A BSE/TSE statement is required whenever a pharmaceutical product, medical device, or regulated food or cosmetic product contains any material derived from animal species susceptible to transmissible spongiform encephalopathies (TSEs), primarily cattle, sheep, and goats. The statement serves as a formal risk assessment proving the animal-origin material does not pose a risk of transmitting prion diseases like BSE (mad cow disease). Both the FDA and the European Medicines Agency (EMA) require this documentation, though their specific triggers and formats differ.
Products That Trigger the Requirement
The requirement applies across a broad range of regulated products. In the EU, any medicinal product for human or veterinary use that includes animal-derived starting materials needs a TSE risk assessment. In the US, the FDA requires documentation for human food, dietary supplements, cosmetics, pharmaceuticals, and medical devices that incorporate materials from ruminant animals.
The key question is simple: does your product contain anything that came from an animal capable of carrying a TSE? If yes, you need a statement. This includes not just obvious ingredients like gelatin capsules or bovine-derived enzymes, but also excipients, processing aids, culture media components, and any substance that contacted animal tissue during manufacturing. Common triggers include:
- Gelatin (used in capsules, tablet coatings, and as a stabilizer)
- Tallow and tallow derivatives (used in lubricants, emulsifiers, and excipients like magnesium stearate)
- Lactose (a milk-derived filler in tablets)
- Bovine serum albumin (used in cell culture and vaccine manufacturing)
- Collagen and tissue-based materials (in medical devices such as wound dressings and surgical meshes)
What the Statement Must Cover
A BSE/TSE statement is not a single checkbox. It is a documented risk assessment built on three pillars, as defined by the EMA’s guidance on minimizing TSE transmission risk: the source animals and their geographic origin, the nature of the animal tissue used, and the manufacturing processes applied to the material.
For each animal-derived material, the statement needs to identify the species, the specific tissue or organ used, the country where the animals were raised and slaughtered, and the age of the animals at slaughter. It should also describe the manufacturing steps that reduce or eliminate potential TSE agents, along with any quality assurance systems (GMP, HACCP, or ISO certification) in place to ensure traceability and batch consistency.
For medical devices specifically, the FDA expects premarket submissions to document the animal species, age at slaughter, tissue type, country of origin and residence, herd health monitoring methods, tissue transport procedures, USDA status of the slaughterhouse, and any tests performed with their release criteria. Each lot of product manufactured must carry this documentation in the device history record.
Tissue Risk Categories
Not all animal tissues carry the same level of TSE risk, and the type of tissue used directly affects what your statement needs to justify. The EMA classifies tissues into three infectivity categories.
High-infectivity tissues (Category IA) include brain, spinal cord, eyes, and other central nervous system tissues. These carry the highest concentration of prion agents and are essentially prohibited from use in medicinal products unless a manufacturer provides an exceptional justification. Lower-infectivity tissues (Category IB) are peripheral tissues that have tested positive for prion agents in at least one form of TSE. Tissues with no detectable infectivity (Category IC) have been tested without any prion agents found.
The FDA takes a similar approach by defining “specified risk materials” (SRMs) that are outright prohibited in human food, supplements, and cosmetics. These include brain, skull, eyes, spinal cord, and vertebral column from cattle 30 months of age and older, plus tonsils and the distal ileum of the small intestine from cattle of any age. Material from cattle that were non-ambulatory, not inspected and passed, or mechanically separated is also banned.
When a Statement Is Not Required
Certain materials are explicitly excluded from the requirement. The FDA confirms that milk and milk products, hides and hide-derived products, tallow containing no more than 0.15 percent insoluble impurities, and tallow derivatives are not considered prohibited cattle materials. Gelatin also gets a carve-out if it is manufactured using customary industry processes, though the EMA still requires that skulls and spinal cord be removed from collected bones regardless of the animals’ age or country of origin.
Products that use only synthetic materials, plant-derived ingredients, or materials from non-susceptible animal species (like fish or poultry) do not need a BSE/TSE statement. However, if there is any possibility of cross-contamination with ruminant-derived materials during manufacturing, the risk assessment may still be necessary.
Geographic Sourcing and Country Risk
Where the animals were raised matters significantly. The World Organisation for Animal Health (WOAH) officially classifies countries into two BSE risk categories: negligible risk and controlled risk. A negligible risk designation requires that the country has shown no evidence of the classical BSE agent recycling within its cattle population for at least 8 years, backed by an ongoing surveillance program over the same period.
The EMA guidance is direct: animals should be sourced from countries with negligible BSE risk unless the use of material from higher-risk countries can be justified. This means a BSE/TSE statement for material sourced from a controlled-risk country requires more detailed documentation and stronger justification than one for material from a negligible-risk country. The geographic origin of your source animals can be the difference between a straightforward filing and a complex regulatory challenge.
The EDQM Certificate of Suitability Option
In Europe, manufacturers of animal-derived raw materials can apply for a Certificate of Suitability (CEP) from the European Directorate for the Quality of Medicines and HealthCare (EDQM). This certificate demonstrates that a material complies with the European Pharmacopoeia’s requirements for TSE risk, specifically its general monograph on products with risk of transmitting animal spongiform encephalopathy agents.
A CEP functions as a pre-evaluated, standardized alternative to submitting an individual BSE/TSE statement from each raw material supplier. If your gelatin or tallow supplier already holds a valid CEP for TSE risk, you can reference that certificate in your regulatory submission instead of compiling a separate risk assessment for that ingredient. This streamlines the process considerably, especially for products with multiple animal-derived components from different suppliers.
EU vs. US Requirements
The core logic is the same on both sides of the Atlantic, but the mechanics differ. In the EU, the EMA’s guidance note applies to all marketing authorization applications for human and veterinary medicinal products. The risk assessment is a formal section of the application dossier, and it must be updated whenever there is a change in the source, origin, or manufacturing of any animal-derived material.
In the US, the FDA’s approach varies by product type. For food, supplements, and cosmetics, the focus is on prohibiting specific high-risk materials outright rather than requiring a formal statement. For pharmaceuticals, animal-derived ingredients must be addressed in the drug master file or application. For medical devices, the documentation is part of the premarket submission (510(k), PMA, or De Novo), and the FDA expects sourcing and processing records to be maintained in the device history record for every manufactured lot.
If you are manufacturing for both markets, the practical approach is to build your BSE/TSE documentation to the more detailed EMA standard. A dossier that satisfies the EMA’s three-pillar risk assessment will generally contain everything the FDA requires as well, saving you from maintaining parallel documentation systems.