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Joint report: 6th Meeting of the CETA Regulatory Cooperation Forum

24-25 April 2024, Ottawa and by videoconference

1. Introduction

The Co-chairs of the Regulatory Cooperation Forum (RCF) welcomed the opportunity to strengthen the partnership between Canada and the European Union (EU), expressing gratitude for the chance to share insights and expertise on regulatory cooperation. They underscored the value of regulatory cooperation, which is instrumental in advancing Canada and the EU’s shared priorities and commitments.

To further highlight regulatory cooperation initiatives between Canada and the EU and to facilitate the consolidation of this information, a non-exhaustive list of regulatory cooperation activities undertaken under other CETA specialized Committees and Dialogues has been included in an annex at the end of this report.

2. Discussion and status update with regulators on work plan items and items of interest

Regulators from Canada and the EU provided updates on their joint streams of work under the RCF. Progress was notable in all areas of cooperation. No new work plan items or items of interest have been added to the list of cooperation areas since the last Annual Meeting.

a) Consumer product safety

The consumer product safety work plan item is carried out by Health Canada and the Directorate-General for Justice and Consumers (DG JUST).

In May 2023, Health Canada and DG JUST held an extended bilateral meeting on a number of topics, including:

In fall 2023, Health Canada and DG JUST collaborated on a coordinated awareness campaign focused on safe online shopping for children’s products. The campaign included a number of posts to social media platforms, highlighting important tips for consumers to consider before buying these products online. Planning has started on the 2024 campaign to identify possible areas of focus, based on shared priorities.

Health Canada and DG JUST exchange information on a regular and ongoing basis through Health Canada's RADAR consumer product incident reporting system and the EU's Safety Gate alert system. In December 2023, Health Canada, in collaboration with industry, initiated a product recall, following information received from DG JUST concerning a product of Canadian origin. This concrete example highlights the importance of the cooperative relationship in safeguarding the health and safety of consumers in both jurisdictions.

The regulators also continue to exchange experiences in market surveillance and have agreed to cooperate on compliance verification for children’s highchairs. The timing is opportune, as both Canada and the EU are pursuing independent compliance verification projects in 2024-25. While the projects will follow different timelines, regulators from both jurisdictions foresee benefits in exchanging information regarding methodologies, testing results, and other topics as the projects progress

b) Animal welfare

This work plan item is led by Agriculture and Agri-Food Canada and the Directorate-General for Health and Food Safety (DG SANTE).

The two organizations last met on December 15, 2023, and discussed two key topics.

The first topic focused on the use of science to inform and guide legislation and regulation. This included a presentation by the European Food Safety Authority on its process for producing Scientific Opinions, as well as a presentation by Canada’s National Farm Animal Care Council on how Code Scientific Committees create recommendations that may be incorporated into species-specific Codes of Practice. Through this information exchange, regulators recognized that, while the methodologies used by the two jurisdictions vary, outcomes are similar. Both jurisdictions strive to use the latest science when developing and implementing policy in this field.

The second topic focused on the regulatory proposal that the EU released on December 7, 2023, on the protection of animals during transport. The EU delivered a short presentation on the proposal, which introduced, among other requirements, stricter rules regarding travel times, transport conditions for vulnerable animals, and transportation in extreme temperatures. The presentation enhanced Canada’s understanding of the proposal, enabling Canadian regulators to better consult with industry stakeholders and gather feedback on the proposal.

The regulators are aiming to hold their next meeting in late spring or early summer 2024. They emphasized that ongoing exchanges of technical information have been crucial to better understand the benefits and challenges of different approaches regarding animal welfare.

c) Pediatric medicines

The pediatric medicines work plan item is carried out by Health Canada and the European Medicines Agency (EMA).

The two organizations last met in May 2023. At the meeting, the EMA provided insight into the development and implementation of the updates to their pediatric regulation. These updates provided Health Canada with valuable support as it prepared to launch a pilot project for pediatric plan submission and consider potential pediatric policies for Canada.

In February 2024, Health Canada launched a Pediatric Submission Policy Pilot, which encourages sponsors to submit pediatric studies and/or pediatric plans as part of certain drug submissions for market authorisation in Canada. Participation in the pilot is voluntary and will not affect the outcome or timelines for the review of drug submissions.

The objectives of the pilot are to:

  1. encourage sponsors to submit, in a timely manner, safety and efficacy information for drugs expected to be used in pediatric populations;
  2. provide more information on the safety, efficacy and dosage of drugs used in pediatric populations to health care providers, patients and their families; and
  3. inform future policy.

Regulators have observed that the discussions under the RCF have been very engaging, impactful, and integral to the launch of Health Canada's Pediatric Submission Policy Pilot. Health Canada and the EMA will continue to explore ways to work together more closely on pediatric medicines, particularly in areas of high unmet therapeutic needs.

d) Cooperation Agreement between the Standards Council of Canada, the European Committee for Standardization and the European Committee for Electrotechnical Standardization

The Standards Council of Canada (SCC) and the European Committee for Standardization and the European Committee for Electrotechnical Standardization (CEN-CENELEC) will renew their cooperation agreement this year to strengthen their collaboration in standardization. Building on this agreement, the SCC and CEN-CENELEC aim to deepen mutual understanding, share expertise, and promote transparency and predictability in the development and implementation of standards.

Priority areas currently include hydrogen, artificial intelligence, and circular economy.

Hydrogen

The SCC is currently co-leading the Standards and Codes Working Group in partnership with Natural Resources Canada. The Working Group was created out of the Hydrogen Strategy for Canada and will include an expert representative from CEN-CENELEC. The Working Group is developing a Hydrogen Codes and Standards Roadmap, which is currently under review. The Roadmap includes a gap analysis of the hydrogen value chain, which yielded over 2000 relevant standards and included recommendations for improvement.

In January 2024, CEN-CENELEC provided recommendations on the Roadmap to the SCC, including that:

  1. Canada should consider developing standards for loading, storing, and controlling liquified hydrogen for export;
  2. Canada should consider developing “Guarantee of Origin” standards that specify the country of origin from which hydrogen and liquid hydrogen are imported; and,
  3. Canada should develop standards at the national level that covers the entirety of the hydrogen value-chain. This means either adopting existing global standards or developing national standards as needed.

The SCC and Natural Resource Canada also met with the European Commission in October 2023 to gain insight on how to address limitations in the European Commission’s development on its Hydrogen Alliance Roadmap. Through this engagement, Canada recognized the value of having technical subject-matter experts and Standards Development Organizations to review and validate the list of hydrogen standards uncovered from the gap analysis.

SCC and CEN-CENELEC will continue to exchange information on how standardization supports Canada and the EU’s respective hydrogen strategies, aiming to develop an aligned approach to support regulatory cooperation as closely as possible.

Artificial Intelligence (AI)

In December 2023, the SCC was granted permission to observe at meetings of CEN-CENELEC’s technical body responsible for drafting AI standards. This included access to related work plans, draft standards and proposals.

The SCC and CEN-CENELEC agreed to cooperate on AI and Data under the RCF in 2024 through quarterly touchpoints. The first meeting took place in January 2024, with the aim to provide an overview of each jurisdiction’s AI regulatory landscape. The SCC also provided an update on Canada’s AI and Data Act (AIDA), which is currently under review in Parliament.

Additional efforts involve pinpointing AI domains where both parties can exchange information, share best practices, and collaboratively develop standardization strategies to promote consistency and improve interoperability.

Circular Economy

In August 2023, the SCC and CEN exchanged information on circular economy initiatives, identifying areas for collaboration such as plastics, sustainability, and construction.

That same month, CEN established a new Technical Committee on Circular Economy, as a counterpart to the ISO Technical Committee on Circular Economy, to meet European-specific prerequisites, legislation, and policy. Standards in the field aim to provide recommendations, requirements, methodologies, and tools to support and measure the transition of the market.

The SCC is currently advising Environment and Climate Change Canada on a verification program for recycled plastics content. The program is scheduled to begin in spring/summer 2024 and would entail verification bodies providing services to companies reporting on recycled content. Regular meetings on this topic will be scheduled in 2024, with specific areas of cooperation depending on the identification of common priorities for the upcoming years.

In 2024, a number of CEN and CENELEC technical committees will continue working on the deliverables mandated by the Standardization Request on plastics recycling and recycled plastics. This Standardization request was issued by the European Commission in support of the European Strategy for Plastics in a Circular Economy. It mandates CEN and CENELEC to revise 11 European standards, as well as to develop around 45 new deliverables on a variety of topics, including quality grades for sorted plastic waste, and design-for-recycling guidelines for a wide range of products.

The SCC and CEN-CENELEC will continue exploring collaboration on the circular economy and climate change mitigation efforts to support larger cooperative initiatives between Canada and the EU, including the Green Alliance.

e) Small Solid Biomass Combustors (SSBC) (Formerly “Wood Pellet Boilers”)

Canada continues to facilitate conversations with officials in Canadian provinces and territories to determine potential paths forward for the import and sale of small solid biomass combustors in Canada.

In September 2023, a project team created by the Provincial-Territorial Advisory Committee (PTAC), a statutory committee of the SCC, presented a White Paper to PTAC. The paper recommended adopting the European standard EN 303-5 for small solid biomass combustors as a Canadian national standard and adding necessary deviations to meet national interests. In line with this recommendation, the CSA Group, a global standards organization that includes a focus on standards development, has filed a Notice of Intent with the SCC to develop a national standard for small solid biomass combustors.

The CSA Group is currently exploring funding options to develop the standard. The SCC will continue to follow progress on this item as the work on the new standard continues.

3. General updates

The next iteration of the work plan is expected to be published in late spring 2024. 

During internal discussions, the Co-chairs considered initiatives that RCF could undertake to help identify new areas for cooperation under the forum, and to increase awareness of, as well interest in, the RCF. The Co-chairs also discussed ways to further showcase the work and benefits of the RCF going forward.

4. Discussion of potential new work plan items

During the meeting, the Co-chairs discussed several topics to determine their suitability for discussion under the RCF. While no decisions were taken at the meeting, discussions will continue on a number of the proposals.

5. Stakeholder debrief

The Co-chairs shared updates regarding the RCF’s activities and results with over 60 stakeholders from Canada and the EU, including representatives from businesses, trade associations, non-governmental organizations, academic institutions and public servants.

Following the debrief, the Co-chairs engaged in a Q&A session with the stakeholders. Participants sought clarifications and additional details on work plan items. The participants also provided feedback on topics they believe could benefit from further cooperation. Proposed topics included electronic invoicing, carrier cycles and questions about the EFSA’s scientific process. The Co-chairs committed to following up and thanked all participants for their questions and suggestions.

6. Wrap-up and next steps

The next annual meeting of the RCF should take place in Belgium in spring 2025.

For those who are interested in providing input to Canada, the Treasury Board of Canada Secretariat has published guidance on how to report a regulatory cooperation barrier and established a centralized mailbox at rcd-dcmr@tbs-sct.gc.ca.

For submissions to the EU, a dedicated functional mailbox has been set up at EU-CETA-RCF@ec.europa.eu.

Participants

Annex: Other regulatory cooperation initiatives under CETA

The Canada-European Union Comprehensive Economic and Trade Agreement (CETA) established specialized committees between the EU and Canada to develop, supplement and/or implement the agreement, including the Regulatory Cooperation Forum (RCF). While the RCF is intended to be the primary vehicle to advance regulatory cooperation, discussions of this nature also take place under other specialized CETA Committees and/or Dialogues. The following is a list of regulatory cooperation initiatives, which were not discussed at the RCF, but recently took place under CETA:

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