In Spain, the legislation to register certain cosmetic products requires prior health registration. The Spanish Agency for Medicines and Health Products (AEMPS) is the competent authority responsible for granting this authorisation.
What is a cosmetic product?
Cosmetic products are substances or mixtures intended to be applied to the external parts of the human body, such as the skin, hair, nails, lips, and teeth, to cleanse, perfume, alter their appearance, protect, or maintain them in good condition.
Regulation 1223/2009 of the European Parliament defines cosmetics as products that require prior registration by national authorities, such as the AEMPS in Spain, for marketing and sale. Many consumers associate the term cosmetic with facial care products, perfumes, or make-up products when, in fact, many more everyday items are considered cosmetics under Regulation 1223/2009, including items such as shampoo, soap, and toothpaste. Cosmetics represent a broader class of products beyond just make-up or skincare.
Who should apply for marketing registration?
Natural or legal persons who manufacture or import cosmetic products must apply for registration to the AEMPS before starting the activity, accompanied by a declaration of responsibility.
Are exempt from submitting the responsible declaration:
- Distributors of cosmetic products already placed on the EU market who carry out the labelling translation or modify it to adapt it to the relevant legislation.
- Companies or facilities subcontracted to carry out storage or control of manufacturers and importers.
- Pharmacies producing cosmetic products exclusively for sale in the pharmacy itself
- Natural or legal persons subcontracting the entire production of cosmetic products
Which products require prior registration?
The AEMPS classifies cosmetic products as follows:
- Hygiene products
- Tooth whiteners
- Toothpaste
- Beauty products
The sale of these products is subject to a fee and the submission of specific technical documentation for each product to the relevant authorities.
When applying for registration beauty products are subject to strict controls and evaluation by the relevant authorities. They require the submission of detailed and comprehensive technical documentation. A single mistake in the documentation may imply the rejection of the application by the AEMPS, delaying the product’s release to the market.
When applying for registration, the documentation required for cosmetic products must specify, but not be limited to:
- A complete list of the raw materials used in the product, including the amounts used and their physical and chemical properties
- Information about the finished product, including packaging, and clear instructions on how to use the product, including warnings and precautions
- A report that proves that the product is safe to use
- Proper labelling, including the name of the company responsible for the product, the amount contained in the packaging, and clear instructions on how to use the product, which should be visible and readable on the packaging.
Validity of the registration
Generally, marketing approvals issued by the AEMPS are valid for five years and can be renewed upon expiration. The application process for renewal starts in the last half-year of the license’s validity. If not rendered, the registration will become invalid at the expiration date.
During the sale, all the criteria that led to the product’s approval must be kept up to prevent it from being taken off the market or facing financial penalties. Any modifications to the product or its labelling need updating and authorization by the AEMPS.
Not being aware of the legal requirements to obtain marketing authorization for cosmetic products in Spain may result in them being denied by the AEMPS, causing a loss of time and money. On the other hand, selling or using products without registration can result in severe administrative penalties.
Eduardo de Sousa Gama
If you need additional information on the registration of cosmetic products in Spain,
