In almost all countries, special government bodies oversee the safety of chemicals included in tattoo and permanent makeup inks.
In the European Union, the REACH protocol, approved by the European Parliament Commission and the Council on the Registration, Evaluation, Authorization, and Restriction of Chemicals, is in effect. This regulation on chemicals and their safe use has been in place since June 1, 2007. The latest version of the document was approved on December 14, 2020. Regulation No. 2020/2081, which supplemented and expanded Regulation No. 1907/2006, is the main law "on substances in tattoo and permanent makeup inks" and regulates their registration, production, and circulation.
Since 2020, about 90 new compounds (most of them organic pigments/dyes) have been added to the list of prohibited chemicals under REACH. Long-term studies have shown that these substances in PMU inks pose potential health risks, including adverse effects on the reproductive system, the risk of developing malignant tumors, hereditary mutations, and other serious systemic reactions, not to mention allergic reactions.
In the United States, the safety of tattoo and PMU inks is overseen by the FDA (Food and Drug Administration), a government agency under the Department of Health. The FDA's activities are regulated by the "Federal Food, Drug, and Cosmetic Act." No product can be used in the production of pigments unless it is approved by the FDA and listed as safe or "not subject to certification."
Under US law, tattoo and permanent makeup inks are classified as cosmetics, and there have been no significant changes in recent decades. Some PMU ink components are listed as safe, but many are "not subject to certification" and thus not prohibited. Chemicals and dyes in PMU inks whose harmful effects have not been proven are not preventively banned. However, it cannot be said that European laws have had no impact on manufacturers in the US (the largest companies producing tattoo and PMU inks are located in the US). Despite the absence of a ban on some PMU ink components in the US, manufacturers exporting their products to Europe must comply with the REACH regulation.
Since the approval of the REACH regulation in 2020, manufacturers and suppliers of tattoo and permanent makeup inks have been given a deadline to bring their ink formulations and documentation into compliance with the law. For most compounds, the final compliance date is January 4, 2022. However, for Blue Pigment 15:3, known as CI 74160 (EC No 205-685-1, CAS No 147-14-8), and Green Pigment 7, known as CI 74260 (EC No 215-524-7, CAS No 1328-53-6), the deadline was extended to January 4, 2023, at the request of manufacturers. Unfortunately, no safe alternative has been found for these pigments at the time of the regulation's approval. For the production of tattoo inks, green and blue colors are undoubtedly important. However, in permanent makeup inks, aside from the negative health effects, they cause almost irreparable aesthetic damage.
In one of the following posts, I will explain why some manufacturers continue to use CI 74160 and CI 74260, and why I am categorically against these pigments in PMU inks.
Below is a table of chemicals banned in the production of PMU and tattoo inks in the EU (specifically their allowable content, say 0.005%, which effectively makes their use impossible).
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