It has been considered necessary to develop an appropriate European-wide legal instrument for cosmetic products that imposes clear and detailed rules that avoid divergent transpositions by individual Member States. To this end, Regulation (EC) No. 1223/200 of the European Parliament and the Council of 30 November 2009 on cosmetic products has been adopted.

Below is a summary of the most important aspects of Royal Decree 85/2018, February 23, which regulates cosmetic products.

“The aforementioned Regulation establishes that cosmetic products must be safe under normal or reasonably foreseeable conditions of use, and must respect the rules of composition and labelling provided. Each product must be traceable to a responsible person in the European Union and the traceability of each of the cosmetic products in the supply chain must be guaranteed.

To ensure their safety, all commercially available cosmetic products must be manufactured in accordance with the principles of best manufacturing practices, with compliance being monitored by national authorities. The aspects that the European standard leaves to the Member States can be regulated at national level. Therefore, the new Royal Decree is issued which specifies issues such as the competent authorities for the supervision of the market and for the reception and transmission of notifications of serious undesirable effects and serious risks to health, the powers of inspection and the adoption of health protection measures that correspond to these authorities, as well as the procedures to be followed. The procedures for compliance with the administrative cooperation principle are also regulated and the instrument also specifies other issues such as those relating to the language to be used in the labelling and the information sheet supplied with cosmetic products.

In addition, the aforementioned Regulation allows each Member State to regulate the notification by health professionals or by consumers of any serious undesirable effects caused by cosmetic products to the competent national authorities. In the Spanish Cosmetovigilance System, the rules for operation will be dictated in accordance with the functions contemplated in article 35.6 of the Statute of the AEMPS, approved by Royal Decree 1275/2011, of September 16, by which the State Agency “Spanish Agency for Medicines and Health Products” has been created and its Statute approved.
With respect to cosmetics manufacturers and importers, the Royal Decree also regulates the requirements and conditions that must be met and the procedure for presenting the declaration of responsibility before the Spanish Agency for Medicines and Health Products (hereinafter AEMPS), developing section 3 of the third additional provision of the revised text of the Law on guarantees and rational use of medicines and health products, approved by Royal Legislative Decree 1/2015, of July 24.

At a national level, article 40, sections 5 and 6 of Law 14/1986, of April 25, General Health attributes to the General State Administration powers for regulation, authorisation, registration or homologation, as appropriate , of medicines for human and veterinary use and of other health products and articles and of those that, by affecting human beings, may pose a risk to public health, as well as to regulate and authorise the activities of manufacturers and importers of the aforementioned products. Additionally, based on article 40.6 of the aforementioned law, the AEMPS has been issuing authorisations for activities involved in the manufacture and importation of cosmetic products.

The revised text of the Law on Guarantees and Rational Use of Medicines and Medical Devices establishes that the conditions and requirements to be met for the manufacture, importation, clinical research, distribution, commercialisation, dispensation and use of medical devices and the respective administrative procedures will be determined by regulation in accordance with the provisions of European Union regulations. It is further provided that what is established in this section shall also apply, as appropriate, to personal care products and cosmetics.

This same additional provision establishes that the activities of manufacturing and importing cosmetics and personal care products are subject to the system of the declaration of responsibility regulated in article 69 of Law 39/2015, of October 1, of the Common Administrative Procedure of Public Administrations. This declaration of responsibility must be presented to the AEMPS. The presentation of the declaration of responsibility will enable the company to commence activities, without prejudice to subsequent verification by the AEMPS, through documentary verification and, where appropriate, inspection of the elements and circumstances revealed by the interested party in the declaration of responsibility.