On October 2, 2024, Regulation (EU) No 2024/2463, establishing the methods of analysis for official controls on the microbiological criteria laid down in Regulation (EC) No 2073/2005, entered into force. (1)
This is an opportunity to recall the criteria established by Official Controls Regulation (EU) No 2017/625 regarding the legal requirements for the accreditation of official laboratories and methods of analysis (2,3).
1) Official Controls Regulations
Official Controls Regulation (EU) No 2017/625 regulates the performance of official controls and other official activities carried out by the competent authorities of the Member States to verify compliance with Union legislation in the field of, inter alia, food safety at all stages of production, processing and distribution.
1.1) Official laboratories, designation
The EU Member States competent authorities must designate official laboratories to whom they delegate the performance of laboratory analyses, tests and diagnoses on samples taken during official controls and other official activities.
Such laboratories may also be located in another Member State or in a third country that has joined the European Economic Space (EES: Iceland, Liechtenstein, Norway), provided that:
– there are appropriate provisions authorising the competent authorities to carry out audits and inspections, or to delegate their execution to the competent authorities of the Member State or EES country where the laboratory is located, and
-the laboratories have already been designated as official laboratories by the competent authorities of the Member State where they are located.
The designation must be in written form and contain a detailed description of the tasks, conditions and solutions necessary to ensure efficient and effective coordination and collaboration between the laboratories and the competent authorities.
1.2) Official laboratories, conditions and requirements
The conditions and requirements of the laboratories, with a view to their designation as official laboratories, concern:
-experience, equipment, infrastructure necessary to perform analyses, tests or diagnoses on samples;
-an adequate and sufficient number of suitably qualified, trained and experienced personnel;
– guarantee of impartial execution of the assigned tasks, in the absence of any conflict of interest;
-ability to provide timely results of analyses, tests or diagnoses carried out on samples taken during official controls and other official activities (EU Reg. 2017/625, Article 37).
1.3) Accreditations
Every designated official laboratory must operate according to ISO 17025 and be accredited by the national accreditation body, in accordance with Regulation (EC) No 765/2008. Accreditation:
-must include the methods of laboratory analysis, testing, or diagnosis that the laboratory must use for analyses, when it operates as an official laboratory;
-may include one or more methods of laboratory analysis, testing or diagnosis, or groups of methods.
The accreditation scope can be defined in a flexible way, so as to:
– be able to integrate modified versions of the methods used during the accreditation phase, or new additional methods, on the basis of the validations already carried out by the laboratory itself
-without the need for a new preliminary assessment by the national accreditation body (EU Reg. 2017/625, article 37).
1.4) Obligations
The official laboratories obligations concern:
– immediate information to the competent authorities, in cases where the results of analyses, tests or diagnoses carried out on samples taken during official controls or other official activities reveal a health risk for humans, animals or plants or, in relation to GMOs and plant protection products, also for the environment, or a probable non-compliance;
-participation in interlaboratory comparative tests or proficiency tests requested by a European Union reference laboratory or a national reference laboratory;
-making available to the public the names of the methods used for analyses, tests and diagnoses carried out in the context of official controls and other official activities, upon request by the competent authorities;
-indication of the method used for each analysis, test or diagnosis carried out in the context of official controls and other official activities, together with the results, upon request of the same authorities (EU Reg. 2017/625, Article 38).
1.5) Audit
The official laboratories audits must be organised regularly by the competent authorities that have designated them. They may carry out audits at any time, unless they are deemed unnecessary in the light of the assessments of the national accreditation body.
The designation revocation of an official laboratory is also mandatory, ‘in whole or for specific tasks, if it fails to take appropriate and timely corrective action after an audit (…) has found that it’:
a) no longer meets the conditions and requirements set out in paragraph 1.3 above;
b) fails to comply with the obligations set out in the previous paragraph 1.4;
c) is below average in inter-laboratory comparative tests (EU Reg. 2017/625, article 38).
2) Microbiological Criteria Regulation
Microbiological Criteria Regulation (EC) No 2073/2005 establishes the criteria that food business operators must respect to ensure the safety of food processes and products. (4)
Is the competent authorities of the Member States task to verify the compliance of food business operators with the rules and criteria laid down in Regulation (EC) No 2073/2005.
To that end the authorities – during official controls and other official activities, including on the premises of food business operators – take samples and send them for analysis to designated official laboratories.
2.1) Objectives and scope of application
Objective of the regulation (EC) 2073/2005 – which is part of the Hygiene Package (EC regulations 852,853/04 and subsequent ones) – is to define a series of homogeneous microbiological criteria to guarantee food safety, with regard to some pathogenic microorganisms.
This regulation is aimed primarily, it should be noted, at food business operators. Who must comply with the microbiological criteria, in the application of the general and specific hygiene measures established in Hygiene 1 Regulation (EC) No 852/2004, in Article 4.
The competent authority then verifies compliance with the aforementioned standards and criteria, without prejudice to its right to proceed with further sampling and analysis for the detection and measurement of the presence of other microorganisms, their toxins or their metabolites (EC Regulation 2073/05, Article 1).
2.2) Reference methods
Reference methods for the analyses, as well as for the sampling plans and methods are defined by the Microbiological Criteria Regulation (Annex I). And the sampling of food processing areas and equipment must be carried out in compliance with ISO 18593.
‘The operators food sector operators may use other sampling and testing procedures, provided they demonstrate to the satisfaction of the competent authority that such procedures provide at least equivalent guarantees’ (EC Regulation 2073/05, Article 5).
3) Official controls, methods of analysis of microbiological criteria
Regulation (EU) No 2024/2463 ‘establishes the methods of analysis applicable to official controls carried out to verify the compliance of food business operators with Regulation (EC) No 2073/2005’.
3.1) Declared objective
‘There are no Union rules on specific methods to use for laboratory analyses in the context of official controls to verify compliance with the rules and criteria laid down in Regulation (EC) No 2073/2005.
This situation could negatively impact the quality of official controls of food products placed on the market and create distortions of competition.
In order to ensure greater uniformity, reliability and coherence of official controls, it is therefore appropriate to establish Union requirements for the methods of analysis to be used by official laboratories when analysing official samples to verify compliance with the criteria laid down in Regulation (EC) No 2073/2005′. (5)
3.2) Basic criterion
The official laboratories designated by the competent authorities, in the analysis of samples taken during official controls carried out to verify compliance with the microbiological standards and criteria, must use ‘the reference analysis methods set out in Annex I to EC Regulation 2073/2005’ (EU Reg. 2024/2463, Article 1.1).
3.3) Validated alternative methods
In derogation to the basic criterion, ‘the competent authorities may authorise designated official laboratories to use alternative analysis methods, including proprietary methods, provided that such alternative analytical methods are validated‘:
-based on the reference analysis methods set out in Annex I to Regulation (EC) 2073/2005, in accordance with the protocol set out in ISO 16140-2, and
-for the category of food specified in the relevant microbiological criterion in Annex I to Regulation (EC) No 2073/2005, or
-for a wide range of foods covered by ISO 16140-2.
‘The competent authorities may also authorise designated official laboratories to use alternative analytical methods if such alternative analytical methods are validated in accordance with other scientific protocols internationally recognized’ (EU Reg. 2024/2463, article 1.2).
3.4) Certified proprietary methods
‘When alternative methods (…) are proprietary methods, they are certified by an independent certification body’. The certification:
-‘includes a summary of the validation results of the proprietary method or a reference to them and a statement on the quality management of the method production process’;
– ‘demonstrates that the manufacturer’s production process guarantee has been assessed and is subject, at least every five years, to a reassessment through renewal procedures’ (EU Reg. 2024/2463, article 1.3).
4) Critical issues
The European Commission – in the opposite direction to the declared objective of ensuring the ‘uniformity, reliability and coherence’ of official controls – introduces the possibility for each Member State to authorise the indiscriminate use of alternative analysis methods, provided they are ‘validated’.
The fragmentation and asymmetry of analysis methods in various countries, are thus legitimized, which may be more or less rapid, economical and unreliable, depending on the case, compared to methods whose reliability has been recognised by ISO (International Standard Organisation).
The obvious risk of this approach is to reduce the levels of food safety safeguards compared to pathogens which can be very dangerous for public health. In addition to distorting competition between operators, who may decide to base risky activities in countries with the most lenient and imprecise official testing methods.
Dario Dongo and Maria Ada Marzano
Footnotes
(1) Commission Implementing Regulation (EU) 2024/2463 of 12 September 2024 laying down analytical methods applicable to official controls performed for the verification of compliance of food business operators with Regulation (EC) No 2073/2005 https://tinyurl.com/3ytaze5k
(2) Dario Dongo, Giulia Torre. Official public controls, EU regulation 2017/625 is underway. FT (Food Times). 18.12.19
(3) Dario Dongo. Official controls, European Commission guidelines on the regulation. EU 2017/625. FT (Food Times). 2.1.23
(4) Commission Regulation (EC) No 2073/2005 of 15 November 2005 on microbiological criteria for foodstuffs. Consolidated text at 8.3.20 https://tinyurl.com/3m6kyhan
(5) Regulation (EU) No 2024/2463, Recital 3
Dario Dongo, lawyer and journalist, PhD in international food law, founder of WIISE (FARE - GIFT - Food Times) and Égalité.
Veterinary surgeon specialising in inspection of food of animal origin and PhD in animal nutrition and food safety.
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