CA Canada has recently become aware of a last minute amendment that was recently reflected as final amendments to the Pest Control Products Regulations (PCPR) [Canada Gazette 2] that potentially could be of relevance to our members that also have interest in broader health and wellness products classified as Class 1 medical devices in Canada, such as toothbrushes, band-aids, dental floss, Q-tips, etc., that could be as a ‘treated article’ (i.e., containing a material preservative). It is also possible that this amendment could also broadly implicate those who import raw materials or packing materials that are treated with preservatives.
Although the PCPR is not a regulatory area that CA Canada typically engages with, given that this amendment impacts a subset of health and wellness products that certainly cross into the personal care space, we wanted to ensure that our membership are aware of these emerging developments, as it is possible that they could implicate regulatory operations/compliance considerations.
What You Need to Know
- With this amendment, Class 1 medical devices that are treated with material preservatives would be subject to the PCPR (i.e., featured preservatives must be registered material preservatives under the PCPR.
- This clarification in scope was introduced at the last minute (as amendments were finalized) without the benefit of adequate due process, consultation and stakeholder engagement
- Similarly, raw materials and packing materials imported into Canada that are treated with preservatives would also appear to be subject to the PCPR
- In essence, this is yet another regulatory list that members should be looking to monitor for regulatory compliance when importing goods that are now considered to be ‘treated articles’ under the PCPR
- Previously, it was understood that preservative use in F&DA regulated commodities and corresponding raw materials would be regulated under the principles of ‘Best Placed Act’
Representations and Collaborations
- CA Canada is collaborating with other Trade Associations (CCSPA and FHCP) who are best placed to intervene on matters related to the PCPR to look to clarify and right-size these amendments. In this regard, the following recommendations are being pursued:
- Seeking that Class 1 medical devices (along with other medical devices and other F&DA regulated commodities) are exempt from these considerations under the purview of ‘Best-Placed Act’ principles;
- Clarifying that treated raw materials also receive due consideration under the purview of ‘Best-Placed Act” principles;
- Should these provisions stand, need for further consultation and extended transition provisions and timelines to enable importers of these ‘treated articles’ to pivot and come into compliance (i.e., compliance action planning);
- Again, if these provisions stand, seek commitment for a broader communication/education outreach program to ensure greater awareness of these last minute changes.
- In the interim, we will be outreaching to Health Canada officials (i.e. Manon Bombardier, who we know really well) to further clarity intent and register our stakeholder concerns
- We are also outreaching to our international colleagues at PCPC and elsewhere to socialize awareness to these developments.
- Finally, we have now added the PCPR as another ‘regulatory list’ that we will need to look to integrated into the broader ‘single window compliance tool’ that CA Canada is pursuing with Environment and Climate Change Canada and Health Canada. This is yet another example of the need for more effective and efficient tools to facilitate regulatory compliance.
Questions
Please don’t hesitate to reach out to your CA regulatory team (regulatory@cosmeticsalliane.ca).
