Environment and Climate Change Canada (ECCC) and Health Canada (HC) published their Final Screening Assessment Report (FSAR) for Selenium and its compounds under the Canadian Chemicals Management Plan (CMP). This publication was also accompanied by the corresponding Risk Management Approach (RM Approach) document. This final report largely reflects the draft conclusions as reflected in the corresponding Draft Screening Assessment Report (DSAR) previously published for comment in 2015.
The FSAR re-affirms that Selenium and its compounds (by virtue of their Selenium moiety) be found ‘CEPA-Toxic’ on the basis of both environmental and human health concerns. On this basis, it is proposed that “…selenium and its compounds be added to the List of Toxic Substances in Schedule 1 of the Act.” (Section 2.2, Page 2, RM Approach).
As you are aware, Selenium sulfide (Chemical Abstracts Service [CAS] Registry Number: 7488-56-4) is one of the Selenium compounds included in this grouped assessment. Selenium sulfide is a critical active ingredient in certain anti-dandruff and medicated skin care products, regulated as Natural Health Products in Canada. These findings are therefore relevant from a personal care products perspective.
Overall, none of the underlying drivers behind the environmental or human health concerns identified is specific to these personal care applications. The focus of the environmental findings is primarily based on industrial environmental releases related to coal and metal mining/smelting and electrical generation sectors. On the human health front, the FSAR acknowledges that Selenium sulfide is lawfully “…permitted in anti-dandruff shampoos and skin lotions at concentrations up to 2.5%” and these uses “…are not considered to contribute significantly to total Selenium intake” (Section 7.2, Page 66, FSAR). In this regard, the existing use of Selenium sulfide in anti-dandruff and medicated skin care products are recognized and re-affirmed to be safe, based on current use restrictions. Therefore, no supplemental risk management considerations are proposed for the use of Selenium sulfide in personal care product applications.
Despite these findings, as per the input Cosmetics Alliance (then CCTFA) submitted in response to the DSAR, we remain concerned with how the Government of Canada will ultimately approach the listing of Selenium and its compounds on Schedule 1 of CEPA. Specifically, we are looking to continue to engage with officials to understand how this listing will attempt to reflect on the lawful use of Selenium sulfide in personal care products under present conditions of use. In this regard, Cosmetics Alliance will be providing some input on this FSAR and RM Approach by the close of the posted comment window due February 14, 2018.
If you are interested in these developments or would like to discuss these developments in further detail, please do not hesitate to touch base with your CA Regulatory Team at regulatory@cosmeticsalliance.ca.
