Food System

Official controls, European Commission guidelines on reg. EU 2017/625

January 2, 2023

144

On December 8, 2022, the European Commission published guidelines for the implementation of reg. EU 2017/625 on official controls in the agri-food chain (so-called Official Controls Regulation, OCR. See notes 1,2,3).

The document contributes to the understanding and harmonized application of OCR by EU member state authorities and stakeholders for the purpose of official controls and other official activities (4,5).

1) Reg. EU 2017/625, European Commission guidelines. The cornerstones

The European Commission’s guidelines on reg. EU 2017/625 focus on five key points:

distinction between official controls and other official activities (OCR, Art. 2),
Delegation of certain tasks of Competent Authorities (Articles 28-33),
sampling, analysis, testing and diagnosis (Articles 34-42),
Financing of official controls and other official activities (Articles 78-85),
laboratories and reference centers (Articles 92-101).

2) ‘Official checks’ and ‘other official activities’

The distinction between ‘official controls’ and ‘other official activities’ delegated to competent authorities is essential because different rules and conditions apply to them. These are also relevant for evidentiary and risk analysis purposes, as seen in the case of monitoring activities, which are not in themselves capable of justifying sanction measures or alert notifications. (6)

“Official controls” and “other official activities,” it is recalled, must in any case always be carried out by a “competent authority,” i.e., a “delegated body” or a natural person to whom “certain tasks” related to official controls or other official activities have been delegated (EU Reg. 2017/625, Article 2).

2.1) Official controls, the three requirements

The “official controls” subject to the uniform regulation of reg. EU 2017/625 are carried out in order to verify operators’ compliance-and thus, the compliance of animals and goods-with the requirements of the OCR and the regulations referred to therein.

Therefore, the three elements that an activity must simultaneously satisfy in order to qualify as “official control” first and foremost pertain to the purpose of:

verify the compliance of
activities of the operators (and/or animals and goods) at the
reg. EU 2017/625 and/or the legislation referred to therein.

In cases of non-compliance, activities to verify the extent, origin or responsibility of the operator are qualified as “official controls” in relation to these purposes. Table 1 of the guidelines gives some practical examples of official controls and other official activities.

3) Delegation of certain tasks of competent authorities

Reg. EU 2017/625 sets the conditions for delegating certain tasks related to official controls and other official activities (OCR, Article 31) to delegated bodies or individuals (Articles 29,30).

3.1) Accreditation of delegated bodies

Accreditation of delegated bodies is provided to ensure the maintenance of impartiality, quality and consistency of official controls. However, the granting of delegation is subject to special verifications(audits. See Section 3.2). even in the case of accreditation.

Provisional delegation of certain tasks to delegated bodies may also be allowed pending their accreditation, under certain conditions that include the successful submission of the relevant application (EU Reg. 2017/625, Art. 1).

3.2) Audit of delegated bodies

Delegated bodies must be audited and/or inspected, including to ensure compliance of irrelevant activities that were not considered in the accreditation audits.

In cases of findings of non-compliance, the competent authority may order partial or full revocation of the delegation (EU Reg. 2017/625, Art. 33).

The conditions for delegation of official controls and other official activities, verification procedures and follow-up measures in case of non-compliance are continuously monitored.

4) Methods of sampling and analysis

A hierarchy of criteria-so-called “cascade method”-must be followed to identify the methods of sampling and analysis, laboratory testing or diagnosis, to be applied to official controls and other official activities:

in the absence of official criteria, and
regardless of whether some methods are already used by the competent authorities, their delegates or official laboratories (OCR, Art. 34. See Fig. 1).

Figure 1 “Waterfall” for laboratory methods of analysis, testing and diagnosis in the context of official controls and other official activities

NB: the choice of methods other than those indicated in the basic hierarchy is still allowed if they are provided for by sector regulations(lex specialis)

5) Official Laboratories

Official laboratories must in turn follow the hierarchy described above to identify sampling methods, sample preparation, laboratory analysis, testing or diagnosis, sampling methods, and for sample preparation, in the absence of applicable standards (7,8).

The basic criteria for sampling methods must in all cases meet the requirements set out in Annex III to the Official Controls Regulation. The guidelines, in Table 2, also provide an overview of the methods to be applied.

5.1) Designation of official laboratories

The competent authorities of the member states:

designate in writing the official laboratories, which must be accredited according to the international standard EN ISO/IEC 17025,
may conduct periodic audits of accreditation evaluations to verify that the official laboratory continues to meet requirements.

Provision is made for the possibility of designating official laboratories located in another EU state or an EEA (European Economic Area) country. The CIRCABC platform is referred to for this purpose.

6) Counter-expertise and analysis review.

Counter-expertise and analysis review are recognized by reg. EU 2017/625 as rights to which the operator must have access, at its own expense. In relation to sampling, analysis, testing or diagnosis performed for official controls, not also in other official activities.

In any case, competent authorities must take immediate action where there is a need to eliminate or mitigate health risks to humans, animals and plants, or risks to animal welfare or the environment (e.g., GMOs, plant protection products). (5)

6.1) Rights of operators

The right to counter-expertise may be expressed by operators, according to reg. EU 2017/625, by request of:

Documentary examination by a recognized and appropriately qualified appraiser,
collection of a sample, by the competent authority, for a second counter-examination analysis,
taking of another sample, by the competent authority, for further analysis to be entrusted to a different official laboratory-if provided for by national law, with good peace to uniformity of rules-in case of dispute over initial analysis and/or counter-expertise.

6.2) Limits and duties of information

Limits to the right of counter-examination and review of analysis arise where taking a sufficient amount of sample is not “appropriate, relevant and technically feasible.”

Upon fulfillment of these sampling conditions, actually provided by reg. EU 2017/625, the authority must in any case:

justify the act, based on specific elements that consider the type of matrix (or animal), the contingencies, and the type of analysis to be performed,
Inform the operator and/or operators concerned.

7) Financing of official controls and other official activities

Mandatory fees or charges are provided to cover the costs incurred by authorities in connection with certain official controls.

Official controls must be part of an integrated system, managed at the national level to ensure effective surveillance in the agrifood chain in the EU.

In contrast, the costs of ‘other official activities’ do not include any form of direct mandatory reimbursement from operators in the form of rates or fees.

7.1) Calculation of costs

Mandatory rates or fees of official controls must meet the cost level calculated in reg. EU 2017/625 (OCR, Art. 82), or the amounts shown in its Annex IV. In contrast, a combination of the two methods may not be used.

It is possible to calculate a lump sum for a specific sector, activity or category of operators, based on the total costs of official controls within the scope of reg. EU 2017/625 (OCR).

OCR determines what expenses are included in costs and when they may be part of the official controls involved. Referring to “staff salaries,” “the cost of facilities and equipment,” “the cost of training,” and “travel expenses” including overhead costs incurred in carrying out official inspections. As well as the costs of organizing and supporting the planning and execution of official controls.

7.2) Cost Reduction

Member states may reduce the amount of tariffs or fees, taking into account:

interests of low-capacity operators,
Traditional methods used for production, processing and distribution,
needs of operators located in regions subject to specific geographical constraints, and
compliance history of operators, as verified through official controls.

7.3) Transparency of funding

Maximum transparency of official controls must also come on the fees or charges collected from operators, so that citizens and businesses can understand the method and data used to set the fees or charges.

8) Laboratories and reference centers

EURL and NRL-i .e., EU and national reference laboratories, respectively-aim to promote uniform practices in the development and adoption of methods applied by official laboratories designated by member states. So as to ensure the reliability and consistency of the results of tests, analysis and diagnosis performed in the context of official controls and other official activities.

EURCs, EU reference centers, on the other hand, have the function of promoting scientific and technical expertise in the areas of integrity and authenticity of the agrifood supply chain as well as animal welfare. And thus promote scientific sharing as the basis for official controls and other official activities.

8.1) EURL and NRL, accreditation and notification.

Accreditation under the EN ISO/IEC 17025 standard-noteworthy, including for laboratory methods of analysis, testing or diagnosis-is:

mandatory for EURLs(European Union reference laboratories) and NRLs(national reference laboratories),
not mandatory for EURCs(European Union reference centers), as they have a support function.

The updated list of NRL names and addresses should be published and communicated to both other member states and relevant EURLs.

9) Submission of reports and monitoring of the Commission.

EURL and EURC are subject to audits by the Commission, to verify compliance of their activities. Their work in official controls is also subject to documentary review of reports, based on their annual or multi-year work programs.

It is within the Commission’s authority to order on-the-spot audits of EURCs on a case-by-case basis to verify the compliance of laboratories and the proper implementation and reporting of submitted annual or multi-year programs.
LNRs, on the other hand, are not subject to Commission controls.

The results of inter-laboratory comparative tests(ring tests) and evaluative tests of NRLs are monitored by EURLs, periodically, through inter-laboratory comparative tests or evaluative tests. Also based on legal requirements in relation to the use of certain methods. NRLs must participate in interlaboratory comparative tests/evaluation trials.

In cases of insufficient results from an NRL, in the context of a test organized by EURLs, follow-up procedures must be activated.

Dario Dongo and Giulia Pietrollini

Notes

(1) Commission Notice on the implementation of Regulation (EU) 2017/625 (2022/C 467/02) %3A52022XC1208%

(2) Reg. EU 2017/625, Concerning official controls and other official activities carried out to ensure the enforcement of food and feed legislation, animal health and welfare, plant health and plant protection products. Version consolidated as of 28.1.22 on Eur-Lex https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02017R0625-20220128&qid=1672780701484

(3) Dario Dongo, Giulia Torre. Official public controls, EU Regulation 2017/625 kicks off. GIFT (Great Italian Food Trade). 18.12.19

(4) Dongo Dongo, Amaranta Traversa, Sarah Lanzilli, Claudio Biglia. Official controls, d .lgs. 27/21. Implementation of EU reg. 2017/625. GIFT (Great Italian Food Trade). 14.3.21

(5) Dario Dongo, Andrea Sodero. Official checks. Law 71/2021, converting LD 42/2021, and warning of operators. GIFT (Great Italian Food Trade). 22.5.21

(6) Fabrizio De Stefani, Dario Dongo. Official controls, sampling and analytical methods. Vademecum of the Regions. GIFT (Great Italian Food Trade). 27.4.21

(7) An example of a uniform and comprehensive framework for sampling and analytical methods is provided by the current framework for official controls on olive oils. V. Dario Dongo, Giulia Pietrollini. Olive oils, compliance checks. Reg. EU 2022/2105. GIFT (Great Italian Food Trade). 11.12.22

(8) One problematic example concerns the DNA extraction method for PCR analysis to test for the possible presence of GMOs. In the absence of a shared method, the use of different solvents or solvent mixtures in different laboratories can lead to contradictory results on matrices where DNA is almost absent (e.g., lecithins, refined oils). Another example, of great importance for ensuring food safety and public health, concerns allergen testing. See footnote 10 below

(9) Reg. EU 2020/689, Supplementing reg. EU 2016/429 regarding rules on surveillance, eradication programs and disease-free status for certain listed and emerging diseases EUR-Lex – 32020R0689 – EN – EUR-Lex (europa.eu)

(10) From theory to practice, a widespread critical issue already reported on this site relates to methods of sampling and analysis of food matrices aimed at ascertaining and measuring the presence of allergens. V. Dario Dongo. Allergens and RASFF, European blackout. GIFT (Great Italian Food Trade). 13.7.22

(11) Dario Dongo, Giulia Pietrollini. WHO Global Strategy for food safety 2022-2030. GIFT (Great Italian Food Trade). 30.10.22