Registering Cosmetic Products in Spain

National Registration

The European Union is a complex system of different countries sharing regulations in order to harmonize their national legislations. However, while the EU is a coordinated entity, it does not have a single legislative system – there are some differences regarding specific matters, such as the placement of cosmetic products on the market.

Why is the first country of import relevant?

For a cosmetic product manufactured outside of the EU, the first country of import is the gateway to the European market. Some countries, such as Spain, Italy, Portugal and Switzerland still require an additional national registration after the European notification has been completed.

The National Competent Authorities in these countries may require the importer to provide additional documentation. The importer is considered to be the Responsible Person by default and has the same responsibilities as an EU manufacturer, except for the GMP compliance and manufacturing.

Additionally, the CPNP portal registration is also performed for the National registration, since the manufacturer must provide the products´ labels in the official language of the country into which they are being introduced.

Spanish registration

Cosmetic products must meet the following conditions must be fulfilled before being introduced on the Spanish market:

  • The product must fall under the legal scope of the Cosmetic Regulation 1223/2009
  • Responsible Person in the EU, a service gladly provided by Obelis
  • Manufactured according to the Good Practices of Manufacturing (GPM)
  • Security Report mentioned in a Sanitary Certificate
  • Notified in the CPNP Portal
  • Respect the restrictions for specific substances
  • The label must bear at least the following information in Spanish: nominal content, expiry date, precautions and function of the cosmetic product
  • If the product has been imported to Spain, the importer must inform the AEMPS (Agencia Española de Medicamentos y Productos Sanitarios) of their activity, submitting a self-declaration (Declaración Responsble) in order to be invoiced with the specific tax payment

This registration does not by any means substitute the required CPNP portal registration.

Obelis has almost 30 years of experience helping clients around the world to place their products on the European market. We are ready to assist you with the CPNP portal registration and be your partner in your next business project in Europe. Don’t hesitate to contact us!

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