Honey testing and analysis in relation to the adulteration of honey with exogenous sugars has been a point of contention for a number of years. Commercial laboratories have developed a number of test methods which they have subsequently marketed to a wide audience however none of these method have been validated or harmonised by a standardisation body or to internationally recognised scientific protocols.
A number of such methods have been used by the EU in carrying out action plans as was the case with ‘From The Hives’ which only focused on Non EU honey and was much narrower in it’s scope that a previous action carried out in 2015 -2017.
The outcome of this latest action saw its results and subsequent publicity being used as the catalyst to amend the EU Honey Directive despite the methods not being validated or harmonised. Given this is an ongoing issue, the need for fair play to all stakeholders and the discrimination toward non EU honeys clarity is required as to what methods can be used for enforcement or indeed for official actions.
1) Official controls and legal certainty
Legal certainty is guaranteed by Official Controls Regulation (EC) No 2017/625, OCR, which provides common rules for all official activities carried out by the competent authorities of the EU Member States on the agri-food chains and their products, including those arriving from non-EU countries. OCR regulation indeed clarifies that a hierarchy of analysis methods, s.c. ‘cascade principle’, must be duly followed.
Compliance with this hierarchy, termed the s essential to ensure the legal effectiveness of analyses. As are the accreditation requirements of the designated official laboratories. (1)
2) Methods used for sampling, analyses, tests and diagnoses
‘Methods used for sampling and for laboratory analyses, 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 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 interpreting the results of analysis, testing and diagnosis.
3) The 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).
4) 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 no such national reference laboratory exists, any other laboratory designated’ in other Member States or in Iceland, Liechtenstein, Norway
– ‘may use methods other than those referred to in paragraphs 1 and 2 (…) until the validation of an appropriate method in accordance with internationally accepted scientific protocols’ (OCR, Article 34.3).
5) 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)
5.1) 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)
6) 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)
7) 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.
8) Conclusions
At the time being, there are no harmonised tests for honey authenticity other than EA-IRMS and EA/LC-IRMS, that cover both C4 and C3 sugars and according to the cascade principle neither official action plans or enforcement authorities should use methods outside of this.
Whether a harmonised method does exist it takes precedence over other tests which results, by consequence, Union.
Infringements by control authorities can be appealed to the competent administrative and judicial authorities.
Dario Dongo
Footnotes
(1) See paragraph 1 (Official Controls Regulation) in the previous article by Dario Dongo, Maria Ada Marzano. Microbiological criteria, methods of analysis in the EU. FT (Food Times). October 10, 2024
(2) Official Controls Regulation (EU) 2017/625 (OCR) delegates the Commission to adopt such implementing acts (Article 34.6). Reference is made, for example, to Implementing Regulation (EU) 2024/2463, which specifies the methods of analysis to be applied to certain microbiological criteria (see paragraph 2 in the article cited in footnote 1)
(3) OCR, Article 34.4, Annex III.1
(4) OCR, Annex III.2. See the following points for further characterisation specifications
(5) OCR, Article 34.4, Annex III.5
(6) OCR, Article 35
(7) OCR, Article 34.5
