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.
Scientific opinion of BIOHAZ Panel on the request from the Commission for review of the opinion on microbiological risks in infant formulae and follow-on formulae with regard to Enterobacteriaceae as indicators
Cerf, O. ; Colin, P. ; Collins, D. ; Forsythe, S. ; Noerrung, B. ; Roberts, T. ; Zwietering, M.H. - \ 2007
EFSA Journal 444 (2007). - p. 1 - 14.
The European Commission requested EFSA to review the former EFSA/BIOHAZ opinion on microbiological risks in infant formulae and follow-on formulae. Particularly it was requested to provide a scientific opinion on the possible correlation between Enterobacteriaceae and Enterobacter sakazakii and Enterobacteriaceae and Salmonella in infant formulae as well as on the correlation between Enterobacteriaceae and Salmonella in follow-on formulae, in the light of new scientific data. The usefulness of Enterobacteriaceae as indicators for E. sakazakiiand Salmonella in powdered infant formulae and follow-on formulae was also requested if available scientific data do not indicate a clear correlation. The products of concern are powdered infant formulae and powdered follow-on formulae. Consideration of microbiological criteria is outside of the remit of this opinion. Enterobacter sakazakii and Salmonella, both in the family Enterobacteriaceae, are hazards that are occasionally present in powdered infant formulae and powdered follow-on formulae. Given that Salmonella and E. sakazakii are both members of the family Enterobacteriaceae, there is some relationship between the presence of E. sakazakii and Salmonella and the presence of Enterobacteriaceae. If E. sakazakii or Salmonella are present, Enterobacteriaceae should be found provided that the methods are equally sensitive. In some instances levels are so low that if E. sakazakii or Salmonella is detected, Enterobacteriaceae are not detected, just due to “chance”. However, the reverse is not inevitably true since the presence of Enterobacteriaceae does not necessarily mean the presence of Salmonella or E. sakazakii. Industry data from different companies showed that E. sakazakii / Enterobacteriaceae ratios range from 9 to 30%. A correlation between the prevalences of Enterobacteriaceae and that of E. sakazakii was observed in one plant but sufficient specific information was not available for the other plants. A correlation might be apparent according to the ecology of industrial units, with each unit having a characteristic ratio. The BIOHAZ Panel concluded that there is a relationship between the presence of Enterobacteriaceae and E. sakazakii in powdered infant formulae. No universal correlation can be established. There are indications that correlations could be established at individual plant level. It is not possible to establish a correlation between Enterobacteriaceae and Salmonella in infant formulae and in follow-on formulae and, because Salmonella is so rarely present, suitable data are not available. Industrial experience indicates that monitoring Enterobacteriaceae in the processing environment and in the product can be used to confirm the application of GMP/GHP and HACCP and would be expected to reduce the prevalence of E. sakazakii. The BIOHAZ Panel recommended that documented data ideally using standardized methods be accumulated (by industry, regulators, academia) testing for Enterobacteriaceae, Salmonella, and E. sakazakii in the same samples (ingredients, end-product and environmental) across the industry to explore correlations and their relevance in setting control measures