Under the food supplements Directive (Directive 2002/46/EC) food supplements’ are defined as foodstuffs that are meant 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, where nutrients could be vitamins, minerals, herbal extracts and other ingredients.
Basic Applicable Legislation
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
Harmonized Areas Covered by Existing Legislation
- Definition of Food Supplements
- Specific Labelling requirements contributing to the general labeling requirement for food
- Provisions for the addition of nutrients in the Annexes
- Provision for the ‘future’ setting of upper limits for vitamins and minerals in food supplements
Non- Harmonised Areas
- Maximum amounts of vitamins and minerals
- Other substances than vitamins and minerals
- Obligation for product registration at national level
National Divergence in Transposition
Contrary to Regulations, Directives have to be transposed from the EU Member States in order to become National Law. Transposition is the process of actual ‘translation’ of EU laws into national laws. Yet policy transposition and implementation are not flawless, a fact that creates trade barriers and unfair market competition among EU members.
In the case of Directive 2002/46/EC, there are several occasions among EU member states which transposed the Directive driven mainly by stringent or medicine oriented national preferences with the result of establishing restrictive laws in the marketing of food supplements at national level. In several occasions this meant that products being lawfully manufactured and marketed in one member state were prohibited from being marketed in another.
The most notorious area was the non- harmonised area of upper limits of vitamins and minerals that could be added in food supplement. In addition, the lack of a harmonised union list on herbal extracts that could be added in food supplements created several borderline issues, the most prominent of which being product classification (food supplement vs medicinal status).
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