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.