Are you going to import cosmetics? This is what you need to know about the Responsible Declaration
If you are about to start an import activity of cosmetic products in Spain, one of the first mandatory steps is to submit the Responsible Declaration to the Spanish Agency for Medicines and Health Products (AEMPS).
This procedure is essential to communicate to the administration that your company complies with the legal requirements to import and market cosmetics from outside the European Union. In short, it is your license to import cosmetic products from outside the EU to Spain.
What is the Responsible Declaration?
It is a document through which a company declares that it complies with current regulations and is prepared to start its activity.
In the case of cosmetics, it implies compliance with Regulation (EC) 1223/2009, Royal Decree 85/2018 and other obligations related to the safety, documentation and traceability of cosmetic products.
Main Requirements to Submit the Responsible Declaration
- Be legally constituted as a company in Spain.
- Have adequate facilities to carry out the import activity (although storage or distribution can be subcontracted).
- Have a system for document control and traceability of imported products.
- Have a Qualified Person or Technical Manager who guarantees regulatory compliance and the review of the documentation of each product.
- Have the product information file (PIF) before commercialization.
- Notify the products in the European CPNP portal.
Who Reviews this Declaration?
The AEMPS does not approve the Responsible Declaration in advance, but may review it later. That is, it can carry out inspections or audits at any time.
Therefore, it is essential that all the information declared is truthful and that the company has the supporting documentation from day one.
How Can CosmeExpert Help You?
At CosmeExpert, we help you prepare and correctly submit your Responsible Declaration to the AEMPS.
In addition, we offer comprehensive advice so that your company meets all the requirements from the beginning, including:
- The figure of the external Qualified Person or Technical Manager.
- Documentary and regulatory support.
- Cost savings by avoiding internal hiring.
📩 Do You Have Questions or are You Ready to Start?
Contact us and we will accompany you throughout the process of importing cosmetics to the EU.
