In-Commerce List of Food and Drugs Act Substances

The In-Commerce List (ICL) is a list comprised of substances contained in products regulated under the  Food and Drugs Act (F&DA) that were in Canadian commerce between 1 January 1987 and 13 September 2001. The ICL contains approximately 9000 substances found in pharmaceuticals, veterinary drugs, biologics and generic therapies, cosmetics, medical devices and food additives.

The ICL is often referred to as the "current ICL" since this is the version of the list that is currently in use. This list is static and will not be changed.

There is also a list known as the "revised ICL" which, as the name implies, is an updated version of the "current ICL". Health Canada is currently in the process of updating and finalizing the revised ICL, so this list--unlike the current ICL--will be changed in the coming months.

The current ICL consists 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

"Substances in products regulated under the Food and Drugs Act In Commerce between 1984-1986 - Eligible for Addition to the Domestic Substances List" continue to be covered by the ICL policy; i.e. these substances may continue in Canadian commerce until such time as environmental assessment regulations for substances contained in Food and Drug Act products come into effect. Substances on this list may be nominated to the revised ICL without proof of in commerce. However, once the aforesaid regulations come into effect substances which are on neither the revised ICL nor the DSL will be considered to be out of regulatory compliance. It is therefore recommended that eligible substances be placed on the appropriate list.

On this page

• ICL Background
• Need to revise the ICL
• Process for revising the ICL
• Related Resources

ICL Background

On 13 September 2001, the Minister of Environment announced that substances found in products regulated under the F&DA would no longer be exempt from the requirements of the  Canadian Environmental Protection Act, 1999 (CEPA 1999). At that time, the Minister of Health announced Health Canada's intention to develop environmental assessment regulations that would address the unique properties of these substances. In addition to this objective, the Minister of Health also took the immediate measure of creating an administrative list of substances which eventually would become the ICL.

It should be noted that:

• Substances in products regulated under the Food and Drugs Act entering into Canadian commerce after 13 September 2001 are subject to the notification and assessment requirements under the New Substances Notification Regulations (NSNR) of CEPA 1999 until appropriate environmental assessment regulations are developed;
• Based on Health Canada records, substances that were in Canadian commerce between 1 January 1987 and 13 September 2001 were placed on the ICL until a regulatory framework could be developed to determine potential environmental and indirect human health risks. As Health Canada records were not exhaustive, not all eligible substances were placed on the ICL.

The ICL is not a statutory instrument. It is an administrative list designed to assist Health Canada officials in protecting the health of Canadians and their environment until a revised regulatory structure is in place.

Need to Revise the ICL

There are several deficiencies in the list as it currently exists. For example, there are duplicate entries, missing entries and ambiguous entries containing generic terms, common names and trade names.

Recognizing the need to address these issues in a timely and constructive manner, an ICL subcommittee was formed under the Environment Assessment Working Group (EAWG). This subcommittee was made up of experts from Health Canada and Environment Canada as well as industry representatives and representatives from environmental NGOs.

Process for Revising the ICL

After consulting with stakeholders, the ICL Subcommittee developed a mechanism for revising the current ICL. It was determined that the best way to proceed was through a voluntary nomination process wherein industry would supply the information required to correct the list.

The nomination process for including substances on the revised ICL has two phases. Phase I is already complete. Phase I participation was limited in scope to ensure that all appropriate internal mechanisms were in place and functioning smoothly. As such, in this phase, a limited number of volunteer companies were allowed to nominate eligible substances for addition to the ICL. Health Canada is now pleased to announce the successful completion of this first phase.

Health Canada is now able to open Phase II of the nomination process. Any company wishing to nominate one or more substances to the revised ICL is now able to do so without further delay and may continue to do so up until the February 14, 2012, the closing date of Phase II of the nomination process.

Further information concerning how to nominate substances in Phase II can be found on the nominations section of this website.

The current ICL will continue to be available to nominators as an indication that a substance was in Canadian commerce between January 1, 1987 and 13 September 2001.

Substances do not need to be nominated to the revised ICL if:

1. they meet the definition of Naturally Occurring Substances (for further information please consult the Guidance Document obtainable at: publications@hc-sc.gc.ca); or
2. for Phase 2 of the nomination process, they are substances, other than medicinal ingredients in a drug product regulated by the Food and Drug Regulations, that meet the following description:
   
   1. is a natural source material or an extract or isolate from a natural source material; and
   2. the primary molecular structure is unaltered from its original form (regardless of processing method); or
   3. the substance is a salt or derivative of a substance which meets 1) and 2) provided that the structural alterations are reversible under environmentally relevant conditions.

For (b), it should be noted that:

1. guidance on the description is not available at this time;
2. this description applies exclusively to phase 2 of the ICL nomination process; and
3. these substances may become subject to notification requirements at a later time and their nomination to the revised ICL may be required at a future date.

Related Resources

•  Chemicals Management Plan
•  Domestic Substance List (DSL)
•  Guidelines for the Notification and Testing of New Substances: Chemicals and Polymers
•  Guidelines for the Notification and Testing of New Substances: Organisms
• List of substances in products regulated under the Food and Drugs Act which are eligible for nomination to the DSL
•  New Substances Notifications Regulations (NSNR)
• Health Canada programme areas:
  • Biologics
  • Cosmetics
  • Generic therapies
  • Medical devices
  • Natural Health Products
  • Novel foods and food additives
  • Pharmaceuticals
  • Veterinary drugs