SCCS - Scientific Opinion on Tea Tree Oil (CAS/EC No. 68647-73-4 /285-377-1)

SCCS members: U. Bernauer, L. Bodin, Q. Chaudhry (Rapporteur), P.J. Coenraads (Chairperson), J. Ezendam, E. Gaffet, C. L. Galli  (Rapporteur), E. Panteri, V. Rogiers, Ch. Rousselle, M. Stepnik, T. Vanhaecke, S. Wijnhoven
SCCS external experts: E. Benfenati, N. Cabaton, E. Corsini, Ch. Delmaar, A. Koutsodimou, H. Louro, W. Uter, N. von Goetz
Contact: SANTE-SCCSec [dot] europa [dot] eu (SANTE-SCCS[at]ec[dot]europa[dot]eu)
On request from: European Commission
SCCS Number: SCCS/1681/25
Adopted on: 28 May 2025

Conclusion of the opinion:

(1) In light of the data provided and taking under consideration the possible classification as ‘Repr.1B’ under Regulation (EC) No 1272/2008 (CLP Regulation) and the conditions laid out in Article 15 (2) (d) of the Regulation (EC) No 1223/2009, does the SCCS consider TTO safe when used as an anti-seborrheic and anti-microbial agent in rinse-off and leave-on cosmetic products up to the maximum concentrations provided by the applicant?

The SCCS considers the use of Tea Tree Oil (TTO) as an anti-seborrheic and anti-microbial agent safe up to the maximum concentration of 2.0% in shampoo, 1.0% in shower gel, 1.0% in face wash and 0.1% in face cream. The assessment has considered all available data, a possible classification as ‘Repr.1B’ under Regulation (EC) No 1272/2008, the conditions laid out in Article 15 (2) (d) of the Regulation (EC) No 1223/2009, as well as the aggregated exposure from cosmetics and non-cosmetics uses of TTO. 

This Opinion is only applicable to:

• TTO with chemical composition that conforms to the updated International Standard (ISO 4730:2017) in the intended final cosmetic products.
• the use of TTO in the intended dermally applied cosmetic products, and not in aerosolised or sprayable products that may give rise to inhalation exposure of the consumer.

(2) Alternatively, what is according to the SCCS, the maximum concentration considered safe for use of TTO in cosmetic products? 

/

(3) Does the SCCS have any further scientific concerns regarding the use of TTO in cosmetic products?

Based on the data provided, TTO is a moderate skin sensitiser.

The submission did not provide any data on the stability of TTO under the conditions of storage and use. Since the chemical composition of TTO may change due to exposure to light, heat, air and /or moisture, it is not clear how TTO will be stabilised in the final cosmetic products to prevent degradation/transformation of the components. The SCCS is therefore of the opinion that stability of TTO must be maintained in the final cosmetic products so that the components remain within the specifications of the updated ISO 4730:2017 standard.

The SCCS mandate does not address environmental aspects. Therefore, this assessment has not covered the safety of TTO for the environment.

Keywords:

SCCS, scientific Opinion, Tea Tree Oil, Regulation 1223/2009, CAS/EC No. 68647-73-4 /285-377-1

Opinion to be cited as:

SCCS (Scientific Committee on Consumer Safety), Scientific Opinion on Tea Tree Oil (CAS/EC No. 68647-73-4 /285-377-1) used in cosmetic products, preliminary version of 28 May 2025, SCCS/1681/25.