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Tuesday, May 14, 2019Regulation

Canada is preparing several amendments to the Cosmetic Ingredient Hotlist

Modification de la Liste critique des ingrédients cosmétiques

On May 3, 2019, Health Canada opened a consultation on several updates of the Cosmetic Ingredient Hotlist. In the scope: the authorisation of Dihydrocoumarin and Thiurames which were previously prohibited, the mandatory labelling of a warning statement for eucalyptus essential oil, the prohibition of Sodium Bromate and new conditions of use for Thioglycolic Acid and its salts.. The consultation is opened until July 1st, 2019.

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In the words of the Canadian institution, the Cosmetic Ingredient Hotlist is “an administrative tool that Health Canada uses to communicate to manufacturers and others that certain substances, when present in a cosmetic, may contravene the general prohibition found in section 16 of the Food and Drugs Act or a provision of the Cosmetic Regulations.”
Its last update was in September 2018.
The one proposed today covers five ingredients.

Dihydrocoumarin (CAS: 119-84-6)

A revision is being considered to change this entry from a prohibition to a restriction.

Health Canada’s explanation
The ingredient is naturally occurring in some plant derivatives at low levels. A review of the available scientific data indicates that the ingredient may cause sensitization at higher concentrations but can be used at low levels without significant risk.

Proposed Hotlist Conditions
• In leave-on products, maximum concentration permitted: 0.035%
• In rinse-off products, maximum concentration permitted: 3.5%

Regulation in Europe
The substance, when used as a fragrance ingredient, is listed in Annex II (Prohibited Substances) to Cosmetics Regulation.

Disulfiram, Thiuram, Thiuram disulfides, and Thiuram monosulfides (CAS: 97-77-8 / 137-26-8 )

A revision is being considered to combine these entries under a single entry for “Thiurams”. This entry will also …

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