EU food supplement registration in Spain: AESAN notification guide

Before placing any food supplement — including sports supplements — on the Spanish market, the responsible operator is legally required to notify AESAN (Agencia Española de Seguridad Alimentaria y Nutrición — Spain’s Food Safety Agency). This is a mandatory, free procedure that many brands discover too late. This guide explains everything you need to know to do it correctly from the start.

What is the AESAN notification and why is it mandatory?

The AESAN notification is the mechanism by which a food business operator informs the competent Spanish authority that it intends to market a food supplement in national territory. Its legal basis is Royal Decree 1487/2009, which regulates food supplements in Spain, and Directive 2002/46/EC of the European Parliament, which harmonises this regulation across the EU.

The purpose of the notification is not to obtain a “sales permit” (food supplements do not require prior authorisation, unlike medicines), but to ensure that the competent authority is aware of the product circulating in the market so it can exercise the corresponding health surveillance.

Who must notify? The operator responsible for first placing the product on the Spanish market. If you manufacture in Spain and sell in Spain, that is you. If you import from another EU country, you are also the notifying party as the first distributor in the Spanish market.

When must you notify? Before first placing the product on the market. There is no minimum lead time required (unlike health notifications in some countries that require X weeks’ notice in advance), but the notification must have been submitted by the time the product goes on sale.

Which products must be notified?

All food supplements, as defined by Article 2 of RD 1487/2009:

“Foodstuffs the purpose of which is to supplement the normal diet and which are concentrated sources of nutrients or other substances with a nutritional or physiological effect, alone or in combination, marketed in dose form.”

This covers virtually all common sports supplements:

• Protein powders (whey, plant-based, casein)
• Pre-workouts, intra-workouts, recovery products
• Creatine, BCAAs, amino acids
• Vitamins and minerals
• Omega-3 and essential fatty acids
• Herbal and botanical extract supplements (with additional regulation)
• Probiotics

Not food supplements (and therefore subject to a different legal regime): medicines, foods for special medical purposes, and specific foods for athletes regulated under separate legislation.

Food supplement vs. medicine: the line you must not cross

This is the most important distinction in supplement regulation. If your product crosses this line, the consequences are very serious (market withdrawal, fines, criminal liability).

A product may be classified as a medicine (and removed from the supplement market) if:

• It contains substances classified as pharmaceutical active ingredients
• Its claims imply therapeutic, preventive, or curative effects on diseases
• The dose of a nutrient exceeds the limits set for food supplements
• Its presentation (name, labelling) could lead the consumer to believe it is a medicine

The “medicinal by presentation” criterion is particularly relevant: a food supplement sold in pharmacies with packaging similar to a medicine may be reclassified as such even if its composition is legally compliant as a food.

The notification process step by step

Step 1: Prepare the technical documentation

Before notifying, you need to have the following documentation ready:

Step 2: RGSEAA registration (if not already in place)

The General Register of Food Businesses and Foods (RGSEAA) is the register in which all companies that manufacture, process, package, store, distribute, or market food in Spain must be registered.

If your company does not yet have an RGSEAA number, you will need to obtain one before being able to notify food supplements. This procedure is carried out before the competent authority in your autonomous community (not directly with AESAN).

Step 3: Submit the notification

The notification is submitted through the NAOS system (Nutrition, Physical Activity, Obesity Prevention, and Health) of AESAN, available through the electronic registry of the Ministry of Consumer Affairs.

The procedure is:

1. Log in with a digital certificate or Cl@ve (Spanish electronic ID system)
2. Select “Notification of food supplements”
3. Complete the form with all product details
4. Attach the required documentation
5. Sign electronically and submit

The notification is free of charge. There is no associated fee.

Step 4: Confirmation and case number

Once the notification is submitted, you will receive an acknowledgement of receipt with the case number. In some cases, AESAN may request additional information or clarifications about the product. If the file is correct, it is incorporated into the register and the product may be marketed.

Important: receiving the acknowledgement is not an “approval” of the product. AESAN does not pre-approve or validate food supplements. The responsibility for ensuring the product complies with all applicable regulations rests entirely with the operator.

Timelines and penalties for non-compliance

There is no minimum lead time for the notification, but the product cannot be marketed without having submitted it.

Penalties for marketing a food supplement without notification or with regulatory non-compliance are:

• Minor infringement: up to €3,000
• Serious infringement: €3,001 to €60,000
• Very serious infringement: more than €60,001 and possible product withdrawal from the market

In addition to financial penalties, infringements are recorded and can affect the company’s reputation with other operators in the food supply chain.

Notification in other EU countries

If you want to market your product in other European countries, the situation varies:

• Germany: notification to BVL (Federal Office of Consumer Protection and Food Safety)
• France: notification to DGCCRF, with a more complex process for certain ingredients
• UK (post-Brexit): notification to the FSA (Food Standards Agency), with additional Responsible Person requirements
• Italy: notification to the Ministry of Health

The European principle of mutual recognition facilitates cross-border marketing, but does not eliminate local notifications. A GMP manufacturer with export experience can guide you on the requirements of each market.

The role of a GMP manufacturer in the notification process

A GMP-certified manufacturer does not just produce your supplement — it can also be a key ally in the notification process:

• Provides product technical documentation: ingredient technical data sheets, specifications, raw material COA
• Carries out a regulatory pre-review of the formula to ensure all ingredients are legal in Spain and the target market
• Verifies that labelling claims comply with Regulation EC 1924/2006
• Issues the GMP certificate that may be required for export to certain markets
• Advises on country-specific restrictions for certain ingredients (botanicals, fat-soluble vitamin doses, novel ingredients not yet authorised)

At Akumal we support our clients in preparing the AESAN notification dossier and in the regulatory review prior to launch. Before starting the process, we also recommend reviewing the guide to launching your first supplement brand in Europe and the article on GMP certification explained.

Request a regulatory consultation before starting production — it is far cheaper to prevent than to correct an incorrect notification or non-compliant labelling.