Registration of food supplements in Spain

In Spain, food supplements are regulated by the Spanish Agency for Food Safety and Nutrition (AESAN), and it is required to notify this agency of their marketing, as we indicated in our post on how to notify food supplements.

Products such as sports nutrition, as well as other food supplements in Spain, must first be communicated to the Spanish health authorities before being put on sale.

It is important bear in mind the notification of food supplements is mandatory in Spain, and that the lack of notification can lead to economic sanctions and the withdrawal of the product from the market. In addition, it is advisable to have the advice of experts in the field to ensure compliance with legal and technical requirements in the notification of food supplements.

In order to notify products, it is first necessary to differentiate between companies with registered offices outside of Spain and those with domiciles in Spain.

Let’s talk, first of all, about those companies domiciled in Spain:

The first requirement is to process the registration in the health registry of the autonomous community where you are domiciled. And before notifying the marketing of a food supplement, it is mandatory to verify that it complies with the legal requirements established in Spanish and European regulations. For this, it will be necessary to carry out a study of the product label.

After the product has been reviewed and adapted to Spanish regulations by experts in the field, the notification of the product is made, where detailed information about the product must be provided, such as the composition, the recommended dose, the nutritional declarations and health, among other aspects. According to each Autonomous Community, a fee must be paid for this notification process.

Once the notification is made, the product can be marketed immediately. Although it will not be necessary to wait for AESAN’s response, the company that places the food supplement on the market is responsible for its commercialization and compliance with all regulations.

Secondly, for companies domiciled outside of Spain but in any other country of the European Union:  In Europe, the products are notified directly in Spain to AESAN. Previously, the evaluation of the product must be carried out to ensure that its composition and labeling comply with Spanish regulations, among the labeling requirements that the product must comply with is the translation into the official language of the country, Spanish.

A notification must be made for each product that you want to put on the market (each notification can include the same product with different flavors or presentations, providing all the labels). Finally, a Notification Fee per product must be paid to the Spanish health authorities, which today is €128.16.

Finally we have in the case of companies domiciled outside the European Union:  In this case the notification must be made through an importer or distributor that has its registered office in Spain or in any other country but the European Union. The company name and registered office that must appear on the label must be that of the company domiciled in the European Union, which will be the importer of the product or distributor. There are many brands that work in this way in Spain. If said importer or distributor were a company domiciled in Spain, it must be previously registered in the General Sanitary Registry and would notify the autonomous community where it has its registered office and the rate will depend in this case on the Autonomous Community where the product is notified. , as we indicated in our post about how much it costs to notify a food supplement.

In most cases (according to the composition of the product, ingredients and dose) if the product is going to be notified in Spain for sale in our country, it will be necessary to additionally submit a document proving that the product is already for sale in another country of the European Union to thus apply the principle of mutual recognition.

At LegaleGo we are experts in the review and notification of food supplements in countries of the European Union. We are currently notifying (after translation and adaptation of the label to the internal regulations of each country) in Spain, Portugal, Ireland, France, Italy, Germany, Luxembourg, Belgium, UK, Holland, Poland, Sweden, Finland, Austria and Hungary.

As a food safety consultancy specialized in the registration of food supplements, our team is made up of lawyers and technicians with extensive experience in this field and our services include:

• Label translations into the local language of the country where you want to sell the product.
• Verification of the label and adaptation to the internal regulations of the country where you want to market.
• Notify food supplements both in Spain and in most countries of the European Union
• Answer any requirement or observation of the health authorities after the notifications made.

If you need help to start with your project feel free to write us we will be pleased to help you with the registration of food supplements in Spain or in any other country of the European Union where to market your products.