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GM food safety assessment sharing

Last updated: 9 February 2021

​Since 2013, FSANZ and the Food Directorate of Health Canada have been working together to improve the efficiency of genetically modified (GM) food safety assessments.

This partnership builds on a long history of information sharing between our two agencies, and broader international collaboration on GM foods.

In 2019, FSANZ and Health Canada agreed to a system for GM food safety assessment sharing. This sharing arrangement commenced in November 2019 and will be reviewed in 2021/22.

What ​​​is safety assessment sharing?

Where approval for a GM food is being sought from both FSANZ and Health Canada, companies can request to have their application assessed under a safety assessment sharing arrangement.

Under this arrangement, and in line with agreed protocols, the application is submitted to both agencies, but only one food safety assessment is prepared (either by FSANZ or Health Canada). The assessment is then referred to the other agency for review and input to ensure it meets the requirements of both agencies.

The joint food safety assessment will then be used by both FSANZ and Health Canada for their own separate and independent assessment of the GM food.

What are the benefits?

Safety assessment sharing will reduce duplication, time and resources for both agencies, as well as costs for applicants. Shared safety assessments will create efficiencies in the broader assessment of GM food applications in both countries.

Will the FSANZ application process change under safety assessment sharing?

No, the FSANZ application process will not change.

In line with the current process:

  • applicants will be required to submit an application that meets the requirements set out in the Application Handbook
  • the application will be assessed according to FSANZ statutory processes
  • FSANZ will invite public comment and consider all submissions received as part of its assessment
  • FSANZ will make its own independent decisions about whether to approve a GM food, and whether any risk management measures are required.

Are Health Canada's safety assessment processes the same?

Both approaches to GM food safety assessment are based on internationally agreed scientific principles and guidelines developed through the Organization for Economic Cooperation and Development (OECD), Food and Agriculture Organisation (FAO), World Health Organisation (WHO) and the Codex Alimentarius Commission.

As part of the collaboration we also did a number of joint exercises to directly compare our approaches, data requirements and assessments, including the conclusions reached. This confirmed the similarity of our approaches.

Will I be able to comment on the joint food safety assessment?

Yes.

If the food safety assessment has been initially undertaken by Health Canada this will be made clear in our Call for Submissions document. The joint food safety assessment will be included in the Call for Submissions and will be available for comment, just like a FSANZ safety assessment. The application will also be available on the FSANZ website, in line with standard practices.

What will assessment of the first application under the new arrangement involve?

It was agreed the first food safety assessment under the new arrangement would be undertaken by Health Canada.

In 2020, Bayer CropScience made an application to Health Canada for a new herbicide tolerant GM canola (MON94100). The initial food safety assessment by Health Canada was reviewed by FSANZ to confirm it met all relevant requirements for Australia and New Zealand. A separate application was then submitted to FSANZ in October 2020. FSANZ is using the joint safety assessment as part of its assessment of the application. 

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