Report: The Seventeenth Canada-EU Dialogue on Biotech Market Access Issues

December 17, 2025 (by videoconference)

1. Introductions and opening remarks

Both Canada and the European Commission (‘Commission’) acknowledged that the Canada-EU Dialogue on Biotech and Market Access Issues (‘Dialogue’) continues to be an important instructive meeting where both parties can discuss aspects related to agricultural biotechnology legislation and authorisation processes affecting trade in a constructive manner. The Dialogue is a good opportunity to recognize the significant role of biotechnology innovation in the agricultural sector to support global food security goals and mutual climate and sustainability objectives.

The Commission acknowledged the strong focus on the GMO authorisations and priority applications in view of the origin of the Dialogue and emphasised the usefulness of also covering exchanges in regulatory and other developments.

Canada called on the Commission to continue its effort in processing GM authorisations as fast as possible within the EU’s procedures and encouraged them to consider how further gains in efficiency could be realized in relation to data requirements, renewal authorisations and stack assessments. In addition, Canada sought information on the state of play of its request from 2024 to terminate the flax seed sampling and testing protocol.

2. GM event approvals: EFSA assessment and timelines

2.1 Status of specific applications under EFSA assessment/post-EFSA approval

The Commission reminded Canada that the status of ongoing assessments can be consulted on OpenEFSA. The representative of the European Food Safety Authority (EFSA) informed of the regular applicant meetings, and the possibilities offered to applicants under EFSA’s catalogue of services. EFSA and the Commission further provided updates on the state of play of  applications of specific interest to Canada. The EU committed to sharing its presentation with Canada on the status of all applications raised during the meeting.

At the request of Canada, the Commission and EFSA further expanded on the scope and procedure of low-level presence applications, and shared relevant EFSA guidance.

2.2 Pre and post EFSA assessment process and timelines

Canada reiterated its concerns on the duration of the authorisation procedure and particularly, the risk assessment, resulting in lengthier approvals in comparison to other jurisdictions and the resulting procedural backlog.

The Commission recalled the applicable legal requirements for the authorisation of GMOs in the EU and the fact that the length of the risk assessment is often linked to the time necessary for applicants to demonstrate safety of their products by providing replies to EFSA’s request for further information. EFSA explained its initiatives to support applicants on risk assessment high, e.g., regular meetings for applicants on general aspects of risk assessments and bilateral meetings on specific applications to clarify if needed.

2.3. GM Authorisation Renewals for Food & Feed

Canada informed it has no expiry for GM authorisations, and thus no renewal procedure, but can end an authorisation at any time in case new evidence emerges from post-market monitoring. Canada enquired whether the EU is considering a similar approach.

The Commission explained that their GMO legislation requires the regular renewal of the authorisation, and that the renewal procedures are not specific to GMO authorisations, but a common feature for various authorisation procedures in the EU. The procedure and corresponding risk assessment is focused on new evidence, and data requirements are less burdensome than for an initial authorisation. The Commission indicated there is no initiative at this stage to change these requirements.

3. EU stacked GM event approval process

Canada provided a brief overview of its approach to the assessment of stacked events and reiterated that the EU’s approach to reviewing these products continues to be an important topic for Canada. Canada encouraged the EU’s consideration of efficiencies that are predictable and science-based. Canada also sought further information surrounding the derogations outlined in Regulation 503/13, when scientifically justified.

The Commission reiterated that the EU approach to stack assessments requiring the risk assessment of each single event and the stack is embedded in legislation and based on scientific considerations from EFSA, and indicated that no changes are envisaged at this stage. EFSA reported on ongoing work taking stock of 20 years of experience in stack assessments.

Canada also inquired on the status of EFSA’s Cross Cutting Working Group that cover stacks. EFSA explained that the Working Group is a forum where complex applications and relevant GM topics, including stacks, are discussed. The Working Group meets when needed, and the meeting minutes are published on EFSA’s website. The Cross Cutting Working Group reports to the EFSA GMO Panel.

4. EU’s New Genomic Techniques regulation

4.1 Update on New Genomic Techniques regulation proposal

The Commission informed Canada of the main elements of the provisional political agreement between the European Parliament and the Council and of future steps in the procedure.

Canada raised concerns about the automatic exclusion of herbicide tolerant and insecticidal traits from category 1 NGT plant status. Canada enquired whether consideration was given to exempt  EU imports for food, feed, and further processing purposes, given the apparent rationale for the exclusions appears focussed on cultivation-related risks, to which the Commission responded that the relevant provision of the provisional agreement would apply also to imports. On this point, Canada raised concerns over asynchronous approval timelines due to misalignment with global treatment of similar products in other markets.  

5. Status of Canada’s proposal to terminate Triffid testing protocol on flaxseed exports to EU

Canada referred to its request to terminate this protocol, which it considers is no longer required. The Commission informed Canada on the steps that have been taken by the Commission since receiving the request  and possible future steps. The Commission informed Canada of the EU food business operators’ concern that commercial conditions related to trade in flaxseed may need to be adjusted once the protocol is terminated. In response to an inquiry from the Commission as regards to flaxseed testing for export to other destinations, Canada informed the Commission that the protocol to export to Japan has been terminated and that it would seek an update on the status of the protocol with Brazil.

6. EU’s new proposed Biotech Act

6.1 Canada requesting EU to provide regulatory overview of new proposed Biotech Act

The Commission informed Canada on the recent proposal for a Biotech Act, with a second proposal currently scheduled for end of 2026. The current Biotech Act mostly covers health biotech and only contains a few targeted elements on food / feed aspects such as widening the possibilities for pre-submission advice by EFSA and the creation of regulatory sandboxes. Specifically related to the GMO legislation, the proposal envisages the adaptation of Directive 2001/18/EC to the specificities of genetically modified micro-organisms in relation to procedures and data requirements.

7. Closing remarks and next steps

Both delegations expressed gratitude for the open dialogue and the opportunity to exchange information.