The EFSA Journal (2005) 262, 1-6

Transcription

1 The EFSA Journal (2005) 262, 1-6 Opinion of the Scientific Panel on Additives and Products or Substances used in Animal Feed on the safety of the enzyme preparation Bio-Feed Wheat for use as feed additive for ducks and pigs for fattening (Question No EFSA-Q ) Adopted on 20 July 2005 SUMMARY The European Food Safety Authority received a request from the European Commission to assess the safety of product Bio-Feed Wheat for use in feeds for pigs for fattening and ducks for fattening. Bio Feed Wheat is an enzyme preparation based on endo-1,4-betaxylanase produced by Aspergillus oryzae carrying a gene from Thermomyces lanuginosus. It is intended for improvement of the digestibility of feed rich in non-starch polysaccharides. This product has already been approved for use in chickens for fattening, turkeys for fattening and piglets, and the general safety for the user, consumer and environment established at this time. Two tolerance tests carried out with pigs demonstrated that 15-times the maximum recommended dose did not result in any adverse effects on the animal performance data, showing that Bio-Feed Wheat is well tolerated by the pigs for fattening. Another tolerance test in ducks showed the absence of negative effects on this target species when the diets were supplemented with 25-times the maximum recommended dose. Therefore, it is concluded that Bio-Feed Wheat can be considered safe for ducks and pigs for fattening. Keywords: Enzyme, xylanase, pigs for fattening, ducks, tolerance test

2 Opinion on the product Bio-Feed Wheat 2/6 BACKGROUND Regulation (EC) No 1831/2003 establishes rules governing the Community authorisation of additives for animal nutrition and in particular defines the conditions that a substance/product should meet to be granted authorisation. This Regulation replaces Council Directive 70/524/EEC. The Regulation foresees transition procedures for handling applications submitted under the earlier directive in its Article 25. The applicant Novozymes is seeking provisional Community authorisation of its enzyme preparation with the trade name Bio Feed Wheat, as a feed additive intended for use in pigs for fattening and ducks for fattening under the category "Enzyme" (Table 1). Table 1. Description of the product Product category: Trade name: Description: Target animal category: Applicant: Member State Rapporteur: Type of request: Enzyme Bio Feed Wheat Preparation of endo-1,4-beta-xylanase produced by Aspergillus oryzae (DSM 10287) Pigs for fattening, Ducks for fattening Novozymes Denmark Provisional authorization In accordance with the above legislation, the Commission received an application, through Denmark, the Member State rapporteur chosen by the applicant, requesting authorization for the above described preparation under the conditions of use set out in Table 2, under Council Directive 70/524. Supporting data produced by the applicant were compiled in a dossier and accompanied that application. All Member States received the dossier, which was introduced at the Standing Committee on the Food Chain and Animal Health. This dossier was made available to the European Food Safety Authority. This enzyme preparation is already authorised for chickens for fattening, turkeys for fattening and piglets, as enzyme E1607 by Regulation 1332/2004 (OJ L 247 of 21/7/2004). This enzyme preparation was evaluated by the former Scientific Committee of Animal Nutrition (SCAN) 1. TERMS OF REFERENCE In view of the above, the Commission asks the European Food Safety Authority to deliver an opinion on the safety of the enzyme preparation of trade name Bio-Feed Wheat, enzyme E 1607, which is a preparation of endo-1,4-beta-xylanase produced by Aspergillus oryzae (DSM 10287), for the target animal categories pigs for fattening and ducks for fattening, when used under the conditions set out in Table 2 below, taking into account the background and the information submitted by the applicant in the dossier. 1

3 Opinion on the product Bio-Feed Wheat 3/6 Table 2. Annex entry proposal Additive Chemical formula, description Species or category of animal Maximum age Minimum content Maximum content Units of activity kg -1 of complete feedingstuff Other provisions 1. In the directions for use of the additive and premixture, indicate the storage temperature, storage life and stability to pelleting. Endo-1,4-beta-xylanase EC Preparation of endo-1,4-betaxylanase produced by Aspergillus oryzae (DSM 10287) having a minimum activity of: Pigs for fattening FXU - 2. Recommended dose per kg of complete feedingstuff: FXU. 3. For use in compound feed rich in non-starch polysaccharides (mainly arabinoxylans), e.g. containing more than 50 % cereals (e.g wheat, barley, rye or trticale). Coated form: FXU 2 g -1 Liquid form: 650 FXU ml -1 Ducks for fattening FXU - 1. In the directions for use of the additive and premixture, indicate the storage temperature, storage life and stability to pelleting. 2. Recommended dose per kg of complete feedingstuff: FXU. 3. For use in compound feed rich in non-starch polysaccharides (mainly arabinoxylans), e.g. containing more than 50 % cereals (e.g wheat, barley, rye or trticale). 2 1 FXU is the amount of enzyme which liberates 7.8 micromole of reducing sugars (xylose equivalents) from azo-wheat arabinoxylan per minute at ph 6,0 and 50 C.

4 Opinion on the product Bio-Feed Wheat 4/6 ASSESSMENT 1. Introduction Bio-Feed Wheat is an enzyme preparation based on endo-1,4-beta-xylanase produced by Aspergillus oryzae (CAS ). It is intended for the improvement of digestibility of feed rich in non-starch polysaccharides. It is already approved as a feed additive for use in chickens for fattening, turkeys for fattening and piglets. The safety for those target species as well as for users and consumers has been evaluated by the SCAN. Such approval implies compliance with safety assessment requirements (including absence of toxic effects in a bacterial mutagenicity assay and an in vitro test for chromosome aberrations, absence of skin and eye irritation and acute inhalation toxicity, and absence of adverse effects in a 90- day rodent repeated dose toxicity study). For the present specific target species a tolerance study is required, therefore the applicant has submitted tolerance studies for the extension of use to pigs for fattening and ducks for fattening. 2. Safety for the target species 2.1. Safety for the pigs for fattening. The applicant has performed two tolerance studies. In both experiments an overdose of 6000 FXU kg -1 of feed were tested in a dose-response study. Seventy two pigs were distributed into six experimental groups (12 per experimental group). Bio-Feed Wheat was administered at 0, 100, 200, 300, 400 and 6000 FXU kg -1 for 35 days. The initial weight of the animals was around 27 kg and the final weight was 60 Kg. Animal performance parameters such as daily gain, daily feed intake and feed conversion were recorded. No analyses of enzyme in the feed were provided, although separately requested by EFSA. Pigs fed with 15 times the maximum recommended dose did not show any negative effects compared to the control or the recommended dose group on the parameters studied (Table 3). Table 3. Performance parameters of pigs (0-35 days) fed diets with Bio-Feed Wheat up to 6000 FXU kg -1 Bio-Feed Wheat (FXU kg -1 ) Start weight, kg Daily gain, kg Feed conversion 2.18 a 2.00 b 2.10 ab Daily feed intake, kg Weight 35 days, kg a, b: Means within a row not sharing a common superscript differ significantly (P 0.05). In a second experiment 216 pigs were distributed in five experimental groups (36 pigs per group) that were administered Bio-Feed Wheat at 0, 200, 300, 400, and 6000 FXU kg -1 during 130 days. The initial weight was 24 kg and the final weight 108 kg. Data reported include animal performance parameters, carcass measurements and residual enzyme activity in feed. The overdose of Bio-Feed Wheat had no adverse effect on the zootechnical performance (Table 4).

5 Opinion on the product Bio-Feed Wheat 5/6 Table 4. Performance parameters of pigs ( kg) fed diets with Bio-Feed Wheat up to 6000 FXU kg -1 Bio-Feed Wheat (FXU kg -1 diet) Daily weight gain (g) Daily feed intake Feed conversion b Enzyme activity in feed: 43/24, 11/0, 104/191, 249/351, 424/496, 6517/5450 FXU kg -1 for grower/finisher diets Safety for the ducks A tolerance test was made with ducks given Bio-Feed Wheat at 25-times the maximum recommended dose. The twelve-week study involved a total of 448 day-old male ducklings Moscovy strain), that were distributed into four treatments (eight replicates of 14 ducks), supplemented with Bio-Feed Wheat at 0, 100, 200 and FXU kg -1 feed. The main animal performance parameters were studied. Analytical data confirming the presence of the enzyme in feed at the expected concentration was not provided. Table 5. Performance parameters of ducks fed diets with Bio-Feed Wheat during 84 days Bio-Feed Wheat (FXU kg -1 diet) Initial weight, g Mortality, % Live weight, g at day b 900 a 901 a 919 a at day c 2054 bc 2082 ab 2098 a at day FCR, kg kg -1 days a 1.50 bc 1.52 b 1.49 c days a 1.93 b 1.92 b 1.93 b days a, b, c: Means within a row not sharing a common superscript differ significantly (P 0.05). The results showed that there were no significant differences between the treatments for all parameters studied (Table 5). The intended 25-times overdose showed no adverse effects compared with the control and the recommended dose groups, indicating that Bio- Feed Wheat was well tolerated. CONCLUSIONS It is concluded that the inclusion of Bio-Feed Wheat is well tolerated for pigs for fattening and ducks for fattening when given at concentrations substantially above the maximum recommended dose. Therefore FEEDAP Panel considers that Bio-Feed Wheat is safe for ducks and pigs for fattening. DOCUMENTATION PROVIDED TO EFSA 1. Addendum XI to Bio-Feed Wheat dossier. Extension to include use in pigs for fattening and ducks for fattening. September Submitted by Novozymes A/S. 2. Addendum XII to Bio-Feed Wheat dossier. Answers to questions from EFSA and Member States. June Submitted by Novozymes A/S.

6 Opinion on the product Bio-Feed Wheat 6/6 PANEL MEMBERS Arturo Anadón, Margarita Arboix Arzo, Georges Bories, Paul Brantom, Joaquim Brufau de Barberà, Andrew Chesson, Pier Sandro Cocconcelli, Joop de Knecht, Noël Dierick, Gerhard Flachowsky, Anders Franklin, Jürgen Gropp, Ingrid Halle, Anne-Katrine Lundebye Haldorsen, Alberto Mantovani, Kimmo Peltonen, Guido Rychen, Pascal Sanders, Amadeu Soares, Pieter Wester and Wilhelm Windisch