The Thirteenth Canada-EU Biotech Market Access Issues Dialogue
December 3, 2021, by videoconference
The thirteenth meeting of the European Union (EU)-Canada Dialogue on Biotech Market Access Issues (the Dialogue) took place on 3 December 2021 through an online meeting, with participants in Brussels, Ottawa, and Parma.
1. Introductions and Opening Remarks
Both Canada and the European Commission consider the Dialogue to be a useful forum for mutual information on topics related to regulatory, technical, and emerging issues affecting trade in agricultural products of biotechnology. The Dialogue further allows an open and transparent information exchange on new and pending product approvals. To further facilitate exchange on topics of mutual interest, Canada proposed an intersessional meeting before the next official Dialogue during its opening statements. The DG SANTE invited further bilateral discussion on the proposal.
2. GM Event Approvals: EFSA assessment and timelines
2.1 Status of specific applications under EFSA assessment
Canada brought forward a list of specific applications that are in risk assessment, seeking an update. The European Food Safety Authority (EFSA) offered to provide a written summary of the status of EFSA opinions on those specific events.
2.2 EFSA assessment process and timelines
Canada stressed continued concern with the length of time for product approvals in the EU, and enquired how the pre-submission meetings initiated in 2020 have been realized into efficiencies or new directions for processes in regards to EFSA’s procedures or timelines.
EFSA pointed out that the overall time for risk assessment decreased the last two years as a result of a leaner internal process. The current average time spent on risk assessment is 205 days. EFSA indicated that the generation of the additional information by the applicants following additional data requests by EFSA (stop-the-clock mechanism) represents 80 to 90% of the total time of the risk assessment process (from valid dossier to adopted scientific opinion). EFSA’s current priority is to adopt all scientific opinions within 180 days.
Incomplete or non-compliant studies in the application file (studies that are not in line with good laboratory practice, non-compliant or missing 90-day toxicology studies, etc.) are responsible for most delays in the actual risk assessment process. When confronted with such deficiencies, EFSA offers clarification teleconferences with the applicants to facilitate the mutual understanding. In addition, three meetings with applicants were organised in 2021, where among others, Regulation (EU) 2019/1381 of the European Parliament and of the Council of 20 June 2019, known as the "Transparency Regulation" implementation, including requirements, procedures, and guidance documents were discussed. Additionally, several webinars have also been organized by EFSA since November 2020. Finally, in specific cases in accordance to the EFSA catalogue of services, EFSA invited applicants to technical working groups allowing them to present their rationale and scientific approach and discuss it with the Panel Experts.
Since the entry into force of the Transparency Regulation in March 2021, pre-submission advice became an integral part of the catalogue of services available to applicants. So far, EFSA received at least one request related to biotech products, a number expected to increase in the future.
Canada noted that applicants often report that additional requirements seem to sometimes be created during the assessment process (i.e. after acceptance of a dossier) and inquired if pre-application consultation is forward looking and transparent. DG SANTE noted a prime concern identified during the risk assessment process is the completeness of the dossier, with the objective to achieve a conclusive outcome as often as possible. Applying the stop-the-clock mechanism allows for the submission of additional data further substantiating the safety of the product.
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 assessment of the stack and single events or other opportunities to streamline stack approvals. EFSA noted that the “single first principle” not only is embedded in the EU legislation, but also that it makes sense from a scientific point of view: the comprehensive evaluation of each single event allows for the identification of intended and unintended effects linked to the genetic modification, relevant for the assessment of potential interactions in stacks of relevance for food and feed safety. This principle makes the assessment of the stack events a speedy process. Furthermore, in the case of segregating crops, the “single first principle” has an additional advantage given that not only the high stacks are authorised but also all lower sub-combinations (further information is available in the minutes of the 115th Plenary Meeting of Scientific Panel on GMO, May 2017Footnote 1).
3. GM Event Approvals: Post EFSA approval process and timelines
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. DG SANTE agreed to provide a written update.
3.2 Post-EFSA approval process and timelines
DG SANTE gave a detailed explanation of the subsequent steps from the publication of the EFSA opinion as provided for in the applicable EU legislation: public consultation on the EFSA opinion and EFSA assessment if comments are received, the internal procedure leading to the presentation for vote in the Standing Committee, the possible passage through the Appeal Committee, and the adoption by the College of Commissioners. DG SANTE stressed that the GMO legislation and the overarching comitology legislation lays down these steps, which are mandatory. Timelines can be affected by the reception of scientific comments during the public consultation, or the need to establish a post marketing monitoring plan for the draft authorisation.
Canada expressed concern over the frequency of the European Commission's Standing Committee on Plants, Animals, Food and Feed (PAFF Committee). DG SANTE also explained its approach to the planning of Standing Committee and Appeal Committee meetings. DG SANTE assured Canada a date is reserved approximately every month for a PAFF Committee meeting and only cancel the meeting if there are no agenda items. DG SANTE believes the post-EFSA process has been considerably shorter than the past couple of years.
DG SANTE noted that 18 authorizations were issued since the last Dialogue.
4. EU Policy – Updates
4.1 EU Green Deal and Farm to Fork Strategy in relation to biotechnology
Canada opened the conversation by discussing its common goals and interests and provided a brief overview of the Strengthened Climate Plan and development of the Canadian Agri-Environmental Strategy. Canada emphasized that it has shared ambitions with the EU, but different pathways to success, due to differing circumstances such as geography, crops, and consumer preferences. Canada expressed that it views biotechnology as one of the tools that can be used to help both mitigate the impacts of climate change on agricultural production, as well as to help develop more environmentally friendly and sustainable agriculture, and pointed out that the Farm to Fork Strategy (F2F) also acknowledged this explicitly. Canada expressed agreement that decoupling new genomic techniques (NGTs) from GMO regulations should allow innovative products to be developed and commercialized, and help the agriculture sector meet the F2F targets and contribute to sustainable food system going forward.
DG SANTE discussed the role of innovation –including biotechnology- in the context of the goals of the European Green Deal and Farm to Fork objectives. DG SANTE mentioned the on-going work on a Union sustainable food framework which, if adopted, will apply generally to food and both to regulated (including GM food) and non-regulated products. DG SANTE reminded Canada it had explained the broader context of Green Deal and Farm to Fork during the CETA Sanitary and Phytosanitary (SPS) Joint Management Committee (JMC) held on 16 November 2021.
DG SANTE enquired whether the current global challenges have resulted in the development of additional interesting traits or traits in more diverse crops, and whether Canada actively steers innovation to achieve such developments. Canada responded that the Government of Canada focuses on policy development and legislation.
4.2 Legislation for plants produced by certain new genomic techniques initiatives
Canada expressed its support for the European Commission’s initiative on Legislation for plants produced by certain new genomic techniques, and stressed the potential of products of NGT to help address pressing global challenges, such as environmental sustainability, climate change resilience, and food security.
Canada encouraged the European Commission to develop innovation friendly, trade-facilitative, science-based policy options that align with existing and emerging international regulatory approaches, noting that many products developed through NGTs will, for the most part, be similar or undistinguishable from products that could have otherwise been produced through conventional breeding.
DG SANTE presented the current state of play of the policy action for plants obtained by targeted mutagenesis and cisgenesis. The publication of the inception impact assessment and subsequent one-month period for public comments resulted in more than 70.000 reactions. The next step will be the impact assessment, to be conducted during 2022, with a public consultation in the second quarter of the year. Further to Canada’s inquiry, DG SANTE confirmed that risk assessment, traceability & labelling, and sustainability will be developed as part of the policy options for impact assessment and public consultation.
DG SANTE also informed Canada of the high-level event "New genomic techniques - the way forward for safe and sustainable innovation in the agri-food sector" organised on 29 November 2021. A recording of the event is available onlineFootnote 2.
4.3 Member State Food and Feed Opt-Out Proposal
DG SANTE informed Canada that this proposal has not made progress since the last Biotech Dialogue meeting in October 2020.
4.4 Comitology Reform Proposal
DG SANTE informed Canada that the proposal has not made progress since the previous meeting held in October 2020. The Commission continues to apply existing procedures as long as the new proposal is not adopted.
5. CAN Policy – Updates
5.1 Product approvals
Canada informed DG SANTE that all authorised products are listed in online databases on the Government of Canada’s website. Canada provided an overview of relevant websites in advance of the meeting (annex to this doc). DG SANTE inquired on the possibility for Canada to share with the EU the detection methods for products authorized in Canada. Canada informed DG SANTE that is not legally in a position to share the detection methods. Canada shares information regarding the determination of safety of products in decision documents, available online (Annex A). Canada referred to these documents as a source of accurate information on the method of development for each product. Canada shared the linksFootnote 3 to the summary of Canada’s risk assessments.
5.2 Policy update: Novel Food Regulations in Canada: Overview, Genetically modified animals, and recent guidance updates
At DG SANTE’s request, Canada provided an overview of the Novel Food Regulations in Canada. Furthermore, Canada provided an update on Health Canada’s (HC) ongoing regulatory review addressing the requirements for novel foods derived from plant breeding. This review seeks to increase the predictability and transparency of the Canadian regulatory system for novel foods, particularly for products produced through new breeding techniques (NBTs) commonly referred to as NGTs in the EU.
The EU sought to understand who determines whether a product is novel, regulators or product developers. HC explained that it is the responsibility of the developer to determine if their product is novel. However, it was noted that developers may request opinions from HC, which are provided on a case-by-case basis. HC noted that the no history of safe use trigger comprises a significant amount of HC’s work in this area.
5.3 Policy update: Canadian efforts to update guidance related to the Seeds Regulations
Canada provided an update on Canadian Food Inspection Agency’s (CFIA) ongoing regulatory review addressing the requirements for novel plants derived from NBTs. This review seeks to increase the predictability and transparency of the Canadian regulatory system for novel plants, particularly for products produced through NBTs. The CFIA recently held a consultation on a guidance proposal to provide improved clarity, and is in the process of analyzing feedback from this consultation.
5.4 Policy update: Canadian efforts to update guidance related to the Feeds Regulations
Canada provided a policy update regarding Canadian efforts to update guidance related to the Feeds Regulations. The CFIA’s Animal Feed program is working on updating existing policy related to novel feeds that will help address those feeds derived from new plant breeding techniques. The Feeds Regulations has a positive list of ingredients (Schedule IV and V) that permits use of ingredients in feeds if the ingredient meets the definition found in this list. The focus in the current exercise is to improve clarity related to how Canada identifies and assesses ingredients that do not meet the definitions (i.e., that trigger novelty). The ultimate objective of this work is to provide clarified guidance to assist developers in understanding the required regulatory pathway for their products earlier in the development process.
6. Updates on International Activities
6.1. Global Low Level Presence (LLP) Initiative (GLI)
Canada informed the Commission that the 8th Meeting of the Global Low Level Presence Initiative (GLI) is being planned for March 2022, highlighting some of the key GLI themes of interest for the 8th GLI. Canada encouraged the Commission’s attendance at the 8th GLI meeting, taking place virtually in March.
7. Any other business
No other points were raised.
During the closing remarks, both delegations expressed gratitude for the open dialogue and opportunity to exchange information. Canada repeated its concerns on procedures and proposed the use of an intersessional meeting to follow-up on specific technical aspects. DG SANTE questioned whether additional meetings are necessary given that the annual meeting allows for a very comprehensive exchange, however DG SANTE will consider the proposal. DG SANTE mentioned that detection and identification of products that are regulated in the EU are key points for exports to the EU. Both parties agreed to stay in contact and discuss priorities of the Dialogue going forward.
Genetically Modified (GM) Plants: authorised and pending applications in Canada
- The Canadian Food Inspection Agency (CFIA) maintains an online database that provides information on plants authorized for unconfined environmental release (e.g. cultivation), novel livestock feed use, and novel food use. The database distinguishes both genetically modified (GM) and non-GM plants, and is available at: https://www.inspection.gc.ca/active/netapp/plantnoveltraitpnt-vegecarnouvcn/pntvcne.aspx.
- A list of novel food decisions is also provided at: http://www.hc-sc.gc.ca/fn-an/gmf-agm/appro/index-eng.php .
- The CFIA also prepares "decision documents" whenever plants are authorized for environmental release and use as feed. They explain what information was reviewed to make the decision, and why certain conclusions were reached. Decision documents provide background information, describe the plant's novel traits, and discuss the results of the assessment and evaluation of the potential environmental and livestock feed use impacts. Decision documents are available to the public at: http://www.inspection.gc.ca/english/plaveg/bio/dde.shtml.
- Health Canada publishes similar summaries for novel foods on their web site, available at: http://www.hc-sc.gc.ca/fn-an/gmf-agm/appro/index-eng.php.
- Although not a Party to the Cartagena Protocol on Biosafety, Canada also is responsible for submitting summaries of its decisions with respect to GMOs to the Biosafety Clearing-House.
GM plant authorizations since the last meeting of the Biotech Dialogue
Since the last Biotech Dialogue on October 21, 2020, Canada authorized the following products for use in feed and food and for environmental release in Canada:
- MON 95379 corn: insect resistance – Bayer CropScience
- DP23211 corn: Herbicide tolerance (Glufosinate ammonium) and insect resistant – --Pioneer Hi-Bred Production
- IND-00410-5(HB4) soybean: Herbicide tolerance (Glufosinate ammonium), increased yield and drought tolerance
- Verdeca LLGMB151 soybean: Nematode resistance and herbicide tolerance (HPPD inhibitors) – BASF Canada Inc.
- MON 94100 canola: Herbicide tolerant (Dicamba) – Bayer CropScience
- 14CS0851-01-14 camelina: Herbicide tolerance (Thifensulfuron-methyl) Smart Earth (non-LMO)
The following product from a crop not cultivated in Canada was authorized for feed and food use in Canada:
- RTA1 Rice: Herbicide tolerant (Quizalofop) – RiceTec
As well, the following product from a crop not cultivated or used as feed in Canada was authorized for food use in Canada:
- EF2-114 pineapple: pink-coloured fruit flesh - Del Monte Fresh Produce Company
Applications for authorization currently under review
The CFIA and Health Canada post “notices of submission” on the CFIA web site that describe the product and the data they receive from certain product developers who have requested safety assessments of novel plant products for unconfined release and safety assessments of novel feeds and novel foods derived from them. The list of notices of submission is available at http://inspection.gc.ca/english/plaveg/bio/subs/subliste.shtml. Participation in the notice of submission process is voluntary. There are no new products on the list of notices of submission at this time.
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