The Spanish Agency of Medicines and Health Products has ordered Alkimia to withdraw several of its tattoo and permanent makeup inks from the market for non-compliance with EU regulations.
The Spanish Agency of Medicines and Health Products (Aemps) has issued an order for Alkimia Technology and Stetic S.A.U. to halt the marketing and usage of several of its tattoo and permanent makeup inks. This decision comes as these products failed to meet the compliance requirements of Regulation (EU) 2020/2081, which governs the substances contained within such products. The regulation, aimed at enhancing safety standards, restricts the use of certain substances deemed hazardous in cosmetic products, including tattoo inks and permanent makeup.
Aemps had previously notified that the implementation of Regulation 2020/2081 would result in specific restrictions becoming effective as of 4 January 2022. This included prohibitions on the marketing and use of any products that did not adhere to the set criteria. Notably, additional restrictions concerning blue pigment 15:3 and green pigment 7 took effect on 4 January 2023, further tightening regulations for cosmetic products containing tattoo inks.
The current action underscores the heightened scrutiny of health regulations surrounding cosmetic products in Spain and the EU at large. By enforcing compliance, the Spanish health authorities aim to ensure consumer safety and maintain high standards within the cosmetics industry. This withdrawal also reflects a broader trend in regulatory frameworks that prioritize public health amid growing concerns about the potential dangers posed by the chemicals used in tattoo inks and permanent makeup.
