BIOHAZ statement on QPS: suitability of taxonomic units notified until March 2015

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Article
safety, QPS, bacteria, Bacillus circulans, Xanthomonas campestris, Streptomyces mobaerensis, Streptomyces violaceoruber 
First published in the EFSA Journal
25 June 2015
Adopted
4 June 2015
Last Updated
27 October 2015. 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 85 biological agents were notified to EFSA between October 2014 and March 2015. From those, 35 biological agents already had a QPS status and were not further evaluated, and 45 were also not included as they are filamentous fungi or enterococci, biological groups which have been excluded from the QPS activities since 2014. Two notifications referred to two taxonomic units which were evaluated for the QPS status, one of which was recommended for the QPS list: Xanthomonas campestris, only for the production of xanthan gum, while the other, Bacillus circulans, was not due to insufficient body of knowledge on a safe history of use in foods and feeds. Three notifications belonging to the genus Streptomyces were not evaluated for the QPS status, because the genus was recently considered not suitable for the QPS approach.

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 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.2015.4138
EFSA Journal 2015;13(6):4138 [29 pp.].
Question Number
On request from
EFSA
Print on demand
Number of Pages
29