TSE/BSE EMA Transmissible & Bovine Spongiform Encephalopathy

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The European Medicines Agency guideline EMA/410/01 (current rev.4) enforces zero-risk from Transmissible Spongiform Encephalopathies (TSE/BSE). The fatal brain diseases linked to “mad cow” prions (misfolded proteins). If your product uses any animal-derived material (gelatin, collagen, tallow, glycerin, magnesium stearate, lactose, peptides, enzymes, etc.) in:

• Medical devices (sutures, hemostats, dental membranes, wound dressings)  
• Pharmaceuticals and excipients  
• Cosmetics (creams, lipsticks, soaps)  
• Food supplements and vitamins

YOU must prove the source tissue is from countries with negligible BSE risk, processed with validated prion-killing steps, and fully documented with TSE Certificates of Suitability (CEP) or manufacturer declarations.

No valid TSE certificate = immediate product ban. EU customs and national authorities seize entire shipments, force recalls, suspend marketing authorizations, and destroy stock. Fines run into millions, and one single BSE mishap can wipe out your brand forever. Many manufacturers of raw materials, semi-finished / finished goods and every major retailer now demand TSE-free documentation before listing.

Even “vegetable” magnesium stearate or capsule shells can hide tallow derived stearic acid. One missing certificate or unlisted bovine trace can trigger a total market shutdown overnight.

Professional TSE risk assessment, supplier audits, CEP verification, and full documentation packages are the only way to stay legal and keep selling. Don’t gamble your entire revenue on a hidden animal ingredient. 

Perform a risk assessment  or Book a compliance review and secure your TSE/BSE compliance today before your next shipment is halted.