# Safety and efficacy of a feed additive consisting of alpha‐amylase (produced with Bacillus licheniformis DSM 34315) (Ronozyme® HiStarch) for chickens for fattening, turkeys for fattening and minor growing poultry species (DSM Nutritional Products Ltd)

## TL;DR

This paper evaluates the safety of a genetically modified enzyme additive for poultry feed and finds it safe for use in chickens, turkeys, and minor poultry species.

## Contribution

The paper provides a safety assessment of a new feed additive for poultry based on a genetically modified Bacillus licheniformis strain.

## Key findings

- The additive is safe for chickens, turkeys, and minor poultry species at the recommended inclusion level.
- The additive is safe for consumers and the environment under the proposed conditions of use.
- The additive is considered a respiratory sensitiser due to its protein nature.

## Abstract

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of the alpha‐amylase (Ronozyme® HiStarch CT/L) produced with a genetically modified strain of Bacillus licheniformis (DSM 34315) as a zootechnical feed additive for chickens for fattening, turkeys for fattening and minor growing poultry species. The additive is available in two forms, a coated thermotolerant granulate formulation and a liquid formulation. The production strain and its DNA were not detected in an intermediate concentrated product representative of the final formulations. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the final product did not trigger safety concerns with regard to the genetic modification. The Panel concluded that Ronozyme® HiStarch CT/L is safe for chickens for fattening, turkeys for fattening and minor growing poultry species at the recommended inclusion level of 80 KNU/kg complete feed. The use of Ronozyme® HiStarch CT/L in animal nutrition under the proposed conditions of use is safe for the consumers and the environment. The additive in any form was shown to be non‐irritant to the skin and the solid form was shown to be non‐irritant to the eyes. No conclusions could be drawn on the potential of the liquid form to be irritant to the eyes or on the potential of both forms of the additive to be dermal sensitisers due to lack of data. Owing to the proteinaceous nature of the active substance, the additive in either form was considered to be a respiratory sensitiser and any exposure by inhalation is considered a risk. In the absence of data, the Panel was not in the position to conclude on the efficacy of Ronozyme® HiStarch CT/L for chickens for fattening, turkeys for fattening and minor growing poultry species.