The Spanish Agency for Medicines and Health Products (Aemps) has ordered the company Swiss Color Spain to suspension of marketing and withdrawal from the market of tattoo and permanent makeup inks for containing “isopropyl alcohol in a concentration higher than that accepted”.
In a statement, the AEMPS (dependent on the Ministry of Health), details that the entry into application of the Regulation 2020/2081 established the restriction of the use of certain substances in inks for tattoos or permanent makeup.
Besides, prohibited the marketing or use products that did not meet the criteria established in this regulation as of January 4, 2022, and specified that the restrictions relating to “the blue pigment 15:3 and to green pigment 7“would apply from January 4, 2023.
Headquarters in Balearic Islands
In this sense, Health emphasizes that the company Swiss Color España (with headquarters in the Balearic Islands) has not reformulated the composition of several of its products, which is why they have failed to comply with the aforementioned regulation.
The Aemps decision has affected all the unitys of the following products, distributed to tattoo centers for use by professionals:
611-PE: Swiss Color pigments for permanent makeup 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 makeup 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 makeup 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.
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