In Australia if you Import or manufacture a Cosmetic Tattoo Pigment for client services, resale or other business related activities you are known as 'introducers of industrial chemicals' and legally must be registered with the National Industrial Chemicals Notification and Assessment Scheme (NICNAS).

What percentage of pigment importers/suppliers are actually complying with Australian laws?
 

As described by NICNAS¹;

"Chemicals used in tattoo and PMU inks are classified as industrial chemicals in Australia. Their introduction is subject to the same requirements as any other industrial chemical under the Industrial Chemicals (Notification and Assessment) Act 1989."

Not only are importers required to register with NICNAS but all individual ingredients within each Cosmetic Tattoo Pigment must be checked to see if the chemicals used in the tattoo or PMU ink is listed on the Australian Inventory of Chemical Substances (AICS), checked also for compliance with the Poisons Standard June 2018². In addition, if a chemical within a Cosmetic Tattoo pigment is not on the AICS, or is listed on AICS with specific conditions, it needs be assessed by NICNAS before it can be introduced in Australia even by those who are registered. Also under Work Health and Safety Regulations administered by SafeWork Australia Safety Data Sheets (SDS) should be available to pigment handlers in the workplace, it is advisable that these are present and available to pigment purchasers at the point of sale.
 

Discussion

Based on our interaction with Australian technicians it seems likely that there are probably technicians and suppliers of cosmetic tattoo pigments who are not complying with Australian regulations related to the introduction of cosmetic tattoo pigments. Even more concerning is the fact that many technicians are completely unaware of Australian regulations. This could have serious implications for individual technicians and their clients.

Insurance: Most technicians that we have spoken with are aware of the importance of holding professional indemnity insurance however very few seem aware that these types of policies frequently have specific exclusions related to non compliance with Australian laws and Regulations. In other words if something goes wrong you are insured provided that you have complied with the law, if you have not complied with the law your insurer may decline to cover a claim against you via escape clauses.

Based on our own interactions with insurers and compensation lawyers there seems to be varying levels of knowledge of the regulatory requirements mentioned above, however it is safe to assume that a compensation lawyer acting for their client will make every effort to establish negligence and failure to comply with regulatory requirements would be a starting point for their investigation and requests during discovery.

Importation: If you import cosmetic tattoo pigments for use in providing client services then most likely you need to register with NICNAS as a chemical introducer and check that the product is in full compliance with Australian laws, as an importer it is also advisable to ensure that you hold product liability insurance as well as your standard professional indemnity insurance.

In the interests of a reasonable standard of product disclosure it would be prudent for International suppliers of Cosmetic Tattoo pigments to be advising Australian customers prior to purchase if the supplier is Registered with NICNAS for the local fulfilment of their order or if the customer is required to Register with NICNAS themselves prior to making their purchase.

Purchase from Local Suppliers: If you purchase from a local supplier take responsibility to ensure that the local supplier is legally registered with NICNAS and is in full compliance. You can check the register of introducers via this link.

If a local supplier is not complying with regulatory requirements then it is possible that their product liability insurance may also be in jeopardy, in the event of a claim both the supplier and their technician customers might find that they are taking substantial personal financial risks.

If your local supplier claims to be Registered with NICNAS and you discover that they are not registered then under consumer law you may be entitled to a refund and possibly compensation for any consequential loss (if in doubt check with your legal advisor).

Penalties

In addition to the risk of the potential loss of insurance cover there are some hefty penalties associated with non compliance with regulations.

As an Australian Cosmetic Tattoo Technician What Should You Do?

If You Purchase Cosmetic Tattoo Pigment from Offshore Suppliers

• You need to Register with NICNAS.
• Conduct a full audit of the pigments and their ingredients that you intend to import and check for compliance³.
• Check with your insurer as an importer (chemical Introducer) you may need to arrange additional cover for product liability.
• Ask for a copy of the pigment Safety Data Sheets.

If You Purchase Cosmetic Tattoo Pigment from Australian Suppliers

• Check to see if the supplier is Registered with NICNAS - If needed Contact NICNAS and ask for confirmation that your supplier is registered.
• Ask your supplier for written confirmation that they are registered with NICNAS and have audited all of their pigments for compliance with Australian regulations.
• Ask your supplier for written confirmation that they hold product liability insurance.
• Ask for a copy of the pigment Safety Data Sheets.

If You are a Client of an Australian Cosmetic Tattoo Technician

• Ask for confirmation that the pigment being used for your service was imported/supplied by a Registered Chemical Introducer.

Future Developments to Watch Out For

The European Union have a proposal to restrict certain chemicals in tattoo inks and permanent make up⁴ (Cosmetic Tattoo Pigments) under the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), the restrictions will be voted on by the EU members next year and from our perspective it seems likely that the proposed restrictions will probably be adopted. Naturally countries outside of the EU are free to apply their own regulations, however once restrictions on chemicals used in tattoo inks and permanent makeup pigments are adopted by the EU we anticipate that similar restrictions will be adopted by many countries outside of the EU via harmonised legislation/regulations.
 

We believe that it is prudent to be pre-prepared now, for example we have also audited the amiea pigments that we use against the European Chemicals Agency (ECHA) proposed restrictions list to ensure that pigments that are currently in use for client services are compliant not only with existing Australian Regulations but also proposed restrictions under REACH, we suggest that technicians may care to make enquiries with their suppliers now as to their intention (or not) to comply with the ECHA proposed restrictions list once it is adopted by the EU.
 

In 2017 NICNAS conducted an Investigation of the composition and use of permanent make-up (PMU) inks in Australia and found varying levels of compliance⁵, for those who have a broad knowledge of the industry it seems obvious that the report was scratching the surface of the supply of cosmetic tattoo pigments currently taking place in Australia.

Are you and your pigment supplier complying with Australian law?

References

1. NICNAS. Tattoo and permanent make-up inks used in Australia. 29 July 2018
2. STANDARD FOR THE UNIFORM SCHEDULING OF MEDICINES AND POISONS. No. 19. February 2018
3. Australian Inventory of Chemical Substances (the Inventory). 2018
4. ANNEX XV ECHA RESTRICTION REPORT PROPOSAL FOR A RESTRICTION. Substances in tattoo inks and permanent make up. October 2017
5. NICNAS. Investigation of the composition and use of permanent make-up (PMU) inks in Australia. Nov 2017

Date of most recent revision: 05/07/2018 (mutatis mutandis)
Original publication date:  05/07/2018

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