Canada confirms six month probiotic compliance deadline

By Shane Starling

- Last updated on GMT

Related tags: Health canada, Gut flora

Probiotic products on sale in Canada have been given six months to comply with new health claims guidelines by Health Canada.

All marketing materials must comply with the rules issued by Health Canada earlier in the year that administer what can be said about products containing probiotic strains and which were recently updated by the Canadian Food Inspection Agency (CFIA).

“It is the responsibility of all manufacturers and importers to ensure that their products comply with all relevant Canadian legislation,”​ Health Canada wrote.

“Labels, advertisements and web sites are expected to be in compliance with this new guidance on probiotics within six months of the date of publication of this letter. Products which do not meet the requirements at that time may be subject to enforcement action by the CFIA.”

Products bearing drug claims have no such luxury and must be in compliance immediately.

Guidance

In the updated version of the Guide to Food Labelling and Advertising, ​differentiation is made between strain-specific claims and general claims.

While a number of general statements have been approved, Health Canada noted that no specific strains have as yet been accepted.“As these claims are reviewed and accepted, Health Canada will update a list of acceptable strain-specific claims that will be available on its web site,”​ Health Canada said.

The four approved general claims are:

  • Probiotic that naturally forms part of the gut flora.
  • Provides live microorganisms that naturally form part of the gut flora.
  • Probiotic that contributes to healthy gut flora.
  • Provides live microorganisms that contribute to healthy gut flora.

Health Canada said claims must be non-misleading, non-vague and strain-specific claims must be backed by strain-specific science in the food matrix in question.

“When making any probiotic claim, the manufacturer or importer of the product should have documentation supporting the identification, safety, viability, concentration and stability of the probiotic strain added to the food product.”

It added: “The food should contain, at a minimum, the amount of the probiotic microorganism(s) required to result in the claimed effect or health benefit throughout the shelf life of the product. Documentation to support the functionality aspects of the product (i.e. stability and viability of the probiotic strain or mixed culture) should be maintained.”

This equated to highlighting colony forming units (CFUs) on- product, accompanied by the latin name or registered strain number.

Eligible strains are:

  • Bifidobacterium adolescentis
  • Bifidobacterium animalis​ subsp. animalis
  • Bifidobacterium animalis​ subsp. lactis
    -synonym: B. lactis
  • Bifidobacterium bifidum
  • Bifidobacterium breve
  • Bifidobacterium longum​ subsp. infantis​ comb. nov.3
  • Bifidobacterium longum​ subsp. longum​ subsp. nov.3
  • Lactobacillus acidophilus
  • Lactobacillus casei
  • Lactobacillus fermentum
  • Lactobacillus gasseri
  • Lactobacillus johnsonii
  • Lactobacillus paracasei
  • Lactobacillus plantarum
  • Lactobacillus rhamnosus
  • Lactobacillus salivarius

The updated guidance can be found here.

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