Comprehensive Economic and Trade Agreement Regulatory Cooperation Forum – Work plan 2024

Published on: June 7, 2024

Reference period

This work plan covers activities planned under the Regulatory Cooperation Forum (RCF) between January 1, 2024 and December 31, 2024 (i.e. the “reference period”). The work plan will be updated once the reference period is complete, to share progress and report on results.

Background

The RCF was established under the Canada-European Union (EU) Comprehensive Economic and Trade Agreement (CETA), which lays out the framework for regulatory cooperation between Canada and the EU in Chapter 21 of the agreement. The chapter builds on, and replaces, an existing agreement between Canada and the EU on regulatory cooperation, referred to as the Framework on Regulatory Co-operation and Transparency between the Government of Canada and the European Commission (December 21, 2004).

The role of the RCF is to facilitate and promote regulatory cooperation between the Parties. The RCF performs the following functions:

• Provides a forum to discuss regulatory policy issues of mutual interest that the Parties have identified through various means including stakeholder consultations
• Assists individual regulators to identify potential partners for cooperation activities and provides them with appropriate tools for that purpose, such as model confidentiality agreements
• Reviews regulatory initiatives, whether in progress or anticipated, that may provide potential for cooperation
• Encourages the development of bilateral cooperation activities and reviews the progress, achievements and best practices of regulatory cooperation initiatives in specific sectors

RCF structure

The work is led jointly by the Treasury Board of Canada Secretariat and Global Affairs Canada on the Canadian side, and the Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs (DG GROW) and the Directorate-General for Trade (DG TRADE) on the EU side.

Canadian co-chairs:

• James van Raalte (Treasury Board of Canada Secretariat)
• Doug Forsyth (Global Affairs Canada)

EU co-chairs:

• Outi Slotboom (DG GROW, European Commission)
• Lucian Cernat (DG TRADE, European Commission)

The RCF:

• Reports annually to the CETA Joint Committee on the implementation of CETA Chapter 21
• Convenes annually unless the Parties decide otherwise
• Provides an annual forum, unless the Parties decide otherwise, for regulators to engage in topic-specific discussions and update the RCF co-chairs on the status of their cooperation activities
• As required, provides ongoing support and guidance to facilitate regulator-to-regulator discussions on existing and potential regulatory cooperation issues
• Posts online RCF agendas, work plans and reports

Stakeholder engagement

The RCF recognizes the importance of stakeholder engagement in identifying regulatory barriers to trade and opportunities for regulatory cooperation and alignment.

To this end, following each annual meeting of the forum, the RCF co-chairs hold a debriefing session to provide stakeholders with an update on all active work plan items and items of interest.

Stakeholders are welcome to submit their comments, suggestions, and potential topics for EU-Canada cooperation at any time.

• The Treasury Board of Canada Secretariat has established a centralized mailbox (rcd-dcmr@tbs-sct.gc.ca.) for stakeholders interested in providing input to Canada on matters of regulatory cooperation. Guidance is also available regarding what information to include when reporting a regulatory barrier to trade.
• For submissions to the EU, a dedicated functional mailbox has been set up at EU-CETA-RCF@ec.europa.eu.

Work plan development

New work plan items can be formally proposed by either Party at any time, based on discussions with regulators, stakeholder input, external consultations, or internal analysis. Once a general topic is identified, the Parties work with regulators in their respective jurisdictions to gauge interest and discuss the opportunity. The Parties subsequently exchange views on potential topics to gauge whether there is mutual interest to add the topic to the work plan as a new item. A formal work plan item is only established once both Parties agree on its terms (including scope, objectives, activities etc.).

Work plan items

1. Consumer product safety

Canadian lead: Health Canada

European lead: European Commission, Directorate-General for Justice and Consumers (DG JUST)

Regulatory cooperation statement: The safety of consumer products is a major concern for regulators around the world. The increased globalization of markets and supply chains, the rise of online/cross-border shopping, and the increasing number of new products reaching markets have made physical borders non-existent. The same consumer products or types of products appear in similar markets, which means that authorities in the EU and in Canada often face similar product safety challenges. In this context, it is imperative that the Government of Canada and the European Union regulators cooperate to efficiently identify and take appropriate action on potentially dangerous consumer products.

Initiative: Regular exchange of information between the EU RAPEX alert system and Canada's RADAR consumer product incident reporting system; ad hoc information exchange and cooperation on other aspects of non-food product safety.

Desired outcome:

• Easier access to important and timely information related to potentially dangerous products in each jurisdiction
• Better capacity for coordination of communication, market surveillance and enforcement activities in both jurisdictions
• Improved collaboration between regulators in both jurisdictions

2. Animal welfare

Canadian lead: Agriculture and Agri-Food Canada

European lead: European Commission, Directorate-General Health and Food Safety (DG SANTE) and DG TRADE

Regulatory cooperation statement: As animal welfare is an issue of general public concern, Canada and the EU look forward to all opportunities to better understand their respective regimes, methods, and experiences, as well as the challenges and benefits that come with them.

Initiative: Information sharing regarding various animal welfare issues, not limited to farm animals (e.g. long distance transport, slaughter and farming, dogs and cats).

Desired outcome:

• Information sharing on Canada's and the EU's agenda on animal welfare (e.g. actions on animal welfare under the Farm to Fork Strategy)
• Exchange information, expertise and experiences on animal welfare, as well as on science and research, in the area of animal welfare
• Information and experience sharing regarding long-distance transport of animals (e.g. rules & protocols for feed/water/rest stops, experience with carriers for various species, and resulting animal welfare outcomes)
• Improved appreciation of the respective approaches to animal welfare of Canada and the EU, and applicability to long distance transport of animals
• Information sharing regarding animal welfare outcomes in relation to slaughter

3. Pediatric medicines

Canadian lead: Health Canada

European lead: European Commission, DG SANTE & European Medicines Agency (EMA)

Regulatory cooperation statement: Health Canada and the EMA will engage in collaborative work in the area of pediatric medicines with the aim of increasing regulatory alignment, improving access to pediatric medicines and reducing burden on industry.

Initiative: The EMA will share information and documentation regarding the development and implementation of the EU’s Paediatric Regulations, including the Paediatric Investigation Plan (PIP) review process, as Health Canada identifies regulatory opportunities under the Food and Drug Regulations.

Desired outcome:

Health Canada is developing regulatory and policy initiatives to better support access to medicines for children. Drugs with pediatric indications or formulations that are available in Europe are not always submitted to Canada, possibly due to Canada's small market size. In addition, while the EU has regulatory authorities that require the submission of a Paediatric Investigation Plan (PIP) for a drug to be authorized, Canada does not currently have the same requirements. Work to address these gaps is detailed in Health Canada’s Pediatric Drug Action Plan, and some initiatives are under development.

Further collaboration with the EU on pediatric medicines may be beneficial, based on existing models of international collaboration and work-sharing, which Health Canada has been developing over the past few years, such as:

• Access Consortium: In partnership with Australia, Switzerland and Singapore, and, most recently, the United Kingdom, Health Canada has shared review work in order to create efficiencies, and to result in simultaneous drug approvals across multiple jurisdictions, while still taking independent regulatory decisions according to each country’s own legal frameworks
• Project Orbis: Health Canada has participated in parallel reviews with the US Food and Drug Administration (FDA), which have allowed for the sharing of information and expertise, and aligned approval times

Increased collaboration between Health Canada and the EMA in pediatrics would support international regulatory alignment, thus reducing burden on industry to meet unique requirements in both jurisdictions, which could ultimately result in greater access to medicines for more children worldwide.

*The Pediatric Cluster includes the EMA, the US Food and Drug Administration (FDA), Health Canada (HC), the Australian Therapeutic Goods Administration (TGA), and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA)

Items of interest

In addition to official work plan items, the table includes items of interest. These are topics that are of interest to both Parties but, due to the nature of the work, are not well placed as formal work plan items (for example, if an item is led by a third-party organization). These items have the full support of the forum and are discussed at annual meetings.

1. Cooperation on standardization topics of common interest to SCC and CEN-CENELEC

Canadian lead: Standards Council of Canada (SCC)

European lead: The European Committee for Standardization (CEN) and the European Committee for Electrotechnical Standardization (CENELEC)

Issue: 

SCC and CEN-CENELEC renewed their cooperation agreement in 2019, and will renew it again in 2024, to strengthen their cooperation in standardization. Building on this agreement, SCC and CEN-CENELEC are collaborating on standardization and exploring opportunities to undertake additional initiatives under the framework of the RCF.

This work is focused on the interface between regulations and standards and relates specifically to the development, adoption, and implementation of standards, including international standards, in Canada and Europe. It aims to deepen mutual understanding, support the sharing of expertise, perspectives, and best practices, as well as to promote transparency and predictability in the development and implementation of standards. This work may identify new ways for SCC and CEN-CENELEC to advance specific topics.

2. Certification of small solid biomass combustors in Canada

Canadian lead: This item is within provincial jurisdiction in Canada. The Treasury Board of Canada Secretariat serves as the liaison between the SCC, the CSA Group (formerly the Canadian Standards Association) and the European Commission.

European lead: European Commission, DG GROW and CEN & CENELEC

Issue:

The design, manufacture and conformity assessment of small solid biomass combustors (SSBCs) substantially differ between the two jurisdictions. Currently, European-built SSBCs that meet European standard EN 303-5 cannot be installed in Canada unless they also meet Canadian standard CSA B51. The CSA B51 standard is a broad standard used for all boilers with combustion chambers and requires third party certification, while EN 303-5 standard covers smaller boilers that operate at lower temperatures and pressures, with certification that is self-declaratory in nature. EU stakeholders have raised concerns that obtaining third party certification through CSA B51 in Europe is expensive. As a result, European manufacturers only offer a select few models in the Canadian market.

In terms of benefits, Canada is the world’s third largest producer of wood pellets, and currently retains a small portion of this fuel type. Stakeholders believe that an increase in accessibility to SSBCs could be an opportunity to expand their use in Canada. Since SSBCs sold in Canada are primarily sourced from the European Union, acceptance of the EN 303-5 standard could expedite the export process and allow for a larger variety of European combustors to be brought to market in Canada.

Regulations governing pressure vessels is within provincial jurisdiction and, as such, the Canadian federal government has no regulatory role. Canada continues to facilitate conversations between the EU and Canadian stakeholders (provinces and territories, the SCC and the CSA group) to determine a path forward.