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Monday, December 11, 2023Regulation

Tea Tree EO, HEMA and HMPA: ECHA's RAC opinions on the proposed CLH classifications

HE de Tea Tree, HEMA et HMPA : les avis du CER de l'ECHA sur les propositions de classifications CLH

On 7 December 2023, the European Chemicals Agency (ECHA) announced that its Risk Assessment Committee (RAC) had adopted eight opinions on proposals for harmonised classification and labelling (CLH). Three of these concern ingredients that may be used in cosmetic products, and include a CMR classification for Tea Tree extracts and essential oils.

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Tea Tree

Tea tree (Melaleuca alternifolia) extracts and essential oil (CAS: 85085-48-9 / 68647-73-4; EC: 285-377-1) are ingredients listed in the CosIng, with different functions: antioxidant, fragrance…).
Currently, they are not regulated by the Cosmetics Regulation 1223/2009 and are not listed in Annex VI of the CLP Regulation.

The classification proposal
Poland has proposed classifying them: 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

The RAC opinion
The RAC agreed that these substances should be classified as:
Repr. 1B, H360F - May damage fertility
Repr. 2, H360d - Suspected of damaging the …

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