Food Supplements Registration in France - Overview
France is a prominent market for food supplements in the European Union (EU), attracting companies in the sector. National regulations governed by French Decree No. 2006-352, implementing Directive 2002/46/EC, oversee the classification of food supplements. A product's classification in other markets does not automatically classify it as a food supplement in the EU or France. Compliance with permitted substances, maximum levels, and banned substances is crucial. Ensuring accurate food labeling, advertising, and health claims verification is necessary to maintain safety and avoid sanctions, product withdrawal, or recalls.
The current competent authority in France is the DGAL (Direction Générale de l'Alimentation). The French authorities have published a wealth of guidelines over the years, providing valuable information for Food Business Operators (FBOs) on selling and advertising food supplements. Additionally, France has specific guidelines for botanicals, including a positive list of botanicals (plants and fungi) with specific usage conditions. Maximum levels of vitamins and minerals are established at the national level. Furthermore, France has a positive list of other substances with nutritional and physiological effects. The French authorities have also provided guidelines for the use of probiotics.
Despite market distortions and non-conformities existing throughout the EU, the French market maintains discipline. It remains highly attractive for companies operating in the fields of sports nutrition, probiotics, botanicals, and mushroom food supplements. Importing and selling food supplements in France, including online platforms like Amazon or other e-commerce marketplaces, requires undergoing a notification procedure to the DGAL (Direction Générale de l'Alimentation). Once the notification is complete, the product is included in a specific list with a unique registration code. Notification to the DGAL (Direction Générale de l'Alimentation) necessitates verification of formula compliance and product labeling. It is important to note that nutrients used in food must have a significant History of Safe Use (HoSU) within the EU as evidence of safety. Failure to meet this criterion classifies the substance as a "novel food", requiring prior authorization even within the supplement industry. Novel food registration occurs at the EU level.
For those seeking to sell food supplements in France post-Brexit or from non-EU countries [including the United Kingdom (UK)], establishing a legal entity in an EU member state or appointing a third party as the product's Legal Representative (LR) in France or other EU countries is necessary. The representative company must be mentioned on the label, act as the point of contact for the authority, and establish applicable procedures.
Food products other than food supplements generally do not require notification in France. However, Foods for Specific Groups (FSG), such as infant formulas, follow-on formulas, or Foods for Special Medical Purposes (FSMP), fall under regulated products and require notification. Food Business Operators (FBOs) must ensure compliance with all food regulations regarding composition and labeling.
The food market in France and the EU is dynamic, necessitating rapid regulatory adaptation by companies to succeed. Freyr, with an operational and delivery center in the EU, provides comprehensive regulatory support to manufacturers, distributors, and Food Business Operators (FBOs). Our services encompass Regulatory assessments of formulas or ingredients, food labeling, health claims and advertising, product notification, Legal Representation (LR), as well as Regulatory updates, surveillance, and vigilance.
Food Supplements Registration in France
Expertise
- Food Product Classification/Food Supplement Classification.
- Formula Review/Ingredients Assessment.
- Safety Assessment of Finished Products/Food Ingredients.
- Label and Claims Review.
- Nutritional and Health Claims Consultation and Substantiation.
- NHCR Claims Application (EU Register on Nutrition and Health Claims).
- Environmental Labeling/Recycling Labeling Review and Review of Green Claims.
- Packaging Material Requirements.
- Dossier Gap Analysis.
- Dossier Compilation and Submission.
- Food Product Compliance.
- Product Notification/Food Supplement Registration France.
- EU Country-specific Regulatory Support.
- Regulatory Strategy for the EU.
- EU Legal Representation (LR).
- Regulatory Intelligence (RI) Report.
- Product-specific Updates on the Regulatory Guidelines/Standards.
- Novel Food Authorization Request/Traditional Food from a Third Country Registration.
- Consultation Processes for Determining the Status (novel/not novel) of a Food Ingredient.
- Regulatory Guidance on Food Products/Food Supplements Import Services in the EU.
- Translation Support Services.
- Review of Advertising Promotional Material.
- Food Surveillance and Vigilance.
- Post-notification/Post-marketing Follow-up.
- Management of Alerts and Authorities’ Remarks.
- Food Business Operators (FBOs) Registration Support.
- Communication with DGAL (Direction Générale de l'Alimentation.
- Food Product Compliance for European Economic Area Countries Outside the EU (Switzerland, Norway, and Iceland).
- End-to-end Services for Fortified Foods, Food for Special Medical Purposes (FSMP), Infant Formula, Follow-on Formula, and other Foods for Specific Groups (FSG).
Advantages
- End-to-end Regulatory consultation.
- Market-specific Regulatory consulting and advice.
- Harmonized compliance, local labeling, and local market support.
- Qualified team of experts with hands-on experience across all categories of foods.
- Support for region-specific Regulatory activities.
- Extensive partner network across the globe.
- A strong relationship with various HAs.
