3rd Meeting of the CETA Regulatory Cooperation Forum
9-10 February 2021, by Videoconference
- Discussion among Regulatory Cooperation Forum (RCF) Co-chairs regarding status of work plan, reporting and general organizational issues
The Co-chairs of the Regulatory Cooperation Forum (RCF) acknowledged the work of regulators in both jurisdictions throughout the past year, particularly the continued efforts of regulators amid the challenges presented as a result of the COVID 19 pandemic.
The Co-chairs discussed how the COVID 19 pandemic has challenged the current regulatory system and outlined the importance of continued regulatory cooperation in the context of the recovery. They underlined the role of the RCF in view of emerging regulatory needs and discussed how best to bring forward the work of the RCF to reflect new priorities. The Co-chairs also discussed current regulatory trends in a number of jurisdictions including the green and digital transitions. Canadian Co-chairs indicated an interest to cooperate with the EU on upcoming carbon border adjustment mechanisms, with EU Co-chairs offering a positive consideration of such request and noting that the RCF provides a flexible platform to integrate new topics for discussion as they emerge.
- Discussion and status update with regulators of the following RCF items: Consumer Product Safety, Cosmetic-like Drug Products, Pharmaceutical Inspections, Animal Welfare, Paediatric Medicines, SCC-CEN/CENELEC Agreement, and Wood Pellet Boilers.
The past year has been dominated by the response to the COVID 19 pandemic requiring an unprecedented need for flexibility and agility within the regulatory context. Shifting priorities and resources allocation have created some delays in the work of the RCF. Amid these challenges, work plan items continued to see successful implementation, and in October 2020, a new item on paediatric medicines was added to the RCF work plan.
- Consumer Product Safety
In 2020, Health Canada and DG JUST launched both a coordinated pilot for market surveillance of heavy metals in children’s jewellery sold online, and a joint outreach campaign on toy recalls. Confirmed success of joint initiatives has led to the exploration of new opportunities for joint outreach campaigns, with possible initiatives to be launched for the summer 2021.
The work undertaken this year is continued evidence that the co-operation between EU and Canadian regulators in this area has been highly effective and useful and both parties have been working to deepen the co-operation. Regular communication is allowing both parties to further discuss consumer product safety issues, including emerging issues related to COVID 19-related products, and to identify possible areas of cooperation to improve the safety of consumer products in the markets within their respective jurisdictions.
- Cosmetic-like drug products
In 2020, the RCF reported positive responses to the sunscreen pilot in which EU sunscreen products were exempted from re-testing/quarantine. As a result of this success, the exemption/quarantine of EU sunscreen products and anti dandruff shampoos have been implemented through regulation and this initiative is completed.
In 2021, Health Canada will further consult external stakeholders to determine how best to expand the list of products exempted from re-testing and quarantine. Already, as a result of consultations carried out last year, toothpaste will be added to the list.
A targeted consultation with interested stakeholders has also been launched by the EU in 2021, the results of which are expected in the first half of 2021 and may inform possible areas of further cooperation.
- Pharmaceutical inspections
Beyond the existing Protocol for the Mutual Recognition of Good Manufacturing Practices for pharmaceutical products, regulators have agreed to expand the existing approach (i.e. of recognizing inspection results from the respective Parties), to include inspections that are conducted in countries outside the EU’s or Canada’s jurisdiction.
In 2020, regulators examined how inspections are conducted with their territory and third countries and concluded that similar approaches were being followed. Regulators have also agreed to consider a certificate of compliance template. The acceptance of the draft template will be made in 2021, and if in agreement, regulators will define timelines for potential recognition of extra-jurisdictional inspections. Regulators also mentioned the possibility, in a second step, of expanding the scope of cooperation to include active pharmaceutical ingredients (API) when the assessment process of respective EU and Canada API program is completed.
- Animal Welfare
The EU and Canada continue to share information on common animal welfare issues. A meeting was held in November 2020 and it provided the opportunity for a good information exchange on both sides on topics such as the EU Farm2Fork Strategy and sharing of EU experience regarding humane slaughter of poultry. An update was also provided regarding the implementation of the amended Canadian regulations on transport of animals, which came into force in February 2020. Discussions on humane transport issues have remained an ongoing area of interest of both parties since the outset. Regulators from both sides recognised that the EU and Canada, whilst following different approaches, are advanced jurisdictions concerning animal welfare and that dialogue under the RCF has allowed both parties to profit from their knowledge and science in this area.
The next meeting is to be schedule in spring-early summer 2021. Regulators are in contact to establish a list of topics for further discussion, with EU regulators indicating that several developments linked to the Farm2Fork strategy, notably labelling issues, could be part of the discussions. Suggestions from interested stakeholders are welcome. The EU Co-chairs also noted an interest from the EU to cooperate with Canada on Anti-Microbial Resistance and proposed working on a joint EU-Canada statement on animal welfare that could inform both parties’ work in this area beyond the RCF work plan, with Canadian regulators agreeing with the usefulness of the idea.
- Paediatric Medicines
Canada and the EU are seeking to support international alignment in paediatric regulatory review resulting in reduced burden on industry and greater access to medicines for more children worldwide. Progress in this first year of the paediatric work plan was impacted by COVID-19 as resources were deployed in response to the global pandemic, a trend that is expected to continue into 2021/22.
Health Canada and the European Medicine Agency remain committed to the work plan item and will continue conversations throughout 2021. It is expected that work will begin in earnest as the global pandemic winds down.
The RCF is currently following two other regulatory cooperation activities. These areas of interest include Wood Pellets Boilers and the agreement between the Standards Council of Canada and CEN/CENELEC.
- Wood Pellet Boilers
In 2020, Canada and the EU outlined the challenges associated with the import and sale of small solid biomass boilers in Canada. Canada and the EU have different standards for the construction and maintenance of pressure vessels, which limits the sale of certain pressure vessels, such as wood pellet burning boilers, in Canada. Regulations governing pressure vessels is within provincial jurisdiction, and as such, the Canadian federal government has no regulatory role.
Canada has been facilitating conversations between the EU and provinces to explore opportunities for cooperation on this issue. Conversation was initiated through a number of information sessions held throughout 2020, and the lines of communication have remained open allowing the flow of technical information. Canada has committed to maintain this facilitation role into 2021 as the provinces continue to explore the issue.
- SCC and CEN/CENELEC Agreement
In 2012, Canada’s national standards body, the Standards Council of Canada (SCC), and two European Standardization Organizations, the European Committee for Standardization (CEN) and the European Committee for Electrotechnical Standardization (CENELEC), signed a formal cooperation agreement, which was renewed for the third time in 2019. Work under this agreement fits within the principles, objectives and activities of the RCF and, in the past year, SCC and CEN/CENELEC have explored areas for future cooperation under the RCF in consultation with relevant regulatory bodies. The RCF Co-chairs indicated their strong support for this cooperation, noting that they looked forward to updates on progress and inviting the organizations to work to agree on two specific cooperation areas before June 2021, with a view to possibly including cooperation on this file in the RCF work plan.
- Consumer Product Safety
- Discussion among Co-chairs regarding RCF communication
The Co-chairs remain committed to providing a public update to the work plan in Summer 2021.
Acknowledging the ongoing work of the RCF and the changing regulatory context resulting from COVID 19, Co-chairs agreed that targeted stakeholder consultations on the RCF were not a priority in 2021. However, new issues will be welcomed through direct submission to the EU or Canada.
- RCF Co-chair stakeholder debrief and exchange of views
Following discussions with regulators, the RCF Co-chairs and regulators from the EU and Canada debriefed stakeholders about the RCF’s activities and results. The event was hosted by the European Commission and was held virtually to conform to current health and safety guidelines in both the EU and Canada.
In a wide-ranging discussion, comments were received indicating the importance of cooperation in regulatory issues and proposing that the RCF consider further work in the areas of animal welfare, environmental issues, and product safety for both medical and non-medical items. Some stakeholders also commented positively on the work of the regulators and their ability to deliver on work plan items during the COVID 19 pandemic.
Co-chairs expressed openness to receiving suggestions from stakeholders for new topics, specifically regarding new and emerging issues, which the RCF is best placed to address. It was further stressed that all regulatory cooperation activities were voluntary and required mutual interest from both the EU’s and Canadian regulators to be considered. Stakeholders were encouraged to communicate any potential issues to the EU or Canada at their convenience.
Co-chairs confirmed that a report detailing the outcomes of the meeting would be published in the short term, and an updated work plan could be expected in Summer 2021.
- Wrap-up and next steps
The next RCF meeting should take place in approximately one year. The location and format will be dependant on public health recommendations at that time. Both sides will take stock of progress made on work plan items in the summer of 2021. In the interim, suggestions for additional potential work plan items are welcome and regulators are encouraged to continue their exemplary work to achieve positive outcomes on the work plan.
- Director, Directorate D, Directorate General for Trade, European Commission
- Director, Directorate A, Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs, European Commission
- Executive Director, Regulatory Policy and Cooperation Directorate, Regulatory Affairs Sector, Treasury Board of Canada Secretariat
- Director General, Trade Agreements and Negotiations, Market Access, Global Affairs Canada
- Officials from the Treasury Board of Canada Secretariat, Global Affairs Canada
- Officials from the European Commission’s Directorate General for Trade and the Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs
- Officials from the Mission of EU to Canada
- Regulators and officials from the European Commission’s Directorate-General for Health and Food Safety, Directorate-General for Justice and Consumers, Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs, the European Medicines Agency (EMA) and European Committee for Standardization (CEN).
- Regulators and officials from Health Canada, Agriculture and Agri-Food Canada, and Innovation, Sciences and Economic Development Canada
- Registered stakeholders attending the Stakeholder Debrief session (see separate list)
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