The Council of Ministers has published the Royal Decree 85/2018, of 23 February, regulating cosmetic products. This new legislation was published in the «BOE» (Official State Gazette) No. 51 of 27 February 2018 and runs to a total of 21 pages (23055 to 23075).
This new text, according to the AEMPS, “includes the aspects of national development set out in the European Regulation on cosmetic products ”and introduces the necessary provisions to harmonise Spanish legislation, thereby improving the implementation of European legislation”. In other words, it helps Spain to comply more effectively with the Regulation 1223/2009 about cosmetic products.
Compliance with this decree shall apply to cosmetic products. It shall also apply to all individuals and companies that manufacture, import, place on the market, market, distribute, sell or use cosmetics professionally. Furthermore, the Royal Decree 85/2018 introduces changes in the workplace for up to 1,000 companies, with an annual turnover of 6.6 billion euros.
Royal Decree 85/2018 within the regulatory framework for cosmetics
The Regulation 1223/2009, of 30 November, on cosmetic products has been in force in the EU since July 2013. In Spain, until now there were various regulations relating to health and medicines that affected our sector:
- Act 14/1986, 25 April, Director-General of Health.
- Royal Legislative Decree 1/2015, of 24 July, approving the consolidated text of the Law on Guarantees and the Rational Use of Medicines and Medical Devices.
There was also a Royal Decree containing specific legislation on cosmetic products:
- Royal Decree 1599/1997, of 17 October, on cosmetic products.
The Royal Decree 85/2018, recently published in the Official State Gazette (BOE), brings current European regulations into line with those of our country. And as the most recent publication relating to the cosmetics sector, it repeals the Royal Decree 1599/1997.In any case, almost all the items fall under the personal care products category.
What changes does Royal Decree 85/2018 introduce with regard to cosmetic products?
The new decree aims to bring national legislation into line with the European Cosmetics Regulation. However, the Regulation has already been in force throughout the eurozone for the past five years. Consequently, most companies are, in practice, already effectively complying with the requirements of the Royal Decree 85/2018.
In any case, there are a few changes we’d like to tell you about:
- Spanish Cosmetovigilance System. The Royal Decree establishes the new Spanish Cosmetovigilance System and regulates the reporting of serious adverse effects by healthcare professionals. This initiative obviously improves the safety of cosmetics users.
- Tagged. It sets out “which authorities are responsible for matters relating to cosmetic products, the language to be used on labelling and in product information files, as well as the rules for labelling products”.
- Good Manufacturing Practice. “The procedure for the Affidavit of Manufacturing and Import Activities, as set out in the consolidated text of the Law on Guarantees and the Rational Use of Medicines and Medical Devices, is being implemented. Through this declaration, the company states that it manufactures in accordance with Good Manufacturing Practice and that it complies with the requirements established for the conduct of its business.”.
From the Gabinete Técnico Farmacéutico M. Camps, we welcome the publication of the new Royal Decree 85/2018. We believe that this new legislation brings about greater harmonisation with the European Regulation. Furthermore, we welcome the creation of a cosmetovigilance system, which until now had been managed by the Institute of Toxicology and Forensic Sciences. For further information on how the new Royal Decree affects you, please do not hesitate to contact us.