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Scientific Opinion SCIENTIFIC OPINION ADOPTED: 30 November 2016 doi: 10.2903/j.efsa.2017.4664 Scientific Opinion on the update of the list of QPS-recommended biological agents intentionally added to food or feed as notified to EFSA* EFSA Panel on Biological Hazards (BIOHAZ), Antonia Ricci, Ana Allende, Declan Bolton, Marianne Chemaly, Robert Davies, Rosina Girones, Lieve Herman, Konstantinos Koutsoumanis, Roland Lindqvist, Birgit Nørrung, Lucy Robertson, Giuseppe Ru, Moez Sanaa, Marion Simmons, Panagiotis Skandamis, Emma Snary, Niko Speybroeck, Benno Ter Kuile, John Threlfall, Helene Wahlstrom,€ Pier Sandro Cocconcelli, Gunter€ Klein (deceased), Miguel Prieto Maradona, Amparo Querol, Luisa Peixe, Juan Evaristo Suarez, Ingvar Sundh, Just M. Vlak, Margarita Aguilera-Gomez, Fulvio Barizzone, Rosella Brozzi, Sandra Correia, Leng Heng, Fred erique Istace, Christopher Lythgo and Pablo Salvador Fernandez Escamez Abstract EFSA is requested to assess the safety of a broad range of biological agents in the context of notification for market authorisation as sources of food and feed additives, food 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’sscientific 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 was reviewed and updated in the current opinion and therefore becomes the valid list. The 2016 update reviews previously assessed microorganisms including bacteria, yeasts and viruses used for plant protection purposes following an Extensive Literature Search strategy. The taxonomic units related to the new notifications received since the 2013 QPS opinion, were periodically evaluated for a QPS status and the results published as Statements of the BIOHAZ Panel. Carnobacterium divergens, Lactobacillus diolivorans, Microbacterium imperiale, Pasteuria nishizawae, Pediococcus parvulus, Bacillus flexus, Bacillus smithii, Xanthomonas campestris and Candida cylindracea were recommended for the QPS list. All taxonomic units previously recommended for the 2013 QPS list had their status reconfirmed as well their qualifications with the exception of Pasteuria nishizawae for which the qualification was removed. The exclusion of filamentous fungi and enterococci from the QPS evaluations was reconsidered but monitoring will be maintained and the status will be re-evaluated in the next QPS Opinion update. Evaluation of bacteriophages should remain as a case-by-case procedure and should not be considered for QPS status. © 2017 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority. Keywords: safety, QPS, food and feed, bacteria, yeast, fungi, virus Requestor: EFSA Question number: EFSA-Q-2014-00189 Correspondence: [email protected] * The BIOHAZ Panel would like to dedicate this opinion to the memory of Gunter€ Klein – see Obituary in the March 2017 issue of the EFSA Journal. www.efsa.europa.eu/efsajournal EFSA Journal 2017;15(3):4664 BIOHAZ Panel Opinion on QPS Panel members: 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 Wahlstrom.€ Acknowledgements: The BIOHAZ Panel wishes to thank the EFSA staff member: Mirena Ivanova for the support provided to this scientific output. Amendment: 1. (6 June 2017) The name of one author has been corrected on page 1 and in the suggested citation paragraph; text under the additional information column has been added for E. coli rows on page 115. In Table A.1, p. 70, the text on the qualification of the taxonomic unit Pasteuria nishizawae has been deleted, following the decision taken by the BIOHAZ Panel at the meeting held in November-December 2016. 2. (12 September 2017) in Appendix A the paragraph text has been slightly re-edited; deletion of the text ‘and no viable cells are found’ in the Yeasts section. 3. (24 January 2018) Appendix A has been updated, following the revision of the QPS list adopted at the BIOHAZ Panel meeting held in December 2017; at the end of the Appendix a reference list has been added. 4. (25 May 2018). On page 71 in Appendix A the footnote letter attached to ‘Yeasts’ has been corrected from (j) to (e). 5. (17 July 2018) On pages 71–73 Appendix A has been updated, following the revision of the QPS list adopted at the BIOHAZ Panel meeting held in June 2018. 6. (24 January 2019) On pages 70–72 Appendix A has been updated, following the revision of the QPS list adopted at the BIOHAZ Panel meeting held in December 2018. 7. (15 July 2019) On pages 70–73 Appendix A has been updated, following the revision of the QPS list adopted at the BIOHAZ Panel meeting held in June 2019. These editorial corrections do not materially affect the contents or outcome of this scientific output. To avoid confusion, the older version has been removed from the EFSA Journal, but is available on request, as is a version showing all the changes made. Erratum: 1. (12 September 2017) Table A.1 in Appendix A was revised to correct an erroneous footnote on “Paenibacillus lentus” and to add a new footnote ‘d’ on Lactobacillus animalis; in Appendix E the reference to Paenibacillus lentus has been deleted on p. 98; text on Paenibacillus lentus under column Additional information on page 132 for EFSA-Q-2016-00181 has been revised. 2. (24 January 2018) Table A.1 in Appendix A was revised to substitute “Paenibacillus lentus” with “Bacillus lentus”. To avoid confusion, the older version has been removed from the EFSA Journal, but is available on request, as is a version showing all the changes made. Suggested citation: EFSA BIOHAZ Panel (EFSA Panel on Biological Hazards), Ricci A, Allende A, Bolton D, Chemaly M, Davies R, Girones R, Herman L, Koutsoumanis K, Lindqvist R, Nørrung B, Robertson L, Ru G, Sanaa M, Simmons M, Skandamis P, Snary E, Speybroeck N, Ter Kuile B, Threlfall J, Wahlstrom€ H, Cocconcelli PS, Klein G (deceased), Prieto Maradona M, Querol A, Peixe L, Suarez JE, Sundh I, Vlak JM, Aguilera-Gomez M, Barizzone F, Brozzi R, Correia S, Heng L, Istace F, Lythgo C and Fernandez Escamez PS, 2017. Scientific Opinion on the update of the list of QPS-recommended biological agents intentionally added to food or feed as notified to EFSA. EFSA Journal 2017; 15(3):4664, 178 pp. doi:10.2903/j.efsa.2017.4664 ISSN: 1831-4732 © 2017 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority. This is an open access article under the terms of the Creative Commons Attribution-NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited and no modifications or adaptations are made. The EFSA Journal is a publication of the European Food Safety Authority, an agency of the European Union. www.efsa.europa.eu/efsajournal 2 EFSA Journal 2017;15(3):4664 BIOHAZ Panel Opinion on QPS 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. The request included three specific tasks as described in the Terms of Reference (ToR). In 2014, the BIOHAZ Panel decided to change the evaluation procedure: instead of publishing the overall assessment of the taxonomic units previously recommended for the QPS list annually as until 2013, it is now carried out every 3 years in a Scientific Opinion of the BIOHAZ Panel (December 2016). Meanwhile, that list of microorganisms has been maintained based on the evaluation of extensive literature reviews that will be updated regularly with new publications. When an assessment for a QPS recommendation of a microbiological agent notified to EFSA is requested by the Feed Unit, the Food Ingredients and Packaging (FIP) Unit, the Nutrition Unit or the Pesticides Unit, the respective evaluations for a QPS status have been compiled and published in Panel Statements every 6 months. The first ToR requires to keep updated the list of biological agents being notified, in the context of a technical dossier to EFSA Units (such as Feed, Food Ingredients and Packaging (FIP), Nutrition, and Pesticides), for intentional use in feed and/or food or as sources of food and feed additives, enzymes and plant protection products for safety assessment. The list has been updated with the notifications received since May of 2013 until September of 2016. The notifications received within every 6-month period have been included in a table appended to each respective Panel Statement (five in total within this period). These new notifications were also included in Appendix E of this Opinion, compiling all microorganism notified to EFSA from the beginning of the QPS exercise in 2007. From the last notifications included in the previous QPS Opinion in 2013, 405 notifications were received between May 2013 and September 2016, of which, 137 were from Feed, 196 from FIP, 11 from Nutrition and 61 from Pesticides. For the type of microorganisms, 183 were bacteria, 177 filamentous fungi, 9 viruses and 36 yeasts TUs. The second ToR concerns the revision of the taxonomic units previously recommended for the QPS list and their qualifications (especially the qualification regarding antimicrobial resistance (AMR)) when new information has become available and to update the information provided in the previous Opinion published in November 2013 where appropriate.
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