National regulation on food supplements
The national regulation on food supplements is harmonised with the EU legislation on food supplements. Limits on the levels on vitamin and minerals are not harmonised in the EU and each country may have national limits.
Norway has set minimum and maximum levels conform to the recommended daily intake on minerals and vitamins. The levels are set in annex 1 to the regulation on Food Supplement.
Medicinal products or food supplements
Medicinal products are subject to the national legislation on medicinal products. What is defined as a medicinal product may vary in the European countries. The Norwegian Medicines Agency is responsible for administering the national legislation on medicinal products.
Novel food
Note that there is a national prohibition on marketing novel food on the Norwegian market. Approval before marketing must be given. Approval is given by the NFSA.
In particular: herbs
Herbs may be classified as medicinal products. The Norwegian Medicines Agency is responsible for the classification of herbs. See the list of drugs and herbs (Forskrift om legemiddelklassifisering).
For your information:
- Herbs marked with L are classified as medicine
- Herbs marked with RL are classified as prescription drugs
- Food supplements containing ingredients marked L and RL, indicates that the product may be classified as a medicinal product or drug and the
- Norwegian Medicines Agency must be contacted in order to classify the product.
- Herbs marked with H – indicates that the food supplement is not a medicinal product or drug, and is therefore likely to be subject to the national food legislation. Note that this is not a final classification, but an indication only.
Other substances
There are no specific national requirements as to other substances in food supplements. The food businesses must ensure that food supplements are safe in accordance with Regulation (EU) no. 178/2002 article 14 which is incorporated into the national Food Act § 16.
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