Australian Ink Safety Gap, the Future of Tattoo Standards
The issue of tattoo ink safety is becoming a global problem. Australian artists, studios and suppliers can buy pigments and finished inks from Europe, the USA and Asia, but there are huge differences between the regulatory requirements of the various markets.
The Australian industrial-chemical framework regulates tattoo ink chemicals, and state/territory governments also have regulatory powers over aspects of tattooing and tattoo ink safety. This provides a context in which knowledge of international standards can inform suppliers of their purchasing. Choose the best industry tattoo supply to improve your tattoo outcome.
Australia: A Regulatory Landscape Different
In Australia, all tattoo and permanent make-up inks are industrial chemicals regulated by the Australian Industrial Chemicals Introduction Scheme (AICIS). A decision must be made by an importer or manufacturer to determine whether a chemical is on the Australian Inventory of Industrial Chemicals and whether it complies with relevant requirements for introduction.
There is no one national standard for tattoo ink; responsibility is divided. The states and territories monitor tattooing establishments and issues like labels and restrictions on the use of ink.
This implies that Australian suppliers should not only be considering the “approved ink” label.
The difference between EU REACH and other regulations?
The European Union has strict regulations on the use of potentially dangerous ingredients in tattoo and permanent-makeup inks with its REACH regulation. This is especially relevant for suppliers who buy products or pigments formulated in Europe.
The restrictions on the use of certain substances under REACH may apply.
- Heavy metals
- Aromatic amines
- Polycyclic aromatic hydrocarbons (PAHs)
- Other chemicals that might cause harm, such as preservatives
Australian businesses may find it useful to have an additional quality standard for products sourced from Europe that comply with REACH standards; REACH compliance doesn’t necessarily mean Australian compliance.
Where does U.S. MoCRA fit?
The United States has also enacted the Modernization of Cosmetics Regulation Act (MoCRA) to tighten up the oversight of cosmetics. Covered cosmetics must be listed with the FDA and registered at the facility (specific exemptions and requirements exist).
The regulatory issues associated with tattoo inks are special in the USA. According to the FDA, tattoo pigments are color additives, but there are no color additives approved for use specifically in the skin. Another area in which the FDA takes precautions is to prevent microbial contamination of tattoo inks.
Hence, suppliers should refrain from using marketing terms like “FDA-approved tattoo pigment” without being able to identify specifically what approval or authorization is being made. Consult with an expert if you need some assistance regarding tattoo ink supply online.
Organic Doesn’t Mean That It Is Safe
There is a common misconception that using an “organic pigment” is a safer choice than using a synthetic pigment.
In Chemistry, the term organic is used to refer to carbon-containing compounds, rather than to nature or the environment or to any lack of toxicity.
Suppliers should ask for proof of the real pigment and formulation and not just use marketing jargon.
Look for:
- Full ingredient information
- Safety documentation
- Heavy-metal testing
- It is required that the product be batch- or lot-identified.
- Microbial testing
- Certificates of analysis (CoAs)
- Compliance documentation, if applicable, to support REACH compliance.
- Manufacturer traceability
How Can Suppliers Establish a Higher Standard of Safety?
Suppliers can apply a more stringent internal purchasing criterion, even if local standards vary.
Before you import/export tattoo ink, take a moment to think about:
- Check production controls, traceability, and quality systems; verify the manufacturer.
- Ask for certificates in batch: Don’t accept general certificates.
- Test for contamination: Heavy metal and microbiological testing can be useful to help reassure them.
- Verify international restrictions: Reach and U.S. formulations.
- Keep records: Maintain lots and supplier documentation, testing results, and purchase records.
- Check Australian obligations: Check AICIS requirements and applicable state and territory rules prior to introduction and/or use.
- Closing the Australian Ink Safety Gap
International standards are a good point of reference for Australian tattoo-ink suppliers, but should not take the place of Australian compliance.
The best way to buy is to make sure the product is traceable, has verified formulation details, has been tested for contaminants, testifies to microbial control, and is well documented with transparent documentation rather than being labelled “organic,” “non-toxic” or “internationally compliant.
Suppliers which are proactive in developing their quality system around the rigorous international standards may be better placed to protect their artists and clients, as well as their businesses, while also adapting to the changing requirements of Australian tattoo regulations.