Download a file of prohibited PMU pigments!
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)