New Substance Notification
Dell Tech’s regulatory consultants can help you compile a submission package for a New Substance Notification form as well as submit this package to ECCC on your behalf. We also act as the Canadian Agent for any US companies who will be importing the substance into Canada.
New Substance Notification
Under the Canadian Environmental Protections Act (CEPA), all chemical substances imported to, or manufactured in Canada, must be assessed for risk to human health and the environment.
Any substance not included on the Domestic Substances List (DSL) is considered a New Substance and subject to Canada’s New Substance Notification Regulations (NSNR).
The NSNR applies to chemicals, polymers, biochemicals, biopolymers, and animate products of biotechnology (living organisms), such as bacteria, fungi, and genetically modified fish and livestock.
HOW DELL TECH CAN HELP WITH A NEW SUSTANCE NOTIFICATION:
Dell Tech’s Regulatory Affairs professionals can complete the following to assist you with your New Substance Notification:
- Evaluate DSL and NDSL chemical substances
- Determine if Significant New Activity Notices (SNAc), Ministerial Conditions, Prohibitions, or Section 71 notices apply to the substance
- Determine if the product use is exempt from New Substance Notification Regulations (NSNR)
- Determine if the use is eligible for Special Category Notifications for R&D, Site Limits or Export Only activities
- Determine NSNR Notification schedule, data requirements, timing, and costs
- Review the notification dossier to identify potential roadblocks to success
- Prepare and submit NSNs for Manufactures, Non-Resident Importers, and/or Foreign Suppliers
- Prepare and submit Notices of Manufacture/Import (NOMI) or Notice of Excess Quantity (NOEQ)
- Determine eligibility for CEPA’s Reduced Regulatory Requirements (RRR) for polymers
- Act as a Canadian agent for foreign companies
Frequently Asked Questions about New Substance Notification:
What is a new substance?
A new substance or ingredient is considered “new” to the Canadian market if it has not undergone an assessment by Environment and Climate Change Canada (ECCC). ECCC assess ingredients to determine its potential effects on human and environmental health. These substances are often used in other countries with no issues, but if they are imported into Canada, they must undergo a review process in order to determine if the substance is safe under the requirements of Canadian Environmental Protection Act, 1999 (CEPA).
A New Substance Notification (NSN) must be submitted to ECCC to initiate this review process.
What is a new substance notfication?
Under the New Substance Notification Regulations for Chemicals and Polymers and Organisms, a person must submit to the Minister of the Environment the information required in Section 64 of CEPA prior to importation or manufacturing of any substance that is not present on the Domestic Substances List. All substances fall into a Schedule based on the type of substance it is and the volume of that substance that will be imported or manufactured. Specific physical/chemical information is required depending on which Schedule the substance falls under.
How early can I submit a new substance notification?
There are prescribed timelines on the assessment for each submission. ECCC does not appreciate notifications being submitted too early as this can slow the review process down for all notifications submitted. Each of the Schedules have different assessment periods. You will need to take into account the amount of time it will take to reach the trigger volume and how long the assessment period is for the substance.
What is a trigger volume or limit and can I go over that limit?
The New Substance Notification Regulations are based on volume, either, manufactured or imported. Each submission type (or Schedule) has a different “cutoff” or trigger volume that must be projected before a notification is required. For example, a substance that is present on the NDSL has an initial trigger volume of 1000 kg/calendar year. A notification must be submitted prior to reaching this trigger volume.
Can a notification be rejected by Environment and Climate Change Canada?
Yes. An NSN submission can be rejected by ECCC for a number of reasons. A notification will be rejected if:
- The submission package is incomplete or missing information. The assessment period will not begin until all information has been provided; or
- The substance is deemed to be toxic or capable of becoming toxic as defined by CEPA.
What happens after I receive approval from Environment and Climate Change Canada?
Once the assessment period is over and you receive confirmation from ECCC, you may import or manufacture the substance up until it reaches the next trigger volume. At this point, you may need to submit another notification, depending on the volume of the substance being imported or manufactured.
What are the potential consequences of not complying with the NSNR?
If a notification is not received or has been rejected, then you are unable to import or manufacture the substance in question. Companies that continue to import without following CEPA are subject to up to $1 million per day fines for non-compliance.