As reported by the AEMPS and echoed by some media, the Spanish Agency for Medicines and Health Products (AEMPS) has ordered the withdrawal from the market, the suspension of the marketing and the use of certain tattoo and permanent make-up inks.
The AEMPS itself has argued that these products contain "isopropyl alcohol in a concentration higher than that accepted" in the European Union. This cessation of distribution and use of the product, as well as its withdrawal from the market, has affected all the units of three batches of products, according to the AEMPS.
The affected products and batches are as follows:
- 611-PE: Swiss Colour pigments for permanent make-up range 2 IL16 Sangria Pigment / range 2 IL15 Cherri Pigment / range 2 IL14 Bordeaux Pigment / range 2 IL13 Kiss Pigment / range 2 IL12 Diva Pigment / range 2 IL11 Strawberry Pigment
- 613-PE: Swiss Color pigments for permanent make-up range 4 IL19 Peach Pigment / range 4 IL10 Candy Pigment / range 4 IL18 Rosewood Pigment / range 4 IL17 Maron Pigment
- 614-PE: Swiss Color pigments for permanent make-up range 5 IB 30 Gold Brown Pigment / range 5 IB 31 Nature Brown Pigment / range 5 IB 32 Medium Brown Pigment / range 5 IB 33 Clasic Brown Pigment / range 5 IB 34 Dark Brown Pigment / range 5 IB 35 Black Brown Pigment / range 5 IB 36 Ash Brown Pigment / range 5 IB 37 Orange Brown Pigment
As the Spanish Agency for Medicines and Health Products itself explains, the company Swiss Color España has not reformulated the composition of several of its products, thus failing to comply with Regulation (EU) 2020/2081, which restricts the use of certain substances in tattoo or permanent make-up inks.