GanedenBC30 gets Health Canada ‘no objections letter,’ expanding formulation, claims flexibility for manufacturers

By Adi Menayang contact

- Last updated on GMT

Photo: iStock/FrancisLM
Photo: iStock/FrancisLM

Related tags: Health canada, Probiotic

A new Health Canada ‘no objections letter’ expands manufacturers’ flexibility to formulate and market products with Ganeden’s branded Bacillus cogulans GBI-30, 6086 (or GanedenBC30 for short) in Canada. This includes leeway to use less than 1 billion CFU per serving, as well as print more health claims associated with the ingredient.

“This letter states that GanedenBC30 meets the criteria of ​[Health Canada’s General Monograph​ on probiotics] and no further approvals would be required for finished products,”​ said Dr. David Keller, VP of scientific operations at Ganeden.

Before the no objections letter, which was sent to Ganeden last month, limitations to using GanedenBC30​ in a product included a requirement to formulate using not less than 1 billion CFU per serving, the daily amount set by Health Canada. Dr. Keller attributed this as one of the bigger challenges finished product manufacturers faced when trying to create or market a product in Canada.

Now, with the assumption that a consumer will eat or drink more than one serving of a product with the probiotic ingredient, manufacturers can use less than 1 billion CFU per product. The condition is that the manufacturer includes a statement indicating that the total daily CFU requirement is 1 billion, printed in close proximity to information of the product's probiotic, and this exception only applies case-by-case to certain products.

Additional health claims for the Canadian market

Another change is what companies could say about a GanedenBC30-fortified product’s health benefits. Products in Canada couldn’t simply feature the word ‘probiotic,​’​ but they could use other words to describe what GanedenBC30 is, such as ‘live bacteria,’ ‘live microorganisms,’ ‘live cultures,’ ​or the full strain name (Bacillus coagulans​ GBI-30, 6086).

However, after petitioning from Ganeden’s part, products containing GanedenBC30 may now use the word ‘probiotic’ on pack when it is in the phrases ‘Probiotic that naturally forms part of the gut flora,​’ or ‘Probiotic that contributes to healthy gut flora.’

There are currently more than 30 products on the market fortified with GanedenBC30 in Canada, as diverse as snacks and bars, smoothies, protein powders, beverages, and pet products.

“Similar to the probiotic trend in the U.S., there is a new push for preventative health efforts vs. reactive ones,”​ Dr. Keller said.

“Consumers in general are taking a healthier approach to foods and beverages, and with that comes an increase in demand for added functional benefits. Because there is a lot of crossover between the U.S. and our bordering countries, trends that grow rapidly in the U.S., such a probiotic fortification, gain popularity in those countries as well,”​ he added.

“The probiotic market in Canada is projected to grow significantly in the next 5 years,"​ said George Paraskevakos, executive director of the International Probiotics Association (IPA).

"Data from Euromonitor shows the compounded annual growth percentages in the probiotic supplements category specifically at about 17%, to reach close to $90 million in sales by 2022,"​ he added. "The IPA believes this rapid expected growth will lend itself to probiotic fortification in the food and beverage category.”

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