Results of the prioritization of the Revised In Commerce List
The Revised In Commerce List (R-ICL) is a list of substances, used in products regulated by the Food and Drugs Act (F&DA), that were in Canadian commerce between January 1987 and September 2001. This was a transition period preceding the date on which new substances used in these products became subject to the New Substances Notification Regulations (NSNR) of the Canadian Environmental Protection Act, 1999 (CEPA 1999). Substances on the R-ICL include substances in pharmaceuticals, veterinary drugs, cosmetics, biologics, food products, natural health products, and medical devices. Under the Chemicals Management Plan (CMP), Health Canada prioritized substances on the R-ICL to identify those that may require further evaluation to determine whether they pose a risk to human health or the environment.
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As of 2016, the prioritization process was applied to approximately 3,500 substances based on information available at the time to separate those that are unlikely to require further work from those that could represent priorities for risk assessment, or which require further information.
The initial prioritization of substances on the R-ICL resulted in approximately 25% of substances being prioritized for further evaluation, while the remaining 75% were of reduced priority in the context of the R-ICL (reduced priority does not preclude actions being taken under other CEPA 1999 initiatives) including some which were on the Domestic Substances List (DSL). Those substances on the DSL have been deleted from the R-ICL to remove this redundancy.
A decision of further consideration means that further work may be required in order to determine whether the substance may pose a risk to human health or the environment as defined by the CEPA 1999. Further work may include: additional information gathering and evaluation to assess risk, targeted research or monitoring to address data gaps, leveraging of work with other CMP partners on similar substances or determining whether existing measures, evaluations, or instruments for management in place are sufficient to address concerns. Information gathering through, for example, inventory update will inform next steps for certain prioritized substances.
A decision of no further consideration means that these substances are reduced priority in the context of the R-ICL. It should be noted that this does not preclude future action to manage these substances under CEPA 1999. Prioritization decisions were based on available information found for the substance, including criteria suggesting low risk or because there was no evidence raising concern.
Substances found on the DSL have been removed from the R-ICL to remove redundancy.
For substances identified as requiring further consideration, a rationale has been provided. The rationales, whether they are for potential concerns to human health, the environment, or both, were based on preliminary information. New information could shift the focus of further consideration or potentially eliminate any concerns.
Removal of DSL substances will prevent duplication of work. This is because substances on the DSL have already been subject to categorization and may have undergone, or will undergo assessment and management under CEPA 1999 or were added to the DSL through notification under the NSNR.
Substances identified for further consideration will undergo further evaluation to determine whether they may pose a risk to human health or to the environment. Their identification for further consideration was based on information indicating potential health or environmental hazard, or because the quantities in use were potentially high with insufficient hazard information to mitigate concerns. Sources of information used to inform these decisions include persistence, bioaccumulation and ecotoxicity, structural alerts, and data or modelling results for hazard and exposure. Additional sources include other programs or international jurisdictions that may have flagged the substance or grouping of substances as a potential concern.
The decision to identify substances for no further consideration, in the context of the R-ICL, was based on criteria including whether the substance was previously considered during DSL categorization, or whether the substance was low risk based on readily available information. For example, substances considered to be low risk could be:
- readily biodegradable
- a natural extract
- used in small quantities
- no longer in commerce
- low hazard based on data from a closely related substance as reported in scientific literature or internal sources
During prioritization of the R-ICL, 675 substances potentially used in products subject to the F&DA were prioritized for further consideration based on an indication of hazard for human health or the environment and limited information on exposure which could mitigate those concerns. A section 71 notice under CEPA 1999 was published in the Canada Gazette, Part I, in January 2017 with the objective of collecting data on the commercial status of these substances. The R-ICL substances were listed in part 4 of Schedule 1 of the section 71 notice. Information gathered from the section 71 notice was used to identify substances that are not in commerce or are in use at limited quantities of less than 100 kg/yr in products regulated under the F&DA. Active pharmaceutical substances that have been discontinued or that were not commercially marketed, or that were approved for limited use in Canada (for example, this could include substances used in clinical trials or provided through Health Canada’s Special Access Programme) were also identified. These substances are proposed to be removed from the R-ICL.
Enquiries related to the prioritization of the R-ICL, including requests for a searchable format of the Table of prioritization results of substances on the Revised In Commerce List, may be directed to the following address:
Environmental Assessment Unit 1
Mail stop PL 4905B
Ottawa, Ontario K1A 0K9
Telephone: 1-866-996-9913 (in Canada) or 613-948-3591
Email to: email@example.com
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