France is, along with Belgium and Italy, of the countries in the European Union that has most developed and keeps its regulations on food supplements constantly updated.
Like Belgium, it has a generic Royal Decree regulating food supplements, which transposes Directive 2002/46 EC on food supplements, and several other specific Royal Decrees which regulate the addition of certain nutrients and substances such as vitamins, minerals, botanical species, as well as other nutrients.
Thus, France sets maximum limits for vitamins and minerals, also taking into account whether they refer to the adult general population, or to the child population (differentiating by age range in some cases), determining certain safety warnings to be used when using some vitamins, such as for example Vitamin K and its interaction with anticoagulant medication.
It also regulates in the most detailed way the use of botanical species or plants in food supplements, not only through its specific Royal Decree on botanicals, which establishes the names and parts of said plant species that are allowed in the manufacturing of food supplements, but also which also incorporates the recommendations of certain safety warnings from the European Medicines Agency (EMA) on medicinal plants contained in food supplements since June 2023.
Thus it turns out that, almost certainly, in a food supplement that is legally marketed and notified in France and that is composed of several herbal preparations, we will find on its labeling the presence of one or more safety warnings in addition to the generic ones required in the labeling of food supplements.
Finally, France also regulates the maximum quantities for certain nutrients commonly used in food supplements such as melatonin, glucosamine sulphate or caffeine, so it is vital to be up to date with legislative and regulatory developments on food supplements, so that they are taken into consideration when designing the labeling of food supplements that are going to be marketed in France as well as the food information provided for said products.
Regarding the notification procedure of food supplements in France, an online platform called Teleicare has been developed so that it allows the online notification of products, requiring the indication of all relevant and detailed data on the composition of the product, instructions for use, safety warnings, distributor´s identification, etc as well as the need of sending the dietary supplement label or any other document that may be required due to the composition of the product such as certain certificates of análisis on certain active substances.
In addition to the above France is currently one of the countries that does not impose a food supplements notification fee, being therefore a more than interesting and advantageous option for food business operators who market food supplements in France, whether these are companies located in France, or in other European Union countries.
Once the French Health Authority has received the notification of the product, it takes around 4 or 5 weeks to issue an answer or attestation. In this case, the French Health Authority will issue either an acceptance or a rejection of the notification of the food supplement based on the detection of non-conformities, or the need to complete or expand any relevant information.
If there is needed to expand or correct any information, the platform allows you to modify the notification dossier and resend the notification so that it can be evaluated and processed again.
It is therefore very important to be up to date with the legislative developments that affect the regulations and regulations of food supplements in France, and/or to have specialized legal advice in the composition review and labeling of food supplements, so that operators can develop formulas and labeling for their products that result in successful notification files that allow them to market safe products in French market.
At LexSupplements Food Legal Consulting we are up to date and specialized in food regulations and in the notification procedure of food supplements in France to guarantee that our clients develop safe formulas and proper product labelings that comply with the legal regulations applicable to the food supplements they market.
We carry out the composition review, labeling review, and subsequent registration or notification of placing on the market before the competent Health Authority of France (DGCCRF Direction générale de la concurrence, de la consommation et de la répression des frauds).
We also carry out the revision and notification of food supplements in other EU countries such as Spain, Belgium, Italy, Germany, Ireland, Portugal or Malta.
You can get in contact with us to get more information.