Canada In-Commerce List for Food and Drug Act Substances Services
Intertek’s scientific and regulatory experts help companies successfully complete Canada’s ICL substance nomination process.
Health Canada’s In-Commerce List (ICL) is an administrative list designed to assist the priorities and policies for protecting the health of Canadians and their environment until a full regulatory structure for Food and Drug Act regulated substances is in place.
On September 13, 2001 the Minister of Health confirmed the government’s intention to proceed with the development of new environmental legislation for all products regulated under the Food and Drugs Act (F&DA), as these substances would no longer be exempt from the requirements of the Canadian Environmental Protection Act, 1999 (CEPA). These new Environmental Assessment Regulations (EAR) will address the unique properties of these substances and, accordingly, are anticipated to have lower notification trigger levels than chemical substances which are currently notifiable under the New Substances Notification Regulations (NSNR).
While the authorities started their efforts to develop the EAR they immediately formed an administrative list called the In-Commerce List (ICL). F&DA substances that were in Canadian commerce between January 1, 1987 and September 13, 2001 were placed on the ICL until a regulatory framework could be developed to determine the potential environmental and indirect human health risks associated with these materials.
Thus, F&DA substances fall into one of three categories:
- Substances entering into Canadian commerce after September 13, 2001:
- are subject to the notification and assessment requirements under the NSNR until appropriate EARs are developed;
- assessments are carried out by the Environmental Assessment Unit within Health Canada; and
- eventually NSNR assessment will be replaced by assessment under the EARs.
- Substances that were in Canadian commerce between 1984 and 1986:
- are eligible for grandfathering onto the Domestic Substances List (DSL); and
- Substances that were in Canadian commerce between January 1, 1987 and September 13, 2001:
- were placed on the ICL until the EARs are developed.
The Revised ICL is a policy-driven inventory that provides a guidepost to improve the understanding of “new” versus “existing” for F&DA-regulated substances in Canada. Listing on the ICL is a way to recognize that these substances were placed into Canadian commerce in compliance with the Regulations at that time but that they do not meet the timeline eligibility to be grandfathered onto the DSL. Substances listed on the Revised ICL should not experience market interruption in order to comply with the NSNR of CEPA or the pending EAR being developed to specifically address F&DA substances. It is anticipated, however, that a priority assessment program may eventually be developed (either inside or apart from the EAR) to manage any risk that may be associated with substances on this list. The original ICL contained approximately 9000 substances found in pharmaceuticals, veterinary drugs, biologics and generic therapies, cosmetics, medical devices and food additives.
The ICL consisted of four sub-lists:
- Substances in Human Pharmaceuticals, Veterinary Drugs and Similar Products In Commerce Between 1987 and 2001 - CAS Registry Number Known
- Substances in Cosmetics and Personal Care Products In Commerce Between 1987 and 2001 - CAS Registry Number Known
- Substances in Cosmetics and Personal Care Products In Commerce Between 1987 and 2001 - CAS Registry Number Not Found
- Substances in Cosmetics and Personal Care Products In Commerce Between 1987 and 2001 - Ingredient or Mixture of Ingredients Unknown
In an effort to more accurately identify the substances listed on the ICL, Health Canada published a Notice of Intent on September 4, 2010, to begin the nomination process to the ICL. The purpose of this initiative was to ensure that substances listed on the ICL were correctly identified and verified by Health Canada. The updated list is referred to as the “Revised” ICL.
The nomination process was divided into Phase I and Phase II. Phase I was from July 2010 to October 2010, for a group of pre-selected nominators, and Phase II (open to all nominators) commenced in March 2011 and concluded February 4, 2012. On May 3, 2013, the results of the nomination process were published on the Government of Canada’s website.
Canada In-Commerce List for Food & Drug Act Substances Services
- Advise if a substance is eligible for addition to the Revised ICL
- Review the data available to determine if there are any application deficiencies when adding a substance to the Revised ICL
- Prepare and submit applications to the regulating authority
- Negotiate with regulatory authorities to maintain confidential business information
- Work with you to respond to any questions or issues raised by EAU
- Monitor the Canada Gazette to ensure that any future updates to the Revised ICL include eligible and/or nominated substance(s) of interest
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