CEPA Compliance Support
Dell Tech helps you navigate the CEPA regulatory pathway. We determine if your substance qualifies as a New Substance and prepare the documentation needed for submission.
Before introducing a new chemical or polymer into Canada, companies must comply with CEPA’s New Substance Notification (NSN) requirements. Dell Tech evaluates substances, prepares complete NSN submissions, and serves as your Canadian Agent to help ensure timely regulatory compliance and market entry.
Dell Tech’s regulatory team can complete a full submission package or provide consulting at any stage.
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 assesses 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.
Under the New Substance Notification Regulations for Chemicals and Polymers and the New Substances Notifications for 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 that will be imported or manufactured into Canada. Specific physical/chemical information is required depending on which Schedule the substance falls under.
There are prescribed timelines on the assessment for each submission. ECCC does not appreciate notifications being submitted too early as this can create extra burden on their reviewers 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.
The New Substance Notification Regulations are based on volume, either manufactured or imported. Each submission type or Schedule has a different “cutoff” for trigger volume and 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.
Yes. A NSN submission can be rejected by ECCC for a number of reasons. A notification will be rejected if:
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.
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.
Whether you are preparing to launch a new device in Canada or need support maintaining compliance for an existing product, Dell Tech can help. Contact us today to get started.