Safety and efficacy of Biosaf Sc 47 (Saccharomyces cerevisiae) as feed additive for pigs for fattening 1

Transcription

1 The EFSA Journal (2007) 585, 1-9 Safety and efficacy of Biosaf Sc 47 (Saccharomyces cerevisiae) as feed additive for pigs for fattening 1 Scientific Opinion of the Panel on Additives and Products or Substances used in Animal Feed (Question No EFSA-Q ) Adopted on 22 November 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, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the use of Biosaf Sc 47, a preparation consisting of the yeast Saccharomyces cerevisiae, in pigs for fattening. This additive is already authorised for use in cattle for fattening, dairy cows, rabbits for fattening, sows, piglets, lambs for fattening, horses, dairy goats and dairy sheep. The applicant is now asking for authorisation to use the additive in feed for pigs for fattening at a dose range of 1.25 x x CFU kg -1 complete feed. The FEEDAP Panel considers that the safety of this organism for the consumer, the user and the environment has already been established and would not be changed by the proposed extension of use. Consequently, in the present opinion only the safety and efficacy of the additive for the proposed additional target species are considered. The efficacy of the product in pigs for fattening has been demonstrated at the lowest recommended dose in three studies, in which significant improvements were seen in performance parameters. In all three studies daily weight gain was significantly improved, and in two of the studies there was a significant improvement of feed to gain ratio. Since the product was shown to be safe for weaned piglets, the FEEDAP Panel considers that safety for pigs for fattening can be assumed. 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 and efficacy of Biosaf Sc 47 (Saccharomycescerevisiae) as feed additive for pigs for fattening. The EFSA Journal (2007) 585, 1-9 European Food Safety Authority, 2007

2 Key words: zootechnical additive, gut flora stabilisers, Biosaf Sc 47, Saccharomyces cerevisiae, pigs for fattening, efficacy, safety The EFSA Journal (2007) 585, 2-9

3 TABLE OF CONTENTS Panel Members...1 Summary...1 Table of Contents...3 Background...4 Terms of reference...4 Acknowledgements...4 Assessment Introduction Characterisation of the product Evaluation of the analytical methods by the Community Reference Laboratory (CRL) Efficacy Safety for the target species Post-market monitoring...7 Conclusions...8 Documentation provided to EFSA...8 References...8 Appendix...9 The EFSA Journal (2007) 585, 3-9

4 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 lays 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 Lesaffre Feed Additives 3 for authorisation of the product Biosaf Sc 47 to be used as a feed additive for pigs for fattening (category: zootechnical additives; functional group: gut flora stabilisers) under the conditions described 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 10 August The additive Biosaf Sc 47 is a preparation of Saccharomyces cerevisiae NCYC Sc 47. This product is already permanently authorised for use in cattle for fattening, dairy cows, rabbits for fattening, sows and piglets (E 1702). It has also been authorised under Regulation (EC) No 1831/2003 for lambs for fattening, 4 horses 5 and dairy goats and dairy sheep. 6 The Scientific Committee on Animal Nutrition (SCAN) issued an opinion on the safety of this product for the piglets, sows, beef and dairy cattle, including the safety for the user, the consumer and the environment (EC, 1997/2003), and another on the efficacy for cattle for fattening (EC, 2002). EFSA issued four opinions on the safety and efficacy of this product for the following species: lambs for fattening (EFSA, 2006), dairy small ruminants (EFSA, 2006), horses (EFSA, 2006) and calves for rearing (EFSA, 2007). 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, user and consumer and the environment of the additive Biosaf, which is a preparation of the yeast Saccharomyces cerevisiae NCYC Sc 47 when used under the conditions described in Table 1. 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 3 Lesaffre Feed Additives, 1 rue du Haut Touquet Marquette-Lez-Lille, France 4 OJ L 271, , p.28 5 OJ L 63, , p.6 6 OJ L 57, , p.3 The EFSA Journal (2007) 585, 4-9

5 Table 1. Register entry as proposed by the applicant Additive Saccharomyces cerevisiae NCYC Sc 47 Registration number/ec No/No Category of additive Zootechnical additives Functional group of additive Gut flora stabilisers Composition, description Preparation of Saccharomyces cerevisiae NCYC Sc 47 containing a minimum of 5 x 10 9 CFU g -1 of additive Chemical formula Description Purity criteria Method of analysis - Not appropriate Not appropriate Trade name BIOSAF Sc 47 Name of the holder of authorisation Société Industrielle Lesaffre Conditions of use Species or category of animal Maximum Age Minimum content Maximum content mg (or Units of activity or CFU) kg -1 of complete feedingstuffs Withdrawal period Pigs for fattening x x Not appropriate 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 labelling Reserved exclusively to the manufacture of animals feed Production/ expiry dates and batch number printed on the commercial packaging Stable for pellets at dye temperatures up to 83 C Stable for milk replacer at milk temperature under 62 C and for mix preparation time under 5 minutes Store in a cool and dry place Not appropriate Not appropriate Marker residue Maximum Residue Limit (MRL) Species or category of animal Target tissue(s) or food products Maximum content in tissues Not appropriate Not appropriate Not appropriate Not appropriate The EFSA Journal (2007) 585, 5-9

6 ASSESSMENT 1. Introduction The microbial additive Biosaf Sc 47, which is based on a well-known and researched strain of bakers/brewers yeast (Saccharomyces cerevisiae), has been assessed for its safety when included in feed for farmed animals. The Scientific Committee on Animal Nutrition (SCAN) issued a first opinion on the safety of this product for the piglets, sows, beef and dairy cattle, including the safety for the user, the consumer and the environment (EC, 1997/2003), and a second on its efficacy for cattle for fattening (EC, 2002). EFSA issued four opinions on the safety and efficacy of this product: lambs for fattening (EFSA, 2006), dairy small ruminants (EFSA, 2006), horses (EFSA, 2006) and calves for rearing (EFSA, 2007). The FEEDAP Panel is not aware of any new or additional information that would lead to the revision of those opinions. Given the ubiquitous nature of the organism, its long history of safe use in human food and food production, the FEEDAP Panel considers that the safety of this organism for the consumer, the user and the environment is established and will not be changed by the proposed extension of use. Consequently, in the present assessment the FEEDAP Panel has considered only the efficacy and the safety of the additive for the proposed additional target species. 2. Characterisation of the product The additive is composed of a concentrate of dried live yeast Saccharomyces cerevisiae (NCYC Sc 47). The S. cerevisiae strain is deposited in the UK National Collection of Yeast Cultures and can be identified and distinguished from other strains of yeast by pulsed field gel electrophoresis or by DNA hybridisation techniques. The additive contains a minimum of 5 x 10 9 CFU g -1 with a dry matter concentration of 91 to 94 %. It is intended for use in feed for pigs for fattening to improve growth at a minimum content of 1.25 x 10 9 and a maximum content of 1.0 x CFU kg -1 complete feedingstuff. Quality control parameters are in place for heavy metals (cadmium, lead, arsenic and mercury) and bacterial contaminants (coliforms, Escherichia coli, Staphylococcus aureus, Salmonella and Clostridium perfringens). The stability of the additive after storage at different temperatures in its original packaging, opened packages and during feed processing and subsequent storage was considered by the SCAN and found satisfactory for farming practices. Newly provided data supports that the shelf life of the product is 12 months 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 feed. The Executive Summary of the CRL report can be found in the Appendix. 3. Efficacy Three recent studies with similar experimental designs using the minimum recommended dose are reported. The number of animals, the duration of the studies and the main results are given in Table 2. All three studies comprised the growing period of the slaughter pigs, starting at 70 - The EFSA Journal (2007) 585, 6-9

7 72 days and lasting until days from birth, and the finishing period lasting 48 to 60 days. In trial 1, the data on individual feed intake are not reported. In trial 3, the same feed composition was used for both periods, whereas in trials 1 and 2 the feed composition differed for the two test periods. Biosaf Sc 47 was incorporated in the feed at the lowest recommended dose during the study periods, except for the control groups. In trials 1 and 3, all piglets were given Biosaf Sc 47 from weaning at approximately 28 days to the start of the experiment, when Biosaf was withdrawn from the control group. The pigs were individually weighed, the feed intake measured on a pen basis (trial 1, two-pen basis) at the start, at halfway and at the end of the trials. No health disorders were reported in any of the trials. Final live weight, average daily gain (ADG), feed intake and feed conversion were measured and calculated. The results were analysed by the GLM procedure. The content of live yeast in the complete feed was examined in all the trials and was within the expected range. Table 2. Trial Summary of efficacy studies performed with Biosaf Sc 47 in pigs for fattening Total number of animals (replicates/treatment) pigs/replicate (8) (4) (3) 15 Duration (days) Dose (CFU kg -1 ) Initial live weight (kg) x x x * : Statistically significantly different to the negative control (P<0.05) **: Statistically significantly different to the negative control (P<0.01) Final weight (kg) ADG (g day -1 ) Feed/gain (kg kg -1 ) * 837 * ** 681 ** 2.30 * * 794 ** 2.13 ** In trials 2 and 3, final weight, ADG and feed to gain ratio were significantly improved (P<0.01). In trial 1, only the final weight and ADG were significantly improved compared to the control group (P<0.05). In trial 2, significant reduction of the feed intake was observed (1.65 vs kg day -1, P<0.01). 4. Safety for the target species Safety has been demonstrated for weaned piglets, for which Biosaf Sc 47 is already authorised. Piglets are considered a more sensitive category and therefore an additional tolerance study in pigs for fattening is not required. 5. Post-market monitoring No risks associated with the use of the product are foreseen. It is considered that there is no 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 Manufacturing Practice. 7 Technical dossier/section III/Appendix Technical dossier/section III/Appendix Technical dossier/section III/Appendix 3.7 The EFSA Journal (2007) 585, 7-9

8 CONCLUSIONS The efficacy of Biosaf Sc 47 has been demonstrated at the lowest recommended dose (1.25 x 10 9 CFU kg -1 complete feed) for pigs for fattening in three trials. Since the product was shown to be safe for weaned piglets, the FEEDAP Panel considers that safety for pigs for fattening can be assumed. DOCUMENTATION PROVIDED TO EFSA 1. Biosaf Sc 47 (Saccharomyces cerevisiae Sc 47 Strain). Additive for pigs for fattening. April Submitted by Lesaffre Feed Additives. 2. CRL evaluation report on the analytical methods of Biosaf Sc 47 for pigs for fattening. 3. Comments from the Member States received through the EFSAnet. REFERENCES EC (European Commission), 1997, updated Scientific Committee on Animal Nutrition. Opinion on the use of certain micro-organisms as additives in feedingstuffs. < EC (European Commission), Scientific Committee on Animal Nutrition. Evaluation of the efficacy of micro-organism product Biosaf Sc 47. < EFSA (European Food Safety Authority), Opinion of the Scientific Panel on additives and products or substances used in animal feed (FEEDAP) on the safety and efficacy of the product Biosaf Sc 47, a preparation of Saccharomyces cerevisiae (NCYC Sc 47), as a feed additive for lambs in accordance with Regulation (EC) No 1831/2003. < EFSA (European Food Safety Authority), Opinion of the Panel on additives and products or substances used in animal feed (FEEDAP) on the safety and efficacy of the product Biosaf Sc 47, a preparation of Saccharomyces cerevisiae, as a feed additive for dairy small ruminants. < EFSA (European Food Safety Authority), Opinion of the Panel on additives and products or substances used in animal feed (FEEDAP) on the safety and efficacy of the product Biosaf Sc 47, a preparation of Saccharomyces cerevisiae, as a feed additive for horses. < EFSA (European Food Safety Authority), Opinion of the Scientific Panel on additives and products or substances used in animal feed (FEEDAP) on the safety and efficacy of Biosaf Sc 47, a preparation of Saccharomyces cerevisiae, as a feed additive for calves for rearing according to Regulation (EC) No 1831/2003. < The EFSA Journal (2007) 585, 8-9

9 APPENDIX Executive Summary of the Evaluation Report of the Community Reference Laboratory Feed Additives Authorisation on the Method(s) of Analysis for Biosaf Sc 47 for pigs for fattening In the current application authorisation is sought for the microbial feed additive BIOSAF Sc47 under the category 'zootechnical additives', functional group 'gut flora stabilisers' according to Annex I of Regulation (EC) No 1831/2003. Specifically, the use of BIOSAF Sc47 for pigs for fattening is requested. BIOSAF Sc47 contains a minimum of 5 x 10 9 of viable cells (c.f.u., colony-forming units) of Saccharomyces cerevisiae NCYC Sc47 (as active agent) per gram. The feed additive is intended to be mixed into complete feedingstuffs at a final concentration of 1.25 x 10 9 to 1.00 x c.f.u./kg. For the determination of the active agent, a strain of Saccharomyces cerevisiae NCYC Sc47, in the feed additive, a pour plate method and a molecular identification method (polymerase chain reaction (PCR)) are proposed by the applicant, which are considered appropriate. For the determination of the active agent S. cerevisiae NCYC Sc47 in feedingstuffs a similar pour plate method for enumeration and the same molecular PCR method for identification of the strain are proposed. The enumeration method was validated in a collaborative study [System. Appl. Microbiol , ]. The method s performance characteristics of the enumeration method are standard deviations for repeatability (s r ) and reproducibility (s R ) of around log 10 and log 10 calculated from the base 10 logarithms of the measured c.f.u./g in feedingstuffs, respectively. The limits of quantification (LOQ) of this method are 100 colony forming units (c.f.u) per gram (g) feed additive or premixture and 10 7 c.f.u./kg feedingstuff to take account of natural background flora. These performance characteristics are considered acceptable. This method is recommended for official controls of the active agent in the feed additive, premixtures and feedingstuffs. The PCR method for strain identification was ring trial validated and demonstrated a high level of correct identification between laboratories [System. Appl. Microbiol , ]. It is therefore considered appropriate for official controls. On the basis of the supplied documentation, no supplementary experimental work (testing or method validation) is required. The EFSA Journal (2007) 585, 9-9