New Opportunities for Customers Working with DE111® (Bacillus subtilis) in Canada

The digestive health landscape continues to be incredibly dynamic, with shifting consumer behaviors and increasing awareness of the connection between the gut and overall health and wellness, including physical, mental and emotional well-being. As such, we are pleased to share an important update with our probiotics customers and manufacturers in Canada developing microbiome-supporting food and beverage product solutions to help meet the growing demand in the health and wellness space.

In response to the voluntary health claim submission submitted to Health Canada's Food Directorate, Health Canada has issued a letter of no objection for DE111. The Food Directorate has no objection with considering Bacillus subtilis DE111®, when added to food, as a bacterial species and strain eligible to use the acceptable non-strain specific claims included in the Table of Acceptable Non-Strain Specific Claims for Probiotics.

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Table of Acceptable Non-Strain Specific Claims for Probiotics (the Table), as follows:

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, and
Provides live microorganisms that contribute to healthy gut flora.

"This is a big win for our customers in Canada, as well as for the ADM Deerland Probiotics and Enzymes portfolio, as brands that wish to include DE111® in their food products in Canada can proceed with confidence that they may make probiotic claims on the product based on the guidelines outlined by Health Canada's Food Directorate," said Dieter Neumann, Vice President, Spores and Enzymes Platform.

A spore-forming probiotic, DE111®¹ is supported by numerous studies showing that it supports factors pertinent to digestive health², regularity³ and body composition⁴. Plus, a groundbreaking study demonstrates that DE111® can germinate in the small intestine, as it can survive gastric transit and the harsh conditions of the stomach and bile salts⁵.

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"DE111® retains functionality through challenging processing conditions that may otherwise damage conventional lactic acid bacteria probiotics – making it an exceptional option for food products. We're pleased to be able to provide our customers in this space with additional assurance via the No Objection letter Food Directorate for Canada to help with creating efficiencies in production as they develop these products," added Neumann.

For more information visit the ADM Deerland Probiotics website.

IMPORTANT DISCLAIMERS AND NOTES:

This communication is intended for B2B use and no statements are meant to be perceived as approved by regulatory authorities. Local regulations must be reviewed to confirm permissibility of ingredients and claims for each food category.

- DE111® is not one of the bacterial species and strains listed in the Table. However, based on the submitted scientific information, the Food Directorate has no objection with considering DE111®, when added to food, as a bacterial species and strain eligible to use the acceptable non-strain specific claims noted above and included in the Table.

- Please note that Health Canada’s opinion pertains only to the eligibility of DE111® to use these claims. In order for a food containing DE111® to make these claims in labelling and advertising, the manufacturer or importer is responsible to ensure the food meets the above noted guidelines and conditions, including the level of DE111® in the product.

- It is important to note that Health Canada has not verified that the food, and ingredients including DE111® in the food, comply with applicable requirements of the Food and Drugs Act (FDA), the food provisions of the Food and Drug Regulations, and applicable guidance such as those noted above. Manufacturers and importers are responsible to ensure that DE111® added to food meets all applicable Canadian Acts, Regulations, and applicable guidance.

- This letter is not an affirmation or acceptance of claims or representations about DE111® other than those requested by Gowling WLG (Canada) LLP on behalf of Deerland Probiotics and Enzymes, Inc. Claims and representations about probiotic effects of DE111®, other than the acceptable non-strain specific claims about the nature of probiotics noted above, should be accompanied by measurable, specific, validated statements of the beneficial effect of DE111® in food, in accordance with the above noted guidance documents, and the Guidance Documents for Preparing Health Claims Submissions to help ensure compliance with Subsection 5 (1) of the FDA.

LEGAL

DE111® is a trademark of Deerland Probiotics & Enzymes, Inc. in the US and other countries.

¹Deaton et al., J Nutr Food Sci 2018, 8:5
²Labellarte, G., et al. (2019) Food and Nutrition Sciences, 10, 626-634
³Cuentas, A.M., et al. (2017) Journal of Probiotics & Health, vol. 05, no. 04
⁴Toohey, J.C., et al. (2018) Journal of Strength and Conditioning Research,1
⁵Colom J., et al. (2021) Front. Microbiol., 12:715863