The latest clarifications published in the Compl’Alim newsletter provide important guidance on the notification and labelling of food supplements.
They also serve as a reminder that the compliance of a food supplement must be monitored throughout its entire lifecycle on the market.
- Product changes: any change to the formula, product name, packaging or manufacturer should prompt the operator to assess whether a new notification is required.
- Multiple target populations: where recommendations differ depending on the target population, the label must specify, for each population, the recommended daily portion and the corresponding amounts of nutrients or other substances. However, only the highest recommended daily portion should be entered in Compl’Alim.
- Solid dosage forms intended for children: the statements “Keep out of reach of children” and “Not recommended for children under 6 years of age” serve different purposes and must both appear on the label where applicable.
- Full composition disclosure: all ingredients, whether active or non-active, must be declared. Generic names may be used for certain flavourings, additives, or fruit and vegetable concentrates, but this does not exempt operators from verifying their regulatory compliance.
- Maximum daily amounts: the maximum daily amount for vitamin E has been increased to 180 mg/day. The maximum amount for chondroitin sodium sulfate has been reduced to 760 mg/day, while the limit applicable to chondroitin sulfate remains set at 1,140 mg/day.
Any intake reaching a pharmacological dose may create a risk that the product will be classified as a medicinal product by function. - New notification certificate format: notification certificates now include the full list of declared ingredients, including additives.
In addition, the discontinuation of a product may be reported directly through Compl’Alim, taking into account the date of minimum durability of products that are still on the market.
Please remember that a Compl’Alim notification is neither a marketing authorisation nor a confirmation of the product’s compliance. Responsibility for ensuring compliance at every stage remains with the food business operator placing the product on the market.