Abstract

Food Safety Commission of Japan (FSCJ) conducted two sets of risk assessment on phytase produced using Schizosaccharomyces pombe ASP595-1 strain. One is the safety assessment on feed additives produced using genetically modified microorganisms. None of new harmful substance is generated in the additive and thus not transferred to animal products, such as meat, milk and eggs. Components associated with genetic modification in the additive are unlikely to yield harmful substances to be accumulated in animal products. The components are unlikely to affect the metabolism of the target animals to generate new harmful substances. No safety concern is thus raised in the products from animals fed with this phytase. The other is the risk assessment related to the revision of the Standards and Specifications of Feeds and Feed Additives. The feed additive was considered to have no genotoxicity relevant to human health. No adverse effects were observed in 14-day and 90-day subacute toxicity studies in rats as well as in feeding trials in pigs and poultry. On the formulations with polyvinyl alcohol, human intake of polyvinyl alcohol via animal products was recognized to be negligible. Consequently, FSCJ judged that the risk on human health via food is negligible as long as the 6-phytase produced using S. pombe ASP595-1 strain is properly used as a feed additive.

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