Opinion of the Scientific Panel on Additives and Products or Substances used in Animal Feed on the safety of the enzyme preparation “Bio-Feed® Pro” (proteinase) as a feed additive for chickens for fattening, piglets and pigs for fattening
The European Food Safety Authority (EFSA) has previously issued an opinion on the safety and efficacy of Bio-Feed® Pro, in which concerns were expressed on the safety for the consumer. These were derived from the serious adverse effects seen in laboratory studies in which rats were given the enzyme preparation in relatively large volumes by gavage. The effects observed included significant mortality due to arterial and lung damage; hence a risk for consumers could not be excluded. The company has supplied additional laboratory studies and the European Commission has requested the EFSA to consider these studies in view of consumer safety. The new studies included an intratracheal instillation study and an 8-week gavage study. Small amounts of the product by intratracheal installation caused acute mortality, while small volumes of concentrated material by gavage were without such effect. While the data submitted by the applicant provide a possible explanation of the effects seen in the sub-chronic gavage toxicity studies, they do not entirely exclude oral toxicity of Bio-Feed® Pro. The product causes severe pulmonary damage if it reaches the respiratory tract, as shown by an intratracheal instillation and an acute inhalatory study on rats. Based on the newly submitted data, the FEEDAP Panel is not in a position to revise its former opinion on consumer safety. Bio-Feed® Pro is a potential skin sensitizer and may be irritant to human eye. Potential adverse effects on the target animals and the user cannot be fully assessed because the absence of toxin-encoding genes in the production strain was not demonstrated.