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

Ronozyme ProAct is the trade name of the feed additive under assessment and contains serine protease produced by a genetically modified strain of . 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.