CE Marking
Baby & Toddler
Spain 🇪🇸

Identify product type and applicable EU directiveRequired

Assign your product to the correct directive: Toy Safety Directive 2009/48/EC (Real Decreto 1205/2011) for toys, PPE Regulation (EU) 2016/425 for protective items, Low Voltage Directive 2014/35/EU for electrical devices like baby monitors. Note that some products may fall under multiple directives.

Determine harmonized EN standards for the productRequired

Identify the relevant harmonized EN standards: EN 716 for cots (cunas), EN 12221 for changing units (cambiadores), EN 14988 for highchairs (tronas), EN 1273 for baby walkers (andadores), EN 13209 for baby carriers (mochilas portabebes). The Spanish standardization body UNE (Una Norma Espanola) publishes the national versions as UNE-EN.

Check Spanish additional requirements and AESAN regulationsRequired

Check specific Spanish requirements: The Ministerio de Consumo and AESAN (Agencia Espanola de Seguridad Alimentaria y Nutricion) regulate products with food contact (e.g., baby bottles, teething rings). The Comunidades Autonomas have their own market surveillance authorities (Direcciones Generales de Consumo) that may conduct additional inspections.

Select accredited testing laboratory or Notified BodyRequired

Select an ENAC (Entidad Nacional de Acreditacion) accredited laboratory or Notified Body (Organismo Notificado) for conformity assessment. For toys under Toy Safety Directive 2009/48/EC, an EC type-examination (Module B) by a Notified Body is required when no harmonized standards exist or the manufacturer does not apply them. Spanish Notified Bodies are listed in the EU NANDO database.

Conduct product testing per applicable EN standardsRequired

Have all tests conducted per relevant standards: mechanical and physical tests, chemical analyses (especially heavy metals, phthalates, PAHs per REACH and EN 71-3), flammability (EN 71-2 for toys), electrical safety (EN 62115 for electric toys, EN 60065 for monitors), and product-specific tests per EN 716, EN 12221, EN 14988, EN 1273, or EN 13209.

Create safety assessment and risk evaluationRequired

Create a comprehensive risk assessment (Evaluacion de riesgos) for your baby product per EN ISO 14121 or product-specific standards. Pay particular attention to suffocation risks, strangulation hazards, entrapment risks, and chemical hazards. The risk assessment is part of the technical documentation.

Compile technical documentationRequired

Prepare the complete technical dossier (Expediente tecnico) including: product description and design drawings, list of applied harmonized standards (UNE-EN), test reports (Informes de ensayo), risk assessment (Evaluacion de riesgos), description of manufacturing processes, quality assurance measures, and photos of the finished product with CE marking. Documentation must be retained for 10 years from the last date of placing on the market.

Draft EU Declaration of Conformity in SpanishRequired

Draft the EU Declaration of Conformity (Declaracion UE de conformidad) per the annex of the applicable directive. It must include: product identification, name and address of the manufacturer or Authorized Representative (Representante autorizado), reference to applied directives and standards, Notified Body reference (Organismo Notificado) if applicable, date and signature. For the Spanish market, the declaration must be available in Spanish.

Apply CE marking correctlyRequired

Apply the CE marking visibly, legibly, and indelibly on the product or its nameplate. The CE marking must be at least 5 mm high and maintain correct proportions. For toys, it must appear on the toy, the packaging, or an attached label. If a Notified Body (Organismo Notificado) was involved, its identification number must appear next to the CE mark.

Create Spanish warnings and instructions for useRequired

All warnings (Advertencias) and instructions for use (Instrucciones de uso) must be written in Spanish (castellano). For toys per EN 71-1, warnings are mandatory, e.g., 'ADVERTENCIA: No apto para ninos menores de 36 meses' (Not suitable for children under 36 months) or 'ADVERTENCIA: Utilicese bajo la vigilancia directa de un adulto' (Use under direct adult supervision). Warnings must begin with the word 'ADVERTENCIA' or the warning symbol.

Packaging labeling and Ecoembes registrationRequired

Ensure compliance with Spanish packaging regulations under Ley 7/2022 de Residuos y Suelos Contaminados and Real Decreto 1055/2022. Register with Ecoembes (the Spanish packaging recovery system) to fulfill Extended Producer Responsibility (Responsabilidad Ampliada del Productor / RAP). Apply the Punto Verde (Green Dot) or corresponding recycling symbol on packaging and correctly declare packaging materials.

Upload CE documents to Amazon Seller CentralRequired

Upload the following documents to Amazon Seller Central: EU Declaration of Conformity (Declaracion UE de conformidad), test reports (Informes de ensayo) from accredited laboratories, Notified Body certificates (if applicable), photos of CE marking on product and packaging. Amazon.es requires these documents before activating baby product listings and may request them at any time.

Maintain listing information and compliance attributesRequired

Ensure your Amazon.es listing contains correct compliance attributes: age recommendation (Edad recomendada), warnings in the product description in Spanish, reference to applied standards and directives, ASIN-specific safety data fields. Use Amazon's compliance attributes for baby categories correctly, including fields for CE marking and age suitability.

Establish post-market surveillance systemRequired

Establish a post-market surveillance system for products after placing on the market. Monitor RAPEX/Safety Gate notifications for similar products, track customer complaints and Amazon returns for safety-related defects, and document corrective actions. In case of safety incidents, notification must be made to the Ministerio de Consumo and the relevant Comunidad Autonoma.

Monitor standards updates and regulatory changesRequired

Monitor changes to harmonized standards (UNE-EN), new Reales Decretos, and EU directives affecting baby products. The new EU Toy Safety Regulation (revision of Directive 2009/48/EC) and the General Product Safety Regulation (EU) 2023/988 introduce additional requirements. Update your technical documentation and testing accordingly.