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Tea Tree Oil (TTO), also known by its INCI name Melaleuca Alternifolia Leaf Oil, is a widely used natural ingredient in cosmetics thanks to its antimicrobial and soothing properties. You’ll find it in a wide range of products, including shampoos, facial cleansers, and creams. Now, its regulatory status in the European Union is now under scrutiny.
Following its classification as a CMR substance category 1B for reproductive toxicity by ECHA, the future use of Tea Tree Oil in cosmetics depends on strict regulatory conditions and risk assessments. On the 6th of June 2025, the Scientific Committee on Consumer Safety (SCCS) published a preliminary opinion evaluating its safety.
Where is Tea Tree Oil used in cosmetics?
Its popularity in the natural cosmetics segment makes this opinion particularly relevant for brands looking to maintain market access in the EU.
Tea Tree Oil is a common ingredient in cosmetic products such as:
- Shampoos and scalp treatments (for its anti-dandruff and antimicrobial action).
- Facial cleansers and gels (targeting blemishes and excess sebum).
- Face creams and leave-on formulations (often promoted as natural purifiers).
- Fragranced products and minor preservative uses.
What does the SCCS opinion say about Tea Tree Oil?
The SCCS concludes that Tea Tree Oil can be considered safe under specific conditions. These include maximum concentration limits and strict compositional requirements to mitigate its toxicological and sensitising effects.
The following concentrations are deemed safe by the SCCS:
- Up to 2.0% in shampoos
- Up to 1.0% in shower gels and facial cleansers
- Up to 0.1% in face cream
Beyond these limits, safety cannot be guaranteed under the SCCS criteria due to the oil’s potential for skin sensitisation and reproductive toxicity.
Importantly, Tea Tree Oil used in cosmetics must comply with ISO 4730:2017, a standard that defines acceptable ranges for key constituents such as terpinen-4-ol and limits on impurities. This ensures chemical consistency and reduces the risk of degradation products forming during storage.
Additionally, its use is limited to rinse-off or water-based leave-on formulations. Spray products or aerosols are excluded, as inhalation exposure has not been deemed safe by the SCCS.
Key regulatory timeline for Tea Tree Oil
The classification of Tea Tree Oil as a CMR category 1B was adopted by the ECHA Risk Assessment Committee (RAC) in November 2023, triggering a potential ban under EU cosmetics law. However, a derogation was proposed, leading to this SCCS safety assessment.
Key dates include:
- 6th June 2025 – SCCS preliminary opinion published.
- 18th August 2025 – Deadline for public consultation.
- July 2026 (tentative) – Expected enforcement of restrictions or bans based on final regulatory decisions.
If the opinion remains unchanged and no further derogation is granted, products that do not meet the established limits will no longer be allowed on the EU market.
What do cosmetic brands need to do now?
To remain compliant with EU Cosmetic Regulation, companies using Tea Tree Oil must act quickly. This involves a combination of technical documentation, supplier coordination, and proactive regulatory strategy.
Participate in the public consultation before the 18th of August 2025, if your business may be affected, and prepare contingency plans in case a ban or tighter restriction is confirmed in the final SCCS opinion.
Failure to comply could lead to market withdrawal, reformulation needs, or enforcement actions by national authorities.
How Cosmeservice can help
At Cosmeservice, we provide end-to-end support for regulatory compliance across the EU, UK, USA and Canada. If your cosmetic products contain Tea Tree Oil or other substances under evaluation, we can help you with:
- Checking your formulations, to ensure they fall within the permitted concentration limits.
- Guidance in obtaining certificates of conformity from your raw material suppliers to confirm compliance with ISO 4730:2017.
- Assessing product stability and confirm that Tea Tree Oil remains chemically stable under storage conditions.
- Updating your Product Information File (PIF), particularly CPSR and toxicological data.
With our regulatory expertise, you can stay ahead of EU changes and avoid costly disruptions. Need support adapting your formulas to the new SCCS Tea Tree Oil opinion?
Contact our team at info@cosmeservice.com for expert assistance.
References
- SCCS Preliminary Opinion on Tea Tree Oil – SCCS/1681/25 (June 2025)
- RAC Opinion – Classification of Tea Tree Oil as CMR 1B (ECHA)
- ISO 4730:2017 – Oil of Melaleuca, terpinen-4-ol type (Tea Tree Oil)
