Compliance Checklist

GPSR (General Product Safety Regulation)
Beauty & Cosmetics
Spain 🇪🇸

Complete GPSR compliance checklist for cosmetic products on the Spanish market. Spanish market requirements, AEMPS registration, Ministerio de Consumo and Amazon.es mandatory fields.

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 all cosmetic and beauty products on Amazon.es. In Spain, the Ministerio de Consumo together with AEMPS (Agencia Espanola de Medicamentos y Productos Sanitarios) and the Comunidades Autonomas monitor compliance with product safety regulations. For beauty sellers on Amazon.es this means: extended documentation requirements, obligation to designate an EU Responsible Person (Persona responsable), Spanish-language labeling per Real Decreto 1468/1988 and the Ley General de Defensa de Consumidores y Usuarios, CPNP registration, and GPSR-compliant traceability. Spain is the EU's fourth-largest cosmetics market with strict regional enforcement through the Comunidades Autonomas.

Does this apply to my product?

This checklist applies to all economic operators placing cosmetic products on Amazon.es. This includes: skincare (cuidado de la piel), haircare (cuidado del cabello), makeup (maquillaje), perfume (perfumeria), nail care (cuidado de unas), sun protection (proteccion solar), and decorative cosmetics. Cosmetic tools such as brushes, sponges, and electrical devices are also affected. In Spain, all product information must be in Spanish (Ley General de Defensa de Consumidores y Usuarios, Real Decreto Legislativo 1/2007). AEMPS is the central authority for cosmetic products and monitors compliance with the EU Cosmetics Regulation (EC) No 1223/2009 in Spain.

Step-by-Step Guide

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Determine Economic Operator Role and Designate EU Responsible Person

Clarify your role under the GPSR (manufacturer, importer, distributor) and designate an EU Responsible Person. For the Spanish market, the responsible person must be able to cooperate with the Ministerio de Consumo, AEMPS, and the Comunidades Autonomas.

Estimated time: 1-5 Tage

Document economic operator roleRequired

Document in writing whether you are a manufacturer (fabricante), importer (importador), or distributor (distribuidor). Private label sellers are considered manufacturers. For cosmetic products, this overlaps with the 'Persona responsable' role under the EU Cosmetics Regulation. In Spain, AEMPS maintains the Registro de cosmeticos and verifies the correct assignment of the economic operator role.

Written determination of economic operator role

Designate EU Responsible Person for the Spanish marketRequired

Designate a person established in the EU as Responsible Person (Persona responsable). For the Spanish market, it is advantageous if the responsible person can communicate in Spanish, as AEMPS and the Comunidades Autonomas frequently correspond in Spanish. The responsible person must be able to present technical documentation within 10 days upon request and act as contact for the Direccion General de Consumo.

Power of attorney or mandate agreement with the EU Responsible PersonProof of EU establishment (commercial register extract / Certificado del Registro Mercantil)

Verify NIF/NIE or CIF for Spanish business activity

For business activity in Spain, foreign companies need a Numero de Identificacion Fiscal (NIF) or for individuals a NIE (Numero de Identidad de Extranjero). Spanish companies use the CIF (Codigo de Identificacion Fiscal). This is relevant for AEMPS registration and correct invoicing.

NIF/NIE proof or CIF registration

Prepare Safety Assessment and Technical Documentation

For cosmetic products on the Spanish market, the EU Cosmetics Regulation (EC) No 1223/2009 and GPSR apply in parallel. Technical documentation must include risk analysis, Product Information File (PIF), CPNP registration, and GPSR-specific documents. AEMPS can request the PIF at any time.

Estimated time: 1-4 Wochen

Prepare safety assessment per Cosmetics Regulation and GPSR risk analysisRequired

The safety assessment per Annex I of the EU Cosmetics Regulation by a qualified Safety Assessor is mandatory and can serve as the basis for the GPSR risk analysis. Additionally, a GPSR-specific risk analysis must cover general product safety (packaging, application risks, allergens). In Spain, AEMPS particularly reviews the assessment of nanomaterials and UV filters in sun protection products.

Safety assessment by Safety Assessor (Evaluacion de seguridad)GPSR risk analysis document

Complete Product Information File (PIF) and CPNP registrationRequired

The PIF must contain product description, safety assessment, manufacturing method, evidence for claims, and animal testing negative declaration. Each cosmetic product must be registered in the CPNP (Cosmetic Products Notification Portal) before market placement. In Spain, AEMPS reviews CPNP entries and can prohibit distribution if inconsistencies are found.

Product Information File (PIF) per Art. 11 Cosmetics RegulationCPNP registration confirmation

Prepare traceability documentationRequired

Document the complete supply chain with batch/lot numbers (numero de lote). Each product unit must be traceable from production to end customer. For Amazon FBA, batch numbers must be linked with shipment IDs. Spanish authorities can request traceability data via the SIRIPQ system (Sistema de Intercambio Rapido de Informacion de Productos Quimicos).

Traceability matrix with batch numbers and supply chain

Spanish-Language Labeling and Packaging Requirements

In Spain, all product information must be in Spanish (Real Decreto 1468/1988, Ley General de Defensa de Consumidores y Usuarios). Labeling obligations for cosmetics arise from the EU Cosmetics Regulation and Spanish consumer protection laws.

Estimated time: 1-3 Wochen

Create complete product labeling in SpanishRequired

For cosmetics on Amazon.es, the following must be in Spanish: product name (denominacion del producto), INCI list, batch/lot number (numero de lote), best-before date (utilizar preferentemente antes de) or PAO symbol, usage instructions (modo de empleo), warnings (advertencias), and allergen warnings. All 26 notifiable fragrance allergens must be listed separately. In Comunidades Autonomas with co-official languages (Catalonia, Basque Country, Galicia, Valencia), the regional language may additionally be required.

Packaging layout with complete Spanish labeling

EU Responsible Person contact details on packaging and listingRequired

Name, postal address, and email of the EU Responsible Person must appear on the packaging or an accompanying document. Additionally, the data must be entered in the GPSR mandatory fields of the Amazon.es listing. A website URL alone is not sufficient. The details must match the CPNP entries.

Packaging design with GPSR-compliant contact details

Packaging and disposal labeling for SpainRequired

Spain has the Packaging Law Ley 7/2022 de residuos y suelos contaminados para una economia circular (effective since April 2022). Packaging must be labeled with material identification codes per Decision 97/129/EC. Above certain thresholds, registration in the Registro de Productores de Productos (Seccion de Envases) at the Comunidad Autonoma is required. The Punto Verde is no longer mandatory in Spain but is assigned by Ecoembes for registered companies.

Packaging layout with material codes and disposal instructionsEcoembes registration confirmation (if applicable)

Complete Amazon.es GPSR Compliance Fields

Complete all GPSR mandatory fields in Amazon Seller Central for Amazon.es. Since December 2024, Amazon.es requires complete GPSR details for all cosmetic products.

Estimated time: 1-3 Tage

Complete GPSR mandatory fields in Amazon Seller Central for Amazon.esRequired

Enter the complete EU Responsible Person data, manufacturer information, safety warnings, and product images with visible labeling in the Amazon GPSR fields. Ensure all data matches the physical packaging and CPNP registration.

Screenshots of completed GPSR fields in Seller Central

Verify Spanish-language product images and A+ contentRequired

All product images for Amazon.es must show the Spanish labeling. A+ content (Enhanced Brand Content) must be in Spanish and must not contain impermissible health claims (alegaciones de salud). Spanish advertising regulations (Ley General de Publicidad and Real Decreto 1907/1996) prohibit misleading efficacy claims for cosmetics.

Product images with visible Spanish labeling

Establish Market Surveillance and Complaint Management

Establish processes for market surveillance and complaint management on the Spanish market. In Spain, market surveillance is conducted decentrally through the Comunidades Autonomas (Inspeccion de Consumo) and centrally through the Ministerio de Consumo.

Estimated time: 2-5 Tage

Set up complaint management and reporting channels to Spanish authoritiesRequired

Set up a complaint register (registro de reclamaciones) and define reporting channels to the Ministerio de Consumo and the EU Safety Gate. In Spain, consumers can file complaints via OMIC (Oficina Municipal de Informacion al Consumidor) or Juntas Arbitrales de Consumo. Regularly monitor RAPEX/Safety Gate notifications for cosmetic products.

Internal procedure document for complaints and recallsTemplate for Safety Gate notifications

Cosmetovigilance and reporting of undesirable effectsRequired

The EU Cosmetics Regulation requires reporting of serious undesirable effects (efectos indeseables graves) to AEMPS. Set up a system to capture customer complaints about skin reactions, allergic reactions, or other adverse effects and report them to AEMPS within the prescribed deadlines. AEMPS maintains the national cosmetovigilance database.

Cosmetovigilance procedure document

Common Mistakes to Avoid

Product labeling not in Spanish or incomplete INCI list

Consequence: Violation of the Ley General de Defensa de Consumidores y Usuarios and the EU Cosmetics Regulation. Comunidades Autonomas can impose fines from EUR 3,001 to EUR 100,000 for serious violations (infracciones graves). Amazon.es suspends listings with missing Spanish labeling.

Prevention: Ensure all mandatory information is in Spanish (Castellano). Have the INCI list reviewed by a specialist and list the 26 notifiable allergens separately.

Cosmetics Regulation treated as sole compliance basis, GPSR ignored

Consequence: Listing suspension on Amazon.es due to missing GPSR mandatory fields. The Direccion General de Consumo can impose additional sanctions. GPSR extends obligations beyond the Cosmetics Regulation to include traceability, market surveillance, and notification duties.

Prevention: GPSR must be observed IN ADDITION to the Cosmetics Regulation. Check all Amazon Seller Central GPSR mandatory fields and supplement your documentation accordingly.

No EU Responsible Person designated or authority inquiries from Comunidades Autonomas ignored

Consequence: The Ministerio de Consumo can impose a market placement ban (prohibicion de comercializacion). Amazon.es suspends listings without a designated EU Responsible Person. Comunidades Autonomas can impose their own sanctions, as market surveillance in Spain is organized decentrally.

Prevention: Designate an EU Responsible Person who can communicate with Spanish authorities. Note that inquiries can come from both the Ministerio de Consumo and individual Comunidades Autonomas.

CPNP registration not updated for the Spanish market

Consequence: AEMPS actively reviews CPNP entries. Missing or outdated registrations can lead to immediate distribution bans. Without valid CPNP registration, placing cosmetics on the EU market is unlawful.

Prevention: Register each product in the CPNP before listing on Amazon.es. Update entries when formulation or packaging changes. Ensure the Spanish product name is correctly recorded.

Impermissible efficacy claims in Spanish listings and advertising

Consequence: Violation of Real Decreto 1907/1996 and the Ley General de Publicidad. The Direccion General de Consumo can impose fines and prohibit advertising measures. Amazon.es can suspend listings for misleading claims.

Prevention: Adhere to the EU Common Criteria for cosmetic claims (Regulation (EU) No 655/2013). Avoid medical healing claims and substantiate all efficacy claims with appropriate studies.

Frequently Asked Questions

Q1Does the GPSR also apply to cosmetic products already covered by the EU Cosmetics Regulation?

Yes. The GPSR applies in addition to the EU Cosmetics Regulation (EC) No 1223/2009. While the Cosmetics Regulation governs specific safety requirements for ingredients, the GPSR covers general product safety aspects: traceability, market surveillance, EU Responsible Person, and notification duties for safety incidents. On Amazon.es, both regulations must be complied with.

Q2Which authority is responsible for cosmetic market surveillance in Spain?

In Spain, several authorities are responsible: AEMPS (Agencia Espanola de Medicamentos y Productos Sanitarios) monitors the Cosmetics Regulation and maintains the cosmetics register. The Ministerio de Consumo and the Direccion General de Consumo are responsible for general product safety (GPSR). The Comunidades Autonomas conduct local inspections through their Inspeccion de Consumo. Consumers can file complaints with OMIC (Oficina Municipal de Informacion al Consumidor).

Q3Do I need Ecoembes registration for cosmetic packaging on Amazon.es?

If you place packaged products on the Spanish market for the first time, you must register as a packaging producer per Ley 7/2022 and join an authorized compliance system (SCRAP - Sistema Colectivo de Responsabilidad Ampliada del Productor). Ecoembes is the largest SCRAP in Spain. The registration obligation also applies to Amazon FBA sellers. Costs depend on packaging type and volume.

Q4Can SpaceGoats help with GPSR compliance for beauty products on Amazon.es?

Yes. SpaceGoats offers a full service for GPSR compliance on the Spanish market: assumption of the EU Responsible Person role, support with CPNP registration, coordination of Spanish labeling, Ecoembes registration, and communication with AEMPS and the Comunidades Autonomas. Especially for non-EU sellers, an experienced EU partner is crucial for successful market entry on Amazon.es.

Q5How does GPSR compliance for beauty products on Amazon.es differ from Amazon.de?

GPSR requirements are identical across the EU, but Spain has additional national requirements: Spanish-language mandatory information per the Ley General de Defensa de Consumidores, decentralized market surveillance through 17 Comunidades Autonomas, Ecoembes registration for packaging per Ley 7/2022, and the special role of AEMPS as cosmetics supervisory authority. Authority communication is typically in Spanish.

Q6What happens if AEMPS conducts an inspection of my cosmetic products?

AEMPS can request the Product Information File (PIF), CPNP registration proof, safety assessments, and traceability documents at any time. Documents must be provided within 10 working days. In case of violations, AEMPS can prohibit distribution, order recalls, or refer the product to the Comunidades Autonomas for further sanctions. Ensure your EU Responsible Person has all documents up to date and readily available.

GPSR (General Product Safety Regulation)Beauty & CosmeticsSpain 🇪🇸