Safety and efficacy of a feed additive consisting of serine protease produced by Bacillus licheniformis DSM 19670 (Ronozyme® ProAct) for chickens for fattening (DSM Nutritional Products Ltd.)

• Main Authors: EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP), Vasileios Bampidis, Giovanna Azimonti, Maria de Lourdes Bastos, Henrik Christensen, Birgit Dusemund, Maryline Kouba, Mojca Fašmon Durjava, Marta López‐Alonso, Secundino López Puente, Francesca Marcon, Baltasar Mayo, Alena Pechová, Mariana Petkova, Fernando Ramos, Yolanda Sanz, Roberto Edoardo Villa, Pier Sandro Cocconcelli, Boet Glandorf, Lieve Herman, Miguel Prieto Maradona, Maria Saarela, Montserrat Anguita, Jaume Galobart, Orsolya Holczknecht, Paola Manini, Fabiola Pizzo, Jordi Tarrés‐Call, Elisa Pettenati
• Format: Article
• Language: English
• Published: Wiley 2021-03-01
• Series: EFSA Journal
• Subjects: Zootechnical additive; digestibility enhancer; serine protease; Ronozyme® ProAct; chickens for fattening; safety
• Online Access: https://doi.org/10.2903/j.efsa.2021.6448

Abstract Ronozyme® ProAct is the trade name of the feed additive under assessment and contains serine protease produced by a genetically modified strain of Bacillus licheniformis. Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of Ronozyme® ProAct when used as a zootechnical additive for chickens for fattening. The additive is available in coated thermotolerant granulated and liquid forms (Ronozyme® ProAct CT/L). The production strain and its recombinant DNA were not detected in an intermediate concentrated product used to produce the final formulations. The final products do not trigger a safety concern with regard to the genetic modification. Based on the results obtained in a tolerance study in chickens for fattening and the data from a subchronic oral toxicity study the FEEDAP Panel concluded that the additive is safe for chickens for fattening. The FEEDAP Panel concluded that the use of Ronozyme® ProAct CT/L as a feed additive gives rise to no concern for consumers and for the environment. The additive, in either form, is not an eye irritant but should be considered a skin irritant. In the absence of data, no conclusions on the skin sensitisation potential can be reached. Owing to the proteinaceous nature of the active substance it should be considered a respiratory sensitiser. The FEEDAP Panel also concluded that the additive has the potential to be efficacious at 15,000 PROT/kg compound feed for chickens for fattening.