European regulatory update Role of EU Reference Laboratory for Coagulase Positive Staphylococci
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1 European regulatory update Role of EU Reference Laboratory for Coagulase Positive Staphylococci Workshop of IT-NRL CPS, IZSTO, Torino November 2015 Bertrand LOMBARD Manager EURL Coagulase Positive Staphylococci ANSES-Laboratory for Food Safety, Maisons-Alfort, France Nov B Lombard 1
2 EUROPEAN REGULATORY UPDATE Nov B Lombard 2
3 EC Regulation 2073/2005 Regularly updated No current change of microbiological criteria on Coagulase positive staphylococci (CPS) Staphyloccal enterotoxins (SEs) Nov B Lombard 3
4 Revision EC Regulation 882/2004 (1) On official controls (OCs) Deep revision Incl. scope enlarged to plant health Before work conducted by DG SANTE Now at European Council & European Parliament Methods to be used for OCs Requirements and duties for Official labs (OLs) EU Reference Laboratories (EURLs) National Reference Laboratories (NRLs) Extracts from earlier draft (end 2014): not the latest & subject to changes Nov B Lombard 4
5 Revision R. 882/2004: methods Nov B Lombard 5
6 Revision R. 882/2004: official labs (1) Nov B Lombard 6
7 Revision R. 882/2004: official labs (2) Nov B Lombard 7
8 Revision R. 882/2004: official labs (3) Nov B Lombard 8
9 Revision R. 882/2004: official labs (4) Nov B Lombard 9
10 Revision R. 882/2004: EURLs (1) Nov B Lombard 10
11 Revision R. 882/2004: EURLs (2) Nov B Lombard 11
12 Revision R. 882/2004: EURLs (3) Nov B Lombard 12
13 Revision R. 882/2004: EURLs (4) Nov B Lombard 13
14 Revision R. 882/2004: EURLs (5) Nov B Lombard 14
15 Revision R. 882/2004: NRLs (1) Nov B Lombard 15
16 Revision R. 882/2004: NRLs (2) Nov B Lombard 16
17 Revision R. 882/2004: NRLs (3) Nov B Lombard 17
18 ROLE OF EURL CPS Nov B Lombard 18
19 ANSES-Laboratory for Food Safety (1) 2 locations Maisons-Alfort Boulogne-sur-Mer Accredited by COFRAC EN ISO for most of its activities in particular analyses involved in EURL/NRL mandates Nov B Lombard 19
20 Laboratory for Food Safety, Maisons-Alfort and Boulogne-sur-Mer sites Laurent LALOUX, Director, Anne BRISABOIS, Deputy director MAISONS-ALFORT COORDINATION OF REFERENCE ACTIVITIES Team Bertrand Lombard, Head HYGIENE, SAFETY AND OCCUPATIONAL HEALTH Laurence Bouhier, Christine Delpont, Ghislaine Merle, health and safety assistants 2 services and 2 common teams with the Maisons-Alfort Laboratory for Animal Health ADMINISTRATIVE AND FINANCIAL Service Christelle Gautheron, Head ANIMAL HOUSE Service Sébastien Allix, Head Océane Le Bidel, Deputy QUALITY Team Cécile Cecconi, Quality Manager, Head SECURITY AND SAFETY BIOLOGICAL Team Sébastien Allix, Head Department of Chemical Food Contaminants Thierry Guérin, Head METALLIC AND MINERAL TRACE ELEMENTS Unit Laurent Noêl, Head PESTICIDES E& MARINE BIOTOXINS Unit Frédéric Hommet, Head Chanthadary Phandanouvong, Dputy SUPPORT AND DEVELOPMENT OF RESEARCH ACTIVITIES Team Sylviane Dragacci, Head TECHNICAL SUPPORT TO LABORATRY ACTIVITIES Service Sylvie Rudelle, Head Department of Microbiological Food Contaminants Michel-Yves Mistou, Head LISTERIA, SALMONELLA, E. COLI Unit Renaud Lailler, Head David Albert, Deputy STAPHYLOCOCCUS, BACILLUS, CLOSTIDIA, MILK Unit Jacques-Antoine Hennekinne, Head Frédéric Auvray, Deputy CENTRAL VETERINARY SERVICES LABORATORY Unit Agnès Chamoin, Head ENTERIC VIRUSES Unit Sylvie Perelle, Head QUANTITATIVE RISK ANALYSIS AND MODELLING Team Annie Beaufort, Head ANTIMICROBIAL RESISTANCE Team Sophie Granier, Head HIGH-THROUGHPUT PLATFORM FOR IDENTIFICATION AND TYPING OF PATHOGENS Patrick Fach, Head BOULOGNE/MER HYGIENE, SAFETY AND OCCUPATIONAL HEALTH Graziella Bourdin, health and safety assistant ADMINISTRATIVE AND FINANCIAL Service Sophie Holuigue, Head Updated: November 2014 QUALITY Régine Quenu, Quality Manager Department of Fishery products and Aquaculture Anne Brisabois, Head Guillaume Duflos, Deputy Nov B Lombard Unit for the BACTERIOLOGY AND PARASITOLOGY OF FISHERY PRODUCTS AND AQUACULTURE Graziella Bourdin, Head, Mélanie Gay, Deputy Unit for the PHYSICAL CHEMISTRY OF FISHERY PRODUCTS AND AQUACULTURE Guillaume Duflos, Head Unit for the BIOCHEMISTRY OF AQUATIC PRODUCTS Thierry Grard, Head 20
21 ANSES-Laboratory for Food Safety (3) EU Reference Laboratory for Staphylococci (incl. staphylococcal enterotoxins) Milk and dairy product hygiene Listeria monocytogenes French National Reference Laboratory for Staphylococci and staphylococcal enterotoxins Listeria monocytogenes Vibrio sp Anisakidae in fish Milk and dairy product hygiene Marine biotoxins Pesticides residues in food of animal origin Pesticide residues (single-residue methods) Heavy metals Histamine in fish Avian botulism (with Anses-Ploufragan) Antimicrobial resistance (with Anses-Fougères) Salmonella(with Anses-Ploufragan) Nov B Lombard 21
22 Introduction to EURL CPS (1) ANSES-Laboratory for Food Safety Designated EU Reference Laboratory for Coagulase Positive Staphylococci (including staphylococcal enterotoxins -SEs) (EURL CPS) In 2006 by EC Regulation 776/2006, modifying EC Regulation 882/2004 In charge of implementing the microbiological criteria on CPS & SEs of EC Regulation 2073/ Nov B Lombard 22
23 Introduction to EURL CPS (2) 5 process hygiene criteria on CPS/MMP Nov B Lombard 23
24 Introduction to EURL CPS (3) 1 process hygiene criterion on CPS/cooked crustaceans and molluscan shellfish 1 food safety criterion on SEs/MMP Nov B Lombard 24
25 Introduction to EURL CPS (4) 3 types of activities 1. Coordination of NRL network 2. Analytical development 3. Technical & scientific support to EC Nov B Lombard 25
26 1. Coordination of NRL network (1) Network of 36 National Reference Laboratories (NRLs) At least 1/EU Member State and associated country (Norway) For IT: IZSTO Designated by MS Competent Authorities Annual workshops General scope or thematic Regulatory update Epidemiological context (EFSA/ECDC annual reports) Works undertaken by EURL since last workshop Presentations of NRLs: On-going works, National staphylococcal food-borne outbreaks (SFBOs) EURL work programme for next year Nov B Lombard 26
27 1. Coordination of NRL network (2) Organization of proficiency testing (PT) trials To assess proficiency of NRLs to use reference methods cited in Reg. 2073/2005 2/year CPS enumeration, EN ISO or 2 SE detection, EURL CPS European Screening Method Investigation of new test material «naturally» contaminated cheeses (pilot production): collaborative project with IZSTO CPS inoculation techniques of solid food matrices Nov B Lombard 27
28 1. Coordination of NRL network (3) Organization of training sessions CPS typing (PFGE, spa typing) PCR detection of se genes SE analysis ELISA screening detection ELISA quantification of SE types Nov B Lombard 28
29 1. Coordination of NRL network (4) Scientific & technical advice Confirmatory analyses CPS typing, se genes detection, SE quantification/typing In particular for investigating national SFBOs Replies to queries Input in national meetings In particular for the Italian workshops! Nov B Lombard 29
30 At EURL 2. Analytical development (1) On-going & scheduled for 2016/2017 (not yet approved by DG SANTE) CPS enumeration Measurement uncertainty Impact & optimization of sub-sampling of test portion Current works: impact of test portion size 10 vs. 25 g 2015: comparative trials with volunteering NRLs Recommendation to ISO/TC 34/SC 9 to modify the test portion size in general case, EN ISO Impact of CPS & SE distribution in cheeses Nov B Lombard 30
31 2. Analytical development (2) CPS characterization Validation of a multiplex PCR method for se genes detection 2015: inter-lab trial with volunteeering NRLs Molecular alternative methods (MLVA) to PFGE for CPS typing MLVA until 2015 WGS Nov B Lombard 31
32 2. Analytical development (3) SE analysis Use of MS for characterization and quantification Collaboration with SE and BE NRLs Developement of Certified Reference Materials Collaboration with EC/JRC/IRMM, Geel To be soon avaiable at IRMM Development of new ELISA-based methods to detect other SEs than SEA-SEE SEG, SEH & SEI Known to cause SFBOs Nov B Lombard 32
33 3. Technical & scientific support to EC When needed, development/update of microbiological criteria on CPS/SE Participation to CEN/ISO standardization Alexandra CAUQUIL Project leader for the amendment to EN ISO Alternative confirmation by stab-inoculation of RPFA Participates to the revision of EN ISO Jacques-Antoine HENNZKINNE Project leader for intra-lab & inter-lab validation of a method for SE detection in food Convenor of TAG 12 of CEN/TC 275/WG 6 to standardize this method Nov B Lombard 33
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