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HOW TO SELL FOOD SUPPLEMENTS IN SPAIN
Do you want to sell food supplements in Spain and don't know where to start? Keep reading as we tell you the steps you must follow so that you can operate in the food supplements sector.
Do you want to sell food supplements in Spain and wonder how to start? Keep reading to know the steps you must follow so that you can operate in the food supplements sector.
WHAT YOU SHOULD DO TO SELL FOOD SUPPLEMENTS IN SPAIN
I.- The first requirement that you must meet is to register in the General Sanitary Registry of Food Companies and Foods (RGSEAA hereinafter). It is necessary for your company to have a Health Registration number to be able to sell in the food supplements sector since in this way the protection of public health and the interests of consumers is guaranteed. In the case of a direct sale to the public, you must be registered in the corresponding Regional Registry.
The RGSEAA is a public database managed by the Spanish Agency for Food Safety and Nutrition (AESAN) of the Ministry of Consumer Affairs and facilitates the official control of companies and food establishments that must register in it.
If you want more information about who must register in the Food safety registry and what the steps are to do so, you can read our previous post:
Once you have requested registration in the Health Registry of Companies, you must have either the Autocontrol System document or a Hazard Analysis and Critical Control Points (HACCP) for more complex production stages that involve food handling or processing that could compromise their security and therefore require greater control. The Autocontrol System is a “living” document that includes the different actions, controls and procedures carried out in the company, so as to guarantee that the products sold (food or food supplements) are safe for the consumer. This document should be updated as the company markets new products or expands the manufacturers they work with. The HACCP is a more extensive document, which in addition to housing the Autocontrol System document, is made up of the General Hygiene Plans based on the category of activity carried out (manufacturing, packaging, storage, etc.).
II.- Secondly, and once obtained the Health Registry we must focus on the product itself. The first thing we must take into account is that the composition of the product complies with the applicable health regulations. That is, they are ingredients allowed for the manufacturing of food supplements and, in turn, that ingredient amounts are compliant with any minimum or maximum limits that may be set up by the applicable regulations.
LexSupplements Regulatory consultants can fully help you with the food supplements composition revision using the Manufacturer´s composition certificate or certificate of analysis.
Once we ensure that the composition of the product meets the legal requirements, we must focus on the product label. We must proceed with the labelling revision of the food supplement and ensure that it complies with the applicable health regulations and specifically, with (i) Regulation (EC) 1924/2006, of December 20, 2006, relating to nutritional and health claims on foods and its modification, (ii) 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 October 25, 2011 on the food information provided to the consumer.
In addition, the label must contain the mandatory information established by law:
1.- The name under which the product is marketed, which must include the mention: “Food supplement”.
2.- The name of the categories of nutrients or substances that
characterise the product, or an indication of the nature of those nutrients or
substances.
3.- The portion of the product recommended for daily consumption.
4.- The warning not to exceed the stated recommended daily dose.
5.- The express statement that dietary 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.
III.- Once we have a compliant label, we must proceed with the last step which is the pre-market authorisation on the Spanish market, that is, we must inform the Autonomous Administration where the company has its registered office which products are going to be marketed.
The notification of placing on the market can be done in two different ways depending on the product´s composition.
Direct registration in Spain could be done if the ingredients of the product are regulated in Royal Decree 1487/2009, of September 26, relating to different substances with nutritional or physiological effect and in Directive 2002/46/EC on vitamins and minerals. On the other hand if the ingredients of the product are not regulated by Spanish regulations, then the Mutual Recognition Principle must be applied. This means that operator must prove that the product complies with other EU regulations on Food supplements, and that it has been registered and sold there so as to be able to proceed with the pre-market authorisation of the product in Spain.
You can expand the information regarding notification by mutual recognition in our post:
Once the product has been notified to the competent health authority, it can be sold in the Spanish market.
WE CAN HELP YOU
At LexSupplements, international food supplements regulatory specialists in the food supplements sector, we can help you so that you can sell food supplements in Spain and other countries in the European Union, with the peace of mind of complying with all applicable legal requirements.
Trust in food supplements labelling experts to have a fully legal product´s brand in the European market.
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