AESAN Notification for Food Supplements in Spain: 2026 Guide

Before placing any food supplement, including sports supplements, on the Spanish market, the responsible operator is legally required to notify it to the competent authority. This is a mandatory 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 notification and why is it mandatory?

The notification is a mandatory procedure: the operator responsible for first placing a food supplement on the Spanish market must file it electronically, before the product goes on sale. 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 official procedure is listed as Comunicación de puesta en el mercado de complementos alimenticios, and AESAN publishes the reference documentation and the fee payment procedure on its own site.

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.

And who receives it? This is where brands most often go wrong, because it is not always AESAN:

If you are a Spanish brand manufacturing in Spain — the most common case — your notification does not go to AESAN: it goes to your autonomous community. AESAN publishes the contact details of each regional authority.

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

Each step in detail:

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 electronically only, through the electronic office of the competent authority — your autonomous community in the most common case, or AESAN’s own electronic office (operational since 25 September 2023) where AESAN is competent.

The procedure is:

1. Log in with an electronic certificate, DNI electrónico, Cl@ve PIN or Cl@ve permanente
2. Select the comunicación de puesta en el mercado de complementos alimenticios
3. Complete the form with all product details
4. Attach the required documentation, including the labelling
5. Pay the applicable fee (tasa) and attach the proof of payment
6. Sign electronically and submit

On the fee: the notification is subject to an administrative fee. AESAN publishes its own fee payment procedure, and regional authorities publish theirs, so check the amount in force for your case before filing rather than budgeting from a figure found online.

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 the authority may request additional information or clarifications about the product. Filing allows marketing of the product from the day the notification is submitted, without prejudice to the powers of verification, control and inspection held by the public administrations.

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.

Marketing a food supplement without having notified it, or with regulatory non-compliance, is an administrative infringement. The classification sits in Article 51 and the amounts in Article 52 of Law 17/2011 on food safety and nutrition:

For very serious infringements the competent administration may also order the temporary closure of the establishment for up to five years (Art. 52.2).

A nuance almost nobody explains, and worth understanding: Article 52.3 itself states that closing an establishment that lacks the required health registrations, suspending its activity until defects are corrected, and withdrawing a product from the market on health and safety grounds do not have the character of a sanction. They are public-health protection measures, not punishment. In practice that means they can be applied without a sanctioning procedure, and therefore far faster than a fine.

Amounts from Article 52.1 of Law 17/2011. Autonomous communities run their own procedures — check the consolidated text linked above before relying on a figure.

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.