EFSA unable to confirm efficacy of Kemin additive for broilers

However, the FEEDAP Panel concluded that the additive, Xygest HT, has a potential to be efficacious for laying hens.

EFSA was asked to deliver an opinion​​ on the safety and efficacy of endo‐1,4‐β‐xylanase produced by Komagataella phaffii ATCC PTA‐127053 (Xygest HT) as a zootechnical feed additive for poultry.

The additive had not been authorized previously as a feed additive in the EU.

The production strain is genetically modified. No viable cells nor recombinant DNA of the production strain were detected in the final product, said the scientists. And they concluded that the additive does not pose any safety concern regarding the production strain.

The EFSA team also found the product is safe for broilers at 30,000 U/kg and in laying hens at 45,000 U/kg, with a wide margin of safety.

“These conclusions can be extended to chickens reared for laying/breeding and extrapolated to all poultry species for fattening and reared for laying/breeding.” ​

The use of Xygest HT in animal nutrition is of no concern for consumer safety and this feed additive is considered safe for the environment, they added.

Vitamin E source ​

The FEEDAP panel, in another recently published opinion​​, also assessed the safety and efficacy of Avecho Biotechnology’s additive consisting of tocopheryl phosphate mixture (TPM) and used as a source of vitamin E in feed for all animal species and categories

Again, this additive had not had prior approval for use in animal nutrition in the EU.

TPM is produced by chemical synthesis and is a mixture of two different phosphorylated tocopheryl compounds in approximate 2:1 weight ratio: all‐rac‐α‐tocopheryl di‐hydrogen phosphate (TP) and all‐rac‐di‐α‐tocopheryl hydrogen phosphate (T2P).

Considering the limited information on the components of the additive and the uncertainties on the potential aneugenicity and clastogenicity of the product, the Panel said it could not conclude on the safety of the additive for the target species, for the consumer, and for the user.

Nor could they determine the safety of the TPM for the environment, again due to lack of data.

In addition, the available data did not allow them to establish the relative bioequivalence of TPM as vitamin E, so they did not draw any conclusions on the efficacy of the TPM for use with all animal species.