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Compliance Checklist

GPSR (General Product Safety Regulation)
Personal Care
Spain ๐Ÿ‡ช๐Ÿ‡ธ

Complete checklist for the General Product Safety Regulation (GPSR, EU 2023/988) for personal care products on Amazon.es. Covers risk assessment, technical documentation, EU responsible person, and traceability.

Overview

The General Product Safety Regulation (GPSR, Regulation EU 2023/988) has been directly applicable in all EU member states since 13 December 2024, replacing the old Product Safety Directive 2001/95/EC. In Spain, the GPSR is enforced by the consumer protection authorities of the Autonomous Communities and at the national level by the Agencia Espanola de Seguridad Alimentaria y Nutricion (AESAN) for cosmetics and personal care. For Amazon sellers, this means expanded obligations: contact details on the product or packaging, risk assessment, technical documentation, and designation of a responsible person in the EU.

Does this apply to my product?

This checklist applies to all economic operators placing personal care products on the Spanish market โ€” manufacturers, importers, and distributors selling via Amazon.es (FBA or FBM). The GPSR acts as a safety net for all consumer products. Personal care products such as shampoo, shower gel, toothpaste, creams, and deodorants are primarily subject to the EU Cosmetics Regulation (EC) No 1223/2009, but the GPSR supplements it with general safety requirements, particularly regarding traceability, contact information, and marketplace obligations.

Step-by-Step Guide

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1

Determine Your Role as Economic Operator

First clarify your role under the GPSR: manufacturer, importer, or distributor. Obligations differ significantly by role. For personal care products, you must also determine your role under the EU Cosmetics Regulation (responsible person).

Estimated time: 1-2 Tage / 1-2 days

2

Risk Assessment and Safety Evaluation

Conduct a risk assessment for your personal care products. The GPSR requires that products are safe before being placed on the market. For cosmetic products, the safety assessment under the Cosmetics Regulation supplements this requirement.

Estimated time: 2-4 Wochen / 2-4 weeks

3

Technical Documentation and Product Information File

Create and maintain technical documentation per the GPSR and the Product Information File (PIF) per Art. 11 of the Cosmetics Regulation. These documents must be available to authorities upon request.

Estimated time: 2-4 Wochen / 2-4 weeks

4

Labeling and Traceability

The GPSR tightens requirements for product labeling and traceability. The product or its packaging must display contact details of the manufacturer/importer and the responsible person in the EU. All information must be available in Spanish.

Estimated time: 2-4 Wochen / 2-4 weeks

5

Amazon.es-Specific GPSR Compliance

Amazon.es as an online marketplace actively enforces GPSR requirements. Since December 2024, Amazon requires expanded product information in listings, including contact details of the manufacturer/importer and the EU responsible person.

Estimated time: 1-2 Tage / 1-2 days

Common Mistakes to Avoid

Missing Spanish-language labeling on the product

Consequence: Violations of Spanish consumer protection law (Ley General para la Defensa de los Consumidores y Usuarios). Consumer protection authorities of the Autonomous Communities can order product recalls and impose fines. Amazon.es can deactivate listings.

Prevention: Provide all consumer-relevant information โ€” usage instructions, warnings, ingredients โ€” in Spanish on the product or packaging.

No responsible person in the EU designated

Consequence: Violations of Art. 16 GPSR and Art. 4 Cosmetics Regulation. The product may not be made available on the EU market. Amazon can block the listing.

Prevention: Before the first sale, designate a responsible person based in the EU and display their contact details on the product and in the Amazon listing.

Missing CPNP notification for cosmetic personal care products

Consequence: Violations of Art. 13 of the Cosmetics Regulation. AESAN and poison centers (Centro Nacional de Toxicologia) have no access to product data in case of poisoning incidents. Fines and market withdrawal possible.

Prevention: Always complete CPNP notification before first placing on the market. Submit a separate notification per product and market.

Incomplete manufacturer details in the Amazon listing

Consequence: Since the GPSR introduction in December 2024, Amazon.es increasingly deactivates listings without complete manufacturer and importer details. Consumers cannot contact the product manufacturer.

Prevention: Enter complete contact details in all Amazon listings: company name, postal address, email. Regularly check whether Amazon has introduced new mandatory fields.

No batch or lot number on the product

Consequence: In case of a safety issue, targeted tracing is not possible. Authorities may order recall of the entire product inventory instead of individual batches.

Prevention: Mark every product with a unique batch or lot number. Link this number in internal documentation with manufacturing dates, suppliers, and test reports.

Frequently Asked Questions

Q1Do I need both GPSR and Cosmetics Regulation compliance for personal care products?

Yes. Personal care products such as shampoo, shower gel, toothpaste, and creams primarily fall under the EU Cosmetics Regulation (EC) No 1223/2009 with its specific requirements (safety assessment, CPNP notification, responsible person). The GPSR supplements these with general safety requirements such as traceability, expanded contact obligations, and marketplace duties. Both regulatory frameworks must be complied with simultaneously.

Q2What does Amazon.es require since the GPSR introduction in December 2024?

Since December 2024, Amazon.es requires for all product listings: complete manufacturer contact details (company name, postal address, email), importer contact details (for non-EU manufacturers), and designation of the responsible person in the EU. Amazon provides specific fields in the product catalog management and can deactivate listings if these fields are not completed.

Q3Must all information on the product be in Spanish?

Yes. Spanish consumer protection law (Ley General para la Defensa de los Consumidores y Usuarios) requires all consumer-relevant information to be provided in Spanish (castellano) โ€” including usage instructions, warnings, ingredient lists, and disposal instructions. Additional languages are permitted but do not replace the Spanish labeling.

Q4Who monitors GPSR compliance in Spain?

In Spain, market surveillance is divided: at the national level, AESAN (Agencia Espanola de Seguridad Alimentaria y Nutricion) is responsible for cosmetic products. General product safety is monitored by the consumer protection authorities of the 17 Autonomous Communities. These authorities conduct market controls, can order product recalls, and impose fines.

Q5Can SpaceGoats help with GPSR compliance for Spain?

Yes. As an Amazon broker, SpaceGoats provides comprehensive support with GPSR compliance, including determination of the economic operator role, coordination of safety assessments, support with CPNP notification, review of labeling obligations, and ensuring Amazon listing compliance. This allows you to focus on your core business.

Q6What happens in case of a product recall in Spain?

In case of a safety issue, you must immediately inform the competent authorities (AESAN or the consumer protection authority of the respective Autonomous Community). The GPSR also requires notification via the Safety Gate/RAPEX system. Amazon.es can independently suspend listings and freeze FBA inventory. The costs of a recall (logistics, customer notification, disposal) are borne by the responsible economic operator.