Compliance Checklist

GPSR (General Product Safety Regulation)
Dietary Supplements
Spain 🇪🇸

Complete GPSR compliance checklist for dietary supplements (complementos alimenticios) on the Spanish market. Covers notification to AESAN, Real Decreto 1487/2009, Health Claims Regulation, Novel Food verification, Ecoembes packaging obligations, and Amazon.es-specific requirements.

Overview

The General Product Safety Regulation (GPSR, Regulation (EU) 2023/988) has been mandatory for all consumer products in the EU since December 13, 2024, including dietary supplements (complementos alimenticios) on Amazon.es. Spain is a growing market for dietary supplements with high demand for natural and herbal products. AESAN (Agencia Espanola de Seguridad Alimentaria y Nutricion) is the central authority overseeing compliance with food law provisions, while the Comunidades Autonomas conduct on-the-ground market surveillance. Before market placement, every dietary supplement must be notified via the AESAN electronic registry (Real Decreto 1487/2009). Additionally, the Health Claims Regulation (EC) No. 1924/2006, the Novel Food Regulation (EU) 2015/2283, and the PNCA (Plan Nacional de Control de la Cadena Alimentaria) for ongoing inspections apply. The GPSR adds obligations for designating an EU Responsible Person, enhanced traceability, and economic operator contact details on the product.

Does this apply to my product?

This checklist applies to all economic operators placing dietary supplements (complementos alimenticios) on Amazon.es. This includes: vitamins, minerals, amino acids, plant extracts (extractos vegetales), probiotics, omega-3 fatty acids, sports nutrition, and other dietary supplements in the form of capsules, tablets, powders, or liquids. Covers manufacturers (fabricantes), importers (importadores), distributors (distribuidores), and online sellers. Especially relevant for non-EU manufacturers and private-label providers selling via Amazon.es, eBay.es, or own shops to Spain. All information must be in Spanish (castellano) per Real Decreto Legislativo 1/2007 (Ley General para la Defensa de los Consumidores y Usuarios).

Step-by-Step Guide

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Legal Classification and Ingredient Verification Under Spanish Law

Before market entry, you must ensure your product is classified in Spain as a dietary supplement (complemento alimenticio) and not as a medicinal product (medicamento), novel food (nuevo alimento), or dietetic food. The AEMPS (Agencia Espanola de Medicamentos y Productos Sanitarios) decides in doubtful cases on the demarcation from medicinal products.

Estimated time: 1-3 Wochen

Verify demarcation from medicinal products under Spanish lawRequired

In Spain, the AEMPS (Agencia Espanola de Medicamentos y Productos Sanitarios) decides on medicinal product classification. Check whether your product could be classified as a medicinal product due to dosage, dosage form, or claims. Spain generally follows EU guidelines but has specific thresholds for certain substances such as melatonin (up to 1.9 mg permitted as supplement). Products with therapeutic indications (indicaciones terapeuticas) are automatically classified as medicinal products.

Verify permitted ingredients per Real Decreto 1487/2009Required

Real Decreto 1487/2009 transposes EU Directive 2002/46/EC into Spanish law and defines the permitted vitamins, minerals, and their compounds for dietary supplements in Spain. Check all ingredients against the Annexes (Anexos) of the Real Decreto. For plant-based ingredients (plantas), additional AESAN lists apply. Substances not listed may not be used without further authorization.

Cross-check of all ingredients against Real Decreto 1487/2009 Annexes and AESAN plant lists

Check Novel Food status of all ingredientsRequired

Check every ingredient in the EU Novel Food Catalogue (Regulation (EU) 2015/2283). Ingredients not consumed to a significant degree in the EU before May 15, 1997 qualify as Novel Food and require EFSA authorization. AESAN verifies the Novel Food status during notification and rejects products with unauthorized novel ingredients. Examples of commonly affected substances: CBD, certain algae extracts, exotic superfoods.

Novel Food status check for all ingredients

AESAN Notification and Food Law Registration

In Spain, notification of every dietary supplement to AESAN BEFORE market placement is legally required (Real Decreto 1487/2009, Art. 7). Notification is done via the electronic registry (Registro General Sanitario de Empresas Alimentarias y Alimentos, RGSEAA). Additionally, the food business operator must register in the RGSEAA.

Estimated time: 2-4 Wochen

Submit notification via the AESAN electronic registryRequired

Submit the notification (comunicacion de puesta en el mercado) via the AESAN electronic portal. Required: complete formulation with quantities per daily dose (dosis diaria recomendada), dosage form, complete label specimen in Spanish, certificates of analysis, and for imported products proof of legal sale in another EU country. AESAN reviews the documentation and may request amendments. After successful notification, the product is recorded in the registry.

AESAN notification confirmation (acuse de recibo)Complete label specimen in Spanish (modelo de etiqueta)

Registration in the RGSEAA (General Health Registry for Food Businesses and Products)Required

Every food business operator placing dietary supplements on the Spanish market must be registered in the RGSEAA. Registration is done through the competent Comunidad Autonoma (Consejeria de Sanidad or Salud). For EU importers operating through a Spanish responsible person, this person can handle the registration. The RGSEAA number (numero de registro sanitario) must be displayed on the label.

RGSEAA registration confirmation with registration number

Ensure HACCP concept and food safety managementRequired

Per Regulation (EC) No. 852/2004, every food business operator must have implemented a HACCP concept (Analisis de Peligros y Puntos de Control Critico, APPCC). In Spain, inspectors from the Comunidades Autonomas verify HACCP documentation under the PNCA (Plan Nacional de Control de la Cadena Alimentaria). Document critical control points for storage, transport, and prevention of cross-contamination.

Implement GPSR Requirements and EU Responsible Person

The GPSR introduces additional product safety requirements beyond specific food law. In particular, the designation of an EU Responsible Person (responsable establecido en la Union), enhanced traceability, and reporting obligations for safety incidents must be implemented.

Estimated time: 1-2 Wochen

Designate EU Responsible Person for the Spanish marketRequired

Non-EU manufacturers must designate an EU Responsible Person per GPSR Art. 16. For dietary supplements on the Spanish market, the responsible person should have both GPSR and food law expertise and be able to communicate in Spanish with AESAN, the Comunidades Autonomas, and AECOSAN. Name (nombre), postal address (direccion postal), and email address (correo electronico) must be displayed on the packaging and in the Amazon listing.

Power of attorney or mandate agreement with the EU Responsible Person

Set up product traceability and batch managementRequired

Implement a traceability system with lot numbers (numero de lote) meeting both GPSR requirements and food law provisions of Regulation (EC) No. 178/2002 Art. 18. Each batch must be traceable from raw material supplier to end consumer. The lot number (Lote) must be visible on the packaging. Spanish authorities can request traceability documentation at any time under the PNCA.

Traceability protocol with batch linkage

Set up rapid alert system and GPSR reporting obligationsRequired

Set up processes to fulfill both RASFF (Sistema de Alerta Rapida para Alimentos y Piensos) and GPSR reporting obligations to the EU Safety Gate in case of safety issues. In Spain, the Comunidades Autonomas and AESAN conduct inspections. Report safety incidents immediately to the competent Comunidad Autonoma and AESAN. Implement an internal process for product recalls (retirada de productos).

Spanish-Language Labeling and Health Claims

Labeling of dietary supplements in Spain must simultaneously comply with the FIC (Regulation (EU) No. 1169/2011), Real Decreto 1487/2009, Health Claims Regulation (EC) No. 1924/2006, and GPSR requirements. All information must be in Spanish (castellano). Incorrect labeling is one of the most common reasons for objections.

Estimated time: 1-3 Wochen

Create complete mandatory labeling in SpanishRequired

The label must contain in Spanish: designation 'Complemento alimenticio', nutrition table with nutrient amounts per daily dose and %NRV (Valores de Referencia de Nutrientes), complete ingredient list (lista de ingredientes) in descending order, recommended daily intake (dosis diaria recomendada), warning 'No superar la dosis diaria expresamente recomendada' (Do not exceed the expressly recommended daily dose), note 'Los complementos alimenticios no deben utilizarse como sustituto de una dieta equilibrada' (Food supplements should not be used as a substitute for a balanced diet), storage instructions (condiciones de conservacion), best before date 'Consumir preferentemente antes de' or use-by date 'Fecha de caducidad', net quantity, lot number (Lote), RGSEAA number, EU Responsible Person contact details.

Label design with complete Spanish labeling

Verify health claims and use only authorized claims in SpanishRequired

Check every health claim in the EU register of authorized health claims (Regulation (EU) No. 432/2012). Use exclusively the officially translated Spanish version of claims (e.g., 'La vitamina C contribuye al funcionamiento normal del sistema inmunitario'). Disease risk reduction claims (alegaciones de reduccion del riesgo de enfermedad) are strictly regulated. In Spain, AESAN together with the CNMC (Comision Nacional de los Mercados y la Competencia) monitors compliance with the Health Claims Regulation.

Allergen labeling and warnings for special groupsRequired

Label all 14 declarable allergens per FIC Annex II in Spanish and highlighted (e.g., soja, leche, pescado, crustaceos, frutos de cascara). Add warnings for pregnant women (mujeres embarazadas), nursing mothers (mujeres en periodo de lactancia), children (ninos), and persons under medical treatment (personas bajo tratamiento medico) where relevant. In Spain, the note 'Mantener fuera del alcance de los ninos pequenos' (Keep out of reach of small children) is mandatory.

Prepare Packaging Obligations and Amazon.es Listing

For distribution in Spain, packaging obligations per Ley 7/2022 de residuos y suelos contaminados must be met, registration with Ecoembes or another authorized system must be completed, and Amazon.es GPSR mandatory fields must be filled out.

Estimated time: 3-7 Tage

Complete Ecoembes registration and packaging labelingRequired

Register with Ecoembes (ecoembes.com) as a packaging first-importer in Spain and pay the Punto Verde contribution. Registration is mandatory per Ley 7/2022 and Real Decreto 1055/2022 for all companies placing packaged products on the Spanish market for the first time. Label all packaging components (container, lid, label, outer packaging) with material codes and disposal instructions. The Punto Verde symbol is recommended when joining the Ecoembes system.

Ecoembes registration confirmationPackaging layout with material codes and disposal instructions

Amazon.es GPSR mandatory fields and listing complianceRequired

Enter all GPSR mandatory information in Amazon Seller Central: complete EU Responsible Person contact details, manufacturer information, safety warnings in Spanish. Ensure the Amazon.es listing meets FIC distance selling requirements: ingredient list, allergens, nutrition table, net quantity, best before date, storage instructions in Spanish. Avoid prohibited health claims in product titles, bullet points, and A+ content. Proactively upload the AESAN notification confirmation and lab reports to the Amazon Compliance Hub.

Quality Control and Ongoing Compliance

Dietary supplements in Spain require ongoing quality controls and monitoring of regulatory developments. The Comunidades Autonomas conduct regular inspections of supplement providers under the PNCA (Plan Nacional de Control de la Cadena Alimentaria).

Estimated time: laufend

Regular laboratory analyses and batch controlsRequired

Regularly test retention samples and new batches for microbiological purity, heavy metal contamination (especially lead, cadmium, mercury, arsenic), pesticide residues, and active ingredient content. For supplements, the contaminant maximum levels of Regulation (EC) No. 1881/2006 apply. Laboratories accredited by ENAC (Entidad Nacional de Acreditacion) are preferentially accepted in Spain.

Certificates of Analysis (Certificados de Analisis) per batch

Monitor regulatory changes and update notificationRequired

Continuously monitor: changes to Real Decreto 1487/2009 and its Annexes, updates to the health claims positive list (Regulation (EU) No. 432/2012), changes in the Novel Food Catalogue, new AESAN recommendations on maximum levels and plant lists, and updates to Ecoembes contribution rates. For formulation changes, the notification with AESAN must be updated. Regularly check RASFF notifications for dietary supplements on the Spanish market.

Common Mistakes to Avoid

AESAN notification not submitted before sales start

Consequence: Violation of Real Decreto 1487/2009 with fines from EUR 601 to EUR 30,000 (minor to serious infraction). The competent Comunidad Autonoma can impose an immediate sales ban. Amazon.es can suspend the listing if the notification cannot be provided.

Prevention: Submit the AESAN notification before the first sale. Keep the notification confirmation (acuse de recibo) digitally available to present it immediately upon request.

Unauthorized or incorrectly translated health claims on label or Amazon listing

Consequence: AESAN and the CNMC actively pursue misleading health claims. Fines can range from EUR 5,001 to EUR 600,000 depending on severity (serious to very serious infractions per Ley 17/2011). Additionally, listing suspension on Amazon.es and loss of customer trust.

Prevention: Use exclusively health claims from the EU positive list in the official Spanish translation. Have all marketing texts reviewed by an advisor specializing in Spanish food law before publishing.

Labeling not in Spanish or missing mandatory markings

Consequence: Violation of Real Decreto Legislativo 1/2007 and Real Decreto 1487/2009. Fines from EUR 3,001 to EUR 100,000. Amazon.es suspends listings with missing or incomplete Spanish labeling. Consumers can file complaints with the Oficinas Municipales de Informacion al Consumidor (OMIC).

Prevention: Ensure ALL mandatory markings (including warnings, intake recommendation, lot number, RGSEAA number) are in Spanish on the label. Have the label reviewed by a native speaker with food law knowledge.

Novel Food ingredients used without authorization

Consequence: Violation of Regulation (EU) 2015/2283 - the product is not marketable. AESAN rejects the notification or orders market withdrawal. Immediate sales ban, recall obligation, and fines up to EUR 600,000 for serious violations. The entire product must be removed from the market.

Prevention: Check every ingredient in the EU Novel Food Catalogue (ec.europa.eu/food/safety/novel-food) BEFORE formulation development. If in doubt, submit an inquiry to AESAN or commission regulatory consulting.

Ecoembes registration and packaging obligations ignored

Consequence: Fines up to EUR 1,750,000 per Ley 7/2022 de residuos y suelos contaminados for serious violations. In practice, fines for supplement providers typically range from EUR 1,001 to EUR 50,000. Missing disposal instructions on packaging lead to additional sanctions.

Prevention: Register with Ecoembes (ecoembes.com) in time and apply material codes and disposal instructions on all packaging components. Registration must occur BEFORE the first market placement.

Frequently Asked Questions

Q1Do I need to wait for AESAN confirmation before I can sell my supplement in Spain?

The AESAN notification is fundamentally a notification obligation (comunicacion), not an approval. You must submit the notification BEFORE first market placement and can generally start selling afterward. However, AESAN reviews the documentation and may request amendments or reject the notification if ingredients are not permitted. It is recommended to wait for the confirmation (acuse de recibo) before selling larger quantities.

Q2Can I sell a supplement approved in Germany directly in Spain?

Not without adjustments. Although the principle of free movement of goods and mutual recognition applies, for Spain you must: 1) verify the formulation against Spanish requirements (Real Decreto 1487/2009) - Spain has partly different maximum levels than Germany, 2) submit a notification to AESAN, 3) fully adapt the label to Spanish, 4) complete RGSEAA registration, 5) fulfill Ecoembes packaging obligations. SpaceGoats supports you in expanding from Germany to Spain and handles the entire compliance process including AESAN notification and EU Responsible Person.

Q3Does the GPSR also apply to dietary supplements in Spain?

Yes. The GPSR applies to all consumer products in the EU, including food and supplements, insofar as not regulated by specific EU food law. For supplements in Spain, this means additional obligations: designating an EU Responsible Person (responsable establecido en la Union), enhanced traceability, GPSR mandatory fields on Amazon.es (economic operator contact details), and reporting obligations for safety incidents to the EU Safety Gate. These GPSR obligations apply in addition to Real Decreto 1487/2009 and general food law requirements.

Q4Which authorities inspect dietary supplements in Spain?

In Spain, several authorities are responsible: AESAN (Agencia Espanola de Seguridad Alimentaria y Nutricion) for notification, risk assessment, and central coordination. The Comunidades Autonomas (Consejerias de Sanidad/Salud) for market surveillance and on-site inspections. AEMPS (Agencia Espanola de Medicamentos y Productos Sanitarios) for the demarcation from medicinal products. CNMC (Comision Nacional de los Mercados y la Competencia) for misleading advertising and unfair competition. The PNCA (Plan Nacional de Control de la Cadena Alimentaria) coordinates annual inspection programs at the national level.

Q5How much does GPSR compliance cost for a single supplement on Amazon.es?

For a single dietary supplement, expect EUR 400-3,000: AESAN notification incl. service provider (EUR 150-600), laboratory analyses (EUR 100-800), EU Responsible Person (EUR 50-200/month), Spanish label adaptation (EUR 100-500), health claims legal advice (EUR 150-600), Ecoembes registration (EUR 50-300/year). For multiple products, unit costs decrease significantly through shared notification procedures and framework agreements with service providers.

Q6Are there special requirements for plant-based supplements (productos a base de plantas) in Spain?

Yes. Spain has its own AESAN plant list defining the permitted plants and plant parts for dietary supplements. This list can differ from lists in other EU countries. Certain plants permitted as supplement ingredients in Germany or France may be restricted or not authorized in Spain. Check the current AESAN plant list and note that for plant-based supplements, authorized health claims often do not exist, as many botanical claims are still 'on hold' at EFSA.

GPSR (General Product Safety Regulation)Dietary SupplementsSpain 🇪🇸