12th meeting of the bilateral dialogue on biotech market issues

21 October 2020 (by videoconference)

Joint Report

The twelfth meeting of the EU-Canada Dialogue on Biotech Market Issues took place on 21 October 2020 through an online meeting with participants in Brussels, Ottawa, and Parma.

1. Introductions and Opening Remarks
   

   The European Commission and Canada value the Biotech Dialogue as an important instrument for information exchange related to regulatory, technical, and emerging issues affecting trade in agricultural products of biotechnology. The forum also provides the opportunity to exchange information on new and pending product approvals, and to discuss new biotech-related measures that may affect trade.

2. GM Event Approvals: EFSA assessment and timelines
   

   Canada expressed continued concern with the length of time for product approvals in the EU, and enquired regarding planned improvements to the European Food Safety Authority's processes, procedures or timelines.

   1. 2.1. Status of specific applications under EFSA assessment
      

      The European Food Safety Authority (EFSA) updated Canada on the state of play of the on-going risk assessment of applications for genetically modified organism (GMO) authorisation in the European Union. EFSA offered to provide a written summary of the status of EFSA opinions on those specific events.

      Canada underscored its desire for expedited processing of certain biotech applications of priority to the Canadian industry, which are currently being assessed by EFSA.

   2. 2.2. EFSA assessment process and timelines
      

      Further to Canada’s enquiry on process improvements, EFSA explained that in 2019 and 2020, it further invested in familiarising applicants with existing guidelines and, as a result, applicants make more use of existing services, the quality of the application file has improved, and the benefits for risk assessment are already visible. EFSA expects this will further improve once pre-submission meetings will become a standard option after March 2021. Canada expressed concerns that progress had slowed down again since the previous dialogue in March 2019. EFSA stressed that this was largely due to one application, where additional information was submitted spontaneously by an applicant who previously did not reply to requests to send the supplemental information to complete its application.

      EFSA’s LEAN process improvement project, evaluating EFSA’s internal procedures, also highlighted the need for improved quality of the applications for authorisation. As a result, EFSA will increase communication between the application desk and the applicants during the acceptance phase, while respecting the arms-length separation between applicants and the risk assessors that conduct the review.

      Canada encouraged EFSA to consider changes to its procedures that would improve the efficiency of the risk assessment process, with a view to bringing the timelines closer to the targeted timeframe of six months. Canada also encouraged EFSA to improve the functioning of the system from an applicant’s perspective.

      Canada enquired on the applicability of guidance for low-level presence for discontinued events, as adventitious presence cannot be excluded for many years due to industry practices. Although the Commission and EFSA are confident with the guidance, it has not been applied so far in absence of low-level presence applications.  The Commission stressed the EU’s zero tolerance policy for non-authorised GMOs.

      Canada expressed concern over the EU’s automatic time-limited approvals and re-authorisation requirements for GM products, including discontinued products, from the perspectives of scientific rationale and administrative burden, as well as potential trade disruptions associated with low-level presence. Canada explained that authorisations do not expire in Canada and re-assessment of authorised products is only undertaken in cases where relevant new information warrants a revision. In the EU, applicants need to introduce a renewal application prior to the expiration of the first 10-year authorisation. At this moment, applicants bring forward any new information that arose during the validity of the authorisation. EFSA noted that some applicants opt for a renewal application, even for products that are no longer marketed, as the resulting renewal authorisation also protects them from the risks of low-level presence.

      As for the assessment of stacks, Canada expressed concern over the EU approach of assessing individual events followed by a full assessment of the stacked product as disproportionate to risk. Canada also enquired on the potential for parallel assessments or other opportunities to streamline stack approvals. EFSA noted that the EU legislation requires that the single event is first assessed and EFSA cannot deviate from this obligation. As there is a growing familiarity with the evaluation, the process is now of a reasonable length. In addition, a study performed in 2016 demonstrated that the parallel evaluation of singles and stacks would not result in a significant time gain.

3. GM Event Approvals: Post EFSA approval process and timelines
   1. 3.1. Status of specific applications post-EFSA approval
      

      Canada stressed the importance of timely approvals for Canadian industry. Canada brought forward a list of specific applications that are in the comitology process, seeking an update. The Commission gave information on the progress on various applications for genetically modified organism (GMO) authorisations that have already received a favourable EFSA Opinion.

   2. 3.2. Post-EFSA approval process and timelines
      

      Canada expressed disappointment that the first meeting of the European Commission's Standing Committee on Plants, Animals, Food and Feed (PAFF Committee) in 2020 was only held on September 15 and did not include all GM events that were pending. The Commission explained the administrative steps from reception of the EFSA scientific opinion, over to public consultation, Standing Committee, and Appeal Committee leading to adoption of the authorisation decision by the Commission.

      Canada noted that significant delays occurred during the first half of 2020 and called upon the Commission to grant authorisation as soon as the voting procedure is finalised. Canada believes this would have a favourable impact on global trade and would be a positive signal to trading partners.

      Canada inquired about the planned Appeals Committee in November (2020) and signals it may be combined with the regularly scheduled Committee where initial voting takes place. The Commission informed Canada that organisation of the Committees follows strict procedures. Therefore, a PAFF Committee and Appeals Committee do not take place at the same time.

4. EU Policy – Updates
   1. 4.1. Potential impacts of EU Green Deal and Farm to Fork Strategy
      

      Canada and the Commission share the view on the need for more sustainable agriculture and food production systems. Canada considers biotechnology to be an important tool to achieve this goal, and would like to be kept informed of any new initiatives implemented through these strategies.

      The Commission informed Canada of the organisation of outreach events on the wider content of these policies organised with third countries.

      The Commission noted that the European Green Deal and the Farm to Fork strategy recognised that innovative techniques may play a role in increasing sustainability. The new technologies of biotechnology are only one of the possible tools in the toolbox to achieve the desired outcomes.

   2. 4.2. New Breeding Techniques
      

      The Commission informed Canada of the continued efforts to enforce the GMO legislation since the interpretation by the Court of Justice of the European Union in Case C-528/16. In addition, the Commission is addressing a request from the Council of the European Union for a study on the status of innovative breeding techniques by April 2021. This request includes the possible submission of a proposal (accompanied by an impact assessment) or any other measure. Information on the progress on the study is available online^{Footnote 1}.

      Canada expressed appreciation for, and interest in, the Commission’s study and is hopeful that due consideration will be given to regulatory options that could facilitate innovation in the agricultural sector.

      Canada inquired whether Member States and value chain stakeholders have had opportunity to determine how they intend on addressing compliance enforcement and verification for products of new breeding techniques. The Commission confirmed that Member States and value chain stakeholders, as well as civil society groups were invited to reply to a number of questions related to enforcement in the context of the study. Canada encouraged the Commission to consider a pragmatic approach to compliance, in recognition that many products of gene editing are not distinguishable from their conventional counterparts.

   3. 4.3. Regulation (EU) 2019/1381 on Transparency and Sustainability of EU Risk Assessment in the food chain
      

      Canada signalled support for initiatives to increase transparency and build trust in EFSA. Canada expressed hope that any additional funding considerations for EFSA will help to increase efficiencies in the EFSA review process along with additional work on risk communication and urged for details to be shared. The Commission explained that this Regulation aims at increasing transparency and the independence of studies, strengthening EFSA’s governance and scientific cooperation, and developing comprehensive risk communication. The Regulation will only apply to applications received after 27 March 2021. Canada enquired on the separation of EFSA staff involved in the future pre-submission advice and actual risk assessment. The Commission underscored that there would be strict separation between staff providing advice and those conducting the risk assessment. Canada also expressed some concerns on the expansion of EFSA’s management board causing possible additional discussions and delays. The Commission responded that this is a mere alignment to other executive agencies, with properly functioning management boards.

   4. 4.4. Member State Food and Feed Opt-Out Proposal
      

      The Commission informed Canada that this proposal has not made progress since the last meeting in March 2019.

   5. 4.5. Proposed French Decree on in-vitro Mutagenesis
      

      Canada places strong value on the EU single market and consistent market access across all Member States. Consequently, Canada is concerned that the approach taken by France may lead to a patchwork of different regulations across the EU, making it difficult for exporting countries to meet EU requirements.

      Canada expressed concern with the lack of scientific basis for singling out products developed using certain mutagenesis techniques as being more risky than any other methods of plant breeding. In addition, the definitions of GMO or LMO found in international agreements and standards refer to modern biotechnology with the exclusion of random in-vitro mutagenesis. Moreover, Canada fails to see any reason for singling out certain rape oilseed varieties. Canada expressed hope that France would revoke the adoption of these Decrees, as their adoption would lead to a patchwork of different regulations within the EU and a disturbance of the global market. Canada will closely monitor further developments.

      The Commission informed Canada that the Commission and a number of Member States had submitted detailed opinions on the proposed Decrees, supported by several European stakeholders. The Commission is now waiting for France’s response.

   6. 4.6. Comitology Reform Proposal
      

      The Commission informed Canada that the proposal is still being discussed by the Council and the European Parliament. The Commission continues to apply existing procedures as long as the new proposal is not adopted.

   7. 4.7. Impact of Brexit on comitology
      

      Canada enquired as to how Brexit could affect the Qualified Majority Voting (QMV). The Commission explained that the United Kingdom no longer takes part in the Union’s decision making process, including in the GMO area. Voting in the Standing Committee follows the qualified majority rule set out in the Treaty on European Union. The calculation of qualified majority is based on the number of countries as well as the percentage of the total Union population represented in the votes. Those figures have been adapted according to the UK withdrawal.

5. CAN Policy – Updates
   1. 5.1. Product approvals
      

      Canada informed the EU that all authorised products are listed in online databases on the Government of Canada’s website.

   2. 5.2. Policy updates: intent to publish new guidance
      

      Canada informed the EU of planned public consultations in January 2021 on new draft guidance related to plant breeding. A main goal of this guidance is to improve the clarity and predictability of Canada’s regulatory approach for novel plant products. Canada explained that the proposals were in development, but would remain consistent with the product-based approach to regulation that Canada has always employed. Canada also highlighted that the final guidance will be science-based and result in oversight that is commensurate with risk

6. Updates on International Activities
   

   Canada encouraged the Commission’s attendance at the 7^th Meeting of the Global Low Level Presence Initiative (GLI), taking place virtually, October 27-28, 2020.

7. Any other business
   1. 7.1. Recent EFSA Consultations
      

      EFSA informed Canada on recent and forthcoming public consultations on EFSA’s website.