TSE and BSE are of interest to regulators and health agencies around the world. Guidance is promulgated by various authorities including the FDA, European Medicines Agency, NIH, and World Health Organization. The concern from a flexible barrier packaging prospective is if the materials packaging is made from contain materials of allergen origin, they could, in theory, contain contamination. Further customers using packaging for certain applications should not have animal derived materials in them.
The regulation of TSE and BSE go hand-in-hand with food contact regulations. With relation to flexible barrier lamination structures, the primary risk would relate to raw materials, excipients and adjuvants, basically contamination.
- Transmissible Spongiform Encephalopathy (TSE)
- Bovine Spongiform Encephalopathy (BSE)
- Animal Derived Materials