Safety and efficacy of a feed additive consisting of Lacticaseibacillus rhamnosus CNCM I‐3698 and Companilactobacillus sp. CNCM I‐3699 for weaned piglets (STI Biotechnologie)

Abstract 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 safety and efficacy of Sorbiflore® ADVANCE, a feed additive consisting of Lacticaseibacillus rhamnosus CNCM I‐369...

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Main Authors: EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP), Vasileios Bampidis, Giovanna Azimonti, Maria de Lourdes Bastos, Henrik Christensen, Birgit Dusemund, Mojca Durjava, Maryline Kouba, Marta López‐Alonso, Secundino López Puente, Francesca Marcon, Baltasar Mayo, Alena Pechová, Mariana Petkova, Fernando Ramos, Yolanda Sanz, Roberto Edoardo Villa, Ruud Woutersen, Pier Sandro Cocconcelli, Elisa Pettenati, Montserrat Anguita, Rosella Brozzi
Format: Article
Language:English
Published: Wiley 2023-04-01
Series:EFSA Journal
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Online Access:https://doi.org/10.2903/j.efsa.2023.7858
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author EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP)
Vasileios Bampidis
Giovanna Azimonti
Maria de Lourdes Bastos
Henrik Christensen
Birgit Dusemund
Mojca Durjava
Maryline Kouba
Marta López‐Alonso
Secundino López Puente
Francesca Marcon
Baltasar Mayo
Alena Pechová
Mariana Petkova
Fernando Ramos
Yolanda Sanz
Roberto Edoardo Villa
Ruud Woutersen
Pier Sandro Cocconcelli
Elisa Pettenati
Montserrat Anguita
Rosella Brozzi
author_facet EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP)
Vasileios Bampidis
Giovanna Azimonti
Maria de Lourdes Bastos
Henrik Christensen
Birgit Dusemund
Mojca Durjava
Maryline Kouba
Marta López‐Alonso
Secundino López Puente
Francesca Marcon
Baltasar Mayo
Alena Pechová
Mariana Petkova
Fernando Ramos
Yolanda Sanz
Roberto Edoardo Villa
Ruud Woutersen
Pier Sandro Cocconcelli
Elisa Pettenati
Montserrat Anguita
Rosella Brozzi
author_sort EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP)
collection DOAJ
description Abstract 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 safety and efficacy of Sorbiflore® ADVANCE, a feed additive consisting of Lacticaseibacillus rhamnosus CNCM I‐3698 and Companilactobacillus sp. CNCM I‐3699 intended to be used as a zootechnical additive (functional group: other zootechnical additives) in feed for weaned piglets to improve their performance. In a previous opinion, the additive was described as containing viable but not cultivable cells of the two strains in a 1:1 ratio, with a minimum of total lactic acid bacteria counts of 5 × 108 viable‐forming units (VFU)/g additive. However, in that opinion, the Panel could not fully characterise the additive or conclude on its dermal/ocular irritancy or sensitisation potential. In the current assessment, the applicant provided supplementary information to address the missing information for the characterisation of the additive. The proposed methodology to discriminate and individually quantify the two strains composing the additive still presented limitations. Therefore, the Panel concluded that the data available do not allow to fully characterise the additive. The Panel was not in the position to conclude on the taxonomical identification of the strain CNCM I‐3699, and consequently, on its eligibility for the application of the qualified presumption of safety (QPS) approach. Therefore, the previous conclusions on the safety of the additive based on the QPS approach could not be confirmed. The Panel was not in the position to conclude on the safety of the additive for the target species, consumer and the environment. Sorbiflore® ADVANCE is not irritant to skin. The Panel could not conclude on the eye irritancy or skin sensitisation potential of the additive.
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spelling doaj-art-244a0eab5a454a70b35eb8af80a846d32025-08-20T02:11:38ZengWileyEFSA Journal1831-47322023-04-01214n/an/a10.2903/j.efsa.2023.7858Safety and efficacy of a feed additive consisting of Lacticaseibacillus rhamnosus CNCM I‐3698 and Companilactobacillus sp. CNCM I‐3699 for weaned piglets (STI Biotechnologie)EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP)Vasileios BampidisGiovanna AzimontiMaria de Lourdes BastosHenrik ChristensenBirgit DusemundMojca DurjavaMaryline KoubaMarta López‐AlonsoSecundino López PuenteFrancesca MarconBaltasar MayoAlena PechováMariana PetkovaFernando RamosYolanda SanzRoberto Edoardo VillaRuud WoutersenPier Sandro CocconcelliElisa PettenatiMontserrat AnguitaRosella BrozziAbstract 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 safety and efficacy of Sorbiflore® ADVANCE, a feed additive consisting of Lacticaseibacillus rhamnosus CNCM I‐3698 and Companilactobacillus sp. CNCM I‐3699 intended to be used as a zootechnical additive (functional group: other zootechnical additives) in feed for weaned piglets to improve their performance. In a previous opinion, the additive was described as containing viable but not cultivable cells of the two strains in a 1:1 ratio, with a minimum of total lactic acid bacteria counts of 5 × 108 viable‐forming units (VFU)/g additive. However, in that opinion, the Panel could not fully characterise the additive or conclude on its dermal/ocular irritancy or sensitisation potential. In the current assessment, the applicant provided supplementary information to address the missing information for the characterisation of the additive. The proposed methodology to discriminate and individually quantify the two strains composing the additive still presented limitations. Therefore, the Panel concluded that the data available do not allow to fully characterise the additive. The Panel was not in the position to conclude on the taxonomical identification of the strain CNCM I‐3699, and consequently, on its eligibility for the application of the qualified presumption of safety (QPS) approach. Therefore, the previous conclusions on the safety of the additive based on the QPS approach could not be confirmed. The Panel was not in the position to conclude on the safety of the additive for the target species, consumer and the environment. Sorbiflore® ADVANCE is not irritant to skin. The Panel could not conclude on the eye irritancy or skin sensitisation potential of the additive.https://doi.org/10.2903/j.efsa.2023.7858zootechnical additivesother zootechnical additivesLacticaseibacillus rhamnosus CNCM I‐3698 and Companilactobacillus sp. CNCM I‐3699pigletssafety
spellingShingle EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP)
Vasileios Bampidis
Giovanna Azimonti
Maria de Lourdes Bastos
Henrik Christensen
Birgit Dusemund
Mojca Durjava
Maryline Kouba
Marta López‐Alonso
Secundino López Puente
Francesca Marcon
Baltasar Mayo
Alena Pechová
Mariana Petkova
Fernando Ramos
Yolanda Sanz
Roberto Edoardo Villa
Ruud Woutersen
Pier Sandro Cocconcelli
Elisa Pettenati
Montserrat Anguita
Rosella Brozzi
Safety and efficacy of a feed additive consisting of Lacticaseibacillus rhamnosus CNCM I‐3698 and Companilactobacillus sp. CNCM I‐3699 for weaned piglets (STI Biotechnologie)
EFSA Journal
zootechnical additives
other zootechnical additives
Lacticaseibacillus rhamnosus CNCM I‐3698 and Companilactobacillus sp. CNCM I‐3699
piglets
safety
title Safety and efficacy of a feed additive consisting of Lacticaseibacillus rhamnosus CNCM I‐3698 and Companilactobacillus sp. CNCM I‐3699 for weaned piglets (STI Biotechnologie)
title_full Safety and efficacy of a feed additive consisting of Lacticaseibacillus rhamnosus CNCM I‐3698 and Companilactobacillus sp. CNCM I‐3699 for weaned piglets (STI Biotechnologie)
title_fullStr Safety and efficacy of a feed additive consisting of Lacticaseibacillus rhamnosus CNCM I‐3698 and Companilactobacillus sp. CNCM I‐3699 for weaned piglets (STI Biotechnologie)
title_full_unstemmed Safety and efficacy of a feed additive consisting of Lacticaseibacillus rhamnosus CNCM I‐3698 and Companilactobacillus sp. CNCM I‐3699 for weaned piglets (STI Biotechnologie)
title_short Safety and efficacy of a feed additive consisting of Lacticaseibacillus rhamnosus CNCM I‐3698 and Companilactobacillus sp. CNCM I‐3699 for weaned piglets (STI Biotechnologie)
title_sort safety and efficacy of a feed additive consisting of lacticaseibacillus rhamnosus cncm i 3698 and companilactobacillus sp cncm i 3699 for weaned piglets sti biotechnologie
topic zootechnical additives
other zootechnical additives
Lacticaseibacillus rhamnosus CNCM I‐3698 and Companilactobacillus sp. CNCM I‐3699
piglets
safety
url https://doi.org/10.2903/j.efsa.2023.7858
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