(Question No EFSA-Q ) Adopted on 10 July 2007

Transcription

1 The EFSA Journal (2007) 520, 1-8 Opinion of the Scientific Panel on Additives and Products or Substances used in Animal Feed on the safety and efficacy of the enzyme preparation Safizym X (endo-1,4-beta-xylanase) as a feed additive for ducks in accordance with Regulation (EC) No 1831/2003 (Question No EFSA-Q ) Adopted on 10 July 2007 SUMMARY The additive Safizym X is a preparation of endo 1,4 beta-xylanase (EC ) produced by Trichoderma longibrachiatum CL 847 (CNCM MA 6/10W). This product is authorised for chickens for fattening, turkeys for fattening, laying hens and piglets. The applicant is now seeking extension for use of this product for ducks. The minimum dose requested for ducks for fattening is 700 IFP kg -1 complete feedingstuff although the applicant recommends a dose of 2800 IFP kg -1 complete feedingstuff. The safety of Safizym X for consumer, user and environment has been already established in an earlier SCAN opinion. The FEEDAP Panel is not aware of any new data that would indicate that these conclusions should be reconsidered. Efficacy has been previously demonstrated in chickens and turkeys for fattening at a minimum dose of 1050 and 1400 IFP kg -1 complete feed, respectively. As the mode of action of xylanases in ducks is the same as in the major species, an extrapolation can be made provided the dose range is similar. In this case, the minimum effective dose in ducks has been derived from a dose-range trial provided by the applicant showing a positive effect on feed to gain ratio of the supplementation with 700 IFP kg -1. Therefore, the FEEDAP Panel concludes that evidence of efficacy of Safizym X for ducks for fattening has been provided at a dose of 700 IFP kg -1. No adverse effects on animal performance were observed due to supplementation of the diets with 12.5 times the recommended dose of Safizym X. The FEEDAP Panel concludes that Safizym X is safe for the target species. Key words: Trichoderma longibrachiatum, Safizym X, enzyme, xylanase, ducks, efficacy, safety for ducks, minor species, zootechnical additive European Food Safety Authority, 2007

2 Opinion on Safizym X for ducks 2/8 BACKGROUND Regulation (EC) No 1831/ establishes the rules governing the Community authorisation of additives for use in animal nutrition. In particular, Article 4(1) of that Regulation lies down that any person seeking an authorisation for a feed additive or for a new use of a feed additive shall submit an application in accordance with Article 7. The European Commission received a request from the company Société Industrielle Lesaffre 2 for authorisation of the product Safizym X to be used as a feed additive for ducks (category: zootechnical additives; functional group: digestibility enhancers) under the conditions mentioned in Table 1. According to Article 7(1) of Regulation (EC) No 1831/2003, the Commission forwarded the application to the European Food Safety Authority (EFSA) as an application under Article 4.1 (authorisation of a feed additive or new use of a feed additive). EFSA received directly from the applicant the technical dossier in support of this application. According to Article 8 of that Regulation, EFSA, after verifying the particulars and documents submitted by the applicant, shall undertake an assessment in order to determine whether the feed additive complies with the conditions laid down in Article 5. The particulars and documents in support of the application were considered valid by EFSA as of 2 March The additive Safizym X is a preparation of endo-1,4-beta-xylanase produced by Trichoderma longibrachiatum CL 847 (CNCM MA 6-10W). This product is authorised for chickens for fattening, turkeys for fattening, laying hens (EC 1613) and piglets (4a1613). The Scientific Committee on Animal Nutrition (SCAN) issued an opinion on the safety of this preparation for chickens for fattening, turkeys for fattening and laying hens (adopted 4 June 1998, updated 16 October 2002). 3 EFSA issued an opinion on the safety and efficacy of Safizym X for piglets (adopted on 17 October 2006). 4 TERMS OF REFERENCE According to Article 8 of Regulation (EC) No 1831/2003 EFSA shall determine whether the feed additive complies with the conditions laid down in Article 5. Therefore, EFSA shall deliver an opinion on the efficacy and the safety for the target animals, consumer, user and the environment of the product Safizym X, which is a preparation of endo-1,4-beta-xylanase produced by Trichoderma longibrachiatum CL 847 (CNCM MA 6/10W) when used under the conditions described in Table 1. 1 OJ L 268, , p Société Industrielle Lesaffre, 137 rue Gabriel Péri, Marcq en Baroeul. France

3 Opinion on Safizym X for ducks 3/8 Table 1. Register entry as proposed by the applicant. Additive Registration number/ec No/No Category of additive Functional group of additive Endo-1,4-beta-xylanase 1613 Zootechnical additives Digestibility enhancers Composition, description Preparation of endo-1,4- betaxylanase produced from Trichoderma longibrachiatum (CNCM MA 6-10W) having a minimum activity of: Liquid form: 7000 IFP ml -1 Powder form: IFP g -1 Chemical formula Not appropriate Description Purity criteria Not appropriate Method of analysis 1IFP unit is defined as the quantity of enzyme which liberates one micromole of reducing reaction in equivalent xylose per minute, using oat xylan as substrate and under specific conditions (ph = 4.8 Temp=50ºC) Trade name Name of the holder of authorisation Safizym X Société Industrielle Lesaffre Conditions of use Species or category of animal Maximum Age Minimum content Maximum content Units of activity kg -1 of complete feedingstuffs Withdrawal period Ducks Other provisions and additional requirements for the labelling Specific conditions or restrictions for use Specific conditions or restrictions for handling Post market monitoring Specific conditions for use in complementary feedingstuffs Reserved exclusively to the manufacture of animals feeds. Production/expiry dates and batch number printed on the commercial packaging Store in a cool place Not appropriate The recommended content is 2800 IFP kg -1 of complete feedingstuffs Marker residue Maximum Residue Limit (MRL) Species or category of animal Target tissue(s) or food products Maximum content in tissues

4 Opinion on Safizym X for ducks 4/8 ASSESSMENT 1. Introduction Safizym X is a preparation of endo 1,4 beta-xylanase (EC ) produced by Trichoderma longibrachiatum CL 847 and deposited in the Pasteur Institute, France, under the reference CNCM MA 6/10W. The active substance is obtained by a submerged fermentation of the micro-organism. The additive is intended for use in ducks for fattening feed rich in arabinoxylans, notably in wheat. The minimum dose requested for ducks is 700 IFP kg -1 complete feed although the applicant recommends a dose of 2800 IFP kg -1 complete feed. This product is permanently authorised for chickens for fattening, turkeys for fattening and laying hens. Safizym X is marketed into two forms: Safizym XP20 (pale yellow powder) containing IFP g -1 and Safizym XL200 (brown liquid) containing 7000 IFP ml -1. SCAN issued an opinion on the safety of this preparation for chickens for fattening, turkeys for fattening and laying hens, including the safety for the consumer, user and the environment. The FEEDAP Panel is not aware of any new information that would lead to review this earlier opinion. Consequently, in the present assessment the FEEDAP Panel has considered only the safety and the efficacy of the additive for the target species. 2. Evaluation of the analytical methods by the Community Reference Laboratory (CRL) EFSA has verified the CRL report as it relates to the methods used for the control of the active substance in animal feeds. The Executive Summary of the CRL report can be found in the Appendix. 3. Efficacy and safety for the target species 5 The applicant has provided one trial in ducks to study efficacy and tolerance. A total of 288 Muscovy male ducks were distributed randomly into one of four treatments (six pens of 12 ducks per treatment) resulting from the supplementation of starter (0-21 days) and grower (22-49 days) wheat-soybean meal-corn basal diets with Safizym XP20 at 0, 700, 2800 (1X) or (12.5X recommended dose) IFP kg -1 (confirmed by analysis). The trial lasted for seven weeks. The parameters recorded were body weight (1, 21 and 49 days), feed consumption and feed to gain ratio. Data was analysed using GLM. Table 2. Growth performance of ducks fed diets supplemented with Safizym XP20 (0-49 days) Safizym XP20 (IFP kg -1 ) Final body weight (g) 3606 b 3673 ab 3703 a 3701 a Feed intake (g day -1 ) Feed/gain(kg kg -1 ) 2.04 a 2.00 b 1.99 b 1.96 c Mortality and culling (%) a, b: Means in a row not sharing a common superscript are significantly different (P<0.05) During the seven week growing trial, feed intake was not affected but feed to gain ratio was significantly improved by the supplementation with Safizym XP20 at any of the doses (Table 2). The final body weight was significantly higher when the diet was supplemented with 2800 IFP kg -1. Mortality was not affected by treatment. Supplementing the diet with 5 Technical dossier/section III/Appendix 3.1.

5 Opinion on Safizym X for ducks 5/ IFP kg -1 (12.5 times the recommended dose) did not result in any negative effects on animal performance or mortality Conclusions of efficacy Efficacy has been previously demonstrated in chickens and turkeys for fattening at a minimum dose of 1050 and 1400 IFP kg -1 complete feed, respectively. As the mode of action of xylanases in ducks is the same as in the major species, an extrapolation can be made provided the dose range is similar. In this case, the minimum effective dose in ducks has been derived from a dose-range trial provided by the applicant showing a positive effect on feed conversion of the supplementation with 700 IFP kg -1. Therefore, the FEEDAP Panel concludes that evidence of efficacy of Safizym X for ducks for fattening has been provided at a dose of 700 IFP kg Conclusion of safety for the target species Since the product appears to be well tolerated by ducks at IFP kg -1 (representing 12.5 times the recommended dose 2800 IFP kg -1 ), the FEEDAP Panel concludes that the use of Safizym X at 2800 IFP kg -1 is safe for ducks for fattening. 4. Post-market monitoring The FEEDAP Panel does not see the need for specific requirements for a post-market monitoring plan other than those established in the Feed Hygiene Regulation (Regulation (EC) No 183/2005) and Good Manufacture Practice. CONCLUSIONS Although only the solid form of the product has been tested in the efficacy and tolerance study, the FEEDAP Panel considers that the conclusions reached can be extrapolated to the liquid preparation. Efficacy has been previously demonstrated in chickens and turkeys for fattening at a minimum dose of 1050 and 1400 IFP kg -1 complete feed, respectively. As the mode of action of xylanases in ducks is the same as in the major species, an extrapolation can be made provided the dose range is similar. In this case, the minimum effective dose in ducks has been derived from a dose-range trial provided by the applicant showing a positive effect on feed conversion of the supplementation with 700 IFP kg -1. Therefore, the FEEDAP Panel concludes that evidence of efficacy of Safizym X for ducks for fattening has been provided at a dose of 700 IFP kg -1. The FEEDAP Panel concludes that the target species safety of Safizym X (L/P) has been demonstrated for ducks for fattening at 12.5X the maximum recommended dose (2800 IFP kg -1 ). DOCUMENTATION PROVIDED TO EFSA 1. Dossier on Safizym X. Additive for ducks. November Submitted by Lesaffre Feed Additives. 2. Evaluation Report of the Community Reference Laboratory Feed Additives Authorisation on the Method(s) of Analysis for Safizym X for ducks

6 Opinion on Safizym X for ducks 6/8 SCIENTIFIC PANEL MEMBERS Georges Bories, Paul Brantom, Joaquim Brufau de Barberà, Andrew Chesson, Pier Sandro Cocconcelli, Bogdan Debski, Noël Dierick, Anders Franklin, Jürgen Gropp, Ingrid Halle, Christer Hogstrand, Joop de Knecht, Lubomir Leng, Anne-Katrine Lundebye Haldorsen, Alberto Mantovani, Miklós Mézes, Carlo Nebbia, Walter Rambeck, Guido Rychen, Atte von Wright and Pieter Wester

7 Opinion on Safizym X for ducks 7/8 APPENDIX Executive Summary of the Evaluation Report of the Community Reference Laboratory Feed Additives Authorisation on the Method(s) of Analysis for Safizym X for ducks In the current application authorisation is sought for Safizym X under the category 'zootechnical additives' and the functional group 4(a), according to the classification system of Annex I of Regulation (EC) No 1831/2003. Specifically, cf. EFSA-Q , authorisation is sought to use Safizym X as a digestibility enhancer for ducks. The active agent of Safizym X is endo-1,4-β-xylanase, produced by a strain of Trichoderma longibranchiatum CNCM MA 6-10W. Enzymatic activity is expressed in IFP (Institut Français du Pétrole) units. One IFP unit is defined as the amount of enzyme that liberates one μmol of reducing sugars (xylose equivalents) from oat xylan per minute at ph 4.8 and 50 o C. The additive is intended to be marketed in two forms, namely as a powder (Safizym XP20) containing IFP/g and as liquid formulation (Safizym XL200) containing 7000 IFP/ml of the product. Safizym X is intended to be mixed into premixtures and/or feedingstuffs to obtain an enzyme activity level of minimum 700 IFP/kg in feedingstuffs. The recommended enzyme activity in feed is 2800 IFP/kg. Safizym X also contains a residual activity of endo-1,3-(4)-β glucanase. For the determination of the activity of endo-1,4-β-xylanase in the feed additive, the applicant proposes an absolute colorimetric method based on the fact that endo-1,4-βxylanase releases xylose from the substrate oat spelt xylan. Released sugar reduces the added 3,5-dinitro-salicylic acid to a coloured compound that is measured spectrophotometrically and quantified against the xylose standard curve. Transferability of the method on Safizym XP20 has been checked among three laboratories [Anim. Feed Sci. Techn. 1999, 77: ] obtaining similar results. For the determination of the endo-1,4-β-xylanase activity in premixtures, the applicant proposes a relative colorimetric method, based on the principle that xylanase releases water soluble dyed fragments from the substrate oat azo-xylan. The formed dyed fragments are then measured with a spectrophotometer and quantification is performed via a standard line based on the reference enzyme Safizym XP20, available from the applicant upon request. Method performance characteristics, when checked between two laboratories, include a limit of detection (LOD) of 0.14 IFP/g, a limit of quantification (LOQ) of 0.35 IFP/g, a relative standard deviation for repeatability (RSDr) of 6.5% and an intermediate relative standard deviation for reproducibility (RSDR) of 16.6%. For the quantification of the endo-1,4-β-xylanase activity in feedingstuffs, the applicant proposes the same method as for premixtures, just the sample extraction is modified and the incubation time is prolonged. The enzyme activity in feedingstuffs is quantified against matrix matched standards which are blank feed samples fortified with a known dose of the reference enzyme Safizym XP20. In the case that a matrix matched blank feed is not available the applicant proposes the use of the standard addition technique for quantifying the enzyme activity in feed. Transferability of the method on Safizym XP20, using matrix matched standards, has been checked between two laboratories [Anim. Feed Sci. Techn. 1999, 77: ] obtaining similar results. The applicant also reported on another study with independent measurements between two laboratories. The LOD and LOQ correspond to 140 IFP/kg and 350 IFP/kg of feedingstuffs, respectively. The average RSDr is 8.3% for powder form and 9.2% for liquid form. The average intermediate RSDR is 15.8% for the liquid form and 24% for the powder form. Since the method shows acceptable performance characteristics, it is considered fit for official controls in the frame of the authorisation.

8 Opinion on Safizym X for ducks 8/8 The CRL recommends that for the quantification of the enzyme activity in feedingstuffs the declared activity of endo-1,4-β-xylanase in Safizym XP20 is confirmed by applying the method proposed for the pure additive or in the case of major deviations - substituted by the actual measured activity of the enzyme. Further testing or validation is not considered necessary.