Amended at the 3rd AFTLC Meeting
THE ASEAN FOOD TESTING LABORATORY COMMITTEE (AFTLC)
___________________________________________________________________
G U I D E L I NE F O R ASEAN F O O D
REFERENCE LABORATORIES
Content
Foreword
Glossary of abbreviations
1. Introduction
2. Terms and definitions
3. General requirements for the AFRLs
4. Key activities of the AFRLs
4.1 Provision of training in relevant areas of expertise
4.2 Proficiency testing provider (PTP)
4.3 Resource of information
4.4 Selection of test methods
4.5 Coordinating and networking of NFRLs
5. References
Annex I
: The AFRL areas of responsibility and fields of expertise (Information is updated via AFSN website)
Annex II : Terms of Reference of the ASEAN Food Reference Laboratories (AFRLs)
Annex III : Flow diagram for the establishment of the AFRL.
Annex IV : General criteria for the selection of test methods
Annex V : Selection of suitable methods
Annex VI : Method validation
2
Foreword
This Guideline has been prepared in order to provide a reference document for ASEAN Food
Reference Laboratories (AFRLs) and it may be used as the guideline for National Food Reference
Laboratories (NFRLs), where appropriate. The intentions of the Guideline are to provide the
performance criteria for AFRLs as well as to ensure they understand their responsibilities, roles and
key activities within the ASEAN Network of laboratories supporting the food sector.
The Guideline also provides references to internationally accepted standards, its associated
requirements, and specific technical requirements of food reference laboratories. The Guideline also
provides a common understanding of the technical terms and methodologies used in food reference
laboratories.
More definitive information which applies to laboratories is included in the international standard,
ISO/IEC 17025 “General requirements for the competence of testing and calibration laboratories”.
3
Glossary of Abbreviations
ACCSQ
AFSN
AMS
AOAC
AFRL
ARASFF
BAM
CAC/GL
CEN
CRM
GMO
GHP
GMP
HACCP
NFRL
ISO/IEC
IUPAC
PFPWG
PT
PTP
RM
VIM
ASEAN Consultative Committee on Standards and Quality
ASEAN Food Safety Network
ASEAN Member State
Association of Official Analytical Chemists
ASEAN Food Reference Laboratory
ASEAN Rapid Alert System for Food and Feed
Bacteriological Analytical Manual
Codex Alimentarius Commission/Guideline
Committee for European Standardization
Certified reference material
Genetically Modified Organism
Good Hygiene Practice
Good Manufacturing Practice
Hazard Analysis and Critical Control Point
National Food Reference Laboratory
International Organisation for Standardisation/International Electrotechnical Commission
International Union of Pure and Applied Chemistry
Prepared Foodstuff Products Working Group
Proficiency testing
Proficiency testing provider
Reference material
International vocabulary of metrology
4
1. Introduction
Effective national food control systems are essential to protect the health of consumers. They are also
critical in enabling countries to ensure the safety and quality of their food.
The ASEAN Member States (AMSs) in recognizing these facts have, in moving towards an ASEAN
Economic Community by 2015, focussed on building a regional food safety infrastructure which
comprises of the followings:




ASEAN Common Requirements for Food Control, Food Hygiene and Food Labelling
Guidelines and training tools for the application of Good Hygiene Practice (GHP), Good
Manufacturing Practice (GMP) and Hazard Analysis and Critical Control Point (HACCP) in the
industry;
ASEAN Rapid Alert System for Food and Feed (ARASFF)
Network of ASEAN Food Reference Laboratories (AFRLs) covering areas, such as
Genetically Modified Organism (GMO), heavy metals and trace elements, veterinary drug
residues, pesticide residues, mycotoxins, microbiology, and other areas related to food.
This Guideline deals with the development of the network of AFRLs to meet the needs of the regional
food safety infrastructure and to satisfy subsequent legislation and policies in Food Control Systems.
2. Terms and definitions
Terms and definitions used in this document are referred to those identified in internationally
recognized organizations, such as Codex Guidelines on Analytical Terminology (CAC/GL 72-2009),
Conformity assessment - Vocabulary and general principles (ISO/IEC 17000), and International
vocabulary of basic and general terms in metrology (VIM). Other specific definitions used in this
document are defined below.
ASEAN Food Reference Laboratories (AFRLs) are government testing laboratories competent
in the specific areas of expertise designated by ACCSQ PFPWG.
National Food Reference Laboratories (NFRLs) are testing laboratories in the specific areas of
expertise designated by the governments of ASEAN Member States. The NFRLs shall be
members of the network led by AFRLs.
Government laboratory is a laboratory which reports directly to the government through the
command line and it is the government which controls and administers the laboratory policy and
functions.
Accreditation means the third-party attestation related to a conformity assessment body
conveying formal demonstration of its competence to carry out specific conformity assessment
tasks.
Proficiency testing (PT) means a periodic assessment of the performance of individual
laboratories and groups of laboratories that is achieved by an independent testing body of typical
materials for unsupervised analysis by the participants. (ISO/IEC 17043: Conformity assessment General requirements for proficiency testing)
Method validation means the confirmation by examination and the provision of objective
evidence that the particular requirements for the specific intended use are fulfilled.
The process of proving that analytical method is acceptable for its intended use.
3. General requirements for the AFRLs
An AFRL shall be an ISO/IEC 17025 accredited government laboratory and the management shall
have clear policy in supporting AFRL activities including capacity building and resource
allocation. It is designated mainly to provide technical support in the area of competence. The details
of roles and responsibilities of AFRLs are described in the Terms of Reference of AFRL in Annex IIPart 3 - Technical Competence of ASEAN Food Reference Laboratories as shown below.
5
3.1 The AFRLs shall be accredited by internationally recognized accreditation bodies
based on ISO/IEC 17025 General Requirement for the Competence of Testing and
Calibration Laboratories.
3.2 The AFRLs shall participate and demonstrate competence in the relevant international
proficiency testing for the respective designated area of expertise.
3.3 The AFRLs shall have adequate facilities to conduct training, including competent
personnel with adequate training experience in the analytical techniques applied in
their area of competence.
3.4 The AFRLs shall provide/coordinate PT programme according to ISO/IEC 17043,
ISO/TS 22117 or interlaboratory comparison as appropriate.
3.5 The AFRLs shall be the resource center for provision of information for certified
reference materials (CRMs) or reference materials (RMs).
4. Key activities of the ASEAN Food Reference Laboratories (AFRLs)
There are many activities that AFRLs shall perform in the specific areas in order to serve food testing
laboratories in AMSs. Key activities of AFRLs are elaborated as shown below.
4.1
Provision of training in relevant areas of expertise
To strengthen capabilities of NFRLs of AMSs, AFRLs should conduct the training in the specific
areas of expertise as appropriate, when:
4.1.1 PT results obtained by the AMSs laboratories are not satisfactory.
4.1.2 new technology or methodologies are introduced.
4.1.3 requested by AMSs.
Ideally, the training should consist both theoretical and practical sessions.
4.2
Proficiency testing provider (PTP)
This is the only independent means by which a laboratory’s competence (proficiency) can be
demonstrated. It is of outmost importance that the NFRLs and other AMSs laboratories take part
in relevant PT.
Therefore, AFRLs shall provide and/or coordinate proficiency testing (PT) in the ASEAN region
and provide pertinent information on proficiency testing or interlaboratory comparisons held by
other relevant organizations.
PT scheme should be conducted according to ISO/IEC 17043 Conformity assessment – General
requirements for proficiency testing. The microbiological PT scheme should also comply with
ISO/TS 22117 – Microbiology of food and animal feeding stuffs – specific requirements and
guidance for proficiency testing by interlaboratory comparison.
In case PT scheme is not available, AFRL should conduct interlaboratory comparison.
4.3
Resource of information
The AFRLs will provide information on:
-
certified reference materials (CRMs) or Reference Materials (RMs);
PT programme provider;
test methods;
experts in the specific areas;
NFRLs of AMSs;
reference laboratories in other regions.
6
4.4
Selection of test methods
4.4.1. AFRLs should suggest suitable official test methods elaborated by internationally
recognised organizations such as Codex, ISO, BAM, CEN, AOAC, IUPAC, etc. The suitable
test methods should be selected by using the criteria approach, such as described in the
Codex Procedural Manual or other appropriate criteria of relevant internationally recognised
organizations. Further details are shown in Annexes IV and V.
4.4.2. Method Validation
In case existing methods are not suitable, AFRLs should develop and validate test methods
by collaborative trial according to international recognized protocol. Approaches to be used
for method validation include single-laboratory method validation and collaborative (inter
laboratory) study. Further details are described in Annex VI.
4.5
Coordinating and networking of NFRLs
Each AFRLs should establish their own networking in specific areas of expertise among the
AMSs in order to strengthen food testing laboratories in the region.
5. References
CODEX ALIMENTARIUS COMMISSION PROCEDURAL MANUAL, 20th Edition. Rome, 2011
Commission Decision 2002/657/EC of 12 August 2002 Implementing Council Directive 96/23/EC
Concerning the Performance of Analytical Methods and the Interpretation of Results
Guidelines for Collaborative Study of Procedures to Validate Characteristics of a Method of Analysis,
J. AOAC Int., 1995, 78(5) 143A-160A
ISO/IEC 17025:2005, General Requirements for the Competence of Testing and Calibration
Laboratories
ISO/IEC 17043:2010, Conformity Assessment - General Requirements for Proficiency Testing
ISO/TS 22117 – Microbiology of Food and Animal Feeding Stuffs – Specific Requirements and
Guidance for Proficiency Testing by Interlaboratory Comparison
ISO 5725-2: Accuracy (Trueness and Precision) of Measurement Methods and Results - Part 2: Basic
Method for the Determination of Repeatability and Reproducibility of a Standard Measurement Method
JCGM 200:2008, International Vocabulary of Metrology – Basic and general concepts and associated
terms (VIM), 3rd Edition
The International Harmonized Protocol for the Proficiency Testing of Analytical Chemistry
Laboratories, Pure Appl. Chem., 2006, Vol. 78, No. 1, pp. 145-196
7
Amended at the 3rd AFTLC Meeting
Annex I
The AFRL Areas of Responsibility and Fields of Expertise (as of 4th Dec 2012)
The contact persons and address details of the designated ASEAN Food Reference laboratories.
Residing
Organization
Food Safety Laboratory,
Applied Sciences Group,
Health Sciences
Authority, Singapore
(HSA).
No.
AFRL
1
AFRL for Mycotoxins
2
AFRL for Pesticide
Residues
Veterinary Public Health
Laboratory, Agri-Food
and Veterinary Authority
of Singapore (AVA)
Dr. Paul Chiew King Tiong
E-mail :
paul_chiew@ava.gov.sg
AFRL for Genetically
Modified Organisms
Department
Chemistry,
(DOC)
Ms Jasbeer Kaur
jasbeer@kimia.gov.my
jasbeerk1@yahoo.com
3
of
Malaysia
Contact Person(s)
Tel/Fax
Ms. Chan Sheot Harn Joanne Tel +65-62130722
E-mail :
chan_sheot_harn@hsa.gov.sg
Fax +65-62130839
Ms. Angela Li
E-mail: angela_li@hsa.gov.sg
Tel:+65 67952818
Fax +65 6861
9491
Tel:+603 7985
3000
Fax:03-79853028
Field of Expertise
a. Aflatoxin B1, B2, G1, G2 in peanut,
corn, oil, coffee, copra, rice and
animal feeds;
b. Aflatoxin M1 & M2 in dairy products;
c. Ochratoxin A in coffee and wheat
products;
d. Fumonisin B1 & B2,
Deoxynivalenone, Zearalenone in
corn and corn products;
e. Patulin in Apple juice.
Pesticide residues in Food, eg:
a. Organophosphorus pesticides;
b. Fungicides;
c. Pyrethroids;
d. Organochlorine.
Raw and processed foods from plant
materials using DNA technique;
a. Endogenous gene: soy, maize,
potato, tomato, rapeseed, papaya,
wheat and rice;
b. GMO screening: 35S promoter,
NOS terminator, pat, bar, cry1A(b),
ctp2-cp4 EPSPS, nptII
c. Soya events: RRS, MON89788,
DP305423, DP356043, A5547-127,
A2704-12
d. Maize events: MON810, MON863,
Bt11, Bt176, CBH-351 (StarLink),
T25, GA21, NK603, DAS59122-7,
MON89034, MON88017, TC1507,
No.
4
5
6
AFRL
AFRL for Veterinary
Drug Residues
AFRL for Heavy
Metals and Trace
Elements
AFRL for
Microbiology
Residing
Organization
Contact Person(s)
Tel/Fax
Veterinary Public Health
Laboratory (VPHL),
Bureau of Quality
Control of Livestock
Products (BQCLP),
Department of Livestock
Development (DLD),
Ministry of Agriculture
and
Cooperatives (MoAC),
THAILAND
Dr. Wimolporn Thitisak
E-mail :
Wimolporn_2000@ yahoo.com
Tel +662 653 4403
Fax +662 653
4900
Dr. Pairoj Tamrongopas
E-mail :
Tamrongopas@ gmail.com
Tel +662 967 9741
Fax +662 967
9755
Dr. Sujittra Phongvivat
E-mail :
Sujittra_dvm@ yahoo.com
Sujittrap@dld.go.th
Tel +662 967 9705
Fax +662 963
9217
Bureau of Quality and
Safety of Food (BQSF),
Department of Medical
Sciences, Ministry of
Public Health, Thailand
Mrs.Laddawan Rojanapantip
E-mail
laddawan.r@dmsc.mail.go.th
Tel+6629510000
Ext: 99518
Fax +6629511021
Mayuree Uraroongroj
E-mail
Mayuree.u@dmsc.mail.go.th
Tel+6629510000
Ext: 99578
Fax +6629511021
Quatest 3 (Quality
Assurance & Testing
Centre 3), MOST,
Vietnam
Luong Thanh Uyen,
E-mail:
lt-uyen@quatest3.com.vn
Tel +84-61836 212
Pham Van An
E-mail:
9
Fax +84-618368
Field of Expertise
MIR604
e. Rice events: Bt63, LLRICE62,
LLRICE601
f. Rapeseed events: GT73/RT73
g. Potato events: EH92-527-1
Veterinary Drug Residues in foodstuffs
of animal origin
a. Prohibited substance
e.g. Nitrofurans
Chloramphenicol
Dimetridazole
Metronidazole
Ronidazole
b. B-Agonists
c. Antibiotics
e.g. Aminoglycosides
Macrolides
Quinolones/Fluoroquinolones
Sulfonamides
Tetracyclines
d. Anticoccidial Substances
e. Steroid/NSAIDs
f. Anthelmintics
Heavy metals and trace elements in
foods
a. Heavy Metals:
Mercury, Lead, Cadmium, Arsenic,
etc.
b. Trace Elements:
Nickel, Selenium, Chromium, etc.
a. Pathogenic micro-organisms relevant
to food and food products: salmonella,
E. coli O157:H7, shigella, Listeria
monocytogenes, Campylobacter,
Yersinia enterocolytica, Clostridium
perfringens, Clostridium botulinum,
No.
AFRL
Residing
Organization
Contact Person(s)
pv-an@quatest3.com.vn
tn-visinh@quatest3.com.vn
10
Tel/Fax
Field of Expertise
Bacillus cereus, Staphylococcus
aureus, Vibrio parahaemolyticus,
Vibrio cholerae, Pseudomonas
aeruginosa;
b.Yeasts and molds;
h. Indicator bacteria;
Amended at the 3rd AFTLC Meeting
Annex II
TERMS OF REFERENCE OF THE ASEAN FOOD REFERENCE LABORATORIES
(AFRLs)
1. Objective:
The ASEAN Food Reference Laboratories (AFRLs) shall be established
1.1
as a means of networking among ASEAN Member States (AMS) to support technical
issues related to food and food-related testing in ASEAN;
1.2
to provide technical support to the National Food Reference Laboratories (NFRLs);
1.3
as a means for provision of technical assistance and transfer of knowledge to other
food and food-related laboratories in ASEAN;
1.4
for the networking with other international and regional reference laboratories for the
purpose of exchanging technical information and promoting collaboration.
2. Roles and functions:
The AFRLs shall:
2.1
As a means of networking among AMSs, support technical issues related to food and
food-related testing in ASEAN in the areas of their expertise.
2.1.1 Recommend new analytical test methods to be used by NFRLs.
2.1.2 Provide/Coordinate proficiency testing (PT) or interlaboratory comparisons in
the ASEAN region and provide pertinent information on proficiency testing or
inter
laboratory comparisons organised by other relevant organizations.
2.1.3 Conduct training in the specific areas of expertise, if necessary.
2.1.4 Provide information on the availability of food and food-related testing
laboratories in the area of expertise in ASEAN upon request.
2.1.5 Become resource of information for certified reference materials (CRMs) or
reference materials (RMs).
2.1.6 Upon request, serve as reference laboratories in cases where there are
dispute in analytical test result.
2.2 To provide technical support to the NFRLs and other laboratories in ASEAN.
2.2.1
2.2.2
2.2.3
Provide training on the methods of analysis as well as on quality assurance in
food analysis laboratories;
Establish and maintain a pool of ASEAN experts related to food and food
testing to advise AMS;
For the networking with other international and regional reference laboratories
for the purpose of exchanging technical information and promoting
collaboration.
3. Technical Competence of ASEAN Food Reference Laboratories (AFRLs)
3.1 The AFRLs shall be accredited by internationally recognized accreditation bodies
based on ISO/IEC 17025 General Requirement for the Competence of Testing and
Calibration Laboratories.
3.2 The AFRLs shall participate and demonstrate competence in the relevant
international proficiency testing for the respective designated area of expertise.
3.3 The AFRLs shall have adequate facilities to conduct training, including competent
personnel with adequate training experience in the analytical techniques applied in
their area of competence.
3.4 The AFRLs shall provide/coordinate PT programme according to ISO/IEC 17043,
ISO/TS 22117 or interlaboratory comparison as appropriate.
3.5 The AFRLs shall be the resource center for provision of information for certified
reference materials (CRMs) or reference materials (RMs).
4. Procedures for Establishment of AFRLs
4.1
Any AMS may propose the establishment of an AFRL from any suitable
government laboratory in their respective country to the PFPWG in line
with the procedure for the establishment of AFRL.
5. National Food Reference Laboratories [NFRLs]
5.1
5.2
5.3
5.4
5.5
Member States may appoint one or more government laboratory(s) related to food and
food testing as NFRLs to be linked with the AFRLs in their area of competence;
The NFRLs shall demonstrate their competence preferably through accreditation by
the recognised accreditation bodies.
The NFRLs shall coordinate the activities of official laboratories responsible for the
analysis of samples at the national level; such as participation in training and PT.
Where appropriate, the NFRLs shall organise comparative tests between the
designated laboratories and ensure an appropriate follow-up of such comparative
testing.
The NFRLs shall establish and maintain a pool of experts related to food and food
testing and submit it to the AFRLs to be incorporated into the panel of ASEAN experts.
12
Annex III
Key Steps for the Establishment of New AFRLs
Step1
Step 1
AFTLC considers the appropriateness and prioritise the new areas1 of AFRLs.
Step 2
ASEAN Secretariat makes an announcement of the application for new areas of AFRLs to
AFTLC contact points.
Interested AMSs submit the application to AFTLC via ASEAN Secretariat within 6 months.
Step 3
Step 4
Step 5
Step 6
ASEAN Secretariat initially verifies the completeness of the application forms and the list of
documents.
ASEAN Secretariat forwards the application forms and relevant documents to AFTLC for consideration.
AFTLC initially evaluates the competence of the applicants based on application forms and
relevant documents. AFTLC may request for further evidence where necessary.
Step 7
AFTLC appoints the panel of experts for the proposed area.
Step 8
Verification of documentation by the panel of experts
Step 9
Step 10
The panel of experts conducts the onsite visit according to the Procedure for Panel
of Experts for Onsite Visit. In case of multiple applications, refer to Note 2.
AFTLC reviews the report of the panel of experts and makes decision.
Disapproved
Inform
the applicant.
Approved
Step 11
Recommendation for designation of the new AFRL by AFTLC
Step 12
Endorsement of the new AFRL by the PFPWG
____________________________________________________________________________________________________________________
1 AMSs
propose new areas of AFRLs to AFTLC via ASEAN Secretariat. The AFTLC subsequently recommends new areas of
AFRLs to the PFPWG for approval.
13
Annex IV
General Criteria for the Selection of Test Methods
a)
Preference should be given to official and validated test methods elaborated by internationally
recognised organizations such as Codex, ISO, BAM, CEN, AOAC, IUPAC, etc.
b)
Preference should be given to test methods, the reliability of which has been established in respect
of the following criteria, selected as appropriate;
(i)
selectivity
(ii)
accuracy
(iii) precision
(iv) limit of detection
(v)
other criteria which may be selected as required
14
Annex V
Selection of Suitable Methods
The suitable test methods should be selected by using the criteria approach, as described in Codex
Procedural Manual or appropriate criteria of relevant internationally recognised organizations which
includes:
a) General Criteria for the Selection of Methods of Analysis using the Criteria Approach
b) Working Instructions for the Implementation of the Criteria Approach
c) Guidelines for Establishing Numeric Values for Method Criteria and/or Assessing
Methods for Compliance thereof
When a laboratory is in the phase of starting up a new food control activity it may have neither methods
nor instrumentation that is fit for the purpose. By using the criteria approach that was recently adopted by
the Codex Committee for Methods of Analysis and Sampling (CCMAS) it is possible to identify those
methods that have suitable performance criteria. The basis for the criteria is the specified maximum
level/minimum level/ normative level or concentration range (ML) of, for example, a contaminant in a food
commodity. A suitable method should be able to determine the ML with a specific precision.
When reviewing a method for possible compliance with the established criteria, the method performance
characteristics have to be assessed. The result of a method performance study is available in the method
and/or published in an international journal.
Only the analyte for the food commodity along with its ML is needed when establishing numeric values for
method criteria.
Note: These criteria are applicable to fully validated methods except for methods such as PCR and
ELISA, which requires other set of criteria.
15
Annex VI
Method Validation
1. Collaborative study
Method validations through collaborative study should follow procedures described by internationally
recognized organizations e.g. ISO 5725-2: Accuracy (trueness and precision of measurement methods
and results) Part 2: Basic method of the determinations of repeatability and reproducibility of a standards
measurement method or
AOAC/IUPAC Guideline for collaborative study of procedure to validate characteristic of a method of
analysis.
A collaborative study requires acceptable results from at least eight laboratories.
However, a validation can be carried out with fewer laboratories, when it is not possible to make a full
collaborative study due to lack of participating laboratories.
2. Single laboratory method validation
When interlaboratory method validations are not available or applicable, the single laboratory method
validation may be appropriate.
Single laboratory method validation should follow an internationally recognized protocol (e.g. those
referenced in the IUPAC Harmonized Guidelines for Single-Laboratory Validation of Methods of Analysis
,
CD 2002/657/EC implementing Council Directive 96/23/EC concerning the performance methods and the
interpretation of analytical results).
In-house validation (or single laboratory validation, which is the preferred expression) is the process in
which a method is introduced into a laboratory and tested to see that it functions as anticipated. Methods
should be validated when they are:
-
non-standard methods,
laboratory-designed/developed methods,
standard methods used outside their intended scope,
standard methods with amplifications and modifications methods
16