Safety and efficacy of the feed additive consisting of 6‐phytase (produced by Aspergillus oryzae DSM 33699) (RONOZYME® Hiphos GT/L) for poultry, pigs for fattening, weaned piglets and sows (DSM Nutritional Products Ltd)
Meta data
Legal notice Relevant information or parts of this scientific output have been blackened in accordance with the confidentiality requests formulated by the applicant pending a decision thereon by the European Commission. The full output has been shared with the European Commission, EU Member States and the applicant. The blackening will be subject to review once the decision on the confidentiality requests is adopted by the European Commission.
Abstract
The additive RONOZYME® Hiphos (GT/L) contains 6‐phytase produced with a genetically modified strain of the filamentous fungus Aspergillus oryzae, it is currently authorised for poultry, pigs for fattening, weaned piglets and sows. The applicant has requested to change the production strain, substituting strain A. oryzae DSM 22594 for A. oryzae DSM 33699. RONOZYME® Hiphos (GT/L), manufactured with the production strain A. oryzae DSM 33699, did not give rise to safety concerns with regard to the genetic modification of the production strain. No viable cells of the production strain nor its recombinant DNA were detected in an intermediate product representative of both final forms of the additive. RONOZYME® Hiphos (GT/L) was considered safe for poultry, pigs for fattening, weaned piglets and sows at the recommended inclusion levels of 500–4,000 FYT/kg complete feed. The use of RONOZYME® Hiphos GT and L manufactured with the production strain A. oryzae DSM 33699 raised no concerns for consumers. In the absence of data on the final formulations, the Panel could not conclude on the potential of the additive to be irritant to eyes or skin, or a skin sensitiser. Due to the proteinaceous nature of the active substance, the additive was considered a respiratory sensitiser. The additive manufactured by A. oryzae DSM 33699 raises no safety concerns for the environment. The additive has the potential to be efficacious in poultry, pigs for fattening, weaned piglets and sows at 500 FYT/kg complete feed.