Update on Pigment and Tattoo Ink Regulations

This week we had an in-depth meeting with Queensland health with updates on the regulatory process with regards to inks and pigments.

THE EUROPEAN POSITION

Europe has had guidelines in place for ingredients and purity standards since 2003, with some member countries adopting them into regulation. In December 2020, the EU adopted detailed uniform regulations across all member countries after extensive research and consultation by the European Chemicals Agency (ECHA) with compliance required by January 2022.

I had a communication with Professor Serup, President of the European Society of Tattoo and Pigment Research this week. He told me that since the new regulations released in January this year of the 27 EU nations only three are fully compliant with the new regulations – Germany, Switzerland and Italy, as meeting compliance is a real challenge to pigment manufacturers. 

On 29 March 2022, the European Commission and ECHA are organising an online info session to address technical questions that industry, such as ink formulators and tattoo artists, might have on the implementation of the restriction. The aim is to help those impacted to meet the new legal requirements set by Annex XVII of the EU’s chemicals legislation, REACH.

Meanwhile, in Australia, Queensland Health is steadfastly continuing its review process on what the Australian regulations will look like.  They are pursuing ongoing conversations with both EU regulators and manufacturers, as well with their counterpart in the USA – the FDA discussing the challenges and options on where to draw the line on compliance. As much as we all want to ensure that manufacturers move forward with cleaner and safer formulations, this process is thwarted with challenges as this is a very costly process.

Those who are resisting this process are stating that “there is really no scientific evidence of toxicity that can attribute a tattoo link to cancer and that the evidence is only anecdotal and not scientific”. 

They claim that the cancer could be the result of a lifestyle or a pre-existing condition.  This is not dissimilar to what happened with cigarettes in the days when it was considered cool to smoke.   Whenever cancer was linked to smoking there were endless lobby groups and their lawyers who tried to dispute the connection.  However, over the years we progressively have further evidence. 

While we acknowledge that contaminated inks and pigments have many components and are difficult to isolate which are the most hazardous, particularly with colours, studies are constantly surfacing to encourage us on this quest.

A recent 2021 study was forwarded to me by the University of Queensland this week.  The study by

Wang et al. investigated the labels and the contents of metals and pigments in 73 tattoo inks, considering restrictions within the European Union. Some 93% of the bought tattoo inks violated European, legal requirements on labelling. 50% of the tattoo inks declared at least one pigment ingredient incorrectly. 61% of the inks contained pigments of concern, especially red inks. Iron, aluminium, titanium, and copper (most in green/blue inks) were the main metals detected in the inks. The level of metal impurities exceeded current restriction limits in only a few cases. Chromium (0.35-139 μg/g) and nickel (0.1-41 μg/g) were found in almost all samples. The levels of iron, chromium, manganese, cobalt, nickel, zinc, lead, and arsenic was found to vary significantly.

I have received several similar reports from credible researchers. Many of the formulas that were examined come from China. While you may be getting beautiful colours, the content of the product might be highly toxic.

As new studies are constantly surfacing, the search for further evidence that can be directly linked to the level of hazard to certain colours continues. However, we do have sufficient evidence that without any form of regulation, we will be dealing with the unknown in terms of what we are really inserting into our client’s skin, so the push towards regulation remains high on our agenda.

Coming back to the Australian it is important to note that regulations have three levels:

1. An ACT which is established through parliament as law
2. A Regulations which must go through state parliament
3. A Departmental Standard which is also enforceable through regulation, however this instrument is more flexible for amendments as new information comes to hand. 

What we are working towards in Australia is establishing measures under the Medicines and Poisons Act through Departmental Standard.  Our aim is that these measures will include specifications for the three categories – manufacturers, suppliers and users with a transitional period of one year for commencement.

I don’t believe that the Australian standards will be as strict as the EU regulations. There will be colours that will be required to be removed, however, to minimise risk, the legal percentage of certain colours will be determined.  Either way, I can assure you that in the next few months, we should achieve a draft Departmental Standard for regulatory consideration.

APAN believes we have a duty of care to the PMU industry, laser practitioners who perform tattoo removal procedures and the public, to continue to pursue a regulatory outcome for safe pigments and inks that are introduced into the body.

Thank you to all of you who are encouraging us to continue this pursuit for a safer industry. Your encouragement is appreciated. While the progress is slow we are moving in the right direction.