Safety and efficacy of a feed additive consisting of endo-1,4-beta-xylanase and endo-1,3(4)-beta-glucanase produced with Talaromyces versatilis IMI 378536 and DSM 26702 (ROVABIO® ADVANCE) for weaned piglets and pigs for fattening (ADISSEO France SAS)

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of ROVABIO (R) ADVANCE (liquid and solid) which contains endo-1,4-beta-xylanase and endo-1,3(4)-beta-glucanase. The enzymes present in the additive are produced by two strains of Talaromyces versatilis, one of them genetically modified. The additive is intended to be used as a feed additive for weaned piglets and pigs for fattening. Viable cells of the production strains and DNA of the genetically modified strain were not detected in the fermentation product used to formulate the additive. Based on the results of a tolerance trial in weaned piglets, the FEEDAP Panel concluded that ROVABIO (R) ADVANCE is safe for weaned piglets under the recommended conditions of use. This conclusion was extended to pigs for fattening. Based on the outcome of the toxicological studies performed, the Panel concluded that the additive is of no concern regarding consumer safety. ROVABIO (R) ADVANCE is not irritant to the skin or eyes but it is a skin and respiratory sensitiser. No risks to the environment are expected from the use of the additive in animal nutrition. Owing to the lack of sufficient data, the FEEDAP Panel could not conclude on the efficacy of ROVABIO (R) ADVANCE.

Automated summary

As requested by the European Commission, EFSA evaluated the safety and efficacy of the feed additive ROVABIO(R) ADVANCE containing endo-1,4-beta-xylanase and endo-1,3(4)-beta-glucanase. The additive was found to be safe for weaned piglets and pigs for fattening, posing no concern for consumer safety. It is not irritant to the skin or eyes but can cause sensitization. No environmental risks were identified. However, due to insufficient data, the efficacy of the additive could not be concluded.