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

Tabs

Article
safety, QPS, bacteria, gen. nov., sp. nov. DSM 11798 of the Coriobacteriaceae, Pasteuria nishizawae, Chromobacterium subtsugae, Pseudomonas chlororaphis
First published in the EFSA Journal
11 December 2015
Adopted
2 December 2015
Last Updated
5 June 2017. This version replaces the previous one/s.
Type
Statement
Abstract
EFSA was 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 was assessed. Safety concerns identified 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 49 biological agents were notified to EFSA between March and September 2015. From these, 24 biological agents already had a QPS status and did not require further evaluation, and 16 were not included as they are filamentous fungi or enterococci, biological groups which have been excluded from the QPS activities since 2014. Three notifications for Streptomyces were not included because the genus have already been evaluated in the previous statement of December 2014 and found unsuitable for QPS. Two notifications belonging to the species Escherichia coli were not evaluated for QPS status, because this species was recently re-assessed and considered not suitable for QPS status. Therefore, there were four notifications related to four taxonomic units that were evaluated for QPS status. Pasteuria nishizawae may be recommended for the QPS status to be used in plant protection products to combat cyst nematodiasis. The other three units were not recommended for the QPS list: gen. nov., sp. nov. DSM 11798 of the Coriobacteriaceae family, Chromobacterium subtsugae and Pseudomonas chlororaphis.  
Panel members at the time of adoption
Ana Allende, Declan Bolton, Marianne Chemaly, Robert Davies, Pablo Salvador Fernandez Escamez, Rosina Girones, Lieve Herman, Konstantinos Koutsoumanis, Roland Lindqvist, Birgit Nørrung, Antonia Ricci, Lucy Robertson, Giuseppe Ru, Moez Sanaa, Marion Simmons, Panagiotis Skandamis, Emma Snary, Niko Speybroeck, Benno Ter Kuile, John Threlfall, and Helene Wahlström.
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
Contact
biohaz@efsa.europa.eu
doi
10.2903/j.efsa.2015.4331
EFSA Journal 2015;13(12):4331 [25 pp.].
Question Number
On request from
EFSA
Print on demand
Number of Pages
25