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


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 Dietetic Products, Nutrition and Allergies
Panel on Plant Protection Products and their Residues
EFSA Journal
EFSA Journal 2013;11(11):3449 [106 pp.].
Panel Members
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.

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.

Opinion of the Scientific Committee/Scientific Panel
On request from
Question Number
24 October 2013
Published in the EFSA Journal
14 November 2013
Last Updated
2 February 2017. This version replaces the previous one/s.
European Food Safety Authority (EFSA), Parma, Italy

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.

safety, QPS, bacteria, yeast, fungi, virus
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