Canada Environmental Assessment Regulations for Food and Drug Act New Substances Services

On September 13, 2001, Canada’s Minister of Health confirmed the government’s intention to proceed with the development of the new Environmental Assessment Regulations (EAR) for new substances present in products regulated under the Food and Drugs Act (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 “New Substances Notification Regulations (NSNR)” under the Canadian Environmental Protection Act (CEPA).

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).

Canadian Environmental Assessment Regulation (EAR) Services
Intertek’s global scientific and regulatory experts have detailed understanding of international substance regulations impacting a wide range of industries. This combination of knowledge and experience aids our clients in developing effective, timely and successful regulatory strategies.

Intertek can:

• Advise if a substance is eligible for addition or nomination to the ICL
• Review available data to determine if there are any application deficiencies
• Prepare and submit applications to the regulating authority
• Negotiate with regulatory authorities to maintain confidential business information
• Assist your company in responding to any questions or issues raised by the Environmental Assessment Unit (EAU)
• Monitor the Canada Gazette to ensure that the revised ICL includes eligible and/or nominated substance(s) of interest.

Related Services

Canada In-Commerce List for Food & Drug Act Substances Services
Chemical Regulatory Services