EU Regulatory Developments Affecting Tea Tree Oil
ATTIA’s expert perspective on this development and what it truly means for safe, responsible formulation.
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.
