NABL Guidelines For Food Testing Laboratories
NABL Guidelines For Food Testing Laboratories
10
Amendment Sheet 1
Contents 2
Abbreviations 3
Introduction 4
1. Scope 5
2. References 7
3. Terms and Definitions 8
4. Management Requirements 11
5. Technical Requirements 12
Annexure A
6. Food Sampling for Microbiological Analysis 19
Annexure B
7. Design of Sampling Containers for Foods 22
Annexure C
8. Codex Alimentarius References 24
9. Bibliography 25
The requirements specified in ISO/ IEC 17025:2005, General requirements for the competence
of testing and calibration laboratories, are stated in general terms and, while they are applicable
to all test and calibration laboratories, explanations might be needed. Such explanations on
applications are herein referred to as applications. Applications should not include additional
general requirements not included in ISO/ IEC 17025:2005. Applications can be thought of as
an elaboration of the generally stated criteria (requirements) for specified fields of test, test
technologies, products, materials or specific tests. (ISO/ IEC 17025:2005 Appendix B).
This document is intended to provide guidance for laboratories implementing ISO/ IEC
17025:2005 for food testing, especially in support of international food trade activities. This
document does not re-state all the provisions of ISO/ IEC 17025:2005 and laboratories are
reminded of the need to comply with all of the relevant criteria detailed in ISO/ IEC 17025:2005.
The clause numbers in this document follow those of ISO/ IEC 17025:2005 but since not all
clauses require interpretation, the numbering may not be continuous.
Laboratories are also reminded of the need to comply with relevant statutory or legislative
requirements.
1.1 The Codex Alimentarius (Codex) has become the key reference for consumers, food
processors, national food control agencies and the international food trade. Furthermore
the Agreement on the Application of Sanitary and Phytosanitary Measures (SPS) and
the Agreement on Technical Barriers to Trade (TBT) both encourage the international
harmonization of food standards and also cite Codex standards, guidelines and
recommendations as the preferred international measures for facilitating international
trade in food. (See http://www.codexalimentarius.net/) However it should be recognized
that the Codex is only intended as guidelines, and governments themselves must decide
what use to make of them.
1.3 The subject document is intended as a NABL specific guideline document for food
testing laboratories in harmony with the wider interests of the Codex Alimentarius
recommendations.
1.4 Food analysis is inter-disciplinary in nature. The phenomenal growth in our knowledge of
food sciences and analytical techniques has facilitated accurate reporting of food
composition. Food testing is required to evaluate food products for their nutritive and
safety values in terms of microbiology, mycotoxins, pesticide and other chemical
residues, toxic metals, additives and packaging materials, in addition to their proximate,
biochemical, biophysical and engineering analysis.
Specific guidance for the accreditation of each discipline is not addressed in this
document. There are several good guidelines in the bibliography that apply to food
testing laboratories, including:
2.1 APLAC MR001, Procedures for Establishing and Maintaining Mutual Recognition
Arrangements Amongst Accreditation Bodies.
2.2 ISO/ IEC 17025:2005 General requirements for the competence of testing and
calibration laboratories.
2.3 ISO/ IEC Guide 2, General terms and their definitions concerning standardisation and
related activities (now ISO/IEC 17000).
2.4 ISO Guide 30:2015, Reference materials -- Selected terms and definitions
2.5 ISO/ IEC 17011:2004, Conformity assessment -- General requirements for accreditation
bodies accrediting conformity assessment bodies.
For the purpose of the Guidelines, the relevant terms and definitions given in ISO/ IEC Guide 2
apply.
Terms published in guidelines from the AOAC/ FAO/ IAEA/ IUPAC expert consulting groups are
especially useful (Bibliography Ref. A7).
3.1 Culture
An isolated microorganism grown on laboratory medium.
3.4 Verification
Confirmation by examination and provisions of evidence that specify requirements have
been met.
For Quantitative test such as Staph. aureus, there must be a quantitative assessment of
recovery of such as 50% of differences or 1- log 4 of differences.
3.8 Selectivity
The extent to which a method can determine particular analyte(s) in a complex mixture
without interference from the other components in the mixture. A method which is
perfectly selective for an analyte or a group of analytes is said to be specific.
Applicability of the method should be studied using various samples, ranging from pure
standards to mixtures with complex matrices. In each case, the recovery of the
analyte(s) of interest should be determined and the influences of suspected
interferences duly stated. Any restrictions in the applicability of the technique should be
documented in the method.
3.9 Sensitivity
The difference in analyte concentration corresponding to the smallest difference in the
response of the method that can be detected. It is represented by the slope of the
calibration curve and can be determined by a least square procedure, or experimentally,
using samples containing various concentrations of the analyte.
3.10 Chromatography
A technique for separation for identification of complex mixture of compounds.
3.11 Resolution
A measure of the separation in chromatography, which takes into account both the
retention differences of the analysed components and the column efficiency.
3.14 Lot
An identifiable quantity of food commodity delivered at one time and determined to have
common characteristic, such as origin, variety, type of packing, consignor, markings etc.
3.15 Sub-lot
Designated part of a large lot in order to apply the sampling methods on that designated
part. Each sub - lot must be physically separate and identifiable.
3.16 Sample
A quantity of the material taken from a single place in the lot or sub lot.
The numbering of the clauses below refers to the numbering of ISO/ IEC 17025:2005.Where
clause numbers from that standard are omitted no further clarification is required for food testing
laboratories.
4.3.2.2b Laboratory should use Codex as a guideline for standard methods and should also
monitor the requirements of their National and other Regulatory Authorities to ensure
that documents and methods they are using continue to be suitable and are in
compliance with applicable requirements, especially while carrying out testing that
falls under a regulatory mandate.
4.4.1c Such reviews should take into account the current regulatory requirements and
specifications of the regulatory authority(s) when selecting the appropriate test
method.
4.9, 4.10 and 5.10.9 The requirements in these sections of the standard are very important,
especially when dealing with food safety issues. Laboratories should seek regulatory guidance if
necessary and ensure that the needs of the client are met. Rapid notification to clients and
perhaps regulators of results indicating non-conforming food may be necessary to prevent/
reduce public health incidents.
5.2 Personnel
Personnel need to clearly understand the nature of the foods they are testing and
reasons for testing when undertaking contract review and method selection.
The qualification and experience of personnel shall meet the requirements as mentioned
in specific criteria documents NABL 102 or NABL 103 as applicable.
5.3.1.2 Laboratories should be designed to meet both the generic and specialised activities.
Generic activities include wet chemistry, which requires extensive fixed benches with
provision of water, power, sinks, cupboards, fume cupboards, reagent shelves,
glassware cleaning and storage. In comparison, instrument rooms may have less
extensive and even flexible arrangement of movable tables and benches.
5.3.1.2 Specialised rooms are required for clean-air-work or for work on substances, which
need special care for reasons of safety (e.g., working with radioactive materials or
storage or work on toxic substances).
5.3.2.1 Dust, both from environmental sources or from other samples, must be avoided
since dust contamination of test materials is sporadic and uneven and is likely to be
missed by normal quality control checks. Ventilation intakes and fume cupboard
exhaust must be placed carefully so as to avoid re-circulation of laboratory air and
the associated risk of contamination of test materials and hazard to laboratory staff.
Work surfaces and floor shall be made of impervious, smooth, easy to clean
materials. There shall be sufficient work place for each analyst. Walls and ceilings
shall be made of materials that are smooth and easy to clean.
5.3.2.2 There shall be at least 300-lux light intensity at working surfaces other than those
required for specified tests.
5.3.3.2 It is recommended that the media preparation and media/ glassware sterilization
areas be separated from the testing areas.
5.3.3.3 Laboratories located in facilities where products or ingredients are manufactured are
not to test for infectious pathogens (such as Listeria monocytogenes, Salmonella
species, Escherichia coli 0157:H7, Shigella species, Campylobacter species, Vibrio
cholerae, Clostridium perfringens) unless the laboratory is physically separated with
limited access, equipped with bio-safety cabinets and is supervised by a qualified
microbiologist.
5.3.3.5 Eating, drinking and smoking should be prohibited in the laboratory. Separate area,
physically separated from the laboratory, may be provided for such activities.
5.3.4 Entry in laboratory areas shall be restricted as appropriate for reasons such as
security, safety or sensitivity to contamination. Where such restrictions are in force,
staff shall be made aware of the intended use of the areas and the restrictions
imposed on working within such areas.
5.3.5.1 The responsibility for the house keeping activities must be clearly defined with
respect to the following duties:
Where regulatory authorities prescribe methods to be used for testing under their
regulations, laboratories shall ensure that the requisite method is used as
appropriate. The Codex Alimentarius, Harmonization of food standards are
recommended as acceptable references for sourcing of test methods when these are
not specified by regulation or by the client.
Every measurement has an uncertainty associated with it, resulting from various
stages of sampling, analysis and other factors.
5.5 Equipment
5.6.1.1 For the purpose of food microbiological analysis, reagents such as culture media,
sera etc. are critical materials that shall be verified for the performance against
cultures obtained from nationally/ internationally recognized culture collection
centres.
5.6.2.1 Calibration
5.6.2.1.1 For volumetric and mass measuring equipment, results of the calibration
measurements relative to tolerances and appropriate calibration certificates
demonstrating tractability to national standards shall be maintained.
5.6.2.1.2 The measuring instruments shall be calibrated using reference materials and
performance standards shall be verified and documented (for instance, consistency
of retention times and resolution of analytes in chromatographic system; wavelength
accuracy of spectrophotometers; linearity of detectors, etc).
5.6.2.1.3 The calibration record shall specify the date of calibration, due date for next
calibration, periodicity of calibration and reference standards used for calibration.
Often analytical chemistry instruments will be calibrated every time they are used or
atleast daily.
5.6.2.2 Testing
5.6.2.2.1 Most food test methods are empirical (the result depends on the defined method)
and therefore traceability is to the consensus result to that method and matrix. Even
minor deviations from the detail of the standard must be validated for all practices to
which the method is to be applied and to all matrices, to confirm that the results are
the same as those obtained from defined standard methods.
5.6.3.1.1 The use of RCs and CRCs to quantify recovery on every occasion that a test is
performed.
5.6.3.1.3 Reference culture from laboratory sources shall be identified and traceable to
standard reference sources.
5.6.3.1.4 Reference cultures shall be handled to maintain their biochemical reaction and
Physiological characteristic of integrity.
5.6.3.1.5 The laboratory shall have an effective system of maintaining the stability, sensitivity
and purity of the reference cultures.
Note: An example of an effective system is given below:
RCs and CRCs shall not be transferred more than five times from the original source.
After the fifth transfer, the laboratory may purchase another culture from a type
culture collection or re-identify the culture for key biochemical and physiological
characteristics using nationally or internationally recognized reference sources.
Alternatively, the type culture may be grown, then freeze dried, kept in frozen
storage, etc. and used periodically thereby extending the length of time after which
they must be repurchased or re-identified.
5.7 Sampling
Laboratories may need to provide sampling protocols to their clients which includes
collection, handling, packaging and transportation. Preserving sample integrity and
preventing contamination are important issues, especially when dealing with a
perishable product and the possibility of cross contamination. Where laboratory is to
report on the results for a food shipment, valid statistical sampling is required and a
component for variation should be included in the uncertainty estimate.
5.8.1 It is critical for food testing laboratories to preserve sample integrity and to avoid
contamination and deterioration. Food is frequently perishable and should be stored
in a manner to prevent deterioration such as refrigeration for short time storage.
Some parameters deteriorate rapidly and analysis should be done upon receipt.
Chain of custody issues could apply to certain regulatory samples.
Laboratories should have quality control procedures in place with rigor appropriate to
the test and its intended use. For example, the approach may differ if a substance is
banned by law or if there is a regulatory limit for the substance. The laboratory
should implement a quality control plan. Typically, this plan should include blanks,
control samples, spike recoveries and/or duplicates, where applicable.
5.9 b) Laboratories are required to take part in Proficiency Testing Programmes, which are
conducted in accordance with ISO/ IEC 17043:2010. The proficiency testing records
should include:
full details of the analyses? examination undertaken and the results and
conclusions obtained;
an indication that the performance has been reviewed
details of the investigations and corrective action undertaken, where
necessary.
A representative sample is essential when the microorganisms are sparsely distributed within
the food. Whenever possible, submit samples to the laboratory in the original unopened
containers. If products are in bulk or in containers too large for submission to the laboratory,
transfer representative portions to sterile containers under aseptic conditions.
Use containers that are clean, dry, leak-proof, wide-mouthed, sterile and of a size suitable for
samples of the product. Containers such as plastic jars or metal cans that are leak-proof may be
used. Whenever possible avoid glass containers, which may break and make the sample
susceptible to contamination.
Deliver samples to the laboratory promptly with the original storage conditions maintained as
nearly as possible. Transport frozen or refrigerated products in approved insulated containers of
rigid construction so that they will arrive at the laboratory unchanged. Collect frozen samples
solidly frozen at all times. Cool refrigerated samples in ice at 0 - 4°C and transport them in a
sample chest with suitable refrigerant capable of maintaining the sample at 0 - 4°C until arrival
at the laboratory. Do not freeze refrigerated products. Unless otherwise specified, refrigerated
samples should not be analyzed more than 36 hrs after collection.
A. Sampling plans
1. Salmonella
a. Sample Collection
Because of the widespread occurrence of Salmonella in foods, sampling plans for the samples
containing these organisms have received considerable attention. The number of samples from
a particular lot of food varies according to the sampling category to which a food is assigned.
For the Salmonella sampling, three categories of food are identified.
Food category – II
Foods that would not normally be subjected to process lethal to Salmonella between the time of
sampling and consumption and are intended for consumption by the normal adult population.
The numbers of sample units to be collected in each food category are as follows:
Food Category I:60 sample units, Food category II : 30 sample units, Food category III: 15
sample units. Submit all collected samples to the laboratory for analysis.
b. Sample analysis
The laboratory will analyze each sample for the presence of Salmonella according to methods
described in the manual. Take 25 g analytical unit at random from each 100 g sample unit.
When a sample unit consists of more than 1 container, aseptically mix the contents of each
container before taking the 25 g analytical unit. To reduce the analytical workload, the analytical
units may be composited. The maximum size of 1 composite unit is 375g or 15 analytical units.
The minimum number of composite units to be tested for each food category is as follows:
Food category – I
Four composite units; Food category – II: Two composite units; Food category – III: Three
composite unit. For each 375g composite, the entire amount of 375 g is analyzed for
Salmonella.
2. Listeria
Sample collection
For crabmeat, shrimp, processed imitation seafood (surimi), crayfish and lobster (cooked or
paraboiled), langostinos (cooked), smoked or salted fish, cheese, milk, ice cream and other
dairy products, collect ten sub-samples (or retail packages) at random each of the size of 227 g
(8 oz). Do not break or cut larger retail packages to obtain a 227 g sub-sample. Collect the
intact retail unit as the sub-sample even if it is larger than 227g. Make two composites from the
10 sub-samples. Prepare each composite by removing 100 g from each of 5 sub-samples. Each
composite will contain a total of 500 g.
a. These require packaging materials having very good low temperature resistance,
seal integrity, absence of corrosion and long durability. Packages made of all
varieties of low and high-density polyethylene, PET/ foil/ PE pouches and bags
and co-extruded structures based on PE, polyamides and polyester films shall be
used.
b. Cast poly propylene and glass containers should be avoided. Tinplate containers
may corrode at the seams.
a. These comprise fresh fruits and vegetables meat, fish and poultry as well as
marine products. All these products have moisture contents and hence have
short shelf life due to microbiological and chemical deterioration, and also require
clean and hygienic wraps.
b. For short- term storage, polyolefin films of more than 25 microns can be used.
Glass and metal containers provide long term protection. Multi- layered flexible
structures could also be used.
a. These have packaging requirements similar but less severe to those of liquid
foods. Filling and dispensing pose problems.
b. Suitable containers include wide- mouth glass jars, and rigid plastic containers
with appropriate closures.
5. Fragile foods:
a. These include food products like biscuits, paste products, confectionery and
snack foods. These require greater physical or mechanical protection against
breakage during transportation and storage.
b. Packages with suitable constructional features such as cartons, boxes and with
appropriate cushioning materials like expanded plastics are suitable.
b. Suitable containers for these solid dry foods include flexible packages made of
monolayer or multilayer structures, paper- board containers with over wrap as
well as lined packages.
The Codex Alimentarius Commission was created by FAO and WHO to develop food standards,
guidelines and related texts such as codes of practice under the joint FAO/WHO Food Standards
programme. The main purpose of the Codex Programme are protecting health of the consumers and
ensuring fair trade practices in food trade, and promoting coordination of all food standards work
undertaken by international governmental and non-governmental organizations. The Codex website is
at http://www.codexalimentarius. The Codex Alimentarius Volume 13 contains Methods of Analysis
and Sampling.
Codex SECTION 8.6 CAC?GL 27-1997, Guidelines For The Assessment Of The Competence Of
Testing Laboratories Involved In The Import And Export Control Of Food, provides a framework for
the implementation of quality assurance measures to ensure the competence of testing laboratories
involved in the import and export control of foods.
The guidelines are intended to assist countries in the application of requirements for trade in
foodstuffs in order to protect the consumers and to facilitate fair trade. Codex recommends adoption
of ISO/IEC 17025:2005 by the laboratories involved in the import and export control of foods. They
also recommend participation in appropriate proficiency testing schemes for food analysis which
conform to the requirements laid down in “ The International Harmonized Protocol for Proficiency
Testing of (Chemical) Analytical Laboratories”, Pure & Applied Chemistry 65 (1993) 2132-2144, the
use of method of analysis which have been validated according to the principles laid down by the
Codex Alimentarius Commission; and use of internal quality control procedures, such as those
described in the “Harmonized Guidelines for Internal Quality Control in Analytical Chemistry
Laboratories”, Pure & Applied Chemistry 67 (1995) 649-666,
Alinorm reports are available in the Meeting and events section under Reports. Subjects such as
proposed draft guidelines for measurement uncertainty have been discussed and recommendations
formulated: ALINORM 03/23, APPENDIX V
A3. EURACHEM Guide, The Fitness For Purpose for Analytical methods, A guide to method
validation and related topics. Also available as a free download from
http://www.vtt.fi/ket/eurachem
A4. EA 4-10 Accreditation for Microbiological Laboratories Edition July 2002 rev 02. The
publication has been prepared by the working group food of the EA Laboratory
Committee in collaboration with Eurachem. This is also available as a free download
from http://www.vtt.fi/ket/eurachem
A5. Harmonized Guidelines for Internal Quality Control in Analytical Chemistry Laboratories”,
Pure & Appl. Chem. 67 (1995) 649-666.
A6. Quality Assurance Principles for Analytical Testing Laboratories, 1992 AOAC
International – Frederick M Garfield, AOAC International Updated version: Quality
Assurance Principles for Analytical Laboratories, 2000 AOACInternational – Frederick M
Garfield, Eugene Klestra and Jerry Hirsch.http://www.aoac.org/
A7. Principles and Practices of Method Validation, edited by A. Fajgelj and A. Ambrus, The
Royal Society of Chemistry. Includes “Guidelines for single-laboratory validation of
analytical methods for trace-level concentrations of organic chemicals”; these guidelines
were elaborated by the AOAC/FAO/IAEA/IUPAC expert consultation group.
A8. The APLAC website maintains a list of Technical Publications available form its
members at the following address http://www.aplac.org/documents/technical.htm These
publications refer to all subjects and include amongst them guidelines for the
accreditation of food laboratories along with evaluation checklists.
A10. EA-4/09, Accreditation for sensory testing laboratories, 2003. Many other documents are
also available on the EA – European co-operation for accreditation web site, especially
the E4 series that relates to ISO/IEC 17025:2005. http://www.european-
accreditation.org/
A11. APLAC PT003 Proficiency testing directory. Available in the documents section of the
APLAC website. http://www.aplac.org