BSE/TSE Statements for QA Teams: Reject Claims Missing a Lot
A valid BSE/TSE statement declares the animal-origin status of a named product and lot, is signed and dated by a named signatory, and carries the supplier’s contact details. Ask first for a signed, lot-linked statement together with the certificate of analysis (CoA). When a statement is unavailable, request documentation that the material is free of animal-derived components (ADCF) or documented, validated inactivation.
TL;DR:
- An audit file should also define the declaration’s intended use and include a same lot CoA, processing description, and upstream origin records when relevant.
- Put the documentation requirement in the RFQ, then verify that the declaration, CoA, and shipping papers carry matching lot numbers before accepting the claim.
- When inputs derived from cattle are declared, request country of origin and upstream traceability; if the claim relies on processing, obtain validation evidence.
- Unsigned, undated, vague, or unlinked declarations are red flags; request specific corrections and quarantine the lot until usable documentation arrives.
- If a supplier cannot issue a statement, choose an ADCF alternative or require documented, validated inactivation; any promised validation summary must be attached.
Table of Contents
- What is a BSE/TSE statement and why does it matter?
- When should you require a BSE/TSE statement?
- What belongs on an audit-ready statement, and what can you copy?
- How do you request, authenticate and store supplier statements?
- Why we document every lot we ship
- How we can help with compliant chemical sourcing
- FAQ
- Sources
What is a BSE/TSE statement and why does it matter?
BSE (bovine spongiform encephalopathy) belongs to the group of transmissible spongiform encephalopathies (TSEs), diseases caused by misfolded infectious proteins called prions. According to the WOAH fact sheet, BSE is a fatal, progressive neurological disease of cattle with a long incubation period. Because routine testing may not establish the material’s animal-origin status, buyers can rely on the supplier’s written declaration about what went into the material and where it came from.
For procurement and QA, the statement is a supplier-qualification record. It tells an auditor that you asked the right question and got a traceable answer. Suppliers typically make some combination of these claims:
- No animal or human materials were used in manufacture.
- The product is ADCF, meaning no animal-derived components were used in production or processing.
- Any bovine-derived input comes from a stated country of origin.
- The statement applies to a defined intended use and not to every possible application.
- The declaration is tied to a specific catalog number and lot.
Wording is where statements succeed or fail in audits. “Our products are BSE free” on letterhead, with no lot, no date and no name, tells an auditor almost nothing. A statement that names the product, cites the lot, makes an explicit origin claim and carries a signatory’s name and title can be filed, cross-checked against the CoA and defended. We treat the signatory as an important detail: someone accountable has to stand behind the claim.
When should you require a BSE/TSE statement?
Request a statement whenever a material could plausibly contain, or have been processed with, ruminant-derived inputs. Some categories are obvious, and some only show up once you read the supplier’s process description.
Product categories that usually warrant a request:
- Biological reagents and culture components
- Proteins and peptides
- Gelatin and gelatin-based excipients
- Albumin carriers and stabilizers
- Reagents that may be made with tallow or other ruminant derivatives, such as certain fatty acid derivatives and surfactants
- GMP inputs used in pharmaceutical or medical device manufacture
Situations that trigger a request:
- A customer contract or quality agreement requires it
- A regulatory filing needs a declaration for each input
- A GMP vendor qualification is under way
- An RFQ or tender includes a TSE clause
- An upcoming audit exposes a gap in your supplier file
Regulators do ask for this documentation in practice. FDA’s draft guidance on human- and animal-derived materials for cell and gene therapy and tissue-engineered products recommends that manufacturers relying on processing steps to remove or inactivate contaminants describe and qualify those steps, and that bovine-derived materials come with documentation of negligible-BSE-risk origin or other evidence of freedom from BSE.
If a supplier cannot produce a statement, you have workable options. You can switch to an ADCF alternative, require documented and validated processing steps for inactivation, or restrict use of the material to applications where the risk is not relevant.
Pro Tip: Put the statement requirement into the RFQ itself. Making the document a condition of quoting can prompt suppliers to address it earlier in the process.
What belongs on an audit-ready statement, and what can you copy?
Check every incoming statement against these mandatory items:
- Product identification: the product name, catalog number and lot number.
- An explicit animal-origin claim, either ADCF wording or a clear country-of-origin declaration.
- An intended-use disclaimer that states what the claim covers.
- The signatory’s name and title.
- The company name, address and contact details.
- The date of signature.
- Reference to the relevant standard or guidance where applicable.
Recommended attachments strengthen the file considerably:
- A CoA tied to the same lot
- A supplier processing description, when the claim depends on inactivation
- Country-of-origin certificates for any bovine-derived input
- Traceability back to the upstream raw material source
Two short templates cover most requests. Replace the capitalized fields with your own details before sending.
Template A: simple ADCF declaration
We, SUPPLIER NAME, of SUPPLIER ADDRESS, declare that PRODUCT NAME (catalog number CATALOG NUMBER, lot LOT NUMBER) is free of animal-derived components. No materials of animal or human origin are used in its manufacture, processing or packaging. This declaration applies to the stated lot and to the intended use of INTENDED USE. Signed: SIGNATORY NAME, SIGNATORY TITLE. Date: DATE. Contact: PHONE AND E-MAIL.
Template B: conditional origin-and-processing declaration
We, SUPPLIER NAME, of SUPPLIER ADDRESS, declare that PRODUCT NAME (catalog number CATALOG NUMBER, lot LOT NUMBER) contains or is derived from ruminant-origin material from COUNTRY OF ORIGIN. The material comes from animals born, raised and slaughtered in that country. The manufacturing process includes PROCESS STEP DESCRIPTION, which has been validated for removal or inactivation of TSE agents; the validation summary is attached. This declaration applies to the stated lot and to the intended use of INTENDED USE. Signed: SIGNATORY NAME, SIGNATORY TITLE. Date: DATE. Contact: PHONE AND E-MAIL.
Template B only works if the attachments exist. A conditional statement that promises a validation summary and then delivers none is worse than no statement, because it creates a documented claim you cannot support. For related documentation habits in chemical supply, see our audit-ready checklist for USP grade compliance.
How do you request, authenticate and store supplier statements?
Work through the request in a fixed order so nothing slips between procurement and QA.
- Ask for a signed, dated statement tied to the specific catalog number and lot you are buying.
- Request the matching CoA for the same lot.
- Obtain the supplier’s contact person and, where relevant, a processing description.
- Ask for upstream traceability or attestations when the product contains a derived ingredient.
- Log the request date and keep the e-mail trail with the response.
Then verify. Confirm that the signatory’s name and title match the company’s own records or earlier correspondence. Match the lot number on the statement to the lot number on the CoA and on the shipping documents, character for character. Where the claim rests on an upstream ingredient, ask for that upstream supplier’s own attestation rather than accepting a second-hand assurance. Store the signed PDF and the e-mail trail in an indexed document repository, filed by supplier, product and lot, so that an auditor can pull the full chain in minutes.
Watch for red flags:
- Vague wording such as “our products are safe” with no origin claim
- Unsigned or undated statements
- Statements that are not tied to a lot
- A supplier that cannot name where its raw materials come from
When you see one of these, go back to the supplier with a specific correction request, quarantine the lot pending a usable document, and consider whether an ADCF alternative or a different supplier is the safer route. A pattern of weak statements from one supplier is itself a qualification finding.
Distinguishing classical from atypical BSE sometimes comes up in supplier replies. Practitioner-level WOAH terrestrial manual guidance notes that atypical strains are treated differently from classical BSE, so a statement that mentions only one form is not automatically deficient, but ask the supplier to clarify what its claim covers.
Some buyers also store material in bonded facilities during import. If that applies to you, vet the facility’s record keeping too, since lot-level documentation has to survive the handoff. A useful starting point is this guide to vetting bonded warehouses before you ship.
Pro Tip: Name the file after the lot, not the supplier. When an auditor asks about a lot, you can find the statement, the CoA and the e-mail trail in one search.
Why we document every lot we ship
We source food, technical and pharmaceutical-grade chemicals from suppliers, and documentation is part of that sourcing. Our procurement flow is designed to support chemical sourcing with documentation.
In our experience, gaps in BSE/TSE documentation can create problems during audits. A supplier may be willing to say “no animal-derived materials,” but buyers still need a statement specific enough to support an audit. A declaration without a lot number is a marketing line, and treating it as compliance evidence is the real risk. We would rather hand you a narrow statement you can defend than a broad one you cannot.
If you are running an RFQ, ask us about the documentation available for your order. Our team will tell you what we can document and what we cannot.
— RJR Worldwide
How we can help with compliant chemical sourcing
Auditors want a complete file, and a missing declaration can stall a qualification. We supply chemicals with compliance documentation. Through our Chemical Sourcing Division, we offer sourcing of food, technical and pharmaceutical-grade chemicals with compliance documentation, including:
- Sodium Metabisulfite, with technical and compliance information available for grade selection
- Xanthan Gum
- Bio Glass, with a product page covering documentation context
- Calcium Hypochlorite
We provide compliance documentation to support your audits and regulatory submissions. Contact our procurement team through the chemical sourcing pages to request documentation and discuss supply options.
FAQ
What causes bovine spongiform encephalopathy?
BSE is caused by a misfolded infectious protein called a prion. The WOAH explains that it spread historically through contaminated meat-and-bone meal.
What is a TSE certificate?
It is a supplier-issued document declaring the animal-origin and TSE-risk status of a specific product. A usable one names the product and lot, makes an explicit origin claim and carries a signatory’s name, title and date.
What does “BSE free” mean?
On its own, very little. Without a lot, a date, a signatory and a stated basis such as ADCF manufacture or negligible-risk country of origin, the phrase cannot be verified. Ask the supplier to replace it with an explicit declaration.
What is TSE and BSE in pharma?
TSE is the umbrella term for prion diseases, and BSE is the form affecting cattle. In pharma, the concern is ruminant-derived inputs in GMP materials, so manufacturers collect declarations and origin documentation, as FDA’s guidance on animal-derived materials describes.
How do I handle a statement that looks wrong?
Check the lot against the CoA, confirm the signatory, and send the supplier a specific correction request. Quarantine the lot until you have a usable document.
Sources
Quoting authoritative text makes a request harder to brush aside and gives suppliers a clear standard to answer against. Three kinds of references cover most needs:
- Encephalopathy (BSE)
- Considerations for the Use of Human-and Animal-Derived Materials in the Manufacture of Cell and Gene Therapy and Tissue-Engineered Medical Products; Draft Guidance for Industry
FDA’s own framing is precautionary: the agency noted that the risk from such products is theoretical and remote, and that there is no evidence vaccines caused variant CJD (FDA). Precaution, not demonstrated harm, is what drives the documentation expectation.
In your audit file, record the retrieval date and the exact section or page you relied on. Country lists and guidance documents are revised, so a citation without a date cannot show what you knew at the time of the supplier decision.