BioCraft calls for new transparency standard with first public safety dossier for cultivated pet food ingredient

BioCraft Pet Nutrition has published what it says is the first publicly available safety dossier for an animal cell-cultured ingredient intended for pet food, while urging other cultivated ingredient developers to adopt the same level of transparency.

• BioCraft published the first public safety dossier for a cultivated pet food ingredient.
• Company proposed a voluntary disclosure standard for the industry.
• Testing found no evidence of tumorigenicity or genotoxicity.

"When I started BioCraft, I promised myself we'd never ask a pet parent to trust something I wouldn't feed my own dogs," said Shannon Falconer, Founder & CEO of BioCraft Pet Nutrition.

The dossier, released as a preprint on bioRxiv, details years of testing on the company's proprietary PE25 mouse embryonic stem cell line and the resulting ingredient, covering cell line characterization, tumorigenicity, genotoxicity, viral safety, chemical contaminants and production media. The company argues that every cultivated ingredient should be assessed individually rather than assuming safety findings can be applied across the entire category.

Unlike cultivated ingredients for human food, animal cell-cultured ingredients entering the European pet food market can currently be commercialized without an independent ingredient-level safety assessment, provided manufacturers comply with feed regulations. BioCraft argues that this places responsibility on manufacturers to generate and disclose robust safety data voluntarily.

According to the paper, the PE25 cell line showed no evidence of tumor-forming behavior after a series of complementary assays, including soft agar colony formation, p53 stress testing and analysis of cancer-associated biomarkers CD44 and BMI1. The finished ingredient also contained no viable cells following production.

Independent genotoxicity testing using OECD Test Guideline 471 (Ames test) and OECD Test Guideline 487 (micronucleus assay) found the ingredient was neither mutagenic, clastogenic nor aneugenic. Heavy metals, residual solvents and chemical residues were all reported below regulatory limits, while production media components were sourced from ingredients already approved under EU feed legislation.

Rather than presenting the work solely as validation of its own ingredient, BioCraft says the publication is intended to establish a minimum level of disclosure for the cultivated pet food sector.

"That’s why BioCraft has decided to make all of its safety information public. Because the precedent set in these earliest days will determine whether people can trust this whole category for years to come," Falconer said.

The paper concludes that voluntary publication of comprehensive safety data should become 'an ethical obligation' as well as a commercial one, arguing that transparent evidence will be essential for building confidence among regulators, manufacturers, veterinarians and pet owners. It also proposes a minimum disclosure framework covering cell bank characterization, tumorigenicity testing, viral safety, chemical analysis, genotoxicity testing and media transparency that other developers could adopt.

The authors also argue that cultivated ingredients should be evaluated on a case-by-case basis because differences in cell lines, culture media, manufacturing processes and testing protocols can lead to fundamentally different safety profiles.