Safety and efficacy of APSA PHYTAFEED® 20,000 GR/L (6‐phytase) as a feed additive for chickens for fattening, chickens reared for laying and minor growing poultry species

Abstract

APSA PHYTAFEED ® 20,000 GR/L is a preparation of 6-phytase which is presented in solid and liquid forms. This additive is intended to be used as a zootechnical additive in chickens for fattening or reared for laying/breeding and minor poultry species for fattening or reared for laying/breeding. The 6phytase present in the additive is produced by a genetically modified strain of Komagataella phaffii. The production strain and its recombinant DNA were not detected in intermediate products used to produce the additive. The final products do not trigger a safety concern with regard to the genetic modification. Based on the results obtained in a tolerance study in chickens for fattening and the data from a subchronic oral toxicity study the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the additive is safe for chickens for fattening. This conclusion was extended to chickens reared for laying/breeding and extrapolated to all minor poultry species for fattening or reared for laying/breeding. The FEEDAP Panel concluded that the use of APSA PHYTAFEED ® 20,000 GR/L as a feed additive gives rise to no concern for consumers. The additive, in either form, is not toxic by inhalation or irritant for skin or eyes and it is not a dermal sensitizer, but it is considered a potential respiratory sensitizer. The use of the product as a feed additive is of no concern for the environment. The FEEDAP Panel evaluated three efficacy trials in which the retention of the phosphorus was studied. The data showed that the additive has the potential to improve the retention of phosphorus in the diets in chickens for fattening at 250 U/kg feed. This conclusion was extended to chickens reared for laying/breeding and extrapolated to all minor poultry species for fattening or reared for laying/breeding.

Safety and efficacy of APSA PHYTAFEED® 20,000 GR/L (6‐phytase) as a feed additive for pigs for fattening

“…In a previous opinion, the Panel described the additive and its manufacturing process including the production strain (EFSA FEEDAP Panel, 2019a).…”

“…The safety aspects regarding the use of this additive in feed including the safety of the genetic modification of the production strain, the safety for the consumers, for the user and for the environment have been previously assessed (EFSA FEEDAP Panel, 2019a). The Panel concluded that the use of the product as a feed additive raises no concerns for consumer safety and for the environment.…”

“…However, the Panel noted that the control group in that study showed reduced growth. The subchronic oral toxicity study in rats, that has been assessed by the FEEDAP Panel (EFSA FEEDAP Panel, 2019a), was also provided . The results of that study indicate a no observed adverse effects level (NOAEL) of 119,228 U/kg body weight and day in rats.…”

“…The FEEDAP Panel adopted three opinions on the product, one on the safety and efficacy of APSA PHYTAFEED ® 20,000 GR/L (6‐phytase) as a feed additive for chickens for fattening or reared for laying and minor poultry species for fattening or reared for laying (EFSA FEEDAP Panel, 2019a), the second on the use in turkeys for fattening or reared for breeding (EFSA FEEDAP Panel, 2019b) and a third one regarding its use in weaned piglets and minor porcine species (EFSA FEEDAP Panel, 2019c).…”

Safety and efficacy of APSA PHYTAFEED® 20,000 GR/L (6‐phytase) as a feed additive for piglets (suckling and weaned) and growing minor porcine species

“…The FEEDAP Panel adopted an opinion on the safety and efficacy of APSA PHYTAFEED ® 20,000 GR/L (6‐phytase) as a feed additive for chickens for fattening or reared for laying and minor poultry species for fattening or reared for laying (EFSA FEEDAP Panel, ).…”