Learn about the

Regulatory advice

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.

You wish to Contact us

Céline LE STUNFF

Advice Division Manager