Until 2013, the importation of cosmetic and personal hygiene products was subject to prior control by the Spanish Agency of Medicines and Medical Devices (AEMPS), which granted authorization once the interested company demonstrated compliance with the requirements established by the regulations. With the new Law 10/2013, this system was replaced by the Responsible Declaration, which streamlines the importation procedures. Companies interested in importing cosmetic products and personal hygiene must obtain authorization by submitting the document in which they take responsibility for the entire importation process and commit to complying with a code of good practices. Streamlining the process does not mean that controls have disappeared. Simply put, the importation of cosmetic and personal hygiene products can be carried out without waiting for inspection, which can be done subsequently. In fact, the Technical Inspection Committee (CTI) conducts inspections at the border to prevent the entry of illegal products. The Responsible Declaration for the importation of cosmetic and personal hygiene products streamlines procedures and ensures that the importing company complies with all the requirements necessary to market the goods safely. The regulation of requirements and conditions for the importation of cosmetic and personal hygiene products, including the procedure for submitting the Responsible Declaration, is included in the Royal Decree 85/2018, of February 23. From the AEMPS website, the document can be downloaded for completion.
Advantages of the Responsible Declaration for the importation of cosmetic and personal hygiene products
Obtaining the Responsible Declaration for the importation of cosmetic and personal hygiene products not only results in an agile procedure for importing companies. It has many other advantages, among which the following stand out:
- Ensures compliance with import requirements, avoiding economic sanctions
- Ensures that the importing company has suitable facilities and security and control measures.
- Requires the implementation of a quality control system that facilitates compliance with supplier delivery deadlines to customers.
- Optimizes costs in terms of human and material resources
- Generates confidence among consumers, reducing risks in product use
This is achieved because, in the document submitted to the Administration, the company initiating the importation of cosmetic and personal hygiene products takes responsibility for having warehouses approved by the AEMPS and for having a qualified and certified technician for supervising related activities. The Responsible Declaration for the importation of cosmetic and personal hygiene products can be submitted in person or electronically to the AEMPS. It is worth remembering that this document does not replace, under any circumstances, the sanitary import license, essential for other healthcare or pharmaceutical products. Additionally, as a preliminary step to importation, it is essential to notify the product to the European Cosmetic Products Notification Portal (CPNP) and conduct a safety assessment if it is the first time importing. Bull Importer assists you in completing and submitting the Responsible Declaration for the importation of cosmetic and personal care products by providing you with the necessary guidance to meet all the regulatory requirements.
