Proven Experience

With extensive experience in the French market, we have successfully developed and delivered food supplements that comply with the stringent regulations set forth by the Directorate-General for Competition, Consumer Affairs and Fraud Prevention (DGCCRF). Our expertise encompasses every stage, from formulation to delivery, ensuring adherence to both European Union directives and specific French regulations to guarantee consumer safety and product quality.

Definition of Food Supplements

In France, food supplements are defined as foodstuffs intended to supplement the normal diet and which are concentrated sources of nutrients or other substances with a nutritional or physiological effect, alone or in combination.

Notification Process.

Before marketing a food supplement in France, a mandatory notification must be submitted to the DGCCRF. This process is facilitated through the TéléIcare online platform, which streamlines the declaration procedure.

1.
Determine the Appropriate Procedure:

Depending on the substances present in the food supplement, two distinct procedures are possible:

Standard Declaration (Article 15): If the substances used comply with national provisions, the declaration is made under Article 15. A “certificate of declaration” is issued, which does not constitute a marketing authorization but acknowledges the notification.

Mutual Recognition (Article 16): If the substances do not meet national requirements but the food supplement is lawfully manufactured or marketed in another EU Member State or a state part of the European Economic Area, a prior authorization procedure under Article 16 is required.

2.
Prepare Required Documentation:

Each declaration must include:

Labeling: A legible copy of the labeling in French, complying with regulatory requirements and including mandatory information and warning statements specific to certain constituents.

Technical Data Sheets: Documents demonstrating that quality requirements are fully satisfied.

Proof of Legal Manufacturing or Marketing: For declarations under Article 16, evidence that the food supplement is legally manufactured or marketed in another Member State or EEA country.

Commitment Agreement: A signed undertaking by the manufacturer to place on the market a product that complies with its declaration and all applicable regulations.

3.
Submit the Declaration:

Use the TéléIcare platform to submit the declaration along with all required documents.

Common Mistakes to Avoid

The DGCCRF has identified common errors during the declaration process:

  • Choosing the incorrect declaration procedure.
  • Failing to declare every ingredient in the supplement.
  • Inaccuracies between declared quantities of active substances and those shown on the label.
  • Omitting mandatory information on the label as per Decree 2006-352.
  • Not providing clear and concise instructions for use.
  • Incorrect or missing warning statements related to the ingredients used.
  • Not indicating that the product is a “food supplement” and failing to list ingredients in descending order of weight on the labeling, in accordance with Article 9 of European Regulation 1169/2011.

Labeling Requirements

In addition to general EU food labeling rules, French regulations require that food supplements display:

  • The portion of the product recommended for daily consumption.
  • A warning not to exceed the recommended daily dose.
  • A statement that food supplements should not be used as a substitute for a balanced diet.
  • A statement that the product should be stored out of the reach of young children.

The labeling, presentation, or advertising of food supplements must not claim that the product prevents, treats, or cures a disease.

Additional Considerations

France has specific guidelines for botanicals, including a positive list of plants and fungi with specific usage conditions. Maximum levels of vitamins and minerals are established at the national level. There is also a positive list of other substances with nutritional and physiological effects. Guidelines for the use of probiotics are provided as well.

We’re Certified.

Our company holds all necessary certifications, including BRC and NSF GMP, ensuring that our manufacturing processes meet the highest quality standards.

accreditation

Accreditations

Multi-language Labelling

To enhance product appeal in France’s market, we offer assistance in creating labels in French, ensuring compliance with regional language requirements.