Although the Regulation on cosmetic products is directly applicable in the countries of the European Union, it is necessary to nationalize the aspects that the European standard leaves to the Member States. For this reason, the Spanish Royal Decree 85/2018, has been issued and addresses certain aspects not envisaged in the EU Cosmetics Regulation 1223/2009.
Specifically, the purpose of the Spanish Royal Decree is to regulate:
- the competent national authority for cosmetic products, called the Agencia Española de Medicamentos y Productos Sanitarios (AEMPS).
- the national language of the labeling and the information file of cosmetic products
- the rules in relation to the labeling of cosmetic products presented without previous packaging or packaged at the place of sale.
- procedures for communication of risks to human health and serious unwanted effects by responsible persons and distributors of cosmetic products.
- the procedures for transmitting information on health risks and serious unwanted effects between competent authorities.
- market surveillance.
- the manufacturing and import activities of cosmetic products.
Language and labeling of cosmetic products
The labeling information provided in section (1), paragraphs b), c), d) and f), and in sections (2), (3), and (4) of article 19 of the EU Cosmetics Regulation 1223/2009 must be in Spanish.
The information contained in the product information file that is kept in Spanish territory must be in Spanish. However, specialized scientific documentation in French or English may be accepted. Interestingly, the documentation and information necessary to assess the conformity of cosmetics required by the competent authority must be submitted in Spanish, although their submission in other languages easily understandable by the authority may be accepted.
Labeling of cosmetic products presented without prior packaging or packed at the place of sale
Cosmetic products, described in article 19 (4) of the EU Cosmetics Regulation 1223/2009, that are presented without prior packaging, packaged at the place of sale at the request of the buyer, or previously packaged for immediate sale, shall have labels or prospectuses that contain the obligatory information described in article 19 (1) of the EU Cosmetics Regulation. These labels or prospectuses will be attached to the containers of cosmetic products or accompany them at the time of delivery to the consumer and must comply with the requirements of language as described above.
Responsible declaration of manufacturing and import activities of cosmetic products
The natural or legal persons who carry out the manufacture, conditioning, packaging, or labeling of cosmetic products in Spain, as well as importers of cosmetic products from third countries must submit a responsible declaration to the AEMPS, before the start of the activity. In the responsible declaration, the company declares that they comply with good manufacturing practices (GMP). The responsible declaration will include all the data required in sections 1 and 2 of article 19 to the Spanish Royal Decree 85/2018 and will be accompanied by the document accrediting the payment of the corresponding fee.
The responsible declaration will not be required from distributors of cosmetic products already introduced into the EU market who carry out the translation of the labeling or modify it to register as the person responsible.
Personal Care products
At the national level, personal care products are those that, without being legally considered cosmetics, biocides, health products, or medicines, are intended to be applied to the skin, teeth, or mucous membranes of the human body, for aesthetic or hygiene purposes. , or to neutralize or eliminate ectoparasites.
The following products are considered personal care products:
- Toothpaste
- Aesthetic products (inks for tattoos and permanent make-up products, chemical skin abrasion masks, and transdermal patches)
- Pediculicides
- Vaginal moisturizers
- Anal cleaners in case of hemorrhoids
- Sports massage products
- Nasal cleansers or eye cleansers
Personal care products must have prior authorization to be able to enter the Spanish market. The Spanish Agency for Medicines and Health Products is the competent authority to grant this 5-year authorization and register it in the corresponding registry. To this end, the technical documentation related to the product must be presented, including safety information and instructions for use.
If, after the 5 years of validity of the marketing authorization, the holder is still interested in maintaining it, he must apply to the AEMPS for its revalidation in the last six months of its validity. Failure to submit the revalidation request will void the authorization of the product, from the date specified in the authorization document.