Canada HC, Announced Government Notices on the Use of Trisiloxane in Cosmetics

On January 25, 2025, Health Canada (HC) announced a government notice regarding the use of trisiloxane (3-ethyl-1,1,1,3,5,5,5-heptamethyl-) in cosmetics in the Canada Gazette, Part I, Volume 159, Number 4.

 

The notice states that trisiloxane is not listed on Canada’s Domestic Substance List. Therefore, due to potential concerns regarding reproductive, developmental, and oral toxicity, particularly in cosmetic applications, the notice specifies that information must be provided to the Minister at least 90 days before the substance is used for any Significant New Activity (SNAc).

 

The cases subject to SNAc are as follows:

(a) the use of trisiloxane in the manufacture of a cosmetic other than

(i) hair dye in which the substance is present at a concentration of 5% by weight or less,

(ii) a rinse-off cosmetic in which the substance is present at a concentration of 10% by weight or less, or

(iii) foundation makeup, facial makeup remover, hair gel, or lipstick in which the substance is present at a concentration of 1% by weight or less; and

(b) the distribution for sale of the substance if it is contained in a cosmetic other than those referred to in (a)(i) to (iii).

 

However, the following cases are exempt from SNAc requirements for the use of trisiloxane:

(a) as a research and development substance or as a site-limited intermediated substance or

(b) in the manufacture of a cosmetic that is for export only.

 

Therefore, companies intending to conduct a SNAc involving trisiloxane must provide safety data on toxicity through a SNAN (Significant New Activity Notification) at least 90 days in advance.

 

This guidance has been in effect since January 27, 2025.

 

Please refer to the link below. 

https://gazette.gc.ca/rp-pr/p1/2025/2025-01-25/html/notice-avis-eng.html

Canada Gazette, Part 1, Volume 159, Number 4: GOVERNMENT NOTICES

 

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