Notification of supplements in Europe
The notification of supplements in Europe is regulated in the European Union by Directive 2002/46/EC of the European Parliament and of the Council, of 10 June 2002, on the approximation of laws in the Member States regarding supplements food. Directive 2002/46/EC establishes specific rules for a part of nutrients: vitamins and minerals, and leaves for a later stage, specific rules relating to other nutrients or substances with nutritional or physiological effects used as ingredients in food supplements.
From this Directive, each European State has established its own legislation on food supplements. Therefore, there are differences in food supplements legislation in the EU. In the absence of a Spanish standard for ingredients other than vitamins and minerals, as well as for other substances with a nutritional or physiological effect, the principle of mutual recognition shall apply.
In that case, the distributor or manufacturer may previously notify the product in a country that by its national regulations allows such composition. For the notification of complements in Europe, the differences in the notification process as well as in the rates that are required in other European Union member countries such as Portugal, France, Belgium and Italy must be taken into account. Thus, while France or Portugal do not require administrative fees to carry out the process of notification of food supplements, other countries such as Belgium and Italy require the payment of a fee which amounts to 180 Euros per product in the case of Belgium and 160.20 Euros per product in the case of Italy.
Each country has its own system to notify the placing on the market of food supplements, but all of them require providing data on the manufacturer and distributor of the product, the ingredients that make up the food supplement or the contribution of the label with which it goes to market the product in the language of the country in question. For example, in the case of notification in Italy, it is done through an online platform provided by the Italian health authorities for this purpose.
In order to have access to this platform, it is necessary that the authorities provide the person responsible for the notification with access credentials in order to enter the platform and be able to notify the food supplements. In this platform you must enter all the data required by the authorities of Italy in relation to the food supplement to be notified. From the same day that the notification of the food supplement is carried out in Italy, the product can be marketed in that country. The Italian authorities usually take about 90 days to give a resolution.
If the resolution of the notification is positive, the product together with its manager are incorporated into a national database of notified food supplements, which is a public consultation for all operators in the sector and in general any person interested in knowing this information. The main difference between these countries is that both in Portugal and in Italy, from the notification of the food supplement (it is considered a responsible declaration of the food operator) to the health authorities, the product can be placed on the market, with the distributor taking responsibility on the food information provided to the consumer in any case.
However, in Belgium or France, it is not a “notification” as such, but these countries study the documentation that the distributor has provided and within 6-8 weeks they will pronounce by means of an express resolution authorizing or denying the commercialization of the food supplement in question, taking into account that, as in the previous case and despite having a positive certificate authorizing the marketing of the product, the distributor will continue to assume responsibility for the food information provided to the consumer.
From LegaleGo food safety consultancy we are at your complete disposal to clarify any questions you may have and advise you, in each case, what would be the best way to proceed for the notification of supplements in Europe.