Compliance Checklist

GPSR (General Product Safety Regulation)
Food & Beverages
Spain 🇪🇸

Complete checklist for compliance with the EU General Product Safety Regulation (GPSR, EU 2023/988) for food and beverages on the Spanish Amazon marketplace, including AESAN requirements, INCO Regulation, and Spanish labeling obligations.

Overview

The EU General Product Safety Regulation (GPSR, EU 2023/988) has been applicable since 13 December 2024, replacing the former Directive 2001/95/EC. For food and beverages on Amazon.es, sellers must comply with both the general GPSR requirements and the specific food law regulations of the EU (Regulation EC 178/2002 — General Food Law, EU 1169/2011 — INCO) and Spain. The Spanish authority AESAN (Agencia Espanola de Seguridad Alimentaria y Nutricion) oversees food safety at the national level, while the Comunidades Autonomas (Autonomous Communities) handle local enforcement. Spanish language labeling is mandatory. Amazon.es additionally requires complete product documentation and the designation of an EU-based responsible economic operator.

Does this apply to my product?

This checklist applies to all food and beverages (including dietary supplements, non-alcoholic beverages, and packaged foods) sold to consumers in Spain via Amazon.es. Particularly relevant for: sellers outside the EU importing food into Spain; EU sellers cross-border selling on Amazon.es; private-label brands with their own food products. Not applicable to: unprocessed agricultural products sold directly by producers; pharmaceuticals and medical products; animal feed (separate regulations).

Step-by-Step Guide

Progress0/15 (0%)

Product Classification and Regulatory Analysis

Determine the exact product category of your food product under Spanish and EU law and identify all applicable regulations, including sector-specific ordinances.

Estimated time: 3-5 Tage / days

Determine food category per AESAN classificationRequired

Classify your product according to AESAN categories (Agencia Espanola de Seguridad Alimentaria y Nutricion): general food, dietary supplement (complemento alimenticio), novel food, dietetic food, or beverage. The classification determines the specific requirements for composition, labeling, and registration. Check the AESAN register (Registro General Sanitario de Empresas Alimentarias y Alimentos — RGSEAA) for existing entries.

Product data sheet with ingredient list and nutritional analysisAESAN classification confirmation

Identify applicable EU and Spanish regulationsRequired

Compile a complete list of all applicable regulations: GPSR (EU 2023/988), General Food Law (EC 178/2002), INCO Regulation (EU 1169/2011), Health Claims Regulation (EC 1924/2006), as well as Spanish national regulations such as Royal Decree 126/2015 (food information for non-prepacked foods) and Ley 17/2011 de Seguridad Alimentaria y Nutricion. Consider regional requirements of the Comunidades Autonomas.

Regulatory requirements list mapped to the product

Designate EU Economic Operator (Responsible Person)Required

According to GPSR Articles 4 and 16, an EU-based economic operator (manufacturer, importer, or authorized representative) must be designated. For non-EU manufacturers, an EU-based authorized representative (representante autorizado) or importer is mandatory. This entity must be listed on the product and in the Amazon listing with full address and contact details.

Authorization agreement or importer documentationContact details of the EU economic operator

Create Spanish Food Labeling (Etiquetado)

Create complete food labeling in Spanish language according to the INCO Regulation (EU 1169/2011) and Spanish national requirements. Spanish is the mandatory language for all food labels on the Spanish market.

Estimated time: 5-10 Tage / days

Mandatory label information in Spanish languageRequired

The label must contain the following mandatory information in Spanish (castellano): product name (denominacion de venta), ingredient list (lista de ingredientes) in descending order, allergens highlighted (e.g., bold), net quantity (cantidad neta), best-before date (fecha de duracion minima: 'consumir preferentemente antes de/del') or use-by date (fecha de caducidad: 'consumir antes de'), storage conditions (condiciones de conservacion), name and address of the food business operator, country of origin (pais de origen) when required, lot number (lote), alcohol content for beverages >1.2% vol.

Label draft in Spanish languageTranslation certificate by qualified translator

Create nutrition declaration (Informacion nutricional)Required

The nutrition declaration must contain the following information per 100 g or 100 ml according to INCO Articles 30-35: energy value (valor energetico) in kJ and kcal, fat (grasas), of which saturates (acidos grasos saturados), carbohydrate (hidratos de carbono), of which sugars (azucares), protein (proteinas), salt (sal). Additionally, voluntary per-portion information may be provided. In Spain, the Nutri-Score is increasingly used as a voluntary front-of-pack system.

Laboratory nutritional analysis (accredited laboratory)Nutrition table in prescribed format

Allergen labeling per Spanish requirementsRequired

All 14 major allergens per INCO Annex II must be clearly highlighted in the ingredient list (e.g., bold, capitals, or underlined): cereals containing gluten (cereales con gluten), crustaceans (crustaceos), eggs (huevos), fish (pescado), peanuts (cacahuetes), soy (soja), milk/lactose (leche/lactosa), tree nuts (frutos de cascara), celery (apio), mustard (mostaza), sesame (sesamo), sulphur dioxide/sulphites (dioxido de azufre/sulfitos), lupin (altramuces), molluscs (moluscos). In Spain, non-prepacked foods must also provide allergen information (Royal Decree 126/2015).

Allergen management planSupplier declarations on allergens

Food Registration and Business Authorization

Register your business and products with the relevant Spanish authorities. For importing food into Spain, registration in the RGSEAA (Registro General Sanitario de Empresas Alimentarias y Alimentos) is mandatory.

Estimated time: 1-3 Wochen / weeks

RGSEAA Registration (General Health Register)Required

Every food business operating in Spain (including importers) must be registered in the RGSEAA (Registro General Sanitario de Empresas Alimentarias y Alimentos). Registration is done through AESAN and requires: business identification (CIF/NIF or EU tax ID), description of activity (importer, distributor, manufacturer), product categories, proof of business premises. The RGSEAA number (format: 26.XXXXX/XX) must be stated on the label.

RGSEAA registration certificateBusiness registration or trade register entry

AESAN notification for special food categoriesRequired

Certain food categories must be notified to AESAN before being placed on the market: dietary supplements (complementos alimenticios) per Royal Decree 1487/2009, foods for special medical purposes (alimentos para usos medicos especiales), infant and young child formula (alimentos para lactantes y ninos de corta edad), novel foods per EU 2015/2283. Notification is done electronically via the AESAN platform.

AESAN notification confirmationProduct specification and composition documentation

Create GPSR Product Safety Documentation

Create the product safety documentation required under GPSR (EU 2023/988), adapted to the specifics of food products and the Spanish market requirements.

Estimated time: 5-10 Tage / days

Internal risk analysis and HACCP documentationRequired

GPSR Article 5 requires a risk analysis. For food, this is covered by a HACCP concept (Hazard Analysis and Critical Control Points — Analisis de Peligros y Puntos de Control Critico, APPCC), which is mandatory in Spain under Royal Decree 640/2006 and EU Regulation EC 852/2004. Document: identified hazards (biological, chemical, physical), critical control points (puntos de control critico), limits and monitoring measures, corrective actions, verification procedures.

HACCP/APPCC planRisk analysis report

Establish traceability and recall systemRequired

GPSR Article 14 and the General Food Law (EC 178/2002, Article 18) require complete traceability (trazabilidad). Implement: one-step-back/one-step-forward system, lot identification (identificacion de lote) on every product, documentation of all suppliers and customers, rapid alert system connection (RASFF — Rapid Alert System for Food and Feed), recall plan (plan de retirada) with contact to AESAN and the Comunidades Autonomas. Amazon.es requires the ability to remove affected batches from sale within 24 hours.

Traceability system documentationRecall plan with contact details of responsible authorities

GPSR-compliant contact information on product and listingRequired

According to GPSR Articles 9 and 16, the following information of the responsible economic operator must appear on the product and in the Amazon.es listing: full company name, postal address in the EU, email address or telephone number, website (optional but recommended). For products imported from non-EU countries, both the manufacturer and the EU importer/authorized representative must be stated. Amazon.es has set up specific GPSR mandatory fields in Seller Central.

Updated label with GPSR contact informationAmazon Seller Central GPSR entries

Packaging EPR and Environmental Regulations (Ecoembes)

Fulfill the Extended Producer Responsibility (EPR — Responsabilidad Ampliada del Productor) for packaging in Spain, including registration with Ecoembes and compliance with Ley 7/2022 de Residuos y Suelos Contaminados.

Estimated time: 1-2 Wochen / weeks

Ecoembes registration for packaging EPRRequired

Under Ley 7/2022 de Residuos y Suelos Contaminados, all companies placing packaged products on the Spanish market must participate in a packaging take-back system. Ecoembes (Ecoembalajes Espana S.A.) is the dominant system. Register with Ecoembes, declare your packaging quantities (declaracion de envases), and pay the corresponding fees (punto verde). Place the Green Dot symbol (punto verde) on your packaging.

Ecoembes registration confirmation and contractPackaging declaration (declaracion de envases)

Food contact materials compliance (materiales en contacto con alimentos)Required

All packaging materials in contact with food must comply with EU Framework Regulation EC 1935/2004 and the Plastics Regulation EU 10/2011. For the Spanish market, the provisions of Royal Decree 847/2011 (positive list for certain materials) also apply. Obtain a declaration of conformity (declaracion de conformidad) and, if necessary, migration tests (ensayos de migracion) from an accredited laboratory.

Declaration of conformity for food contact materialsMigration test reports (if applicable)

Amazon.es Listing Compliance and Approval

Ensure your Amazon.es listing meets all platform requirements for food products and GPSR mandatory information, and prepare for Amazon Grocery approval.

Estimated time: 3-7 Tage / days

Apply for Amazon.es Grocery category approvalRequired

The food category (Alimentacion y bebidas) on Amazon.es is a restricted category (categoria restringida) requiring approval. Submit the following documents via Seller Central: valid RGSEAA number, product photos with readable labels in Spanish, proof of food safety certification (IFS, BRC, or similar), sample invoices from an approved supplier, GPSR mandatory information (economic operator with EU address). Amazon typically reviews applications within 3-5 business days.

Amazon Grocery category approval applicationFood safety certificate (IFS/BRC)

Create Amazon.es listing with all GPSR and INCO mandatory informationRequired

Create the Amazon.es listing in Spanish with all mandatory information: product title with product name, complete ingredient list in the product description, nutritional information in bullet points or description, allergen information clearly highlighted, GPSR economic operator in the designated fields (manufacturer, address, contact), country of origin, net quantity, storage instructions, best-before/use-by date format. Use the Amazon A+ Content feature for more detailed nutritional and allergen information.

Completed Amazon.es listing (draft for review)GPSR mandatory fields checklist in Seller Central

Common Mistakes to Avoid

Labels only in English or German instead of Spanish

Consequence: Seizure by the Comunidades Autonomas, fines of EUR 2,001 to 15,000 under Ley 17/2011 de Seguridad Alimentaria y Nutricion (serious infringement), immediate suppression of the Amazon.es listing.

Prevention: Engage a qualified translator with experience in Spanish food terminology. Have the label reviewed by a Spanish food law expert. Use the correct Spanish terms (e.g., 'consumir preferentemente antes de' rather than literal translation).

Missing or incorrect allergen labeling

Consequence: AESAN recall and RASFF alert, fines up to EUR 600,000 for very serious infringements (infraccion muy grave), civil liability for health damages, permanent reputation damage on Amazon.es through negative reviews.

Prevention: Have the allergen list verified by an accredited laboratory. Implement an allergen management system in the supply chain. Regularly check for cross-contamination (contaminacion cruzada). Update the allergen list with every recipe change.

Missing RGSEAA registration before starting sales

Consequence: Illegal placing of food on the market, seizure of all goods, fines of EUR 2,001 to 600,000, loss of Amazon.es seller account for repeated violations.

Prevention: Start RGSEAA registration at least 4 weeks before the planned sales launch. Engage a gestor administrativo (administrative consultant) in Spain for the application. Ensure your EU importer is also registered.

Non-authorized health or nutrition claims

Consequence: Warning and fine by the Ministerio de Consumo, product removal from Amazon.es, classification as misleading advertising (publicidad enganosa) under Ley 3/1991 de Competencia Desleal, AESAN alert with public announcement.

Prevention: Use only health claims authorized in the EU register under Regulation EC 1924/2006. Check the EU register for permitted claims. Avoid disease claims which are generally prohibited for food. Have all marketing texts approved by a regulatory affairs expert.

Missed Ecoembes registration and packaging EPR

Consequence: Fines of EUR 901 to 1,750,000 under Ley 7/2022 de Residuos (Articles 108-110), back payment of packaging fees with interest, sales ban in Spain until registration, possible Amazon.es account restrictions.

Prevention: Register with Ecoembes before the first sale in Spain. Calculate your packaging quantities per material (plastic, paper/cardboard, metal, glass). Submit the declaration (declaracion de envases) on time. Place the Punto Verde symbol on all packaging.

Frequently Asked Questions

Q1Must all food labels on Amazon.es be in Spanish?

Yes, Spanish law (Royal Decree 1334/1999 and INCO Regulation EU 1169/2011) mandates that all mandatory information on food labels must be written in Spanish (castellano). Additional languages are permitted but must not obscure or diminish the visibility of the Spanish information. In some Comunidades Autonomas (e.g., Catalonia, Basque Country, Galicia), the regional language may additionally be recommended or required for certain products.

Q2Do I need my own RGSEAA number or is my importer's sufficient?

If you sell as a foreign manufacturer through a Spanish-registered importer, their RGSEAA number on the label is sufficient. However, the importer must be identified as the responsible food business operator (operador de empresa alimentaria) on the label. If you act as your own importer or distributor in Spain, you need your own registration. The GPSR additionally requires the designation of the responsible economic operator — this can be the same importer.

Q3How can SpaceGoats help with Amazon.es food sales?

SpaceGoats supports food manufacturers and brands entering Amazon.es with comprehensive expertise: connecting you with EU authorized representatives and Spanish importers, assistance with GPSR-compliant listing creation in Spanish, guidance on Ecoembes registration and packaging EPR, support through the Amazon Grocery approval process, and ongoing compliance monitoring for the Spanish market.

Q4What penalties apply for food safety violations in Spain?

Ley 17/2011 de Seguridad Alimentaria y Nutricion distinguishes three severity levels: minor infringements (infracciones leves) with fines up to EUR 2,000, serious infringements (infracciones graves) with fines from EUR 2,001 to 15,000, and very serious infringements (infracciones muy graves) with fines from EUR 15,001 to 600,000. For violations of Ley 7/2022 de Residuos (packaging EPR), fines up to EUR 1,750,000 may be imposed. Additionally, product seizure, temporary business closure, and public announcement of the violation may follow.

Q5Does GPSR apply to food even though specific food laws exist?

GPSR (EU 2023/988) acts as a safety net for aspects not covered by sector-specific EU food regulations. Since food is already comprehensively regulated by the General Food Law (EC 178/2002), INCO (EU 1169/2011), and other regulations, GPSR primarily supplements in the following areas: requirements for marketplace operators (Amazon as an online marketplace), obligation to indicate the responsible economic operator on the product and listing, extended recall notification obligations through the Safety Gate (formerly RAPEX), and specific requirements for distance selling (e-commerce).

Q6How does origin labeling (origen) work for food in Spain?

Origin labeling (etiquetado de origen) is mandatory in Spain for certain food categories: fresh meat (EC 1337/2013), honey, olive oil, fruit and vegetables (specific EU marketing standards), fish and seafood (EU 1379/2013), and milk and dairy products as ingredients (Royal Decree 1181/2018). Spain also has its own origin designations: Denominacion de Origen Protegida (DOP) and Indicacion Geografica Protegida (IGP). The indication 'Manufactured in' or 'Packed in' (envasado en, elaborado en) must not be confused with the country of origin — the correct indication of the country of origin (pais de origen) is crucial to avoid violating the prohibition of misleading practices.

Estimated Costs

200–2,000 EUR

Professional label adaptation and translation into Spanish100-400 EUR

RGSEAA registration (fees and administrative costs)50-200 EUR

AESAN notification for dietary supplements (if applicable)100-300 EUR

Laboratory analyses (nutritional values, allergens, contaminants)150-500 EUR

Ecoembes registration and packaging fees (first annual period)50-300 EUR

Regulatory affairs consulting and documentation review100-500 EUR

Timeline

2–8 weeks

Context

Category: Food & Beverages

Marketplace: amazon.es

Authority: AEMPS / AECOSAN

MwSt.: 21%

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Related Glossary Terms

gpsr inco-verordnung aesan rgseaa ecoembes haccp allergen-kennzeichnung naehrwertdeklaration health-claims lebensmittelkontaktmaterial rueckverfolgbarkeit eu-wirtschaftsakteur punto-verde rasff denominacion-de-origen

GPSR (General Product Safety Regulation)Food & BeveragesSpain 🇪🇸