Safety and efficacy of montmorillonite‐illite (FIMIX 1g557) for all animal species

Abstract Following a request from European Commission, the Panel on Additives and Products or Substances used in animal Feed (FEEDAP) was asked to deliver a scientific opinion on the modification of the terms of authorisation of montmorillonite‐illite (FIMIX 1g557) for all animal species. The FEEDAP Panel adopted in 2014 an opinion on the safety and in 2015 on the efficacy of this additive. The additive montmorillonite‐illite (FIMIX 1g557) is currently authorised for use in feedingstuffs for all animal species as an anticaking agent with a minimum and a maximum content of 20,000 mg/kg. The applicant proposed to use the additive in premixtures and complementary feeds for all animal species and categories at a minimum concentration of 20,000 mg/kg premixture and 10,000 mg/kg complementary feeds. The FEEDAP Panel considers that the proposed modification (reduction of the inclusion level in feed) would not affect the conclusions reached in the previous assessment as related to the safety for the target species, consumers, users and the environment. Montmorillonite‐illite is efficacious as an anticaking agent in premixtures for all animal species at inclusions levels starting at 20,000 mg/kg premixture and in complementary feeds at inclusions levels starting at 10,000 mg/kg. When the premixtures or complementary feeds are incorporated into complete feed, the concentration of montmorillonite‐illite would range from 50 to 100 mg/kg complete feed for poultry and all other animal species, respectively. There is no evidence that the anticaking effect of the additive will persist at these concentrations in complete feed. In the absence of specific data, the FEEDAP Panel is not in the position to comment on the efficacy of the additive at these concentrations when used in complete feed.