What is the cost of notifying a food supplement?
Any business that sells food supplements in Spain has the obligation of reporting to the Health Authorities the first time it places its products on the market. This is required by article 9 of Royal Decree 1487/2009 relating to food supplements. Although in another post we already discussed how notice of food supplements is given, in this one we will explain the cost of notifying a food supplement.
This requirement, as is the case with the rest of European Union countries, is dictated by Directive 2002/46/CE of 10 June 2002 relating to the approximation of law of the member states in regard to food supplements. According to article 10 of this regulation: “To facilitate efficient monitoring of food supplements, Member States may require the manufacturer or the person placing the product on the market in their territory to notify the competent authority of having placed them on the market by forwarding the authority a model of the label used for the product.“.
Either at the start of the activity undertaken or simultaneously to it. The person responsible for carrying out this procedure will be the actual manufacturer or the operator that undertakes the distribution of food complements. But, what does it cost to notify a food supplement? Firstly, a company responsible for the production, processing, packaging, storage, distribution, importation and/or sale of food supplements has to be registered in code 26 of the Food Safety Registry (RGSEAA). The fees established for this procedure are set annually by each Autonomous Region and can be consulted in the following map according to the company’s registered address:
Once the operator is registered, the food supplement has to be notified. Keeping in mind that in Spain the regulation only covers the sale of food supplements whose composition only contains vitamins and minerals as well as a few nutrients and ingredients with a physiological function, it is mandatory to first notify in another European Union country that does have a regulation covering these kinds of ingredients, such as France, Belgium, Italy, Portugal, Ireland or Germany. This is the principle of mutual recognition. The notification fees established by each European Union country depend on each country and, in Spain, on each Autonomous Region. This is why, in order to make it easy to consult each fee, at legalegonutrition.com we created a set of interactive fee maps for each country or Spanish Autonomous Region.
The choice of one country or another will depend, as well as on the fee, on the substances contained in the food supplement and on the timeframes considered by the operator. In this regard, each country has different timeframes and operability. When the food supplement has been accepted in the chosen country, and upon application of the principle of mutual recognition, it may be notified in Spain, attaching said response or the certificate of free sale. Furthermore, the original label with which that product is sold must be submitted in the language of the country of origin. In this case, it has to be notified to the Autonomous Region where the operator has its registered address in Spain. The fee will depend on the Autonomous Region where the product is notified and can be consulted on our interactive maps.
If the company belongs to another European Union state and has no registered address in Spain, or if the company selling the products imported from third countries is Spanish, it shall report the notification of those products to the Spanish Agency for Consumption, Food Safety and Nutrition (AECOSAN). The rest of communications will be addressed to the competent authorities of the autonomous region in which the company in question has its registered address. It is important to indicate that this mandatory notification procedure for food supplements does not exempt the operator responsible for notifying its products from breaching any regulation in force on Food Safety and labelling.
At LegaleGo Nutrition we ensure that the sale of any food complements placed on the Spanish market complies with applicable legislation by performing the following actions among others:
- Entering or adapting the company in the Registry of Food Businesses in the corresponding category and adapting the technical document (self-monitoring system).
- Review and notification of food supplements in Spain, including:
- Review of labelling and technical data sheet.
- Notification in another European Union country.
- Notification in Spain.
- Replying to any communication or requirement from the health authorities.
In this way, and right from the start, we establish how much it costs to notify a food supplement.