If you make or sell food supplements or herbal preparations you need to comply with the European directive on food supplements and Dutch Legislation.
Food supplements are vitamins, minerals, and other substances that have a nutritional or physiological effect and that aim to supplement our regular diet. They come in a variety of forms, such as tablets, capsules, powders, liquid drops or drinks. If you sell or make these supplements in the Netherlands, you must comply with Dutch legislation (in Dutch).
Herbal preparations are herbal substances that may or may not have been processed and that are intended for human use. They are made up of plant material. Herbal preparations are absorbed through the mouth, skin, or via inhaling. Herbal or spice extracts and some food supplements are also considered herbal preparations.
Do you sell herbal preparations or food supplements containing herbal preparations? Make sure you comply with Dutch legislation on herbal preperations, such as the Herbal Preparations (Commodities Act) Decree (Warenwetbesluit Kruidenpreparaten, in Dutch), amongst others: herbal preparations may not contain herbs listed under part II of the annex of the Herbal Preparations (Commodities Act) Decree (in Dutch). Some of these herbs contain toxins like lead, aristolochic acid or PAHs (polycyclic aromatic hydrocarbons).
European directive for food supplements
The Food Supplement (Commodities Act) Decree is based on the European directive on food supplements. The directive contains rules regarding:
- average daily quantities (ADQ)
- minimum and maximum quantities of vitamins and minerals a supplement must contain
- health-related claims on packaging and in advertisements
If you make food supplements you may only use vitamins and minerals specified in Annex I and vitamin and mineral substances specified in Annex II of the food supplements directive.
Medical and health claims
Food supplements are not considered as medicines. This means they may not contain medicinal ingredients, as stated in the Medicines Act (Geneesmiddelenwet, in Dutch). You are not allowed to make medical claims. Health-related claims are allowed, but only if you can prove the claim to be true.
The European Union has drafted a list of scientifically substantiated claims.
Food supplements and herbal preparations are subject to the standard requirements for food labelling. Food supplements labels require a few extra statements:
- the recommended daily dosage and instructions on how to use the supplement safely
- the designation 'food supplement'
- the name, type and quantity of active ingredients
- a warning to keep the food supplement out of children’s reach
- a statement that the supplement must not be used as a substitute for a healthy balanced diet