Regulatory Affairs in Canada This Year: What’s New for 2024!

 In Regulatory Affairs

By: Jacqui Jenskey, DIRECTOR OF REGULATORY AFFAIRS, email

Now that the dust has settled on the new year, let’s take a look at just some of the regulatory changes coming 2024.  Be prepared!

1. Biocides Regulation

Canada will see disinfectants and sanitizers (including food contact surface sanitizer) come under a single biocides regulatory framework this year.  There will be new application forms and some new classifications and requirements for your regulatory actions.  All current hard Surface Disinfectant DIN’s will need to be transitioned over to the new registration system and there will be a prescribed time period for this to occur.   Use of Foreign Decision (UFD) will be offered as a way for international companies to use registrations from other countries to assist in the registration of products in Canada.

Food Processing Aid applications for those sanitizers that come into direct contact with foods during processing that are not part of the new Biocides regulation.  They will continue to fall under the Foods Directorate and require iLONO’s and/or LONOs.

2.VOC Regulations – Disinfectants

Volatile Organic Compound Concentration Limits for Certain Products Regulations are now in force for products manufactured or imported into Canada that fall into one of the 130 categories.  The categories include some personal care products, automotive and household maintenance products, adhesives, adhesive removers, sealants and caulks.  If a product was imported prior to Jan 1, 2024 companies can sell through inventory but cannot import any product that fits into a category that exceeds the VOC maximum.

The regulation will apply to Disinfectants as of Jan 1, 2025.   See the exclusions below to determine if you should be checking your formulations to confirm that they meet the Aerosol VOC Maximum of 70% or the Non-aerosol Maximum of 1%.  Reformulations will take time and they will require registration amendments with Health Canada prior to importing a new formula.  Reformulations could also require you to perform confirmatory testing to ensure your new formula still have sound efficacy.

3. Regulatory Modernization of foods for special dietary use and infant foods

Health Canada is working towards modernizing regulations for Food for Special Dietary use (FSDU) and infant foods, currently covered under Divisions 24 and 25 of the Food and Drug Regulations. All stakeholders are hoping that these regulation changes open up the potential for research, innovation, and flexibility within the regulations while keeping nutrition and consumer safety as priorities.

Canada Gazette Part I has published a proposal for the regulatory modernization as well as a public regulatory consultation for comments. The consultation will be open for feedback until February 6, 2024.

These are long overdue changes and industry is hoping that the proposed changes will allow more international formulations for foods to enter Canada as a regulated food rather than going through the lengthy and complicated TMA process.  Temporary marketing authorizations (TMAs) would no longer be needed under the modernized framework. TMAs are used to temporary allow the sale of a product while information is generated to address data gaps in support of an amendment to the Regulations. However, one of the principles we are basing our proposed framework on is to eliminate the need for temporary solutions such as TMAs.

4. Cosmetic Hot List

The  Cosmetic Hot List is an administrative tool that Health Canada uses to communicate to manufacturers and importers that certain substances may be prohibited or restricted for use in cosmetics.  Entries on the Hotlist can be linked to particular legislative provisions.   The Hotlist is reviewed and updated periodically (i.e. when new scientific data becomes available) and Health Canada can take actions at any time to enforce the contents of the list.

Several additions are being proposed for 2024 that could impact your formulations and/or your labels so take a look at the links included and reach out to Dell Tech if you have any questions.

5. NHP labelling and Monograph updates

Health Canada has published new labelling requirements under the Natural Health Products Regulations (NHPR). Health Canada feels these changes needed to be made to help consumers better understand the purchases they make with consistent, clear, and easy to understand product labels.  The labels will look like a Drug label that includes a Drug Facts tablet, but will have a Product Facts table.

In addition, it is now mandatory for NHP labels to disclose any sources of food allergens, gluten, and added sulphites, under “Warnings”.  NHP’s using aspartame, also now require “Contains aspartame” on the label as well.

Other changes include grouping sugar-based ingredients together in brackets after the word “sugar(s)”. This is a similar approach to new Canadian food labels and will help consumers identify all sources of sugar added to an NHP.

While Health Canada encourages the implementation of the improved labelling requirements as early as possible, the following transition periods are in place:

  • NHPs licenced before June 21, 2025 have until June 22, 2028 to comply.
  • NHPs licenced on or after June 21, 2025 have to comply immediately.

With labelling requirements now changes, Health Canada has been updating the NHP Monographs to reflect the labelling, as well as other changes.  If you have NHP’s that are registered to a set Monograph you will want to stay connected to all proposed monograph changes that are being published and ensure your products will meet the new monographs. They can include new active ingredients, changes to existing levels of active ingredients, additional warnings, allergen statements etc that you currently do not have on your labels.  They will also include examples of Product Facts tables.

Dell Tech is here to help you navigate these regulatory challenges so let us know how we can assist you.

 


Dell Tech has provided professional, confidential consulting services to the specialty chemical 

industry in Canada, the USA, Europe, and Asia for the last 40 years.

 

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