Making or selling food supplements

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

Food supplements are vitamins, minerals, and other substances 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 regulations (in Dutch).

Rules for food supplements

The Food Supplement (Commodities Act) Decree is based on the European directive on food supplements. The directive contains rules on:

• average daily quantities (ADQ)
• which minerals and vitamins you are allowed to use to make food supplements
• labelling requirements
• minimum and maximum quantities of vitamins and minerals a supplement may 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.

Herbal preparations

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.

Rules for herbal preparations

Do you sell herbal preparations or food supplements containing herbal preparations? Make sure you comply with Dutch legislation on herbal preparations, such as the Herbal Preparations (Commodities Act) Decree (Warenwetbesluit Kruidenpreparaten, in Dutch). Among other things:

• 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).
• The amount of herbs may not be harmful to health.

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. With a medical claim you state that your product can prevent, treat, or cure a disease. Health-related claims are allowed, but only if you can prove the claim to be true. With a health-related claim, you say that your product had a positive effect on health.

The European Union has drafted a list of scientifically substantiated claims.

Labelling requirements

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' (using this words)
• 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