Canada Environmental Assessment Regulations for Food & Drug Act New Substances Services
Intertek’s scientific and regulatory experts help companies comply with Canada’s new Environmental Assessment Regulations (EAR) for Food & Drug Act new substances.
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).
Canada Environmental Assessment Regulation (EAR) Services
Intertek’s global scientific and regulatory experts have detailed understanding of government 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. Our services include:
- 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
- Regulatory consulting experts will assist your company respond to any questions or issues raised by EAU
- Monitor the Canada Gazette to ensure that the revised ICL includes eligible and/or nominated substance(s) of interest.
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