Safety and efficacy of a feed additive consisting of endo-1,4-ß-d-mannanase produced by Paenibacillus lentus DSM 33618 (Hemicell® HT/HT-L) for chickens and turkeys for fattening, chickens reared for laying, turkeys reared for breeding, minor poultry species to point of lay, pigs for fattening, weaned piglets and minor porcine species (Elanco GmbH).

ABSTRACT

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of endo-1,4-ß-d-mannanase (Hemicell® HT/HT-L) produced by a genetically-modified strain of Paenibacillus lentus (DSM 33618) as a zootechnical feed additive for chickens and turkeys for fattening, chickens reared for laying, turkeys reared for breeding, minor poultry species to point of lay, pigs for fattening, piglets (weaned) and minor porcine species. The production strain was obtained from a Paenibacillus lentus recipient strain that has been evaluated previously by EFSA and considered to be safe. The genetic modification does not raise safety concerns and there were no antibiotic resistance genes from the genetic modification in the production strain. Viable cells and the DNA of the production strain were not found in the intermediate product used to formulate the additive. Hemicell® HT/HT-L produced by Paenibacillus lentus DSM 33618 is considered safe for the above-mentioned target species at the intended conditions of use. The use of Hemicell® HT/HT-L as a feed additive raises no concerns for the consumer or for the environment. Hemicell® HT/HT-L is not irritant to the skin and eyes but is regarded as a dermal sensitiser and a potential respiratory sensitiser. The additive has a potential to be efficacious at 32,000 U/kg in chickens for fattening, chickens reared for laying, minor poultry species for fattening or reared for laying/breeding, pigs for fattening and minor porcine species, and at 48,000 U/kg in turkeys for fattening, turkeys reared for breeding and weaned piglets.