Canada-European Union Comprehensive Economic and Trade Agreement (CETA)
11th Meeting of the Bilateral Dialogue on Biotech Market Access Issues,
Videoconference, 4 March 2019
The eleventh meeting of the EU-Canada Dialogue on Biotech Market Issues took place on 4 March 2019 in Brussels, with video connections to Ottawa and Parma. The European Commission and Canada value the Biotech Dialogue as an instrument for information exchange related to regulatory and technical issues affecting trade in agricultural products of biotechnology and on the evolution of biotech issues on both sides.
GM Event Approvals: EFSA assessment and timelines
Status of specific applications under EFSA assessment
The European Food Safety Authority (EFSA) updated Canada on the status of two applications for the placing on the market of a genetically modified oilseed rape and soybean currently in the risk assessment pipeline.
EFSA assessment process and timelines
EFSA explained the risk assessment process and related timelines from the reception of an application to the publication of a Scientific Opinion. Canada acknowledged that progress has been made in speeding up the assessment phase, but considered that further improvement is desirable.
On Canada’s enquiry on the possibilities to have one-on-one meetings between EFSA and applicants at the pre-submission stage, EFSA replied that such meetings are currently not implemented. However, according to its Catalogue of Services to applicants during the risk assessment process, EFSA or applicants may call for a meeting in order to clarify the additional information received from companies or the questions sent by EFSA, respectively. To avoid unnecessary delays when questions arise in one sector of the assessment, the assessment of the other aspects continues to the extent possible.
On Canada’s enquiry on the possibilities of improving communications between EFSA and applicants, EFSA highlighted its efforts to increase efficient communication with applicants. Webinars, technical meetings and phone calls with applicants aim at explaining complex technical issues in order to ensure a better understanding by applicants of EFSA’s assessment needs, resulting in a reduction of follow-up questions.
On Canada’s enquiry, EFSA explained the selection of external experts to renew its scientific panels operating during a three-year mandate. It was made clear that Panel members act in their personal capacity. Notwithstanding the renewal of its scientific panels according to the EU legislation, EFSA confirmed its commitment to ensure business continuity. EFSA further explained that the risk assessment is framed by its guidelines defining the data requirements to be met by applicants, and that the Panel follows these guidelines.
GM Event Approvals: Post EFSA approval process and timelines
Status of specific applications post-EFSA
The Commission gave information on the procedural status of various applications for genetically modified organism (GMO) authorisations that have already received a favourable EFSA Opinion.
Post-EFSA approval process and timelines
Canada stressed the importance of timely approvals of biotechnology events in the EU and the importance for the EU to ensure that proposals for GM events are processed as fast as possible within the procedures laid down in EU approval legislation. Canada enquired about the potential impact of the EU elections, the selection of a new Commission and withdrawal of the United Kingdom from the European Union on the comitology process. The Commission explained that no impact is expected as the current Commission would continue to function as usual.
The Commission explained the procedural steps set out in the EU legislation, following the adoption by the EFSA GMO Panel of a favourable Scientific Opinion. The first step, after the publication of the EFSA overall opinion, is to launch a public consultation on the EFSA opinion for a period of one month. In case scientific comments are received during this period, EFSA is consulted to assess if they contain new information that could lead the GMO Panel to reconsider its opinion. Subsequently, a draft authorisation decision is prepared and presented for a vote in the Standing Committee on Plants, Animals, Food and Feed (section GMO). In case this vote does not result in a qualified majority, the draft decision is submitted to the Appeal Committee for a vote. In case no opinion is delivered by the Appeal Committee, it is for the Commission to decide on the draft authorisation.
EU Policy – Updates
“Precision Breeding Techniques”
The Commission informed Canada that the ruling of the Court of Justice of the European Union (CJEU) provided important clarification on the scope of application of the GMO legislation in relation to organisms obtained by mutagenesis techniques. The Court judgement clarified that the GMO legislation is applicable to organisms obtained by new mutagenesis techniques.
The ruling did not extend the scope of the legislation but clarified how it should be read. The Commission reminded Canada that the current EU legislation on GMOs is based on science and has been in place since the 1990s and updated in 2001. The EU GMO legislation is compatible with the WTO SPS Agreement, where each party has regulatory autonomy.
Canada, in full respect of the independence of the CJEU and its interpretation, enquired whether the Commission envisaged a new legislative proposal to address products from new plant breeding techniques and noted that different approaches are applied by many other countries in the world. The Commission informed that there are no plans to make a legislative proposal under the current College of Commissioners.
Canada requested an update on compliance and enforcement with EU legislation following the CJEU ruling, particularly for imports. The Commission emphasized the responsibility of those putting products on the EU market to meet EU legislation requirements. Canada noted that Canadian exporters are fully aware of the EU requirements.
Update on the EC legislative proposal on Transparency and sustainability of EFSA Risk Assessments
The Commission informed Canada of the provisional agreement of the European Parliament and the Council on the Commission's proposal for a Regulation on the transparency and sustainability of the EU risk assessment in the food chain. The European Parliament and the Council will still need to adopt formally this provisional agreement. The new legislation would be applicable in early 2021.
The Commission explained that the aim of the proposal is to increase transparency and the independence of studies, to strengthen EFSA’s governance and scientific cooperation, and to develop comprehensive risk communication.
Canada expressed its satisfaction that pre-submission meetings will become routine practice and was confident that this will help to speed up the application process by improving dossier completeness. Both parties agreed on the importance of risk communication and consistent engagement, as being complementary to scientific risk assessment of the biotech products. At the request of Canada, the Commission confirmed that it would notify this adopted text to the WTO for information.
Member State Food and Feed Opt-Out Proposal/ Proposed changes to comitology process
The Commission updated Canada on the state of play of the Commission's proposals on the possibility for the Member States to restrict or prohibit the use of GM food and feed in their territory and on changes to the comitology process.
The Commission will continue to enforce the existing legislation until the adoption of both proposals.
CANADA Policy – Updates
GMOs and new techniques in agricultural biotechnology – Policy update, product approvals and approval system and criteria
At the request of the Commission, Canada clarified the notion “novel trait” and the related approval system and criteria. The Commission welcomed the clarification, which allowed for a better understanding of Canada’s approval system for cultivation and feed and food uses.
Canada confirmed it has not assessed and authorized any products obtained by precision biotechnology (i.e. new breeding techniques) since the last Canada – EU Biotechnology Dialogue meeting and that there is no public notice for any new applications for products obtained by these techniques. The Commission enquired whether Canada is considering a system that would provide information on the techniques (including precision biotechnology techniques) used for the development of seeds. Canada replied it is not opposed to transparency on this point, and discloses information on the techniques used in the development of products that are authorized for use as food and feed, and for environmental release in Canada.
Traceability of GMOs and exports to the EU
The Commission reminded Canada that only EU-authorised GMOs can be exported to the EU, which, in line with the clarification by the CJEU ruling, include also gene edited products. Operators in and outside the EU remain responsible for ensuring that products which are placed on the market are safe and comply with all relevant regulatory requirements.
Canada informed that Canadian exporters are very aware of their obligations. Canada is confident that exports to the EU fulfil EU requirements.
Updates on International Activities
Low Level Presence (LLP)
Canada recalled that LLP is when small amounts of a GM crop that has been assessed as safe following Codex Guidelines by at least one country, but has not been approved in the importing country, is unintentionally present in shipments exported to that country. Canada highlighted that, as more GM products are developed and approval timelines increase, the risk of LLP increases, which continues to be a growing concern for the international community. Canada emphasized the importance for countries, including the EU, to adopt a pragmatic approach to managing LLP to avoid unnecessary disruptions to trade.
Canada emphasized the value of having an EU contribution to the international LLP discussion and invited the EU to participate in the next meeting of the Global LLP Initiative (tentatively scheduled for September 2019).
Canada informed that it is one of the 14 jurisdictions, which supported the ‘International Statement on Agricultural Applications of Precision Biotechnology’ in November 2018. Canada explained that the statement recognizes that, as more countries determine how they will regulate products of new technologies such as gene editing, collaboration (including regulatory and policy alignment, where possible) to minimize unnecessary barriers to trade related to differences in regulatory oversight of products of precision biotechnology is important.
Canada encouraged the EU to take part in international discussions on the trade and economic considerations related to the regulatory oversight of products of new technologies.
Any other business
No points were raised under AOB.
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