TY - JOUR
T1 - Assessment of the feed additive consisting of endo-1,3(4)-beta-glucanase and endo-1,4-beta-xylanase (produced with Talaromyces versatilis IMI CC 378536) (Rovabio® Excel) for all poultry species, weaned piglets, pigs for fattening and sows for the renewal of its authorisation (Adisseo France SAS)
AU - Villa, Roberto Edoardo
AU - Azimonti, Giovanna
AU - Bonos, Eleftherios
AU - Christensen, Henrik
AU - Durjava, Mojca
AU - Dusemund, Birgit
AU - Gehring, Ronette
AU - Glandorf, Boet
AU - Kouba, Maryline
AU - López-Alonso, Marta
AU - Marcon, Francesca
AU - Nebbia, Carlo
AU - Pechová, Alena
AU - Prieto-Maradona, Miguel
AU - Röhe, Ilen
AU - Theodoridou, Katerina
AU - Brantom, Paul
AU - Yurkov, Andrey
AU - Anguita, Montserrat
AU - Innocenti, Matteo L.
AU - Tarrés-Call, Jordi
AU - Pettenati, Elisa
AU - EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP)
PY - 2025/1/15
Y1 - 2025/1/15
N2 - Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of the feed additive consisting of endo-1,3(4)-beta-glucanase and endo-1,4-beta-xylanase (produced with Talaromyces versatilis IMI CC 378536) (Rovabio® Excel) for the renewal of its authorisation as a zootechnical feed additive for all poultry species, weaned piglets, pigs for fattening and sows. The applicant provided evidence that the additive complies with the conditions of the authorisation. The FEEDAP Panel concluded that the additive in all its formulations remains safe for all poultry species, weaned piglets, pigs for fattening and sows, and remains safe for consumers and the environment. Regarding user safety, all the forms of the additive are non-irritant to the eyes or skin. Rovabio® Excel LC2 and Rovabio® Excel LC are not dermal sensitisers. Rovabio® AP and Rovabio® Excel AP T-Flex should be considered dermal sensitisers; therefore, exposure to these forms of the additive by dermal routes is considered a risk. All the forms of the additive are considered respiratory sensitisers; any exposure by inhalation is considered a risk. There is no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.
AB - Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of the feed additive consisting of endo-1,3(4)-beta-glucanase and endo-1,4-beta-xylanase (produced with Talaromyces versatilis IMI CC 378536) (Rovabio® Excel) for the renewal of its authorisation as a zootechnical feed additive for all poultry species, weaned piglets, pigs for fattening and sows. The applicant provided evidence that the additive complies with the conditions of the authorisation. The FEEDAP Panel concluded that the additive in all its formulations remains safe for all poultry species, weaned piglets, pigs for fattening and sows, and remains safe for consumers and the environment. Regarding user safety, all the forms of the additive are non-irritant to the eyes or skin. Rovabio® Excel LC2 and Rovabio® Excel LC are not dermal sensitisers. Rovabio® AP and Rovabio® Excel AP T-Flex should be considered dermal sensitisers; therefore, exposure to these forms of the additive by dermal routes is considered a risk. All the forms of the additive are considered respiratory sensitisers; any exposure by inhalation is considered a risk. There is no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.
KW - digestibility enhancers
KW - pigs
KW - poultry
KW - Rovabio® excel
KW - safety
KW - zootechnical additives
U2 - 10.2903/j.efsa.2025.9131
DO - 10.2903/j.efsa.2025.9131
M3 - Article
AN - SCOPUS:85215514339
SN - 1831-4732
VL - 23
JO - EFSA Journal
JF - EFSA Journal
IS - 1
M1 - e9131
ER -