Update: Publication of the Revised In-Commerce List

06 May 2013

On May 3, 2013, the results of the nomination process were published on the Government of Canada's website. Learn how this could affect you and the industry.

The Revised In-Commerce List (ICL) is an administrative list of F&DA substances that were identified as having been in Canadian commerce between January 1, 1987 – September 13, 2001; therefore, these substances were not eligible to be grandfathered onto the Canadian Domestic Substances List (DSL).

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. The list is a way to recognize that these substances were placed into Canadian commerce in compliance with the regulations at that time, but do not meet the timeline eligibility to be grandfathered onto the statutory Domestic Substances List. Substances listed on the Revised ICL should not experience market interruption in order to comply with the New Substance Notification Regulations (NSNR) of CEPA or the pending Environmental Assessment Regulations (EAR) 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 9,000 substances found in pharmaceuticals, veterinary drugs, biologics and generic therapies, cosmetics, medical devices and food additives, divided across 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; and
• 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.

On May 3, 2013, the results of the nomination process were published on the Government of Canada's website https://www.canada.ca/en/health-canada/services/environmental-workplace-health/environmental-contaminants/drugs-personal-care-products/environmental-impact-initiative/commerce-list-food-drugs-act-substances.html.

How does this affect Industry? Substances that are not present on the Domestic Substances List or the Revised In-Commerce List are now considered to be "new" substances and may be subject to notification under the Canadian New Substances Notification Regulations (NSNR).

Do you need to nominate substances to the Revised In-Commerce List post formal nomination period? Do you have questions about the Revised In-Commerce List or the Canadian New Substances Notification Regulations or another related topic? Share your comments or questions below and one of our experts will get back to you.

Blogger:

Joyce Borkhoff, Vice President, Chemicals Group, Intertek Scientific & Regulatory Consultancy