Removal of substances from the Revised In Commerce List

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Overview

The following are criteria and considerations that influenced the decision of when to remove a substance from the   Revised In Commerce List (R-ICL), such as:

  1. substances with no commercial activity in Canada in products regulated under the Food and Drugs Act (F&DA) or not supported by Canadian manufacturers or importers with information on commercial activity
  2. duplication with substances already on the Domestic Substances List (DSL) (that is, present on both lists – DSL and R-ICL)
  3. substances which were subject to risk management actions, such as a Ministerial Condition or listing on Schedule 1 to the Canadian Environmental Protection Act, 1999 (CEPA)
  4. at any time that environmental or human health concerns were identified

1. Commercial status in Canada

Commercial status in Canada was determined by Health Canada internal records, the results of CEPA section 71 surveys, or through direct stakeholder communications.

R-ICL information gathering:

During prioritization of the R-ICL, substances potentially used in products subject to the F&DA were prioritized for further consideration based on an indication of potential hazard for human or environmental health. A total of 675 R-ICL substances were included in Part 4 of Schedule 1 of a mandatory survey pursuant to section 71 of CEPA published in the Canada Gazette, Part I: Vol. 151, No. 2 – January 14, 2017. The intent of this survey was to collect data on the commercial status of these substances to verify the commercial status of the substances and inform human and environmental exposure potential.

In September 2020, based on the results of the 2017 section 71 notice and information available from Health Canada records, a Notice of intent to remove low volume or discontinued substances from the Revised In Commerce List was published in the Canada Gazette, Part I: Vol. 154, No 39 – September 26, 2020 along with the consultation document. This notice was followed by a 60-day comment period, as well as a voluntary follow-up questionnaire to obtain further details from stakeholders as necessary.

Comments received in response to the notice of intent, as well as responses to the voluntary follow-up questionnaire, identified 602 substances from the R-ICL were found to have no commercial activity in Canada that would meet the threshold for notification under the NSNR, and thus were removed from the R-ICL. The Notice of removal of substances with no commercial activity from the Revised In Commerce List, was published in the Canada Gazette, Part I: Vol. 156, No 8 – February 19, 2022.

2. Duplication with substances already on the Domestic Substances List

Removal of substances from the R-ICL that are on the DSL prevents duplication. This is because substances on the DSL have already been subject to categorization or to notification and assessment which is considered sufficient to fulfil the requirement for R-ICL substance assessment and management under CEPA . The R-ICL is also updated periodically by removing substances that have been added to the DSL through more recent notifications under the New Substances Notification Regulations (NSNR) of CEPA, to prevent duplication. When R-ICL substances are notified under NSNR for a non-F&DA use, or added to the DSL, this removes the general restriction that an R-ICL listed substance is to be used in F&DA products only.

3. Substances which are subject to risk management actions

Substances which were subject to risk management actions such as a Ministerial Condition or listing on Schedule 1 to CEPA will be removed from the R-ICL. These substances are considered risk managed under CEPA for human health and the environment.

4. Substances removed based on environmental or human health concerns

Substances may have been removed based on environmental or human health concerns, even if no formal risk management action had been implemented under CEPA.

All substances on the R-ICL are subject to CEPA, and appropriate action may be taken at any time under that Act in respect to substances on the R-ICL that posed a risk to human health or the environment.

Once substances were removed from the R-ICL, those substances could still enter into Canadian commerce subject to applicable statutes, including the NSNR (Chemicals and Polymers), or NSNR (Organisms).

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