Health Canada (HC) and Food Standards Australia New Zealand (FSANZ) have implemented a collaborative arrangement for the pre-market assessment of genetically modified (GM) foods: the HC-FSANZ Shared Assessment Process.

The Shared Assessment Process (SAP) allows food developers to submit an application for joint assessment. One agency leads the scientific assessment, while the other reviews the results independently, with each agency making its own decision.

“By removing duplication, the process cuts down approval times while upholding each country’s high safety standards,” FSANZ notes. “The SAP has been piloted on several GM food applications and is expected to offer greater consistency and potential cost and time savings in assessments.” 

To help businesses navigate the new pathway, FSANZ and Health Canada have released joint guidance covering every step of the process—from preparing a submission to final approval. The guidance outlines key expectations, indicative timelines and procedural details, providing clarity for applicants. 

The new process builds on more than a decade of collaboration between FSANZ and Health Canada and reflects a strong shared commitment to streamlining regulation while maintaining world-class safety standards.

Products Suitable for the Shared Assessment Process

The current scope of the Shared Assessment Process is restricted to foods derived from GM plants that require pre-market assessment under the regulatory frameworks of both agencies.

Furthermore, applications should meet the following criteria:

• Pre-market assessment and authorization by both agencies is sought by the applicant within the same or similar time period.
• For applications which refer to information provided in a past application of another GM food, applicants should ensure that the GM food was previously assessed by both agencies such that each agency has access to the same information.
• Applicants provide identical information in their applications to each agency. The application format can be specific to the requirements of each agency.
• Applicants agree to inter-agency sharing and discussion of application-specific information, including confidential information, for the sole purpose of conducting the shared assessment.

More information on the HC-FSANZ Shared Assessment Process can be found here.