Assessment of the application for renewal of authorisation of Biosprint® (Saccharomyces cerevisiae MUCL 39885) for sows.

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.

Introduction

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).

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).

Data and methodologies

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

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).

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.

Characterisation

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

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.

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.

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).

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.

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.

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.

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

Abbreviations

Belgian Coordinated Collection of Microorganism

colony forming unit

European Union Reference Laboratory

EFSA Panel on Additives and Products or Substances used in Animal Feed

Mycothéque de l'Université Catholique de Louvain

polychlorinated biphenyl

polychlorinated dibenzo‐p‐dioxin

polychlorinated dibenzofuran

qualified presumption of safety

single nucleotide polymorphism

whole genome sequence

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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