The European Commission's Scientific Committee on Consumer Safety (SCCS) has issued a preliminary opinion confirming the safe use of Tea Tree Oil (TTO) in cosmetic products under defined limits. Published on 28 May 2025, this finding holds major implications for manufacturers, formulators, and regulatory teams across the cosmetics and consumer goods sectors.
The SCCS’s assessment follows proposals to classify TTO as a Category 1B reproductive toxicant under the CLP Regulation (EC) No 1272/2008. Despite these concerns, TTO has been deemed safe when used as an anti-seborrheic and anti-microbial agent, provided concentrations do not exceed:
- 2.0% in shampoos
- 1.0% in shower gels and face wash
- 0.1% in face creams
The opinion supports continued use of TTO under Article 15(2)(d) of the Cosmetics Regulation (EC) No 1223/2009, which permits use of classified substances under tightly controlled circumstances.
Background on Tea Tree Oil Safety and Regulation
Tea Tree Oil, derived from Melaleuca alternifolia, is a widely used essential oil with known anti-microbial and skin-conditioning properties. While effective, it is also a moderate skin sensitiser, and its chemical stability under consumer use conditions remains a concern.
The SCCS’s approval is limited to TTO that conforms to the ISO 4730:2017 standard and excludes any aerosol or spray-based products due to potential inhalation risks. Formulators must also ensure the stability of TTO throughout the product lifecycle to avoid degradation into potentially harmful compounds.
This move comes amid wider scrutiny under the EU’s Chemicals Strategy for Sustainability, where essential oils and natural extracts are being re-evaluated for their long-term safety profiles.
What the Policy Means
The ruling provides regulatory clarity for industry professionals navigating the complex intersection of natural ingredients and CMR classifications. Manufacturers, especially those exporting into the EU, must now verify the chemical composition and sourcing of TTO used in their formulations.
Non-compliance could result in product reformulations or withdrawals. Meanwhile, downstream users—including retailers, quality control teams, and safety assessors—must stay abreast of labelling obligations and safety documentation.
