The Fifteenth Canada-EU Biotech Market Access Issues Dialogue

October 11, 2023, by videoconference

Joint report

The fifteenth meeting of the EU-Canada Dialogue on Biotech Market Access Issues (“Biotech Dialogue”) took place on 11 October 2023 virtually with participants in Brussels, Ottawa, and Parma.

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.

The increasing importance of supporting innovation in agriculture was highlighted by both parties due to the unprecedented challenges facing the sector including extreme weather events driven by climate change and the rising costs of agricultural inputs. Parties noted the negative impact on global agricultural supply chains resulting from Russia's invasion of Ukraine. Canada thanked the Commission for its pivotal role in supporting global food security through the movement of Ukrainian agricultural products to third countries via the EU Solidarity Lanes.

Within this broader context of sustainability and food security, Canada and the Commission noted the role of agricultural products of biotechnology. In light of this, Canada called on the Commission to conduct approvals for GM events, including stacked GM events, as efficiently as possible through the existing EU GMO legislative process. In response, the Commission concurred that the discussion of specific GM event applications continues to be an important aspect of the annual Dialogue. However, the Commission expressed the view that assessment and authorization procedures under the GMO legislative framework are being well applied.

Canada recognized the efforts leading to the Commission’s adoption of the legislative proposal for a new regulation on plants obtained by certain new genomic techniques (NGT) for the purposes of food and feed on July 5, 2023. Canada noted overall support for the initiative and encouraged the Commission to ensure that as the legislative process continues, the final proposal is trade-facilitative, science-based, and risk-proportionate. Canada reiterated the importance of global regulatory alignment to foster innovation and investment and to enable the commercialization of new products derived from gene editing technologies. The Commission confirmed the adoption of the NGT proposal, and additionally informed of the upcoming launch by the Commission in 2024 of an “EU biotech and biomanufacturing initiative” as announced by the President of the European Commission at her State of the Union address.

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 and communicated an expectation that authorizations would soon follow for GM product applications that have been granted a positive scientific opinion from EFSA. EFSA and the Commission provided information focusing on pending applications as identified by Canada. EFSA also included in their presentation a number of public facing tools primarily stemming from the Transparency Regulation, including the web platform “Open EFSA”. Drawing information from “Open EFSA”, a timeline history for each priority application still in the risk assessment phase was provided, including its current status. EFSA also highlighted a drop in the number of instances where they used the “stop the clock” mechanism.

2.2 Pre and post EFSA assessment process and timelines

Canada acknowledged timelines for GM product applications to advance through the risk management (approvals) phase continue to show year over year improvement but raised specific concerns regarding timelines for the risk assessment phase. 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. Canada called for further procedural changes to be made to expedite procedures such that timelines are more closely aligned with the EU’s legislative framework. While Canada appreciated EFSA’s inclination for thoroughness during the assessment process, the issue of relevancy for all information being sought by the EFSA continues to be of concern.

The Commission and EFSA expressed the view that the procedures are working as intended. Many of their procedures seek to fulfill the legal obligations related to fundamental elements of transparency and public consultation. The Commission underscored the importance of the scientific opinion of EFSA in maintaining the public’s confidence in the GMO authorization process. In regard to the information requested for the risk assessment process, EFSA reaffirmed its commitment to work closely with applicants to make the risk assessment process as efficient as possible.

3. EU stacked GM event review and approval process

Carrying on from the discussion during the last Dialogue 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. Canada continues to believe that the EU should consider process improvements or utilizing alternative approaches to assess the safety of stacked events that would save time and enhance predictability for applicants. The Commission and EFSA explained the approach to stacked events set out in the applicable legislation and its rationale.

4. EU Policy updates

4.1 EU presentation: Legislative proposal on New Genomic Techniques

4.2. Questions and answers

The Commission provided a presentation on the proposed new genomic techniques (NGT) regulation^{Footnote 1} , including its scope, an overview of two differentiated regulatory pathways, its status in the EU legislative process and future plans for monitoring and evaluating the regulation’s effectiveness. Regarding the timelines for entry into force of the NGT Regulation, the Commission explained that the proposal provided for application of the new rules two years after entry into force. Canada expressed concern over the uncertainty around how products will be treated in the interim. The Commission explained that the current GMO legislation applies.

Canada noted appreciation for the Commission’s presentation and asked questions to better understand the EU legislative process and how the proposed regulation may change as the EU Parliament and EU Council conduct their deliberations. Canada also sought to better understand the estimated time for entry into force taking into consideration the upcoming EU elections in June 2024. The Commission confirmed that both the EU Council and Parliament have the authority to amend the proposal and explained the next steps in the procedure.

At the request of Canada, the Commission explained the rationale behind the proposed criteria for Category 1 NGT plants, specifically the basis for setting a maximum limit of no more than 20 nucleotide substitutions or insertions.

5. CAN Policy updates

5.1 Canada presentation: Updated guidance for Part V of the Seed Regulations

5.2 Questions and answers

The Canadian Food Inspection Agency (‘CFIA’) provided a presentation on updates to the regulatory guidance for Part V of the Seeds Regulations. The presentation included: a summary of the engagement and consultation undertaken to inform the updates; overview of the Industry-Government Technical Committee and other bodies and initiatives to advise on and oversee transparency elements related to the use of gene editing technologies; explanation of the policy rationale for updated guidance on plants regulated under the Seeds Regulations; and, key elements in the updated guidance, such as, clarity on plants that require a pre-market assessment from CFIA. In terms of next steps, CFIA is updating guidance on information requirements for the assessment of herbicide tolerant plants without foreign DNA, and formalizing existing procedures for requesting a CFIA opinion on whether a seed would be considered novel.  Finally, the presentation also included a reminder about updates made on May 19, 2022 to Health Canada’s guidance on what constitutes a novel food, and a notification about the launch of consultations to inform CFIA updates to its proposed regulatory guidance on feed.

The EU thanked Canada for the presentation, particularly the clear explanation of the policy rationale behind Canada’s approach to regulating seeds, and asked for further clarification about Canada’s treatment for a modified seed exhibiting a novel trait due to inserted genetic material from a compatible species, as well as about the transparency elements in Canada’s approach to plants with novel traits, which Canada provided.

6. Updates on international activities

Canada provided an update on international activities outside of this forum on agricultural biotechnology, with a focus on recent activities under the auspices of the Asia Pacific Economic Cooperation (APEC) High Level Policy Dialogue on Agricultural Biotechnology (‘HLPDAB’). Canada highlighted various events over the last year about science-based and risk-proportionate approaches for biotechnology to help mitigate climate change, strengthen supply chains, increase food security, and facilitate trade. A workshop was also held on solutions to addressing redundancies, decreasing resource costs, and increasing efficiencies in regulatory processes.

7. Intersessional and Any Other Business

Canada expressed an interest in more frequent meetings, as required, specifically the scheduling of an intersessional meeting ahead of the next Dialogue in 2024. The Commission conveyed an openness to discussing the purpose, format and topics that could form the basis of an intersessional meeting. Both parties agreed the intersessional would not seek to duplicate the format and purpose of the annual Dialogue, and to co-explore options for meeting again ahead of the next Dialogue.

Closing remarks:

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