Ban Me? - The Latest on Tattoo Regulations
As the popularity and world of tattoo has continued to grow and expand at a phenomenal rate, the consequences have included a larger interest in commercial and investment groups, as well as the eye of various global government regulators and of course news outlets.
This blog article continues our focus on the role and responsibilities of tattoo equipment suppliers, to provide an update on some of the significant global regulatory changes we are seeing.
We hope you find it useful.
When discussing legislation we will refer to tattooing and tattooists. For everyone, please know this includes cosmetic artists, SMP and PMU work. We are just not going to say all those words everytime it’s mentioned, so just please forgive us and know it applies to both tattooists and cosmetic artists in the same way.
MoCRA
MoCRA is a new regulatory acronym we all need to become familiar with, it stands for the “Modernization of Cosmetic Regulation Act”.
This Act has been passed and is now a law.
This update to USA cosmetic regulations moved or expanded the FDA’s (United States federal agency, the Food and Drug Administration) authority to oversee the cosmetics industry, of which tattooing is a part of, for regulatory purposes.
Yes, if you didn’t know that, USA regulators consider tattooing and cosmetic tattooing part of the same.
For MoCRA purposes, a “cosmetic” is anything that is intended to be rubbed, poured, sprinkled or sprayed, rubbed, applied or inserted into the human body for the purpose of cleansing, beautification or altering the appearance.
MoCRA specifically provides the FDA with specific authority over:
• Facility and product registration – manufacturing facility safety and cleanliness standards
• Good manufacturing practices – for safe and sanitary production of products
• Cosmetic safety substantiation –evidence supporting product safety
• Clear and informative labelling – ingredients listings and warnings
• Post-market surveillance – ongoing monitoring and event reporting
This new set of laws enables to the FDA to scrutinise and examine everything tattooists use in tattooing. This includes ink, creams, stencil gels, needles. Everything that goes on, or in, the body during the tattoo process.
One of the biggest challenges facing both the regulators, FDA and advocacy groups representing tattooists and manufacturer’s is that not a lot of scientific data exists for tattoo products, at least not at a detailed or molecular level that may exist for other medicines and food products.
Tattooing has not had to do that before or had considered reason for it. This creates some uncertainty or lack of facts that can be used when creating rules, guidelines or consultation in regard to new laws affecting tattoo.
While MoCRA focusses on the manufacturers of tattoo products and equipment, it does have a direct impact on USA tattoo artists, requiring them to:
• Ensure pigments and supplies are compliant to MoCRA directives
• Ensure studio hygiene standards meet MoCRA directives and standards
• Monitor manufacturer registration and safety data
• Keep records of product safety support for the tattoo products they use
• Report client adverse reactions to the FDA
The FDA, at this time, has not made significant changes. They are in process however, including a public hearing on goods (equipment and consumables) manufacturing processes. This was attended by over 2,300 people who raised concerns over ability to meet new protocols.
In March 2024 the FDA issued a warning for people not to use certain topical numbing products used to relieve pain from tattooing and piercing, further advising some companies they were marketing these products in violation of federal law.
These related to numbing creams that contain ingredients, such as lidocaine, at concentrations that are higher than what is permitted for over-the-counter, topical pain relief products. “These products pose unacceptable risks to consumers and should not be on the market,” said Jill Furman, J.D., director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research.
You can read more on that including the specifically mentioned numbing products <here>
FDA have also released a “guide” – Recommendations to Help Reduce Microbial Contamination in Tattoo Inks. This guide and the suggestive nature of its title was picked up larger news outlets such as USA Today and WebMD. The contained advice that can safely be considered part of tattooists general knowledge and typical standards already in place at tattoo studios. That did not stop inflammatory headlines for tattoo related click-bait.
This points to one of the challenges all tattooists will have to face. As regulatory changes are made, and tattoo related studies are quoted or associated by news outlets, tattooists can expect rises in the numbers of questions raised by their clients. We will discuss a couple of ways to get information for this to assist in any research preparations later in this article.
The FDA is still figuring out how to implement and manage these new responsibilities from MoCRA and so some uncertainty and volatility exists. They have a Statute that provides them with this power, and are now creating and implementing various rules and frameworks that will determine what artists and manufacturers must do.
Based in the USA, the FDA Body Art Committee, includes representatives of which the APT is part of and is actively engaged in ongoing consultation around how the FDA manages its responsibilities under MoCRA.
The APT are the Alliance of Professional Tattooists and for further information and updates, it is worth checking out the website for at www.safe-tattoos.com or the YouTube seminars released on the subject by a member of their team, Ben Shaw.
REACH
REACH stands for Regulation, Evaluation, Authorisation and Restriction of Chemicals and is an existing regulatory change implemented in countries part of the European Union or “EU”. For completeness, the EU is a group of 27 countries in Europe that work together on political and economic government. This includes countries such as Germany, France, Italy, Netherlands, Poland, Spain and others.
In January 2022, under the REACH Regulation, the EU restricted certain ingredients commonly found in tattoo inks and cosmetic permanent make-up.
The new REACH regulations actually ban over 4,000 substances that can no longer be included in tattoo ink, most significantly two specific pigments that are found commonly cross a large majority of coloured inks, Green 7 and Blue 15:3.
It's important to note at no time in the roll out of these restrictions was it suggested there was direct evidence of tattoo ink causing serious medical issues. This does not stop the alarmist headlines and blogs we can find on the subject.
A number of ink manufacturers have now released REACH-compliant lines for European artists. Visiting studios in Europe this year we talked to many artists about their experiences with these inks and opinions vary, mostly poor.
Costs are typically higher for REACH compliant inks, related to the cost of the manufacturing development and speciality equipment and processes now required. Artists views on the performance and results of these inks also vary.
With this in mind, it is reasonable to expect that some motivation for use of banned inks exists, although obtaining these inks is more difficult with suppliers not providing them to artists in EU countries.
Potential punishments under REACH for tattooists breaching the REACH rules can include:
• A fine of EUR50,000 (AUD$83,000)
• Up to 2 years imprisonment
There is also a risk of a client taking specific action against a tattooist should banned inks be used.
These impacts result from regulatory changes made and enforced despite no material medical evidence that these changes were required. So, we must consider them very seriously when these changes may have implications for other countries, such as Australia.
Let’s talk about what artists can do right now
Stay informed and engaged!
As well as other roles and responsibilities they carry out, we have two principal bodies for engagement with regulatory authorities in Australia, the Professional Tattooing Association of Australia (PTAA) and the Australian Tattooist Guild, ATG. These organisations are for a run by tattooists and are also a source for media comment from journalists seeking comment on current issues.
It is critical that artists have a united voice amongst stakeholders involved in regulatory change, and reporting of those changes. That ensures a consistent and considered response, and a much more effective consultation process and engagement with regulatory bodies. The need for this is vital given the magnitude of regulatory impacts created by global regulatory changes such as MoCRA and REACH.
Professional Tattooists are able to join the ATG and PTAA and we would recommend to any artist who is not a member to join up to either or both of these groups to ensure Australian tattoo has a united and coordinated voice when dealing proactively with regulators and the media.
ATG membership is not available to apprentices or non-tattooists, such as suppliers like us. Given the importance of the changes we are seeing, this intentional lack of unity should be reconsidered or alternatives channels to ATG engagement with those groups be provided and stated.
A USA MoCRA focussed advocacy group, the Alliance of Professional Tattooists (APT) now exists. Artists can access their resources and plenty of informative videos through the APT website www.safe-tattoos.com
Also APT member, Ben Shaw (@benshawarchetype), has a great social media account and YouTube channel running with more resources artists can follow to keep up to date. Ben provides great analysis on some of the reporting and commentary on MoCRA related subjects to assist artists when faced with related questions from their customers.
Talk to your supplier
Your tattoo equipment supplier should be fully versed in the latest regulatory changes or discussions relating to tattoo equipment and be supporting you in dealing with customer questions. Talk to them, ask questions and request help or guidance where you can. They may not have all the answers, but they should be able to assist you in finding them.
We discussed what makes a "good supplier" in our previous blog article <here>. A good supplier will be ready to assist you in being prepared for equipment and supply related matters including the goings on with MoCRA and REACH.
News outlets are picking up stories on both of these regulatory changes, as well as associated various studies with tattoo related content. Artists should actively seek out and read these articles. Their headlines are usually click bait attracting with misleading subjects that may be the core message members of the public take on, so reading the content of those articles and the scant facts they include will assist in dealing with the questions that may arise.
Instagram hashtags worth following include #mocra #allianceofprofessionaltattooists #australiantattooistsguild
For those wanting to know some of the science behind tattooing better, then a book worth checking out is The Science of Tattooing, by Hannah Wolf available on amazon and other retailers, here is their website https://www.thescienceoftattooing.com/
You can also reach out to us anytime on our socials or email at shop@industrytattoosupply.com.au. We will be attending the Sydney Tattoo Convention and Perths own West Australian Tattoo & Arts Festival at UWA August 24-25th so come over and chat if you are there ❤️