Safety of milk and milk derivatives in relation to BSE: the lactoferrin example

Bovine Spongiform Encephalopathy (BSE) belongs to Transmissible Spongiform Encephalopathies (TSEs) or Prion diseases. BSE is a feed borne infection of cattle. Epidemiological and laboratory data suggest that the BSE infectious agent is responsible for the variant form of Creutzfeldt-Jakob Disease (vCJD) and that the oral route is the most plausible way of infection. Therefore there is concern that the BSE agent can be transmitted to humans by biological materials (i.e. meat products, blood, milk) from susceptible BSE animal species (mostly cows but possibly, sheep and goats). Lactoferrin (LF) can be produced by purification from large volumes of cow's milk or whey. Therefore, a potential BSE risk for milk and milk products needs to be evaluated by risk assessment. The Committee for proprietary Medicinal Products--CPMP of the European Commission and the WHO have categorized risk tissues from TSE susceptible ruminant species in different classes in relation to the BSE risk for medicinal products. Milk, colostrum, and tissues of the mammary gland have been classified in the category of no detectable infectivity. A secondary contamination of milk can be virtually excluded (i.e. milk is taken from living animals). In the light of current scientific knowledge and irrespective of the geographical origin, milk and milk derivatives (e.g. lactoferrin, lactose) are unlikely to present any risk of TSE contamination provided that milk is sourced from healthy animals in the same conditions as milk collected from human consumption. So the risk of milk and milk derivatives in relation to BSE is negligible.