The EFSA Journal (2005) 271, 1-6

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1 The EFSA Journal (2005) 271, 1-6 Opinion of the Scientific Panel on Additives and Products or Substances used in Animal Feed on the safety of the enzymatic product Kemzyme W Dry for use as feed additive for layin hens and turkeys for fattenin (Question No EFSA-Q ) Adopted on 22 September 2005 SUMMARY The enzyme preparation Kemzyme W dry is based on a mixture of endo-1,3(4)-β-lucanase produced by Asperillus aculeatus, endo-1,4-β-lucanase produced by Trichoderma lonibrachiatum, alpha-amylase produced by Bacillus amyloliquefaciens, bacillolysin produced by Bacillus amyloliquefaciens and endo-1,4-β-xylanase produced by Trichoderma viride has been provisionally authorised for the use as a feed additive, (feed enzyme No. 53), for chickens for fattenin and pilets. The applicant company has submitted a request for an extension of use of the product to layin hens and turkeys for fattenin. The safety assessment for the consumer, user and the environment of this enzyme preparation has already been done by the Scientific Committee on Animal Nutrition (SCAN) in its "Opinion of the Scientific Committee on Animal Nutrition on the use of certain enzymes in animal feedinstuffs". In addition, FEEDAP Panel of EFSA concluded that the Bacillus production strains, when used as a source of extracellular enzyme for the preparation of Kemzyme W dry, do not present a toxienic risk. A tolerance test was conducted with 48 layin hens over a period of 28 days, with ten times the hihest recommended dose of Kemzyme W Dry (10 k -1 ). Due to the short duration of the tolerance trial, the FEEDAP Panel cannot conclude on the safety of Kemzyme W Dry for layin hens. A tolerance test conducted with 315 male turkeys (21 week period) and with 351 female turkeys (12 week period) with ten times the maximum recommended dose of Kemzyme W Dry (10 k -1 ) did not show any sinificant adverse effects on health and performance of the animals. Therefore, the FEEDAP Panel concludes that Kemzyme W dry is safe for turkeys for fattenin. Keywords: Enzyme, layin hens, turkeys for fattenin, tolerance test

2 Opinion on Kemzyme W Dry for layin hens and turkeys 2/6 BACKGROUND Council Directive 70/524/EEC establishes rules overnin the Community authorisation of additives for animal nutrition and in particular defines the conditions that a substance/product should meet to et authorisation. The company Kemin Europe is seekin provisional Community authorisation of its enzyme product with the trade name KEMZYME W Dry, as a feed additive intended for use in layin hens and turkeys for fattenin under the cateory "Enzyme" (Table 1). Table 1 Description of the product Product cateory: Trade name: Description: Taret animal cateory: Applicant: Member State Rapporteur: Type of request: Enzyme KEMZYME W Dry Preparation of endo-1,3(4)-beta-lucanase produced by Asperillus aculeatus (CBS ), endo-1,4-betalucanase produced by Trichoderma lonibrachiatum (CBS ), alpha-amylase produced by Bacillus amyloliquefaciens (DSM 9553), bacillolysin produced by Bacillus amyloliquefaciens (DSM 9554) and endo- 1,4-beta-xylanase produced by Trichoderma viride (NIBH FERM BP 4842) Layin hens and turkeys for fattenin Kemin Europe BE Provisional authorisation In accordance with the above leislation, the Commission received a request from this company, throuh BE, the Member State rapporteur chosen by the company, to authorise its product under the conditions set out in Table 2. Supportin data produced by the company were compiled in a dossier and accompanied that application. All Member States received the dossier. This dossier was made available to the European Food Safety Authority directly by the company, via its Member State rapporteur. The safety of the product KEMZYME W Dry had been evaluated by the SCAN in its opinion on the use of certain enzymes in animal feedinstuffs adopted on 4 June 1998, updated on 16 October for use as feed additive in pilets and pis for fattenin, chickens for fattenin and layin hens and turkeys for fattenin and in the opinion about the possible toxin production from Bacillus in Opinion of the Scientific Committee on Animal Nutrition on the safety of use of Bacillus species in animal nutrition (Expressed on 17 February 2000)

3 Opinion on Kemzyme W Dry for layin hens and turkeys 3/6 Table 2. Conditions of use of Kemzyme W Dry Additive Endo-1,3(4)- betalucanase EC Endo-1,4- betalucanase EC Alpha-amylase EC Bacillolysin EC Endo-1,4- betaxylanase EC Chemical formula, description Preparation of endo-1,3(4)-betalucanase produced by Asperillus aculeatus CBS ), endo-1,4-betalucanase produced Trichoderma lonibrachiatum CBS ), alphaamylase produced by Bacillus amyloliquefaciens (DSM 9553), bacillolysin produced by Bacillus amyloliquefaciens (DSM 9554) and endo-1,4-beta-xylanase produced Trichoderma viride (NIBH FERM BP 4842) havin a minimum activity of: Endo-1,3(4)-beta-lucanase: U 3-1 Endo-1,4-beta-lucanase:4 000 U 4-1 Alpha-amylase: 400 U 5-1 Bacillolysin: 450 U 6-1 Endo-1,4-beta-xylanase: U 7-1 Species or cateory of animal Layin hens Turkeys for fattenin Maximum ae - Minimum content Maximum content Units of activity k -1 of complete feedinstuff Endo-1,3(4)- betalucanase: U Endo-1,4-betalucanase: U Alpha-amylase: 100 U Bacillolysin: U Endo-1,4-betaxylanase: U Other provisions 1. In the directions for use of the additive and premixture, indicate the storae temperature, storae life and stability to pelletin. 2. Recommended dose per k of compound feedinstuff: Endo-1,3(4)-beta-lucanase: U Endo-1,4-beta-lucanase: U Alpha-amylase: U Bacillolysin: U Endo-1,4-beta-xylanase: U. 3. For use in compound feed rich in nonstarch polysaccharides (mainly betalucans and arabinoxylans), e.., containin more than 30 % wheat. 3 1 U is the amount of enzyme which liberates 1 micromole of reducin suars (lucose equivalents) from oat beta-lucan per minute at ph 4,0 and 30 C 4 1 BGU is the amount of enzyme which liberates 0,15 micromoles of lucose from azurine-cross-linked beta-lucan per minute at ph 5,0 and 40 C. 5 1 RAU is the amount of enzyme which converts 1 m of soluble starch into a product havin an equal absorption to a reference colour at 620 nm after reaction with iodine, per minute at ph 6,6 and 30 C. 6 1 U is the amount of enzyme which liberates 1 microram of phenolic compound (tyrosine equivalents) from casein substrate per minute at ph 7,5 and 40 C. 7 1 U is the amount of enzyme which liberates 1 micromole of reducin suars (xylose equivalents) from oat spelt xylan per minute at ph 5,3 and 50 C

4 Opinion on Kemzyme W Dry for layin hens and turkeys 4/6 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 "KEMZYME W dry", which is a preparation of endo-1,3(4)-beta-lucanase produced by Asperillus aculeatus (CBS ), endo-1,4- beta-lucanase produced by Trichoderma lonibrachiatum (CBS ), alpha-amylase produced by Bacillus amyloliquefaciens (DSM 9553), bacillolysin produced by Bacillus amyloliquefaciens (DSM 9554) and endo-1,4-beta-xylanase produced by Trichoderma viride (NIBH FERM BP 4842), for the layin hens and turkeys for fattenin, when used under the conditions set out in Table 2 above, takin into account the backround and the information submitted by the applicant in the dossier. ASSESSMENT 1. Introduction The enzyme preparation Kemzyme W Dry is based on a mixture of endo-1,3(4)-β-lucanase produced by Asperillus aculeatus (CBS ), endo-1,4-β-lucanase produced by Trichoderma lonibrachiatum (CBS ), alpha-amylase produced by Bacillus amyloliquefaciens (DSM 9553), bacillolysin produced by Bacillus amyloliquefaciens (DSM 9554) and endo-1,4-β-xylanase produced by Trichoderma viride (NIBH FERM BP 4842). It has been provisionally authorised for the use as a feed additive, (feed enzyme No. 53), for chickens for fattenin and pilets. The applicant company submitted a request for an extension of use of the product for layin hens and turkeys for fattenin. The safety (consumer, user, and environment) of this enzyme preparation was evaluated by the Scientific Committee on Animal Nutrition (SCAN) in its "Opinion of the Scientific Committee on Animal Nutrition on the use of certain enzymes in animal feedinstuffs" 8. In addition, the FEEDAP Panel has already concluded that the Bacillus production strains DSM 9553 and DSM 9554, used as a source of extracellular enzyme, do not present a toxienic risk. 9 Therefore, only a tolerance test for the taret animals (layin hens and turkeys for fattenin) is considered necessary. 2. Safety for the taret species 2.1. Tolerance study in layin hens A 28-day tolerance test was conducted with 48 Isa-brown individually caed layin hens (two diets, 24 replicates per diet) at zero and ten times the hihest recommended dose of Kemzyme W dry (10 k -1 ) in a barley, wheat and soybean meal based mash diet. The birds were inspected daily in their caes. Feed intake, daily e mass, e/feed ratio, weiht chanes, e production, eshell thickness and health conditions were reported and presented in Tables 3 and 4. One bird from the tolerance roup was culled (broken le)

5 Opinion on Kemzyme W Dry for layin hens and turkeys 5/6 Table 3. Effect of 10 times overdose of Kemzyme W dry on performance of layin hens durin 28 days Kemzyme 1 Feed intake FCR Culled Weiht ain, k -1 day -1 e -1 feed n/n / /24 1Enzyme recovery between % for the 5 enzyme activities Table 4. Effect of ten times overdose of Kemzyme W dry on e parameters Kemzyme 1 k -1 Daily e mass, bird -1 E production, % Shell thickness, mm Cracked es, % Dirty es, % Enzyme recovery between % for the 5 enzyme activities No sinificant differences were noted for performance and e parameters between the two diets. Blood chemistry, haematoloy and ross patholoy measurements were not done. However it is not expected that these endpoints would be affected. However, due to the short duration of the tolerance trial (only 4 weeks) the FEEDAP Panel cannot conclude on the safety of Kemzyme W dry for layin hens Tolerance study in turkeys for fattenin A tolerance test was conducted in 1999 as part of a larer performance study with 1050 one-day old BUT males and 1170 one-day old BUT females. Only the data relevant to the tolerance are reported here. The tolerance test was conducted with nine pens of 35 males and nine pens with 39 females. Three diets were used: control, control + Kemzyme W dry 1 k -1, control + Kemzyme W dry 10 k -1. Kemzyme W dry was applied before pelletin the diets. The three diets were based on wheat and soybean meal and were fed as prestarter crumb (0-4 weeks), starter 1 (5-8 weeks) and 2 (9-12 weeks) pellets, rower 1 (13-16 weeks) and 2 (17-20 weeks) pellets and finisher (21 week) pellets. The duration of the experiment was 12 and 21 weeks for hens and males respectively. At 12 weeks, all hens were slauhtered and their pens used to re-house and reduce the stockin density of the males. The birds were inspected daily in their pens for eneral health. Birds in poor condition were killed and dates of death recorded. Weiht ain, feed intake and mortality were recorded and feed/ain calculated for the different periods. Only the overall results are presented here (Tables 5 and 6). From tables 5 and 6 it can be concluded that Kemzyme W dry at 10 k -1 feed did not adversely affect the performance of turkeys. Table 5. Effect of Kemzyme W dry on performance of female turkeys (1-12 weeks) Kemzyme 1 Weiht ain, Feed intake Mortality FCR k -1 n/n / / /117 1Alpha-amylase in-feed recovery: 125 %; beta-lucanase in-feed recovery: 87 % (means for all phase feeds) 2Alpha-amylase in-feed recovery: 78 %; beta-lucanase in-feed recovery: 21 % (means for all phase feeds) No post-mortem examinations were carried out. A number of deaths were the result of cullin because of feather peckin and broken wins. Blood chemistry and haematoloy measurements were not done. Based on the data available and in the absence of

6 Opinion on Kemzyme W Dry for layin hens and turkeys 6/6 sinificant adverse effects on health and performance, the FEEDAP Panel concludes that Kemzyme W dry is safe for turkeys. Table 6. Effect of Kemzyme W dry on performance of male turkeys (1-21 weeks) Kemzyme 1 Weiht ain, Feed intake Mortality FCR k -1 n/n / / /105 1Alpha-amylase in-feed recovery: 125 %; beta-lucanase in-feed recovery: 87 % (means for all phase feeds) 2Alpha-amylase in-feed recovery: 78 %; beta-lucanase in-feed recovery: 21 % (means for all phase feeds) CONCLUSIONS Due to the short duration of the tolerance trial (only 4 weeks), the FEEDAP Panel cannot conclude on the safety of Kemzyme W Dry for layin hens. On the basis of the data provided and in the absence of sinificant adverse effects on health and performance, the FEEDAP Panel concludes that Kemzyme W Dry is safe for turkeys for fattenin. DOCUMENTATION PROVIDED TO EFSA 1. Extension dossier for the reistration of Kemzyme W Dry for layin hens and turkeys. March Submitted by Kemin Europa N.V. SCIENTIFIC PANEL MEMBERS Arturo Anadón, Mararita Arboix Arzo, Geores Bories, Paul Brantom, Joaquim Brufau de Barberà, Andrew Chesson, Pier Sandro Cocconcelli, Joop de Knecht, Noël Dierick, Gerhard Flachowsky, Anders Franklin, Jüren Gropp, Inrid Halle, Anne-Katrine Lundebye Haldorsen, Alberto Mantovani, Kimmo Peltonen, Guido Rychen, Pascal Sanders, Amadeu Soares, Wilhelm Windisch and Pieter Wester