According to European Union legislation, and in particular Regulation (EC) 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products, cosmetic products are those substances or mixtures intended to be placed in contact with the superficial parts of the human body (epidermis, hair and capillary system, nails, lips and external genital organs) or with the teeth and oral mucous membranes, with the sole or main purpose of cleaning, perfuming, modifying their appearance, protecting, maintaining them in good condition or correcting body odours.
In Spain, the specific regulation of cosmetic products is outlined in Royal Decree 85/2018, of 23 February, regulating cosmetic products (RDPC).
The Spanish Agency for Medicines and Health Products (AEMPS) determines a product’s classification based on its characteristics and definitions in the Regulation. RDPC applies to cosmetic products and manufacturers, importers, marketers, distributors, sellers, or professional users of cosmetic products.
This article discusses the regulatory requirements for manufacturing and importing cosmetic products in Spain as detailed in articles 17 and following of the RDPC.
Responsible declaration
First, it is noteworthy that natural or legal persons who physically manufacture, prepare, package or label cosmetic products in Spanish territory and importers of cosmetic products from third countries must submit a responsible declaration to the AEMPS before starting the activity.
Exemptions to the responsible declaration
They are exempt from the obligation to submit the responsible declaration:
- Distributors of cosmetic products already on the European Union market who translate the labelling or modify it to register as a responsible person.
- Companies or facilities subcontracted to carry out storage or control of manufacturers and importers.
- Pharmacies that manufacture cosmetic products exclusively for sale in the pharmacy itself
- Establishments fractionating bulk cosmetic products for public sale, like colognes and solid soaps, in alignment with the original purpose of the manufacturer.
Content of the responsible declaration
As regards the content of the responsible declaration, it is necessary to include the following data:
- Information on the owner of the activity: name or company name, address or registered office, NIF or NIE and address for notification purposes. If a legal representative signs the declaration, his or her details are required.
- Details of a qualified contact person: name and qualification. The qualification shall be justified by training or experience:
- Training: specific courses on cosmetic products (manufacturing, cosmetic good manufacturing practice standards, quality control, etc.) and legislation applicable to cosmetic products.
- Expertise in cosmetic manufacturing or importing companies.
- Description of the activities covered by the responsible declaration, whether materially carried out by the operator or subcontracted companies, including bulk manufacturing, conditioning (packaging and labelling), control, storage, and importation.
- Information on the facilities or plants where the activities included under the responsible declaration are to be carried out: name, address, and VAT number.
- Specification of the cosmetic categories and forms covered by the activities, only for the manufacturing activity.
- Planned date of commencement of the activities covered by the declaration.
Statements in the Declaration of Responsibility
In addition, the holder of the activity shall state in the responsible declaration:
- Compliance with the requirements and obligations inherent to the exercise of the manufacturing and importing activity set out in the annexe of the RDPC
- By way of example, to carry out the activity of manufacturing or importing cosmetic products into Spanish territory from third countries, the holder of the activity is required, depending on the type of activity, to have in place:
- An up-to-date quality system setting out the responsibilities, processes and management measures necessary to ensure that the manufacture of cosmetic products takes place under the principles of good manufacturing practice
- An organisational structure with defined responsibilities appropriate to the size of the company and the type of cosmetic products manufactured or imported. In the case of cosmetics manufacturing, it must be able to guarantee the quality of the cosmetic products manufactured and have sufficient and appropriately qualified staff. If involved in the importation of cosmetics from third countries, it must be able to ensure the implementation of the relevant procedures and controls and to document, in case the importer is the responsible person, the aspects required by the applicable legislation
- Sufficient and appropriate facilities and equipment, whose design, location, and layout allow for cleaning and disinfection, as well as an appropriate flow of materials, products and personnel, or sufficient to carry out labelling, storage and control activities to preserve the quality and hygiene of cosmetic products.
- That it has the documentation to prove it.
- It undertakes to comply with these requirements throughout the activity.
Once the Responsible Declaration is submitted and from the same date, the holder may start manufacturing or importing cosmetic products at the indicated facilities and plants without prejudice to the AEMPS’s powers of verification and checking.
In addition, the AEMPS will keep an updated register of cosmetic product manufacturing and importing companies at the State level. This register will record the responsible declarations submitted, the notifications regarding modifications or cessation of activity and the resolutions adopted. Through this register, the AEMPS will keep the health authorities informed.
If you need additional information regarding the requirements for Manufacturing and Importing Cosmetic Products in Spain,
