Composition Audit of a Food Product: Compliance and Regulation
Le 13 January 2025
Regulatory Context: Composition of Food Products in Europe
The composition of food products in Europe is subject to strict regulations. Belgium, for instance, has a list of prohibited plants (List 1 of the Belgian Royal Decree), while France maintains a list of plants exempt from the pharmaceutical monopoly, identifying those permissible for use in food products.
At the European level, certain member states have established lists of authorized plants. Additional references include the Council of Europe’s list of flavoring substances and the Novel Food Catalogue, which provides information on the status of plants used in food.
Composition Audit: Ingredient Analysis and Compliance
Rocket Leaf (Eruca sativa Mill.)
– Quantity: 550.5 mg (36.7% per sachet)
– Status in France: Food ingredient
– Status in Belgium: Authorized food ingredient in dietary supplements with restrictions
Commentaire : Novel Food Catalogue: Not listed for all food categories. Not listed by Tea and Herbal Infusions Europe (THIE) as an infusion plant.
Regulatory Note: In Belgium, its use in dietary supplements is restricted due to goitrin content, which must not exceed 5 mg per day.
Nettle Leaf (Urtica dioica L.)
– Quantity: 550.5 mg (36.7% per sachet)
– Status in France: Exempt from the pharmaceutical monopoly
– Status in Belgium: Authorized food ingredient in dietary supplements without restrictions
Comments:
- Novel Food Catalogue: Not listed for all food categories.
- Listed in the Council of Europe’s flavoring substances.
- Listed by THIE as an infusion plant.
Regulatory Note: ANSES advises against its use in cases of cardiac or renal-origin edema.
Lemon Verbena Leaf (Lippia citriodora H.B. et K.)
– Quantité : 400 mg (26.6 % par sachet)
– Status in France: Exempt from the pharmaceutical monopoly
– Status in Belgium: Authorized in dietary supplements
Comments:
- Listed by THIE as an infusion plant.
- Novel Food Catalogue: Non-concentrated aqueous infusions are non-Novel Food but restricted to dietary supplements.
- Listed in the Council of Europe’s flavoring substances.
Conclusion
For both France and Belgium, the formula presents a Novel Food risk due to lemon verbena, recently added to the Novel Food Catalogue as a new ingredient for food products, except in dietary supplements.
The nettle and rocket leaves are compliant, but precautions should be taken:
- For nettle: Include a warning regarding use by individuals with cardiac or renal-origin edema.
- For rocket: Verify the goitrin content to meet Belgian requirements for dietary supplements, which could also apply to food products.
- To ensure market compliance, evidence of significant consumption before May 15, 1997, must be established.
Frequently Asked Questions on Plant Compliance in Food
Why are some plants considered Novel Food?
Plants are classified as Novel Food if they lack a history of significant consumption in Europe before 1997. These plants must undergo a safety assessment before authorization.
Can I use a plant listed for dietary supplements in a food product?
Not necessarily. Some plants authorized in dietary supplements are not permitted in other food products, depending on their regulatory status and traditional use.
What are the main risks of misclassifying plants in food?
Misclassification can lead to product recalls, regulatory sanctions, and reformulation requirements if the ingredient does not comply with existing regulations.