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Monday, September 24, 2018European Commission

RAC concludes on 14 opinions on harmonised classification and labelling

Proposition du RAC de classifications harmonisées

ECHA’s Committee for Risk Assessment (RAC) adopted its opinions on 14 harmonised classification and labelling proposals. Several substances are used in cosmetics, including two fragrance ingredients – Citral and Geraniol, a film-forming – Methyltrimethoxysilane, a solvent – Butoxyethanol, and two preservatives – Sodium Hydroxymethylglycinate and Zinc Pyrithione (also anti-dandruff agent).

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Methyltrimethoxysilane

• Chemical name: Trimethoxy(methyl)silane
• CAS number: 1185-55-3
• CosIng function: film-forming

RAC’s Opinion
The substance has no existing entry in Annex VI to the CLP Regulation.
RAC did not find the available skin sensitisation data conclusive and thus, contrary to the proposal by Sweden, did not classify trimethoxy(methyl)silane as a skin sensitiser.

Sodium hydroxymethylglycinate

• Chemical name: Sodium N-(hydroxymethyl)glycinate
• CAS number: 70161-44-3
• CosIng functions: hair conditioning, preservative (entry 51, Annex V to Cosmetics Regulation 1223/2009)

RAC’s Opinion
The substance sodium N-(hydroxymethyl)glycinate is an active substance releasing formaldehyde.
The substance has no existing entry in Annex VI to the CLP Regulation.
RAC supported the proposal by Austria to classify sodium N-(hydroxymethyl)glycinate as a substance that may cause cancer (Carc. 1B; H350) and as suspected of causing genetic defects (Muta 2; H341), assigning additional notes 9 and 8 to carcinogenicity and mutagenicity for classification of mixtures. RAC further supported the proposal to classify the substance as harmful if swallowed (Acute Tox. 4, ATE = 1050 mg/kg bw), causing skin irritation (Skin Irrit. 2), serious eye irritation (Eye Irrit. 2) and as a substance that may cause an allergic skin reaction (Skin Sens. 1). In addition, contrary to the …

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