Food supplements are defined as foodstuff which are concentrated sources of nutrients (i.e. mineral and vitamins) or other substances with a nutritional or physiological effect. They are marketed in “dose” form (e.g. pills, tablets, capsules, liquids in measured doses) to be included in the normal diet
The European Union regulates Food Supplements through the Directive 2002/46/EC. However, they are considered foodstuff and therefore several additional European legislations will apply, on top of specific national laws. Due to the complexity of the applicable legislative frameworks, guidance of professional regulatory advice is critical.
I would like to place food supplements in Europe, how can Obelis help me?
We will check the formula of your products, identifying restricted and banned ingredients at both a European and national level
- We will assess the necessary documentation for your type of product
- We will review and propose strategies to compile a complete Food Supplement Information File
- We will check the compliance of your labels and packaging towards the/both EU and national requirements
- We will submit the pre-market authorization at a national level
Make sure to safeguard the compliance of your product before placing it on the EU market! Obelis, has been providing expert consultancy services to non-European companies for more than 30 years, we can help you!Get in touch