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New Substances Program - Operational Policies Manual
3. Processing New Substances Notifications
- 3.A. Operational Policy for Processing New Substances Notifications
- 3.B. Operational Policy for Processing Fees and Refunds
- 3.C. Operational Policy for Early Termination of Assessment Periods
- 3.D. Operational Policy for Maintaining Confidentiality of Substance Identities
3.D. Operational Policy for Maintaining Confidentiality of Substance Identities
This document describes Environment Canada's operational policy for maintaining confidentiality of new substance identities under the Masked Name Regulations and the New Substances Notification Regulations (NSNR) of the Canadian Environmental Protection Act, 1999 (CEPA 1999).
This policy applies to all new substances notifications.
Under section 81 and section 106 of CEPA 1999, importers and manufacturers of new substances must provide prescribed information so that Environment Canada and Health Canada can assess the new substances to determine if they are "toxic" (in accordance with the criteria set out in section 64 of CEPA 1999) or capable of becoming "toxic." A substance is considered "new" if it is not listed on the Domestic Substances List (DSL). The information requirements are established in the NSNR.
According to section 313 of CEPA 1999, a notifier who provides information to the Minister of the Environment may also submit a request for the substance to be identified with a masked name to prevent disclosure of the specific identity of the substance when it becomes eligible for listing on the DSL or the Non-Domestic Substances List (NDSL).
When a non-confidential substance is added to the public portion of the DSL or NDSL, the substance's specific identity is revealed through publication of its:
- Chemical Abstracts Service (CAS) Registry Number (chemicals, polymers, biochemicals and biopolymers);
- Culture Collection Number (living organisms) if applicable; or
- International Union of Biochemistry and Molecular Biology Number (enzymes).
If a substance identity confidentiality request is accepted, the substance is available for publication on the confidential portion of the DSL or NDSL using an appropriate masked name. Masked names must be developed in accordance with the criteria established in the Masked Name Regulations.
Environment Canada will review each request for a masked name to determine whether it is valid. Notifiers will be advised if their request is not accepted and given an opportunity to provide additional justification in support of their request. If the supplementary information is not supplied or is not satisfactory, the request may be rejected, or alternatively, the company may choose to withdraw the notification.
If a request for a masked name is made for a substance that is already in the public domain, it will be rejected and the substance will be added to the public portion of the DSL or NDSL. Public commercial substances inventories include, but are not limited to, the United States Environmental Protection Agency Toxic Substances Control Act Inventory, the European Inventory of Existing Commercial Chemical Substances, and the Australian Inventory of Chemical Substances.
Identification of Masked Names
If a request for a masked name is valid, the masked name proposed by the notifier will be evaluated against the criteria in the Masked Name Regulations. If assessed to be consistent with these regulations, the masked name will be available for use in publications such as the DSL. If not, inconsistencies will be communicated to the notifier and an alternative name requested. Environment Canada will try to reach a consensus with the company on a masked name. If consensus is not reached, Environment Canada will publish a masked name that, in its opinion, will respect the confidentiality claim of the company while retaining the generic molecular structure of the substance. Alternatively, the company may choose to withdraw the notification.
Reversal of Substance Identity Confidentiality Claims
If a substance was listed on the confidential portion of the DSL or NDSL and Environment Canada learns that the identity of the substance was subsequently published on another public inventory, the substance will be transferred from the confidential portion to the public portion of the DSL or NDSL. The original notifier will be informed before this is done.
Use of Masked Names in Published Notices
When a request for a masked name has been accepted following the process stated above, the Department will use this masked name when and if there is publication of a new substance condition, prohibition, or significant new activity (SNAc) notice.
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