Anticipate and solve regulatory issues by calling upon our consultants at any stage of your project.
We take care of the files:
- Novel Foods
- Health claims
- Foods for special medical purposes (FSMP)
- Safety of food supplements (Appendix III required since the publication of the Plants Decree)
- Nutritional justification and safety of enrichments
- Notification of food supplements
- Specific regulatory watch
We are also able to support you on:
- your regulatory positioning strategy,
- the regulatory validation of your formulas, labels and communication media.
Finally, our team makes it a priority to respond quickly to your urgent questions (hotline) and can consult the authorities confidentially and anonymously.
File Novel Foods / Nouveaux aliments
The new regulation Novel Food n°2015/2283 came into force on 1st January 2018. It facilitates the placement of certain products onto the market, particularly traditional foods from other continents.
Our support can include:
- The suitability for contact with food diagnosis ruling on whether food is novel or not: on the basis of the criteria defined by the regulations and if necessary, exchanges with the authorities;
- The market access strategy: regulatory positioning of the ingredient/food, targeted applications, doses incorporated into the matrices, prioritization;
- Project management: retro-planning, data to be collected for file submission, request for quotes from providers for analysis and toxicity/allergenicity studies, preparation of a provisional budget;
- The editing of the Novel Food file: documentary research (benchmark, scientific bibliography, usage and consumption data, etc.), coordination of the service providers’ work, writing, translations;
- File follow-up: administrative submission, exchanges with the competent authorities, adaptation of the schedule up to the adoption of the authorization decision by the EC;
- Additional information: in the case where the expertise raises missing information, coordination of the actions for the collection of data and its submission to the authorities.