The European Union's introduction of widespread pigment regulations, under the REACH 2020/2081 standards, has seen a lot of changes to the pigments market for cosmetic tattoo technicians and body art tattooists.

Technicians worldwide, even outside the EU are opting to convert to cosmetic tattoo pigments that are not banned under the regulations. But what about the manufacturers and technicians who are not following the new regulations?

Well, there is a whole system for this sort of thing! Recently 23 tattoo inks and PMU pigments were recalled for safety breaches through the EU's Safety Gate (formerly RAPEX) alerts system.

So, let's dive into the recent changes!

Acronym Definitions

To understand more, you need to understand two acronyms:

  • REACH stands for Registration, Evaluation, Authorisation and Restriction of Chemicals, which includes pigments/inks.

  • RAPEX (Rapid Exchange of Information System), now "Safety Gate", is the European Union rapid alert system for dangerous consumer goods, including body art and cosmetic tattoo pigments that are considered dangerous.
    EU's rapid safety alert system 'RAPEX' has been renamed to 'Safety Gate'

EU REACH Pigment Regulations, what now?

The new REACH regulation 2020/2081 for inks and pigments (all referred to as “inks”) came into effect in 2021. Not only are the rules a lot stricter, but they are a regulatory requirement for all EU countries. The old REACH requirements (2008) were essentially guidelines.

If the regulators in an EU country inspect a product and find it does not comply with the regulations and/or is considered dangerous, the information is shared with all EU countries via the Safety Gate system. THink Aesthetics subscribes to Safety Gate's weekly reports to check for any pigment alerts.

Pigments and "Tattoo Inks" on 'Safety Gate'

The latest batch of alerts on Safety Gate that dropped into THink’s inbox contained 23 alerts. That’s 23 body art inks or cosmetic tattoo pigments that were considered dangerous. And the majority were reported by Sweden, which is just one EU country where they are obviously doing checks on the products being used in their country.

Tattoo ink search on the EU alerts system, safety gate (formerly RAPEX)

There were a couple of well-known brands in the list of 23 inks and pigments, but many appeared to be private labels (relabeled or repackaged products). There are a lot of brands like this on the Australian market. Do these people get checks done to ensure their pigments are safe? Probably not.

When things are cause for concern!

So, how bad were the 23 pigments? Not good, with one almost unbelievably bad. Most of the problems were with high concentrations of substances like:

  • Lead, a highly poisonous substance.
  • Cobalt, a skin and respiratory sensitiser, and known carcinogen.
  • Nickel, a skin irritant.
  • Polycyclic aromatic hydrocarbons (PAHs), which are known carcinogens, with some being mutagenic and reprotoxic.

One pigment contained a “measured value up to 25% by weight” of lead (seriously toxic stuff!). That is over 30,000 times the legal limit! You would hope there has been a mistake, otherwise technicians would be at serious risk of lead poisoning, as well as the poor clients.

And finally, when they're cause to confirm...

One of the pigments was even labelled “BioTouch”. Biotouch fakes are very common and not always so easy to pick, and this particular fake contained “excessive concentrations of lead and nickel”. This emphasises the need to make sure you are buying genuine Biotouch product (made in the USA), through an authorised and reputable distributor (which THink MBC is!).

October 17, 2023 — THink Aesthetics

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THink Tech Talks is our informative blog series that discusses technical industry news, training advise and more! Written in partnership with THink Aesthetics, an industry-leading training school that specialises in all things cosmetic tattooing.