Safety and efficacy of 3‐phytase FLF1000 as a feed additive for chickens for fattening and laying hens

Abstract

The additive is a preparation of 3-phytase which is produced by a genetically modified strain of Komagataella pastoris. The production strain and its recombinant DNA were not detected in the final product. Therefore, the additive does not give rise to safety concerns with regard to the genetic modification of the production strain. Based on the results of the tolerance studies provided, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the additive is safe for chickens for fattening and laying hens at the dose of 1,000 FTU/kg feed. However, a margin of safety could not be established for laying hens. The production strain belongs to a species considered to qualify for the qualified presumption of safety (QPS) approach to safety assessment when used for enzyme production. Since the identity of the strain was unambiguously established and the genetic modification raised no concerns, the FEEDAP Panel concludes that the use of the additive as a feed additive is of no concerns for consumers. The additive is not an irritant to eyes and skin, and it is not a dermal sensitiser. Owing to the proteinaceous nature of the active substance, the additive is a potential respiratory sensitiser, however, exposure may be limited. The use of the product as a feed additive does not pose risks to the environment. The Panel concluded that the additive has a potential to increase the availability of phytate phosphorus in chickens for fattening at 500 FTU/kg and in laying hens at 1,000 FTU/kg feed. This is an open access article under the terms of the Creative Commons Attribution-NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited and no modifications or adaptations are made.The EFSA Journal is a publication of the European Food Safety Authority, an agency of the European Union. SummaryFollowing 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 3-phytase FLF1000 (3-phytase) as a feed additive for chickens for fattening and laying hens.The additive contains a 3-phytase (EC 3.1.3.8.) which is produced by a genetically modified strain of Komagataella pastoris. The identity of the strain was confirmed as K. pastoris. The viable production strain and its recombinant DNA were not detected in the final product. The additive does not give rise to safety concerns with regard to the genetic modification of the production strain.Based on the results of the two studies provided, the FEEDAP Panel concluded that the additive is safe for chickens for fattening and laying hens at the dose of 1,000 FTU/kg feed. However, in the tolerance study in laying hens, the 10-fold dose group showed a tendency to have a lower body weight at the end of the study and had a significantly higher concentration of alkaline phosphatase in blood compared to the hens fed the negative control diet. Consequently, a mar...

Safety and efficacy of 3‐phytase FSF10000 as a feed additive for chickens for fattening or reared for laying, laying hens and minor poultry species

“…Safety aspects regarding the use of the liquid formulation of the additive in feed for poultry species, including the safety aspects of the genetic modification, have been previously evaluated (EFSA FEEDAP Panel, 2016).…”

“…No studies have been conducted with 3-phytase FSF10000 to support the safety for the target species. In a previous assessment, tolerance studies done with the liquid formulation of the additive in chickens for fattening and laying hens were evaluated (EFSA FEEDAP Panel, 2016). From the results, the FEEDAP Panel concluded that the use of the liquid formulation is safe for chickens for fattening and laying hens at 1,000 FTU/kg feed.…”

Safety and efficacy of 3‐phytase FLF1000 as a feed additive for pigs for fattening and minor porcine species for growing

“…The additive 3-phytase FLF1000 in its liquid formulation contains 3-phytase (Enzyme Commission number 3.1.3.8) produced by a genetically modified strain of K. phaffii (CECT 13094) with a minimum phytase activity of 1,000 FTU/mL. In a previous opinion, the Panel described the additive and its manufacturing process including the production strain and its genetic modification (EFSA FEEDAP Panel, 2016).…”

“…Safety aspects regarding the use of this additive in feed including the safety of the production strain, the safety for the consumer, for the users and for the environment have been previously evaluated (EFSA FEEDAP Panel, 2016). The FEEDAP Panel concluded that there are no concerns regarding the genetic modification of the production strain, that there are no concerns for the consumer safety and no risks for the environment are expected from the use of the product as a feed additive.…”

Safety and efficacy of 3‐phytase FLF1000 as a feed additive for chickens reared for laying and minor poultry species

“…The additive 3-phytase FLF1000 contains 3-phytase (Enzyme Commission number 3.2.1.8) produced by a genetically modified strain of Komagataella pastoris (CECT 13094) and is authorised as a feed additive for chickens for fattening and laying hens. 4 The FEEDAP Panel adopted on opinion on the safety and efficacy of the product as a feed additive for chickens for fattening and laying hens (EFSA FEEDAP Panel, 2016). The applicant is now requesting for an extension of the use of the additive to chickens reared for laying and minor poultry species (excluding minor poultry species for laying/breeding).…”