ATTIA Ltd represents more than 90% of the Australian tea tree oil industry. As the
peak body for producers, exporters and associated industries, we welcome the
opportunity to clarify the current EU regulatory developments and their relevance to
formulators worldwide.
The proposed harmonised classification for tea tree oil currently progressing
through the EU system has generated understandable concern across cosmetics,
personal care, biocides and other downstream sectors. For Australian producers,
formulators and global brands, the issue is not a new safety signal but the
implications of a regulatory pathway that does not reflect the totality of evidence.
1.Divergence in EU Scientific Assessments
The current proposal originates from the Risk Assessment Committee (RAC) under
the CLP Regulation, which applies a hazard-only methodology. This approach does
not consider exposure, realistic use conditions, or the extensive real-world history of
tea tree oil in formulated products.
This stands in clear contrast to the SCCS’s comprehensive 2023 opinion, which
reviewed the full toxicological dataset, dermal exposure scenarios, impurity profiles
and consumer use patterns. The SCCS concluded that tea tree oil can be used
safely in cosmetic applications within established conditions.
The inconsistency between these two assessments — one hazard-based, one risk-
based — has created significant uncertainty for global markets. From ATTIA’s
perspective, this is fundamentally a process issue, not a question of product safety.
Regulatory decisions with wide-ranging commercial and scientific ramifications
must be grounded in the full body of evidence.
2.ISO 4730: Identity Standard, Not a Quality or Safety Standard
Many formulators have asked whether the EU developments relate specifically to
compliance with ISO 4730. They do not.
ISO 4730 defines the characteristic identity profile of Melaleuca alternifolia essential
oil, specifying compositional ranges and basic physical properties. It
does not assess:
• purity
• adulteration
• traceability
• safety
• agricultural or manufacturing practice
Because it is an identity-only standard, it is technically possible for adulterated or
reconstructed products to meet the ISO profile if blended to fall within the required
terpene ranges.
For Australian producers, ISO 4730 is therefore the starting point, not the quality
benchmark.
3.ATTIA’s Code of Practice: The Global Quality and Purity Standard
The ATTIA Code of Practice (COP), now in its 25th year, goes far beyond ISO 4730
to establish a comprehensive quality, purity and authenticity framework. It includes:
• impurity and adulteration testing
• strict good agricultural and distillation practice
• independent auditing
• full traceability from plantation to finished oil
• verification of batch authenticity
Formulators seeking confidence in ingredient integrity should view ATTIA COP–
certified oil as the benchmark for high-quality, fully traceable Australian supply.
4.Guidance for Formulators and Brands
While the EU process continues, formulators are encouraged to:
• Use pure Australian tea tree oil within recognised safe-use levels and
according to regional requirements.
• Request full documentation from suppliers, including Certificate of Analysis
and evidence of COP compliance.
• Avoid premature reformulation driven by misconceptions rather than
regulatory facts.
• Seek clarification early when preparing EU or global cosmetic dossiers.
5.ATTIA’s Ongoing Commitment
ATTIA remains actively engaged with stakeholders and committed to providing
transparent, evidence-based information throughout the EU process. Formulators,
R&D teams and procurement specialists seeking further guidance are welcome to
contact ATTIA directly.