Assessment of the feed additive consisting of <i>Limosilactobacillus fermentum</i> NCIMB 30169 for all animal species for the renewal of its authorisation (Microferm Ltd.)

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Abstract

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the assessment of the application of renewal of Limosilactobacillus fermentum NCIMB 30169 as a technological feed additive (functional group: silage additives) for all animal species. The applicant has provided evidence that the additive currently on the market complies with the existing terms of the authorisation. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the additive remains safe for all animal species, consumers, and the environment. Regarding user safety, the additive should be considered a skin and respiratory sensitiser. No conclusions can be drawn on the eye irritancy potential of the additive. There is no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.

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Guidance on the characterisation of microorganisms used as feed additives or as production organisms

Guido Rychen, Gabriele Aquilina, Giovanna Azimonti … (2018)

Draft Endorsed by the FEEDAP Panel * 18 May 2017 Submitted for public consultation 15 June 2017 End of public consultation 15 September 2017 Adopted by the FEEDAP Panel 21 February 2018 Implementation date 1 September 2018 * Sections 3.1 and 3.2 were also endorsed by the EFSA Panel on Genetically Modified Organisms (GMO), EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) and EFSA Panel on Food Additives and Nutrient Sources Added to Food (ANS) on 18 May (GMO) and 7 June (CEF and ANS) 2017. Abstract This guidance document is intended to assist the applicant in the preparation and the presentation of an application, as foreseen in Article 7.6 of Regulation (EC) No 1831/2003, for the authorisation of additives for use in animal nutrition. It specifically covers the characterisation of microorganisms used as feed additives or as production organisms.

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EFSA statement on the requirements for whole genome sequence analysis of microorganisms intentionally used in the food chain

(2021)

Microorganisms, genetically modified or not, may be used in the food chain as such or as production organisms of substances of interest. The placement of such microorganisms or derived substances/products in the European market may be subject to a pre‐market authorisation process. The authorisation process defines the need to perform a risk assessment to establish the safety and/or the efficacy of the microorganisms when used in the food chain as such or as production strains of substances of interest. In order to perform a risk assessment, the microorganism/s subject to the application for authorisation need/s to be characterised. In this regard, data obtained from whole genome sequence analysis can provide information on the unequivocal taxonomic identification of the strains and on the characterisation of their potential functional traits of concern which may include virulence factors, resistance to antimicrobials of clinical relevance for humans and animals, production of known toxic metabolites. In fact, in some areas of the regulated products, the use of whole genome sequence‐based data has been established as a requirement for the risk assessment. This document provides recommendations to applicants on how to describe the process and results which should be provided to the risk assessor in the context of an application for market authorisation of a regulated product. Indications are given on how to perform WGS and the quality criteria/thresholds that should be reached as well as the data and relevant information that need to be sent along whenever such kind of data is required.

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Update of the list of qualified presumption of safety (QPS) recommended microorganisms intentionally added to food or feed as notified to EFSA

Konstantinos Koutsoumanis, Ana Allende, Avelino Álvarez‐Ordóñez … (2023)

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Author and article information

Contributors

: feedap@efsa.europa.eu

Journal

Journal ID (nlm-ta): EFSA J

Journal ID (iso-abbrev): EFSA J

Journal ID (doi): 10.1002/(ISSN)1831-4732

Journal ID (publisher-id): EFS2

Title: EFSA Journal

Publisher: John Wiley and Sons Inc. (Hoboken )

ISSN (Electronic): 1831-4732

Publication date (Electronic): 23 May 2024

Publication date Collection: May 2024

Volume: 22

Issue: 5 ( doiID: 10.1002/efs2.v22.5 )

Electronic Location Identifier: e8794

Author notes

[*] [* ] Correspondence: feedap@ 123456efsa.europa.eu

Article

Publisher ID: EFS28794

DOI: 10.2903/j.efsa.2024.8794

PMC ID: 11112457

PubMed ID: 38784841

SO-VID: 496736cc-4482-4c6c-9855-fd0eeabc05f8

License:

This is an open access article under the terms of the http://creativecommons.org/licenses/by-nd/4.0/ License, which permits use and distribution in any medium, provided the original work is properly cited and no modifications or adaptations are made.

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Figures: 0, Tables: 0, Pages: 7, Words: 3100

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source-schema-version-number 2.0

cover-date May 2024

details-of-publishers-convertor Converter:WILEY_ML3GV2_TO_JATSPMC version:6.4.3 mode:remove_FC converted:23.05.2024

Keywords: limosilactobacillus fermentum ncimb 30169,qps,renewal,safety,silage additives,technological additives

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Keywords: limosilactobacillus fermentum ncimb 30169, qps, renewal, safety, silage additives, technological additives

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Assessment of the feed additive consisting of Limosilactobacillus fermentum NCIMB 30169 for all animal species for the renewal of its authorisation (Microferm Ltd.)

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Most cited references 5

Guidance on the characterisation of microorganisms used as feed additives or as production organisms

EFSA statement on the requirements for whole genome sequence analysis of microorganisms intentionally used in the food chain

Update of the list of qualified presumption of safety (QPS) recommended microorganisms intentionally added to food or feed as notified to EFSA

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