5^th Meeting of the CETA Regulatory Cooperation Forum

a) Consumer product safety

Health Canada and the Directorate-General for Justice and Consumers (DG JUST) continue to share best practices and learnings in areas such as online marketplaces and new technologies.

In February 2022, a training session was delivered by the EU to Canadian users on the European rapid alert system for dangerous non-food products (Safety Gate/RAPEX). In January 2023, Canada held an information session for EU users on the Canadian consumer product incident reporting system (RADAR) and its data in the context of the Consumer Product Safety Program’s operations and processes.

A coordinated awareness campaign focused on safe online shopping took place in the second half of 2022, which provided young people with tips on how to identify and buy safe products online. The campaign was showcased at the International Product Safety Week session on young people and product safety. Going forward, regulators in the EU and Canada agreed that at least one coordinated awareness campaign will be held per year, with varying product and audience focus. The next campaign is planned for autumn 2023.

In February 2023, Health Canada participated in the EU Coordinated Activities on the Safety of Products (CASP) workshop on online market surveillance. At this workshop, Health Canada gave a presentation on best practices and practical steps on how to temporarily take down the website of a company that is in non-compliance with Canada’s consumer product safety legislation or regulations. These measures may be used as a last resort, for example, when establishments are non-responsive to Health Canada’s multiple communication attempts. Likewise, EU national market surveillance  authorities shared their experiences with website takedowns and mystery shopping, which are new powers granted by the EU Regulation 2019/1020 on Market Surveillance and Compliance of Products. Finally, information on planned compliance verification projects is also shared annually to facilitate discussions on opportunities for collaboration, including surveillance of emerging hazards and to tackle common challenges.

b) Animal welfare

The Directorate-General for Health and Food Safety (DG SANTE) and Agriculture and Agri-Food Canada (AAFC) continued their exchanges in a range of areas, including adverse impacts on animal welfare, welfare of horses used for meat production in Canada, and the process to revise EU legislation on animal welfare. The regulators reported on three success stories since the beginning of their work under the RCF in 2019:

1. Transport of animals – In February 2019, Canada amended the provisions of its Health of Animals Regulations dealing with the transport of animals to better reflect current animal welfare science and societal expectations. The initiative also aligned Canada’s regulations more closely to the World Organisation for Animal Health standards, as well as the standards of Canada’s international trading partners, including the EU. Through the Forum, Canada has shared information regarding its regulatory approach, which has shifted to a balance of prescriptive and outcome-based measures, encouraging innovation in the sector, and helping support the welfare of the animal under a variety of conditions. European regulators have benefited from learning about initiatives implemented in Canada, such as the electronic certification of livestock transport, training in multiple languages, certification in other languages to facilitate cross-border transport, and training regarding the handling of animals. Canadian regulators noted that they similarly have benefitted from learning about the EU’s approach to livestock transportation and consideration of EU standards.
2. Canada’s animal welfare measures – During bilateral discussions, including at the most recent meeting in November 2022, Canada shared information with the EU regarding its approach to animal welfare assessment measures. Through Canada’s National Farm Animal Care Council’s Animal Care Assessment Framework, three types of assessment measures are outlined: animal- or outcome-based, input- or resource-based, and management-based measures. Canada indicated that outcome-based measures have been beneficial as they are less prescriptive and allow for more flexibility, as well as innovation within the sector. EU regulators found this information beneficial in its consideration of animal welfare indicators.
3. European Food Safety Authority (EFSA) scientific opinions – The EFSA’s scientific opinions are shared with Canada through the RCF, and then passed on to scientists throughout the country to inform future research questions. For example, in November 2022, the EU shared an update with Canada on the main findings from EFSA’s scientific opinions on the protection of animals during transport. These findings were shared with provincial and territorial officials working on animal welfare issues in Canada, to ensure they are informed of the latest work in the sector.

c) Pediatric medicines

Regular meetings continue to take place between Health Canada and the European Medicines Agency (EMA). Topics discussed included risk-based approaches to the assessment of regulatory submissions, the upcoming revision of the EU Paediatric Regulation, proposed changes to the approach to Paediatric Investigation Plan (PIP) development, and improvements to data collection and outcome reporting.

Regulators on both sides indicated that these conversations have been highly interactive and very impactful. Indeed, they have been instrumental in providing insight to Health Canada’s work as it develops its own pediatric provisions in the Food and Drug Regulations and prepares to launch a Pediatric Submission Policy Pilot, expected to begin before the end of 2023. Similarly, input received from Canada contributed positively to considerations with respect to the review of the EU’s Paediatric Regulation.

Going forward, discussions are expected on how Health Canada and the EMA can further collaborate on the pediatric front, such as discussions around the possibility of the EMA sharing PIP assessments with Health Canada and having Health Canada staff attend the EMA’s Paediatric Committee (PDCO) meetings and participate in parallel PIP reviews.

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

The SCC and CEN-CENELEC initially identified two priority areas of interest: circular economy and hydrogen technology.

On circular economy, the SCC and CEN-CENELEC continue to share information and have begun developing a work programme for 2023-2024. Both parties will also reach out to their respective experts to identify potential areas for future cooperation under the circular economy umbrella.

Regarding hydrogen, the SCC is currently co-leading the Standards and Codes Working Group in partnership with Natural Resources Canada (NRCan), created out of the Hydrogen Strategy for Canada. The Working Group met with CEN-CENELEC in August 2022 to discuss the progress on standardisation initiatives related to hydrogen technologies. CEN-CENELEC named a permanent European expert to this Working Group, who presented an overview of the European standardisation framework and CEN-CENELEC’s hydrogen activities in November 2022. The Standards and Code Working Group is also developing a Hydrogen Codes and Standards Roadmap, with a first draft of the roadmap expected to be completed by spring 2023. The EU’s permanent representative will participate in the review committee overseeing the development of this document.

Beyond circular economy and hydrogen, the SCC and CEN-CENELEC have agreed to focus on artificial intelligence (AI), including data. This priority was chosen as both the EU and Canada have proposed AI legislation that is expected to rely on standards during implementation. Initial exchanges on this new topic of cooperation took place at the start of 2023.

e) Wood pellet boilers

Canada continues to facilitate conversations between the EU and Canadian provinces and territories to determine potential paths forward with regards to the import and sale of European-made small solid biomass boilers in Canada. The Provincial-Territorial Advisory Committee (PTAC), a statutory committee of the SCC, created a project team to explore the issue and examine potential solutions.

The project team presented a White Paper on the Certification of Small Solid Biomass Combustors in Canada to PTAC at the committee’s meeting in November 2022. PTAC members agreed that before a recommendation is made, the White Paper should be shared with relevant stakeholders in each of their jurisdictions.

In November 2022, an amendment to European standard EN 303-5 was published and included a number of changes to ensure alignment with the essential requirements of the European Commission’s Machinery Directive and the EU Regulation pertaining to Eco-Design. The Canadian project team will need time to assess whether these changes will impact the recommendations laid out in the White Paper. 

The SCC and PTAC will continue to work on this issue into 2023. It is important to note that any implementation of solutions recommended by the white paper will be dependent on resources, agreement by partners to undertake work, and uptake by provincial/territorial governments.