About the Revised In Commerce List (R-ICL)

On this page

• Overview
• Prioritization of substances on the Revised In Commerce List (R-ICL)
• Information gathering
  • Mandatory section 71 notice
• Removal of substances from the R-ICL
• Risk assessment
  • Risk assessment summaries of pharmaceutical substances on the R-ICL
• Additional information
• Contact information

Overview

The Revised In Commerce List (R-ICL) is comprised of substances which were in products that were regulated under the Food and Drugs Act (F&DA) and that were in Canadian commerce between January 1, 1987 and September 13, 2001.

The process for nomination of substances for addition to the R-ICL closed on November 3, 2019. Manufacturers and importers who wish to market a new substance for use in a product regulated under the F&DA that is not already listed on the Domestic Substances List (DSL) must submit a notification under the New Substances Notification Regulations (NSNR) (Chemicals and Polymers) or NSNR (Organisms).

The R-ICL was initially posted on May 3, 2013, and is periodically revised to reflect updates and corrections.

Substances that are on the R-ICL are under review. Information gathering clarifies use patterns and quantities in Canadian commerce and identifies stakeholders who import or manufacture substances on the R-ICL. It supports identification of those substances that require further evaluation to determine whether they present a risk to human health or the environment, while providing information to refine risk-based screening and assessment. All substances on the R-ICL are subject to the Canadian Environmental Protection Act, 1999 (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.

Prioritization of substances on the R-ICL

Substances on the R-ICL have been prioritized by the Government of Canada to identify substances that require further evaluation (higher priority) to determine whether they present a risk to human health or the environment. Higher priority substances may be subject to a more rigorous assessment, which involves further information gathering. Substances on the DSL that previously appeared on the R-ICL were removed from the R-ICL to avoid appearing on both lists. It should be noted that results and decisions for these substances made during categorization of the DSL in accordance with Section 73 of CEPA 1999 were not revisited, and these substances will continue to be managed as existing substances.

The R-ICL tracking table shows the results of prioritization and is periodically updated based on new information which may be generated through:

• surveys
• assessments
• DSL listings
• risk management initiatives or
• updates to substance identification resulting in corrections

Actions taken are recorded alongside the prioritization results. View the R-ICL tracking table of prioritization results, status and outcomes for substances on the R-ICL.

Information gathering

Mandatory section 71 notice

• 2017 section 71 notice:
  This notice was published in the Canada Gazette, Part I: Vol. 151, No. 2 – January 14, 2017 under section 71 of CEPA 1999 and contained 675 R-ICL substances that were listed in Part 4 of Schedule 1 of the notice. The purpose of the notice was to obtain data on their recent commercial status in Canada.
• 2022 section 71 notice:
  This notice was published in the Canada Gazette, Part I: Vol. 156, No. 11 - March 12, 2022 under section 71 of CEPA 1999 and contains approximately 700 substances. The purpose of the notice is to collect information on import and manufacture quantities in Canada, and uses of these substances. For more information, please visit the information gathering initiatives web page.
• A third information gathering initiative is planned to collect information on other substances on the R-ICL.

The information collected will be used to update the commercial status of the substances, identify stakeholders with a commercial interest, support decisions to remove substances from the R-ICL, or support screening risk assessments by providing information on use patterns as well as quantities manufactured or imported.

Removal of substances from the R-ICL

Substances may be removed from the R-ICL for various reasons, 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 a substance already on the 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 of CEPA 1999
4. any time that environmental or human health concerns are identified

Substances that are removed from the R-ICL can still enter into Canadian commerce subject to applicable statutes, including the NSNR (Chemicals and Polymers), or NSNR (Organisms). The R-ICL tracking table is the list of all substances added to the R-ICL, the results of prioritization, and also shows the status of substances, including the removal of substances when this occurs.

For more information on considerations for the removal of substances from the R-ICL, please visit the Removal of substances from the Revised In Commerce web page.

Risk assessment

Risk assessment summaries of pharmaceutical substances on the R-ICL

Health Canada's Therapeutic Products Directorate is responsible for authorizing therapeutic drugs for sale in Canada, verifying that they meet the safety, efficacy and quality requirements of the F&DA and its regulations. Health Canada is also responsible for undertaking assessments of pharmaceutical substances as environmental contaminants under the authority of CEPA 1999, extending risk assessment to the potential exposure of Canadians through environmental media such as air, soil, sediments and water while also considering the potential for exposure and impacts on the environment and its biological diversity.

A draft summary report of risk assessments for the first group of 20 pharmaceutical substances (and associated salts and isomers) is being prepared for publication. The summary report includes the following substances:

20 Pharmaceutical substances in report

CAS RN	Pharmaceutical substance
34381-68-5	Acebutolol hydrochloride
66376-36-1 (and 129218-43-0, 121268-17-5)	Alendronic acid (and alendronic sodium)
82248-59-7	Atomoxetine hydrochloride
31677-93-7 (and 234447-17-7)	Bupropion hydrochloride (and isomer)
27164-46-1	Cefazolin
169590-42-5	Celecoxib
120202-66-6 (and 113665-84-2)	Clopidogrel bisulfate (and clopidogrel)
76584-70-8	Divalproex sodium
57808-66-9 (and 83898-65-1)	Domperidone (and domperidone maleate)
130929-57-6	Entacapone
299-42-3 (and 90-81-3 and 134-72-5 and 7460-12-0)	Ephedrine (and ephedrine dl-and ephedrine sulfate and pseudoephedrine sulfate)
60142-96-3	Gabapentin
84057-84-1	Lamotrigine
192725-17-0	Lopinavir
68693-11-8	Modafinil
132539-06-1	Olanzapine
28721-07-5	Oxcarbazepine
630-93-3	Phenytoin sodium
115436-72-1	Risedronate sodium
144701-48-4	Telmisartan

Further summary assessment reports will follow for other R-ICL pharmaceuticals that are prioritized for risk assessment, as well as for R-ICL substances in other functional use categories, such as substances used in natural health products and cosmetics.

These summaries provide an overview of information examined during the screening assessment, as well as the risk assessment conclusions. The key elements found in the summaries include:

1. substance identity
2. use
3. hazard
4. exposure
5. environmental fate
6. assessment of environmental risk
7. assessment of human health risk through environmental exposure

Additional information

1. The substance names for chemicals and polymers that appear on the R-ICL accord with either the Chemical Abstracts Service (CAS) nomenclature, or the International Union of Pure and Applied Chemistry (IUPAC) nomenclature, or in the case of a living organism, acceptable international codes of nomenclature and standard taxonomic sources
2. The term "substance identifier" can refer to:
   1. a CAS Registry Number (CAS RN)^{Footnote 1}
   2. an Enzyme Commission (EC) Number assigned by the International Union of Biochemistry and Molecular Biology (IUBMB)
   3. an International Numbering System for Food Additives Number (INS Number) or
   4. an acceptable identifier for living organisms

Where multiple substance identifiers (CAS RNs) are listed on the R-ICL for a substance, the bold font and an asterisk (*) indicates the substance identifier which has most recently been assigned by CAS.

Contact information

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

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