BIOHAZ statement on QPS: suitability of taxonomic units notified to October 2014

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Article
safety, QPS, bacteria, yeast, Carnobacterium divergens, Microbacterium imperiale, Candida cylindracea
First published in the EFSA Journal
22 December 2014
Adopted
4 December 2014
Last Updated
5 June 2017. This version replaces the previous one/s.
Type
Statement
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. A total of 99 biological agents were notified to EFSA between May 2013 and October 2014. From those, 26 biological agents already had a QPS status and were not further evaluated, and 54 were also not included as they are filamentous fungi or enterococci, biological groups which have been excluded from the QPS activities since 2014. The remaining 19 notifications were considered for the assessment of the suitability for the QPS list. These 19 notifications referred to 13 taxonomic units which were evaluated for the QPS status, three of which were recommended for the QPS list: a) Carnobacterium divergens, with the qualification of absence of acquired antibiotic resistance determinants; b) Microbacterium imperiale, only for enzyme production, and c) Candida cylindracea, only for enzyme production.

Panel members at the time of adoption
Olivier Andreoletti, Dorte Lau Baggesen, Declan Bolton, Patrick Butaye, Paul Cook, Robert Davies, Pablo S. Fernandez Escamez, John Griffin, Tine Hald, Arie Havelaar, Kostas Koutsoumanis, Roland Lindqvist, James McLauchlin, Truls Nesbakken, Miguel Prieto Maradona, Antonia Ricci, Giuseppe Ru, Moez Sanaa, Marion Simmons, John Sofos and John Threlfall.
Panel on Biological Hazards
Contact
biohaz [at] efsa.europa.eu
doi
10.2903/j.efsa.2014.3938
EFSA Journal 2014;12(12):3938 [41 pp.].
Question Number
On request from
EFSA
Print on demand
Number of Pages
41