Food supplements are defined as foodstuff which are concentrated sources of nutrients (i.e. minerals and vitamins) or other substances with a nutritional or physiological effect.
Food supplements are defined as foodstuff which are concentrated sources of nutrients (i.e. minerals 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 framework, guidance of professional regulatory advice is critical.
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 framework, guidance of professional regulatory advice is critical.
Check the formula of your products, identifying restricted and banned ingredients at both a European and national level
Check the formula of your products, identifying restricted and banned ingredients at both a European and national level
Assess the necessary documentation for your type of product
Assess the necessary documentation for your type of product
Check the compliance of your labels and packaging towards both EU and national requirements
Check the compliance of your labels and packaging towards both EU and national requirements
Review and propose strategies to compile a complete Food Supplements Information File
Review and propose strategies to compile a complete Food Supplements Information File
All Right Reserved 2021 © Obelis Group
All Right Reserved 2021 © Obelis Group
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Why should you choose Obelis Group?
Why should you choose Obelis Group?
Creating compliance for safer markets is in our roots.
Managing dedicated Information platform to ensure EU MDR & IVDR compliance as well as UK compliance.
At Obelis, we are helping more than 3,000 companies over 70 countires to sell their products on the European market, UK included.
Creating compliance for safer markets is in our roots.
Managing dedicated Information platform to ensure EU MDR & IVDR compliance as well as UK compliance.
At Obelis, we are helping more than 3,000 companies over 70 countires to sell their products on the European market, UK included.


We represent the largest center for consultancy in Europe
We represent the largest center for consultancy in Europe
We have more than 30 years of business experience
We have more than 30 years of business experience
Located in Brussels, Belgium, at the heart of the European Union, we are active members of EU Associations and EU Commission working groups.
Located in Brussels, Belgium, at the heart of the European Union, we are active members of EU Associations and EU Commission working groups.
We are ISO 9001:2015 and ISO 13485:2016 Certified
We are ISO 9001:2015 and ISO 13485:2016 Certified
Ensuring the highest quality of service for your business in Europe.
Member of European Association of Authorized Representatives (E.A.A.R.). With a strong international network, Obelis Group supports your business in 18 global markets accross the world.
Ensuring the highest quality of service for your business in Europe.
Member of European Association of Authorized Representatives (E.A.A.R.). With a strong international network, Obelis Group supports your business in 18 global markets accross the world.

Obelis registers your Food Supplements in the Europe within 8 working days!
Obelis registers your Food Supplements in the Europe within 8 working days!
Submit the pre-market authorization at a national level
Submit the pre-market authorization at a national level


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