Selling food supplements in Spain
Foreigner companies interested in selling food supplements on the Spanish market do not need prior authorisation to be entitled to place their complements in our country. However, the company does has to notify its intervention in the market to the Spanish Agency of Consumption and Food Safety (AECOSAN, Agencia Española de Seguridad Alimentaria y Nutrición) and provide them with a copy of the product’s label.
But, if the company is not present in the European Union, there are two possibilities to make a food supplement registration:
AUTHORISATION AND NOTIFICATION OF FOOD SUPPLEMENTS IN SPAIN
1º.-In the case the company does not have a domicile in Spain and the product comes from a third (no-Eu) country, nutritional supplements can be notified directly to AECOSAN in Madrid. A fee of 125,63 € per product will have to be paid. Each notification can include different flavors and different weights providing all the labels.
2º.- If the company has a registered office and social address in Spain must be registered in the Register of Food Industries of Spain (RGSEAA, Registro Sanitario de Empresas Alimentarias). After, the product will be notified to the region where the company is settled. Depending on the region, fees change. For instance, in Canarias is 2,50 €, in Andalusia 49,60 €, Valencia 210 €. There are other areas where the notification is free of charge such as Asturias or Pais Vasco. Anyway, the price is much less than the rate of the AECOSAN.
LABEL OF FOOD SUPPLEMENTS IN SPAIN
The label must read “food supplement” and It must not suggest that a balanced diet doesn’t provide enough nutrients, nor that the supplement will prevent, treat or cure any illness or disease.
It is compulsory that the label detail:
- nutrients or substances contained in the product,
- the dose of the product recommended for daily consumption,
- a warning not to exceed the daily dose expressly recommended,
- an affirmation which says that food supplements must not be used as a substitute for a balanced diet,
- that the product must be kept out of the reach of younger children,
- and all types of allergens present.
FOOD SUPPLEMENTS AND LEVEL OF CONSUMPTION
A varied diet, rich in fruit and vegetables, may provide all the sources of nutrients required by our body, but this is not always the case for all categories of the population.
According to professional researches, some nutrients can be lacking even with a relatively well-balanced diet and therefore food supplements can be a good way to complement meals. Food supplements can contain vitamins, minerals, amino acids, essential fatty acids, fibre and different plants and herbal extracts, among other substances.
They cannot however substitute a balanced diet and one should not ingest a bigger daily dose than the authorities recommend.
Nowadays, the European Union regulates the nutrients that can be present in food supplements sold in the European Community, but it does not regulate the maximum levels of all the substances.
Therefore, it is the Scientific Committee on Human Food and other international institutions that produce reports and recommendations on the doses that can be ingested by European consumers.
If you have any questions about how to market food supplements in Spain, please ask us. LegaleGo lawyers are at your disposal as an alimentary consultant.
As a food regulation consultants specialized in the registration of food supplements we take care of:
- Revision of label and adaptation to regulation.
- Notify in another country of the European Union (ie. France, Belgium, Portugal or as needed). It will be necessary that the labels are also in the official language of this country or we can prepare a sticker.
- Communication of the placing on the Spanish market.
- Answer to any requirement or observation of the sanitary authority.