On May 6, 2025, the Spanish Agency for Medicines and Health Products (AEMPS) issued a new warning regarding the use of hyaluronidase in aesthetic settings, highlighting the risks associated with its improper application as an injectable product when marketed as a...
Legal Cosmetic Area
The AEMPS implements the automatic processing of the Hague Apostille.
The Spanish Agency for Medicines and Medical Devices (AEMPS), in collaboration with the Ministry of the Presidency, Justice, and Relations with Parliament, has launched the automatic processing of the Hague Apostille for Free Sale Certificates (CLV) and Export...
The AEMPS conducts market control actions vis-à-vis seven sunscreens
The Spanish Agency for Medicines and Health Products (AEMPS), has learned, through a study carried out by the Organization of Consumers and Users (OCU), of alleged non-compliance in the labeling of seven sunscreens. The AEMPS, as the competent authority in controlling...
The AEMPS reports a 130% increase in notifications of unwanted effects of cosmetics in 2023
According to the 2023 Cosmetovigilance Report, the AEMPS received and investigated 120 notifications, of which 74% were not serious. Of them, 30% corresponded to skin care products, 28% to deodorants, 10% to solar products and 7% to depilatories. In addition, another...
AEMPS – New functionality in the CERTCOS_CLV application to speed up the processing of certificates for free sale of cosmetics
In order to facilitate the management of cosmetics exporting companies, the AEMPS reports a new function in the CERTCOS_CLV application, now available on the AEMPS electronic headquarters. This new function allows up to four applications to be grouped in the same...
The AEMPS (Spanish Agency of Medicines and Medical Devices) reports the cessation of commercialization and use of several batches of Orravan Distilled Water.
The Spanish Agency of Medicines and Medical Devices (AEMPS) published, on January 26th, the informative note COS, 01/2024 regarding the cessation of commercialization and use of several batches of Orravan Distilled Water. These measures were ordered by the Government...
Sanitary guarantees applicable to cosmetic products
The AEMPS has published detailed information on the guarantees applicable to cosmetic products. These guarantees reported by AEMPS are applicable in the European Union. And, it also refers to some additional guarantees included in the legislation in Spain. The...
CERTCOS_CLV – New application
The new CERTCOS_CLV application, launched by the AEMPS, aims to facilitate the procedures related to the management of free sale certificates for the export of cosmetic products. The application is developed with the purpose of achieving a greater guarantee of data...
AEMPS – Claims for hydroalcoholic gels and other cosmetic products for cleaning hands without rinsing
The Spanish Agency for Medicines and Health Products (AEMPS) carries out an Information Campaign on Cosmetic Products 2022. The objective of the campaign is to spread the claims that are inappropriate in cosmetic hydroalcoholic gels and other cosmetic products for...
New instructions for the application for authorization of personal care products
In accordance with the experience of the AEMPS in the evaluation of these products, the Agency has published new instructions on its website for the request for authorization of personal care products. Aesthetic products (tattoo inks and permanent makeup products,...
Inks for tattoo or permanent makeup
Regulation 2020/2081 comes into force, restricting the use of certain substances in tattoo inks or permanent makeup. Inks for tattoos and permanent makeup are considered personal care products and, in Spain, they are regulated by Royal Legislative Decree 1/2015, of...
Guide to microbiologically safe cosmetics
The AEMPS together with STANPA have drawn up a conservation guide for cosmetic ingredients and products. This guide presents conservation as a global process, which must start from a correct microbiological risk assessment. For this, the raw materials used, their...