Food supplements Notification in the European Union

We assist you with the pre-market notification procedure for your food supplements wherever necessary, ensuring their proper commercialization

We assist companies in notifying or registering their food supplements both in Spain and in most European Union countries.

The notification of the market placement of food supplements originates from Directive 2002/46/EC of the European Parliament and Council of June 10, 2002, on the approximation of the laws of the Member States relating to food supplements. This directive is mandatory for countries that have transposed it into their national legislation. Thus, there are a few countries, such as the Netherlands and Sweden, that do not require notification of dietary supplements' market placement, while most countries do require this notification prior or simultaneously to the product marketing in that country.

In Spain, this obligation is imposed by Royal Decree 1487/2009 on food supplements. The marketing of non-notified dietary supplements can result in administrative sanctions of varying amounts, determined specifically by each Autonomous Community.

Therefore, the notification process for market placement of dietary supplements depends significantly on the country in which the product is to be notified. This results in the consideration of both the national regulations of that country and the procedures established by the competent Health Authorities.

Spain is one of the countries with minimal national health legislation specific to food supplements, making it difficult to be able to notify food supplements in a direct way in Spain. This is means that it is very likely that Mutual recognition principle shall be applied ir order to register and market food supplements in Spain. Thus, a prior notification and commercialization in another EU country must be considered before notifying and marketing the product in Spain.

What's moere, the notification of food supplements in Spain can be done directly if the product's composition complies with the provisions of Royal Decree 1487/2009, of September 26, concerning various substances with nutritional or physiological effects and Directive 2002/46/EC on vitamins and minerals. In this case, the responsible operator must submit a sample of the dietary supplement's label to the competent health administration, i.e., the Administration of the Autonomous Community where the responsible company is domiciled, along with proof of payment of the notification fee required by some Autonomous Communities (such as Madrid, Catalonia, Andalusia, Valencia, Castilla y León, Canary Islands, etc.).

If the food supplements to be marketed contains other substances not regulated by applicable Spanish law (such as plants, fungi, etc.), the market placement notification must follow the principle of mutual recognition. This means that notification must first be made in another EU state (France, Belgium, Italy, Portugal, Malta, Ireland, Germany, Romania, etc.) according to its national health regulations, and subsequently, the food supplement must be notified to the Spanish Health Authorities. In this case, a sample of the label notified in the first marketing country, a sample of the label in Spanish for Spanish market, an invoice or other document proving the product's sale in the first marketing country, and proof of payment of the administrative fee required by the Spanish Health Authority, if applicable, must be submitted.

Once the market placement notification has been communicated in Spain, the food supplement can be marketed in the country.

At LexSupplements, Food Legal Consultancy, we help you with the market placement notification of food supplements in the European country you need. We ensure that the brands working with us have the peace of mind of comprehensive legal advice, covering all the steps starting from the formula´s definition, its ingredients, and quantities, to designing the labeling and food information, and finally, to the notification or registration of the products with the competent Health Authority.