Scientific Opinion of the Panel on Additives and Products or Substances used in Animal Feed. (Question No EFSA-Q ) Adopted on 18 October 2007

Transcription

1 The EFSA Journal (2007) 573, 1-5 Compatibility of the microbial preparation of licheniformis and subtilis (BioPlus 2B) with the coccidiostat lasalocid A sodium in feed for turkeys 1 Scientific Opinion of the Panel on Additives and Products or Substances used in Animal Feed (Question No EFSA-Q ) Adopted on 18 October 2007 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 SUMMARY Following a request from the European Commission (EC), the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to assess the compatibility of the micro-organism product BioPlus 2B with lasalocid A sodium when mixed in turkey feed. In a previous opinion, the FEEDAP Panel concluded that the compatibility of BioPlus 2B with lasalocid A sodium (Avatec 15 %) was not established. In response to this, the applicant provided an in vivo trial with one-day-old turkeys given feed supplemented with BioPlus 2B or BioPlus 2B + lasalocid A sodium 15 % (30 birds per treatment). The results of this study did not reveal any significant differences between the experimental groups for the studied zootechnical parameters or morbidity/mortality. The absence of statistical differences in the total spore counts based on 30 animals per treatment provides evidence of the compatibility between lasalocid A sodium and BioPlus 2B in spore form. However, spores are able to germinate in the digestive tract to an unknown extent and it is likely that the vegetative form would be more susceptible to coccidiostats. Data was provided which attempted to distinguish between the sensitivity of spores and vegetative cells but this was insufficient to allow statistical assessment. Consequently, the FEEDAP Panel is unable to conclude on the compatibility of BioPlus 2B with lasalocid A sodium. Key words: micro-organisms, BioPlus 2B, licheniformis, subtilis, turkeys for fattening, lasalocid A sodium, compatibility 1 For citation purposes: Scientific Opinion of the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) on a request from the European Commission on the compatibility of the microbial preparation of licheniformis and subtilis (BioPlus 2B) with the coccidiostat lasalocid sodium in feed for turkeys. The EFSA Journal (2007) 573, 1-5 European Food Safety Authority, 2007

2 BioPlus 2B for turkeys Compatibility with lasalocid sodium TABLE OF CONTENTS Panel Members...1 Summary...1 Table of Contents...2 Background as provided by EC...3 Terms of reference as provided by EC...3 Acknowledgements...3 Assessment Introduction Compatibility with lasalocid A sodium...4 Conclusions...5 Documentation provided to EFSA...5 References...5 The EFSA Journal (2007) 573, 2-5

3 BACKGROUND AS PROVIDED BY EC BioPlus 2B for turkeys Compatibility with lasalocid sodium Regulation (EC) No 1831/ 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 the authorisation. This Regulation replaces Council Directive 70/524/EEC. The Regulation also foresees the possibility to modify authorisations already given in accordance with its Article 13. The company Chr. Hansen A/S is seeking to modify the current Community authorisation and has requested an assessment of the compatibility of its additive licheniformis DSM 5749 and subtilis DSM 5750 (BioPlus 2B) with the coccidiostat lasalocid A sodium. (Table 1). Table 1. Description of the preparation under Regulation (EC) No 600/2005 Product category Micro-organisms Trade name - Description licheniformis DSM 5749 and subtilis DSM 5750 (in ratio 1/1) containing a minimum 3.2 x 10 9 CFU g -1 (1.6 x 10 9 of each bacterium) Target animal category Turkeys for fattening Applicant Chr. Hansen A/S Type of request Modification of authorisation The EFSA, in its opinion adopted on 22 September 2005 (Opinion of the Scientific Panel on Additive and Products or Substance used in Animal Feed on the modification of terms of authorisation of the micro-organism product licheniformis DSM 5749 and subtilis DSM 5750 (BioPlus 2B) authorised as feed additive in accordance with Council Directive 70/524/EEC), was not able to give a conclusive opinion on the compatibility because of lack of data and inadequacy of tests provided by the company. Therefore, the Commission gave the possibility to the company to submit complementary information to complete the assessment. The Commission has received a supplementary dossier from the applicant company Chr. Hansen A/S containing new data on compatibility of BioPlus 2B with Lasalocid sodium. The data generated by the company and complied in the above mentioned supplementary dossier have been sent directly to the Authority. TERMS OF REFERENCE AS PROVIDED BY EC In view of the above, the Commission asks to the European Food Safety Authority to deliver an opinion on the compatibility of this additive with the coccidiostat lasalocid sodium under the authorised conditions of use. ACKNOWLEDGEMENTS The European Food Safety Authority wishes to thank the members of the Working Group on Micro-organisms for the preparation of this opinion. 2 OJ L 268, , p.29 The EFSA Journal (2007) 573, 3-5

4 BioPlus 2B for turkeys Compatibility with lasalocid sodium ASSESSMENT 1. Introduction In a previous opinion (EFSA, 2005), the FEEDAP Panel concluded that the compatibility of BioPlus 2B with lasalocid A sodium (Avatec 15 %) was not established. The in vivo growth study provided, involving four experimental groups (control, BioPlus 2B, coccidiostat, BioPlus 2B + coccidiostat), did not make it possible to demonstrate the survival of the bacilli in presence of lasalocid A sodium. The applicant has now provided a supplementary in vivo study. 2. Compatibility with lasalocid A sodium One-day-old female turkeys were individually identified by coloured, numbered wing bands and randomly distributed to experimental groups (30 birds per treatment). One treatment was supplemented with BioPlus 2B at the minimum recommended dose (1.28 x 10 9 spores kg -1 ) and the other was supplemented with BioPlus 2B at 1.28 x 10 9 spores kg -1 feed and lasalocid A sodium at a dose of 125 mg of active substance per kg feed. The experiment duration was 42 days. The animals were allocated in groups of three birds and there were ten replicates per treatment. The diet, based on wheat, corn and soybean meal and added essential amino acids, was prepared three to four weeks before onset of the experiment. Care was taken to avoid cross-contamination in the manufacture of feed. No other antibiotic or medicinal substances were added to the diets. The content of BioPlus 2B viable spores were checked in all supplemented feed batches and were always found close to the expected value. Zootechnical parameters (feed intake, body weight and feed conversion ratio), mortality and morbidity were measured or monitored. Caecal samples from all turkeys were collected aseptically after slaughter and total spores were enumerated. The pen means for body weight, intake and feed conversion and mortality were analysed by ANOVA as a randomised block experiment to compare dietary treatments. Caecal spore counts were tested statistically by a student t-test. The results of this study did not reveal any significant differences between the experimental groups for the different studied zootechnical parameters (body weight from 2.51 kg to 2.60 kg, feed conversion ratio from 1.69 to 1.73) and for mortality or morbidity. Only two birds died at the beginning of the experiment and were replaced. The mean caecal spore counts were 2.77 x 10 5 and 3.07 x 10 5 CFU g -1 for BioPlus 2B and BioPLus 2B + lasalocid, respectively, which were not significantly different. There is evidence of the germination of spores in the digestive tract of experimental animals (Hong et al., 2005). The applicant performed a second approach involving a selective medium and heat treatment to distinguish between vegetative cells and spores using the caecal samples from two animals from each treatment. Microbial counts given in Table 2 indicate that total caecal counts in animals treated with BioPlus 2B and lasalocid A sodium were in the same range than those in animals treated with BioPlus 2B alone. However, the use of only two animals per treatment did not allow statistical evaluation. When considering the individual B. licheniformis or B. subtilis enumerations in caecal contents, similar counts were found in animals whether on not treated with lasalocid A sodium. The EFSA Journal (2007) 573, 4-5

5 Table 2. Treatment BioPlus 2B BioPlus 2B + lasalocid BioPlus 2B for turkeys Compatibility with lasalocid sodium counts (CFU ml -1 ) of vegetative cells and spores (without heat treatment) and total spore count (with heat treatment) in caecal samples of animals treated with BioPlus 2B and BioPlus 2B + lasalocid A sodium Total counts Without heat treatment licheniformis subtilis Total counts With heat treatment licheniformis subtilis 5.8 x x x x x x x x x x x x x x x x x x x x x x x x 10 4 CONCLUSIONS The absence of statistical differences in the total spore counts based on 30 animals per treatment provides evidence of the compatibility between lasalocid A sodium and BioPlus 2B in spore form. However, spores are able to germinate in the digestive tract to an unknown extent and it is likely that the vegetative form would be more susceptible to coccidiostats. Some data was provided which attempted to distinguish between the sensitivity of spores and vegetative cells but this was insufficient to allow statistical assessment. Consequently, the FEEDAP Panel is unable to conclude on the compatibility of BioPlus 2B with lasalocid A sodium. DOCUMENTATION PROVIDED TO EFSA 1. BioPlus 2B. Supplementary dossier vol. 34. Compatibility with the permitted coccidiostat lasalocid A sodium (Avatec 15 %) in feedingstuffs for turkeys. August Submitted by Chr. Hansen A/S. 2. Supplementary information on the evaluation of BioPlus 2B ( licheniformis and subtilis). Compatibility with lasalocid sodium (EFSA-Q ). July Submitted by Chr. Hansen A/S. REFERENCES EFSA (European Food Safety Authority), Opinion of the Scientific Panel on Additives and Products or Substances used in Animal Feed on the modification of terms of authorisation of the micro-organism product licheniformis (DSM 5749) and subtilis (DSM 5750) (BioPlus 2B) authorised as a feed additive in accordance with Council Directive 70/524/EEC. < Hong, H.A., Duc, L.H. and Cutting, S.M., The use of bacterial spore formers as probiotics. FEMS Microbiology Reviews. 29, The EFSA Journal (2007) 573, 5-5