oSIST prEN 18218-1:2025

SLOVENSKI STANDARD
01-september-2025
Pristnost živil – Netarčne metode preskušanja – 1. del: Splošne ugotovitve in
definicije
Food authenticity - Non-targeted testing methods - Part 1: General considerations and
definitions
Lebensmittelauthentizität - Nicht-zielgerichtete Prüfverfahren - Teil 1: Allgemeines und
Begriffe
Authenticité des aliments - Méthodes d’essai non ciblées - Partie 1 : Généralités et
définitions
Ta slovenski standard je istoveten z: prEN 18218-1
ICS:
01.040.67 Živilska tehnologija (Slovarji) Food technology
(Vocabularies)
67.020 Procesi v živilski industriji Processes in the food
industry
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

DRAFT
EUROPEAN STANDARD
NORME EUROPÉENNE
EUROPÄISCHE NORM
July 2025
ICS
English Version
Food authenticity - Non-targeted testing methods - Part 1:
General considerations and definitions
Authenticité des aliments - Validation des méthodes Lebensmittelauthentizität - Validierung von nicht-
d'essai non ciblées dans l'authenticité des aliments et zielgerichteten Prüfverfahren für die Authentizität von
des aliments pour animaux - Partie 1 : Considérations Lebens- und Futtermitteln - Teil 1: Allgemeines und
générales et définitions Begriffe
This draft European Standard is submitted to CEN members for enquiry. It has been drawn up by the Technical Committee
CEN/TC 460.
If this draft becomes a European Standard, CEN members are bound to comply with the CEN/CENELEC Internal Regulations
which stipulate the conditions for giving this European Standard the status of a national standard without any alteration.

This draft European Standard was established by CEN in three official versions (English, French, German). A version in any other
language made by translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC
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United Kingdom.
Recipients of this draft are invited to submit, with their comments, notification of any relevant patent rights of which they are
aware and to provide supporting documentation.

Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without
notice and shall not be referred to as a European Standard.

EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2025 CEN All rights of exploitation in any form and by any means reserved Ref. No. prEN 18218-1:2025 E
worldwide for CEN national Members.

Contents Page
European foreword . 3
Introduction . 4
1 Scope . 5
2 Normative references . 5
3 Terms and definitions . 5
3.1 General terms . 5
3.2 Samples . 7
3.3 Analysis and analytical quality . 8
3.4 Data processing . 10
3.5 List of abbreviations . 12
4 General considerations on non-targeted testing methods . 13
5 Development of a NTTM . 14
5.1 Scope and method performance criteria . 14
5.2 Sampling and reference sample sets . 14
5.3 Measurement methods and analytical features . 15
5.4 Data analytics and statistical model . 15
5.5 Method performance . 16
6 Validation of a non-targeted testing method . 18
6.1 General. 18
6.2 Validation plan and performance characteristics . 18
6.3 Validation samples . 18
6.4 Performance evaluation . 18
6.5 Validation study designs . 19
7 Routine use, quality control and long-term maintenance . 19
7.1 Introduce NTTM into routine use . 19
7.2 Internal quality control . 19
7.3 Conformance probability of samples . 19
7.4 Long-term maintenance . 20
7.4.1 Modification of the validated method . 20
7.4.2 Data maintenance . 20
Bibliography . 21

European foreword
This document (prEN 18218-1:2025) has been prepared by Technical Committee CEN/TC 460 “Food
authenticity”, the secretariat of which is held by DIN.
This document is currently submitted to the CEN Enquiry.

Introduction
Food and feed authentication aims at verifying whether a proposed product claim matches with the
expected product characteristics. Traditionally, the majority of analytical methods for food
authentication are based on targeted approaches. However, non-targeted testing methods (NTTM) could
provide a more cost-effective approach for authentication of food and feed in the increasingly complex
international supply chain. Product characteristics of interest are for instance:
— the geographical origin of a product (e.g. a declared country of origin or a region indicated by
“Protected Designation of Origin” or “Protected Geographical Indication” food labels);
— the biological origin (e.g. a declared species or variety);
— the production mode (e.g. produced under organic conditions);
— the absence of adulterants.
A targeted method aims for specific parameters, compounds or markers in a food product. A NTTM
provides a broad subset of chemical/physical features of the product and can detect expected and
unexpected alterations in a food product. The product characteristics often cannot be directly measured,
but they can be modelled and predicted from measurable analytical features using classification methods.
A NTTM used for authenticating food analyses a food product bearing a specific claim, and can be used to
compare the data with those of known authentic materials. The outcome allows to verify whether the
characteristics of the food product and the claim match. Research on NTTM has mainly been driven by
the following factors:
— food product claims have become more complex by declaring, e.g. variety, breed, production and food
transformation processes. Examples of such claims are the “Protected Designation of Origin” and
“Protected Geographical Indication” food labels;
— more food inspections are wanted by stakeholders such as government agencies, policy makers,
control laboratories, producers, industry and consumers in order to provide evidence about the
quality, authenticity and integrity on the large volume of food traded globally.
Until now, no European standard is available for the validation of NTTM in food authenticity. Not having
widely accepted guidelines complicates the acceptability of results of NTTM used in the analysis of food
authenticity. Such methods are regarded as a useful complement to other risk-based food controls to
detect fraudulent and deceptive practices.

1 Scope
This document provides a common language covering NTTM in food authentication. It provides:
— definitions of terms involved in the development and validation of NTTM;
— a general structure and guidelines for development of NTTM;
— general considerations for the validation of NTTM.
NOTE “Food and feed” is implied whenever the term “food” is used in this document.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
EN 17972:2024, Food authenticity — Food authenticity and fraud — Concepts, terms, and definitions
3 Terms and definitions
For the purposes of this document, the terms and definitions given in EN 17972 and the following apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https://www.iso.org/obp/
— IEC Electropedia: available at https://www.electropedia.org/
3.1 General terms
3.1.1
adulterant
material used to adulterate food
3.1.2
adulteration
intentionally adding an undeclared ingredient to the food product, or substituting a declared ingredient
with another ingredient, or increasing the volume of a liquid product by dilution
Note 1 to entry: In practice, there might not be a clear difference between dilution, addition, and substitution,
and it might be difficult to distinguish between them.
[SOURCE: EN 17972:2024, 3.20]
3.1.3
analytical features
collection of observations from analysed samples
Note 1 to entry: Analytical features (3.1.3) can include, but are not limited to, quantities of discrete
elements/molecules/marker compounds or electronic records of analytical measurement techniques (3.3.1) such as
spectra, sequences, or chromatograms.
Note 2 to entry: The features resulting from the measurement procedure (3.3.7), independent of its measurement
principle (3.3.6) or analytical measurement technique (3.3.1), can typically not be directly mapped to any
characteristic of the food, such as species, origin (e.g. country, region), agronomical practices (e.g. organic vs.
conventional), production/processing system, or purity.
3.1.4
authentic
state where there is a match between the product characteristic (3.1.7) and the corresponding claims
[SOURCE: EN 17972:2024, 3.5, modified — definition rephrased]
3.1.5
authentication
process of verifying the authenticity (3.1.6) of the food product
[SOURCE: EN 17972:2024, 3.7]
3.1.6
authenticity
quality of being authentic (3.1.4)
[SOURCE: EN 17972:2024, 3.6]
3.1.7
characteristic
distinguishing feature of the product
Note 1 to entry: A product characteristic can be qualitative or quantitative.
Note 2 to entry: A product characteristic can be inherent in the product itself, or it can relate to the conditions
under which the product was produced, or the environment it was produced in.
Note 3 to entry: A product characteristic is sometimes referred to as a product attribute or a product property.
[SOURCE: EN 17972:2024, 3.3, modified — notes to entry removed]
3.1.8
non-targeted testing method
NTTM
set of procedures involving a measurement procedure (3.3.7) yielding several analytical features (3.1.3)
which are contextualized using data analytics (3.4.4), including a reference data set (3.2.3), in order to
ascertain the authenticity (3.1.6) of a claimed characteristic (3.1.7) of a food product
Note 1 to entry: Data analytics (3.4.4) can include, but is not limited to statistical models (3.4.13), to evaluate
similarity to the set of reference samples (3.2.4).
Note 2 to entry: The result from the analytical measurement is commonly referred to as the ‘fingerprint’, ‘profile’,
or ‘signature’. The exact definitions of these terms are different in different scientific fields and not provided in this
document.
3.1.9
product tampering
type of fraud which includes the deliberate changing of product characteristics so that they no longer
match the implicit or explicit claims associated with the product
Note 1 to entry: Product tampering (3.1.9) can happen either by subjecting the food product to an unapproved or
undeclared process, by removing a substance which should have been present in the food product (removal), or by
adding or replacing a substance (adulteration (3.1.2)).
[SOURCE: EN 17972:2024, 3.16, modified — definition rephrased, notes to entry removed]
3.2 Samples
3.2.1
calibration sample set
part of the reference sample set (3.2.5) used for developing (design and optimize) a NTTM (3.1.8)
Note 1 to entry: The calibration sample set (3.2.1) may be split in subgroups for model optimization (division into
training/test sets using resampling techniques). 'Cross validation' is a common resampling technique, and despite
the name, it is not equal to method validation (3.3.11).
Note 2 to entry: The split of the calibration sample set (3.2.1) into training/test sets (note 1) is sometimes also
referred to as training/validation sets. The latter are not to be confused with the validation sample set (3.2.6).
3.2.2
meta-data
meta-information
documented characteristics of samples and analytical data
Note 1 to entry: Typical examples are the name of the species/variety representing the food, food production and
processing specificities, geographical origin, sampling, measurement procedure (3.3.7) and data analytics, etc.
3.2.3
reference data set
reference database
analytical features (3.1.3) obtained from the reference sample set (3.2.5)
3.2.4
reference sample
material with known and documented specified characteristic(s)
Note 1 to entry: Product characteristics are e.g. a certain biological origin (e.g. beef meat, Manuka honey), a
certain geographical origin (e.g. Protected Denomination of Origin), a certain production/processing system (e.g.
organic production, frozen–thawed) or the absence of adulterants (3.1.1), documented through meta-information.
Note 2 to entry: Product characteristics are specified in the scope of the NTTM (3.1.8).
Note 3 to entry: Reference samples (3.2.4) can be authentic or non-authentic with regard to specified
characteristic(s). For example, reference samples (3.2.4) of Greek olive oil are regarded as authentic for the
development, validation (3.3.11) and use of a NTTM (3.1.8) to test whether a test item truly originated from Greece,
but the Greek reference samples (3.2.4) are regarded as non-authentic if the purpose of the NTTM (3.1.8) is to test
whether a test item truly originates from Tunisa.
3.2.5
reference sample set
collection of reference samples (3.2.4) used for establishing a NTTM (3.1.8), including method
development and method validation (3.3.11)
3.2.6
validation sample set
part of the reference sample set (3.2.5) used for validating a NTTM (3.1.8) during method validation
(3.3.11)
Note 1 to entry: Samples in the validation sample set (3.2.6) are, whenever possible, sourced independently from
the calibration sample set (3.2.1).
Note 2 to entry: The validation sample set (3.2.6) is a set of samples which is not used until the validation phase
of the NTTM (3.1.8).
Note 3 to entry: Preferably, samples are gathered sometime after the sampling period of the calibration sample
set (3.2.1), and include as many sources of variation within the defined scope as possible that can be expected in
future use. Examples include different sample providers, storage periods, different analytical instruments (or after
maintenance, part replacements) and different operators.
3.3 Analysis and analytical quality
3.3.1
analytical measurement technique
technology, applying (a) certain measurement principle(s) (3.3.7) to yield results
Note 1 to entry: These technologies include chromatography, electrophoresis, spectroscopy, spectrometry, and
molecular biology based analytical measurement techniques (3.3.1) that are widely used for authentication.
3.3.2
factorial study design
validation by using systematic variation of factors to evaluate its contribution to the variation in the
measurement
3.3.3
intermediate precision
precision where test/measurement results are obtained with the same method, on identical
test/measurement items in the same test or measurement, under some different operating condition
[SOURCE: ISO 3534-2:2006, 3.3.15 and 3.3.16, modified — terms merged, and definition rephrased]
3.3.4
measurement
process of experimentally obtaining one or more values that can reasonably be attributed to a quantity
together with any other available relevant information
[SOURCE: ISO/IEC Guide 99:2007, 2.1, modified — definition rephrased]
3.3.5
measurement method
generic description of a logical organization of operations used in a measurement (3.3.4)
[SOURCE: ISO/IEC Guide 99:2007, 2.5, modified — note to entry removed]
3.3.6
measurement principle
phenomenon serving as a basis of a measurement (3.3.4)
Note 1 to entry: The phenomenon can be of a physical, chemical, or biological nature.
[SOURCE: ISO/IEC Guide 99:2007, 2.4, modified — examples removed]
3.3.7
measurement procedure
detailed description of a measurement according to one or more measurement principles (3.3.7) and to a
given measurement method (3.3.5)
Note 1 to entry: A measurement procedure (3.3.7) is usually documented in sufficient detail to enable an operator
to perform a measurement, which is sometimes called a standard operating procedure, abbreviated SOP.
[SOURCE: ISO/IEC Guide 99:2007, 2.6, modified — definition shortened, notes to entry removed]
3.3.8
repeatability
precision where independent test/measurement results are obtained with the same method on identical
test/measurement items in the same test or measuring facility by the same operator using the same
equipment within short intervals of time
Note 1 to entry: Repeatability (3.3.8) can be expressed quantitatively in terms of the dispersion characteristics of
the results.
[SOURCE: ISO 3534-2:2006, 3.3.5 and 3.3.6, modified — terms merged, definition rephrased and note to
entry removed]
3.3.9
reproducibility
precision where independent test/measurement results are obtained with the same method on identical
test/measurement items in different test or measuring facility with different operators using different
equipment
Note 1 to entry: Reproducibility (3.3.9) can be expressed quantitatively in terms of the dispersion characteristics
of the results.
[SOURCE: ISO 3534-2:2006, 3.3.10 and 3.3.11, modified — terms merged, and definition rephrased, note
to entry 2 removed]
3.3.10
testing
subjecting a sample to a measurement procedure (3.3.7) and data analytics (3.4.4) in order to get results
3.3.11
validation
verification (3.3.12), where the specified requirements are adequate (fit for purpose) for an intended use
EXAMPLE 1 A NTTM (3.1.8) procedure has been newly developed and values for performance characteristics
(3.4.9) should be established and compared to previously defined criteria, to decide whether they are fit for the
intended use.
EXAMPLE 2 A multivariate model derived from samples of past harvests could be validated for samples from a
new year of harvest.
Note 1 to entry: Special case of a verification (3.3.12) confirming whether the achievable performance
characteristics (3.4.9) satisfy the intended purpose.
Note 2 to entry: The validation is as extensive as is necessary to meet the needs of the given application or field
of application (see EN ISO/IEC 17025:2017, 7.2.2.1).
Note 3 to entry: Validation can apply to the NTTM (3.1.8) as a whole as well as to the measurement procedure
(3.3.7).
[SOURCE: ISO/IEC Guide 99:2007, 2.45, modified — Example removed, new examples and notes to entry
added]
3.3.12
verification
provision of objective evidence that a given item fulfils specified requirements
EXAMPLE 1 Confirmation that a particular laboratory is capable of detecting adulteration (3.1.2) with the
performance characteristics (3.4.9) (e.g. sensitivity (3.4.11), specificity (3.4.12) or the precision of underlying decision
scores (3.4.6)) specified in a standardized method.
EXAMPLE 2 Confirmation that the outcome of a particular mathematical routine can be considered equivalent
to the outcome of a previously established evaluation routine that sets specified requirements.
Note 1 to entry: ‘Item’ can be an analytical measurement, a mathematical evaluation routine, a combination of
both, such as a multivariate evaluation of spectral data sets, or a reference material, in particular samples for
training methods in this context. In the context of this document, item represents the combination of analytical
method and the mathematical evaluation routine.
Note 2 to entry: ‘Specified requirements’ typically refers to values and/or ranges for performance characteristics
(3.4.9) defined by a specification.
[SOURCE: ISO/IEC Guide 99:2007, 2.44, modified — example removed and rephrased, and notes to entry
removed]
3.4 Data processing
3.4.1
classification
assignment to which class of objects (product characteristics) an object (product sample) belongs
3.4.2
conformance probability
probability that a test item has a specified characteristic
[SOURCE: JCGM 106:2012, 3.3.7, modified]
3.4.3
confusion matrix
contingency table
table giving the relation between the known classes of samples and the classes predicted by a NTTM
(3.1.8)
Note 1 to entry: The cells for a confusion matrix (3.4.3) contain the observed number of samples, or percentages
of occurrence (an example is shown below). Positive and Negative typically refer respectively to Authentic and Non-
Authentic with regard to the specified characteristics, but shal
...