RECENT DEVELOPMENTS Florence POSTOLLEC - - PowerPoint PPT Presentation

S16: CHALLENGE TESTING FOR LISTERIA MONOCYTOGENES: REQUIREMENTS, NEEDS, DIFFICULTIES AND DEVELOPMENTS

CHALLENGE TESTING & STANDARDISATION, RECENT DEVELOPMENTS

IAFP, Nantes , 25 april 2019

Florence POSTOLLEC florence.postollec@adria.tm.fr

• Quimper

CHALLENGE TESTING & STANDARDISATION, RECENT DEVELOPMENTS

Florence POSTOLLEC florence.postollec@adria.tm.fr

STANDARDIZATION

• Process of developing and implementing technical guidelines based
• n a consensus

Ensure International Recognition Optimize efforts & time Facilitate Food Trade Help in Microbial Risk Assessment

A PROCESS AS A WHOLE

STANDARDIZATION

Development and implemention of technical guidelines based on a CONSENSUS

REGULATION

A law, rule, or other order prescribed by the competent authority

1 2

ACCREDITATION

Competences assessment of a laboratory

4

VALIDATION/CERTIFICATION

Performances assessment of a method

3

WHAT ARE ISO STANDARDS

• International

Standardization Organization: independent, non- governmental international organization with a membership of 164 national standards bodies

• ISO Standard: document, established by consensus and approved by

a recognized body NOTE: Standards should be based on the consolidated results of science, technology and experience, and aimed at the promotion of

• ptimum community benefits
• ISO has published 22 590 international standards covering almost

every industry, from technology, to food safety, to agriculture and healthcare.

WHO IS MAKING ISO STANDARDS

• Member bodies (P-members)

Influence ISO Standard development and strategy by participating and voting in ISO technical and policy meetings Full members adopt ISO standards nationally

• Correspondant members (O-members)

Observe the development of ISO standards and strategy by attending ISO technical and policy meetings as observers Correspondant members can adopt standards

• Creation date: 1947
• Twinned secretariat: AFNOR (France) and ABNT (Brazil)
• Scope: standardization in the field of human and animal foodstuffs,

covering the food chain from primary production to consumption, as well as animal and vegetable propagation materials, in particular, but not limited to, terminology, sampling, methods of test and analysis, product specifications, food and feed safety and quality management and requirements for packaging, storage and transportation

• Members : 140 among 78 participating members
• Sub committees: 16 (SC)

ISO TC34, FOOD PRODUCTS

ISO TC34/SC9, FOOD MICROBIOLOGY

• Creation date: 1982
• Secretariat: AFNOR (France)
• G. Hardouin (Secretary) & J-A. Hennekinne (Chairperson)
• Scope: horizontal methods in the field of microbiological analysis of the

food chain from primary production stage to food and animal feed products, including the environment of food production and handling

ISO TC34/SC9, FOOD MICROBIOLOGY

• Members: 65 experts

ISO TC34/SC9, FOOD MICROBIOLOGY

• Liaisons with other committees

ISO TC34/SC9, FOOD MICROBIOLOGY

• Working groups: 24 (WG)

ISO TC34/SC 9, MICROBIOLOGY OF THE FOOD CHAIN

• Working groups: 24 (WG)

• Context: On the application of general principles of food hygiene, it is

the responsibility of the Food Business Operators (FBO) to control microbial risks in foods. Therefore, the FBO shall conduct studies in order to investigate compliance with the criteria throughout the production and storage processes. In the framework of Microbial Risk Assessment (MRA), several complementary approaches are developed to estimate food safety and food quality risks posed by pathogen or spoilage microorganisms in the food chain. MRA is adopted by regulators under the auspices of the international agency for setting food standards

ISO TC34 / SC9 / WG19, CHALLENGE TESTS

• Creation date: 2014
• Secretariat: AFNOR (France)

S Tiprez (Secretary) & F Postollec (Convenior)

• Objectives: to provide technical rules and calculations approaches to

investigate the ability of inoculated micro-organism of concern to grow or survive in the raw materials, intermediate or end-products under different reasonably foreseeable food processes, storage and use conditions.

• Members: experts from food industry, food technology institute, food

testing laboratory, research center and regulatory bodies + support team, liaison representative, document monitor & technical program manager to ensure smooth & efficient development

ISO TC34 / SC9 / WG19, CHALLENGE TESTS

• Members: 38 experts from AU, BE, CH, CN, DE, ES, FR, IT, NL, UK, US

ISO TC34 / SC9 / WG19, CHALLENGE TESTS

Role Appointed Country Stakeholder category Name Role Appointed Country Stakeholder category Name Committee member AFNOR FR Academic and research bodies Louis COROLLER Committee member NEN NL Academic and research bodies Heidy DEN BESTEN Committee member AFNOR FR Industry and commerce Véronique HUCHET Committee member NEN NL Government Paul IN'T VELD Committee member AFNOR FR Industry and commerce Yvan LE MARC Committee member NEN NL Industry and commerce Taco WIJTZES Committee member AFNOR FR Academic and research bodies Jeanne-Marie MEMBRE Committee member SA AU Industry and commerce Agnes TAN Committee member AFNOR FR Industry and commerce Barbara NIBOUCHE Committee member SAC CN Industry and commerce Ming LIU Committee member AFNOR FR Industry and commerce Stella PLANCHON Committee member SAC CN Industry and commerce Zhen MENG Committee member AFNOR FR Industry and commerce Valérie STAHL Committee member SAC CN Industry and commerce Xiaolong WANG Committee member ANSI US Government Rachel BINET Committee member SAC CN Government Wenjing XU Committee member ANSI US Industry and commerce Patrick BIRD Committee member SAC CN Industry and commerce Xinyang ZHANG Committee member ANSI US Government Alexandre DA SILVA Committee member SAC CN Industry and commerce Wei ZHANG Committee member ANSI US Industry and commerce Gretchen GUTIERREZ Committee member SNV CH Industry and commerce Frédérique CANTERGIANI Committee member ANSI US Industry and commerce Pamela WILGER Committee member SNV CH Industry and commerce Mariem ELLOUZE Committee member BSI UK Industry and commerce Gail BETTS Committee member UNE ES Industry and commerce Sara CID BOVER Committee member DIN DE Academic and research bodies Thiemo ALBERT Committee member UNI IT Government Lucia DECASTELLI Committee member DIN DE Industry and commerce Michael BENNER Committee member UNI IT Industry and commerce Gianni DI FALCO Committee member DIN DE Academic and research bodies Christina BOHNLEIN Committee member UNI IT Government Elisa GOFFREDO Committee member DIN DE Academic and research bodies Jan KABISCH Committee member UNI IT Industry and commerce Luigi LANNI Committee member NBN BE Government Marie POLET Liaison representative EC

• Academic and research bodies

Hélène BERGIS Secretary AFNOR FR / Stéphanie TIPREZ Convenor AFNOR FR / Florence POSTOLLEC Secretary support team AFNOR FR / Angely LAURYN Convenor support team AFNOR FR / Cécile SCALZOLARO Document monitor AFNOR FR / Gwenola HARDOUIN Document monitor NEN NL / Laura MOUT Document monitor DIN DE / Katja SCHILLING Document monitor NSAI IE Government AnneMarie CROWLEY Document monitor JISC JP / Nobuhisa SUZUKI TPM ISOCS CH / Marie-Noëlle BOURQUIN

• Deliverable: standards Microbiology of the food chain

ISO 20976-1:2019 Requirements and guidelines for conducting challenge tests of food and feed products – part 1: challenge tests to study growth potential, lag time and maximum growth rate ISO PWI 20976-2 Requirements and guidelines for conducting challenge tests of food and feed products – part 2: challenge tests to study inactivation potential and kinetics parameters ISO PWI 23691 Determination and use of cardinal values in predictive microbiology

ISO TC34 / SC9 / WG19, CHALLENGE TESTS

• Standards development process: 6 steps

ISO TC34 /SC9 / WG19, CHALLENGE TESTS

ISO PWI 20976-2 Requirements and guidelines for conducting challenge tests of food and feed products – part 2: inactivation Determination and use of cardinal values ISO PWI 23691

New work item proposal (NP) Publication of ISO standard Formal vote

• n FDIS

(final draft international standard ) Enquiry

• n DIS

(draft international standard ) Consensus building within TC/SC Building expert consensus

ISO 20976-1:2019 Requirements and guidelines for conducting challenge tests of food and feed products – part 1: growth

ISO 20976-1:2019

• Requirements and guidelines for conducting challenge tests of food and

feed products – part1: challenge tests to study growth potential, lag time and maximum growth rate

• Publication in march 2019

ISO 20976-1:2019

• Table of content

ISO 20976-1:2019

• Table of content

Scope

This document specifies protocols for conducting microbiological challenge tests for growth studies

• n vegetative and spore-forming bacteria in raw

materials and intermediate or end products. The use of this document can be extended to yeast that do not form mycelium.

ISO 20976-1:2019

• Table of content

Terms and definitions

• CONTROL UNIT

Unit of food identical to the test unit but not artificially contaminated (used as a blank)

• CHALLENGE TEST

Study

• f

the growth

• r

inactivation

• f

microorganism(s) artificially inoculated in food

• TEST PORTION

Measured representative sample taken from the test unit for use in the analysis

• TEST UNIT

Measured amount of food used for inoculation

ISO 20976-1:2019

• Table of content

Principle

• GROWTH POTENTIAL STUDIES

Validate the specific food characteristics and conditions applied. When microbiological criteria are not fulfilled or conditions are changed, a new growth potential study is carried out

• GROWTH KINETICS STUDIES

Estimate and validate the microbiological food shelf-life. These tests are particularly suitable for food innovation, are more informative but as well more complex than growth potential studies

ISO 20976-1:2019

• Table of content

Study design and sampling

Shall address sources of variability (inter-, intra- batch, artificial inoculation)

• SETTING DECISION CRITERIA FOR POTENTIAL
• NUMBER OF BATCHES AND SELECTION CRITERIA

The variability of food and production shall be documented and the characteristics of the studied batches representative based

• n

historical data The use of a single batch shall be clearly justified

• PREPARATION OF TEST UNITS
• NUMBER OF INOCULATED TEST UNITS

ISO 20976-1:2019

• Table of content

Selection of strains

• Each

strain used shall be characterized biochemically and/or serologically and/or genetically and known origin.

• Strains should be held in a collection to enable

them to be used in future testing, if required.

• Selected strain shall be fit for purpose and

growth ability should have been determined prior to challenge test

• Mix of strains is recommended for the estimation
• f growth potential while only one strain shall be

used to estimate growth rate

ISO 20976-1:2019

• Table of content

Controls

• FOOD CONTROLS

To ensure the representativeness of the test units

• CONTROL UNITS

To ensure that the preparation of the test units has not affected the characteristics of the studied food To provide additional information to be used for the interpretation of the results and test report

ISO 20976-1:2019

• Table of content

Expression of the results

• GROWTH POTENTIAL (D)

If 3 or more batches are studied, D=logmax-logi Where logmax is the highest value observed and logi is the initial value of the same batch The final growth potential corresponds to the highest D from the batches If one batch is studied, for each sampling point calculate the mean

• f

the experimental datapoints Suspected outliers shall be investigated Challenge test is rejected at time zero if standard deviation >0.3log10CFU/g

• GROWTH KINETICS PARAMETERS (growth rate

and lag time) Growth rate is estimated at fixed T° and can be used for further simulations using predictive modelling based on the gamma-concept

ISO 20976-1:2019

• Table of content

Test report

• AIM OF THE STUDY & TYPE OF CHALLENGE TEST
• EXPERIMENTAL PROTOCOL
• SAMPLE ANALYSIS
• RESULTS
• CONCLUSIONS
• REFERENCE DOCUMENTS

29

ISO 20976-1:2019

• Table of content

Annexes

• ANNEX A (informative)

Inter-batch variability assessment based on pH and aw + IBPCV calculator & user guide http://standards.iso.org/iso/20976/-1/ed-1/en

• ANNEX B (normative)

Minimum number

• f

units to prepare the challenge test study

• ANNEX C (informative)

Examples of protocols to prepare inocula

• ANNEX D (informative)

Example of how to estimate growth potential, lag time and maximum growth rate from results of a challenge test

• ANNEX E (informative)

Use of simulation to assess a microbial population under different temperature conditions

FOR FURTHER INFORMATION

• ISO website: www.iso.org
• IAFP poster
• ISO/TC34/SC9/WG19

FOR FURTHER INFORMATION

• ISO website: www.iso.org
• IAFP poster
• ISO/TC34/SC9/WG19

• Phenotypic & molecular

characterization

• Risk assessment on sporeforming

complex microflora

• Development of generic predictive

microbiology approaches

• Molecular typing
• Risk assessment on

pathogens & spoilage microflora

• Method validation

studies in food microbiology

Food safety & quality

• Training & events
• Advices, regulatory

support

• HACCP, BRC, IFS,

ISO 22000 Audits

• Functional ingredient

characterization

• Food packaging
• Food innovation

FOR FURTHER INFO ON ADRIA …

Training, audit & advices Food & pack solutions Scientific developments & valorization

MERCI DE VOTRE ATTENTION THANKS