BioCraft Pet Nutrition has published what the company describes as the first publicly available safety dossier for an animal cell-cultured ingredient used in pet food. The dossier, Safety Transparency in Animal Cell-Cultured Ingredients for Pet Food: A Case Study Establishing the Standard for Public Disclosure, is posted on bioRxiv and includes data on cell line identity, tumorigenicity, genotoxicity, chemical safety, viral safety and media compliance.
Shannon Falconer, BioCraft's CEO and founder,BioCraft
Shannon Falconer, BioCraft's CEO and founder, said the company chose to disclose its full safety data ahead of any regulatory requirement to do so.
"The precedent set by manufacturers of animal cell-cultured ingredients in these earliest days will shape whether veterinarians and pet parents can trust this entire category for years to come," Falconer said.
Dossier addresses tumorigenicity, genotoxicity
The dossier centers on PE25, a mouse embryonic stem cell line BioCraft uses in its ingredient. To assess whether the cell line shows signs of cancerous or tumor-forming behavior, BioCraft used a soft agar assay, which measures whether cells can grow and form colonies without attaching to a surface. The company also tested whether the cells' p53-mediated DNA damage response remained intact and checked for two markers, CD44 and BMI1, associated with abnormal cell behavior. BioCraft said the combined results show PE25 is neither cancerous nor tumorigenic.
To evaluate genotoxicity, BioCraft characterized potential hazards in the ingredient, including heavy metals, biogenic amines and solvent residues, and ran internationally recognized genotoxicity assays on the finished product. The company said results confirmed the ingredient is not mutagenic, clastogenic or aneugenic.
Dima Faour-Klingbeil, founder of DFK for Safe Food Environment, worked with BioCraft on its HACCP plan and said the level of disclosure exceeds current industry norms.
"BioCraft's decision to make its safety dossier public, rather than treat it as proprietary, marks an important and meaningful shift for this category and in feed safety," Faour-Klingbeil said. "Choosing to publish detailed safety data and invite external scrutiny is exactly the kind of practice this industry needs more of."
Company proposes disclosure framework
BioCraft is also introducing what it calls the BioCraft Pet Nutrition Standard, a proposed minimum safety disclosure framework for other manufacturers of animal cell-cultured pet food ingredients. The company said cell line origin, growth media and processing methods vary between manufacturers, meaning cell-cultured ingredients cannot be evaluated as a single uniform category.
Falconer told Petfood Industry the timing of the disclosure reflects a shift in interest toward cell-cultured ingredients for pet food, partly because regulatory pathways in the EU and UK are shorter than those for human food.
"That means the safety of animal cell-cultured ingredients for pet food is effectively left to each manufacturer, with no formal, ingredient-level premarket review or independent assessment in place," Falconer said.
Falconer said cell-cultured ingredients for human food have received individual regulatory approvals in markets including the U.S. and Singapore, but those approvals apply to specific ingredients rather than the category broadly. She said cell line type, culture media components and processing aids create distinct safety profiles that should be evaluated and disclosed ingredient by ingredient.
"If several companies adopt similar transparency standards, it will become easier to differentiate robust, data-driven approaches from superficial ones, and harder for any single poorly characterized product to undermine trust in the entire category," Falconer said.
Asked whether BioCraft plans to work with regulators or industry groups such as the Association of American Feed Control Officials (AAFCO) to advance the proposed framework, Falconer said the company's immediate focus is starting a broader conversation about minimum testing standards.
"A transparent set of standards that the wider industry agrees on is better for manufacturers, regulators, pet parents and, most importantly, the cats and dogs consuming our ingredients," she said. "We're not disclosing IP, but we are being transparent about safety, and we believe this is the most responsible path to take."
View Safety Transparency in Animal Cell-Cultured Ingredients for Pet Food here.
