What’s new?
On 30 October 2025, The Scientific Committee on Consumer Safety (SCCS) adopted its final opinion on Tea Tree Oil (TTO), following public consultation that ended in August 2025. This assessment was conducted under Article 15(2)(d) of the EU Cosmetics Regulation, which provides a safety pathway for substances classified as CMR (Carcinogenic, Mutagenic, or toxic to Reproduction) when sufficient safety data demonstrates their safe use in cosmetics.
This assessment addresses the European Chemicals Agency (ECHA) Risk Assessment Committee (RAC) opinion classifying Tea Tree Oil as a category 1B reproductive toxicant. The SCCS evaluation was requested by the European Commission to determine whether industry-submitted safety data could support continued cosmetic use, as an anti-seborrheic and anti-microbial agent, under the CMR derogation provisions.
Tea Tree Oil (CAS/EC No. 68647-73-4 /285-377-1), with INCI name Melaleuca alternifolia leaf oil, is a complex mixture of mono- and sesquiterpenes used in cosmetics for its antimicrobial, skin conditioning, antioxidant and perfuming properties. This Opinion specifically evaluates TTO’s safety, addressing aggregated exposure from both cosmetic and non-cosmetic sources, and considering it as a moderate skin sensitizer.
Key provisions:
The SCCS concludes that Tea Tree Oil is safe when used as an anti-seborrheic and anti-microbial agent at the following maximum concentrations:
- 2.0% in shampoo
- 1.0% in shower gel
- 1.0% in face wash
- 0.1% in face cream
The Opinion applies only to dermally applied cosmetic products for adults, excluding aerosolised or sprayable products that may cause inhalation exposure.
- TTO must maintain stability in final cosmetic products to prevent degradation/transformation of components
- Chemical composition must remain within specifications of the updated ISO 4730:2017 standard throughout product shelf life
- The new version of ISO 4730:2025, related to enantiomeric distribution parameters for terpinen-4-ol type (tea tree oil), should also be taken into account.
What now?
The European Commission will likely amend Annex III of the Cosmetics Regulation to implement these restrictions, with typical transition periods of 18-24 months for compliance.
