Environmental Assessment Regulations and In-Commerce List for Food & Drug Act Substances

Background:

On September 13, 2001, the Minister of Health confirmed the government’s intention to proceed with the development of new Environmental Assessment Regulations (EAR) for new substances present in products regulated under the Food and Drugs Act (F&DA). Until the new EAR come into effect, these F&DA-regulated, “new substances” are subject to reporting requirements prescribed under the existing “new Substances Notification Regulations (NSNR)” under the Canadian Environmental Protection Act (CEPA).

When the EAR are finally developed, they will replace the current NSN regulatory requirements for substances present in products regulated under the F&DA. These new regulations are intended to reflect the government’s prediction of the unique properties of these substances and, accordingly, the EAR are expected to trigger regulatory reporting requirements at lower import and manufacture quantities as compared to the current reporting requirements under the existing NSNR.
In order to refine the definition of “new substances” for the EAR, action was taken by the government to form an administrative inventory of existing F&DA substances called the In-Commerce List (ICL). F&DA-regulated substances that were known by the government to be in Canadian commerce between January 1, 1987 and September 13, 2001 were eligible to be placed on the ICL.

The ICL is not a statutory instrument; it 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 F&DA-regulated substances is in place. The list is a way to recognize that these substances were place into Canadian commerce in compliance with the regulations at the that time but do not meet the timeline eligibility (i.e., import/manufacture/sale between 1984 and 1986) to be grandfathered onto the statutory Domestic Substances List.

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 formal nomination process to add eligible substances to the ICL. The purpose of this initiative is to ensure that substances listed on the “current” ICL are correctly identified and verified by Health Canada. This updated list will be referred to as the “revised” ICL. Health Canada is encouraging stakeholders to participate in a collaborative effort to revise the ICL by making nominations of substances believed to meet the eligibility criteria. Once the government receives and verifies the information of a nomination, the nominated substance will be added to the revised list.

The nomination process is divided into Phase I and Phase II. Health Canada has announced the successful completion of Phase I of the Nominations Process for the revised ICL.

Phase II of the nomination process is now open to all distributors, manufacturers and importers of eligible substances until February 14, 2012. Once Phase II has concluded, the revised ICL will be published in Canada Gazette, Part I, to provide time for review and correction.

Why Nomination is Important

Even if your substance appears on the current ICL unless a nomination for the substance is received and accepted it will not be added to the revised ICL.
Health Canada is currently exploring mechanisms to provide confidentiality. Requests for confidentiality will be examined on a case-by-case basis. The ICL is not a statutory instrument; therefore, the existing DSL and NSNR confidentiality process cannot be applied for the purposes of nomination to the ICL.

Companies are to contact the In-Commerce Substances Unit, if they wish to request confidentiality for substance identity and/or information submitted in support of their nomination.

Failure to nominate your substance to the revised ICL will impact your ability to meet your business needs, as substances that are not present on the list are considered to be “new” substances and will be subject to notification.

Need Help?

To support your company's business interests, Intertek Cantox can:

• Advise if a substance is eligible for addition or nomination to the ICL;
• Review the data available to determine if there are any application deficiencies when adding a substance to the ICL or when nominating 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; and
• Monitor the Canada Gazette to ensure that the revised ICL includes eligible and/or nominated substance(s) of interest.

Contact our Chemicals Consultants: chemicals@cantox.com