Safety and efficacy of Levucell SC20/Levucell SC10ME, a preparation of Saccharomyces cerevisiae, as feed additive for lambs for fattening 1,2

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1 The EFSA Journal (2008) 772, 1-9 Safety and efficacy of Levucell SC20/Levucell SC10ME, a preparation of Saccharomyces cerevisiae, as feed additive for lambs for fattening 1,2 Scientific Opinion of the Panel on Additives and Products or Substances used in Animal Feed (Question No EFSA-Q ) Adopted on 16 July 2008 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 European Food Safety Authority (EFSA) was asked to deliver a scientific opinion on the safety and efficacy of Levucell SC20/Levucell SC10ME, a preparation consisting of the yeast Saccharomyces cerevisiae, for lambs for fattening. This additive is already authorised without a time limit for use in dairy cows and cattle for fattening and has been granted a ten-year authorisation for use in dairy goats and dairy ewes. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) 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. Moreover, Saccharomyces cerevisiae is considered by EFSA to have QPS status and therefore no assessment of safety for the target species, the consumer and the wider environment is required. Consequently, in the present assessment the FEEDAP Panel has considered only the efficacy of the additive Levucell SC20/Levucell SC10ME for the target species. Five trials were provided to demonstrate efficacy of Levucell in lambs for fattening. Evidence that the additive is able to produce a beneficial effect on final weight and average daily gain was shown in three of the five studies provided. However, only one of those trials was performed using the minimum recommended dose for the entire experimental period; consequently, the FEEDAP Panel concludes on the efficacy of Levucell SC10ME at the maximum recommended dose (7.3 x 10 9 CFU/kg feedingstuffs). The FEEDAP Panel extends the above conclusions to both forms of Levucell SC. 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 Levucell SC20/Levucell SC10ME, a preparation of Saccharomyces cerevisiae, as feed additive for lambs for fattening. The EFSA Journal (2008) 772, This scientific opinion has been edited following the provisions of Article 8(6) and Article 18 of Regulation (EC) No 1831/2003. The modified sections are indicated in the text. European Food Safety Authority, 2008

2 Key words: zootechnical additive, gut flora stabilisers, Levucell SC, Saccharomyces cerevisiae, lambs for fattening, efficacy, safety, QPS The EFSA Journal (2008) 772, 2-9

3 TABLE OF CONTENTS Panel Members... 1 Summary... 1 Table of Contents... 3 Background... 4 Terms of reference... 4 Assessment Introduction Characterisation of the product Intended use of the product Evaluation of the analytical methods by the Community Reference Laboratory (CRL) Efficacy... 8 Documentation provided to EFSA... 8 References... 8 Appendix... 9 The EFSA Journal (2008) 772, 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 Lallemand SAS 4 for authorisation of the product Levucell SC20/Levucell SC10ME to be used as a feed additive for lambs (category: zootechnical additives, functional group: gut flora stabilizers) under the conditions mentioned under 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 22 January The additive Levucell SC20/Levucell SC10ME is a preparation of Saccharomyces cerevisiae (CNCM I-1077). This product has been authorised without a time limit for use in dairy cows and cattle for fattening (E 1711) 5 and has been granted a ten-year authorisation for use in dairy goats and dairy ewes. 6 The Scientific Committee on Animal Nutrition (SCAN) issued an opinion on the safety of this product for beef and dairy cattle, including safety for the user, the consumer and the environment (EC, 1997, updated 2003). The FEEDAP Panel has issued two opinions on the safety and efficacy of this product, one for dairy goats and dairy ewes (EFSA, 2006a) and another one for leisure horses (EFSA, 2006b). 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. EFSA shall deliver an opinion on the efficacy and the safety for the target animal(s), user and consumer and the environment of the product Levucell SC20/Levucell SC10ME, which is a preparation of Saccharomyces cerevisiae (CNCM I-1077), when used under the conditions described in Table 1. 3 OJ L 268, , p.29 4 Lallemand SAS, 19, Rue des Briquetiers, Blagnac, France 5 OJ L 195, , p OJ L 64, , p The EFSA Journal (2008) 772, 4-9

5 Table 1. Register entry as proposed by the applicant Additive Saccharomyces cerevisiae CNCM I-1077 Registration number/ec No/No 4b1711 Category of additive Functional group of additive Zootechnical Gut flora stabiliser Description Composition, description Non coated form : > 20 x 10 9 cfu g -1 of active yeast cells of Saccharomyces cerevisiae (CNCM I- 1077). 5% residual water Coated form: 50% non coated form 50% fatty acids Chemical formula Not applicable Purity criteria Se < 1 ppm As < 5 ppm Cd < 1 ppm Hg < 0,1 ppm Pb < 5 ppm Aflatoxins < 1 µg kg -1 Zearalenone < 20 µg kg -1 Ochratoxine < 10 µg kg -1 Coliforms < 10 g -1 Pathogenic Staph. < 100 g -1 SRA < 10 g -1 C. perfringens < 10 g -1 Salmonella: 0 Method of analysis Active dry yeast cell count: Sabouraud medium + chloramphenicol Biochemical stability: API 20 C gallery Genetic purity: PCR method Trade name Name of the holder of authorisation LEVUCELL SC20 / LEVUCELL SC10ME LALLEMAND SAS Species or category of animal Conditions of use Maximum Age Minimum content Maximum content CFU/kg of complete feedingstuffs Withdrawal period Lambs x x Other provisions and additional requirements for the labelling Specific conditions or restrictions for use (if appropriate) Specific conditions or restrictions for handling (if appropriate) Post market monitoring (if appropriate) Specific conditions for use in complementary feedingstuffs (if appropriate) Use the coated form for any inclusion through a pelleted feed If the product is handled or mixed in confined atmosphere, it is recommended to use safety glasses and masks for mixing if the mixers are not equipped with exhaust systems Not applicable Do not overpass 50ºC with Levucell SC20 and 80ºC with Levucell SC10ME Maximum Residue Limit (MRL) (if appropriate) The EFSA Journal (2008) 772, 5-9

6 Marker residue Species or category of animal Target tissue(s) or food products Maximum content in tissues Not applicable The EFSA Journal (2008) 772, 6-9

7 ASSESSMENT 1. Introduction The microbial feed additive Levucell SC20/Levucell SC10ME, a product consisting of dried cells of Saccharomyces cerevisiae (CNCM I-1077), is authorised for use in dairy cows, cattle for fattening and dairy goats and dairy ewes. The current dossier contains data supporting a request for an extension of use in feed of the additive Levucell SC20/Levucell SC10ME to lambs. The Scientific Committee on Animal Nutrition (SCAN) issued an opinion on the safety of this product for beef and dairy cattle, including safety for the consumer, the user and the environment (EC, 1997, updated 2003). The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) is not aware of any new or additional information that would lead to the revision of the opinion. Moreover, Saccharomyces cerevisiae is considered by the European Food Safety Authority (EFSA) to have QPS status (EFSA, 2007) and therefore no assessment of safety for the target species, the consumer, and the wider environment is required. Consequently, in the present assessment the FEEDAP Panel has considered only the efficacy of the additive Levucell SC20/Levucell SC10ME for the target species. 2. Characterisation of the product The active ingredient of the additive Levucell SC20/Levucell SC10ME is the yeast Saccharomyces cerevisiae CNCM I The additive Levucell SC is composed of approximately 80 % revivable Saccharomyces cerevisiae dried yeast cells and approximately 14 % non-viable Saccharomyces cerevisiae yeast cells which lost their viability during the drying process. This feed additive is available under two forms: - Levucell SC20, with a guaranteed minimal concentration of viable yeast cells in the additive of 2 x CFU g -1 - Levucell SC10ME, coated formula, with a guaranteed minimal concentration of viable yeast cells in the additive of 1 x CFU g -1 The yeast strain Saccharomyces cerevisiae CNCM I-1077 was deposited at the Collection Nationale de Cultures De Microorganismes (CNCM) of the Institut Pasteur, in Paris, France. The biochemical and physiological characteristics of this strain have been described and the strain has been unambiguously identified and characterised by means of genetic techniques, such as genomic DNA genetic fingerprints using Restriction Fragment Length Polymorphism (RFLP), genomic DNA karyotype by pulsed field electrophoresis, mitochondrial DNA polymorphism using RFLP and repeated yeast sequence PCR Intended use of the product The product is intended for use in feed for lambs at a minimum content of 3 x 10 9 and a maximum content of 7.3 x 10 9 CFU kg -1 of complete feedingstuff 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 agent in animal feed. The Executive Summary of the CRL report can be found in the Appendix. The EFSA Journal (2008) 772, 7-9

8 3. Efficacy 7 Levucell SC20/SC10ME for lambs for fattening Five studies were performed which aimed at assessing the potential of the additive to improve lambs performance. In all five studies the coated form of the product (Levucell SC10ME) was used and in each case the intended dose confirmed by analysis of treated feed. Of these five studies, two 8 were not further considered due to flaws in the experimental design and the extensive use of antimicrobial therapeutic agents. Evidence that the additive is able to produce a beneficial effect on final weight and average daily gain was shown in the remaining three studies provided. 9 However, only one of those trials was performed using the minimum recommended dose for the entire experimental period; consequently, the FEEDAP Panel concludes on the efficacy of Levucell SC 10 ME at the maximum recommended dose (7.3 x 10 9 CFU/kg feedingstuffs). The FEEDAP Panel extends the above conclusions to both forms of Levucell SC. DOCUMENTATION PROVIDED TO EFSA 1. Levucell SC20/Levucell SC10ME for lambs for fattening July Submitted by Lallemand SAS France. 2. Levucell SC Supplementary information May Submitted by Lallemand SAS. 3. Evaluation report of the Community Reference Laboratory feed additives authorisation on the methods(s) of analysis for Levucell SC20/Levucell SC10ME for lambs for fattening. 4. Comments from Member States received through the EFSAnet. REFERENCES EC (European Commission), 1997, updated Opinion on the use of certain microorganisms as additives in feedingstuffs. < EFSA (European Food Safety Authority), 2006a. Opinion of the Panel on additives and products or substances used in animal feed (FEEDAP) on the safety and efficacy of the product Levucell SC20/Levucell SC10ME, a preparation of Saccharomyces cerevisiae, as a feed additive for dairy goats and dairy ewes in accordance with Regulation (EC) No 1831/2003. < EFSA (European Food Safety Authority), 2006b. Opinion of the Panel on additives and products or substances used in animal feed (FEEDAP) on the safety and efficacy of the product Levucell SC20/Levucell SC10ME, a preparation of Saccharomyces cerevisiae, as a feed additive for leisure horses. < EFSA (European Food Safety Authority), Introduction of a Qualified Presumption of Safety (QPS) approach for assessment of selected microorganisms referred to EFSA - Opinion of the Scientific Committee. < 7 This section has been edited following the provisions of Article 8(6) and Article 18 of Regulation (EC) No 1831/ Technical dossier/section III/Appendices III.2.1 and III Technical dossier/section III/Appendices III.1.1 and III.3.1 and Supplementary information May 2008 The EFSA Journal (2008) 772, 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 Levucell SC20/Levucell SC10ME for lambs for fattening In the current application authorisation is sought for LEVUCELL SC under the category zootechnical additives, functional group 'gut flora stabilisers' according to Annex I of Regulation (EC) No 1831/2003. Specifically, the use of LEVUCELL SC for lambs in its two forms LEVUCELL SC20 and LEVUCELL SC 10ME is requested. LEVUCELL SC20 (non-coated form) contains at least 20 x 10 9 of viable cells (c.f.u., colony forming units) of Saccharomyces cerevisiae CNCM I-1077 as active agent per gram and LEVUCELL SC10ME (coated form) contains at least 10 x 10 9 c.f.u./g, respectively. The feed additive is intended to be mixed into complete feedingstuffs for lambs at a final concentration of 3 to 7.3 x 10 9 c.f.u./kg. For the determination of the active agent (Saccharomyces cerevisiae CNCM I-1077) in the feed additive LEVUCELL SC, a pour plate method for both forms of the additive and a polymerase chain reaction (PCR) method for identification are proposed which are considered appropriate for the intended purpose. The method was shown to be applicable for the coated and uncoated form of the active agent in the feed additive. For official controls of the active agent S. cerevisiae CNCM I-1077 in the feed additive, premixtures and feedingstuffs, a similar ring-trial validated pour plate method that is applicable for the feed additive is proposed. The method s performance characteristics 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 [System. Appl. Microbiol. 2003, 26, ]. The method was shown to be equally applicable for the coated and uncoated form of the active agent in the feed additive, premixtures and is therefore expected to perform similarly in feedingstuffs with regards to the coating. The pour plate method has a limit of quantification (LOQ) of 10 5 c.f.u./kg sample. A PCR method for strain identification which performed appropriately in a ring-trial validation study [System. Appl. Microbiol. 2004, 27, ] is recommended for official controls for the field of application sought. On the basis of the supplied documentation, no supplementary experimental work (testing or method validation) is required by the CRL. The EFSA Journal (2008) 772, 9-9