Service(s) related to this article: Health Sciences Consulting
January 15, 2018 – New Substance Notification for Importing in or Manufacturing a Substance and its Products in Canada
In December, Health Canada and Environment and Climate Change Canada published the final Screening Assessment Report and Risk Management Approach for selenium and its compounds. This report concludes that selenium and its compounds may cause harm to the environment or human health. Given this conclusion, a proposal for public comment has also been published to address these risks. For example, one risk management measure proposed is the maximum dose for selenium from a Natural Health Product be finalized at 200 µg/day.
The Chemical Management Plan jointly administered by Health Canada and Environment and Climate Change Canada is responsible for assessments like the Selenium one. Under this plan risk assessments of existing substances, those listed on the DSL, are conducted. During this process, companies may receive risk management proposals as well as notices under the information gathering phase requesting information on their activities with substances, as well as other available toxicological information that informs these assessments.
Another aspect of the Chemical Management Plan is the regulation of the New Substances in Canada. The Canadian Government requires every importer or manufacture of a chemical, polymer, biochemical, biopolymer and living organisms not on the Domestic Substance List in Canada to submit a New Substance Notification (NSN). Canada’s Domestic Substances List (DSL) is a compilation of all known substances that were in Canadian commerce between 1984 and 1986 or that have been added to the DSL through the New Substance Regulations. Substances not listed on the DSL are considered “New Substances” and therefore oversight for them is mandated.
Canada also has a second list of substances called the Non-Domestic Substance List (NDSL). This list contains substances that are still considered “new” to Canada but are in commercial use in the United States. These substances still require a New Substance Notification but have different quantity restrictions on them and different information requirements. Given this, if you are importing or manufacturing a product that contains a New Substance or the New Substance itself, proper classification and notification must be addressed so as to be compliant. Non-compliance with these regulations can come with hefty fines.
These “new” substances are used in a wide variety of products such as in Cosmetics, Natural Health Products, Food Additives, Novel Foods, Personal Care Products, as well as in many industrial processes. Before a “new” substance can be imported or manufactured, a New Substance Notification may be required pending the yearly volumes of the substance. The New Substance Notification System is tiered, requiring subsequent notifications with increasing annual imported or manufactured amounts of the substance. Testing data and other technical and administrative information is required in a notification as prescribed in the New Substances Notification Regulations. The amount of information and data that is needed and the timing of submission is determined by the type of substance involved and the amount that will be imported or manufactured in Canada annually. Government evaluators from both Health Canada and Environment and Climate Change Canada will then review the notification and determine whether the substance poses an unreasonable risk to the environment and human health.
There are certain exceptions to the need to provide a New Substance Notification. Substances that are regulated under the Pest Control Products Regulations, Feeds Regulations, Fertilizers Regulations, Seeds Regulations and Health of Animals Regulations are not required to go through the New Substance Notification Procedure. This is because these products have a separate and distinct pre-market notification procedure.
In summary, if you are a manufacturer or importer of new chemicals, polymers, organisms in Canada or products that contain these substances, you are likely required to provide a New Substance Notification before you begin manufacturing or importing. As the Canadian government continues to evaluate existing substances already in the Canadian marketplace, such as Selenium, we can expect additional requests for information and scrutiny of the program. If you have any questions if you are impacted by these Regulations of have been provided a notice from the Government requesting information on substances please contact dicentra.
dicentra provides sought-after guidance on product and marketing compliance, quality assurance and safety standards, research and development, new ingredient assessments and overall regulatory strategies for food and health-related products sold in North American marketplaces. We can also assist you with your classification determinations for delivery systems or combination drug-device products. We can be reached at 1-866-647-3279 or info@dicentra.com.
The following article originally appeared in March 2017. The preceding article contains more recent information on New Substance Notifications.
The Canadian Government requires every importer or manufacture of a new chemical, polymer, biochemical, biopolymer and living organisms in Canada to submit a New Substance Notification (NSN) to Environment Canada. The Canadian Environmental Protection Act (CEPA), co-administered by Health Canada and Environment Canada, outlines the responsibility of the Canadian Government to protect against adverse events for human health and the environment from chemicals and other substances. To fulfill this objective the New Substance Notification Regulations were developed.
What is a New Substance?
Canada’s Domestic Substances List (DSL) is the basis to determine if a substance is considered “new” to Canada and therefore requires a New Substance Notification. The DSL is a compilation of all known substances that were in Canadian commerce between 1984 and 1986 or that have been added to the DSL through the New Substance Regulations. Substances not listed on the DSL are considered “New Substances”.
Canada has a second list of substance called the Non-Domestic Substance List (NDSL). This list contains substances that are still considered new to Canada but are in commercial use in the U.S. These substances require a New Substance Notification but have different quantity restrictions on them.
These “new” substances are used in a wide variety of products such as in Cosmetics, Natural Health Products, Food Additives, Novel Foods, Personal Care Products, as well as in many industrial processes.
What is in a New Substance Notification?
If a substance that is termed “new” to Canada is to be imported or brought in, a New Substance Notification is required. The New Substance Notification System is tiered in Canada requiring subsequent notifications with increasing annual amounts of imported or manufactured substance. Testing data and other technical and administrative information is required in a notification as prescribed in the New Substances Notification Regulations. The amount of information and data that is needed and the timing of submission is determined by the type of substance involved and the amount that will be imported or manufactured in Canada annually. Government evaluators from both Health Canada and Environment Canada will then review the notification and determine whether the substance poses an unreasonable risk to the environment and human health.
There are certain exceptions to the need to provide a New Substance Notification. Substances that are regulated under the Pest Control Products Regulations, Feeds Regulations, Fertilizers Regulations, Seeds Regulations and Health of Animals Regulations are not required to go through the New Substance Notification Procedure. This is because these products have a separate and distinct notification procedure.
In Summary, if you are a manufacturer or importer of new chemicals, polymers, organisms in Canada you are likely required to provide a New Substance Notification to Environment Canada for your product before you begin manufacturing or importing.
dicentra is a professional consulting firm that specializes in addressing all matters related to safety, quality and compliance for all product categories in the health sciences and food industries. We evaluate, implement, and provide all the necessary support for your products and operations to gain market access and build confidence in your brand. Contact dicentra at 1-866-647-3279 or visit https://dicentra.comto learn more about us and our services in Label Development for Food & Beverage products.