Open AccessSafety and efficacy of Axtra ® PHY 20000 TPT2 (6‐phytase) as a feed additive for poultry and porcine species
Author(s) -
Rychen Guido,
Aquilina Gabriele,
Azimonti Giovanna,
Bampidis Vasileios,
Bastos Maria de Lourdes,
Bories Georges,
Chesson Andrew,
Cocconcelli Pier Sandro,
Flachowsky Gerhard,
Gropp Jürgen,
Kolar Boris,
Kouba Maryline,
López Puente Secundino,
LópezAlonso Marta,
Mantovani Alberto,
Mayo Baltasar,
Ramos Fernando,
Saarela Maria,
Villa Roberto Edoardo,
Wallace Robert John,
Wester Pieter,
Brantom Paul,
Dierick Noël,
Aguilera Jaime,
Anguita Montserrat
Publication year - 2016
Publication title -
efsa journal
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.076
H-Index - 97
ISSN - 1831-4732
DOI - 10.2903/j.efsa.2016.4625
Subject(s) - phytase , feed additive , animal feed , food science , microbiology and biotechnology , fermentation , biology , chemistry , biochemistry , broiler , enzyme
Axtra ® PHY 20000 TPT 2 is a solid preparation that contains a 6‐phytase produced with a genetically modified strain of Trichoderma reesei . The production strain and its recombinant DNA were not detected in Axtra ® PHY 20000 TPT 2. From the results obtained in tolerance studies, the EFSA Panel on Additives and Products or Substances used in Animal Feed ( FEEDAP ) concluded that the additive is safe for the target species at 2,000 FTU/kg feed. The studies provided to address the safety for the consumer were performed with the fermentation product that is used to formulate the additive and the results do not indicate any reason for concern for consumer safety arising from the use of the product as a feed additive. The studies provided to address the safety for the user were performed with the fermentation product that is used to formulate the additive and have been assessed in a previous opinion. Considering the results of those studies and the substances used during the formulation of Axtra ® PHY 20000 TPT 2, this formulation is not considered a dermal sensitiser. However, it should be considered a potential irritant to skin, eyes and the respiratory tract, and owing to the nature of the active substance, it should be considered a potential respiratory sensitiser. However, the exposure by inhalation is expected to be negligible. No risks to the environment are expected from the use of Axtra ® PHY 20000 TPT 2 as a feed additive. Based on the results of efficacy studies, the Panel concluded that the additive has the potential to be efficacious at 250 FTU/kg feed.