Safety and efficacy of FRA® Octazyme C Dry (α-galactosidase, α-amylase, endo-1,3(4)-β-glucanase, endo-1,4-β-glucanase, mannan-endo-1,4-β-mannosidase, pectinase, protease, endo-1,4-β-xylanase) for chickens for fattening and weaned piglets

zootechnical additive, digestibility enhancers, enzymes, safety, efficacy
First published in the EFSA Journal
2 August 2017
6 July 2017
Last Updated
17 January 2018. This version replaces the previous one/s.
Scientific Opinion

FRA® Octazyme C Dry is a product that presents α-galactosidase, α-amylase, endo-1,3(4)-β-glucanase, endo-1,4-β-glucanase, mannan-endo-1,4-β-mannosidase, pectinase, protease and endo-1,4-β-xylanase. It is intended to be used as a zootechnical additive for chickens for fattening and weaned piglets. The enzymes present in the additive are obtained from different fermentation processes with four different microorganisms, Trichoderma citroviride, Aspergillus niger, Bacillus licheniformis and Bacillus amyloliquefaciens. In the tolerance and efficacy trials done in the target species, major limitations on the analysed enzyme activities in the feed were identified. These limitations did not permit the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) to conclude on the safety and efficacy of FRA®Octazyme C Dry for the target species. The Panel concluded that the additive raises no concerns for the consumers of food products obtained from animals fed with the additive. No specific data were submitted to address the safety for the user, in the absence of such data the FEEDAP Panel could not conclude on the potential of the additive to be irritant to the skin and eyes or on its skin sensitising properties. Owing to the nature of the active substances, the additive should be considered a potential respiratory sensitiser. The use of FRA® Octazyme C Dry as a feed additive poses no risks to the environment.

Panel members at the time of adoption
Gabriele Aquilina, Giovanna Azimonti, Vasileios Bampidis, Maria de Lourdes Bastos, Georges Bories, Andrew Chesson, Pier Sandro Cocconcelli, Gerhard Flachowsky, Jürgen Gropp, Boris Kolar, Maryline Kouba, Secundino López Puente, Marta López-Alonso, Alberto Mantovani, Baltasar Mayo, Fernando Ramos, Guido Rychen, Maria Saarela, Roberto Edoardo Villa, Robert John Wallace and Pieter Wester.
Panel on Additives and Products or Substances used in Animal Feed
feedap [at]
EFSA Journal 2017;15(8):4943
Question Number
On request from
European Commission

This scientific opinion has been amended following the adoption of the decision of the Commission on confidentiality claims submitted by the applicant, in accordance with Article 8(6) and Article 18 of Regulation (EC) No 1831/2003. The modified sections are indicated in the text.