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What is a the regulatory definition of a food supplement ?


Although subject to main general food regulations (such as EU regulation 1169/2011), food supplements also have to respect other specific regulatory obligations.

EU Directive 2002/46 provides a definition of a food supplement in the aim of differentiating it from an ordinary foodstuff.

According to this directive, the food supplement is:

  • A foodstuff the purpose of which is to supplement the normal diet.
  • A concentrated sources of nutrients or other substances with a nutritional or physiological effect, alone or in combination
  • A product marketed in dose form and designed to be taken in measured small unit quantities.


What are they designed for ? Popular sectors of the food supplement market


Despite the quite binding regulations for food supplement, it does not stop this sector to be particularly dynamic, and responding to the growing consumer interest in this category of products.

Indeed, according to the OpinionWay study carried out in 2020 for the Synadiet (french national food supplement association), the sanitary crises has even reinforced the attention that people pay to their health.

From all the health claims associated to food supplements, stress and sleep management are the most popular areas, but immunity and vitality are also growing segments.

According to this study, 60% of French people are looking for solutions to strengthen their immune system, and 43% indicate that they consume food supplements and natural health products to strengthen their natural defenses.

In addition, results of the INCA 3 study conducted by ANSES indicate that while the average age of the French population is increasing, there are also more and more young seniors who are still active and wish to remain in good health for a long time ahead.

Food supplements are designed as solutions adapted to meet current and future concerns. They are not intended to cure diseases, but are intended to maintain health, and to prevent or cure some physiological imbalances.


What about innovation in food supplements ?

At the same time, food supplements actors are making the regulatory environment progress, allowing consumers to access new products. For example, in the EU, the right to use the term “probiotic” as a category of dietary supplement is progressively allowed country by country. After Spain, Italy, the Netherlands, Poland and more recently Denmark, France would also seem to be ready to accept it.

Innovation driven by marketing, regulation and science therefore opens up several opportunities for makers in this market.

FOODINNOV  offers personalized support, from scientific and regulatory analysis to product notification:

  • Scientific and regulatory support for the development of your concepts
  • Regulatory validation of your formulas and claims
  • Regulatory advices for your labeling and promotional communications intended for consumers and healthcare professionals
  • Marketing autorisation application dossier for your food supplements to the competent authorities

Would you like to know more about it and discuss your project with one of our experts?

Our team is at your disposal.