Did you know that Canada’s New Substances Notification Regulations (NSNR) apply to NHPs and VHPs? 

Natural Health Products (NHPs) and Veterinary Health Products (VHPs) are regulated under the Food & Drugs Act, but that does not mean they’re exempt from environmental or new-substance rules. If an ingredient — including a living microorganism such as a probiotic strain — is not listed on the Domestic Substances List (DSL) or Revised In-commerce List (R-ICL), it is new to Canada and may require a New Substances Notification (NSN) under the New Substances Notification Regulations (NSNR) administered by Environment and Climate Change Canada (ECCC) and Health Canada’s New Substances program. The NSNR process is separate and independent from product-level reviews under the Food & Drugs Act (e.g., by the Veterinary Drugs Directorate or the NNHPD). 

How does this affect me? 

Regulatory reviews under the Food & Drugs Act focus on product safety, efficacy and labelling for human or animal use. NSNR assesses new substances for environmental and human-health risks under the Canadian Environmental Protection Act (CEPA). Both reviews can and often should run in parallel during product development, but they address different regulatory obligations — failing to file an NSN can result in importation challenges or regulatory enforcement (including steep fines), separate from product approval issues. 

Who needs to file the NSN? 

• Importer of Record: Responsible where the substance is imported into Canada. 
• Canadian Manufacturer: Responsible where the substance is manufactured in Canada. 

These responsibilities are independent of product submissions to the NNHPD or the VDD. Contract language should explicitly assign the notifier role and responsibilities when suppliers or distributors are involved. 

Practical steps to determine if you need to file an NSN 

1. Classify the ingredient 
   • Living organism (viable bacteria, yeast, fungi) → NSNR Organisms considerations. 
   • Chemical/extract/isolate (purified metabolites, inactivated biomass, extracts) → NSNR Chemicals & Polymers considerations and possible low-volume exemptions. 
   • Ingredients found in nature → could be exempt if the ingredient has undergone the only most minimal processing (i.e. dried herbs, aqueous extract, etc.) 

2. Search the Domestic Substances List (DSL) and Revised in-commerce list (R-ICL)
   • Use the government Substances Search tool to see if the substance is already listed. You can search by genus/species, strain names, CAS numbers, etc.  
   • If the strain cannot be confidently matched, treat it as potentially new.  

3. If the substance is not on the DSL or R-ICL (or uncertain), assume an NSN is required 
   • For organisms, notifications are required in any quantity prior to import or manufacture. 
   • For chemicals/polymers, low-volume exemptions thresholds may apply. 

4. Identify the notifier (importer or manufacturer) and gather required documentation. 

5. Identify if a Canadian Agent is required 

6. Consider a Pre-Notification Consultation (PNC) with ECCC if there’s uncertainty, limited data, or reliance on surrogate strains/waivers. 

7. Submit your notification for approval prior to importation/manufacture. 

What must be included in an NSN submission: 

Organisms: 

1. Information about the micro-organism or organism other than a micro-organism; 

2. Manufacturing and import information; 

3. Information on the introduction; 

4. Information on the site of introduction (schedules 3 and 4) 

5. Information on the experimental field study (schedule 3) 

6. Environmental fate information; 

7. Ecological effects information; 

8. Human health effects information; 

9. Additional information. 

Chemicals and Polymers: 

1. Confirmation if the new substance is a chemical or a polymer  

2. Is the new substance on the Non-Domestic Substances List (NDSL)  

3. The annual quantities of the new substance that will be manufactured in or imported into Canada  

4. Determine whether the new substance will have high release to the aquatic environment or significant public exposure 

How can Dell Tech help? 

Dell Tech can support your product launch by reviewing ingredients, verifying DSL/NDSL/R-ICL status, determining the notifier, outlining requirements, and preparing the NSN information package. If needed, we’ll also guide you through the PNC process. With clear responsibilities, complete data, and early coordination, we help keep your launch on track.