Validation in food and feed microbiology: a unified approach set out by the Food Agencies or different approaches stimulated by the laboratories itself G. De Poorter, Director general Laboratories C. De Backer, National Reference Laboratory in food microbiology MicroVal Symposium, Amsterdam 20th of March 2007 Agence fédérale pour la Sécurité de la Chaîne alimentaire

2 Plan of the lecture Legislative context Analytical context Methods categories Available alternative methodologies Illustration Conclusion References

Agence fédérale pour la Sécurité de la Chaîne alimentaire3 Legislative context Commission Regulation (EC) n° 2073/2005 of 15 November 2005 on microbiological criteria for foodstuffs –Reference methods (mainly « ISO » standard methods) –Alternative validated methods Reference methods issued from the regulation Protocol set out in the standard ISO or internationally accepted similar protocols Third party

Agence fédérale pour la Sécurité de la Chaîne alimentaire4 Analytical context FASFC requirements for the choice of methods according to the analytical context analytical contextFASFC requirementsin practicedate of application R & Dno requirement NA private analysesmethods consistent with the Commission Regulation (EC) n° 2073/2005 any method among : - reference methods - alternative validated methods 01/01/08 FASFC analyses and all counter-analyses methods imposed by FASFC among methods consistent with the Commission Regulation (EC) n° 2073/2005 imposed methods among : - reference methods - alternative validated methods 01/01/08

Agence fédérale pour la Sécurité de la Chaîne alimentaire5 Methods categories Standard methods Alternative validated methods Belgian official methods

Agence fédérale pour la Sécurité de la Chaîne alimentaire6 Methods categories - 2 Standardized methods –Characterized performances –Entire protocol, no simplification –French « routine » standard methods and some other standards : progressive abolition (until January 1, 2008) methodcategoryexamples standardinternationalISO, IDF EuropeanEN nationalNBN, NF, NEN, DIN, NMKL

Agence fédérale pour la Sécurité de la Chaîne alimentaire7 Methods categories - 3 Alternative validated methods –Commercial methods: simpler, faster and/or more economic than the reference methods –Standard ISO : 2003 « Protocol for the validation of the alternative methods» International recognition –FASFC considers that the alternative methods validated by AFAQ AFNOR Certification are in conformity with the provisions of article 5 of the Commission Regulation (EC) n° 2073/2005 –The alternative methods validated by other organizations or laboratories will be also recognized in Belgium if they fulfil the requirements of article 5 of the Commission Regulation (EC) n° 2073/2005 and if they provide at least the same guarantees as those described in the protocol of the standard ISO –Validation file to provide to FASFC and National Reference Laboratory in food microbiology for evaluation and possibly recognition

Agence fédérale pour la Sécurité de la Chaîne alimentaire8 Methods categories - 4 Belgian official methods –Worked out to meet a need –Written by the National Reference Laboratory in food microbiology and recognized by FASFC –Valid until January 1, 2008 for those where another reference method exists

Agence fédérale pour la Sécurité de la Chaîne alimentaire9 Methods categories - end Methods : summary methodecategoryexamples standardizedinternationaleISO, IDF européenneEN nationaleNBN, NF, NEN, DIN, NMKL alternative validatedISO 16140AFNOR Belgian official SP-VG AOAC? MicroVal?

Agence fédérale pour la Sécurité de la Chaîne alimentaire10 Available alternative methodologies Principal available methodologies within the alternative validated methods and some examples –Important : step of confirmation of the positive results per culture example of methods countingdehydrated mediapétrifilm chromogenic mediaRapid’media, media ID NPPTempo detectionCulture mediumsSMS, ALOA, Rapid’, CHROMagar, Compass, OCLA, OAA ImmunoassayOxoid rapid test, Vidas, Transia, Tecra, Reveal, kit Locate, Bioline, Rapidyme Genetic testsBAX, GeneDisc Cycler, IQ-Check, Probelia Molecular hybridizationLumiprobe, Accuprobe

Agence fédérale pour la Sécurité de la Chaîne alimentaire11 Illustration

Agence fédérale pour la Sécurité de la Chaîne alimentaire12 Illustration Salmonella spp detection from January 1, 2008

Agence fédérale pour la Sécurité de la Chaîne alimentaire13 Conclusion List of the analytical methods recognised by FASFC for the food microbiological analyses in Belgium since about 11 years List strongly modified by the Commission Regulation (EC) n° 2073/2005 Reference methods and validated alternative methods Progressive disappearance of some standards and methods (cfr list of recognized methods) Obligation for private analytical controls to also align on Commission Regulation (EC) n° 2073/2005, before January 1, 2008 Imposition of specific methods for the analyses for FASFC from January 1, 2008 Alternative validated methods recognized by FASFC if they fulfil requirements of the Commission Regulation (EC) n° 2073/2005 and if they provide at least the same guarantees as those described in the protocol of the standard ISO Validation file to provide to FASFC for evaluation and possibly recognition List updated twice a year and available on the website of FASFC ( > secteur professionnel > administration des laboratoires > agrément > laboratoires agréés > notes de service) Constant evolution, must anticipate changes

Agence fédérale pour la Sécurité de la Chaîne alimentaire14 References and useful links –Standard ISO 16140:2003, Microbiology of food and animal feeding stuffs – Protocol for the validation of alternative methods. –Commission Regulation (EC) n° 2073/2005 of 15 November 2005 on microbiological criteria for foodstuffs. Official Journal of the European Union, December 22, 2005, L 338/1 – L 338/26. –LECLERCQ A. (2003). EN ISO 16140, Validation des méthodes alternatives d’essais. Lecture during the 8 th Conference on Food microbiology, Liège. – > secteur professionnel > administration des laboratoires : website of the Federal Agency for the Safety of the Food Chain (FASFC) – website of the French Association for Standardization (AFNOR) – : World Standards Services Network : network gathering websites of the international, regional or national organizations of standardization.