Australia Released Current Regulations on Tattoo Inks and Offers Suggestions for Improvement

Takehome:

Australia officially sorted out its management rules on tattoo ink products and offered several administrative improvement measures.

1. Tattoo Inks in Australia

In Australia, tattoos are defined as:

ordinary tattoo to inject ink into the dermal layer of the skin in order to permanently color the skin
permanent make-up (PMU), a specialized form of tattooing used to impart a semi-permanent cosmetic effect to the body

The inks for these two kinds of tattoo are also different. Tattoo ink may include multiple colorants to achieve a certain color, as well as other chemicals such as water, glycerol, isopropyl alcohol, witch hazel, preservatives, resins and contaminants. PMU inks are complex formulations that can have organic and inorganic colorants to achieve specific colors.

2. How does Australia regulate Tattoo inks and PMU inks

Market entry compliance

As a product, 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 Chemical (Notification and Assessment) Act 1989. Firstly, the importers and manufacturers (known as introducers) of the product must be registered with NICNAS. Secondly, if a chemical used in a tattoo or PMU ink is listed on the Australian Inventory of Chemical Substances (AICS), then in general the chemical can be imported into or manufactured in Australia without notifying NICNAS. However, if the chemical is not on the AICS, or is listed on AICS with specific conditions, it must notify NICNAS to assess before can be introduced.

Manage the ingredients

The chemical ingredients used in tattoo ink or PMU inks may contain potentially harmful ingredients (such as heavy metal) or may break down to harmful ones under sunlight or during laser removal. Poisons Standard is the regulation to manage the usage of ingredients in industrial chemicals including tattoo inks. Poisons Standard is a legislative instrument made under the Therapeutic Goods Act and classifies medicines and poisons into Schedules for the protection of public health. It not only decides whether certain ingredients can be used in the product, but also promotes uniform labeling and packaging.

For example, PMU inks are regarded as workplace chemicals, Schedules 5, 6 or 7 apply to them. Chromium, barium and copper are listed as Schedule 6 of the Poisons Standard, so PMU inks that are available to consumers and contain barium, chromium, lead and antimony above a certain concentration are to be labeled with the signal word "Poison". However, products packaged and sold solely for use in the workplace are exempt from this labeling requirement.

Regional requirement

In Australia, although tattoo inks are generally managed under above rules, different regions have their own specific requirements on this product.

Regions	Regulation Information
New South Wales	Skin penetration procedures are regulated by the Public Health Act 2010 and Public Health Regulation 2012 implemented by NSW Health. A factsheet, targeted towards tattooists and other professionals conducting skin penetration procedures, outlines how businesses must comply with this legislation (NSW Health, 2013). PMU artists and business operators are not required to hold a practicing license from Fair Trading NSW; however, PMU artists are required to be registered with local councils. The PMU premises need to meet the operational requirements set out by the local council including premise surfaces, lighting, and ventilation. Premises must also be equipped with appropriate wash basins, liquid soaps, and single use towels. In 2016, an amendment was made to the Public Health Regulations 2012 designating eyeball and tongue tattooing as skin penetration procedures (NSW Health, 2016).
Queensland	Queensland has implemented the Tattoo Industry Act 2013 to regulate the body art tattooing industry. Although PMU operational procedures are very similar to body art tattooing, it is not clear whether PMU is included in this Act. A factsheet published by the Queensland Health Department indicates that, even though the skin is not penetrated to the same depth in PMU as in body art tattooing, both involve similar processes. Therefore, PMU artists are required to possess the necessary infection control qualifications and provide clients with aftercare instructions (Queensland Health Department, 2015).
Victoria	Skin penetration and tattooing procedures are regulated by the Public Health and Wellbeing Act 2008 and Public Health and Wellbeing Regulations 2009. Personal care and body art practitioners, which include tattooists and PMU providers, are required to register the premises in which they conduct their business with the local council. The premises must meet certain infection control requirements as set out by the regulations, which include: being in a clean, sanitary and hygienic condition; having easily accessible hand washing facilities; personal hygiene requirements for the practitioners; and certain sterilization requirements for articles used for skin penetration. There is no provision requiring tattoo or PMU practitioners to have undergone specific training. A factsheet published by the Department of Health's Communicable Disease Prevention and Control Unit provides guidance to people contemplating any tattooing procedure, including PMU.
Western Australia	Requirements for businesses operating skin penetration procedures are described in the Code of Practice for Skin Penetration Procedures 1998 as adopted by the Health (Skin Penetration Procedures) Regulations 1998. This code covers practices such as tattooing, body piercing, acupuncture, depilatory waxing, electrolysis, skin lancing and PMU. PMU must be performed in accordance with the code, particularly in relation to sterilizing appliances. The Health (Miscellaneous Provisions) Act 1911 provides penalties for tattooing minors.
South Australia	A factsheet issued in 2012 provides information on the health risks associated with body art tattoo inks (Government of South Australia, 2012). Under the Tattooing Industry Control Act 2015, body art tattooists are required to notify the business to the commissioner for Consumer Affairs. PMU businesses are exempt from this notification process (Government of South Australia, 2017). SA Health publishes guidelines on the 'Safe and hygienic practice of skin penetration'. These guidelines state that operators for PMU (referred to as micro pigmentation or cosmetic tattooing) must follow the same guidelines for hygiene and sterilization as for body art tattooing (South Australian Health Commission, 2004).
Tasmania	Under the Public Health Act 1997, the Department of Health and Human Services publishes Guidelines for Tattooing, which contains advice for tattooing practices focusing on the health and safety, and hygiene requirements in tattoo parlous. It is applicable to all persons who perform tattooing procedures, including PMU artists. Factsheets published by the Hobart and Launceston city councils state that any person performing skin penetration procedures is required to have a license and the premises must he registered with the local councils (City of Hobart, 2017, City of Launceston, 2017).
Northern Territory	Guidelines published by the Department of Health recommend that beauty therapists and hairdressers who undertake activities that penetrate the skin, or may unintentionally penetrate the skin, be vaccinated against Hepatitis B. PMU is included as a skin penetration procedure so these guidelines apply to PMU service providers. Businesses also need to be registered with the Environmental Health Office (Northern Territory Department of Health Environmental Health Branch, 2014).

3. Current regulatory compliance practice

NICNAS investigated the ingredients used in marketed tattooing inks in Australia to check their regulatory compliance conditions.

The result indicated that heavy metals are often present in tattoo inks. Heavy metals may be included as contaminants when certain metal based colorants are used in tattoo inks. In addition to heavy metals, other contaminants of concern identified in tattoo inks were aromatic amines and polycyclic aromatic hydrocarbons (PAHs).
NICNAS also checked if ingredients used in finished tattoo ink products comply with AICS. The result showed that most of the ingredients in the analyzed inks are listed on the AICS. While pigment red 210 (CI 12477, CAS RN61932-63-6) is not listed on the AICS, but this colorant is mixed coupling product of pigment red 170 (CI 12475, CAS RN 2786-76-7) and pigment red 266 (CI 12474, CAS RN 36968-27-1), both of which are present on the AICS. Therefore, for AICS purposes, pigment red 210 is considered to be an existing chemical and listed on the AICS by virtue of being a mixture of pigment red 170 and pigment red 266.

The PAHs acenaphthylene (CAS RN 208-96-8) and benzo(ghi)perylene (CAS RN 191-24-2) which are found in tattoo inks are not listed on AICS as well. But according to the Industrial Chemical (Notification and Assessment) Act 1989, incidentally produced chemicals are not considered to be new industrial chemicals for regulatory purposes. Considering these two ingredients are incidentally produced, tattoo inks containing these two (CAS RN 208-96-8 and CAS RN 191-24-2) as contaminants can be imported without notification to NICNAS

4. Recommendation on improving current tattoo ink regulations

After the investigation, NICNAS proposed to improve the current regulations to better manage tattoo inks and PMU, general points include:

to ensure human health and safety, certain ingredients used in tattoo inks should be examined further;
consider whether PMU artists should undertake specific training to allow them to perform PMU safely, particularly as the practice requires selection of appropriate chemicals for injection near eyes, on the lips and in other delicate organs;
monitor compliance of the labeling and use of PMU inks with the Poisons Standard and WHS regulations. Some amines that may be found in PMU inks are prohibited for use in tattoo inks in the Poisons Standard.