Bacillus Clausii Strain Becomes First of Its Kind Listed on Health Canada's Veterinary Health Products Registry for Dogs

Specialty Enzymes & Probiotics’ spore-forming probiotic strain, Bacillus clausii 088AE, has been added to Health Canada's Veterinary Health Products list for use in dogs, making it the first and, to date, only Bacillus clausii strain to receive this designation.¹

The listing follows the agency's notification pathway for low-risk animal health products, which requires documented strain identification, safety data, manufacturing consistency, and evidence supporting any claims made. For pet supplement formulators, the listing offers a Canadian regulatory marker for a probiotic strain that already carries Generally Recognized as Safe (GRAS) status with the FDA, and supports claims under Health Canada's natural health products framework for human use.

"With FDA GRAS status and Health Canada NPN-approved claims, Bacillus clausii 088AE has already established a strong regulatory and scientific foundation in human health," said Reshma Rathi, vice president of Specialty Enzymes & Probiotics. "VHP recognition brings that same level of credibility to the pet space and gives formulators a truly differentiated, science-backed probiotic strain."

What Does Health Canada's Veterinary Health Products Listing Require?

Veterinary Health Products in Canada are regulated as a distinct, low-risk category of animal health product under the Food and Drugs Act, separate from the drug approval pathway that requires a Drug Identification Number.² The framework applies to vitamins, minerals, probiotics, enzymes, and botanicals intended to maintain or promote general animal health and welfare rather than to treat, prevent, or cure disease.

In order to obtain a Notification Number, the relevant ingredient must already appear on Health Canada's List of Permitted Substances, and the company must demonstrate compliance with manufacturing practices comparable to those required for natural health products intended for human use, along with objective and credible evidence supporting any health-maintenance claims made on the label.

This structure means that companies cannot make disease-treatment claims for a Veterinary Health Product, regardless of supporting data, and the notification process is comparatively faster than the full veterinary drug pathway because the underlying ingredients are presumed lower risk based on history of use. According to Specialty Enzymes & Probiotics, Bacillus clausii 088AE is the only strain of this species to achieve this specific Canadian listing for use in dogs to date, though this claim reflects the company's own characterization rather than an independently published registry comparison.

What Is the Existing Evidence Base Behind Bacillus Clausii as a Probiotic Strain?

Bacillus clausii is a spore-forming bacterial species with an established history of use in probiotic formulations, owing largely to its ability to survive gastric acid exposure, heat, and other processing stresses that compromise non-spore-forming probiotic strains.³

A peer-reviewed review³ of the species' probiotic applications notes that Bacillus clausii spores demonstrate substantial resistance to industrial food processing conditions, including heat and pressure, while maintaining physiological viability through gastric acid and bile salt exposure in the human gastrointestinal tract. The same review describes a favorable safety profile for the species, supported by prior assessment from the European Food Safety Authority.

The specific 088AE strain referenced in this announcement holds GRAS status in the United States, documented through a GRAS notification filed with the FDA.⁴ It’s important to note that the press release references supporting research for human gut and immune health claims tied to this strain, though it does not specify whether any of the underlying studies were conducted using companion animal subjects, and no canine-specific clinical trial data was identified in the materials reviewed for the article.

Why Does Probiotic Strain Stability Matter Specifically for Pet Supplement Formulation?

Spore-forming probiotics have gained traction in companion animal formulations in part because pet supplement manufacturing, shipping, and storage conditions can be more variable than those for human nutraceuticals, and because palatability requirements often necessitate processing methods, such as extrusion or coating, that can reduce viability of less hardy probiotic strains.

Bacillus clausii 088AE serves as the foundational strain in ProbioSEB CSC3 Pet, a 3-strain spore-forming probiotic blend the company markets for gut and immune health applications in dogs and cats.

For finished product manufacturers, regulatory listings of this kind can shorten internal evaluation timelines when assessing whether an ingredient's claims language and safety documentation are appropriate for the Canadian market, since the notification process requires documentation manufacturers would otherwise need to assemble independently.

References

1. Specialty Enzymes & Probiotics. Bacillus clausii 088AE becomes the first VHP-listed B. clausii for dogs. June 4, 2026. Accessed June 24, 2026. https://www.prnewswire.com/news-releases/bacillus-clausii-088ae-becomes-the-first-vhp-listed-b-clausii-for-dogs-302790994.html

2. Health Canada. Veterinary Health Products. Canada.ca. https://www.canada.ca/en/health-canada/services/drugs-health-products/veterinary-drugs/veterinary-health-products.html

3. Sadrimovahed M, Ulusoy BH. Bacillus clausii: a review into story of its probiotic success and potential food applications. Fermentation. 2024;10(10):522. doi:10.3390/fermentation10100522

4. US Food and Drug Administration. GRAS Notice No. GRN 971: Bacillus clausii strain 088AE spore preparation. https://www.hfpappexternal.fda.gov/scripts/fdcc/index.cfm?set=GRASNotices&id=971