The EFSA Journal (2007) 614, 1-5 Safety of the enzymatic preparation Natuphos (3-phytase) for sows 1 Scientific Opinion of the Panel on Additives and Products or Substances used in Animal Feed (Question No EFSA-Q-2007-189) Adopted on 12 December 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 deliver a scientific opinion on the safety of the enzymatic preparation Natuphos (3-phytase) for sows. Natuphos is a preparation of 3-phytase (EC 3.1.3.8) produced by a genetically modified strain of Aspergillus niger, presented in solid and liquid forms. It is already authorised as a feed additive for weaned piglets, pigs for fattening, chickens for fattening, laying hens and turkeys for fattening. In a previous opinion the FEEDAP Panel could not conclude on the safety of this enzyme preparation for sows due to the short duration of the tolerance study provided. The applicant has now provided a new tolerance study in sows. Based on the tolerance study performed on sows during one reproduction cycle with a 200X overdose of Natuphos, the FEEDAP Panel concludes that Natuphos is safe for sows at the recommended dose, supplied either in solid or liquid form. Key words: zootechnical additive, digestibility enhancer, Natuphos, 3-phytase, Aspergillus niger, enzyme, sows, safety 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 safety of the enzymatic preparation Natuphos (3-phytase) for sows. The EFSA Journal (2007) 614, 1-5 European Food Safety Authority, 2007
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...4 1. Introduction...4 2. Tolerance study for sows...4 Conclusions...5 Documentation provided to EFSA...5 References...5 The EFSA Journal (2007) 614, 2-5
BACKGROUND AS PROVIDED BY EC Regulation (EC) No 1831/2003 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. The company BASF is seeking Community authorisation of its enzyme product with the trade name Natuphos "STIPT" as a feed additive intended for use in sows (Table 1). Table1. Description of the preparation Category of additive Zootechnical additive Functional group of additive Digestibility enhancer Trade name Natuphos Description Preparation of 3-phytase produced by Aspergillus niger (CBS 101.672) Target animal category sows Applicant BASF Type of request Update opinion On June 15th in 2006, the Scientific Panel on Additives and Products or Substances used in Animal Feed of the European Food Safety Authority adopted on a request from the Commission an opinion on the safety of enzyme preparation with the trade name Natuphos, as feed additive for sows (EFSA-Q-2005-116). It was concluded that there is not enough evidence to conclude on the safety of this enzyme preparation for sows. 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 BASF containing new tolerance studies for the target species, sows. 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 safety of this enzyme preparation as feed additive for sows, taking into account its earlier opinion on 15 June 2006 and the new data submitted. ACKNOWLEDGEMENTS The European Food Safety Authority wishes to thank the members of the Working Group on Enzymes as well as Friedrich Schöne for the preparation of this opinion. The EFSA Journal (2007) 614, 3-5
ASSESSMENT 1. Introduction The additive Natuphos is a preparation of 3-phytase (EC 3.1.3.8) produced by a genetically modified strain of Aspergillus niger (CBS 101.672, NPH54), presented in solid (up to 10000 FTU g -1 ) and liquid (up to 10000 FTU ml -1 ) forms. It is already authorised for weaned piglets, pigs for fattening and chickens for fattening (Regulation (EC) No 243/2007) 2 and for laying hens and turkeys for fattening (Regulation (EC) No 1142/2007) 3. In a previous opinion, the FEEDAP Panel could not conclude on the safety of this enzyme preparation for sows due to the short duration of the study provided (EFSA, 2006). The applicant has now provided a new tolerance study in sows. The recommended dose in sows is 500 FTU kg -1 feed. 2. Tolerance study for sows Fifty six sows (German Yorkshire x Scandinavian Landrace) of parity one to six were blocked on the basis of parity, and sows from each block were randomly allocated to the three treatments. The experimental treatments resulted from the supplementation of a basal diet with Natuphos in solid form at 0, 1000 (2X) and 100000 FTU kg -1 (200X the recommended dose) complete feed (gestation, lactation). Activities of the enzyme in the diets were confirmed by analysis. The experiment lasted for one full reproductive cycle, from mating to weaning. From mating to day 108 of gestation, all sows were individually housed and received gestation diets; from day 108 on, the sows were moved to the farrowing pens and fed lactation diets until the end of the experiment, at weaning. The sows were observed daily for health condition. In case of clinical signs of sickness, medical treatments were registered. Sows were weighed and backfat thickness measured at mating, farrowing and weaning. Litter size was standardised before day 3 post-farrowing. Piglets were weighed at birth and at weaning (27 days). Table 2. Effect of Natuphos during gestation and lactation of sows on performance and fat thickness, gestation length, litter size, litter weight at weaning and piglet losses during the suckling period Natuphos (FTU kg -1 ) 0 1000 100000 Number of sows 16 17 17 Body weight (mating), kg 190.2 192.1 191.9 Body weight (farrowing), kg 250.3 248.7 250.6 Body weight (weaning), kg 214.7 213.8 215.6 Backfat thickness (mating), mm 15.8 14.6 15.4 Backfat thickness (farrowing), mm 20.8 19.7 20.5 Backfat thickness (weaning), mm 17.1 15.3 16.7 Gestation length, days 115.2 115.7 115.7 Total born piglets, n 13.7 15.0 14.0 Live born piglets, n 13.0 14.1 13.2 Litter weight at birth, kg 19.0 18.4 19.6 Standardised litter size, n 12.1 12.6 11.7 Weaned piglets, n 10.8 10.9 10.8 Litter weight at weaning, kg 89.2 89.0 91.1 Mortality, % 9.9 13.1 6.8 2 OJ L 73, 13.3.2007, p. 4 3 OJ L 256, 2.10.2007, p. 20 The EFSA Journal (2007) 614, 4-5
Six sows did not complete the trial for several reasons unrelated to treatment (fertility problem, litter size below criteria, diarrhoea, low feed intake): control diet (n=3), 1000 FTU kg -1 (n=1) and 100000 FTU kg -1 (n=2). No statistically significant differences in performance or backfat thickness of sows, in litter size or in piglet performance were noted between the treatments (Table 2). CONCLUSIONS Based on the tolerance study performed on sows during one reproduction cycle with a 200X overdose of Natuphos, the FEEDAP Panel concludes that Natuphos is safe for sows at the recommended dose, supplied either in solid or liquid form. DOCUMENTATION PROVIDED TO EFSA 1. Natuphos in sows. Supplementary information. August 2007. Submitted by BASF Aktiengesellschaft. REFERENCES EFSA (European Food Safety Authority), 2006. Opinion of the Scientific Panel on additives and products or substances used in animal feed (FEEDAP) and the opinion of the Scientific Panel on genetically modified organisms (GMO) on the safety and efficacy of the enzyme preparation Natuphos (3-phytase) produced by Aspergillus niger. <http://www.efsa.europa.eu/efsa/efsa_locale-1178620753812_1178620782877.htm> The EFSA Journal (2007) 614, 5-5