Recent chemical agency reclassification as reprotoxic substance likely to lead to EU cosmetics ban for tea tree extract
Tea tree oil, widely used in cosmetics and personal care products for its skin conditioning, complexion-clearing, and antibacterial properties, has been classified as a reproductive toxin by the European Chemicals Agency Risk Assessment Committee (ECHA RAC), making its eventual removal from the European cosmetics marketplace likely. The ECHA RAC's December 2023 Category 1B (H360) classification of tea tree extract as a reprotoxic substance is one step toward a harmonized classification (CLH) as a hazard of highest concern in EU regulations and a cosmetic product ban.
If a full cosmetics ban is implemented without exemption, this will have significant consequences for all brands and manufacturers selling cosmetic products containing tea tree oil in the EU, and all affected products will need be removed from the market or reformulated to remove tea tree oil.
Banned ingredient exemption protocol
Substances classified as CMRs (carcinogenic, mutagenic, and reprotoxic) in EU Classification, Labelling and Packaging (CLP) regulations, including those classified as Category 1B (H360), are banned for use in EU cosmetics unless industry members receive an exemption by demonstrating safe use according to specific criteria as per Article 15 of the EU Cosmetics Regulation (EC) 1223/2009.
Suppliers of tea tree oil may submit a safety dossier to the EU Scientific Committee on Consumer Safety (SCCS) to apply for this exemption. There is currently no certainty that the ingredient will be defended, and the likelihood that tea tree extract will be banned in cosmetics in the EU and Northern Ireland (where EU rules apply) is high, pending publication of the final legislation.
If confirmed, this change will be published as an Adaptation to Technical and Scientific Progress (ATP) to CLP, followed by the addition of tea tree oil to Annex II (prohibited substances) of the EU cosmetics regulation via the next CMR omnibus. Cosmetics already on the market that contain tea tree oil could then continue to be sold until the new CMR omnibus took effect, at which point the remining stock would have to be removed from circulation.
Implications For U.K. and U.S. markets
As the U.K. now operates under a separate chemical and cosmetics regulatory framework to the EU, a potential tea tree oil ban will not apply to cosmetics sold in Great Britain. This could change if U.K. cosmetics regulators follow the EU in a future decision to reclassify tea tree oil as a CMR substance.
For tea tree oil products sold in the U.S., the formally designated responsible person should consider how they will be able to meet the requirement to substantiate safety of products containing tea tree oil under The Modernization of Cosmetics Regulation Act of 2022 (MoCRA), following the EU reclassification.
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