this study and other available information, the Commission, in accordance with the requirement set out in Article 4(8) of Directive 2002/46/EC on food supplements, has prepared a report
to the Council and the European Parliament on the use of substances other than vitamins and minerals in food supplements.
The report is accompanied by two Commission staff working documents.
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