Regulatory advice

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.

Food for special medical purposes (FSMP) are food products designed for individuals suffering from specific diseases and who cannot fulfil their nutritional needs with conventional foods only. In order to be legally put on the market, these FSMP must comply with regulation EU n°2016/128 (entered into force since February 2019).

Our support includes:

• Nutritional and regulatory diagnosis to check the conformity of your product with the new regulation EU n°2016/128
• New product design in line with FSMP composition requirements and based on reliable scientific data
• FMSP dossier building :
  – Bibliographic research to establish the scientific and regulatory context
  – Product and target population description
  – Nutritional composition analysis and comparison with equivalent products existing on the market
  – Development of a rationale for active components/nutrients doses
  – Study of acceptability, tolerance and efficiency of the product
• Labelling regulatory conformity diagnosis
• Notification to French or European authorities before placing the product on the market
• Reimbursement procedure to allow indemnification for consumers