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Safety Regulations for Permanent Makeup Pigments

In nearly every country, governmental bodies oversee the safety of chemicals used in tattoo and permanent makeup (PMU) pigments.

Regulations in the European Union

In the EU, the REACH protocol (Registration, Evaluation, Authorization, and Restriction of Chemicals) governs chemical safety regulations for tattoo and permanent makeup pigments. This regulation, established by the European Parliament and the Council, came into force on June 1, 2007. The latest amendment, Regulation No. 2020/2081, was issued on December 14, 2020, further expanding Regulation

No. 1907/2006. This regulation is the primary legal framework for managing "substances in tattoo inks and permanent makeup pigments" and mandates the registration, production, and distribution of these chemicals.

Since 2020, REACH has added around 90 new compounds to its list of restricted chemicals, most of which are organic pigments and dyes. Extensive studies have shown that these substances in PMU pigments may pose potential health risks, including negative effects on the reproductive system, increased risk of cancer, genetic mutations, and other serious systemic reactions. Additionally, they may cause allergic reactions.

Regulations in the United States

In the United States, the FDA (Food and Drug Administration), a government agency under the Department of Health and Human Services, oversees the safety of tattoo and PMU inks. The FDA's work is governed by the "Federal Food, Drug, and Cosmetic Act." No ingredient may be used in pigment production unless it is FDA-approved as safe or classified as "exempt from certification."

According to U.S. legislation, tattoo and permanent makeup pigments are categorized as cosmetics. Significant regulatory changes have not occurred in recent decades. Some PMU pigment ingredients are listed as safe, while others are labeled "exempt from certification," which does not restrict their use. Chemicals and dyes in PMU pigments are not preemptively banned unless harmful effects are proven.

Influence of European Standards on the U.S. Market

While the U.S. follows different regulations, European laws still impact American manufacturers, as the largest producers of tattoo and PMU pigments are based in the U.S. To export products to Europe, U.S. manufacturers must comply with REACH requirements.

Transition Period for Manufacturers

The REACH regulation update in 2020 gave manufacturers and suppliers of tattoo and PMU pigments a period to adjust their formulas and documentation to meet legal requirements. For most chemical compounds, the compliance deadline was set for January 4, 2022.

For Blue Pigment 15:3 (CI 74160, EC No 205-685-1, CAS No 147-14-8) and Green Pigment 7 (CI 74260, EC No 215-524-7, CAS No 1328-53-6) — two critical colors in tattoo inks — this deadline was extended to January 4, 2023, at the request of manufacturers, due to the lack of safe alternatives. Although these pigments are essential for tattoo ink formulations, they may not only have negative health effects but also create undesirable aesthetic results in PMU.

Upcoming Insights

In an upcoming post, I will explain why some manufacturers continue to use CI 74160 and CI 74260 and why I am strongly against their inclusion in PMU pigments.

Below is a table of chemical substances banned in the production of tattoo and permanent makeup pigments in the EU, with information on their permissible content levels (e.g., 0.5%), which effectively restricts their use.

Download prohibited components (EN)

Download prohibited components (DE)

Download prohibited components (IT)

Download prohibited components (FR)

Download prohibited components (ES)

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