Navigating Canadian environmental regulations: A case study on NSNR compliance
By Innomar Strategies
Environment requirements for New Substances in Canada
Understanding the regulatory landscape is crucial for companies operating in Canada, especially concerning environmental assessments. The Canadian Environmental Protection Act, 1999 (CEPA 1999) aims to prevent pollution and protect both environment and human health. Under the Act, the New Substances Notification Regulations (NSNRs) mandate that any New Substance (NS) must be evaluated for human health and environmental risks before manufacturing or importation into Canada.
The NSNRs are Canadian specific and define what qualifies as a NS and when an environmental dossier (New Substance Notification – NSN) must be submitted, as well as the information and data required. The NSNRs are not aligned with the approach of either US or EU for Environmental Assessment (EA), including any exemption defined for those jurisdictions.
In Canada, the initial EA is not part of the marketing application/clinical trial application dossier. It is a distinct filing to the New Substances program, which is jointly administered by Environment and Climate Change Canada (ECCC) and Health Canada’s New Substances Assessment and Control Bureau.
The data requirements depend on the class of each NS (chemical/biochemical, polymer biopolymer, or micro-organism/higher level organism), its intended use, and annual quantity/first introduction. Notification involves a tiered approach. Data are provided or updated as thresholds are reached, or previously approved use is changed.
To illustrate the complexities and challenges faced when navigating these regulations, the following case study presents a real-world example of how a client successfully achieved compliance with their NSNRs through the guidance of Innomar’s Regulatory Team. This case study outlines the challenges encountered in identifying new substances, the strategic interventions implemented, and the resulting successes, including the timely filing of all required NSNs and the establishment of robust procedures to maintain ongoing compliance.
The NSNRs are Canadian specific and define what qualifies as a NS and when an environmental dossier (New Substance Notification – NSN) must be submitted, as well as the information and data required. The NSNRs are not aligned with the approach of either US or EU for Environmental Assessment (EA), including any exemption defined for those jurisdictions.
In Canada, the initial EA is not part of the marketing application/clinical trial application dossier. It is a distinct filing to the New Substances program, which is jointly administered by Environment and Climate Change Canada (ECCC) and Health Canada’s New Substances Assessment and Control Bureau.
The data requirements depend on the class of each NS (chemical/biochemical, polymer biopolymer, or micro-organism/higher level organism), its intended use, and annual quantity/first introduction. Notification involves a tiered approach. Data are provided or updated as thresholds are reached, or previously approved use is changed.
To illustrate the complexities and challenges faced when navigating these regulations, the following case study presents a real-world example of how a client successfully achieved compliance with their NSNRs through the guidance of Innomar’s Regulatory Team. This case study outlines the challenges encountered in identifying new substances, the strategic interventions implemented, and the resulting successes, including the timely filing of all required NSNs and the establishment of robust procedures to maintain ongoing compliance.
The information provided in this piece does not constitute legal or medical advice. Innomar Strategies Inc. and its parent Cencora, Inc. strongly encourage the audience to review available information related to the topics discussed to rely on their own experience and expertise in making decisions related thereto. Further, the contents of this piece are owned by Innomar Strategies, and reproduction is not permitted without the consent of Innomar Strategies.
Topics:
Regulatory
