Australian Cosmetic Tattooists now source their pigments from a broad range of suppliers both locally and via international exporters, however our interaction with a wide cross section of Australian technicians revealed that overwhelmingly they are unaware of the need for compliance with Australian Regulations related to importation of tattoo pigments.
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 Australian Industrial Chemicals Introduction Scheme (AICIS)
formerly known as National Industrial Chemicals Notification and Assessment
Scheme (AICIS)1.
What percentage of pigment importers/suppliers are actually complying with Australian laws?
As described by AICIS;
"In Australia, chemicals are regulated under both state/territory and national laws. At the national level, chemicals are regulated according to their use.
There are 4 main regulatory authorities for chemicals – each focusing on a particular type of use:
Australian Industrial Chemicals Introduction Scheme regulates industrial chemicals such as paints, adhesives, inks, plastics, glues, solvents, soaps and ingredients in cosmetics."
The
Industrial Chemicals Act
2019 establishes the Australian Industrial Chemicals Introduction Scheme.
Not only are importers required to register with
AICIS 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)3,
and should be checked also for compliance with the Poisons Standard Jan 20232. 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
AICIS 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
importers 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
AICIS 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
check with Australian customers prior to purchase if the supplier is required to
Registered with
AICIS for the local fulfilment of their order or if the customer is required to Register with
AICIS 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 registered with
AICIS 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
AICIS 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 AICIS.
- 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
AICIS - If needed
Contact AICIS and ask for confirmation that your supplier is registered.
- Ask your supplier for written confirmation that they are registered with
AICIS 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
Future Developments to Watch Out For
The European Union have acted on their 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 were voted on by the EU members
and adopted by member countries as of 04/01/2022. Naturally countries outside of the EU are free to apply their own regulations, however
now that restrictions on chemicals used in tattoo inks and permanent makeup pigments
have been adopted by the EU we anticipate that similar restrictions will be adopted by many countries outside of the EU via harmonised legislation/regulations.
In our view it is only a matter of time.
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)
recommended restrictions list to ensure that pigments that are currently in use for client services are compliant not only with existing Australian
AICIS administered Regulations but also restrictions recommended under REACH as
now implemented by the EU. Cosmetic Tattoo technicians may care to make
enquiries with their suppliers now as to their intention (or not) to comply with
the EU restrictions list as well as local AICIS requirements as compliance with
both standards provides the safest level of colourant restrictions for your
clients.
Some 'for profit' representative trade membership companies may seek to falsely
imply that they are instrumental in the creation of Australian regulations,
cosmetic tattoo technicians are advised to seek guidance direct from AICIS i.e.
the actual government department that is involved in the administration of
Australian chemical regulations rather than second hand information from a 'for
profit' company.
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
- NICNAS. Tattoo and permanent make-up inks used in Australia. 29 July 2018
- Therapeutic Goods (Poisons Standard—February 2023) Instrument 2023
- Australian Inventory of Chemical Substances (the Inventory). Sept 2022
- ANNEX XV ECHA RESTRICTION REPORT PROPOSAL FOR A RESTRICTION. Substances in tattoo inks and permanent make up. October 2017
- NICNAS. Investigation of the composition and use of permanent make-up (PMU) inks in Australia. Nov 2017
Date of most recent revision:
01/02/2023
Original publication date:
05/07/2018
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