Removal of substances from the Revised In Commerce List

On this page

• Overview
  1. Commercial status in Canada
  2. Duplication with substances already on the Domestic Substances List
  3. Substances which are subject to risk management actions
  4. Substances removed based on environmental or human health concerns
• Contact information

Overview

Health Canada is responsible for the prioritization and assessment of substances on the Revised In Commerce List (R-ICL). There are also criteria and considerations that influence the decision of when to remove a substance from the 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 the substances already on the Domestic Substances List (DSL) (that is, present on both lists – DSL and R-ICL)
3. substances which are subject to risk management actions, such as a Ministerial Condition or listing on Schedule 1 to the Canadian Environmental Protection Act, 1999 (CEPA 1999)
4. at any time that environmental or human health concerns are identified

1. Commercial status in Canada

Commercial status in Canada is determined by Health Canada internal records, the results of CEPA 1999 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 1999 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 1999. 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 1999, 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 are subject to risk management actions such as a Ministerial Condition or listing on Schedule 1 to CEPA 1999 will be removed from the R-ICL. These substances are considered risk managed under CEPA 1999 for human health and the environment.

4. Substances removed based on environmental or human health concerns

Substances may be removed at any time based on environmental or human health concerns, even if no formal risk management action has yet been implemented under CEPA 1999. Stakeholders who might be impacted by the removal of a substance will be notified in advance through notices in the Canada Gazette or through direct communications from the program. It is the responsibility of stakeholders, however, to remain aware of the status of any substances of interest on the R-ICL, including removals.

All substances on the R-ICL are subject to CEPA 1999, and appropriate action may be taken at any time under that Act in respect to substances on the R-ICL that pose a risk to human health or the environment.

Once substances are removed from the R-ICL, those substances can still enter into Canadian commerce subject to applicable statutes, including the NSNR (Chemicals and Polymers), or NSNR (Organisms), Substances that remain on the R-ICL continue to be subject to oversight and they may be subject to actions such as surveys, risk assessment, or risk management under the authority of CEPA 1999.

The R-ICL tracking table is periodically revised to reflect updates and corrections.

Contact information

Regulatory Affairs unit
Healthy Environments and Consumer Safety Branch
Health Canada
Mail stop PL 4905B
Ottawa, ON K1A 0K9
Telephone: 1-866-996-9913 (in Canada) or 613-948-3591
Email: eau-uee@hc-sc.gc.ca

Please include your full contact information: name, address, phone number and email address.