Safety and efficacy of the feed additive consisting of protease produced by Bacillus licheniformis DSM 33099 (ProAct 360) for use in poultry species for fattening or reared for laying/breeding (DSM Nutritional Products Ltd)

EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP); Bampidis, Vasileios; Azimonti, Giovanna; Bastos, Maria de Lourdes; Christensen, Henrik; Dusemund, Birgit; Durjava, Mojca; Kouba, Maryline; López‐Alonso, Marta; López Puente, Secundino; Marcon, Francesca; Mayo, Baltasar; Pechová, Alena; Petkova, Mariana; Ramos, Fernando; Sanz, Yolanda; Villa, Roberto Edoardo; Woutersen, Ruud; Herman, Lieve; Louro, Henriqueta; Alija Novo, Natalia; Anguita, Montserrat; Manini, Paola; Casanova, Jordi Ortuño; Pettenati, Elisa; Pizzo, Fabiola; Brozzi, Rosella

http://hdl.handle.net/10400.18/8826

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Authors

EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP)

Bampidis, Vasileios

Azimonti, Giovanna

Bastos, Maria de Lourdes

López Puente, Secundino

Abstract(s)

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of a protease (ProAct 360) produced by a genetically modified strain of Bacillus licheniformis (DSM 33099) as a zootechnical feed additive for poultry species for fattening or reared for laying/breeding. The production strain and its recombinant DNA were not detected in an intermediate concentrated product representative of the final formulation. The final product did not trigger a safety concern with regard to the genetic modification. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that ProAct 360 is considered safe for all growing poultry species at the recommended inclusion level of 30,000 NFP/kg complete feed. The use ProAct 360 as a feed additive did not give rise to concerns for the consumers or the environment. The additive is not an eye or a dermal irritant but should be considered a respiratory sensitiser. In the absence of data, no conclusions could be reached on the skin sensitisation potential of the additive. The FEEDAP Panel concluded that the additive has the potential to be efficacious at 30,000 NFP/kg complete feed for all poultry species for fattening or reared for laying/breeding.

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Keywords

Environmental Genotoxicity ProAct 360 All Poultry Species for Fattening or Reared for Laying/Breeding Digestibility Enhancer Efficacy Protease Zootechnical Additives Zootechnical Additive Genotoxicidade Ambiental