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.
|Titolo:||Safety and efficacy of Belfeed B MP/ML (endo-1,4-beta-xylanase) as feed additive for poultry, piglets (weaned) and pigs for fattening|
|Parole Chiave:||safety; efficacy; zootechnical additives, digestibility enhancers; xylanase; poultry; pigs|
|Settore Scientifico Disciplinare:||Settore VET/07 - Farmacologia e Tossicologia Veterinaria|
|Data di pubblicazione:||2016|
|Digital Object Identifier (DOI):||10.2903/j.efsa.2016.4562|
|Appare nelle tipologie:||01 - Articolo su periodico|