Health Canada Confirms Non-Novel Food Status for ADM's DE111 Probiotic Strain

Health Canada has issued a regulatory determination confirming that the spore-forming probiotic strain *Bacillus subtilis* DE111 does not meet the definition of a novel food under the federal Food and Drug Regulations. The decision removes pre-market notification requirements for the ingredient, permitting brand owners and formulators to incorporate the strain into conventional food and beverage matrices across the Canadian market. Commercialised by ADM following its acquisition of Deerland Probiotics & Enzymes in November 2021, DE111 already holds an established position within the Canadian dietary supplement market. The determination bridges the regulatory gap between natural health products and conventional food manufacturing. ## Safety Assessment and Regulatory Clearance Health Canada’s determination followed an evaluation of the strain's safety profile and microbial characterisation. The regulatory review encompassed manufacturing consistency, whole-genome sequencing, and safety data from clinical studies. Under Canadian regulations, substances categorised as novel foods require pre-market safety reviews prior to commercial sale. In concluding that *Bacillus subtilis* DE111 is non-novel, Health Canada confirmed that the strain demonstrates sufficient evidence of safe historical use and well-characterised microbial attributes, exempting manufacturers from formal novel food notification. ## The NHP and Conventional Food Boundary Canada maintains a bifurcated regulatory framework that distinguishes conventional foods from Natural Health Products (NHPs). Historically, specific microbial strains have obtained market clearance as NHPs—securing Natural Product Numbers (NPNs) for evaluated indications in dosage formats such as capsules, tablets, and drops. However, introducing those same strains into conventional food matrices has frequently triggered novel food evaluations, creating an administrative barrier for brand owners operating across both categories. Prior to this assessment, DE111 held approved NPNs under the NHP regulations. The confirmation of non-novel food status resolves this divide for the strain, permitting Canadian food and beverage manufacturers to deploy the ingredient without submitting duplicate pre-market novel food notifications. ## Formulation Parameters and Heat Stability The non-novel classification is particularly significant for functional food formulation due to the physical characteristics of *Bacillus subtilis*. In contrast to vegetative probiotic genera such as *Lactobacillus* or *Bifidobacterium*, *Bacillus subtilis* produces endospores. These dormant spore structures protect the organism against industrial processing stresses. Published technical data indicate that DE111 can tolerate thermal processing, pasteurisation protocols, and mechanical shear forces that typically reduce the viability of vegetative cultures. This stability facilitates incorporation into applications such as baked goods, hot beverages, extruded snacks, and dairy alternatives without requiring microencapsulation or substantial manufacturing overages. ## Labelling Considerations and Permitted Claims Although the non-novel determination establishes the regulatory baseline for ingredient inclusion, brand owners must navigate specific regulatory constraints regarding commercial communication. Permissible inclusion levels—including colony-forming unit (CFU) counts per serving—must remain aligned with Health Canada’s general food provisions. Furthermore, while DE111 carries permitted health claims within the NHP regulatory framework, applying therapeutic or structure-function claims to conventional foods in Canada remains subject to separate food labelling standards governed by the Canadian Food Inspection Agency (CFIA) and Health Canada. In the absence of specific function claim approvals for food matrices, on-pack communication is typically limited to generic declarations of microbial content rather than health-related indications.