The EFSA Journal (2005) 171, 1-5

Transcription

1 The EFSA Journal (2005) 171, 1-5 Opinion of the Scientific Panel on Additives and Products or Substances used in Animal Feed on the safety of the enzymatic product Avizyme 1500 for use as feed additive for laying hens (Question No EFSA-Q ) Adopted on 26 January 2005 SUMMARY Avizyme 1500 is an enzyme preparation containing xylanase derived from genetically modified Trichoderma longibrachiatum, subtilisin (protease) derived from genetically modified Bacillus subtilis, alpha-amylase produced by Bacillus amyloliquefaciens and polygalacturonase produced by Aspergillus aculeatus. The final product consists of approximately 10% enzyme preparation stabilized onto approximately 90% wheat carrier, with calcium propionate included as a preservative. Avizyme 1500 is currently approved for use in the EU as feed additive for use in feedingstuffs for chickens for fattening. The Notifier is now seeking an authorisation for Avizyme 1500 for inclusion in cereal-based diets for laying hens to be used throughout the life of the animal. A tolerance test carried out with laying hens over a 12-week period with the recommended dose (0.75 g kg -1 ) and 20 times the recommended dose (15 g kg -1 ) of Avizyme 1500 produced no evidence of any adverse effect on performance or mortality. Therefore FEEDAP Panel concluded that the safety of Avizyme 1500 for laying hens has been demonstrated. Key words: Enzyme, laying hens, safety, tolerance test

2 Opinion on Avizyme 1500 for laying hens 2/5 BACKGROUND Council Directive 70/524/EEC 1 establishes rules governing the Community authorisation of additives for animal nutrition and in particular defines the conditions that a substance/product should meet to get authorisation. The company Danisco is seeking provisional Community authorisation of its enzyme product with the trade name Avizyme 1500, as a feed additive intended for use in laying hens under the category "Enzyme" (Table 1). Table 1. Description of the product. Product category: Enzyme Trade name: Avizyme 1500 Endo-1,4-beta-xylanase produced by Trichoderma longibrachiatum (ATCC 2105), endo-1,3(4)-betaglucanase and alpha-amylase produced by Description: Bacillus amyloliquefaciens (DSM 9553), subtilisin produced by Bacillus subtilis (ATCC 2107), polygalacturonase produced by Aspergillus aculeatus (CBS ) Target animal category: Laying hens Applicant: Danisco Member State Rapporteur: UK Type of request: Provisional authorization In accordance with the above legislation, the Commission received a request from this company, through the UK, the Member State rapporteur chosen by the company, to authorise its product under the conditions set out in Table 2. Supporting data produced by the company 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 at its meeting of 24 September This dossier was made available to the European Food Safety Authority directly by the company, via its Member State rapporteur. This product is provisionally authorised for chickens for fattening until 28 February 2005 by the Commission Regulation (EC) No 418/ The safety of the product had been evaluated by the Scientific Committee of Animal Nutrition (SCAN) in its opinion on the use of certain enzymes in animal feedingstuffs adopted on 4 June 1998 and updated on 16 October 2002 (available on ). 1 OJ L 270, , p.1 2 OJ L 62, , p.3

3 Opinion on Avizyme 1500 for laying hens 3/5 Table 2. Annex entry Additive Chemical formula, description Species or category of animal Minimum content Maximum content Units of activity kg -1 of complete feedingstuff Other provisions Maximum age Endo-1,4- betaxylanase EC Endo-1,3(4)- betaglucanase EC Subtilisin EC Alpha-amylase EC Polygalacturonase EC Preparation of endo-1,4-beta-xylanase produced by Trichoderma longibrachiatum (ATCC 2105), endo-1,3(4)-beta-glucanase and alpha-amylase produced by Bacillus amyloliquefaciens (DSM 9553), subtilisin produced by Bacillus subtilis (ATCC 2107), polygalacturonase produced by Aspergillus aculeatus (CBS ) having a minimum activity of: Endo-1,4-beta-xylanase: 300 U 3 g -1 Endo-1,3(4)-beta-glucanase: 150 U 4 g -1 Subtilisin: U 5 g -1 Alpha-amylase: 400 U 6 g -1 Polygalacturonase: 25 U 7 g -1 Laying hens - endo-1,4- betaxylanase: 225 U endo-1,3(4)-betaglucanase: 112,5 U subtilisin: U alpha-amylase: 300 U polygalacturonase: U - 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: endo-1,4-beta-xylanase: 225 U endo-1,3(4)-beta-glucanase: 112,5 U subtilisin: U alpha-amylase: 300 U polygalacturonase: U. 3. For use in compound feed rich in starch and non-starch polysaccharides (mainly arabinoxylans and beta-glucans), e.g., containing more than 40 % maize. 3 1 U is the amount of enzyme which liberates 1 micromole of reducing sugars (xylose equivalents) from oat spelt xylan per minute at ph 5,3 and 50 C. 4 1 U is the amount of enzyme which liberates 1 micromole of reducing sugars (glucose equivalents) from barley beta-glucan per minute at ph 5,0 and 30 C. 5 1 U is the amount of enzyme which liberates 1 micromole of phenolic compound (tyrosine equivalents) from a casein substrate per minute at ph 7,5 and 40 C. 6 1 U is the amount of enzyme which liberates 1 micromole of glucosidic linkages from a water insoluble cross-linked starch polymer substrate per minute at ph 6,5 and 37 C. 7 1 U is the amount of enzyme which liberates 1 micromole of reducing material (galacturonic acid equivalents) from a poly D-galacturonic substrate per minute at ph 5,0 and 40 C.

4 Opinion on Avizyme 1500 for laying hens 4/5 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 "Avizyme 1500", which is a preparation of endo-1,4-beta-xylanase produced by Trichoderma longibrachiatum (ATCC 2105), endo- 1,3(4)-beta-glucanase and alpha-amylase produced by Bacillus amyloliquefaciens (DSM 9553), subtilisin produced by Bacillus subtilis (ATCC 2107) and polygalacturonase produced by Aspergillus aculeatus (CBS ), for the target animals, when used under the conditions set out in Table 2 above, taking into account the background and the information submitted by the applicant in the dossier. ASSESSMENT 1.1. Introduction Avizyme 1500 is a multi-enzyme preparation containing xylanase derived from genetically modified Trichoderma longibrachiatum, subtilisin (protease) derived from genetically modified Bacillus subtilis, alpha-amylase produced by Bacillus amyloliquefaciens and polygalacturonase produced by Aspergillus aculeatus. The final product consists of approximately 10% enzyme preparation stabilized onto approximately 90% wheat carrier, with calcium propionate included as a preservative. Avizyme 1500 is currently approved for use in the EU as feed additive for use in feedingstuffs for chickens for fattening according to Directive 70/524/EEC as first laid down in Commission Regulation 418/2001 as Enzyme Number 59. The Notifier is now seeking an authorisation for Avizyme 1500 for inclusion in cereal-based diets for laying hens to be used throughout the life of the animal Safety for the laying hens One tolerance study was carried out with 576 Hubbard ISA laying hens from 18 to 30 weeks of age. The treatments comprised three ground maize diets to which 0, 0.75 (1X) or 15 (20X) g kg -1 Avizyme 1500 was added. Birds were randomly allocated to 144 cages each with four hens, two cages represented one replicate. There were 24 replicates per treatment. The main animal performance parameters were studied. General health was monitored weekly. No blood chemistry, haematology and gross pathology measurements were made. The concentrations of the enzymes applied to the diet were confirmed by measuring one of the enzymes contained in the preparation as a marker. Laying hen s health and welfare was not compromised by the treatments and there were no significant differences in mortality as a result of the treatments. There were no significant differences between any of the groups on performance parameters (Table 3). Table 3. Effect of Avizyme 1500 on performance parameters of laying hens Treatment Control 0.75 g kg g kg -1 Feed intake, g hen -1 d -1 Laying intensity, % Mean egg weight, g Egg mass production, g d -1 Feed conversion efficiency kg kg

5 Opinion on Avizyme 1500 for laying hens 5/5 CONCLUSIONS A tolerance test carried out with laying hens over a 12-week period with the recommended dose (0.75 g kg -1 ) and 20-fold overdose (15 g kg -1 ) of Avizyme 1500 produced no evidence of any adverse effect on performance or mortality. Although no blood chemistry, haematology or gross pathology data were provided, it is not expected that an overdose of Avizyme 1500 will affect these end points. Therefore FEEDAP Panel concluded that the safety of Avizyme 1500 for laying hens has been demonstrated. DOCUMENTATION PROVIDED TO EFSA 1. Supplementary dossier. Avizyme Application for laying hens. November Submitted by Danisco Animal Nutrition. 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, Anne-Katrine Haldorsen, Ingrid Halle, Alberto Mantovani, Kimmo Peltonen, Guido Rychen, Pascal Sanders, Amadeu Soares, Pieter Wester and Wilhelm Windisch.