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SCCS Issued Final Opinion on Tea Tree Oil

from CIRS by

On November 14, 2025, the European Union's Scientific Committee on Consumer Safety (SCCS) published its final opinion (SCCS/1681/25) on Tea Tree Oil (CAS/EC No. 68647-73-4 /285-377-1). This follows the draft opinion published on June 6, which had been open for public comments. While the final opinion remains largely consistent with the consultation draft, it includes several important updates. These are highlighted in bold throughout the text below.

EU,Cosmetic,SCCS,Ingredient,Safety,Opinion

Final Opinion on Tea Tree Oil

The SCCS concludes the following:

1. The SCCS considers the use of Tea Tree Oil (TTO) as an anti-seborrheic and anti-microbial agent safe in four defended product types – 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 including the aggregated exposure from the defended cosmetic products 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 defended final cosmetic products.
  • The use of TTO in the defended dermally applied cosmetic products exclusively for adults, and not in aerosolised or sprayable delivery formats that may give rise to inhalation exposure of the consumer to TTO through airborne mist/droplets of the TTO-containing products.

2. 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 new version of ISO standard (ISO 4730:2025), which relates to enantiomeric distribution parameters for α-terpineol in the essential oil of Melaleuca, terpinen-4-ol type (tea tree oil), should also be taken into account.

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

Regulatory Requirements Interpretation of Tea Tree Oil (TTO)

The Global Cosmetic Ingredient Regulatory Database – Global CosIng, an upgraded version of China CosIng independently developed by CIRS Group, indicates that Tea Tree Oil (CAS No. 68647-73-4) is included in the following key lists globally.

In China, it has been included in the Inventory of Existing Cosmetic Ingredients in China (IECIC) (I) and the Usage Information of Selected Ingredients Included in the International Authoritative Cosmetic Safety Assessment Data Index. More details could be found in the following figure.

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3.1

For more detailed information about Global CosIng or if you need any assistance or have any questions, please get in touch with us via service@cirs-group.com..

Further Information

https://health.ec.europa.eu/document/download/827f8a57-c6f2-4d6d-9bbd-2ef12384ffbf_en?filename=sccs_o_303.pdf

  

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