This Directive concerns food supplements marketed as foodstuffs and presented as such. These products shall be delivered to the ultimate consumer only in a pre-packaged form.
Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements (Text with EEA relevance)Text with EEA relevance
Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements (Text with EEA relevance)Text with EEA relevance
Article 1
1.
2.
This Directive shall not apply to medicinal products as defined by Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use(1).
Article 2
For the purposes of this Directive:
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‘food supplements’ means foodstuffs the purpose of which is to supplement the normal diet and which are concentrated sources of nutrients or other substances with a nutritional or physiological effect, alone or in combination, marketed in dose form, namely forms such as capsules, pastilles, tablets, pills and other similar forms, sachets of powder, ampoules of liquids, drop dispensing bottles, and other similar forms of liquids and powders designed to be taken in measured small unit quantities;
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‘nutrients’ means the following substances:
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vitamins,
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minerals.
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Article 3
Member States shall ensure that food supplements may be marketed within the Community only if they comply with the rules laid down in this Directive.
Article 4
1.
Only vitamins and minerals listed in Annex I, in the forms listed in Annex II, may be used for the manufacture of food supplements, subject to paragraph 6.
2.
The purity criteria for substances listed in Annex II to this Directive shall be adopted by the Commission, except where such criteria apply pursuant to paragraph 3. Those measures, designed to amend non-essential elements of this Directive by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 13(3).
3.
Purity criteria for substances listed in Annex II, specified by Community legislation for their use in the manufacture of foodstuffs for purposes other than those covered by this Directive, shall apply.
4.
For those substances listed in Annex II for which purity criteria are not specified by Community legislation, and until such specifications are adopted, generally acceptable purity criteria recommended by international bodies shall be applicable and national rules setting stricter purity criteria may be maintained.
5.
Modifications to the lists referred to in paragraph 1, designed to amend non-essential elements of this Directive, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 13(3). On imperative grounds of urgency, the Commission may have recourse to the urgency procedure referred to in Article 13(4) in order to remove a vitamin or a mineral from the list referred to in paragraph 1 of this Article.
6.
By way of derogation from paragraph 1 and until 31 December 2009, Member States may allow in their territory the use of vitamins and minerals not listed in Annex I, or in forms not listed in Annex II, provided that:
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the substance in question is used in one or more food supplements marketed in the Community on the date of entry into force of this Directive,
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the European Food Safety Authority has not given an unfavourable opinion in respect of the use of that substance, or its use in that form, in the manufacture of food supplements, on the basis of a dossier supporting use of the substance in question to be submitted to the Commission by the Member State not later than 12 July 2005.
7.
Notwithstanding paragraph 6, Member States may, in compliance with the rules of the Treaty, continue to apply existing national restrictions or bans on trade in food supplements containing vitamins and minerals not included in the list in Annex I or in the forms not listed in Annex II.
8.
Not later than 12 July 2007, the Commission shall submit to the European Parliament and the Council a report on the advisability of establishing specific rules, including, where appropriate, positive lists, on categories of nutrients or of substances with a nutritional or physiological effect other than those referred to in paragraph 1, accompanied by any proposals for amendment to this Directive which the Commission deems necessary.
Article 5
1.
Maximum amounts of vitamins and minerals present in food supplements per daily portion of consumption as recommended by the manufacturer shall be set, taking the following into account:
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upper safe levels of vitamins and minerals established by scientific risk assessment based on generally accepted scientific data, taking into account, as appropriate, the varying degrees of sensitivity of different consumer groups;
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intake of vitamins and minerals from other dietary sources.
2.
When the maximum levels referred to in paragraph 1 are set, due account should also be taken of reference intakes of vitamins and minerals for the population.
3.
To ensure that significant amounts of vitamins and minerals are present in food supplements, minimum amounts per daily portion of consumption as recommended by the manufacturer shall be set, as appropriate.
4.
The maximum and minimum amounts of vitamins and minerals referred to in paragraphs 1, 2 and 3 shall be adopted by the Commission. Those measures, designed to amend non-essential elements of this Directive by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 13(3).