BSE/TSE-Free and Non-Irradiation Statements: Why Buyers Ask For Them

These two declarations sit in the category of documents a buyer asks for at the last minute and a supplier either has or does not. Neither is complicated, but both reflect real supply-chain requirements — particularly for products containing gelatin, and for markets with strict rules on treatment methods. Here is what each one covers.

On this page: BSE/TSE-Free · Non-Irradiation · Handling the Paperwork

BSE/TSE-Free

1. What is a BSE/TSE-free statement?
   A declaration that the product, and its raw materials, are free from specified risk materials associated with bovine spongiform encephalopathy and transmissible spongiform encephalopathy. It is particularly relevant where the product contains animal-derived material.
2. Which products need it?
   Any product using gelatin, bovine or porcine derivatives, or certain animal-sourced actives. A gelatin capsule shell, a gelatin gummy, or a collagen source raises the question, and buyers in many markets will ask for the statement as a matter of course.
3. What does the statement cover?
   The origin of the animal material, confirmation that it comes from a country or region recognised as controlled for BSE, and confirmation that no specified risk material is used. The precise wording varies by buyer and market.
4. Can I avoid it by using plant material?
   Yes — HPMC capsules and pectin gummies do not raise the question in the same way. Where vegan or halal positioning matters, this is one of several reasons a plant-based shell is the simpler route.

Non-Irradiation

1. What is a non-irradiation statement?
   A declaration that the product has not been treated with ionising radiation for microbial reduction. Some markets permit irradiation and others restrict or require labelling for it; some buyers prohibit it outright.
2. Why do buyers ask for it?
   Because irradiation is a treatment method, not an ingredient, so it may not appear on a label. A buyer with a policy against it needs a written assurance rather than a label check.
3. What is used instead of irradiation?
   Heat treatment, filtration where applicable, and strict control of water activity and hygiene during production. A factory that can achieve microbial specification without irradiation is usually the one to prefer where the buyer prohibits it.
4. Does organic certification require it?
   Organic standards generally restrict irradiation, so an organic-positioned product normally needs the non-irradiation assurance anyway. The two requirements tend to travel together.

Handling the Paperwork

1. When should I request these?
   At the specification stage, before the order, so the factory can confirm it can issue them. A supplier that cannot produce a BSE/TSE statement for a gelatin product is a problem waiting to surface.
2. Who issues them?
   Usually the manufacturer, on company letterhead, sometimes with supporting documentation from the raw-material supplier. Some markets require notarisation or an official endorsement.
3. Can they be combined with other documents?
   Often they are issued alongside a Certificate of Analysis and a Certificate of Free Sale. Ask the buyer which documents they need as a set, and request them in one go rather than one at a time.
4. What if my product changes?
   Reissue the statements. A declaration is specific to the materials and the process, so a change of gelatin source or a change of shell material invalidates the original.

Related Reading

See Certificate of Free Sale for the other export document, and HPMC vs gelatin capsules if you want to remove the question entirely.

These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.