Safety Assessment on the Safety and Efficacy of an Additive Containing 6-Phytase (Ronozyme® HiPhos) Used as a Feed Additive for Poultry, Weaned Piglets, Pigs for Fattening and Sows (RP1298)
Year: 2024
Type: article
Abstract: An application was submitted to the Food Standards Agency in October 2021 from DSM Nutritional Products Ltd. (‘the applicant’) for the renewal and modification of authorisation of an additive (Ronozyme® HiPhos) containing 6-phytase, under the category ‘zootechnical’ additive, functional group ‘digestibility enhancer’. The modification is for a change in production strain from Aspergillus oryzae DSMZ 22594 to a new ‘optimised’ strain (DSMZ 33699). The additive, in both granular (GT) and liquid (L) form, is proposed to be used at an inclusion rate of 500 – 4,000 FYT/kg of feed in poultry, weaned piglets, pigs for fattening and sows. To support the Food Standards Agency (FSA) and Food Standards Scotland (FSS) in evaluating the dossier, the Advisory Committee on Animal Feedingstuffs (ACAF) were asked to review the dossier and the supplementary information from the applicant. The FSA/FSS concluded, based on the ACAF’s advice, that the additive was correctly characterised, and that it is stable for 24 months with loss of activity compensated for through additive overfill. No further concerns were raised for the identity section of the additive. The proposed level of inclusion of the additive in feed is safe for the target species, the consumer and the environment. The active substance is non-irritant to the skin and eyes; however, it is regarded as a potential respiratory sensitiser and, in the absence of skin sensitisation tests, a potential skin sensitiser. Ronozyme® HiPhos is efficacious in poultry, weaned piglets, pigs for fattening and sows at the proposed dose range of 500 – 4,000 FYT/kg of feed. The views of ACAF have been taken into account in the safety assessment which represents the opinion of the FSA and FSS.
Source: FSA research and evidence.
DOI: 10.46756/001c.126864
Authors: Food Standards Agency, Food Standards Scotland
Language: English
Subfield: Food Science
Domain: Life Sciences
SDG: Zero hunger
Open Access status: hybrid
OpenAlex ID: W4405649869