Canadian New Substance Notifications (NSNs)

Experien Health Sciences staff, along with the staff our long-time strategic partner and NSN expert in Ottawa Ontario Canada, have been notifying new substances in Canada since the Canadian Environmental Protection Act (CEPA) NSN regulations were first introduced in 1994 and we have kept up with the many changes that have occurred in the years since.

The agency that regulates the manufacture and import of chemicals placed on the Canadian market is Environment and Climate Change Canada (ECCC) and while there are many similarities with the processes in place in other countries, Canada’s NSN process also has some important differences. For example, there are multiple notification Schedules, each of which apply to specific circumstances depending on the status of your chemical or polymer under the regulations and each Schedule grants a different status under the rules, and not all paths lead to a listing on Canada’s Domestic Substances List (DSL).

Unlike many countries, Canada doesn’t have a polymer exemption category and instead regulates all polymers but allowing some polymers to qualify under their Reduced Regulatory Requirements (RRR). Therefore, choosing the right Schedule to notify under can make the difference between a successful business strategy and a failed one.

Our team here in the U.S., with support from our expert in Canada, is well positioned and has the necessary experience to:

  • Help you understand the impact Canada’s NSN regulations have on your business, and help you decide which role in the notification process best fits your strategic plans.
  • Determine the status of your chemical substance or polymer as either a new or existing substance on the Domestic Substance List (DSL) or non-Domestic Substance List (NDSL). New substances require a notification to ECCC before manufacture in Canada or import into Canada in excess of 100 kg unless the business activity qualifies under an R&D or other exemption.
  • File a Confidential Search Request with ECCC to see if your chemical substance or polymer is on the confidential portion of the DSL or NDSL.
  • Determine if any Significant New Activity (SNAc) determinations apply to your chemical substance or polymer that might require you to submit a Significant New Activity Notification (SNAN).
  • Help you understand the data requirements, cost, and timing of filing an NSN for your substance, and help you identify any cost-saving data waivers that can be applied.
  • Help you obtain the physical-chemical, toxicological, eco-toxicological, environmental fate, and exposure data that may be required to support your notification, whether through testing using qualified laboratories or by identifying analog or read-across data to include in your submission.
  • Complete the required documentation and submit it to ECCC electronically through their Single Window system.
  • Help protect your confidential business information (CBI) by ensuring ECCC’s CBI rules are followed and, if necessary, proposing a masked name for your chemical substance or polymer.
  • File the required Notice of Manufacture or Import to add the chemical substance or polymer to the DSL.
  • Nominate substances on the NDSL to the DSL.
  • Serve as your Canadian Agent.