Assessment of the application for renewal of authorisation of Biosprint® (Saccharomyces cerevisiae MUCL 39885) for sows
2019; Wiley; Volume: 17; Issue: 6 Linguagem: Inglês
10.2903/j.efsa.2019.5719
ISSN1831-4732
AutoresVasileios Bampidis, Giovanna Azimonti, Maria de Lourdes Bastos, Henrik Christensen, Birgit Dusemund, Maryline Kouba, Mojca Fašmon Durjava, Marta López‐Alonso, Secundino López Puente, Francesca Marcon, Baltasar Mayo, Alena Pechová, Mariana Petkova, Fernando Ramos, Yolanda Sanz, Roberto Edoardo Villa, Ruud Woutersen, Montserrat Anguita, Jaume Galobart, Orsolya Holczknecht, Paola Manini, Jordi Tarrés‐Call, Elisa Pettenati, Fabiola Pizzo,
Tópico(s)Pesticide Residue Analysis and Safety
ResumoEFSA JournalVolume 17, Issue 6 e05719 Scientific OpinionOpen Access Assessment of the application for renewal of authorisation of Biosprint® (Saccharomyces cerevisiae MUCL 39885) for sows EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP), EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP)Search for more papers by this authorVasileios Bampidis, Vasileios BampidisSearch for more papers by this authorGiovanna Azimonti, Giovanna AzimontiSearch for more papers by this authorMaria de Lourdes Bastos, Maria de Lourdes BastosSearch for more papers by this authorHenrik Christensen, Henrik ChristensenSearch for more papers by this authorBirgit Dusemund, Birgit DusemundSearch for more papers by this authorMaryline Kouba, Maryline KoubaSearch for more papers by this authorMojca Kos Durjava, Mojca Kos DurjavaSearch for more papers by this authorMarta López-Alonso, Marta López-AlonsoSearch for more papers by this authorSecundino López Puente, Secundino López PuenteSearch for more papers by this authorFrancesca Marcon, Francesca MarconSearch for more papers by this authorBaltasar Mayo, Baltasar MayoSearch for more papers by this authorAlena Pechová, Alena PechováSearch for more papers by this authorMariana Petkova, Mariana PetkovaSearch for more papers by this authorFernando Ramos, Fernando RamosSearch for more papers by this authorYolanda Sanz, Yolanda SanzSearch for more papers by this authorRoberto Edoardo Villa, Roberto Edoardo VillaSearch for more papers by this authorRuud Woutersen, Ruud WoutersenSearch for more papers by this authorMontserrat Anguita, Montserrat AnguitaSearch for more papers by this authorJaume Galobart, Jaume GalobartSearch for more papers by this authorOrsolya Holczknecht, Orsolya HolczknechtSearch for more papers by this authorPaola Manini, Paola ManiniSearch for more papers by this authorJordi Tarrés-Call, Jordi Tarrés-CallSearch for more papers by this authorElisa Pettenati, Elisa PettenatiSearch for more papers by this authorFabiola Pizzo, Fabiola PizzoSearch for more papers by this author EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP), EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP)Search for more papers by this authorVasileios Bampidis, Vasileios BampidisSearch for more papers by this authorGiovanna Azimonti, Giovanna AzimontiSearch for more papers by this authorMaria de Lourdes Bastos, Maria de Lourdes BastosSearch for more papers by this authorHenrik Christensen, Henrik ChristensenSearch for more papers by this authorBirgit Dusemund, Birgit DusemundSearch for more papers by this authorMaryline Kouba, Maryline KoubaSearch for more papers by this authorMojca Kos Durjava, Mojca Kos DurjavaSearch for more papers by this authorMarta López-Alonso, Marta López-AlonsoSearch for more papers by this authorSecundino López Puente, Secundino López PuenteSearch for more papers by this authorFrancesca Marcon, Francesca MarconSearch for more papers by this authorBaltasar Mayo, Baltasar MayoSearch for more papers by this authorAlena Pechová, Alena PechováSearch for more papers by this authorMariana Petkova, Mariana PetkovaSearch for more papers by this authorFernando Ramos, Fernando RamosSearch for more papers by this authorYolanda Sanz, Yolanda SanzSearch for more papers by this authorRoberto Edoardo Villa, Roberto Edoardo VillaSearch for more papers by this authorRuud Woutersen, Ruud WoutersenSearch for more papers by this authorMontserrat Anguita, Montserrat AnguitaSearch for more papers by this authorJaume Galobart, Jaume GalobartSearch for more papers by this authorOrsolya Holczknecht, Orsolya HolczknechtSearch for more papers by this authorPaola Manini, Paola ManiniSearch for more papers by this authorJordi Tarrés-Call, Jordi Tarrés-CallSearch for more papers by this authorElisa Pettenati, Elisa PettenatiSearch for more papers by this authorFabiola Pizzo, Fabiola PizzoSearch for more papers by this author First published: 06 June 2019 https://doi.org/10.2903/j.efsa.2019.5719Citations: 2 Correspondence: feedap@efsa.europa.eu Requestor: European Commission Question number: EFSA-Q-2018-00474 Panel members: Giovanna Azimonti, Vasileios Bampidis, Maria de Lourdes Bastos, Henrik Christensen, Birgit Dusemund, Maryline Kouba, Mojca Kos Durjava, Marta López-Alonso, Secundino López Puente, Francesca Marcon, Baltasar Mayo, Alena Pechová, Mariana Petkova, Fernando Ramos, Yolanda Sanz, Roberto Villa and Ruud Woutersen. Acknowledgements The EFSA FEEDAP Panel (EFSA Panel on Additives and Products or Substances used in Animal Feed) wishes to acknowledge all European competent institutions, Member State bodies and other organisations that provided data for this scientific output. Adopted: 14 May 2019 AboutSectionsPDF ToolsExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onFacebookTwitterLinkedInRedditWechat Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the assessment of the application for renewal of authorisation of the product Biosprint® (Saccharomyces cerevisiae MUCL 39885) as a feed additive for sows. S. cerevisiae is considered by EFSA to have qualified presumption of safety (QPS) status. The applicant has provided data demonstrating that the additive currently in the market complies with the conditions of authorisation. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) Panel confirms that the use of Biosprint® under the current authorised conditions of use is safe for sows, the consumers and the environment. The additive is considered as a potential skin and eye irritant and skin/respiratory sensitiser. There is no need to assess the efficacy of Biosprint® in the context of the renewal of the authorisation. 1 Introduction 1.1 Background and Terms of Reference Regulation (EC) No 1831/20031 establishes the rules governing the Community authorisation of additives for use in animal nutrition. In particular, Article 14(1) of that Regulation lays down that an application for renewal shall be sent to the Commission at the latest 1 year before the expiry date of the authorisation. The European Commission received a request from Prosol S.p.A.2 for renewal of the authorisation of the product Biosprint® (Saccharomyces cerevisiae MUCL 39885), when used as a feed additive for sows (category: zootechnical additive; functional group: gut flora stabiliser). 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 14(1) (renewal of the authorisation). The particulars and documents in support of the application were considered valid by EFSA as of 22 August 2018. According to Article 8 of Regulation (EC) No 1831/2003, 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. EFSA shall deliver an opinion on the safety for the target animals, consumer, user and the environment and on the efficacy of the product Biosprint® (Saccharomyces cerevisiae MUCL 39885), when used under the proposed conditions of use (see Section 3.1.3). 1.2 Additional information Biosprint® (Saccharomyces cerevisiae MUCL 39885) is currently authorised in sows3, dairy cows, horses,4 piglets (weaned),5 cattle for fattening,6 minor ruminants for fattening and minor ruminants for dairy products.7 The EFSA FEEDAP Panel issued several opinions on the safety and efficacy of Biosprint® (Saccharomyces cerevisiae MUCL 39885) in different target species (EFSA, 2004; EFSA FEEDAP Panel, 2009, 2010, 2011, 2013, 2015). 2 Data and methodologies 2.1 Data The present assessment is based on data submitted by the applicant in the form of a technical dossier8 in support of the authorisation request for the use of Biosprint® (Saccharomyces cerevisiae MUCL 39885) as a feed additive. The FEEDAP Panel used the data provided by the applicant together with data from other sources, such as previous risk assessments by EFSA and experts' knowledge, to deliver the present output. The European Union Reference Laboratory (EURL) considered that the conclusions and recommendations reached in the previous assessment are valid and applicable for the current application.9 2.2 Methodologies The approach followed by the FEEDAP Panel to assess the safety and the efficacy of Biosprint® (Saccharomyces cerevisiae MUCL 39885) is in line with the principles laid down in Regulation (EC) No 429/2008 and the Guidance on the renewal of the authorisation of feed additives (EFSA FEEDAP Panel, 2013). 3 Assessment The additive Biosprint® is a preparation of Saccharomyces cerevisiae MUCL 39885. The current application is for the renewal of the authorisation of use as a zootechnical additive (functional group: gut flora stabiliser) in feed for sows. The additive is authorised with a minimum declared content of 1 × 109 CFU/g. 3.1 Characterisation 3.1.1 Characterisation of the additive The additive is authorised in powder and granular forms, both with a minimum content of Saccharomyces cerevisiae MUCL 39885 of 1 × 109 CFU/g. In the first application, three forms were described, powder, oval granulated and spherical. The applicant states that the powder form is not produced anymore, and that the product is present on the market in two forms: Biosprint® oval granulated (G) and Biosprint® spherical (S). The strain is the additive itself and no carriers or excipients are present in the final product. The applicant declared that the manufacturing process and additive have not been modified since the previous authorisation and provided data from recent batches on the composition of the additive. The applicant states that the specifications are 1 × 109 with an average 1.5 × 1010 CFU/g. Compliance with specifications was confirmed by analysis of five batches of the G form (range 1.7–2.0 × 1010, mean 2.0 × 1010 CFU/g) and for five batches of the S form (range 1.8–2.3 × 1010, mean 2.0 × 1010 CFU/g).10 The same batches were analysed for microbial contamination. The results showed confirm compliance with limit levels (Escherichia coli < 10 CFU/g, Salmonella absence in 25 g, moulds < 10 CFU/g, Listeria absent).10 The possible presence of contaminants was measured on three batches of the product. Aflatoxins B1, B2, G1 and G2 < 0.5 mg/kg, deoxynivalenol < 20 μg/kg, ochratoxin A < 1 μg/kg, zearalenone < 10 μg/kg. Arsenic ≤ 0.005 mg/kg, cadmium 0.001 mg/kg, mercury < 0.005 mg/kg, lead ≤ 0.001 mg/kg, nitrites, dioxins, dioxin-like polychlorinated biphenyls (PCBs), polychlorinated dibenzo-p-dioxin/polychlorinated dibenzofuran (PCDD/PCDF), non-dioxin-like PCBs, melamine, cyanuric acid, pesticides.11,12,13 Based on the results, no concern is identified. The applicant provided results on particle size measured by sieving on three samples of the product for each formulation. The analysis confirmed the previous data provided by the applicant. The average particle size of the spherical form was 710 μm, with no particles below 355 μm. The average particle size of the granular form was between 250 and 355 μm, with no particles below 90 μm.14 3.1.2 Characterisation of the active agent The active ingredient of the additive Biosprint® is the yeast S. cerevisiae MUCL 39885. The strain of S. cerevisiae is deposited in Belgian Coordinated Collection of Microorganism BCCM™/MUCL Culture Collection – Mycothéque de l'Université Catholique de Louvain with Deposit number 39885.15 The strain of S. cerevisiae used in the additive is not genetically modified. The applicant provided evidences in support of the taxonomical identification of the strain as S. cerevisiae. In particular, the applicant provided results from a whole genome sequence (WGS) analysis,16 a phylogenetic analysis17 and a whole genome single nucleotide polymorphism (SNP) analysis.18 Based on the data, the strain was confirmed as Saccharomyces cerevisiae. 3.1.3 Conditions of use The additive is currently authorised to be used in sows at a minimum concentration of 6.4 × 109 CFU/kg of complete feedstuffs. The applicant does not propose to modify the conditions of use as authorised. 3.2 Safety The species S. cerevisiae is considered by EFSA to be suitable for the Qualified Presumption of Safety (QPS) approach to safety assessment (EFSA, 2007; EFSA BIOHAZ Panel, 2017). This approach requires the identity of the strain to be conclusively established. In the context of the current application, the identity of the strain was confirmed as S. cerevisiae. Accordingly, this strain is presumed safe for the target species, consumers of products from animals fed the additive and the environment. The safety for the users has been evaluated in a previous opinion (EFSA FEEDAP Panel, 2010). The Panel concluded in 2010 that the additive should be considered as a potential skin and eye irritant and skin sensitiser and that the inhalation exposure would be minimal. No additional data were provided in the current application. Considering the proteinaceous nature of the additive, it should be considered a potential respiratory sensitiser. The applicant submitted the results of a literature search, which covered the period from 2008 to 2018, to provide information on the safety for the target species, the consumers, the users and the environment. The databases used were CAB Abstracts, PubMed and Scopus. The strings used for the search, the exclusion criteria and the search strategy were provided.19 The literature search for the target species produced 22 results, 6 of them were discarded by the applicant based on the exclusion criteria.20 Out of the 16 remaining papers, 9 were EFSA scientific opinions regarding the use of S. cerevisiae in swine as a feed additive. None of the left seven references highlighted a possible safety concern (see Appendix A). The literature search for the consumers produced 30 results, 27 of them were discarded by the applicant based on the exclusion criteria. Out of the three remaining papers, two were EFSA scientific opinions regarding the use of S. cerevisiae as a feed additive. The left one is not relevant for the assessment of the safety for the consumers.21 (see Appendix A). The safety for the users has been evaluated in a previous opinion. No data on skin and eye irritancy or skin sensitisation have been provided; therefore, Biosprint® should be considered as a potential irritant and sensitiser and treated accordingly. Based on the particle size distribution, Biosprint® S and Biosprint® G are unlikely to form respirable dusts. It has been concluded that the inhalation exposure associated with the use of this product would be minimal (EFSA FEEDAP Panel, 2010). The literature search for the user safety produced 26 results, 24 of them were discarded by the applicant based on the exclusion criteria, and 1 was an EFSA scientific opinion regarding the use of S. cerevisiae as a feed additive. The left one is not relevant for the assessment of the safety for the user.22 (see Appendix A). The literature search for the safety of the environment produced 143 results, 95 of them were discarded by the applicant based on the exclusion criteria. All the left papers retrieved did not highlight a safety concern for the environment23 (see Appendix A). 3.2.1 Conclusion on safety The Panel concluded that Biosprint® is considered safe for the target species, for the consumer, and the environment. The additive should be considered as a potential skin and eye irritant and skin sensitiser and the inhalation exposure would be minimal. No additional data were provided in the current application. 3.3 Efficacy for sows The present application for renewal of the authorisation does not include a proposal for amending or supplementing the conditions of the original authorisation that would have an impact on the efficacy of the additive. Therefore, there is no need for assessing the efficacy of the additive in the context of the renewal of the authorisation. 3.4 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 Regulation24 and Good Manufacturing Practice. 4 Conclusions The applicant has provided data demonstrating that the additive currently in the market complies with the conditions of authorisation. The FEEDAP Panel confirms that the use of Biosprint® under the current authorised conditions of use is safe for sows, the consumers and the environment. The additive is considered as a potential skin and eye irritant and skin/respiratory sensitizer. There is no need to assess the efficacy of Biosprint® in the context of the renewal of the authorisation. Documentation provided to EFSA 1) Biosprint® for sows. June 2018. Submitted by Prosol S.p.A. 2) Biosprint® for sows. Supplementary information. April 2019. Submitted by Prosol S.p.A. 3) Comments from Member States. Chronology Date Event 23/05/2018 Dossier received by EFSA. Biosprint® for sows. Submitted by Prosol S.p.A. 04/06/2018 Reception mandate from the European Commission 22/08/2016 Application validated by EFSA – Start of the scientific assessment 15/04/2018 Request of supplementary information to the applicant in line with Article 8(1)(2) of Regulation (EC) No 1831/2003 – Scientific assessment suspended. Issues: characterisation, safety for target species, safety for the consumer, safety for the user, safety for the environment 22/11/2018 Comments received from Member States 14/05/2019 Opinion adopted by the FEEDAP Panel. End of the Scientific assessment Notes 1 Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition. OJ L 268, 18.10.2003, p. 29. 2 Prosol S.p.A. via Carso 99, Madone (Italy). 3 Commission Regulation (EC) No 896/2009 of 25 September 2009 concerning the authorisation of a new use of Saccharomyces cerevisiae MUCL 39885 as a feed additive for sows (holder of the authorisation Prosol SpA). OJ L 256, 29.9.2009, p 6. 4 Commission Regulation (EU) No 1119/2010 of 2 December 2010 concerning the authorisation of Saccharomyces cerevisiae MUCL 39885 as a feed additive for dairy cows and horses and amending Regulation (EC) No 1520/2007 (holder of the authorisation Prosol SpA). OJ L 317, 3.12.2010, p 9. 5 Commission Regulation (EU) No 170/2011 of 23 February 2011 concerning the authorisation of Saccharomyces cerevisiae MUCL 39885 as a feed additive for piglets (weaned) and amending Regulation (EC) No 1200/2005 (holder of authorisation Prosol SpA), OJ L 49, 24.2.2011, p 8. 6 Commission implementing Regulation (EU) No 1059/2013 of 29 October 2013 concerning the authorisation of a preparation of Saccharomyces cerevisiae MUCL 39885 as a feed additive for cattle for fattening and amending Regulation (EC) No 492/2006 (holder of the authorisation Prosol SpA) OJ L 289, 31.10.2013, p 30. 7 Commission implementing Regulation (EU) 2016/104 of 27 January 2016 concerning the authorisation of a preparation of Saccharomyces cerevisiae MUCL 39885 as a feed additive for minor ruminant species for fattening and dairy production (holder of the authorisation Prosol SpA), OJ L 21, 28.1.2016, p 71. 8 FEED dossier reference: FAD-2018-0032. 9 The full report is available on the EURL website: https://ec.europa.eu/jrc/sites/jrcsh/files/FinRep-FAD-2009-0028.pdf 10 Technical Dossier/Section II/Annex_31. 11 Technical Dossier/Section II/Annex_2. 12 Technical Dossier/Section II/Annex_3. 13 Technical Dossier/Section II/Annex_4. 14 Technical Dossier/Section II/Annex_29. 15 Technical Dossier/Section II/Annex_5. 16 Technical Dossier/Section II/Additional information/Annex_1. 17 Technical Dossier/Section II/Additional information/Annex_3. 18 Technical Dossier/Section II/Additional information/Annex_4. 19 Technical Dossier/Section III/Annex_0. 20 Technical Dossier/Section III/Annex_3. 21 Technical Dossier/Section III/Annex_4. 22 Technical Dossier/Section III/Annex_5. 23 Technical Dossier/Section III/Annex_6. 24 Regulation (EC) No 183/2005 of the European Parliament and of the Council of 12 January 2005 laying down requirements for feed hygiene. OJ L 35, 8.2.2005, p. 1. References EFSA (European Food Safety Authority), 2004. Opinion of the Scientific Panel on additives and products or substances used in animal feed (FEEDAP) on a request from the Commission on the safety of 'Biosprint BCCMTM/MUCL39885' for the dairy cow. EFSA Journal 2004; 2(3): 26, 6 pp. https://doi.org/10.2903/j.efsa.2004.26 EFSA (European Food Safety Authority), 2007. Introduction of a Qualified Presumption of Safety (QPS) approach for assessment of selected microorganisms referred to EFSA - Opinion of the Scientific Committee. EFSA Journal 2007; 5(12): 587, 16 pp. https://doi.org/10.2903/j.efsa.2007.587 EFSA BIOHAZ Panel (EFSA Panel on Biological Hazards), Ricci A, Allende A, Bolton D, Chemaly M, Davies R, Girones R, Herman L, Koutsoumanis K, Lindqvist R, Nørrung B, Robertson L, Ru G, Sanaa M, Simmons M, Skandamis P, Snary E, Speybroeck N, Ter Kuile B, Threlfall J, Wahlström H, Cocconcelli PS, Klein G (deceased), Prieto Maradona M, Querol A, Peixe L, Suarez JE, Sundh I, Vlak JM, Aguillera-Gomez M, Barizzone F, Brozzi R, Correia S, Heng L, Istace F, Lythgo C and Fernández Escámez PS, 2017. Scientific Opinion on the update of the list of QPS-recommended biological agents intentionally added to food or feed as notified to EFSA. EFSA Journal 2017; 15(3): 4664, 177 pp. https://doi.org/10.2903/j.efsa.2017.4664 EFSA FEEDAP Panel (EFSA Panel on Additives and Products or Substances used in Animal Feed), 2009. Safety and efficacy of Biosprint® (Saccharomyces cerevisiae) as a feed additive for sows. EFSA Journal 2009; 7(2): 970, 9 pp. https://doi.org/10.2903/j.efsa.2009.970 EFSA FEEDAP Panel (EFSA Panel on Additives and Products or Substances used in Animal Feed), 2010. Scientific Opinion on the safety and efficacy of Biosprint® (Saccharomyces cerevisiae) as a feed additive for dairy cows. EFSA Journal 2010; 8(7): 1662, 8 pp. https://doi.org/10.2903/j.efsa.2010.1662 EFSA FEEDAP Panel (EFSA Panel on Additives and Products or Substances used in Animal Feed), 2011. Scientific Opinion on the safety and efficacy of Biosprint® (Saccharomyces cerevisiae) for cattle for fattening. EFSA Journal 2011; 9(11):2439, 8 pp. https://doi.org/10.2903/j.efsa.2011.2439 EFSA FEEDAP Panel (EFSA Panel on Additives and Products or Substances used in Animal Feed), 2015. Scientific Opinion on the safety and efficacy of Biosprint® (Saccharomyces cerevisiae MUCL 39885) for minor ruminant species for meat and milk production. EFSA Journal 2015; 13(7):4199, 8 pp. https://doi.org/10.2903/j.efsa.2015.4199 EFSA FEEDAP Panel (EFSA Panel on Additives and Products or Substances used in Animal Feed), 2013. Guidance on the renewal of the authorization of feed additives. EFSA Journal 2013; 11(10): 3431, 8 pp. https://doi.org/10.2903/j.efsa.2013.3431 Abbreviations BCCM Belgian Coordinated Collection of Microorganism CFU colony forming unit EURL European Union Reference Laboratory FEEDAP EFSA Panel on Additives and Products or Substances used in Animal Feed MUCL Mycothéque de l'Université Catholique de Louvain PCB polychlorinated biphenyl PCDD polychlorinated dibenzo-p-dioxin PCDF polychlorinated dibenzofuran QPS qualified presumption of safety SNP single nucleotide polymorphism WGS whole genome sequence Appendix A – List of references retrieved from the literature search provided by the applicant to support safety of the additive Abdulsamie H, Malek A, Mouhnad S, Amal D, Motassim S, 2013. 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