Joint report: The sixteenth Canada-EU Dialogue on Biotech Market Access Issues

November 6, 2024 (Ottawa / Videoconference)

1. Introductions and opening remarks

Both Canada and the European Commission (‘Commission’) acknowledged that the Biotech Dialogue continues to be an important meeting to discuss aspects related to biotechnology legislation and authorization processes affecting trade.

This Dialogue is a good opportunity to recognize the significant role of biotechnology innovation in the agricultural sector to support global food security goals and our mutual climate and sustainability objectives.

In light of this, Canada called on the Commission to seek efficiencies to expedite the approvals for genetically modified (GM) applications, including stacked GM events. The Commission expressed its view that the assessment and authorization procedures under the genetically modified organism (GMO) legislative framework are working well.

Canada also took this opportunity to seek further information on the European Union’s (EU) proposed regulation on new genomic techniques (NGTs) and express concern with respect to elements of the proposal. The Commission explained that the NGTs legislative proposal remains under discussion in the Council and the European Parliament.

Canada also raised its proposal for the termination of the Sampling and Testing Protocol for Canadian flaxseed exports to the EU, based on the absence of detected non-compliances in the applications of the Protocol for over 13 years. This could moreover support increased Canadian flaxseed exports to the EU.

2. GM event approvals: EFSA assessment and timelines

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

Canada recognized the work undertaken by the European Food Safety Authority (‘EFSA’) and the Commission since the last Dialogue to advance GM product applications. EFSA and the Commission provided information focusing on pending applications as identified by Canada in advance of the meeting. EFSA reaffirmed its commitment to a transparent and systematic process, as mandated by EU regulations, with all relevant procedural information accessible via its web platform “Open EFSA”. During the discussion, EFSA provided a brief demonstration of the platform, highlighting its capability to display a timeline history for each GM application currently in the risk assessment phase, including status updates. EFSA noted that industry stakeholders can directly access this information through the platform.

2.2 Pre and post EFSA assessment process and timelines

Canada acknowledged the improvements in the EU timelines for advancing GM product applications through the risk management (approval) phase. However, it emphasized the importance of further enhancing transparency and efficiency in these timelines. Canada also highlighted that, despite the observed declining trend in recent years, the duration of GM product approvals remains significantly longer compared to other countries. Canada called on the Commission and EFSA to redouble their efforts and clear the backlog of longstanding applications in the risk assessment phase, while simultaneously working more expeditiously on more recent priority GM applications. Canada highlighted the impacts on trade, sustainability and food security resulting from the length of time required for new GM products to receive EU authorizations. The Commission expressed that from its perspective its approval process is running smoothly, in accordance with the applicable legal framework.

3. EU stacked GM event review and approval process

Carrying on from the discussion from previous Dialogues on each jurisdiction’s different regulatory approaches for stacked GM events, Canada took the opportunity to re-emphasize the importance of GM products with stacked events and the need to seek efficiencies where possible. Canada continues to believe that the EU should consider process improvements or utilizing alternative (including case by case) approaches to assess the safety of stacked events that would save time and enhance predictability for applicants. Both the Commission and EFSA explained the approach to stacked events set out in the applicable legislation, which requires that individual GMO events (singles) be assessed in the context of their combination into stacks. Regulation 503/2013 and the implementing Regulation 1829/2003 on GM food and feed, specify the requirements for stacked events. EFSA approach for the risk assessment of stacks and the related sub-combinations focuses on the assessment of interaction, expression, and stability of the inserts. The evaluation of the stacked events builds on the knowledge acquired during the comprehensive safety assessment of all and each single event.

4. EU Policy updates

4.1 Update on EU’s New Genomic Techniques (NGTS) regulation proposal

Canada introduced this topic, highlighting the potential for new genomic techniques (NGTs) to assist in addressing global challenges associated with food security, sustainability, and climate-resilient crop production. Canada noted the recent publication of its third set of guidance, completing its updates for the regulatory oversight of NGT products intended for the purposes of food, feed, and environmental release.

Canada requested an update from the Commission on the status of the EU’s proposed NGT regulation, the remaining issues of focus with regard to trilogue negotiations between the Commission, Council, and Parliament, and likely timing of finalization of the Regulation. Canada raised its continued concerns over the introduction of traceability and labelling requirements on Category 1 products into the proposed Regulation; including, the significant added costs and operational complexities that will result in having to segregate Category 1 products from conventional bulk grain handling systems – increasing costs for not only producers, exporters, and importers, but also consumers. In Canada’s view, this would constitute a departure from emerging global regulatory alignment in this area. Additionally, these requirements could discourage investments in innovation and limit farmers’ ability to adopt beneficial new varieties developed through new breeding techniques. These requirements would also lead to added regulatory and cost burden, with no correlation to the safety of these products.

The EU stated that the traceability and labelling requirements for Category 1 products in the Commission’s proposal are limited to seeds and propagation materials, and that further requirements for traceability and labelling of Category 1 products of concern to Canada are part of the European Parliament’s position adopted in April 2024. The Council has so far not adopted its position on the proposal. Once it does, further movement on the proposal will be determined once the trilogue negotiations between the Council, the European Parliament and the European Commission begin.

4.2 Flaxseed sampling and testing protocol update

Through written communication to DG SANTE, Canada has proposed terminating the Sampling and Testing Protocol for flaxseed exports to the EU, invoking the long-standing absence of non-compliant findings and citing it as an administrative burden that add costs and effort and thus discourages Canadian exports. This comes at a time when Canadian flaxseed could be a source to support possible diversification of the EU’s grain imports due to recent tariffs on Russian and Belarusian imports. The Commission committed to considering the request and to present to the Member States Canada’s proposal at the November 22 Standing Committee on Plant, Animals, Food and Feed (PAFF). It indicated that it would be requesting further supporting documentation and data from Canada for the Commission and the Member States to be able to assess the results of sampling and testing under the Protocol. Canada responded that it would provide this additional information in time for the PAFF meeting.

5. CAN Policy updates

5.1 Canada presentation: Updated guidance on feed regulations

Canada invited the Animal Feed and Veterinary Biologics Division from the Canadian Food Inspection Agency (CFIA) to present their updated guidance for novel feed products, specifically concerning pre-market evaluation requirements for plant-derived ingredients.

The Commission expressed appreciation to Canada for the presentation, commending the clear explanation of the rationale underpinning Canada’s updated policy approach to feed regulations. The Commission also requested that the CFIA share with it the presented materials to facilitate their comparative analysis of regulatory frameworks across different jurisdictions.

6. Updates on international activities

Canada shared information on some of the Asia Pacific Economic Cooperation (APEC) activities that took place in 2024 under the APEC High Level Policy Dialogue on Agricultural Biotechnology (HLPDAB), including regarding gene-editing. Canada highlighted the country-led seminars that took place in 2024 and noted that a new HLPDAB seminar series will take place in 2025, which the non-APEC economies, including the EU, could attend, if interested.

Closing remarks

Both delegations expressed gratitude for the open dialogue and the opportunity to exchange information. They also agreed on the option to hold additional intersessional discussions at technical level on topics not covered in detail in the Biotech Dialogue, should the need arise.

Date modified:: 2025-03-11

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