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Overview of standard methods development of ISO and CEN Alexandre LECLERCQ Convenor of CEN TC275/WG6 Food
Overview of standard methods
development of ISO and CEN
Alexandre LECLERCQ
Convenor of CEN TC275/WG6 Food Microbiology
IAFP, Berlin, 2009
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CRITERIA / STANDARD (Codex alimentarius, CAC/GL 21 of 1997) • • Micro-organisms of interest - interest
CRITERIA / STANDARD
(Codex alimentarius, CAC/GL 21 of 1997)
Micro-organisms of interest - interest for the product ;
Sampling plan;
Usable detection and/or quantification methods
Satisfactory microbiological limits for the food at the
critical point of the food chain ;
The number of analytical units allowing a conformity
compared to these limits ;
The food to which it applies
Stages of the food chain to which it applies ;
All measures to be taken when it is not satisfied.
IAFP, Berlin, 2009
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Target: Which Microorganisms ? Prions Prions Bacteriophages ?? Bacteriophages Bacteria/ Bacteria/ Food Food Virus Virus Spores
Target: Which Microorganisms ?
Prions
Prions
Bacteriophages
??
Bacteriophages
Bacteria/
Bacteria/
Food
Food
Virus
Virus
Spores
Spores
Human/animal
Human/animal
GMO
GMO ??
Insects
Insects
Fungi
Fungi
Water
Water
Environnement
Environnement
Protozoa
Protozoa
Metabolites
Metabolites
Parasites
Parasites
(Fungi,
(Fungi, bact.)
bact.)
Toxins
Toxins
(Algae,
(Algae, Fungi,
Fungi, bact.)
bact.)
Toxicology ?
IAFP, Berlin, 2009
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Example: Bacteria • Pathogen 1 microorganism • Bacteria resistant to antibiotics • Opportunistic • Deterioration flora
Example: Bacteria
Pathogen
1
microorganism
Bacteria resistant to antibiotics
Opportunistic
Deterioration flora
Bioindicator flora
– Sanitary
– Technology
1
Population,
1
ecology
Probiotics
Floral with technological interest / Starter
Flora of Ali-terrorism
IAFP, Berlin, 2009
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The target becomes more and more complex ! Example of the producing E coli of Shiga-like
The target becomes more and more complex !
Example of the producing E coli of Shiga-like toxins
• Serotype detection
– Interesting public health: as EHEC
– Interesting veterinary sector
• Detection of virulence genes
– VT/eaeA/HlyA
• Test in Vivo / cellular culture
• Immunological detection of verotoxins!
IAFP, Berlin, 2009
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Viable but not cultivable Log CFU Colony viability Survival Culture Enumeration Time Molecular biology / Cytometry
Viable but not cultivable
Log CFU
Colony
viability
Survival
Culture Enumeration
Time
Molecular biology / Cytometry / Microscopy
IAFP, Berlin, 2009
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PROCESS: ASSAY Sample collection Manutention Equipment Personnal Management Calibration Preparation Methods ?? Premises Quality Quality ANALYSES
PROCESS: ASSAY
Sample collection
Manutention
Equipment
Personnal
Management
Calibration
Preparation
Methods ??
Premises
Quality
Quality
ANALYSES
System
Control
Working
Reagents
conditions
Results
Report
Measurement uncertainty
Recording
Validation
Audit
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IAFP, Berlin, 2009
Standardized Standardized methods methods • Reference text • Elaborated by qualified body, with consensus among all
Standardized
Standardized methods
methods
Reference text
Elaborated
by
qualified
body, with consensus among
all the interested parties
Continuous,
repetitive
and
voluntary application
« Speak the same language »
Distinction between full standard and
Technical specification
IAFP, Berlin, 2009
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Standardize Standardize oror Harmonize: Harmonize: Why Why ?? • Avoid disparate methods of microbiological analysis •
Standardize
Standardize oror Harmonize:
Harmonize:
Why
Why ??
Avoid disparate methods of microbiological analysis
Facilitate exchange of food products
Improve reliability of microbiological analysis
Relevant to general development of quality assurance
IAFP, Berlin, 2009
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International International Standardization Standardization (1947) (1947) • ISO (50 Standardization bodies) • ISO standard: optional integration
International
International Standardization
Standardization
(1947)
(1947)
ISO (50 Standardization bodies)
ISO standard: optional integration in national collection, revision each 5 years
TC34: Agricultural food products
SubCommittee 9: Microbiology: horizontal methods
Chairman: B. LOMBARD,
Secretariat: C. DE LAMOTTE
Vienna agreement: ISO standards CEN standards
Scope:
Scope: Standardization
Standardization inin the
the field
field of
of human
human and
and ananimal
imal foodstuf
foodstuffs,
fs, covering
covering the
the food
food chain
chain
from
from primary
primary production
production toto consumption,
consumption, aa well
well asas aanimal
nimal and
and veg
vegetable
etable propagation
propagation
materials,
materials, inin particualr,
particualr, but
but not
not limited
limited to,
to, termi
terminology,
nology, sampl
sampling,
ing, methods
methods of
of test
test and
and
analysis, analysis, product
product specifications,
specifications, food
food and
and feed
feed saf
safety
ety and
and quali
qualityty of
of management
management and
and
requirements
requirements for
for packaging,
packaging, storage
storage and
and transportat
transportation.
ion.
excluded:
excluded: products
products covered
covered byby ISO/TC54
ISO/TC54 Essential
Essential oi
oilsls and
and ISO/TC
ISO/TC9393 (Starch)
(Starch)
Mission: « Standard horizontalisation »
IAFP, Berlin, 2009
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Functioning ISO CASCO/BT ISO TC34 SC9 WG1 WG2 WG3 WG4 WG5 WG6 WG7 Project Microbiological Meat
Functioning
ISO CASCO/BT
ISO TC34
SC9
WG1
WG2
WG3
WG4
WG5
WG6
WG7
Project
Microbiological
Meat and
Proficiency
Culture
Statistics
Method
Parasites
group
examinations
meat products
testing
media
Probiotics
Validation
IAFP, Berlin, 2009
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European European Standardization Standardization (1985) (1985) • • CEN (Bruxelles, 19 Standardization Bodies), TC275: Food Analysis
European
European Standardization
Standardization (1985)
(1985)
CEN (Bruxelles, 19 Standardization Bodies),
TC275: Food Analysis / WG6 Microbial Contaminant
Chairman: A. LECLERCQ,
Secretariat: C. DE LAMOTTE
EN Standard: Obligatory integration in national collection
Pre-established recognition of standards ( by ISO)
Scope:
Scope:
Standardization
Standardization
of
of
horizontal
horizontal
microbiologica
microbiologicall
methods
methods for
for all
all food
food and
and animal
animal feeding
feeding stuff
stuff analy
analysis
sis
and
and for
for any
any other
other sample
sample that
that can
can bebe the
the source
source of
of
microbiological
microbiological contamination
contamination of
of food
food products
products
IAFP, Berlin, 2009
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Functioning CEN BT TC 327 Probiotics TC 302 TC 275 MILK ISO TC34/SC9 WG6 EU PROJECT
Functioning
CEN BT
TC 327
Probiotics
TC 302
TC 275
MILK
ISO TC34/SC9
WG6
EU PROJECT
Ad’Hoc group
Ad’(Hoc group
C. sakazakii
Ad’Hoc group
L. monocytogenes
Histamine, B. cereus
toxins, Staph. toxins
TAG1
TAG2
TAG3
TAG4
TAG5
TAG6
TAG7
Ad’hoc
Primary
Media
Validation
PCR
Virus
Sampling
Parasites
Group
techniques
production
STEC
IAFP, Berlin, 2009
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Alternative method # Full standard? For a given given scope, scope it shall estimate the same
Alternative method
# Full standard?
For a given
given scope,
scope it shall estimate the same
same
analyte
analyte than the one measured by the
corresponding reference method,
and shall meet the following requirements:
–– rapid
rapid analysis and/or response
–– easy
easy carrying and/or automation
– analytical performances
performances (accuracy, sensitivity )
..
IAFP, Berlin, 2009
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Standard and Outbreak (ISO TC34/SC9 and CENTC275/WG6) Possible Introduction of the following text as a note
Standard and Outbreak
(ISO TC34/SC9 and CENTC275/WG6)
Possible Introduction of the following text as a note in the
scope of the standards on pathogen detection
“For
epidemiological
purposes
or
during outbreak
investigations, other methods may need to be used in
addition to this standard”.
A
standard
could
not
cover
all
matrices
and
all
target
microorganisms!
IAFP, Berlin, 2009
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Microbiology of food and animal feeding stuffs ““Microbiology Microbiology of of the the food food chain
Microbiology of food and animal feeding stuffs
““Microbiology
Microbiology of
of the
the food
food chain
chain””
According
According toto the
the DGDG SANCO
SANCO agreement,
agreement, the
the scope
scope of
of WWG6
G6 isis enlarge
enlargedd toto include
include
bottled
bottled water
water and
and water
water used
used inin food
food processing
processing onl
onlyy when
when standa
standardized
rdized water
water
microbiology
microbiology methods
methods dodo not
not exist.
exist.
IAFP, Berlin, 2009
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General General requirements requirements and and guidance guidance for for microbiological microbiological examinations examinations Amemdment Amemdment
General
General requirements
requirements and
and guidance
guidance for
for
microbiological
microbiological examinations
examinations
Amemdment
Amemdment of
of ENEN ISO
ISO 7218
7218 published
published inin 2007
2007
(ISO
(ISO TC34/SC9/WG7,
TC34/SC9/WG7, A.
A. Leclercq)
Leclercq)
•General requirements and guidance/options intended for three main uses:
•implementation of ISO/TC 34/SC 9 or ISO/TC 34/SC 5 standards for detection or enumeration of
microorganisms, named hereafter “specific standards”;
•good laboratory practice for food microbiological laboratories (the purpose is not to detail them in
this International Standard, manuals are available for that purpose);
•guidance for accreditation of food microbiological laboratories (this International Standard
describes the technical requirements according to Annex B of ISO/IEC 17025:2005 for the
accreditation of a microbiological laboratory by national organizations).
•covers examination for bacteria, yeasts and moulds and can be used if supplemented with specific guidance
for prions, parasites and viruses. It does not cover the examination for toxins or other metabolites (e.g.
amines) from microorganisms.
• applies to the microbiology of food, animal feeding stuffs, the food production environment and the
primary production environment.
•The purpose of this International Standard is to help to ensure the validity of food microbiology
examinations, to assist in ensuring that the general techniques used for conducting these examinations are
the same in all laboratories, to help achieve homogeneous results in different laboratories, and to contribute
towards the safety of the laboratory personnel by preventing risks of infection.
IAFP, Berlin, 2009
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Microorganisms IAFP, Berlin, 2009 18/50
Microorganisms
IAFP, Berlin, 2009
18/50
Salmonella: Revision of EN ISO 6579 (ISO TC34/SC9) • Part 1: Detection and AmdA1 (primary production
Salmonella: Revision of EN ISO 6579
(ISO TC34/SC9)
Part 1: Detection and AmdA1 (primary production samples)
deal with the detection of S. Typhi and S. Paratyphi in a normative annex
considering the use of the SC enrichment broth
launch a trial comparing enrichment in the BAM/USP formulation of tetrathionate
broth and in MKTTn.
collect data comparing the use of RVS and MSRV for food analysis
XLD should be retained as the mandatory isolation medium
usefulness of some biochemical tests
Part 2: Enumeration
a new MPN method, able to analyze simultaneously a lot of samples at a lower
cost. This technique is based on the ability of the MSRV medium to select and
enriched motile Salmonella that may be further isolated on chromogenic medium
Part 3: Serotyping
Based on Kauffman white’s scheme
IAFP, Berlin, 2009
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Campylobacter (CEN TC275/WG6) Revision of EN ISO 10272-1:2006 (detection Campylobacter) and of ISO/TS 10272-2:2006 (enumeration Campylobacter
Campylobacter
(CEN TC275/WG6)
Revision
of
EN
ISO
10272-1:2006
(detection
Campylobacter)
and
of
ISO/TS
10272-2:2006
(enumeration
Campylobacter
Colony-count
technique).
To improve the enrichment
and confirmation steps and
microaerobic incubation conditions
IAFP, Berlin, 2009
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Listeria spp. detection and enumeration (CEN TC275/WG6/ad’hoc group, R. Beumer) Revision of EN ISO 11290 L.
Listeria spp. detection and enumeration
(CEN TC275/WG6/ad’hoc group, R. Beumer)
Revision of EN ISO 11290
L. monocytogenes Listeria spp. and L. monocytogenes
Simplification of identification
IAFP, Berlin, 2009
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Revision EN ISO 11290: Identification Scheme Presumptive Other presumptive Listeria L.monocytogenes species ALOA or other chromogenic
Revision EN ISO 11290:
Identification Scheme
Presumptive
Other presumptive Listeria
L.monocytogenes
species
ALOA or other chromogenic
Gram stain (optional)
Gram stain
medium
Haemolysis
Haemolysis
CAMP (if necessary)
CAMP (if necessary)
Rhamnose
VP test
Xylose
Further tests if speciation
required (rhamnose, xylose,
mannitol)
Second medium if not
Gram stain
Gram stain
chromogenic
Haemolysis
Haemolysis
CAMP (if necessary)
CAMP (if necessary)
RhamnoseXylose
VP test
Further tests if speciation
required (rhamnose, xylose,
mannitol)
IAFP, Berlin, 2009
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VTEC non-O157 (CEN TC275/WG6/ad’hoc group, S. Morabito (CRL)) o Project technical specification o CEN ISO/WD TS
VTEC non-O157
(CEN TC275/WG6/ad’hoc group, S. Morabito (CRL))
o
Project technical specification
o
CEN ISO/WD TS 13136 Microbiology of food and animal feeding
stuffs -- Horizontal method for the detection of Shiga toxin-producing
Escherichia coli (STEC) belonging to O157, O111, O26, O103 and
O145 serogroups -- Qualitative Real-time polymerase chain reaction
(PCR)-based method
o
First detection of stx,eae genes and after RT-PCR for serotypes
followed by isolation of colonies
o
Problems of patents: RT-PCR for serogroup detection
o
A new need: An European standard for stx characterization by
PCR or RT-PCR
IAFP, Berlin, 2009
25/50
Bacillus cereus / Bacillus anthracis Revision of EN ISO 7932:2004 Microbiology of food and animal feeding
Bacillus cereus /
Bacillus anthracis
Revision of EN ISO 7932:2004 Microbiology
of food and animal feeding stuffs -
Horizontal method for the enumeration of
presumptive Bacillus cereus - Colony-
count technique at 30 °C
Investigation of chromogenic media
Investigation of the need of a Bacillus
anthracis standard
IAFP, Berlin, 2009
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Enterobacter sakazakii (CEN TC275/WG6/ad’hoc Group, H. Joosten & C. Iversen) • Draft: Horizontal method for the
Enterobacter sakazakii
(CEN TC275/WG6/ad’hoc Group, H. Joosten & C. Iversen)
Draft: Horizontal method for the detection of
Cronobacter spp. (Enterobacter sakazakii)
Relative poor performance with environmental samples
Recovery some sensitive strains from some milk powders
Enrichment broth is a Cronobacter screening broth:
Need to investigate sub cultures of negative broths and the
possibility of recoloration of the broth
IAFP, Berlin, 2009
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Brochothrix thermosphacta (ISO TC34/SC9/WG2 (meat and meat products), E. De Boer) Possible Revision of ISO 13722
Brochothrix thermosphacta
(ISO TC34/SC9/WG2 (meat and meat products), E. De Boer)
Possible Revision of ISO 13722
In parallel with NMKL
IAFP, Berlin, 2009
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Bioindicator - Coliforms: Evolution of methods Acid production from lactose (new definition) Gaz and acid production
Bioindicator - Coliforms:
Evolution of methods
Acid production from lactose
(new definition)
Gaz and acid production
d’acides from lactose (old
definition)
Enzymatic methods (new
definition)
•Escherichia coli
•Klebsiella
•Enterobacter
•Citrobacter
In green, coliforms present in
environment and human
faeces
•Escherichia coli
•Klebsiella
•Enterobacter
•Citrobacter
•Yersinia
•Serratia
•Hafnia
•Pantoea
•Kluyvera
Underlined, coliforms from
environment
•Escherichia coli
•Klebsiella
•Enterobacter
•Citrobacter
•Yersinia
•Serratia
•Hafnia
•Pantoea
•Kluyvera
•Cedeca
•Ewingella
•Moellerella
•Leclercia
•Canella
•Yokenella
IAFP, Berlin, 2009
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Enterobacteriaceae: Bioindicator (ISO TC34/SC9, E. de Boer) • Enterobacteriaceae – Detection and enumeration (ISO 21528:2004) •
Enterobacteriaceae: Bioindicator
(ISO TC34/SC9, E. de Boer)
Enterobacteriaceae – Detection and enumeration (ISO
21528:2004)
Revise
part
1
of ISO
21528 by omitting the EE broth
enrichment
step
and
to
modify
the
confirmation step
(fermentation of glucose has been changed in the
the use of O/F medium).
Establish an amendment to part 2 of ISO 21528 to modify
the confirmation step in order to develop the 2 parts at the
same time
IAFP, Berlin, 2009
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Virus (CEN TC275/WG6/TAG4, R. Rangdale (CRL)) Draft of a full standard: Horizontal method for detection of
Virus
(CEN TC275/WG6/TAG4, R. Rangdale (CRL))
Draft of a full standard:
Horizontal method for detection of hepatitis A virus and norovirus in
food using real-time RT-PCR- Part 1: Method for quantitative
determination
Norovirus genogroups I and II
New target matrices: According to regulation EC 178/2002, bottled
water and water used in the food industry is a food.
IAFP, Berlin, 2009
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Parasites (ISO TC34/SC9/WG6 and CEN TC275/WG6/TAG7, P. Rossi (CRL)) • Work at ISO level (call of
Parasites
(ISO TC34/SC9/WG6 and CEN TC275/WG6/TAG7, P. Rossi (CRL))
• Work at ISO level (call of experts):
• Cryptosporidium
• Giardia
• work at CEN level: Standardize both
• the artificial digestion microscopic method for the
detection of Trichinella in muscles and
serological methods for detection of antibodies to
Trichinella.
• Problem of reference material and antigens.
IAFP, Berlin, 2009
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Yeast and moulds (ISO TC34/SC9, A. Leclercq) •a w 0.95 et >0.6 •a w >0.95 •Media
Yeast and moulds
(ISO TC34/SC9, A. Leclercq)
•a w
0.95 et >0.6
•a w >0.95
•Media DG18
•Media DRBC
•ISO 21527-2
•ISO 21527-1
IAFP, Berlin, 2009
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METHODS IAFP, Berlin, 2009 34/50
METHODS
IAFP, Berlin, 2009
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TAG 6 "Sampling techniques" (CEN TC275/WG6/TAG6, M. Poumeyrol) • Revision of EN ISO series : Preparation
TAG 6 "Sampling techniques"
(CEN TC275/WG6/TAG6, M. Poumeyrol)
• Revision of EN ISO series : Preparation of
test samples, initial suspension and decimal
dilutions for microbiological examination
• Agreement
with
the
development
of
standards about sampling techniques.
IAFP, Berlin, 2009
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General requirements relating to Molecular methods for detection and quantification of microorganisms (CEN TC275/WG6/TAG3, K. Berghof)
General requirements relating to Molecular methods for
detection and quantification of microorganisms
(CEN TC275/WG6/TAG3, K. Berghof)
Standards: General rules for PCR and validation of thermocycler
New project standards for Real Time - PCR
EN ISO/DIS 22119 Microbiology of food and animal feeding stuffs -- Real-time
polymerase chain reaction (PCR) for the detection of food-borne pathogens -- General
requirements and definitions
EN ISO/DIS 22118 Microbiology of food and animal feeding stuffs -- Polymerase chain
reaction (PCR) for the detection of food-borne pathogens -- Performance characteristics
of molecular detection methods
The performance characteristics of molecular methods shall be established according to
the procedures of EN ISO 16140 if applicable
DNA Biochips?
New part of Scope: Primary production stage
IAFP, Berlin, 2009
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CEN ISO/TS PCR detection for specific pathogens (CEN TC275/WG6/TAG3, K. Berghof) • Detection of botulinum neurotoxin
CEN ISO/TS PCR detection for specific pathogens
(CEN TC275/WG6/TAG3, K. Berghof)
Detection of botulinum neurotoxin producing Clostridia
First draft
Real-Time PCR: Detection of neurotoxin genes type A, B, E and F
Pathogenic Vibrio parahemolyticus
Detection and enumeration on account of poor performance of cultural
methods ISO 21871 and 21872
toxR gene sequence R72H and hemolysin genes TDH and TRH
Yersinia enterocolitica and pseudotuberculosis
Investigation on enrichment
IAFP, Berlin, 2009
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ELISA / Immunological methods (CEN TC275/WG6/Ad’hoc group, J. Hennekinne?) • Necessity of General rules and guidelines
ELISA / Immunological methods
(CEN TC275/WG6/Ad’hoc group, J. Hennekinne?)
• Necessity of General rules and guidelines
• Necessity for detection of staphylococcal
enterotoxins
IAFP, Berlin, 2009
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Primary production stage (CEN TC275/WG6/TAG5, R. Danguy des déserts) Scope: • « From primary production (e.g.
Primary production stage
(CEN TC275/WG6/TAG5, R. Danguy des déserts)
Scope:
« From primary production (e.g. farm, natural environment) to
slaughter/harvest ».
The border would be live animals in the slaughter house
Samples taken after slaughter to indicate microbiological status of live animals
are included
Samples taken to indicate hugiene of meat are excluded
Work = 3 projects:
EN ISO/WD 6887-6 Preparation of test samples, initial suspension and
decimal dilutions for microbiological examination -- Part 6: Specific rules
for the preparation of samples taken at the primary production stage
EN ISO/WD 13307 Primary production stage -- Sampling techniques
EN ISO/WD 10272-4 Primary production stage – Detection and enumeration of
Campylobacter in samples from primary production
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New area have to be investigated: “Fish and shellfish products” IAFP, Berlin, 2009
Quality management 40/50
Quality management
40/50
Culture media (ISO/TC34/SC9/WG5 and CEN TC275/WG6/TAG1, M. Greenwood) Revised EN ISO 11133-1 had been published in
Culture media
(ISO/TC34/SC9/WG5 and CEN TC275/WG6/TAG1, M. Greenwood)
Revised EN ISO 11133-1 had been published in February 2009 again as a
TS: Microbiology of food and animal feeding stuffs - Guidelines on
preparation and production of culture media - Part 1 : general
guidelines on quality assurance for the preparation of culture media in
the laboratory.
Joint standard water and food
2
parts of ISO
11133
will become
1
standard pr EN ISO 11133
(Preparation, production, storage and performance testing of culture
media)
Joint standard water and food
Scope extended to reagents and confirmatory media
IAFP, Berlin, 2009
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Validation ( ISO/TC34 SC9/WG3 and CEN TC275/WG6/TAG2, P. In’t Veld) - PG1: Terminology - PG2: Validation
Validation
( ISO/TC34 SC9/WG3 and CEN TC275/WG6/TAG2, P. In’t Veld)
-
PG1: Terminology
-
PG2: Validation of proprietary methods (quantitative and qualitative
methods)
-
PG3: Intermediate validation
-
PG4: Method verification
-
PG5: In-house validation (against and without a reference method)
-
PG6: Technical requirements for establishment/revision of standardized
methods
IAFP, Berlin, 2009
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Validation ( ISO/TC34 SC9/WG3 and CEN TC275/WG6/TAG2, P. In’t Veld) Work – First draft: NWIP EN
Validation
( ISO/TC34 SC9/WG3 and CEN TC275/WG6/TAG2, P. In’t Veld)
Work – First draft:
NWIP EN ISO 16140-1 Terminology of Method Validation
NWIP EN ISO 16140-2 Protocol for the validation of alternative method – Part 2 : Protocol for the
validation of propietary methods against a reference method
Link with ISO TC34/SC9/WG2 “Statistics”
Revision of EN ISO 16140:2003 Microbiology of food and animal feeding stuffs - Protocol for the
validation of alternative methods
Circulation of the draft of project of Amendment A1 of EN ISO 16410:2003 which correct errors in clause 6.3.
Extension of its scope to PCR and Immunological methods
EN ISO standards perhaps recognised by AOAC (Paul WEHLING, AOAC, Chairman Statistical
Committee, new member of WG2.
A full international validation process of microbiological alternative method
EN ISO 16140 and the life of reference method?
IAFP, Berlin, 2009
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New concept of standards (i.e. chemistry) Reference Alternative Validation, Equivalence methods methods Performance criteria without description
New concept of standards
(i.e. chemistry)
Reference
Alternative
Validation,
Equivalence
methods
methods
Performance criteria without
description of method
IAFP, Berlin, 2009
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European Mandate by EC for Validation of reference methods: 15 METHODS 1) 1) 1) 1) Detection
European Mandate by EC for Validation
of reference methods: 15 METHODS
1)
1)
1)
1)
Detection of
Detection
Detection
Detection of food-
of
of food
food
food--borne
-borne
borne
borne viruses
viruses
viruses
viruses inininin food based
food
food
food based
based
based onononon PCR technique”
PCR
PCR
PCR technique
technique technique”””
2)
2)
2)
2)
Detection Detection Detection and quantification quantification quantification of histamine histamine histamine
Detection and and and quantification of of of histamine
3) 3) 3) Detection Detection Detection Detection of of of of staphylococcal staphylococcal staphylococcal staphylococcal enterotoxins enterotoxins enterotoxins enterotoxins for for for for dairy dairy dairy dairy products products products products and and and and other matrices matrices matrices
3)
other other other matrices
4) 4) 4) Detection
4)
Detection
Detection
Detection of
of
of
of Bacillus cereus
Bacillus
Bacillus
Bacillus cereus enterotoxins
cereus
cereus enterotoxins
enterotoxins
enterotoxins inininin food
food
food
food ((((emetic
emetic and
emetic
emetic and diarrheal
and
and di
di diarrheal arrheal arrheal toxin)
toxin) toxin) toxin)
5)
5)
5)
5)
Detection
Detection
Detection
Detection of
of
of
of Enterobacter sakazakii
Enterobacter Enterobacter sakazakii sakazakii
Enterobacter sakazakii
6)
6)
6)
6)
ENENENEN 21872
21872-
21872 21872--1-111 Horizontal method method method for the the the detection of of of pathogenic Vibrio –––– Part 1: Detection of of
Horizontal Horizontal Horizontal method for for for the detection detection detection of pathogenic pathogeni pathogenicc Vibrio
Vibrio
Vibrio
Part
Part 1:
Part 1: Detection of
1: Detection
Detection
of Vibrio parahaemolyticus and
Vibrio
Vibrio parahaemolyticus
Vibrio parahaemolyticus
parahaemolyticus
and
and
and
Vibrio cholerae
Vibrio
Vibrio cholerae
Vibrio cholerae
cholerae
7)
7)
7)
7)
ENENENEN 21872
21872-
21872
21872--2-222 Horizontal method
Horizontal
Horizontal
Horizontal method for
method
method for the
for
for the detection
the
the detection of
detection
detection of pathogenic
of
of pathogenic Vibrio –––– Part 2: Detection of species other than
pathogeni
pathogenicc Vibrio
Vibrio
Vibrio
Part
Part 2: Detection of species other than
Part 2:
2: Detection
Detection of
of species
species other
other
than
than Vibrio
Vibrio
Vibrio
Vibrio
parahaemolyticus parahaemolyticus parahaemolyticus and Vibrio cholerae
parahaemolyticus and Vibrio cholerae
and
and
Vibrio Vibrio cholerae cholerae
8)
8)
8)
8)
Horizontal methods
Horizontal
Horizontal
Horizontal methods for
methods
methods for the
for
for the detection
the
the detection and
detection
detection and enumeratio
and
and enumeratio
enumerat
enumeratioionnnn of Enterobacteriaceae
of
of
of Enteroba
Enteroba
Enterobacteriaceae
cteriaceae
cteriaceae –––– Part 1: Detection and enumeration
Part
Part 1:
Part 1: Detection
1:
Detection
Detection and enumeration bybybyby
and
and enumeration
enumeration
MPN technique with pre--enrichment
MPN
MPN technique
MPN technique with pre
technique with
with pre-
pre
-enrichment
enrichment”
enrichment”””
9)
9)
9)
9)
ENENENEN ISO 11290-
ISOISO
ISO 11290
11290
11290--1-111 Horizontal
Horizontal
Horizontal
Horizontal method
method
method
method for
for
for
for the
the
the
the detection
detection
detection
detection and
and
and
and enumerati
enumerati
enumerat
enumeratiionononon of
of
of
of Listeria
Listeria
Listeria monocytogenes –––– Part
Listeria monocytogenes
monocytogenes
monocytogenes
Part Part 1: 1: 1: Detection
Part 1: Detection Detection Detection
method
method
method
method
10)
10)
10)
10)
ENENENEN ISO 11290-
ISOISO
ISO 11290
11290
11290--2-222 Horizontal
Horizontal
Horizontal
Horizontal method
method
method
method for
for
for
for the
the
the
the detection
detection
detection
detection and
and
and
and enumerati
enumerati
enumerat
enumeratiionononon of
of
of
of Listeria
Listeria
Listeria monocytogenes –––– Part
Listeria monocytogenes
monocytogenes
monocytogenes
Part
Part 2:
Part 2:
2:
2:
Enumeration metho
Enumeration
Enumeration metho
Enumeration metho
metho
11)
11)
11)
11)
ENENENEN ISO
ISOISO
ISO 16654
16654
16654
16654 Horizontal
Horizontal
Horizontal
Horizontal method
method
method
method for
for
for
for the
the
the
the detection
detection
detection
detection of
of
of
of E.
E.
E. coli O157
E. coli
coli
coli
O157”
O157
O157”””
12)
12)
12)
12)
ENENENEN ISO 10271-
ISOISO
ISO 10271
10271
10271--1-111 Horizontal
Horizontal Horizontal Horizontal method method method method for for for for the the the the detection detection detection detection and and and and enumerati enumerati enumerat enumeratiionononon of of of of Campylobacter spp. –––– Part 1: Detection
Campylobacter
Campylobacter spp.
Campylobacter
spp.
spp.
Part Part 1: 1:
Part 1: Detection Detection Detection
method
method”
method
method”””
13)
13)
13)
13)
ENENENEN ISO 10272-
ISOISO
ISO 10272
10272
10272--2-222 Horizontal
Horizontal
Horizontal
Horizontal method
method
method
method for
for
for
for the
the
the
the detection
detection
detection
detection and
and
and
and enumerati
enumerati
enumerat
enumeratiionononon of
of
of
of Campylobacter spp. –––– Part 2: Colony count
Campylobacter
Campylobacter
Campylobacter spp.
spp.
spp.
Part Part 2: 2:
Part 2: Colony
Colony
Colony count
count
count
technique
technique” technique
technique”””
14)
14)
14)
14)
ENENENEN ISO
ISOISO
ISO 6579/FDAmd
6579/FDAmd
6579/FDAmd
6579/FDAmd 1111 Horizontal
Horizontal
Horizontal
Horizontal method for
method
method
method for
for
for the
the
the
the detec
detec
dedetec
tection
tion
tion
tion of
of
of
of Salmonella spp. –––– Amendment
Salmonella
Salmonella
Salmonella spp.
spp.
spp.
Amendment
Amendment 1111 Annex D: Detection of of of
Amendment
Annex
Annex D:
Annex D: Detection of
D: Detection
Detection
Salmonella
Salmonella
Salmonella
Salmonella spp. spp. spp. spp. inininin animal animal animal animal faeces faeces faeces faeces and and and and inininin samples samples samples samples from from from from the the the the prima prima prima primaryryryry production productio productio productionnn stage
stage stage stage
15)
15)
15)
15)
ENENENEN ISO ISOISO ISO 10273 10273 10273 10273 Horizontal
Horizontal
Horizontal
Horizontal method
method
method
method for
for
for
for the
the
the
the detection of
detection
detection
detection of presumptive
of
of presumptive pathogenic
presumptive
presumptive pathogenic
pathogenic
pathogenic Yersinia
Yersinia
Yersinia enterocolitica
Yersinia enterocolitica
enterocolitica
enterocolitica
IAFP, Berlin, 2009
45/50
Proficiency testing (ISO TC34/SC9/WG4, S. Passmore) Final vote: CEN ISO/TS 22117 “Proficiency testing” Request for ILAC
Proficiency testing
(ISO TC34/SC9/WG4, S. Passmore)
Final vote: CEN ISO/TS 22117 “Proficiency testing”
Request for ILAC and EA recommending them to
recognise this TS (Technical Specification) as
technical requirements for proficiency testing
organisation in the field of food microbiology
(DIS ISO 17043).
IAFP, Berlin, 2009
46/50
Measurement uncertainty (ISO TC34/SC9/WG2, B. Lombard) • ISO/TS 19036: measurement uncertainty • Amendment A1: low number
Measurement uncertainty
(ISO TC34/SC9/WG2, B. Lombard)
• ISO/TS 19036: measurement uncertainty
• Amendment A1: low number
• New Work:
• uncertainty of sampling in food microbiology,
• maximum allowable values for measurement
uncertainty
IAFP, Berlin, 2009
47/50
News works or standards projects Iso level: New project group: “Detection of contaminants in starter cultures
News works or standards projects
Iso level: New project group: “Detection of contaminants in starter cultures and probiotics” (projecleader, S. Zuber,
Switzerland)
Iso level: CEN ISO/TS 10272 – 3 Horizontal method for the detection and enumeration of Campylobacter spp - Part
3 – Semi-quantitative method
Iso level: ISO TS 2871 & 2 for vibrio: correction of the volume of culture transferred from first enrichment to
second enrichment.
Iso level: Comparison of ISO 7251 to ISO 16649-3 Horizontal method for the detection and enumeration of
presumptive Escherichia coli - Most probable number technique
ISo level: Horizontal method for the enumeration of microorganisms : EN ISO 4833
Poured plate colony count technique at 30 °°°°C Surface colony-count technique at 30 °°°°C
Iso level: Enumeration of Alicyclobacillus acidoterrestris
CEN level: Enterotoxin Bacillus cereus (P. in’t veld)
CEN level: Standardization of antimicrobial susceptibility analysis of foodborne pathogens
CEN level: Detection and quantification of histamine
IAFP, Berlin, 2009
48/50
Future for standardization of food microbiology • Cover the food chain • Integrate new technology •
Future for standardization
of food microbiology
Cover the food chain
Integrate new technology
Improve the publication delay of standards
More flexible
Avoid to put method inside regulation
Financial support for ring trials !
Description of method or standard based only on performance criteria?
IAFP, Berlin, 2009
49/50
Acknowlegments 50/50
Acknowlegments
50/50