Last Updated on July 6, 2021 by Ithos Global Regulatory Team
Canada is updating its new substance notification and test guidelines, which date back to 2005. Substances which are used in Canada used above certain thresholds need to be listed if not already on the Domestic Substances List (DSL). The process is called New Substance Notification (NSN). If a substance is not on the DSL, one needs to track, test, and do a risk assessment.
A “near final” March 2021 draft was released and is being reviewed by an industry coalition. Industry has received notice that 27 sections and charts have been updated. There will also be new sections on nano materials and assessment technology.
The guidelines are meant to:
- help the user to determine whether a substance is subject to notification and the applicable timelines;
- outline the treatment of confidential information;
- provide guidance on acceptable test methods, alternative information and waiver requests;
- explain how the New Substances program assesses the submitted information; and
- describes the possible decisions following the assessment of a new substance
Current feedback reflects meaningful and practical changes have been made, with clearer details and examples. The finalized document will reside on the NSN website.