Scientific Opinion on the maintenance of the list of QPS biological agents intentionally added to food and feed (2013 update)

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Article
Panel on Biological Hazards
Panel on Additives and Products or Substances used in Animal Feed
Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids
Panel on Plant Protection Products and their Residues
EFSA Journal
EFSA Journal 2013;11(11):3449 [106 pp.].
doi
10.2903/j.efsa.2013.3449
Panel members at the time of adoption
Olivier Andreoletti, Dorte Lau Baggesen, Declan Bolton, Patrick Butaye, Paul Cook, Robert Davies, Pablo S. Fernández Escámez, John Griffin, Tine Hald, Arie Havelaar, Kostas Koutsoumanis, Roland Lindqvist, James McLauchlin, Truls Nesbakken, Miguel Prieto, Antonia Ricci, Giuseppe Ru, Moez Sanaa, Marion Simmons, John Sofos and John Threlfall.
Acknowledgements

The Panel wishes to thank the members of the Working Group on the maintenance of the list of QPS biological agents intentionally added to food and feed (2013 update): Pier Sandro Cocconcelli, Pablo S. Fernández Escámez, Florence Richard Forget, Günter Klein, Tine Licht, Miguel Prieto Maradona, Christophe Nguyen-the, Ingvar Sundh, Ulf Thrane and Just M. Vlak for the preparatory work on this scientific opinion and the hearing expert: Atte von Wright, and EFSA staff: Renata Leuschner for the support provided to this scientific opinion.

Type
Opinion of the Scientific Committee/Scientific Panel
On request from
EFSA
Question Number
EFSA-Q-2013-00019
Adopted
24 October 2013
Published
14 November 2013
Last Updated
11 December 2015. This version replaces the previous one/s.
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
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Abstract

EFSA is requested to assess the safety of a broad range of biological agents in the context of notifications for market authorisation as sources of food and feed additives, 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 is reviewed and updated periodically. Therefore, the only valid list is the one in the most recently published scientific opinion. The 2013 update reviews previously assessed microorganisms including bacteria, yeasts, filamentous fungi, oomycetes and viruses used for plant protection purposes. All taxonomic units previously recommended for the QPS list had their status reconfirmed. The new notifications since the last QPS update were reviewed. Gluconobacter oxydans and Alphaflexiviridae were assessed for the first time and were recommended for the QPS list. The information of the previous opinion was updated for the taxonomic units on the QPS list. Qualifications for the taxonomic units included in the QPS recommended list were reviewed and confirmed. Filamentous fungi and enterococci were not recommended for the QPS list following updating and reviewing of current scientific knowledge.

Summary

The European Food Safety Authority (EFSA) asked the Panel on Biological Hazards (BIOHAZ) to deliver a Scientific Opinion on the maintenance of the list of QPS biological agents intentionally added to food or feed (2013 update). The question included four specific tasks in the terms of reference (ToR).

The first required a preparation of an update of the list of biological agents for intentional use in feed and/or food, or as sources of food and feed additives or enzymes and as plant protection products for safety assessment as notified to EFSA Units and/or Scientific Panels such as Pesticides, the Panels on Additives and Products or Substances used in Animal Feed (FEEDAP) and Genetically Modified Organisms (GMO). The list was updated with the notifications received where applicable by EFSA Panels and Units since the last review.

The second ToR was concerned with an annual review of the list of biological agents recommended for the QPS list. Where appropriate new taxonomic units should be assessed for their suitability for an inclusion in the QPS list, and taxonomic units previously assessed should be reviewed where new information has become available. The information provided in the previous opinion should be updated where appropriate. The BIOHAZ Panel confirmed all taxonomic units previously recommended for the QPS list following review. The notifications were assessed. Gluconobacter oxydans and Alphaflexiviridae were assessed for the first time and recommended for the QPS list. The information of the previous opinion was updated for the taxonomic units on the QPS list.

The third ToR required a review of the qualifications for taxonomic units included in the QPS recommended list and in particular the qualification regarding antimicrobial resistance in taxonomic units recommended for the QPS list. The information of the previous opinion was updated and the qualifications were confirmed.

The fourth ToR concerned a review and update of the body of knowledge for notified filamentous fungi and enterococci. The knowledge of filamentous fungi notified to EFSA was updated. Although numerous data, published since the 2012 QPS opinion, have contributed to partially fulfil gaps of knowledge, too many unknowns remain in 2013 to allow a filamentous fungus to be recommended for the QPS list.

Enterococcus faecium is not recommended for the QPS list in spite of the recent scientific knowledge allowing a differentiation of pathogenic from non-pathogenic strains. This is of value for the FEEDAP Scientific Panel dealing with the strain specific notification, but it is too recent knowledge for a QPS recommendation, considering the recent information on the evolution of the epidemiology of Enterococcus infections in human. 

Keywords
safety, QPS, bacteria, yeast, fungi, virus
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Number of Pages
106