SCIENTIFIC OPINION. EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) 2,3

Transcription

1 EFSA Journal 212;1(6):2728 SCIENTIFIC OPINION Scientific Opinion on the safety and efficacy of AveMix XG 1 (endo-1,4- beta-xylanase and endo-1,3(4)-beta-glucanase) as feed additive for laying hens and minor poultry species 1 EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) 2,3 ABSTRACT European Food Safety Authority (EFSA), Parma, Italy The additive AveMix XG 1 is an enzyme preparation of endo-1,4-beta-xylanase and endo-1,3(4)-betaglucanase, produced by two strains of Trichoderma reesei. This product is currently authorised for use in chickens for fattening and weaned piglets under the functional group of digestibility enhancers. The applicant is now seeking an extension of the authorisation to laying hens and minor laying poultry species at a recommended level of 4 XU and 9 BGU/kg complete feed and to minor fattening poultry species at 3 XU and 675 BGU/kg. AveMix XG 1 is safe for laying hens at the proposed use level as concluded from a tolerance trial. Based on this conclusion and on an equivalent conclusion for chickens for fattening, safety can be extrapolated to all minor poultry species. Avemix XG 1 at the proposed level resulted in an increased performance of laying hens as measured in three trials by an improvement in the feed to egg mass ratio. Since the mode of action of xylanases and glucanases can be reasonably assumed to be the same in all poultry species, the conclusions on efficacy for major poultry species can be extrapolated to include all minor poultry species at 3 XU and 6 BGU/kg complete feed in fattening birds and at 4 XU and 9 BGU/kg complete feed in laying birds. European Food Safety Authority, 212 KEY WORDS Enzyme, zootechnical additive, digestibility enhancers, laying hens, minor poultry species, safety, efficacy 1 On request from the European Commission, Question No EFSA-Q , adopted on 23 May Panel members: Gabriele Aquilina, Georges Bories, Andrew Chesson, Pier Sandro Cocconcelli, Joop de Knecht, Noël Albert Dierick, Mikolaj Antoni Gralak, Jürgen Gropp, Ingrid Halle, Christer Hogstrand, Lubomir Leng, Secundino López Puente, Anne-Katrine Lundebye Haldorsen, Alberto Mantovani, Giovanna Martelli, Miklós Mézes, Derek Renshaw, Maria Saarela, Kristen Sejrsen and Johannes Westendorf. Correspondence: FEEDAP@efsa.europa.eu 3 Acknowledgement: The Panel wishes to thank the members of the Working Group on Enzymes, including Nuria Canibe, Friedrich Schöne and Pieter Wester, for the preparatory work on this scientific opinion. Suggested citation: EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP); Scientific Opinion on the safety and efficacy of AveMix XG 1 (endo-1,4-beta-xylanase and endo-1,3(4)-beta-glucanase) as feed additive for laying hens and minor poultry species. EFSA Journal 212;1(6):2728. [1 pp.] doi:1.293/j.efsa Available online: European Food Safety Authority, 212

2 SUMMARY The additive AveMix XG 1 is an enzyme preparation of endo-1,4-beta-xylanase (xylanase; EC ) and endo-1,3(4)-beta-glucanase (glucanase; EC ), produced by two strains of Trichoderma reesei. This product is currently authorised for use in chickens for fattening and weaned piglets as a zootechnical additive, under the functional group of digestibility enhancers. The applicant is now seeking an extension of the authorisation to laying hens and minor laying poultry species at 4 XU and 9 BGU/kg complete feed and to minor fattening poultry species at 3 XU and 675 BGU/kg. Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of Avemix XG 1 when used under these conditions. AveMix XG 1 is safe for laying hens at the proposed use level as concluded from a tolerance trial. Based on this conclusion and on an equivalent conclusion for chickens for fattening, safety can be extrapolated to all minor poultry species. Avemix XG 1 at the proposed level resulted in an increased performance of laying hens as measured in three trials by an improvement in the feed to egg mass ratio. Since the mode of action of xylanases and glucanases can be reasonably assumed to be the same in all poultry species, the conclusions on efficacy for major poultry species can be extrapolated to include all minor poultry species at 3 XU and 6 BGU/kg complete feed in fattening birds and at 4 XU and 9 BGU/kg complete feed in laying birds. EFSA Journal 212;1(6):2728 2

3 TABLE OF CONTENTS Abstract... 1 Summary... 2 Table of contents... 3 Background... 4 Terms of reference... 4 Assessment Introduction Conditions of use Evaluation of the analytical methods by the European Union Reference Laboratory (EURL) Safety for the target species Laying hens Minor poultry species Efficacy for the target species Laying hens Minor poultry species Post-market monitoring... 9 Conclusions... 9 Documentation provided to EFSA... 9 References... 1 EFSA Journal 212;1(6):2728 3

4 BACKGROUND Regulation (EC) No 1831/23 4 establishes the rules governing the Community authorisation of additives for use in animal nutrition. In particular, Article 4(1) of that Regulation lays down that any person seeking 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 Aveve N.V. 5 for authorisation of the product AveMix XG 1, endo-1,4-beta-xylanase and endo-1,3(4)-beta-glucanase, to be used as a feed additive for weaned piglets (category: zootechnical additive; functional group: digestibility enhancers) under the conditions mentioned in Table 1. According to Article 7(1) of Regulation (EC) No 1831/23, 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. 6 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 15 September 211. The additive AveMix XG 1 is a preparation of endo-1,4-beta-xylanase produced by Trichoderma reesei (MUCL 49755) and endo-1,3(4)-beta-glucanase produced by Trichoderma reesei (MUCL 49754). This product is currently authorised for use as feed additive in feed for chickens for fattening (until 4 December 219) 7, 8 and weaned piglets (until 17 November 221). 9 The European Food Safety Authority issued a scientific opinion on the safety and efficacy of AveMix XG 1 as a feed additive for chickens for fattening (EFSA, 29) and one on the modification of the terms of the authorisation of the product for this species (EFSA, 21). Finally an opinion on the safety and efficacy of the product as a feed additive for weaned piglets was published on 211 (EFSA, 211). TERMS OF REFERENCE According to Article 8 of Regulation (EC) No 1831/23, EFSA shall determine whether the feed additive complies with the conditions laid down in Article 5. EFSA shall deliver an opinion on the safety for the target animals, consumer, user and the environment and the efficacy of the product AveMix XG 1 (endo-1,4-beta-xylanase and endo-1,3(4)-beta-glucanase) when used under the conditions described in Table 1. 4 Regulation (EC) No 1831/23 of the European Parliament and of the Council of 22 September 23 on additives for use in animal nutrition. OJ L 268, , p Aveve N.V., Minderbroederstraat 8, 3 Leuven, Belgium. 6 EFSA Dossier reference: FAD Commission Regulation (EC) No 191/29 of 13 November 29 concerning the authorisation of an enzyme preparation of endo-1,4-beta-xylanase produced by Trichoderma reesei (MUCL 49755) and endo-1,3(4)-beta-glucanase produced by Trichoderma reesei (MUCL 49754) as a feed additive for chickens for fattening (holder of authorisation Aveve NV) OJ L 299, , p Commission Regulation (EU) No 335/211 of 7 April 211 amending Regulation (EC) No 191/29 as regards the minimum content of the enzyme preparation of endo-1,4-beta-xylanase produced by Trichoderma reesei (MUCL 49755) and endo-1,3(4)-beta-glucanase produced by Trichoderma reesei (MUCL 49754) as a feed additive in feed for chickens for fattening OJ L 94, , p Commission Implementing Regulation (EU) No 188/211 of 27 October 211 concerning the authorisation of an enzyme preparation of endo-1,4-beta-xylanase produced by Trichoderma reesei (MULC 49755) and endo-1,3(4)-beta-glucanase produced by Trichoderma reesei (MULC 49754) as a feed additive for weaned piglets (holder of authorisation Aveve NV) OJ L 281, , p. 14. EFSA Journal 212;1(6):2728 4

5 Table 1: Description and conditions of use of the additive as proposed by the applicant Additive Registration number/ec No/No Category(-ies) of additive Functional group(s) of additive endo-1,4-beta-xylanase EC and endo-1,3(4)-beta-glucanase EC (AveMix XG 1) 4a9 Zootechnical additive Digestibility enhancer Composition, description Enzyme preparation containing endo-1,4-beta-xylanase (EC ) produced by Trichoderma reesei and endo-1,3(4)-beta-glucanase (EC ) produced by Trichoderma reesei. Solid or liquid, having a minimum activity of endo-1,4-betaxylanase: 4 XU/g endo-1,3(4)- beta-glucanase:9 BGU/g Description Chemical formula Not applicable Purity criteria Complies with JECFA guidelines on microbial quality, heavy metals, toxins and undesirable substances Method of analysis Assay based on colometric reaction of dinitrosalicylic acid on reducing sugar yield produced by action of endo-1,4-beta-xylanase on a xylan containing substrate or endo-1,3(4)- beta-glucanase on a ß- glucan containing substrate Trade name AveMix XG 1 Name of the holder of authorisation AVEVE NV Conditions of use Species or category of animal Laying hens and minor poultry species Maximum Age Laying hens and minor layer poultry species:until end of lay; minor fattening poultry species: until slaughter age Minimum content Maximum content Units of activity/kg of complete feedingstuffs (select what applicable) endo-1,4-betaxylanase: 4 XU/kg complete feed endo- 1,3(4)-betaglucanase:9 BGU/kg complete feed for laying hens endo-1,4-beta-xylanse: 3 XU/kg complete feed endo-1,3-(4)-betaglucanase:675 BGU/kg complete feed for minor poultry species Withdrawal period Not relevant Specific conditions or restrictions for use Specific conditions or restrictions for handling Post-market monitoring Specific conditions for use in complementary feedingstuffs Other provisions and additional requirements for the labeling In the directions for use of the additive and premixture, indicate the storage temperature, storage life, and stability to pelleting - - Recommended dosages per kilogram of complete feedingstuff for laying hens and minor layer poultry species: endo-1,4-beta-xylanase: 4 XU, endo-1,3(4)-beta-glucanase: 9 BGU; for minor fattening EFSA Journal 212;1(6):2728 5

6 poultry species: endo-1,4-beta-xylanase: 3 XU, endo-1.3(4)-betaglucanase: 675 BGU. For use in compound feed rich in non-starch polysaccharides (mainly arabinoxylans and betaglucans). Marker residue Maximum Residue Limit (MRL) Species or category of animal Target tissue(s) or food products Maximum content in tissues EFSA Journal 212;1(6):2728 6

7 ASSESSMENT 1. Introduction The additive AveMix XG 1 is an enzyme preparation of endo-1,4-beta-xylanase (xylanase; EC ) and endo-1,3(4)-beta-glucanase (glucanase; EC ), produced by two non-genetically modified strains of Trichoderma reesei (MUCL and 49754). The product is produced in two forms, solid and liquid, with an activity of xylanase of 4 XU/g and of glucanase of 9 BGU/g. This product is currently authorised for its use in chickens for fattening and weaned piglets as a zootechnical additive, under the functional group of digestibility enhancers. The applicant is now seeking authorisation of the product as feed additive for laying hens and minor poultry species. The European Food Safety Authority (EFSA) has issued two scientific opinions on the safety and efficacy of AveMix XG 1 as a feed additive for chickens for fattening, and one on its use as a feed additive for weaned piglets (EFSA, 29, 21, 211). The formulations, manufacturing processes, purity, stability and homogeneity of the product have already been described fully in the previous assessment (EFSA, 29). The FEEDAP Panel considers that the safety aspects other than for the new target species are covered in that assessment and would not be affected by the requested extension of use. Therefore, the present opinion focuses only on the safety and efficacy of this enzyme preparation for the new target species. 2. Conditions of use The additive is to be used in laying hens and minor laying poultry species at a proposed level of 4 XU (xylanase) and 9 BGU (glucanase) per kilogram of complete feed and in minor fattening poultry species at 3 XU and 675 BGU per kilogram of complete feed. 3. Evaluation of the analytical methods by the European Union Reference Laboratory (EURL) The EURL considered that the conclusions and recommendations reached in the previous assessment are valid and applicable for the current application Safety for the target species 4.1. Laying hens A tolerance trial 11 was carried out with a total of 432 Lohmann Brown laying hens (29 weeks old). The trial consisted of three treatments, each with eight replicates of 18 animals. The trial lasted 56 days, divided into two periods of 28 days. Each pen/unit consisted of two enriched cages (nine hens per cage). The basal diet was based on wheat, corn and soybean meal. The control diet was supplemented with AveMix XG at either, 1 (1 ) or 1 mg/kg complete feed (1 ) (corresponding to, 4 /9 and 4 /9 XU/BGU per kilogram of feed, respectively; confirmed by analysis). Performance and egg quality parameters were monitored throughout the experimental period. Laying rate was 95.3 %, 94.7 % and 94.3 % in the control, 1 and 1 groups, respectively, and was not significantly different between treatments. In addition, daily egg mass production (59.8, 6.2 and 6.9 g) and feed to egg mass (1.86, 1.85 and 1.84) were not significantly different between the groups. Mortality and culling was 2.7 %, % and 3.5% in the control, 1 and 1 groups, respectively. Based on the results of this tolerance trial, it is concluded that Avemix XG 1 is safe for laying hens at the proposed level (4 XU and 9 BGU/kg). 1 The full report is available on the EURL wesbite: pdf 11 Technical dossier Section III/Annex EFSA Journal 212;1(6):2728 7

8 4.2. Minor poultry species AveMix XG laying hens and minor poultry species The safety of this product was previously established in chickens for fattening at 4 XU and 9 BGU/kg complete feed (EFSA, 29). Safety has been established at the same dose for laying hens. In the view of the FEEDAP Panel and given the margin of safety established for the major poultry species the conclusions can be extrapolated to all minor poultry species for fattening and laying at the level of 4 XU and 9 BGU/kg complete feed. 5. Efficacy for the target species 5.1. Laying hens The applicant presented a total of three trials performed in three different locations. The design of the three trials is shown in Table 2. Table 2: Trial design and dosage confirmation for the efficacy trials Trial Animal Age at start Duration Total no of animals Animals per replicate Replicates per treatment Diet composition Intended activity (XU/BGU/kg) Analysed activity (XU/BGU/kg) 1 12 Hy-Line Brown 2 weeks 24 weeks 2 13 Hy-Line 19 weeks 34 weeks Wheat/soybean meal Wheat/soybean meal/corn 2 /45 4 /9 2 / / / / Lohmann LSL-Classic 2 weeks 28 weeks Wheat/soybean meal/barley 4 / /971 The results showed that Avemix XG 1 at 4 XU/9 BGU increased daily egg mass production in one trial (trial 1). Feed to egg mass ratio was improved in all three trials at 4 XU/9 BGU, and in one trial (trial 2) at 2 XU/45 BGU. Table 3: Effect of Avemix XG 1 (solid form) on the performance of laying hens Trial Intended activity (XU/BGU/kg) /45 4 / / /9 Laying rate 1 (%) Egg mass (g/hen/day) Feed to egg mass ratio Mortality/ (g feed/g egg) 2 culling (%) a 58.7 a 6. b a 2.22 a 2.17 b / / / 2.3 a / b / a / b /2.9 1 Laying rate calculated as number of marketable eggs. 2 In trial 2, replicates served as the experimental unit; the data were condensed and the value shown is the average per hen based on weekly individual data. a, b : Means with different superscript letters are significantly different (P.5). 12 Technical dossier/section IV/Annex IV Technical dossier/section IV/Annex IV Technical dossier/section IV/Annex IV EFSA Journal 212;1(6):2728 8

9 Therefore, based on the positive results seen in three trials, the FEEDAP Panel concludes that Avemix XG 1 has the potential to be efficacious in laying hens at a minimum level of 4 XU and 9 BGU/kg feed Minor poultry species Results from three studies in laying hens showed that the product has the potential to improve laying performance in laying hens at 4 XU and 9 BGU per kg feed. In the previous opinion (EFSA, 21) the FEEDAP Panel concluded that AveMix XG 1 has the potential to be efficacious for chickens for fattening at 3 XU and 6 BGU/kg complete feed. Since the mode of action of xylanases and glucanases can be reasonably assumed to be the same in all poultry species the conclusions on efficacy for major poultry species can be extrapolated to include all minor poultry species at 3 XU and 6 BGU/kg complete feed in minor fattening birds and at 4 XU and 9 BGU/kg complete feed in minor laying poultry. 6. Post-market monitoring The FEEDAP Panel considers that there is no need for specific requirements for a post-market monitoring plan other than those established in the Feed Hygiene Regulation 15 and Good Manufacturing Practice. CONCLUSIONS The two formulations (liquid and solid) of the additive are considered to be equivalent regarding the safety and efficacy for the target species when used at the same level. Laying hens tolerated a 1-fold overdose of the proposed level. Therefore, the FEEDAP Panel concludes that AveMix XG 1 is safe for laying hens at the proposed activity (4 XU and 9 BGU/kg complete feed). Since safety has been established in the major poultry species (chickens for fattening and laying hens) at 4 XU and 9 BGU/kg with a wide margin of safety, this conclusion can be extended to all minor poultry species at the activity 4 XU and 9 BGU/kg. Supplementation of the hens diets with Avemix XG 1 at the proposed activity (4 XU and 9 BGU/kg) resulted in a significantly higher egg mass in one trial and significantly improved feed to egg mass ratio in three trials. Therefore, the FEEDAP Panel concludes that AveMix XG 1 has the potential to be efficacious in laying hens at this supplementation level. Since the mode of action of xylanases and glucanases can be reasonably assumed to be the same in all poultry species, the conclusions on efficacy for major poultry species can be extrapolated to include all minor poultry species at 3 XU and 6 BGU/kg complete feed for fattening birds and at 4 XU and 9 BGU/kg complete feed for laying birds. DOCUMENTATION PROVIDED TO EFSA 1. AveMix XG 1 laying hens. May 211. Submitted by Aveve NV. 2. Supplementary information January 212. Submitted by Aveve NV. 3. Supplementary information April 212. Submitted by Aveve NV. 15 Regulation (EC) No 183/25 of the European Parliament and of the Council of 12 January 25 laying down requirements for feed hygiene. OJ L 35, , p. 1. EFSA Journal 212;1(6):2728 9

10 REFERENCES EFSA (European Food Safety Authority), 29. Safety and efficacy of AveMix XG 1 (endo-1,4- beta-xylanase and endo-1,3(4)-beta-glucanase) for use as feed additive for chickens for fattening. The EFSA Journal, 194, EFSA (European Food Safety Authority), 21. Modification of the terms of the authorisation of AveMix XG 1 (endo-1,4-beta-xylanase and endo-1,3(4)-beta-glucanase) as a feed additive for chickens for fattening. The EFSA Journal, 8(12):1919, 1 pp. EFSA (European Food Safety Authority), 211. Safety and efficacy of AveMix XG 1 (endo-1,4- beta-xylanase and endo-1,3(4)-beta-glucanase) as feed additive for weaned piglets. The EFSA Journal, 9(6):2278. EFSA Journal 212;1(6):2728 1