Pigment Regulations – what are they, what do they involve, and how would they affect the industry?

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.

Regulations and Rules Graphic

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 Make Up, PMU). This will cause some brands to make changes to their pigments or withdraw some from sale.

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.

We will start with the basics – or you can skip to the deeper understanding section.

Pigments & Regulation: The Basics

Who approves pigments for use in Australia currently?
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.

Why does the government want to restrict or ban chemicals from tattoo pigments?
Regulatory authorities, particularly health authorities, want to protect the public from chemicals that are potentially harmful to human health. The main issues are:

  • Increasing use of chemicals classified by the EU as potentially “carcinogenic, mutagenic or reprotoxic” (CMR).
  • Increasing use of laser tattoo removal that can cause pigments to change into chemicals classified as potentially CMR.
  • The increasing number of people with some form of tattoo and the need to protect public health.

Why is this happening now?
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.

If it is my skin, why can’t I put in it whatever I want?
With 15% of Australians having at least one tattoo, if a popular pigment ingredient was found to be causing cancer or another adverse health effect, the scale of the health problem could be substantial. As well as the human cost, there could also be a large public health cost.

Who will be responsible for checking the pigments sold, bought & used are legal?
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.

How long do I have 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.” 

Pictured: A sample of the variety of Cosmetic Tattoo Pigments from around the world.

How many cosmetic tattoo pigment brands are affected by the regulations?
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.

What about my old stock?
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.

What about existing cosmetic tattoos that contain pigments that will be ‘banned’?
If you or your client are concerned, then there are effective methods for cosmetic tattoo removal, but this is entirely personal matter.

Will there be penalties if I sell or use a pigment that does not comply?
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

What has happened in Europe?
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.

What is happening in Australia?
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.

Who will apply regulations in Australia?
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.

How will the AICIS control the importation of pigments?
The AICIS works closely with Australian customs, monitoring imports to Australia and identifying any restricted substances. So far only larger importers, say the main Australian pigment distributors, have been monitored by customs (Border Force), but this is expected to change.

What is happening in Queensland?
Queensland Health has been working on the regulation of pigments for several years, particularly after introducing the new Medicines and Poisons Act 2019. The new regulations are set to be introduced later in 2021, with other states and territories expected to follow.

Where can I have my say? Is there public consultation?
On 28 April 2021 Queensland Health published two factsheets and a Draft Departmental Standard for public comment. One factsheet for businesses and one for suppliers. The departmental standard will form the regulations for any pigments. You can find the documents using these links:

Business factsheet: https://www.health.qld.gov.au/__data/assets/pdf_file/0024/1036608/business-body-cosmetic-tattooing-qld.pdf

Supplier and importer factsheet: https://www.health.qld.gov.au/__data/assets/pdf_file/0031/1036597/supply-importer-tattoo-ink-qld.pdf

Draft Departmental Standard: https://www.health.qld.gov.au/__data/assets/pdf_file/0024/1037076/ds-tattoo-inks.pdf

What exactly is being regulated?
There are several ingredients in pigments: The colours or colorants (typically up to 5), preservatives and carrier liquids. Colorants are very finely ground solids, so they need liquids such as water and an alcohol to make them into a paste. The preservative may be isopropyl alcohol, which is also a carrier liquid, or a mix of chemicals. It is primarily the colorants that are being regulated.

What exactly is being restricted?
The restrictions are on both colorants and impurities. Impurities come from by-products in the chemical manufacturing process. By-products can be almost impossible to remove. Sometimes it is these by-products that are the problem.

There are 27,000 registered chemicals used as colorants, but of course most are not suitable for cosmetic tattoo pigments. Some brands will be unaffected by the colorant restrictions because they already meet the new EU standards.

I am struggling to understand this impurities issue. Give me an example.
A straightforward example is carbon black, which is present in a lot of darker (or black) pigments. Carbon black can come from many sources. Some safe, some not. A few years ago, a scalp micropigmentation manufacturer promoted their pigments as “just made of coal”. In fact, coal is full of impurities, including compounds called Polycyclic Aromatic Hydrocarbons (PAHs). One of these is called benzo-a-pyrene, which is considered highly carcinogenic and is also found in cigarette smoke.

How will impurities be regulated?
Just like colorants, it is hard to simply ban a chemical impurity. When you make something there are usually by-products. The regulations will limit the concentration of chemical by-products to very low concentrations, typically in parts per million (ppm) or even parts per billion (ppb). Some manufacturers may struggle to achieve such low concentrations.

How will pigments be checked to see if they comply with the regulations?
The only way to check what is in a pigment is to analyse what is in it. With such a long list of chemicals being restricted, it could cost literally thousands of dollars for each analysis, so it is not practical to check every batch of a pigment. Pigment manufacturers analyse their bulk ingredients (imagine a big drum of colorant), so that if everything they put in the pigment complies with the regulations, they know the pigment itself complies. 

How will I know the pigments I use comply with the regulations?
Some pigment manufacturers currently get independent laboratories to provide compliance certificates to show their pigments comply with standards or regulations. These are based on the analysis of all the ingredients. Queensland Health has used the term Compliant Analysis Certificate (CAC) to define what sort of certificates will be acceptable.

How can Queensland Health tell manufacturers in Europe or the USA what is required?
They cannot. Queensland Health is defining a standard that agrees with what manufacturers producing or selling pigments in Europe will have to provide anyway. The term Compliant Analysis Certificate defines what is required on an analysis certificate.

What exactly is a Compliant Analysis Certificate?
To quote Queensland Health: “The CAC is a certificate of analysis of specified substances in a tattoo ink to determine if concentrations of these substances are less than the maximum allowable concentrations prescribed in the Departmental Standard for Tattoo Inks.”

Why isn’t a Safety Data Sheet (previously Material Safety Data Sheet) enough?
A Safety Data Sheet (SDS) tells you the main ingredients in a substance, and the safety information. It does not provide a chemical analysis, just a list of the main ingredients. An SDS cannot be used to check for compliance with the new regulations.

Who can produce a Compliant Analysis Certificate (CAC)?
Under the Queensland Health Standard (to quote), “CACs issued by Chemical Technological Laboratory (CTL) in Europe, or another laboratory accredited by an accreditation body operating in accordance with ISO/IEC 17011 General Requirement for Accreditation Bodies Accrediting Conformity Bodies will be accepted. In Australia, the analysis may be undertaken and certified by a NATA accredited laboratory.”

Where do I get a Compliance Analysis Certificate (CAC)?
Australian suppliers and tattoo businesses do not need to prepare their own CACs. Certificates provided or published by manufacturers and/or suppliers need to be available and meet the required standard. They could be on a manufacturer or supplier website. You need to know where to find them when an enforcement officer comes calling. It is unlikely that it will say “Compliant Analysis Certificate”, as that is a term created by Queensland Health to define the information requirements. This aspect can be confusing, so ask your pigment supplier what they have and if it complies. 

If there is a CAC for a pigment, is it always legal to sell or use it? Do they expire?
From Queensland Health: “A CAC certifies an ink formulation as compliant with the required standards and is valid for a period of two years from the date of its issue. This means that a tattoo ink manufactured using the same formulation during this two-year period will be covered by the CAC. For example, a CAC dated 20 Dec 2020 will be able to be used by a manufacturer to manufacture the ink till 19 Dec 2022.  However, the pigments themselves must be used in accordance with the manufacturer’s instruction including any use by date, if specified by the manufacturer.”

What happens if I sell or use a pigment that does not have a Compliant Analysis Certificate?
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).

Why is the body art tattoo industry concerned about losing some blues and greens?
The new EU regulations restrict a Blue 15:3 (phthalocyanine blue) and Green 7 (copper phthalocyanine green). These are popular bright colorants and are considered difficult to replace, so the EU is allowing manufacturers another 36 months to remove these colorants. Queensland Health is not regulating these colorants.

Which other colorants are being ‘banned’?
In the Queensland regulations, about 53 colorants will be restricted to concentrations that typically means they can only be present as an impurity at very low concentrations. One red pigment is limited to 3%, and the rest to either 1000ppm (0.1%) or 0.5ppm (virtually nothing). 

The colorants that some brands use in cosmetic tattoo pigments that are affected by the regulations include four reds, four yellows and two oranges. The Colorant Index or CI numbers should be on the pigment bottles if they are present. They include CI 11680, 11740, 11767, 12085, 12466, 12475, 12477, 21095, 21110, 21160 and 51319.

May 06, 2021 — Robert McGowan

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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.