The suitability of analytical methods for assessing food authenticity
Authors: O'Mahony Pat , Glennon Chloe , McElhinney Cormac , Danaher Martin , Graham Conor , Gutierrez Montserrat , Kelly Alan , Kilcawley Kieran , Lee David , Malone Ed , Molloy Anne , O'Callaghan Tom , Kinahan Ita 
Published: November 2024

Executive summary
The Food Safety Authority of Ireland (FSAI) requested its Scientific Committee to advise on the criteria and analytical controls that should be considered when examining the potential use of new laboratory techniques in assessing food authenticity. A subcommittee of experts in various analytical fields was established to prepare draft advice on the most relevant analytical techniques that have or could have a role in the assessment of food authenticity, within or outside the realm of routine official controls. This draft advice was then considered by the Scientific Committee of FSAI.
Many analytical techniques are routinely used in various research and development settings and have been the subject of peer‐reviewed publications, which indicates that they have a sound scientific basis. However, the successful application of laboratory analysis in a regulatory or legal context is dependent on a high level of rigour that requires both the analytical techniques and laboratories to be accredited. In the absence of accredited test methods, regulators may occasionally need to avail of unaccredited laboratory analysis for the purposes of assessing food authenticity. Anomalous analytical results, if identified, may inform decisions on further action or evaluation under official controls, including further laboratory analysis, traceability checks, audits, or inspections.
This report outlines some of the analytical techniques currently available and which may be of use in assessing the authenticity of food. The report indicates specific or general analytical controls and criteria that are required to ensure that the results obtained are reliable and reproducible. The report also emphasises that to be fit for purpose, laboratory techniques and their application must incorporate various critical controls at the sampling, processing, and analysis stages. An important control, where feasible, is the accurate analysis and reporting of unlabelled samples, whereby the precise content of those samples is not known in advance by the preferred laboratory performing the testing.
A high level of association and communication with analytical experts in the various laboratory settings supports the FSAI in ensuring that it is aware of and has access to the newest and most sophisticated laboratory techniques that could be of use in assessing the authenticity of food. Two key questions that were addressed by the Scientific Committee and their outcomes are summarised here:

What are the essential criteria (e.g. specificity, linearity, range, accuracy, reproducibility, precision, etc.) for unaccredited analytical techniques to be acceptable and reliable tools in examining the food chain, particularly in assessing food authenticity?

For an analytical method that is not based on a standardised protocol or accredited method to be considered acceptable and reliable in examining the food chain, there are a number of important issues to consider as outlined in points (i) to (vi) below. The method should, where possible, be applied in a laboratory that has a robust quality management system in place to ensure traceability and consistent performance of the method.
Important points for FSAI to consider when commissioning a laboratory to carry out non‐standardised analytical testing, or when reviewing results obtained with an unaccredited, non‐routine analytical technique or test method:

Sample(s) should be selected, collected, stored, and transported in a manner that maintains security, traceability, and physical integrity, and prevents any adverse impact on the reliability of the laboratory analysis or results.
Representative samples from different batches of the food under consideration are preferable and should be of sufficient size to allow for replicate analyses.
Sample preparation and extraction protocols (where required) should be clearly documented and optimised for the sample matrix and analysis involved.
The laboratory should be able to provide evidence of the reliability, accuracy, precision, repeatability, and reproducibility of the method, including information on any potential effect on analytical results due to the nature or stability of the sample.
The FSAI should assess the performance and reliability of the non‐standardised analytical method and the competence of the laboratory, for example by submitting for analysis samples where the provenance and composition is unknown to the testing laboratory.
Where necessary and feasible, analytical results obtained using non‐standardised test methods should be supported by other means, including official inspections involving traceability determination and where possible duplicate analysis using standardised/accredited test methods in a separate laboratory.

For the different categories of analytical tests (e.g. spectroscopic, molecular, omics etc.), what are the analytical controls feasible or necessary to ensure that methods are fit for purpose and results are accurate, reliable, and reproducible?

All such analyses should include the following in each batch of tests:

System suitability check(s)
Calibration curve where applicable
Certified reference materials (CRMs) where these are available
Suitable controls that can serve to answer any questions about the precision or accuracy of the test
A suitable number of replicate analyses of test or quality control (QC) samples to confirm the reliability and reproducibility of qualitative or quantitative results produced by the method
Results should be statistically analysed where appropriate in order to interpret the data in a meaningful way.