2022 Pigment Regulations – All You Need to Know

By Emily M.| Last updated on December 28, 2021
2022 Pigment Regulations - All You Need to Know
⏱️ 4 min read

Starting January 2022, the European Chemicals Agency – ECHA – will be either banning or limiting the maximum concentration of over 4000 hazardous chemicals in tattoo ink and PMU pigments in the European Union. This is one of the biggest PMU pigments regulations reforms to date.

Such a huge industry as permanent makeup requires strict regulations, especially since it deals with substances that stay in people’s skin for years. Artists have been campaigning for years to push stricter regulations upon pigment manufacturers, and the reform is finally here.

We explain everything you need to know about the ECHA restriction and its implications.

What Are the 2022 Pigment Regulations?

Starting 4th January 2022, the use of over 4000 substances in manufacturing tattoo inks and PMU pigments on European Union and EEA territories will be limited or forbidden. This will prevent the use of substances that are carcinogenic, toxic, harmful to reproductive health, sensitizing, or irritating in the formulas.

Certain countries already have strict regulations concerning the production and distribution of tattoo inks and PMU pigments, but the time has come to harmonize these legislations across all members of the EU and EEA countries.

Why Is This Important?

The motivation behind this decision is to make the tattooing and PMU industry safer. PMU is a very new field, yet it has exploded beyond anyone’s expectations over the past couple of years. As a result, there are countless pigment brands and formulas on the market.

Permanent makeup is technically a form of tattooing, and as such, it involves injecting substances into the skin which then interact with the entire system. They are broken down by the body and they get absorbed into the bloodstream, so they affect every organ – primarily, they migrate to lymph nodes and to the liver.

Protecting client health and safety is of the utmost importance, and what’s injected needs to be completely non-toxic and non-hazardous.

When they first appeared, not much was known about PMU pigments and which of their ingredients are safe long-term and which are not. Adverse effects can appear years after the initial application, and preventing them through stricter regulations is essential to the safety of the population.

One of the biggest issues is allergic reactions which, although rare, can be quite severe and threatening to the health of the clients. Also worrying is the fact that long-term exposure to some substances can have carcinogenic effects, affect reproductive health, or cause genetic mutations.

According to ECHA, over 1000 cases of allergic reactions a year will be prevented as a result of the restriction.

What Are the 2022 Pigment Regulations?
Image source: Pexels

How Will the Regulation Work?

The regulation will have 2 phases and it comes into effect on January 4th, 2022.

Phase 1 – Replacing Problematic Substances with Safer Alternatives

Over 4000 chemicals, primarily metals, methanol, some azo dyes, carcinogenic aromatic amines, and polycyclic aromatic hydrocarbons (PAHs), will be limited or banned and all formulas manufactured will have to comply.

There will be a 24 month transition period, during which all manufacturers will have to reformulate their pigments and start using safer, approved alternative ingredients.

Phase 2 – Harmonization of Labels

As the second part of the reform, all inks and pigments will have to clearly state all ingredients included in the formula on the label, along with relevant safety measures.

Finally, all ingredients will have to be disclosed. This will finally ensure total transparency and end the years-long battle against unknown substances being injected directly into people’s skin.

What’s Problematic about the Restriction?

ECHA has based the list of problematic ingredients on regulations for topical cosmetics – whatever is banned for use on the skin should also be used for injecting into the skin.

Among the restricted ingredients are Blue 15 and Green 7, two pigments widely used in tattoo ink mixtures, and not uncommon in PMU formulas. There is currently no safer alternative to the pigments and these shades would practically be abolished from the available palette.

This particular issue has caused an outcry from tattoo and PMU artists, who argue that a ban on these substances would harm their businesses.

For that reason, as part of the Save the Pigments initiative, a petition has been filed to the European Parliament to reconsider the decision to ban these two pigments, with the explanation that the logic behind the ban is faulty and that the ban could have disastrous effects on the economy, putting many artists out of business. The petition is still active.

From the economic point of view, the restrictions will be expensive. The cost of replacing the problematic chemicals is estimated to be over $5 million per year.

What’s Problematic about the Restriction?Image source: Instagram @savethepigments

Why Should I Care?

Although the restriction applies to the EU market, it will affect the PMU industry worldwide.

Many of the most widely-used brands of pigments are manufactured in EU countries, primarily Germany. So although you may get your supplies in the US, they’ll have to comply with EU regulations if that’s where they’re made.

Plus, it’s possible US manufacturers will comply with EU market regulations in order to keep exporting.

This means you could potentially be banned from using pigments Blue 15 and Green 7, and any mix that contains them.

You may notice changes in all other pigment formulas starting from next year, wherever you’re located. How this will affect your work is yet to be revealed, but one thing is for sure – transparency in terms of labeling pigment ingredients is priceless.

It will provide you with the information you’ve been missing in order to prevent allergic reactions and skin irritations, therefore presenting a step forward in making the industry much safer for clients.

Another possible effect of the regulations is related to the price of pigments. Cheap raw ingredients used in pigment production that were classified as harmful have to be replaced with higher-quality, more expensive ones. This could cause pigments to become more expensive.

So Is This a Good Thing?

Well, yes and no.

Strict regulations in terms of what can be injected into the skin are definitely important and it’s the only way to protect the health and safety of clients.

But at the same time, restrictions so strict could backfire and cause clients looking for decorative or cosmetic tattoos done with the controversial Blue 15 and Green 7 to seek services from artists performing illegally.

One thing we can all agree on is that transparency in terms of labeling is definitely a good thing – you’ll finally know what’s in the bottle.

Cover image source: Pexels



Exclusive insights into the PMU industry right in your inbox.

FREE newsletter. 100% good stuff.