Health Canada’s letter of no objection means that Deerland Enzymes & Probiotics’ DE111 strain is no longer a Novel Food and can now be sold as a food ingredient without the need for premarket notification.
Deerland Enzymes & Probiotics’ (Kennesaw GA) spore-forming Bacillus subtilis probiotic strain, known commercially as DE111, has been granted non-Novel food approval by Health Canada. Health Canada’s letter of no objection means that DE111 is no longer a Novel Food and can now be sold as a food ingredient without the need for pre-market notification.
Canada considers food ingredients to be novel and require premarket notification if they meet any of the following criteria: have no history of safe use as a food; are formulated via a process that has not previously been applied to food and causes the food to undergo a major change; or are derived from a genetically modified plant, animal, or microorganism. Health Canada has decided that DE111 no longer meets these criteria, and thus it no longer requires premarket notification for use in food and beverage products.
According to John Deaton, PhD, vice president of science and technology, Deerland, achieving non-Novel Food status is an important step for DE111 considering how strongly poised the ingredient is for food and beverage formulating. He said that because DE111 remains viable under a range of temperatures and pH levels, it is well-suited for a variety of food and beverage applications.
And, said Deaton, today’s shoppers are more savvy about beneficial bacteria that ever before. “Supermarket aisles are blooming with foods and beverages with labels proclaiming ‘probiotics’ on them because consumers are demanding beneficial bacteria as they link good digestive and immune health to probiotics,” he said. “We believe that if consumers had a choice between two of the same products but one has added probiotics, that’s the one that will be placed in the shopping cart.”
Deaton added that DE111 also benefits from a body of research that supports not only its digestive-health benefits, but potential sports-nutrition applications, as well. “DE111 has been shown scientifically to be a flexible health ingredient with wide-ranging food and beverage applications that can be aimed at improving digestion, bolstering immunity and overall well-being, and improving athletic conditioning, performance, and desirable body composition,” he explained.
In a recent, unpublished study, DE111 was shown to help control bacteria populations in the gut, thus ensuring a healthy colony of friendly flora while minimizing pathogenic bacteria. A 2017 study1 published in the Journal of Probiotics & Health indicated that DE111 may also improve constipation and diarrhea symptoms. Results from another study,2 which the company said was recently accepted for publication, found that DE111 may improve body composition and athletic performance.
In addition to the new non-Novel Food status, DE111 has also been approved for use in supplements by Health Canada. Last year, Health Canada issued a Natural Product Number (NPN) for the probiotic ingredient. Deerland says DE111 is also Star-K kosher and Non-GMO Project verified.
Deerland Enzymes & Probiotics specializes in customized enzyme and probiotic formulations, but offers a line of branded products, as well. Deerland also provides regulatory support and specialty contract manufacturing services.
1. Cuentas AM et al., “The effect of Bacillus subtilis DE111 on the daily bowel movement profile for people with occasional gastrointestinal irregularity,” Journal of Probiotics & Health, vol. 5, no. 4 (2017): 189
2. Toohey JC et al., “The effects of probiotic (bacillus subtilis) supplementation during offseason resistance training in female Division I athletes,” The Journal of Strength and Conditioning Research.