Official controls carried out by the competent authorities of the EU Member States on agri-food chains and related products – including those arriving from third countries – must follow a specific hierarchy of analysis methods.
Compliance with this hierarchy, termed the ‘cascade principle’, is essential to ensure the legal effectiveness of analyses. As are the accreditation requirements of the designated official laboratories. (1) Some clues to follow.
1) Methods used for sampling, analyses, tests and diagnoses
‘Methods used for sampling and for laboratory analysis, tests and diagnoses during official controls and other official activities shall comply with Union rules establishing those methods or the performance criteria for those methods’ (Official Controls Regulation EU No 2017/625, OCR, article 34.1).
The European legislator and the European Commission – through appropriate implementing acts (2) – may therefore define:
– specific methods for sampling, analysis, tests and diagnosis to be applied, in the context of official controls and other official activities, to conformity checks of individual matrices (i.e. plants, animals, food and feed) or categories thereof;
– performance criteria, analysis, testing and diagnostic parameters, specific tolerances and validation procedures for these methods;
– methods of interpretation of the results of analyses, tests and diagnoses.
2) Hierarchy of analysis methods (cascade principle)
‘In the absence of the Union rules as referred to in paragraph 1, and in the context of official controls and other official activities, official laboratories shall use one of the following methods according to the suitability for their specific analytical, testing and diagnostic needs:
(a) available methods complying with relevant internationally recognised rules or protocols including those that the European Committee for Standardisation (CEN) has accepted; or
– relevant methods developed or recommended by the European Union reference laboratories and validated in accordance with internationally accepted scientific protocols;
(b) in the absence of the suitable rules or protocols, as referred to in point (a), methods which comply with relevant rules established at national level, or, if no such rules exist, relevant methods developed or recommended by national reference laboratories and validated in accordance with internationally accepted scientific protocols; or
– relevant methods developed and validated with inter or intra-laboratory methods validation studies in accordance with internationally accepted scientific protocols’ (OCR, Article 34.2).
3) ‘Cascade principle’, emergency situations
‘Where laboratory analyses, tests or diagnoses are urgently needed and none of the methods referred to in paragraphs 1 and 2’ exists:
– ‘the relevant national reference laboratory or, if there is no national reference laboratory,
– any other laboratory designated in another Member State or in Iceland, Liechtenstein, Norway
– ‘may use methods other than those referred to in paragraphs 1 and 2 (…), pending the validation of an appropriate method based on internationally accepted scientific protocols‘ (OCR, Article 34.3).
4) Methods of analysis characterisation
Methods of analysis and results of measurements within the framework of official controls and other official activities ‘must be characterised wherever possible’ by the following ‘criteria:
a) accuracy (trueness and precision);
b) applicability (matrix and concentration range);
c) limit of detection;
d) limit of quantification;
e) precision;
f) repeatability;
g) reproducibility;
h) recovery;
i) selectivity;
j) sensitivity;
k) linearity;
l) measurement uncertainty;
m) other criteria that may be selected as required’. (3)
4.1) Precision, repeatability and linearity values
The precision values referred to above (OCR, Annex III, point 1.e) ‘shall either be obtained
– from a collaborative trial which has been conducted in accordance with an internationally recognised protocol on collaborative trials (e.g. ISO 5725 ‘Accuracy (trueness and precision) of measurement methods and results’) or,
– where performance criteria for analytical methods have been established, be based on criteria compliance tests.
The repeatability and reproducibility values shall be expressed in an internationally recognised form (e.g. the 95 % confidence intervals as defined by ISO 5725 ‘Accuracy (trueness and precision) of measurement methods and results’). The results from the collaborative trial shall be published or freely available‘. (4)
5) Sampling methods, second expert opinion
‘Samples shall be taken, handled and labelled in such a way as to ensure their legal, scientific and technical validity’. (5) And ‘the competent authorities shall ensure that operators, whose animals or goods are subject to sampling, analysis, test or diagnosis in the context of official controls, have the right to a second expert opinion, at the operator’s own expense’.
‘The right to a second expert opinion shall entitle the operator to request a documentary review of the sampling, analysis, test or diagnosis by another recognised and appropriately qualified expert’.
‘Where relevant, appropriate and technically feasible – having regard in particular to the prevalence and distribution of the hazard in the animals or goods, to the perishability of the samples or the goods and to the amount of available substrate – the competent authorities shall:
a) when taking the sample, and if so requested by the operator, ensure that a sufficient quantity is taken to allow for a second expert opinion and for the review referred to in paragraph 3, should this prove necessary; or;
b) where it is not possible to take a sufficient quantity as referred to in point (a), inform the operator thereof’. (6)
6) Official controls, methods of analysis and legal certainty
The form of official controls – with regard to the requirements mentioned above (sampling, accreditation of laboratories, method of analysis) – becomes substance in all cases in which the competent authorities on that basis assess animals and goods as ‘non-compliant’ and take measures accordingly. (7)
The reference to methods of analysis that are the subject of international standards, by the European legislator and executive, remains the way to ensure legal certainty not only within the Union but also in relations with authorities and economic operators in other countries.
Dario Dongo
Footnotes
(1) See paragraph 1 (Official Controls Regulation) in the previous article by Dario Dongo, Maria Ada Marzano. Microbiological criteria, analysis methods in EU. Food Times. 10.10.24
(2) Official Controls Regulation (EU) 2017/625 (OCR) delegates the Commission to adopt such implementing acts (Article 34.6). For example, reference is made to Implementing Regulation (EU) 2024/2463 which indicates the methods of analysis to be applied to certain microbiological criteria (see the homonymous paragraph 2 of the article cited in note 1)
(3) OCR, Article 34.4, Annex III.1
(4) OCR, Annex III.2. See the following points for further characterization specifications
(5) OCR, Article 34.4, Annex III.5
(6) OCR, article 35
(7) OCR, article 34.5
Dario Dongo, lawyer and journalist, PhD in international food law, founder of WIISE (FARE - GIFT - Food Times) and Égalité.
