In order to be marketed on the French market, a food supplement must be subject to a prior declaration to the competent authority in accordance with Decree No. 2006-352 on food supplements. Since February 3, 2023, food supplements have been declared to the Directorate General for Food using the online declaration platform téléicare.
Notification of food supplements in France: which procedure to choose?
This declaration meets the requirements of Articles 15 or 16 of Decree No. 2006-352. Depending on the nature of the substances present in the food supplement, two distinct procedures are possible:
– if the substances used in the composition of food supplements comply with the national provisions, the declaration shall be made in accordance with the procedure described in the Article 15, a “certificate of declaration of declaration” is issued. This certificate does not constitute a guarantee of compliance with the provisions in force, and does not constitute a marketing authorisation;
– If, on the other hand, substances in the composition do not meet national requirements and the food supplements in question are lawfully manufactured or marketed in another Member State or in another State which is part of the European Economic Area, then a prior authorisation procedure is used in accordance with the principle of mutual recognition described in the Article 16.
Notification of dietary supplementation in France: what documents are required?
Every declaration must include a legible copy of the labelling with the text in French, that complies with regulatory requirements and includes the mandatory information and warning statements specific to certain constituents. It is also necessary to attach technical data sheets showing that the quality requirements are fully satisfied.
In addition, for declarations under Article 16, they must include proof that the food supplement is in fact legally manufactured or marketed in another Member State or in another State party to the Agreement on the European Economic Area.
Finally, the manufacturer must undertake to place on the market a product that complies with its declaration and complies with all the regulations that apply to food supplements. For this purpose, he signs a commitment agreement to join.
Notification of food supplements in France: what are the mistakes not to make?
The DGAL has listed the 10 mistakes to avoid during the tele-declaration procedure under téléicare:
1) Choose the declaration procedure adapted to the characteristics of the food supplement:
- if every constituent fully complies with national regulations, choose the procedure in accordance with Article 15
- if the food supplement contains a substance, a botanical/plant extract which does not comply with national provisions but is lawfully manufactured or marketed in a Member State of the European Community or in a State forming part of the European Economic Area, then the procedure under Article 16 is required.
2) Declare every ingredient that makes up the dietary supplement.
3) Check the existence of ingredients in the Teleicare database before creating a new ingredient.
4) Check the accuracy and correspondence between the quantities of active substances declared and those shown on the label. These amounts should be provided for the recommended daily dose.
5) Correctly draft all the mandatory information to be included on the label in accordance with the requirements of Decree 2006-352.
6) Declare all quantities of active substances.
7) Clearly specify the instructions for use in a clear and concise manner.
8) Check the statements to be included on the label according to the ingredients used.
9) Write all the information on the labelling in French, as this information may appear in another language.
10) Indicate the designation “food supplement” and the list of ingredients in descending order of weight on the labelling in accordance with Article 9 of the European Regulation on Consumer Information 1169/2011.
List of food supplements declared in France:
It is possible to search if a food supplement has been declared in France either by downloading the complete list of declared food supplements or by entering the name of the product on the teleicare search engine.
Orchidali can help you verify that the composition of your food supplements complies with the French regulatory requirements and can declare your products for you on téléicare.
Français
DGAL recommendations for notifying food supplements in France
In order to be marketed on the French market, a food supplement must be subject to a prior declaration to the competent authority in accordance with Decree No. 2006-352 on food supplements. Since February 3, 2023, food supplements have been declared to the Directorate General for Food using the online declaration platform téléicare.
Notification of food supplements in France: which procedure to choose?
This declaration meets the requirements of Articles 15 or 16 of Decree No. 2006-352. Depending on the nature of the substances present in the food supplement, two distinct procedures are possible:
– if the substances used in the composition of food supplements comply with the national provisions, the declaration shall be made in accordance with the procedure described in the Article 15, a “certificate of declaration of declaration” is issued. This certificate does not constitute a guarantee of compliance with the provisions in force, and does not constitute a marketing authorisation;
– If, on the other hand, substances in the composition do not meet national requirements and the food supplements in question are lawfully manufactured or marketed in another Member State or in another State which is part of the European Economic Area, then a prior authorisation procedure is used in accordance with the principle of mutual recognition described in the Article 16.
Notification of dietary supplementation in France: what documents are required?
Every declaration must include a legible copy of the labelling with the text in French, that complies with regulatory requirements and includes the mandatory information and warning statements specific to certain constituents. It is also necessary to attach technical data sheets showing that the quality requirements are fully satisfied.
In addition, for declarations under Article 16, they must include proof that the food supplement is in fact legally manufactured or marketed in another Member State or in another State party to the Agreement on the European Economic Area.
Finally, the manufacturer must undertake to place on the market a product that complies with its declaration and complies with all the regulations that apply to food supplements. For this purpose, he signs a commitment agreement to join.
Notification of food supplements in France: what are the mistakes not to make?
The DGAL has listed the 10 mistakes to avoid during the tele-declaration procedure under téléicare:
1) Choose the declaration procedure adapted to the characteristics of the food supplement:
2) Declare every ingredient that makes up the dietary supplement.
3) Check the existence of ingredients in the Teleicare database before creating a new ingredient.
4) Check the accuracy and correspondence between the quantities of active substances declared and those shown on the label. These amounts should be provided for the recommended daily dose.
5) Correctly draft all the mandatory information to be included on the label in accordance with the requirements of Decree 2006-352.
6) Declare all quantities of active substances.
7) Clearly specify the instructions for use in a clear and concise manner.
8) Check the statements to be included on the label according to the ingredients used.
9) Write all the information on the labelling in French, as this information may appear in another language.
10) Indicate the designation “food supplement” and the list of ingredients in descending order of weight on the labelling in accordance with Article 9 of the European Regulation on Consumer Information 1169/2011.
List of food supplements declared in France:
It is possible to search if a food supplement has been declared in France either by downloading the complete list of declared food supplements or by entering the name of the product on the teleicare search engine.
Orchidali can help you verify that the composition of your food supplements complies with the French regulatory requirements and can declare your products for you on téléicare.
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