::AESAN:: Agencia Española de Seguridad Alimentaria y Nutrición

subseccion EnlacesProcedure for the sale of a food supplement in Spain

Register of the business responsible for sale in the General Food Health Register (RGSA)

Notification of putting the product on the market

- Where to notify

Article 10 of Royal Decree 1487/2009 explains the various routes to follow when notifying the competent authorities that food supplements are going on sale. The place for doing this will depend on the location of the business address of the person responsible for the sale in Spain, and of the origin of the manufacture of the supplements. Therefore, the following situations may arise:

  • If the company responsible for primarily placing the product on the Spanish market has their registered office in Spain and the product does not come from outside the EU,they shall notify the bodies of the relevant Autonomous Community depending on their registered office.
  • If the company responsible for primarily placing the product on the Spanish market has their registered office in Spain and the product comes from outside the EU,the Spanish Agency for Food Safety and Nutrition shall be notified.
  • If the company responsible for primarily placing the product on the Spanish market does NOT have their registered office in Spain,the Spanish Agency for Food Safety and Nutrition shall be notified.

- How to notify

  • When notifying Autonomous Regions, contact the competent organisation in the Autonomous Region, according to the business address of your company.
  • When notifying AESAN, fill in the form for presenting the food supplement, which can be found at the e-mail address below:

http://www.aesan.msps.es/en/AESAN/web/registro_general_sanitario/seccion/rgsa_procedimientos.shtml

- documentation to be provided

  • Notification form
  • Official form for payment of fees (model 791-code 606) –for companies with Spanish CIF or NIF

    These forms are available at the following web link:

    http://www.aesan.msc.es/AESAN/web/registro_general_sanitario/seccion/rgsa_procedimientos.shtml

  • Other documentation:
    • If it is the first time the product has been sold in the European Union: Two examples of the label.
    • If it is already legally sold in another member state: in addition to the label, in order to apply reciprocal recognition, it must be proved that the product is legally sold in that member state. For which the following documentation is required:
      • Original label under which the product is sold in the member state which has given approval for the notification, in order to check that it is the same product as notified in Spain.
      • Reply from the competent authority in the member state to the notification presented to the authority.
      • Translation of the above documents

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