FOOD SUPPLEMENTS NOTIFICATION PROCEDURE SPAIN

Wanting to market food supplements? At LexSupplements, a food legal consultancy specialized in the dietary sector, we help you. Keep reading.

WHAT ARE FOOD SUPPLEMENTS?

As referred to Spain, the definition of a food supplement is given in article 2 of Royal Decree 1487/2009, of September 26, relating to food supplements. Specifically, a food supplement will be understood as: “Food products whose purpose is to complement the normal diet consisting of concentrated sources of nutrients or other substances that have a nutritional or physiological effect, in simple or combined form, marketed in dosed form, i.e. capsules, softgels, tablets, pills and other similar forms, sachets of powders, liquid ampoules, dropper bottles and other similar forms of liquids and powders that must be taken in small unit quantities.”

Regarding their composition, food supplements can be composed of a wide range of nutrients, including vitamins and minerals, essential fatty acids, plants, fiber, amino acids, etc.

In the case of vitamins and minerals, it must comply with the provisions given in Directive 2002/46/EC of the European Parliament and the Council, of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements, which contains vitamins and minerals as well as vitamin substances and mineral substances that can be used in the manufacture of food supplements.

Regarding substances with a nutritional or physiological effect, we must refer to the Annex of the Royal Decree 1487/2009, of September 26, relating to food supplements, which lists the substances that can be used in the manufacture of food supplements as well as the requirements regarding the composition aplicable to food supplements are determined.

In Spain, if the food supplement contain substances other than those included in the Royal Decree 1487/2009, it will be necessary to resort to the principle of mutual recognition, that is, food supplements may be manufactured, food supplements may be notified and food supplements may be distributed taking into account the applicable health regulations in force in other country of the European Union such as, for example, France, Italy, Portugal, Belgium, Germany, etc. Keep reading!!

GENERAL SANITARY REGISTER OF FOOD AND FOOD COMPANIES

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 Consumer Affairs, Food Safety and Nutrition of the Ministry of Health, Social Services and Equality and Its purpose is to protect public health and the interests of consumers, allowing the official control of companies and establishments that must register with it. It is legally based in 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, which will include the data contained in the registries managed by the competent bodies of the different Spanish regions.

In the field of food supplements, all companies and food establishments that are dedicated to the import of food supplements, the manufacture of food supplements, the storage of food supplements or the distribution of food supplements must register with the RGSEAA provided that the headquarters of the establishment or the headquarters or registered office of the company that does not have an establishment is in Spanish territory.

The retail establishments as defined in article 2 of Royal Decree 1021/2022, of December 13, which regulates regarding hygiene in the production and marketing of food products in retail establishments, are excluded from the obligation to register in the Registry, without prejudice to the corresponding official controls.

They must be registered in the records of the competent authorities of the autonomous communities established for this purpose, prior communication or responsible declaration, which will not be authorizing, 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.

FOOD SUPPLEMENTS NOTIFICATION

Once the responsible company or operator is registered in the General Health Registry of Food Companies and Foods, it will be able to communicate 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.

The 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. In this case, the responsible operator must send to the competent health Administration, that is, the Administration of the Autonomous Community where the responsible company has its registered office, a copy of the label of the food supplement that is going to be marketed as well as the notification tax payment proof required by some Autonomous Communities (such as Madrid, Catalonia, Andalusia, Valencia, Castilla León, the Canary Islands, etc.). Therefore, the notification process for food supplements may be carried out before Catalonia, before the Generalitat Valenciana, or the notification of placing food supplements on the market may be carried out in the Community of Madrid, etc.

In the event that the food supplements that are going to be marketed contain other substances that are not regulated in the applicable Spanish regulations (such as plants, mushrooms, etc.), the notification of placing food supplements on the market must be carried out in accordance with the principle of Mutual Recognition. That is, in this case, the notification of placing on the market must be made in another EU State (France, Belgium, Italy, Portugal, Malta, Ireland, Germany, Romania, etc.) in accordance with its national health regulations and subsequently, notify the food supplement before the Spanish health authorities. In this case, a copy of the notified label in the country of first placing on the market, a copy of the Spanish label, an invoice or other document proving the sale of the product in the country of first placing on the market and proof of payment of the administrative fee that the Spanish Authority require must be sent.

Once the placing on the Spanish market of a food supplement has been communicated, it can now be marketed in our country with no need to wait for any answer.

FOOD SUPPLEMENTS LABELING

In addition to all of the above, the labeling of food supplements that are going to be marketed in Spain must comply with the general criteria for labeling, presentation and advertising of food products, as set out in (i) Regulation (EC). 1924/2006, of December 20, 2006, relating to nutritional and health claims on foods and their modification, (ii) in Royal Decree 1487/2009, of September 26, relating to food supplements and (iii) in Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25 October 2011 on food information provided to consumers.

It should be noted that the labeling, presentation and advertising of food supplements may not include any mention that declares or suggests that a balanced and varied diet does not provide adequate and sufficient amounts of nutrients in general, nor will it attribute to food supplements the property of preventing, treating or healing any human disease.

Regarding the mandatory mentions that must be included on the labeling of food supplements, we can highlight:

1.- The name under which the product is marketed, which must include the mention: “Food supplement.”

2.- A mention to the categories of nutrients or substances that characterize the product, or an indication relating to the nature of said nutrients or substances.

The amount of nutrients or substances with a nutritional or physiological effect contained in the product will be declared on the label in a numeric form.

3.- The recommended dose of the product for daily consumption.

4.- The warning not to exceed the stated recommended daily dose.

5.- The express statement that food supplements should not be used as substitutes for a balanced diet.

6.- The indication that the product should be kept out of the reach of young children.

7.- The net quantity of the product.

WE CAN HELP YOU 

If you are interested in the marketing of food supplements in Spain or in another country in the European Union, at LexSupplements we can help you. Contact us and we will advise you on the necessary procedures and specific requirements that you must meet to be able to distribute this type of products.