Implementation of PROMETHEUS 4‐step approach for evidence use in EFSA scientific assessments: benefits, issues, needs and solutions
Aiassa, Elisa ; Martino, Laura ; Barizzone, Fulvio ; Ciccolallo, Laura ; Garcia, Ana ; Georgiadis, Marios ; Guajardo, Irene Muñoz ; Tomcikova, Daniela ; Alexander, Jan ; Calistri, Paolo ; Gundert‐remy, Ursula ; Hart, Andrew David ; Hoogenboom, Ron Laurentius ; Messean, Antoine ; Naska, Androniki ; Navarro, Maria Navajas ; Noerrung, Birgit ; Ockleford, Colin ; Wallace, Robert John ; Younes, Maged ; Abuntori, Blaize ; Alvarez, Fernando ; Aryeetey, Monica ; Baldinelli, Francesca ; Barrucci, Federica ; Bau, Andrea ; Binaglia, Marco ; Broglia, Alessandro ; Castoldi, Anna Federica ; Christoph, Eugen ; Sesmaisons‐Lecarré, Agnes De; Georgiadis, Nikolaos ; Gervelmeyer, Andrea ; Istace, Frederique ; López‐Gálvez, Gloria ; Manini, Paola ; Maurici, Daniela ; Merten, Caroline ; Messens, Winy ; Mosbach‐Schulz, Olaf ; Putzu, Claudio ; Bordajandi, Luisa Ramos ; Smeraldi, Camilla ; Tiramani, Manuela ; Martínez, Silvia Valtueña ; Sybren, Vos ; Hardy, Anthony Richard ; Hugas, Marta ; Kleiner, Juliane ; Seze, Guilhem De - \ 2018
EFSA Supporting Publications 15 (2018)4. - ISSN 2397-8325
In 2014, the European Food Safety Authority (EFSA) started the PROMETHEUS (PROmoting METHods for Evidence Use in Scientific assessments) project to improve further and increase the consistency of the methods it uses in its scientific assessments. The project defined a set of principles for the scientific assessment process and a 4‐step approach (plan/carry out/verify/report) for their fulfilment, which was tested in ten case studies, one from each EFSA panel. The present report describes the benefits, issues, needs and solutions related to the implementation of the 4‐step approach in EFSA, identified in a dedicated workshop in October 2017. The key benefits of the approach, which was deemed applicable to all types of EFSA scientific assessment including assessments of regulated products, are: 1) increased ‘scientific value’ of EFSA outputs, i.e. the extent of impartiality, methodological rigour, transparency and engagement; 2) guarantee of fitness‐for‐purpose, as it implies tailoring the methods to the specificities of each assessment; 3) efficiency gain, since preparing a protocol for the assessment upfront helps more streamlined processes throughout the implementation phase; 4) innovation, as the approach promotes the pioneering practice of ‘planning before doing’ (well established in primary research) for broad scientific assessments in regulatory science; and 5) increased harmonisation and consistency of EFSA assessments. The 4‐step approach was also considered an effective system for detecting additional methodological and/or expertise needs and a useful basis for further defining a quality management system for EFSA's scientific processes. The identified issues and solutions related to the implementation of the approach are: a) lack of engagement and need for effective communication on benefits and added value; b) need for further advances especially in the field of problem formulation/protocol development, evidence appraisal and evidence integration; c) need for specialised expertise in the previous aspects; and specific needs for d) assessments of regulated products and e) outsourced projects.
|Ranking risks posed by composite food products
Stella, P. ; Cerf, O. ; Koutsoumanis, K.P. ; Nguyen-The, C. ; Sofos, J.N. ; Valero, A. ; Zwietering, M.H. ; Hugas, M. - \ 2013
In: Conference proceedings 8th International Conference on Predictive Modelling in Food, Paris, France, 16 - 20 September, 2013. - Paris : CNIEL, IFIP - ISBN 9782356700254 - p. 191 - 192.
Ranking the microbiological safety of foods: A new tool and its application to composite products
Stella, P. ; Cerf, O. ; Hugas, M. ; Koutsoumanis, K.P. ; Nguyen-The, C. ; Sofos, J.N. ; Valero, A. ; Zwietering, M.H. - \ 2013
Trends in Food Science and Technology 33 (2013)2. - ISSN 0924-2244 - p. 124 - 138.
quantitative risk-assessment - yersinia-enterocolitica - escherichia-coli - moisture transfer - water - infection - outbreak - storage - virus
A methodology based on the combination of two complementary approaches to rank microbiological risks in foods is presented. In the forward approach data on the pathogenicity of hazards and their behaviour in food during processing and following steps, up to consumption, are used in decision trees to qualitatively estimate the risk associated with foods. In the backward approach risks are evaluated based on the analysis of data available on the past occurrence of hazards and foodborne outbreaks. The categorisation of foods using the forward approach should prevail, and whenever it leads to a likely risk for a given food, the risk can be further qualified with the results from the backward approach. The methodology developed was applied to rank the public health risk posed by certain composite products, which contain both processed products of animal origin and products of plant origin (e.g., bread, cakes, chocolate). Despite limitations in the data available for these foods, valuable results were obtained. The method is therefore considered suitable for application with success to other types of food, and is proposed as a tool for risk managers to rank foods based on their potential food safety risks
Corrigendum to "Qualified presumption of safety (QPS): a generic risk assessment approach for biological agents notified to the European Food Safety Authority (EFSA)"
Leuschner, R.G.K. ; Robinson, T.P. ; Hugas, M. ; Cocconcelli, P.S. ; Richard-Forget, F. ; Klein, G. ; Licht, T.R. ; Nguyen-The, C. ; Querol, A. ; Richardson, M. ; Suarez, J.E. ; Thrane, U. ; Vlak, J.M. ; Wright, A. - \ 2011
Trends in Food Science and Technology 22 (2011)1. - ISSN 0924-2244 - p. 51 - 52.
Qualified presumption of safety (QPS): a generic risk assessment approach for biological agents notified to the European Food Safety Authority (EFSA)
Leuschner, H.H. ; Robinson, T.P. ; Hugas, M. ; Cocconcelli, P.S. ; Richard-Forget, F. ; Klein, G. ; Licht, T.R. ; Nguyen-The, C. ; Querol, A. ; Richardson, M. ; Suarez, J.E. ; Thrane, U. ; Vlak, J.M. ; Wright, A. - \ 2010
Trends in Food Science and Technology 21 (2010)9. - ISSN 0924-2244 - p. 425 - 435.
yellow mosaic-virus - dairy microorganisms - pediococcus-acidilactici - antibiotic-resistance - escherichia-coli - cross protection - bacillus-cereus - lactobacillus - susceptibility - strains
Qualified Presumption of Safety (QPS) is a generic risk assessment approach applied by the European Food Safety Authority (EFSA) to notified biological agents aiming at simplifying risk assessments across different scientific Panels and Units. The aim of this review is to outline the implementation and value of the QPS assessment for EFSA and to explain its principles such as the unambiguous identity of a taxonomic unit, the body of knowledge including potential safety concerns and how these considerations lead to a list of biological agents recommended for QPS which EFSA keeps updated through an annual scientific review and assessment