Guidance on the assessment of the safety of feed additives for the target species

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Abstract

Draft Endorsed by the FEEDAP Panel	22 March 2017
Submitted for public consultation	6 April 2017
End of public consultation	31 May 2017
Adoption by the FEEDAP Panel	26 September 2017
Entry into force	1 May 2018

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 assessment of the safety for the target species.

Abstract

This publication is linked to the following EFSA Supporting Publications article: http://onlinelibrary.wiley.com/doi/10.2903/sp.efsa.2017.EN-1304/full

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Most cited references 6

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Introduction of a Qualified Presumption of Safety (QPS) approach for assessment of selected microorganisms referred to EFSA - Opinion of the Scientific Committee

(2007)

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Scientific Opinion on the update of the list of QPS ‐recommended biological agents intentionally added to food or feed as notified to EFSA †

Antonia Ricci, Ana Allende, Declan Bolton … (2017)

Abstract EFSA is requested to assess the safety of a broad range of biological agents in the context of notification for market authorisation as sources of food and feed additives, food enzymes and plant protection products. The qualified presumption of safety (QPS) assessment was developed to provide a harmonised generic pre‐assessment to support safety risk assessments performed by EFSA's scientific Panels. The safety of unambiguously defined biological agents (at the highest taxonomic unit appropriate for the purpose for which an application is intended), and the completeness of the body of knowledge are assessed. Identified safety concerns for a taxonomic unit are, where possible and reasonable in number, reflected as ‘qualifications’ in connection with a recommendation for a QPS status. The list of QPS recommended biological agents was reviewed and updated in the current opinion and therefore becomes the valid list. The 2016 update reviews previously assessed microorganisms including bacteria, yeasts and viruses used for plant protection purposes following an Extensive Literature Search strategy. The taxonomic units related to the new notifications received since the 2013 QPS opinion, were periodically evaluated for a QPS status and the results published as Statements of the BIOHAZ Panel. Carnobacterium divergens, Lactobacillus diolivorans, Microbacterium imperiale, Pasteuria nishizawae, Pediococcus parvulus, Bacillus flexus, Bacillus smithii, Xanthomonas campestris and Candida cylindracea were recommended for the QPS list. All taxonomic units previously recommended for the 2013 QPS list had their status reconfirmed as well their qualifications with the exception of Pasteuria nishizawae for which the qualification was removed. The exclusion of filamentous fungi and enterococci from the QPS evaluations was reconsidered but monitoring will be maintained and the status will be re‐evaluated in the next QPS Opinion update. Evaluation of bacteriophages should remain as a case‐by‐case procedure and should not be considered for QPS status.

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Guidance on Statistical Reporting

(2014)

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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): 17 October 2017

Publication date Collection: October 2017

Volume: 15

Issue: 10 ( doiID: 10.1002/efs2.2017.15.issue-10 )

Electronic Location Identifier: e05021

Author notes

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

Article

Publisher ID: EFS25021

DOI: 10.2903/j.efsa.2017.5021

PMC ID: 7009839

PubMed ID: 32625311

SO-VID: f017b2d6-f054-4e65-be16-19f5e68e9b85

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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: 3, Pages: 19, Words: 9218

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cover-date October 2017

details-of-publishers-convertor Converter:WILEY_ML3GV2_TO_JATSPMC version:5.7.5 mode:remove_FC converted:21.01.2020

Guidance on the assessment of the safety of feed additives for the target species

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Relationship between water quality, sanitation quality, and food security to public health

Most cited references 6

Introduction of a Qualified Presumption of Safety (QPS) approach for assessment of selected microorganisms referred to EFSA - Opinion of the Scientific Committee

Scientific Opinion on the update of the list of QPS ‐recommended biological agents intentionally added to food or feed as notified to EFSA †

Guidance on Statistical Reporting

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