In Europe, food supplements must comply with European Directive 2002/46/EC as well as any local legislation in each country. EcoMundo registers your food supplements and guarantees your compliance throughout Europe.
Validation of your labels and nutritional information
BE COMPLIANT WITH MANDATORY LABEL INFORMATION
Labelling of food supplements is subject to the European Commission’s Regulation n° 1169/2011 which provides the mandatory information required on all labels.
- A review of your labels in order to help identify your product positioning
- Validating the mandatory information and nutritional advice appearing on your labels
Validation of your Health or Nutritional Claims
ECOMUNDO’S EXPERTS ACCOMPANY YOU
So you want to showcase your claims? Depending on your product positioning and your marketing and communications strategy, you are subject to different regulatory constraints.
EcoMundo offers a review of your claims in the following areas:
- Health - compared with the list of authorised claims and while awaiting the outcome of an assessment of EC Regulation no.1924/2006 concerning health claims.
- Cosmetics - vis-à-vis the six common criteria in the ED Regulation no. 655/2013.
Validation of your formulas
BE CONFIDENT THAT YOUR FORMULATIONS ARE COMPLIANT
You wish to market your food supplements? You need to be sure that your formulations are compliant in the chosen countries.
EcoMundo will guide you in validating your formulations with regards to the directive no. 2006-352 dated 20 March 2006:
- Nutrients and substances with a nutritional or physiological benefit
- Plants and plant preparations
- Additives, fragrances and technological auxiliaries
- Other ingredients, the use of which being traditional in human consumption or considered as such, in the sense provided by EU Regulation no. 2015/2283 concerning new foodstuffs, or has been authorised in compliance with the above regulation.
DRAFT A DOSSIER CONTAINING ALL MANDATORY INFORMATION
As any food supplement in the market needs to be perfectly safe for human consumption, it is essential to be able to construct a dossier that demonstrates compliance with all the European requirements. In addition, certain national bodies demand such information when they receive notification of the product. And finally, one is required to provide all the scientific evidence for the claims for the product’s effect on health, for example.
EcoMundo helps you collecting the information and proposes a strategy for drafting the dossiers to facilitate registration:
- Collection of mandatory documents from your suppliers
- Guidance in searching the information in the professional literature
- Preparation of your dossiers and regulatory analysis
- Monitoring progress of dossiers in process and guidance when confronted by inspection from the competent authorities
Registration of your products in all European Union countries
REGISTRATION IN EACH COUNTRY
Food supplements are subject to local registration requirements in all countries where they are marketed. There is a specific registration requirement in each member country.
- Submitting the registration dossier compliant with national regulations
- Preparing a registration strategy for several countries which can facilitate the adoption of the mutual recognition principle
- Providing a proof of deposit, notification or registration depending on the country legislation
- Registration progress monitoring
Ensure the ‘Nutrivigilance’ for your products
Once your food supplements are launched into the market, you are strongly recommended to follow very closely the trends in the associated legislation over time.
EcoMundo offers to monitor, with the RASFF, the active substances present in your products.