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Do you know that your company must be registered in the Sanitary Registry if you want to market food supplements in Spain? At LexSupplements, a legal consultant specialized in the food supplements sector, we help you get your registration in the General Health Registry of Food Companies and Foods and we also prepare your self-control system document.

The Spanish General Health Registry of Food Companies and Foods (RGSEAA hereinafter), is a database, of a public and informative nature, managed by the Spanish Agency for Food Safety and Nutrition (AESAN) of the Ministry of Consumer Affairs and Its purpose is to protect public health and the interests of consumers, facilitating the official control of companies and establishments that must register with it. Its legal basis is Royal Decree 191/2011, of February 18, on the General Health Registry of Food Companies and Foods.

It is a national Registry and is considered a unified state-wide registry, in which the data contained in the registries managed by the competent bodies of the Autonomous Communities will be included.



In the field of food supplements, (i) all companies and food establishments whose headquarters or registered office of the company is in Spanish territory must register with the RGSEAA; (ii) its activity has as its object food or food products intended for human consumption, materials and objects intended to be in contact with food or technological aids used for the production of food and (iii) its activity is classified in one of the following categories , import of food supplements, manufacturing of food supplements, packaging of food supplements, storage of food supplements or distribution of food supplements.

The obligation to register food businesses is imposed by Regulation 852/2004 of the European Parliament and of the Council, of April 29, 2004, regarding the hygiene of food products.

Additionally, the following will be subject to registration:

a) The beginning of the activities of companies and food establishments.

b) The placing on the market of food products for special nutrition and the authorization or recognition of natural mineral waters and spring waters.

c) The modification of any of the data of the mandatory information necessary for the registration of companies and food establishments in the Health Registry (name or company name, NIF, NIE or CIF, the object of all their activities and the headquarters of the establishment or, in the case of companies that do not have any establishment, the registered office).

d) The definitive cessation of the economic activity of companies and establishments that will lead to the cancellation of registration.

e) The cessation of the marketing of food products for special nutrition and of natural mineral waters and spring waters, which will lead to the cancellation of registration.




Regarding registration, we can find two different options:


On the one hand, prior and/or simultaneous communication at the start of the activity, without prejudice to the controls that may subsequently be carried out by the Health authorities, for all food establishments or companies that do not market products of animal origin and companies without establishments that sell products of animal origin.


And on the other hand, prior authorization in the case of establishments that work with products of animal origin, before the start of their activity.


The health registration number granted to a company or establishment is solely for administrative identification and the operator is not obliged to use it in the labeling of its products.


However, in the case of prior authorization, the registration number means that the facilities have been authorized by the competent authorities of the Autonomous Community and this must be included in the information on the labeling or accompanying documentation of the products that are marketed within of it and outside its borders.



Those establishments and their companies that exclusively handle, transform, package, store or serve food for sale or delivery on site to the final consumer - with or without home delivery - or to communities, are not required to process registration in the Health Registry nor when they supply to other establishments with these same characteristics, and it is a marginal activity in both economic and production terms, with respect to that carried out by them.


In these cases, they must be registered in the records of the competent authorities of the Autonomous Communities established for this purpose, following communication or responsible declaration from the food business operator to the competent authorities of the place where the establishment is located. However, in the case of establishments in which food is served on site to communities, the communication will be made by the person who owns the facilities.




The responsible company or food establishment must complete the corresponding form to process registration in the Health Registry provided by the Autonomous Community where its registered office is located.


For example, in the case of the Community of Madrid, the initial registration form provided by that autonomous Administration must be completed, indicating the data related to the company name of the responsible company, address, CIF, details of the Administrator, registered office, activity, etc. In addition, you must collect all the necessary additional documentation such as the company's contitution deeds, CIF document, documentation related to the company's administrator, etc.


On the other hand, the administrative fee required by each Autonomous Community must also be paid based on the registered office of the responsible company or location of the food establishment. In the case of the Community of Madrid, the fee that must be paid amounts to a total of 10.72 euros.


Once the competent health Administration receives all the documentation, it will communicate it to the Spanish Agency for Food Safety and Nutrition, which will proceed to register it in the Registry and assign the national identification number.


Companies that request registration in the Food Safety Registry must have a document called Self-Control System in which the different actions, controls and procedures carried out in the company must be recorded, so as to guarantee that the products it sells (food or food supplements), are safe for the consumer. This document is made up of the Good hygiene practices (GHPs) and the Hazard Analysis and Critical Control Points – HACCP.


The Self-Control System is a very effective method of ensuring that the food we consume is safe for consumption, since product withdrawal procedures must be established in the event of a food alert, product traceability to know where the products are located since they are manufactured until they reach the final consumer, what are the data of the specific manufacturers, what is the composition of the products (which must be included in the technical sheet of each of them), etc.


It is a “living” document that must be adapted to the company's activity and collect all the necessary information to guarantee food safety to the consumer.



Once the responsible company or operator has requested its registration in the Food Safety Registry of the competent Autonomous Community (Madrid, Andalusia, Catalonia, Valencian Community, Canary Islands, Asturias, etc.), it may now put the food supplements to be distributed on the market. To do this, the person responsible for marketing the product in Spain must notify the competent Health Authorities of its placing on the national market.


Notification of placing food supplements on the market may be made directly if the composition of the product adapts to the provisions of Royal Decree 1487/2009, of September 26, relating to different substances with a nutritional or physiological effect and to the Directive 2002/46/EC on vitamins and minerals or, taking into account the principle of mutual recognition, in the event that the food supplements to be marketed contain other substances that are not regulated in the applicable Spanish regulations (such as plants, mushrooms, etc.)


Once the placing on the Spanish market of a food supplement has been communicated, it can now be marketed in our country.


You can expand this information regarding the notification of food supplements on our blog: https://www.lexsupplements.com/es/blog/notificacion-de-complementos-alimenticios-20240227132754226



We can help you with the procedures for registration in the Health Registry. Contact us and we will advise you on the necessary procedures and specific requirements that you must meet to obtain your Registration number, which will allow you to market products in national territory and the rest of the EU as a food company.


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