9 octubre, 2017

Registration of food supplements

For the registration of food supplements such as sports nutrition products, it is necessary to inform or communicate to the corresponding Health Authority of Spain of the commercialization or market of the products.

In the case the company isn´t present in the European Union, in order to make this register there are two possibilities:

 

1º.- That the products in Spain can be notified directly to the Spanish Agency of Consumption and Food Safety (AECOSAN) 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 125,63.-€ 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 AECOSAN).

 

2º.- 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).

 

In this case, instead of notifying in Madrid before AECOSAN it would be necessary to notify in the region where the Spanish company has its registered office. The fee for this will depend on the region where the product is notified. For instance, in Canarias it is 2.50.-€, in Andalusia 49.60.-€, Valencia 210.-€, 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 (AECOSAN).

 

Another thing to take into account is that in Spain, only the addition of vitamins and minerals to food supplements is allowed, so for the cases where the composition of products differs from this, it will always be necessary to previously register or justify that this product is already registered or sold in other European Country, so this way we would provide the free sales certificate that enables this products to be accepted in Spain.

If we are going to notify in Madrid or Barcelona it would be necessary to previously register the products in Belgium, where a fee of 180.-€ per product is needed. If the registration in Spain is anywhere different from Madrid o Barcelona, we can register in Irelan or France where free 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.