Chemical, microbiological and biotechnological substances
The Canadian Environmental Protection Act (CEPA) was passed in 1999 to promote sustainable development by preventing pollution, and protecting human health and the environment from risks associated with toxic substances. CEPA defines “toxic” substances as those that may have harmful effects on the environment, could be dangerous to the environment that life depends on, or could be dangerous to human health.
Under CEPA, all chemical and microbial substances new to Canada must be assessed for human health and environmental risks. Any substance not listed on the Domestic Substances List (DSL) is considered a new substance and subject to Canada’s New Substance Notification Regulations (NSNR). NSNR apply to chemicals, polymers, biochemicals, biopolymers, microorganisms and animate products of biotechnology, such as bacteria, fungi, and genetically modified fish and livestock.
TSG can help
- Evaluate DSL and NDSL chemical substances
- Determine notification schedule
- Prepare and submit NSNs
- Prepare and submit Notices of Manufacture/Import (NOMI) or Notice of Excess Quantity (NOEQ)
- Determine eligibility for CEPA’s Reduced Regulatory Requirements (RRR)
- Act as a Canadian agent for non-resident importers
- Undertake a technical review of microbial characterization, for NSNR - Organisms (NSNR-O)
- Prepare and submit Pre-notification Consultation (PNC)
- Technical review of microbial characterization for NSNR-Organisms (NSNR-O)
- Technical review of genetically engineered microorganisms and products of commercial significance
- Technical review and advice on production process and QC check points
- Determine the eligibility of exemptions in the relevant notification package
TSG provides companies with high-quality regulatory and scientific consulting services. We aim to understand our clients' goals and objectives, learn the scientific and technical aspects of projects and anticipate compliance challenges to plan a strategic path forward. TSG's team of experts is deadline-focused, responsive and committed to professionalism. We have the utmost respect for the confidentiality of our work, strong project management skills, and take great measure to cultivate long-term partnerships with clients.
TSG’s consultants are highly knowledgeable in the notification of new chemicals and polymers under CEPA. We can determine which notification schedules are needed and whether new polymers meet the CEPA Reduced Regulatory Requirements (RRR), and which ones require minimal notification data. Our team is led by Saadia Eltayeb, who has over 20 years of experience helping companies navigate and understand the changing regulatory landscapes in both Canada and the USA. The team also includes Om Singh, Senior Scientific Consultant, who has over 20 years of scientific research experience in Molecular Biology and Microbiology assisting industries to navigate the data requirements for NSNR-O submissions.