Registration of food supplements
As we indicated in our post on how to registration of food supplement is done, in Spain and in Europe, food supplements are notified, not registered. However, we often refer to notification as registration. For this reason, we have prepared this post.
For the registration of food supplements such as sports nutrition products, it is necessary to notify the Spanish health authorities before placing them on the market.
In order to process the registration, it is necessary to differentiate between companies domiciled outside Spain and those domiciled in Spain.
In the case of companies that are not located in the European Union, there are two possibilities for registering food supplements:
1º. Firstly.- That the products in Spain can be notified directly to the Spanish Agency of Consumption and Food Safety (AESAN) in Madrid, in the case the company does not have a domicile in Spain and the product comes from a third (non-EU) country.
For this, a fee of 128,16.-€ per product will have to be paid (In each notification, we can include the different flavors of the reference and the different weights providing all the labels to the AESAN).
2º.Secondly.- Notify through a distributor in Spain that has a registered office and social address here. The name and address that should appear on the label (even if it is very small) must be that of the company in Spain. There are many brands that work like this in Spain. This company must be registered in the Register of Food Industries of Spain (RGSEAA).
What to do in the latter case?
In this case, instead of notifying in Madrid before AESAN it would be necessary to notify in the region where the Spanish company has its registered office. That is to say, the fee for this will depend on the region where the product is notified. For instance, in Canarias it is 286,93.-€, in Andalusia 89.46.-€, Valencia 84,19.-€, there are other areas where the notification is free of charge such as Asturias, Pais Vasco … As you can see the price can vary a lot, but in any case, it is much less than the rate of the Spanish Agency of Consumption and Food Safety (AESAN).
Another thing to bear in mind is that in Spain only vitamins and minerals are allowed to be added to food supplements. Therefore, in cases where the composition of the products differs from this, it will always be necessary to previously register or justify that the product is already registered or sold in another European country. In this way, they will provide us with the certificate of free sale that allows these products to be accepted in Spain.
If we are going to notify in Madrid or Barcelona it would be necessary to register the products in Belgium beforehand. Here a fee of 180.-€ per product is required. If the registration in Spain is different from Madrid or Barcelona, we can register in Ireland or France. Here the sales certificate is free of charge.
As a food regulation consultants specialized in the registration of food supplements we take care of:
(i) Revision of label and adaptation to regulation.
(ii) 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.
(iii) Communication of the placing on the Spanish market.
(iv) Answer to any requirement or observation of the sanitary authority.
LegaleGo Regulatory Food Supplements will help you to carry out this procedure and will guide you in the notification and registration of your company. In addition to this, we offer offer a company creation service and we will find you the best way to notify and the most economical way to do so.