Regulatory review update

As many of you would know, APAN has a strong focus and involvement in areas that impact Safety, Health and Best Practices. 

We were the first organisation within our industry to step up and develop COVID clinical safety protocols for business owners to protect their staff and clients from the pandemic and this was before the government released any of their own guidelines and standards.

When it comes to safety, we are also concerned with the issue of tattoo pigments, as in recent years the subject of hazardous substances included in tattoo inks and pigments has also come under regulatory review.

This issue is now supported by scientific evidence that has identified some tattoo inks as hazardous and even carcinogenic.  As a result, in 2019 the national regulator of the importation and manufacture of industrial chemicals in Australia (NICNAS), approached the Queensland Government to undertake a detailed review of this matter. 

This activity was undertaken by the Queensland Health, Environmental Hazards Unit which was appointed to investigate the toxicity levels of various tattoo inks and initiate potential regulation for their removal from future use.

The Departmental Standards – Tattoo Inks was made pursuant to section 233 of the Medicines and Poisons Act 2019 by the Chief Executive of Queensland Health to establish procedures and requirements for the use of the products. The Standard also prescribes the requirements for a Compliant Analysis Certificate (CAC) under section 48A of the Act.

APAN was invited to represent the aesthetics and PMU industry, while the body tattoo art was represented by the Australian Tattooist Guild (ATG) and the Professional Tattooing Association (PTA).  These standards are required as referenced by the Act or Medicines and Poisons (Poisons and Prohibited Substances) Regulation 2021 (Poisons Regulation).

Supporting this move for the introduction of the Departmental Standards was also the Australian Medical Association, as well as other leading academics and laser tattoo removal practitioners who were concerned with practitioner safety when dubious pigments containing toxic substances were vaporised during tattoo removal. 

This concern was supported by scientific evidence.

After two years of extensive meetings, APAN’s revisions for a proposed Departmental Standard and Compliance Analysis Certificate (CAC) were submitted for regulatory consideration. 

The submission included substantial work completed by Robert McGowan who was appointed to represent APAN due to his extensive scientific credentials.

However, due to strong opposition from two tattoo industry bodies who stated that the CAC would “place an unnecessary and unfair burden on suppliers” the regulation was deferred pending a further investigation by the Health Minister.

Meanwhile, APAN was invited to speak at the 5th World Congress of Tattoo and Pigment Research (WCTP), held this year in Holland. 

Our topic was an update on the Australian regulation initiative. It is a well-established fact that the European Union is considered the world leader in tattoo ink and pigment research and in being the first to introduce regulatory requirements. 

Following the Symposium APAN joined as a member of the European Society of Tattoo and Pigment Research (ESTP) to ensure that we remained current with both research outcomes, as well as European regulatory initiatives.

In June this year, ESTP invited its international members to nominate a candidate for consideration to be part of the BfR board. 

This is the German Federal Institute for Risk Assessment. The BfR board published some minimum requirements and test method safety considerations for tattoo inks and is heavily involved in assessing the implementations of the new European Commission Regulation 2020/2081 on tattoo inks and PMU. This regulation is commonly called REACH (Registration, Evaluation, Authorisation and Restrictions of Chemicals) and applies to all inks and pigments manufactured or sold in Europe.

This month BfR completed its review of board applications and introduced the International BfR Committee for tattoo Inks 2023-2025 to review public safety considerations as its focus.  We are pleased to report that Robert McGowan was accepted as a member of this board.  This appointment will allow us to gain inside information on research updates, as well as proposed risk management standards for industry and consumer safety.

Progressively many industries now recognise that they are part of a global community and the importance of establishing standards that aim to be uniform as much as possible throughout different jurisdictions. 

We wish to assure the industry that APAN is not taking a passive stance as we continue to pursue a regulatory position for safer inks and pigments for the benefit of both consumers and practitioners within Australia.

As part of our support of our government to this end, we are vigilant in continuing to expand our knowledge for an evidence-based approach that can benefit a regulatory outcome here in Australia.