On 7 December 2023, the European Chemicals Agency announced that its Risk Assessment Committee (RAC) adopted an opinion on the proposal for harmonised classification and labelling (CLH) of Tea tree (Melaleuca alternifolia) extract and essential oil (CAS no: 85085-48-9).
Background in cosmetics
Tea tree (Melaleuca alternifolia) extract and essential oil are not currently included in any of the Annexes to the EU Cosmetics Regulation 1223/2009, and thus can be used without any restriction in cosmetic products.
Proposed harmonised classifications
Poland has proposed to classify Tea tree (Melaleuca alternifolia) extract and essential oil as:
- Flam. Liq. 3, H226 – Flammable liquid and vapour
- Acute Tox. 4, H302 – Harmful if swallowed, oral: ATE=1049 mg/kg bw
- Acute Tox. 4, H332 – Harmful if inhaled, inhalation: ATE=3.64 mg/L (mist)
- Skin Irrit. 2, H315 – Causes skin irritation
- Skin Sens. 1B, H317 – May cause an allergic skin reaction
- Repr. 2, H361f – Suspected of damaging fertility
- Asp. Tox. 1, H304 – May be fatal if swallowed and enters airways
- Aquatic Acute 1, H400 – Very toxic to aquatic life, M-factor M=1
- Aquatic Chronic 3, H412 – Harmful to aquatic life with long-lasting effects
RAC opinion
RAC concluded that classifications were warranted in nine hazard classes, with reproductive toxicity (cat. 1B) being the most stringent.
Conclusion
The future use of Tea tree (Melaleuca alternifolia) extract and essential oil in cosmetics may face potential threats.
Article 15 of the Cosmetics Regulation 1223/2009 contains provisions on the use of CMR in cosmetic products. As a general principle, substances classified as CMR substances of category 1A, 1B, or 2 under Part 3 of Annex VI to Regulation (EC) No 1272/2008 are banned for use in cosmetic products. Exceptions to this general rule are possible subject to the conditions laid down in Article 15 of the Cosmetics Regulation.