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Joint report: 7th Meeting of the CETA Regulatory Cooperation Forum

14-15 May 2025, Brussels and by videoconference

1. Introduction

The Co-chairs of the Regulatory Cooperation Forum (RCF) appreciated the opportunity to continue and further strengthen the partnership between the European Union (EU) and Canada through regulatory cooperation. They welcomed the opportunity to share knowledge, expertise, and best practices in regulatory cooperation, recognizing its crucial role in advancing shared priorities and commitments.  

Over the past years, regulatory cooperation activities under the RCF and other subcommittees of the EU-Canada Comprehensive Economic and Trade Agreement (CETA) have fostered a deeper understanding of each other's policy approaches and perspectives, built trust and strengthened bilateral relations. By evolving and adapting to new challenges, regulatory cooperation supports economic stability and growth, reinforcing a more resilient and forward-looking partnership.

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 the EU and Canada reported on their ongoing joint initiatives under the RCF, highlighting progress across various areas of cooperation. Notable milestones were achieved with the closure of two key initiatives: Pediatric Medicines in fall 2024 and Animal Welfare in winter 2025.

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).

Under this work plan item, Health Canada and DG JUST continue to exchange information between the EU's Safety Gate system and Canada's RADAR system, which both provide their regulators with detailed consumer product safety information. The aim of this exchange is to improve capacity to coordinate recalls and surveillance activities. DG JUST and Health Canada are currently evaluating the strengths of the current approach and reflecting on possible areas for improvement.

In June 2024, Health Canada and DG JUST held their second annual bilateral meeting. The meeting covered a number of topics, including inclusiveness and product safety; button batteries; and, safety and sustainability. These meetings allow for fruitful discussions on shared issues and pave the way for other collaborative opportunities, such as Health Canada’s participation in a panel at the European Commissions’ International Product Safety Week, further expanding the reach of the important work being done by both jurisdictions. The next meeting is scheduled for June 2025.

Health Canada and DG JUST are also working together on a compliance verification project focused on children’s highchairs. DG JUST has finished product testing and has shared the sampling information and test results with Health Canada.  This has helped identify products that are available in both markets and has been used by Health Canada for its sample selection. At a meeting in February 2025, under the EU’s Coordinated Activities on the Safety of Products (CASP) project, the EU shared their findings and has now moved on to compliance and enforcement activities. Testing in Canada is ongoing and is expected to be completed in June 2025. Health Canada is taking compliance and enforcement actions as the results of the testing become available, as required.

The regulators also continue to work together on coordinated awareness campaigns. The campaign for 2024 focused on safe online shopping and the risk of children choking on easily detachable parts. This collaborative effort led to the development of key messages and jointly branded visuals, with posts published on social media in November and December 2024. Planning has started on the 2025 campaign, continuing with the overarching theme of safe online shopping.

b) Animal welfare

This work plan item was led by the Directorate-General for Health and Food Safety (DG SANTE) and Agriculture and Agri-Food Canada (AAFC). The regulators have reached a joint decision to close the work plan under the RCF.

Since the first RCF work plan in 2019, AAFC and DG SANTE have coordinated the exchange of scientific information and shared best practices on issues related to animal welfare.

Canada presented on topics including:

Over the years, the EU provided regular updates on the revision process for their animal welfare legislation, which ultimately led to the adoption of new rules in December 2023, focused on the protection of animals during transport and related operations. The EU also presented on:

The work between Canada and the EU under the RCF led to a joint statement in 2021, declaring that both are advanced jurisdictions concerning animal welfare. 

The work plan item was closed in January 2025, with the understanding that communication between Canada and the EU will remain open to support future discussions as needed. 

c) Pediatric medicines

This work plan item was carried out by Health Canada and the European Medicines Agency (EMA) and has now been closed.

Over the last few years, both Health Canada and the EMA have engaged in collaborative work in the area of pediatric medicines, with the overarching aim of increasing regulatory alignment and improving access to pediatric medicines in our respective jurisdictions.

Discussions between Health Canada and the EMA in 2024 focused on:

These conversations have been highly impactful and have been instrumental in helping Health Canada work through policy considerations in the implementation of various activities in Health Canada’s Pediatric Drug Action Plan.

On February 26, 2024, Health Canada launched its Pediatric Submission Policy Pilot, to encourage sponsors to submit paediatric plans and studies for drugs approved for adults in Canada. The pilot’s objectives were to:

Through the RCF work plan item, the EMA provided notable insight into the operationalization of their paediatric regulation and shared internal operational documents related to the review and approval of paediatric investigational plans, both of which were integral to the launch of Health Canada’s Pilot.

With the objectives now completed, Health Canada and the EMA have agreed to officially close this work plan item. While the workplan item is now closed, Health Canada and the EMA will continue to work together through regular bilateral meetings and other multilateral fora with the continued goal of increasing access to medicine for pediatric populations in both jurisdictions.

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) have a long-standing history of cooperation, and have worked together under the RCF since 2020.

They are currently working on a new cooperation agreement and have agreed in-principle to the text, with a view to sign the agreement in the fall of 2025.

In regards to their standards work, the SCC and CEN-CENELEC have agreed to collaborate on three areas of focus in 2025:

  1. System-level priorities, such accessibility
  2. Digitization, including artificial intelligence (AI)
  3. The environment and sustainability

Regarding system-level priorities, the SCC submitted a proposal to CEN-CENELEC in March, to jointly develop a standard on Accessible and Equitable AI Systems. The proposal suggests using Canada’s National Standard as it’s base, which is being developed by Accessibility Standards Canada and is expected to be published in August 2025.  Given the rapid advancement of AI and unique expertise in Canada on standards for accessibility, this standard could address harms, especially to people most vulnerable. 

Regarding digitization, the SCC hosted a workshop on 9 May to discuss the role, geopolitics, and governance of AI standards. The Chair of CEN-CENELEC’s Joint Technical Committee 21 on AI presented during the panel on governance and institutional approaches to standards, which compared international approaches and highlighted best practices for collaboration and alignment.

The SCC and CEN-CENELEC’s collaboration on environment/sustainability has been delayed for the time being due to the complexity of this topic and the limited resources.

Over the coming months, the organisations anticipate:

e) Small solid biomass combustors

The CSA Group, a standards development organization in Canada, is in the early stages of developing a National Standard of Canada on Small Solid Biomass Combustors. The expected publication date for the standard is Fall 2026.

This standard, referred to as CSA B414, will specify terminology and technical requirements for the control and safety, design, heating, testing, and marking of small solid biomass combustors. It will also provide requirements for their construction, installation, operation, and inspection. The purpose of this standard is to support efforts by industry and regulators to address the safety and availability of these devices, and to facilitate adoption of uniform requirements by Canadian jurisdictions.

The Working Group developing the standard is looking to make the standard an adoption of the European standard (EN 303-5) with Canadian deviations. An expert is currently investigating what those Canadian deviations should be and will make recommendations to the working group.

3. General updates

a) Hydrogen roundtable

On June 14, 2024, the RCF hosted a roundtable on regulatory cooperation in hydrogen, bringing together Canadian and European stakeholders to share insights and expertise in the field. The discussion topics included current and anticipated regulatory barriers to trade, standards development and alignment, and opportunities to advance regulatory cooperation. Stakeholders raised issues related to a number of topics including: definitions and methodology, traceability requirements and the mutual acceptance of the results of conformity assessments. Regulators from both jurisdictions are now considering whether areas of mutual interest might be advanced under the RCF or through other mechanisms.

b) The European Commission’s Digital Product Passport

At a workshop for Canadian regulators in May 2025, focused on technological solutions to regulatory challenges, the European Commission presented its Digital Product Passport (DPP) initiative. The DPP, a key component of the Ecodesign for Sustainable Products Regulation, aims to enhance transparency across product value chains by providing comprehensive digital records of a product’s lifecycle, including its origin, materials, environmental impact, and disposal recommendations. The presentation was very well received by regulators, and the Committee will consider how such shorter-term initiatives, such as workshops and single-session information exchanges, could complement its long-term work planning. While the RCF traditionally focuses on multi-year initiatives, the effectiveness of this new format offers useful insights that could inform future engagement strategies and regulatory collaboration efforts.

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. Stakeholders debrief

The Co-chairs presented an overview of the RCF's activities and achievements to a diverse audience of over 30 stakeholders from the EU and Canada, comprising representatives from industry, trade associations, civil society, academia, and government. This outreach effort aimed to engage a broad range of stakeholders and foster a deeper understanding of the RCF's work and its impact on regulatory cooperation between the EU and Canada.

The Commission presented the draft study of the ex-post evaluation of CETA, which assessed the impact of the provisionally applied parts of the agreement after six years. The study highlights the importance of regulatory cooperation, primarily to reduce trade barriers while ensuring consumer and environmental protection. The RCF plays a key role in facilitating discussions between EU and Canadian regulators, achieving notable outcomes, such as expanding the Mutual Recognition Agreement (MRA) for pharmaceuticals and a coordinated compliance verification project on heavy metals in children’s jewellery. Initial concerns about regulatory burdens have not materialized; instead, the RCF has enhanced transparency and cooperation. Ongoing discussions aim to prevent regulatory divergences and explore new cooperation areas.

The Q&A session that followed the debrief provided a platform for stakeholders to engage with the Co-chairs, seek additional information, and offer feedback on the work plan. Participants provided comments on a number of topics including e-invoicing, the UN Declaration on the Rights of Indigenous Peoples, and advanced digital technologies and security.

6. Regulatory policy discussion

As part of the annual meeting, the two parties agreed to pilot an exchange of ideas on a regulatory policy issue of mutual interest. This EU - Canada Regulatory Policy Discussion explored strategies for addressing small business needs within the regulatory life cycle, gathering officials from both sides to exchange best practices. The session included participation from the Treasury Board of Canada Secretariat, Global Affairs Canada and Innovation, Science and Economic Development Canada (ISED) on the Canadian side and the European Commission’s Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs, the Directorate-General for Trade and Economic Security and the Secretariat-General on the EU side. It featured presentations examining important tools and approaches that enhance regulatory development and reduce burden on businesses – such as Canada’s Small Business Lens, ISED’s BizPaL tool and the European Commission’s SME Check – followed by a discussion that provided an opportunity for jurisdictions to exchange perspectives, identify challenges, and explore new ideas for supporting small businesses.

7. Wrap-up and next steps

The next annual meeting of the RCF should take place in Canada in spring 2026.

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

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

8. Participants

9. Annex: Other regulatory cooperation initiatives under CETA

CETA established specialized committees between the EU and Canada to develop, supplement and/or implement the agreement, including the 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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