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What happens when your product contains ingredients not regulated in national health regulations or harmonized at the EU level? Keep reading because our new post is for you.

The first thing to consider in order to sell food supplements is that the product must be notified to the relevant Health Authorities in each country where the product is intended to be sold. Therefore, if we want to sell food supplements in France, Italy, Portugal, Belgium, Spain, Malta, Germany, Romania, etc., it is necessary to proceed with the pre-market authorisation in those countries.

The pre-market authorisation will be made directly to the Health Authorities where the product is intended to be sold if the ingredients it contains are regulated in their national rules on Food supplements or if they are harmonized at the EU level. For example, if we want to sell a food supplement in Spain based on carnitine, BCAAs, tryptophan, inulin, konjac glucomannan, chitosan, or FOS (among others), since these are ingredients listed in Annex of Royal Decree 1487/2009, of September 26, regarding food supplements and thus allowed, the notification of these types of products will be made directly to the competent Spanish Health Authorities.

But what about products that have ingredients not covered by national regulations? In this case, we must resort to the so-called Principle of Mutual Recognition in food supplements. For example, if we want to register a product in Spain based on plants (maca, turmeric, tribulus, ginseng, saw palmetto, green tea, etc.) or based on ingredients such as fish oil, probiotics, collagen, hyaluronic acid, resveratrol, etc., we must adhere to the principle of mutual recognition for the Spanish pre-market authorisation.

The European Commission elaborated the Regulation on Mutual Recognition, REGULATION (EU) 2019/515 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of March 19, 2019, regarding the mutual recognition of goods legally marketed in another Member State, which allows for the "free movement of goods between Member States if, in the absence of Union harmonization rules regulating goods or certain aspects of goods, the competent authority of a Member State applies to goods legally marketed in another Member State national rules requiring such goods to comply with certain technical requirements, for example requirements relating to designation, form, size, weight, composition, presentation, labeling, or packaging."

Furthermore, "the principle of mutual recognition stems from the case law of the Court of Justice of the European Union. According to this principle, Member States cannot prohibit the sale on their territory of goods legally marketed in another Member State, even when such goods have been produced in accordance with different technical standards, including goods that are not the result of a manufacturing process."

Therefore, the Principle of Mutual Recognition allows companies that manufacture and/or distribute food supplements to legally market in Spain products and food supplements containing ingredients that, despite not being expressly regulated in our country, are regulated in other Member States. It is an international business opportunity that allows our companies to operate in other EU countries.

Spain is one of the countries with the poorer legislation on food supplements, so if we were limited to the ingredients expressly regulated and authorised in our regulations, the sales possibilities would be very limited. Therefore, the possibility of resorting to the principle of mutual recognition allows Spanish companies to reach the international market and, furthermore, to sell in Spain food supplements based on other ingredients not expressly regulated in our regulations. To do this, it is only necessary to demonstrate to the Spanish Health Authority that a food supplement is already marketed in another Member State, resulting in our Administration being unable to prevent its marketing in accordance with the free movement of goods in Europe. In this case, proof of sale in the country of first notification of placing on the market (or what was known as a certificate of free sale) and the pre-market authorisation proof must be provided.

Currently, at LexSupplements, we help many companies improve their international projection as we notify in almost all EU countries: Germany, Ireland, France, Italy, Belgium, Croatia, Spain, Poland, Greece, Portugal, Romania, etc., and we also advise our clients on which country is most interested for the first notification of placing on the market since we specialize in mutual recognition.


If you are interested in expanding information regarding the principle of mutual recognition, at LexSupplements, we can help you. Contact us without obligation.

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