Safety and efficacy of natural mixture of illite montmorillonite and kaolinite for all animal species

摘要

The additive under assessment is a natural mixture mainly composed of illite (~ 53%), montmorillonite (~ 16%) and kaolinite (~ 17%). In 2016, the Panel on Additives and Products or Substances used in Animal Feed ( ) delivered an Opinion on the safety and efficacy of a natural mixture of illite, montmorillonite and kaolinite ( ). The Panel concluded that the additive is safe for piglets and pigs for fattening at a maximum concentration of 20,000 mg/kg, and for cattle for fattening at a maximum concentration of 50,000 mg/kg. However, no conclusion could be drawn for all other species/categories. The Panel also concluded that the additive is efficacious at a minimum concentration of 50,000 mg/kg. Following this opinion, the European Commission gave the possibility to the applicant to submit complementary information in order to complete the assessment on the safety for all animal species and on its efficacy at a minimum concentration of 20,000 mg/kg. The applicant submitted a new tolerance study in piglets and an analysis of the previous opinion regarding poultry and milk‐producing animals. The Panel concluded that the additive is safe for piglets and pigs for fattening at 50,000 mg/kg. The Panel concluded that the safe level (50,000 mg/kg) found for cattle for fattening could be extrapolated to minor growing ruminants. The conclusion could be extrapolated to dairy cows and minor ruminant species for milk production. The Panel confirmed that no safe concentration of in feed for chickens for fattening could be identified. No conclusions could be drawn for all the other animal species/categories. The additive is effective as a pellet binder and an anticaking agent at the lowest level tested of 5,000 mg/kg feed.