Safety and efficacy of Belfeed B MP/ML (endo-1,4-beta-xylanase) as feed additive for poultry, piglets (weaned) and pigs for fattening

safety, efficacy, zootechnical additives, digestibility enhancers, xylanase, poultry, pigs
First published in the EFSA Journal
8. September 2016
Adopted
13. Juli 2016
Type
Scientific Opinion

Abstract

Belfeed B is a feed additive with endo-1,4-beta-xylanase as the main enzymatic activity, that is available in solid (MP) and liquid forms (ML). The production strain for Belfeed is a genetically modified strain of Bacillus subtilis. Belfeed B does not give rise to safety concerns with regard to the genetic modification of the production strain. Neither the production strain nor its recombinant DNA was detected in the final product obtained from the production strain. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the additive is safe for chickens and turkeys for fattening, laying hens and weaned piglets at the dose of 10 IU/kg feed and this conclusion was extended to chickens reared for laying, turkeys reared for breeding, breeding hens and pigs for fattening and extrapolated to minor poultry species at the same dose. The production strain belongs to a species considered to qualify for the qualified presumption of safety (QPS) approach to safety assessment provided that the qualifications are met. The identity of the strain was unambiguously established, the genetic modification raised no concerns and the relevant qualifications were met. Therefore, the FEEDAP Panel considered that the use of Belfeed B as a feed additive raises no concerns for consumers. Data from toxicological studies supported this conclusion. The additive is not considered to be toxic by inhalation or irritant for skin or eye, but it is considered a potential respiratory sensitiser. The Panel could not conclude on its skin sensitisation potential. The use of Belfeed B as a feed additive poses no risks to the environment. The Panel concluded that the additive has the potential to be efficacious at the dose of 10 IU/kg feed in the target species but owing to the lack of sufficient data the Panel cannot conclude on the efficacy of the product in turkeys for fattening.

Panel members at the time of adoption

Gabriele Aquilina, Giovanna Azimonti, Vasileios Bampidis, Maria de Lourdes Bastos, Georges Bories, Andrew Chesson, Pier Sandro Cocconcelli, Gerhard Flachowsky, Jürgen Gropp, Boris Kolar, Maryline Kouba, Secundino López Puente, Marta López-Alonso, Alberto Mantovani, Baltasar Mayo, Fernando Ramos, Guido Rychen, Maria Saarela, Roberto Edoardo Villa, Robert John Wallace and Pieter Wester
Panel on Additives and Products or Substances used in Animal Feed
Contact
feedap [at] efsa.europa.eu
doi
10.2903/j.efsa.2016.4562
EFSA Journal 2016;14(9):4562
Question Number
On request from
European Commission