The Regulation of Cosmetic Tattoo Pigments

What it will mean for you and your business

Frequently Asked Questions
March 6th, 2021

The regulation of pigments is complicated. When it comes to cosmetic tattoo, the focus is usually on the shape, the technique, and the colour… not so much on the chemistry of the pigment itself. The assumption from both technicians and clients is that pigments are checked for their safety or else they would not be able to buy them. This is not the case, not yet.

In December 2020, the European Union (EU) introduced new regulations that will restrict the chemicals in pigments (or “inks”) used for body art or cosmetic tattooing (aka Permanent Makeup, PMU). This will cause some brands to make changes to their pigments or withdraw some from sales.

As Australia looks to adopt similar regulations, with Queensland the first state to do so, Australian technicians and business owners need to be made aware of the facts surrounding the regulations. We have prepared answers to Frequently Asked Questions (FAQs) that cover everything from the pigments themselves and the new regulations to who it impacts and how.

Pigments & Regulation: The Basics

Surprisingly, no one. There are regulations for poisons that could be applied to tattoo pigments, but until now there has been no legislation to directly control what is used and what goes into people’s skin.

Regulatory authorities, particularly health authorities, want to protect the public from chemicals that are potentially harmful to human health.

In recent years, pigment manufacturers have started to use more and more exotic chemicals in search of brighter body art colours or better pigment retention with cosmetic tattooing. It is these chemicals that sometimes pose a health risk.

Historically, pigments came from natural minerals and metal oxides such as iron oxides. Some old blues and greens contained lead, which was banned in all sorts of products years ago. Over the years, chemicals have replaced a lot of the minerals and oxides used in pigments. More complicated chemical dyes (colorants) have gradually replaced a lot of the metal oxides.

There are a lot more ‘nasties’ finding their way into pigments, and therefore the skin of tattoo clients. The government objective is to regulate pigments to avoid potential health risks.

With 15% of Australians having at least one tattoo, if a popular pigment ingredient was found to be causing skin cancer, the scale of the health problem could be substantial. As well as the human cost, there could also be a large public health cost.

The Queensland regulations, which are expected to be adopted by other Australian states and territories, cover everyone in the supply chain down to the business owner using the pigment. The Australian distributor or seller of imported pigments needs to comply, and the tattooing business owner (user) needs to comply.

To quote Queensland Health: “To enable sufficient time for the tattoo ink manufacturers, suppliers and businesses to comply with new requirements under the Medicines and Poisons Act, the tattoo ink provisions will commence 12 months after the commencement of the Act, i.e. late 2022.” 

All manufacturers that manufacture in Europe or sell into Europe will be affected. Some brands do not contain any of the restricted colorants, and some have them in most of their range. Consult your supplier to try and find out if the brand(s) you use will be affected by the restrictions.

12 months is not a long time to use up pigments (if you do want to use them up). The sooner you start buying compliant pigments, the less chance you will need to throw away illegal stock.

If you or your client are concerned, then there are effective methods for cosmetic tattoo removal, but this is entirely personal matter.

Yes, there will be. After the transition period for compliance has ended, the maximum penalty for a supplier is 100 penalty units (currently $13,300) and for a business or person using the pigment, 50 units ($6,650).

To learn more about compliance, what is required, the transition period and the penalties, please continue to the next section where we dive deeper into the details surrounding the regulation of pigments.

Let’s Dive Deeper: Understanding the Regulations

Europe (the EU) has had quite detailed guidelines for pigment since 2008. Out of 27 countries in the EU, seven countries adopted these into their regulations. Since 2008, the European Chemicals Agency has done a lot of work on pigment chemistry and toxicity, and in December 2020 the EU adopted new, uniform regulations. These respond to all the new chemicals that have been put into pigments in recent years.

Pigments are not made in Australia. Brands that are local to Australia are what are called “Private Labels’. They are made overseas, typically in China, and labelled with whatever the Australia buyer wants. Almost all major pigment brands come from Europe or the USA. Changes to European brands will affect what you can buy in Australia, and US brands that sell into Europe will need to comply with the EU regulations, so their ingredients may change as well.

There are two main ways pigments will be regulated. Import of chemicals (pigments) into Australia is controlled by the AICIS (Australian Industrial Chemicals Introduction Scheme, formerly NICNAS). Also, each state and territory has poisons legislation, which can control chemicals that affect human health. Queensland will be the first state to regulate body art and cosmetic tattoo pigments.