The European directive on food supplements
Food supplements in the European Union (EU) are regulated by framework Directive 2002/46/CE. It sets definitions and general principles on food supplements and product safety, as well as information requirements on labelling, claims, etc.
A directive, unlike a regulation, is not directly applicable in European states. It needs to be transcribed in each Member State’s national law. For this reason, a directive leaves room for interpretation from each state. It is also because of this that the marketing process for food supplements diverges a lot from one country to another.
Apart from this directive, other regulations may intervene in the compliance of food supplements:
- Regulation (EC) 1924/2006 detailing authorised claims (nutritional and related to health) and their authorisation requests
- Regulation (EU) 1169/2011 (also known as INCO Regulation), states general principles and labelling requirements for foodstuffs.
Furthermore, the list of approved nutrients for food supplements is a positive list, meaning that no other nutrients than the ones on this list can be part of a supplement. This list is determined at a European level and also regulates the form of these nutrients.
Different requirement for different countries
To put food supplements on the European market, one must not only abide by the European law but also by national laws specific to each country.
Among the elements which are not harmonised at European level are notification requirements, authorised nutrient levels and supplement compositions.
Similarly, notification fees are not the same in all countries, when the product must be notified. For instance, in France as well as in the Netherlands, notifications are free. However in Spain, Italy, Belgium, and other European countries, a fee must be paid.
It should be noted that an accepted notification does not always mean a compliant product: national control authorities can carry out random checks on marketed products, which sometimes prove to be non-compliant. It is therefore essential for companies wishing to enter this market to make sure that their products are compliant before commercialisation.
How to make sure your food supplements are compliant?
EcoMundo intervenes all along the compliance process of your food supplements. Our experts specifically check:
- Formula
- Labels
- Claims
They then carry out:
- The constitution of the information file
- The notification to national authorities when necessary
- The nutrivigilance, once the product is on the market
For more information, take a look at our page on food supplements.
Wish to know more about food supplements?
For more information, do not hesitate to contact Sylvain de Backer or one of our cosmetics experts via our contact form, indicating "Food supplements" as the purpose of your inquiry.
