Piloting the Health Canada-FSANZ shared assessment process

Health Canada and Food Standards Australia New Zealand (FSANZ) have been exploring regulatory harmonization and through collaboration have developed a shared assessment process aiming to make the GM food approval processes of both agencies more efficient by reducing assessment time, the resources required and costs.

Beginning in 2013, both agencies analysed the feasibility of implementing a collaborative arrangement regarding the pre-market assessment of GM foods. After identifying the type of collaboration that would work best within their respective regulatory frameworks (i.e., a shared assessment), Health Canada and FSANZ conducted two pilot assessments to test the functionality of the process. The following is a brief summary of each pilot:

First pilot

Herbicide-tolerant GM canola MON94100 was assessed in 2020-21 as the first pilot under the shared assessment process. For this pilot, Health Canada undertook the food safety assessment (as the primary assessor) and provided it to FSANZ for review (as the secondary assessor).

The shared assessment process delivered a range of benefits, including:

• time and resource savings for FSANZ
• faster approval time in Australia and New Zealand, resulting in a cost saving for the company
• improved alignment and efficiency in the approval process for both Canada and Australia/New Zealand.

The Health Canada and FSANZ approval processes were both completed in April 2021. You can view the assessment documents below.

• Health Canada assessment
• FSANZ assessment

Lessons learned from this shared assessment:

• Each agency has an established format for their respective reports and public-facing documents. For this pilot, Health Canada used FSANZ's established format for the shared assessment, however it was acknowledged that having to conform to different formats depending on which agency was the secondary assessor posed a challenge to the future use of the shared assessment process. Solutions to address this challenge would be explored.

Post-pilot:

• Preparations began to test the shared safety assessment process with FSANZ acting as the primary assessor, with the next pilot to commence upon identification of a suitable application.

Second pilot

Insect-resistant and herbicide-tolerant GM maize DP-51291-2 was assessed in 2023-24 as the second pilot under the shared assessment process. For this pilot, FSANZ undertook the food safety assessment (as the primary assessor) and provided it to Health Canada for review (as the secondary assessor).

This assessment built upon, and extended, the benefits from the first shared assessment, with additional benefits including:

• time and resource savings for Health Canada
• development of an internal assessment template document to facilitate and improve the efficiency of the sharing process
• validation of the shared assessment process

The FSANZ and Health Canada approval processes for DP-51291-2 maize were completed in February and July 2024, respectively. You can view the assessment documents below:

• FSANZ assessment
• Health Canada assessment

Lessons learned from this shared assessment

• The use of an internal assessment template helped the process by addressing the challenges posed by differences in each agency's respective reports and public-facing documents.
• It is necessary to provide clear information to applicants to enable them to better understand the requirements for submitting an application under the shared assessment process.

Post-pilot:

• Health Canada and FSANZ agreed to develop information for their websites about the shared assessment process and requirements for submitting an application for a shared assessment.