Guidance document to evaluate the competence of laboratories implementing challenge tests on the growth potential of Listeria monocytogenes in ready-to-eat foods
Creators: name: Beaufort, Annie
name: Guillier, Laurent
name: Lardeux, Anne-Laure
name: LOMBARD, Bertrand
name: Bergis, Hélène
name: Polet, Marie
name: Botteldoorn, Nadine
name: Papageourgiou, George
name: Bulawova, Hana
name: Andersen, Jens Kirk
name: Hickey, Bernadette
name: Tupe, Gita
name: Skjerdal, Taran
name: Pires Gomes, Celcidina
name: Biasizzo, Majda
name: Acebal Sarabia, Cristina
name: Thisted-Lambertz, Susanne
name: Fitz-James, Ife
Publisher: name: Zenodo
Year: 2012
Subjects: EURL Lm
Listeria monocytogenes
Ready-to-eat foods
guidance document
guide
food microbiology
laboratory competence
shelf-life study
durability study
challenge test
growth potential
maximum growth rate

description: Regulation (EC) No 2073/20051 of 15 November 2005 on microbiological criteria for foodstuffs sets out specific food safety criteria for L. monocytogenes in ready-to-eat (RTE) foods (Annex I of the Regulation). Particularly for RTE foods, other than those intended for infants and for special medical purposes, placed on the market during their shelf-life, a quantitative limit of 100 cfu/g for L. monocytogenes has been laid down. According to article 3 point 2 of the Regulation, Food Business Operators (FBO) producing RTE foods, shall conduct studies in accordance with Annex II in order to investigate compliance with the criteria throughout the shelf-life.In order to guide RTE producers in identifying the L. monocytogenes risk in their RTE foods and laboratories in implementing the shelf-life studies, two guidance documents have been produced:- “Guidance document on Listeria monocytogenes shelf-life studies for ready to eat foods, under Regulation (EC) No 2073/2005 of 15 November 2005 on microbiological criteria for foodstuffs”, DG-Sanco 1628/2008 ver. 9.3, (DG-SANCO guidance document), intended for FBO,- “Technical guidance document on shelf-life studies for Listeria monocytogenes in RTE foods” CRL for Listeria monocytogenes version.2 - November 2008, (TGD Nov. 2008), intended for laboratories.The laboratory shelf-life studies, especially durability studies and challenge tests, should be implemented properly and carried out in laboratories having the required expertise for such studies and demonstrating good laboratory practices.The purpose of this document is to provide guidance for evaluating the competence of laboratories implementing shelf-life studies according to Annex II of the Regulation, especially challenge tests aimed at assessing the growth potential of Listeria monocytogenes in RTE foods:- to evaluate the required expertise for shelf-life studies,- to ensure that challenge tests are implemented according to the Technical Guidance Document (TGD, Nov. 2008).After an introduction and general information related to the laboratory and the FBO (parts 1 and 2), the part 3 of this document covers the justification of challenge tests, based on the DG-SANCO Guidance document (SANCO/1628/2008 ver.9.3). The FBO is guided on the necessity or not to implement shelf-life studies (e.g. durability and challenge tests). The purpose of this part is also to ensure that the laboratory has collected the relevant information to be used to implement the challenge test.The part 4 of this document aims at ensuring that challenge tests are conducted in compliance with the EURL Lm “Technical guidance document on shelf-life studies for Listeria monocytogenes in RTE foods”.The present document, based on the aforementioned guidance documents (SANCO/1628/2008 ver.9.3 and TGD, Nov. 2008) may be used as a “reference document”, in order to conduct uniform assessment of laboratories performing challenge tests.Tables in the document provide check-lists as support for the assessment.