EFSA journal. European Food Safety Authority2024; 22(11); e9075; doi: 10.2903/j.efsa.2024.9075

Assessment of the modification of the authorisation of the feed additive consisting of Saccharomyces cerevisiae CNCM I-1077 for lambs and its extension of use to all ruminants and camelids reared for milk production/suckling/reproduction, all minor (young) ruminant species and camelids for fattening and Equidae other than horses (Lallemand SAS).

Villa, RE
·
Azimonti, G
·
Bonos, E
·
Christensen, H
·
Durjava, M
·
Dusemund, B
·
Gehring, R
·
Glandorf, B
·
Kouba, M
·
López-Alonso, M
·
Marcon, F
·
Nebbia, C
·
Pechová, A
·
Prieto-Maradona, M
·
Röhe, I
·
Theodoridou, K
·
Woutersen, R
·
Anguita, M
·
Brozzi, R
·
Galobart, J
·
Innocenti, ML
·
Pagés, D

Abstract: Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of a preparation of CNCM I-1077 as a zootechnical feed additive for several animal species. The additive, existing in a not-coated and a coated form, is currently authorised for use in feed for calves, cattle for fattening, dairy cows, dairy goats and dairy sheep, lambs, all minor ruminant species for fattening and rearing, horses and camelids for fattening and rearing. This application regards the request for the extension of use in all ruminants and camelids reared for milk production/suckling/reproduction, all minor (young) ruminant species and camelids for fattening and Equidae other than horses, and the modification of the authorisation for lambs to reduce the minimum use level. The identity of the active agent as was confirmed. Based on the qualified presumption of safety approach and since no concerns are expected from other components, the additive is considered safe for the target species, consumers and the environment. The not-coated form of the additive is not irritant to skin or eyes. The additive in both formulations should be considered a skin and respiratory sensitiser and any exposure through skin and respiratory tract is considered a risk. No conclusion could be drawn on the eye irritation potential of the coated form of the additive due to the lack of data. The additive has the potential to be efficacious when used in feed for all ruminants and camelids reared for milk production/suckling/reproduction at the minimum proposed use level of 5 × 10 CFU (colony forming unit)/kg complete feed, all minor (young) ruminant species and camelids for fattening and lambs at 1 × 10 CFU/kg complete feed, and in all Equidae species other than horses at 3 × 10 CFU/kg complete feed.

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Publication Date: 2024-11-13 PubMed ID: 39540120PubMed Central: PMC11558180DOI: 10.2903/j.efsa.2024.9075Google Scholar: Lookup

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Journal Article

Summary

This research summary has been generated with artificial intelligence and may contain errors and omissions. Refer to the original study to confirm details provided. Submit correction.

The research focuses on the safety and efficacy of Saccharomyces cerevisiae CNCM I-1077, a feed additive, across various animal species including ruminants, camelids, minor young ruminants, and different Equidae species. The additive, previously authorized for specific species, is considered safe for target species, consumers, and the environment, and also has the potential to improve livestock’s health.

What The Research Is About

The research constitutes an assessment of the intended modification of the authorization of a zootechnical feed additive composed of Saccharomyces cerevisiae CNCM I-1077.
The modification is specifically made with regards to its use for lambs, and broadens its use to all ruminant and camelid species reared for milk production, suckling, reproduction and fattening, as well as Equidae species excluding horses.

Insights from EFSA and Objectives

The European Food Safety Authority (EFSA) was requested by the European Commission to deliver its judgement on the safety and impact effectiveness of the feed additive for different animal species.
The use of this additive is currently authorized in calves, cattle meant for fattening, dairy animals like cows, goats and sheep, and other species including minor ruminant types, race horses and camels reared for fattening.
The objective of the research was to evaluate the safety and efficacy of using the feed additive for other species beyond the current limit.

Safety Evaluation of The Additive

The active ingredient of the additive was verified, and the additive was deemed safe for the target species, consumers, and the environment, using the qualified presumption of safety method and considering that no anticipated dangers are expected from its components.
It was found that the uncoated form of this additive is not irritable to skin or eyes.
However, both forms of the additive, coated and uncoated, could cause skin and respiratory sensitization, marking a risk associated with exposure via the skin and respiratory tract.
Due to insufficient data, no conclusion could be drawn about the potential eye irritation caused by the coated form of the additive.

Efficacy of The Additive

The additive showed potential efficacy when used as feed for ruminants and camelids specifically reared for milk production, as well as for suckling, reproduction and fattening, and lambs.
It was also found to be efficient when used in all Equidae species excluding horses.
The minimum proposed use level (varied for different species, as indicated in the research) of the additive was found to be potent.

Cite This Article

APA

Villa RE, Azimonti G, Bonos E, Christensen H, Durjava M, Dusemund B, Gehring R, Glandorf B, Kouba M, López-Alonso M, Marcon F, Nebbia C, Pechová A, Prieto-Maradona M, Röhe I, Theodoridou K, Woutersen R, Anguita M, Brozzi R, Galobart J, Innocenti ML, Pagés D. (2024). Assessment of the modification of the authorisation of the feed additive consisting of Saccharomyces cerevisiae CNCM I-1077 for lambs and its extension of use to all ruminants and camelids reared for milk production/suckling/reproduction, all minor (young) ruminant species and camelids for fattening and Equidae other than horses (Lallemand SAS). EFSA J, 22(11), e9075. https://doi.org/10.2903/j.efsa.2024.9075

Publication

EFSA journal. European Food Safety Authority

ISSN: 1831-4732

NlmUniqueID: 101642076

Country: United States

Language: English

Volume: 22

Issue: 11

Pages: e9075

PII: e9075

Researcher Affiliations

Villa, Roberto Edoardo

Azimonti, Giovanna

Bonos, Eleftherios

Christensen, Henrik

Durjava, Mojca

Dusemund, Birgit

Gehring, Ronette

Glandorf, Boet

Kouba, Maryline

López-Alonso, Marta

Marcon, Francesca

Nebbia, Carlo

Pechová, Alena

Prieto-Maradona, Miguel

Röhe, Ilen

Theodoridou, Katerina

Woutersen, Ruud

Anguita, Montserrat

Brozzi, Rosella

Galobart, Jaume

Innocenti, Matteo L

Pagés, Daniel

References

This article includes 12 references

EFSA. 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 Journal 370.
doi: 10.2903/j.efsa.2006.370google scholar: lookup
EFSA. 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 Journal 4(9), 385.
doi: 10.2903/j.efsa.2006.385google scholar: lookup
EFSA. 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. EFSA Journal 772.
doi: 10.2903/j.efsa.2008.772google scholar: lookup
EFSA. Opinion of the Panel on additives and products or substances used in animal feed (FEEDAP) on the efficacy of the product Levucell SC20/Levucell SC10ME (Saccharomyces cerevisiae) as feed additive for leisure horses. EFSA Journal 7(4), 1040.
doi: 10.2903/j.efsa.2009.1040google scholar: lookup
EFSA BIOHAZ Panel, Koutsoumanis K, Allende A, Álvarez‐Ordóñez A, Bolton D, Bover‐Cid S, Chemaly M, De Cesare A, Hilbert F, Lindqvist R, Nauta M, Peixe L, Ru G, Simmons M, Skandamis P, Suffredini E, Cocconcelli P S, Fernández Escámez P S, Prieto Maradona M, Herman L. Scientific Opinion on the update of the list of qualified presumption of safety (QPS) recommended microorganisms intentionally added to food or feed as notified to EFSA. EFSA Journal 21(1), 7747.
doi: 10.2903/j.efsa.2023.7747google scholar: lookup
EFSA FEEDAP Panel, Rychen G, Aquilina G, Azimonti G, Bampidis V, Bastos M L, Bories G, Chesson A, Cocconcelli P S, Flachowsky G, Gropp J, Kolar B, Kouba M, López Puente S, López‐Alonso M, Mantovani A, Mayo B, Ramos F, Villa R E, Saarela M. Scientific opinion on the safety and efficacy of Levucell® SC (Saccharomyces cerevisiae CNCM I‐1077) as a feed additive for dairy cows, cattle for fattening, minor ruminant species and camelids. EFSA Journal 15(7), 4944.
doi: 10.2903/j.efsa.2017.4944pmc: PMC7009926pubmed: 32625596google scholar: lookup
EFSA FEEDAP Panel, Rychen G, Aquilina G, Azimonti G, Bampidis V, Bastos M L, Bories G, Chesson A, Cocconcelli P S, Flachowsky G, Gropp J, Kolar B, Kouba M, López‐Alonso M, López Puente S, Mantovani A, Mayo B, Ramos F, Saarela M, Innocenti M L. Guidance on the identity, characterisation and conditions of use of feed additives. EFSA Journal 15(10), 5023.
doi: 10.2903/j.efsa.2017.5023pmc: PMC7010039pubmed: 32625313google scholar: lookup
EFSA FEEDAP Panel, Rychen G, Aquilina G, Azimonti G, Bampidis V, Bastos M L, Bories G, Chesson A, Cocconcelli P S, Flachowsky G, Gropp J, Kolar B, Kouba M, López‐Alonso M, López Puente S, Mantovani A, Mayo B, Ramos F, Saarela M, Martino L. Guidance on the assessment of the efficacy of feed additives. EFSA Journal 16(5), 5274.
doi: 10.2903/j.efsa.2018.5274pmc: PMC7009555pubmed: 32625911google scholar: lookup
EFSA FEEDAP Panel, Rychen G, Aquilina G, Azimonti G, Bampidis V, Bastos M L, Bories G, Chesson A, Cocconcelli P S, Flachowsky G, Gropp J, Kolar B, Kouba M, López‐Alonso M, López Puente S, Mantovani A, Mayo B, Ramos F, Saarela M, Galobart J. Guidance on the characterisation of microorganisms used as feed additives or as production organisms. EFSA Journal 16(3), 5206.
doi: 10.2903/j.efsa.2018.5206pmc: PMC7009341pubmed: 32625840google scholar: lookup
EFSA FEEDAP Panel, Bampidis V, Azimonti G, Bastos M L, Christensen H, Dusemund B, Kouba M, Kos Durjava M, López‐Alonso M, López Puente S, Marcon F, Mayo B, Pechová A, Petkova M, Ramos F, Sanz Y, Villa R, Woutersen R, Anguita M, Brozzi R. Scientific Opinion on the safety and efficacy of Levucell SC® (Saccharomyces cerevisiae CNCM I‐1077) as a feed additive for calves and minor ruminant species and camelids at the same developmental stage. EFSA Journal 17(6), 5723.
doi: 10.2903/j.efsa.2019.5723pmc: PMC7009211pubmed: 32626345google scholar: lookup
EFSA FEEDAP Panel, Bampidis V, Azimonti G, Bastos M L, Christensen H, Dusemund B, Kouba M, Kos Durjava M, López‐Alonso M, López Puente S, Marcon F, Mayo B, Pechová A, Petkova M, Ramos F, Sanz Y, Villa R E, Woutersen R, Brozzi R. Scientific Opinion on the assessment of the application for renewal of authorisation of Levucell SC (Saccharomyces cerevisiae CNCM I‐1077) as a feed additive for lambs and horses. EFSA Journal 17(3), 5639.
doi: 10.2903/j.efsa.2019.5639pmc: PMC7009252pubmed: 32626262google scholar: lookup
EFSA FEEDAP Panel, Bampidis V, Azimonti G, Bastos M L, Christensen H, Durjava M, Dusemund B, Kouba M, López‐Alonso M, López Puente S, Marcon F, Mayo B, Pechová A, Petkova M, Ramos F, Villa R E, Woutersen R, Brantom P, Chesson A, Galobart J. Guidance on the assessment of the safety of feed additives for the users. EFSA Journal 21(12), e8469.
doi: 10.2903/j.efsa.2023.8469pmc: PMC10698700pubmed: 38075627google scholar: lookup