This Commission Notice is intended to assist national authorities in the application of Regulation (EU) 2017/625. Only the Court of Justice of the European Union is competent to authoritatively interpret Union law.

CONTENTS

ABBREVIATIONS

4

INTRODUCTION

5

1.

TITLE I - SUBJECT-MATTER, SCOPE AND DEFINITIONS

5

1.1.

Official Controls and Other Official Activities (Article 2 of the OCR)

5

1.2.

The official veterinarian (Article 3 of the OCR)

13

2.

TITLE II - OFFICIAL CONTROLS AND OTHER OFFICIAL ACTIVITIES IN MEMBER STATES

15

2.1.

CHAPTER II – Official controls

15

2.1.1

Official controls of e-commerce

15

2.1.1.1

Registration of e-commerce operators

16

2.1.1.2

Sampling and analysis of animals and goods sold online

16

2.1.1.3

Action in the event of non-compliance and risk

16

2.1.1.4

Digital service providers

17

2.1.1.5

E-commerce control strategies – best practices

18

2.1.2.

Listing of operators (Article 10(2) and (3) of the OCR)

18

2.1.3.

Methods and techniques for official controls: inspections and audits (Article 14 of the OCR)

19

2.1.3.1.

Inspections

19

2.1.3.2.

Audits

20

2.1.4.

Official controls for the production of products of animal origin for human consumption

21

2.2.

CHAPTER III – Delegation of certain tasks of the competent authorities (Articles 28 to 33 of the OCR)

31

2.2.1.

Conditions for delegating certain official control tasks

31

2.3.

CHAPTER IV – Sampling, Analyses, tests and diagnoses (Articles 34 to 42 of the OCR)

33

2.3.1.

Methods used for sampling, analysis, tests and diagnosis (Article 34 of the OCR)

33

2.3.2.

Second Expert Opinion (Article 35 of the OCR)

37

2.3.2.1.

Conditions for sampling for a second expert opinion and for another analysis by another official laboratory

39

2.3.2.2.

Another analysis by another official laboratory

40

2.3.3.

Official laboratories (Articles 37 to 42 of the OCR)

40

2.3.3.1.

Designation

40

2.3.3.2.

Accreditation

41

2.3.3.3.

Cross-border designation

42

2.3.3.4.

Sub-contracting

43

2.3.3.5.

Audits

44

2.4.

CHAPTER V – Official controls on animals and goods entering the Union

44

2.4.1.

Official control rules for consignments entering the Union

44

2.4.1.1.

Consignments and accompanying documents

44

2.4.1.2.

Certification rules for animals, products of animal origin, composite products and germinal products.

45

2.4.1.3.

Certification rules for plants, plant products and other objects

46

2.4.1.4.

Electronic certification

47

2.4.1.5.

Animals and goods entering the Union subject to official controls

47

2.4.1.6.

Performance of checks

49

2.4.1.7.

Use of the CHED

51

2.4.1.8.

Change of purpose and special treatment of consignments

52

2.4.1.9.

CHED-PP linked to a phytosanitary certificate

52

2.4.2.

Illegal entry of consignments in the Union

52

2.4.2.1.

Notification

53

2.4.2.2.

Measures

53

2.4.2.3.

Incorrect CN codes

54

2.4.3.

Handling of non – compliant consignments

55

2.4.3.1.

Non-compliance detected before release for free circulation

55

2.4.3.2.

Non-compliance detected after release for free circulation

57

2.4.4.

Use of commercial storage facilities (Article 64 of the OCR)

57

2.4.4.1.

Use of commercial storage facilities for identity and physical checks of products of non-animal origin

58

2.4.4.2.

Procedure for the use of commercial storage facilities for competent authorities at the BCP

59

2.4.4.3.

Listing of commercial storage facilities and registration in TRACES-NT

59

2.5.

CHAPTER VI – Financing of official controls and of other official activities (Articles 78 to 85 of the OCR)

62

2.5.1.

Financing - general rules

62

2.5.2.

Mandatory fees or charges

62

2.5.3.

Other fees or charges (not mandatory)

62

2.5.4.

Level of costs and methods of calculation of mandatory fees or charges

63

2.5.5.

Transparency

65

2.6.

CHAPTER VII – Official certification (Articles 86 – 91 of the OCR)

66

2.6.1.

Official certification

66

2.6.2.

Official certificate

68

2.6.3.

Official attestation

69

2.6.4.

Certifying officer

70

3

TITLE III - REFERENCE LABORATORIES AND REFERENCE CENTRES

70

3.1.

Designation and scope of mission

71

3.1.1.

EU reference laboratories and EU reference centres (Articles 92 to 99 of the OCR)

71

3.1.2.

National reference laboratories (Articles 100 to 101 of the OCR)

71

3.2.

Accreditation

72

3.2.1.

EURLs (Article 93 of the OCR) and NRLs (Article 100 of the OCR)

72

3.2.2.

EURCs (Articles 95 to 98 of the OCR)

72

3.3.

Publishing and notifying obligations

73

3.3.1.

List of NRLs

73

3.3.2.

Lists of EURLs and EURCs

73

3.3.3.

Data Privacy

73

3.4.

Reporting and Commission controls

73

3.4.1.

EURLs and EURCs

73

3.4.2.

NRLs

73

3.4.2.1.

NRLs: Inter-laboratory comparative tests and proficiency tests

74

4

TITLE VII – ENFORCEMENT ACTION

74

4.1.

CHAPTER I – Actions by the competent authorities and penalties

74

4.1.1.

Reporting of infringements (Article 140 of the OCR)

74

4.1.1.1

Material scope: type of infringements that can be reported

75

4.1.1.2

Reporting mechanisms

76

4.1.1.3

Written procedures

77

4.1.1.4

Contact persons, receipt and handling of reports

77

4.1.1.5

Personal data protection

77

4.1.1.6

Anonymous reporting

78

4.1.1.7

Protection against retaliation

79

ABBREVIATIONS

BCP	Border control post: As defined in point 38 of Article 3 of Regulation (EU) 2017/625
CA	Competent Authority: As defined in point 3 of Article 3 of Regulation (EU) 2017/625 of the European Parliament and of the Council (1).
CHED	Common health entry document: As referred to in Article 56 of Regulation (EU) 2017/625.
CN	Combined Nomenclature
COI	Certificate of Inspection: As referred to in Articles 4 and 5 of Commission Delegated Regulation (EU) 2021/2306 (2)
EU CSW-CERTEX	The electronic European Union Customs Single Window Certificates Exchange System: As defined in Article 4 of Regulation (EU) 2022/2399 (3)
EURC	European Union reference centre
EURL	European Union reference laboratory
HACCP	Hazard analysis and critical control points: As referred to in Article 5 of Regulation (EC) No 852/2004 (4).
IMSOC	Information Management System for Official Controls: Article 131 of Regulation (EU) 2017/625.
iRASFF	The electronic system implementing the RASFF System: As defined in Article 2(7) of Commission Implementing Regulation (EU) 2019/1715 (5) (IMSOC Regulation).
NRL	National reference laboratory
OC	Official control(s)
OCR	Official Controls Regulation: Regulation (EU) 2017/625
OIE	Office international des epizooties – World Organisation for Animal Health
OOA	Other official activity
OV	Official Veterinarian: As defined in point 32 of Article 3 of Regulation (EU) 2017/625.
RASFF	Rapid Alert System for Food and Feed: As defined in Article 2(9) of Commission Implementing Regulation (EU) 2019/1715
TRACES TRACES-NT	TRACES (Trade Control Expert System) New Technology: The computerised system referred to in Article 133(4) of Regulation (EU) 2017/625 for the purposes of exchanging data, information and documents.

INTRODUCTION

Agri-food chain legislation aims to prevent risks and to promote certain aspects of quality of production of animals and goods, both for commodities entering the European Union and those already on the market. Member States have to put in place control systems, which verify operators’ compliance with the requirements set out in agri-food chain legislation.

Regulation (EU) 2017/625 on official controls and other official activities performed to ensure the application of food and feed law, rules on animal health and welfare, plant health and plant protection products (Official Controls Regulation – OCR) represents a harmonised framework for the performance of such official controls and activities along the entire agri-food chain.

Since the date of application of the OCR, Member States have asked the Commission at numerous occasions to provide clarifications and advice on the practical application of certain OCR provisions, as well as provisions laid down in implementing or delegated acts adopted on the basis of the OCR. The purpose of this Notice is to compile the Commission’s views with regard to the most requested provisions in order to contribute to a harmonised understanding and application of these provisions by Member States’ competent authorities and stakeholders.

A first set of clarifications has been published in ‘Commission Notice 2022/C 467/02 on the implementation of Regulation (EU) 2017/625 (Official Controls Regulation)’ of 8 December 2022. Since then, the Commission has continued discussions with Member States and stakeholders in relation to other OCR provisions. The current document is a revision of the first Commission Notice that adds new elements of clarification, while the elements of the earlier Notice remain unchanged.

This Notice is without prejudice to the exclusive competence of the Court of Justice of the European Union to authoritatively interpret Union law.

1.   TITLE I - SUBJECT-MATTER, SCOPE AND DEFINITIONS

1.1.   Official Controls and Other Official Activities (Article 2 of the OCR)

Article 2 of the OCR defines and makes a distinction between ‘official controls’ or ‘other official activities’ carried out by competent authorities designated in accordance with Article 4 of the OCR:

Article 2 of the OCR Official controls and other official activities 1. For the purposes of this Regulation, ‘official controls’ means activities performed by the competent authorities, or by the delegated bodies or the natural persons to which certain official control tasks have been delegated in accordance with this Regulation, in order to verify: (a) compliance by the operators with this Regulation and with the rules referred to in Article 1(2); and (b) that animals or goods meet the requirements laid down in the rules referred to in Article 1(2), including for the issuance of an official certificate or official attestation. 2. For the purposes of this Regulation, ‘other official activities’ means activities, other than official controls, which are performed by the competent authorities, or by the delegated bodies or the natural persons to which certain other official activities have been delegated in accordance with this Regulation, and with the rules referred to in Article 1(2), including activities aimed at verifying the presence of animal diseases or pests of plants, preventing or containing the spread of such animal diseases or pests of plants, eradicating those animal diseases or pests of plants, granting authorisations or approvals, and issuing official certificates or official attestations.

Further clarifications on ‘other official activities’ are provided in recital 25 of the OCR:

Recital 25 of the OCR Union agri-food chain legislation entrusts additionally the competent authorities of the Member States with specialised tasks to be carried out for the protection of animal health, plant health and animal welfare and for the protection of the environment in relation to GMOs and plant protection products. Those tasks are the public interest activities which the competent authorities of the Member States are required to carry out for the purpose of eliminating, containing or reducing any hazard which may arise for human, animal or plant health, animal welfare or also for the environment. Those other official activities, which include the granting of authorisations or approvals, the epidemiological surveillance and monitoring, eradication and containment of diseases or pests, as well as the issuance of official certificates or attestations, are governed by the same sectoral rules which are enforced through the official controls and therefore by this Regulation.

This distinction is important, because different rules and conditions apply, depending on whether an activity is an ‘official control’ or an ‘other official activity’. In particular, Article 1(5) of the OCR specifies which provisions of the OCR also apply to other official activities and, as a corollary, which provisions only apply to official controls. For example, while operators are entitled to a second expert opinion with regard to the sampling, analysis, test or diagnosis carried out on their animals or goods in the context of official controls (Article 35 of the OCR), this right does not extend to the sampling, analysis, test or diagnosis of animals or goods in the context of other official activities. The distinction between official controls and other official activities is also relevant in relation to the calculation of mandatory fees and charges in accordance with Article 79 of the OCR because that provision only applies to official controls and not to other official activities (see also 2.5. CHAPTER VI – Financing of official controls and of other official activities (Articles 78 to 85 of the OCR) below).

As stated in Article 2 of the OCR, both ‘official controls’ and ‘other official activities’ are carried out by a ‘competent authority’, ‘delegated body’  (6) or a natural person to which certain official control tasks or other official activities have been delegated in accordance with the OCR. Article 2(1) of the OCR defines that ‘official controls’ are performed for the purpose of verifying compliance by operators or by animals or goods (7) with the OCR and/or the rules referred to in Article 1(2) thereof. This definition implies three characteristics that an activity must fulfil at the same time in order to be regarded as an ‘official control’ in the meaning of the OCR:

Its purpose is

(i)	the verification of compliance,

(ii)	by operators or by animals or goods,

(iii)

with the OCR and/or the rules referred to in Article 1(2) thereof.

For example, with regard to point (i) above, while the verification of compliance with the rules referred to in Article 1(2) of the OCR for the purpose of issuing an official certificate or official attestation is an ‘official control’, the issuance of a certificate (on the basis of an official control performed prior to the issuance) is not itself carried out ‘in order to verify compliance’ and is therefore an ‘other official activity’.

With regard to point (ii) above, for example, the verification of compliance of the competent authority with OCR rules would not be considered an ‘official control’, because the ‘competent authority’ in the meaning of Article 3(3) of the OCR is not an ‘operator’ in the meaning of Article 3(29) of that Regulation. By analogy, verifications of compliance of official laboratories or delegated bodies with obligations established in the OCR would be considered ‘other official activities’. However, it is not excluded that the rules referred to in Article 1(2) of the OCR establish obligations for those entities and, in that case, those entities could qualify as ‘operators’, and verifications of compliance with such rules could therefore qualify as ‘official controls’.

With regard to point (iii) above, for example, checks of compliance with rules other than the OCR and the agri-food chain legislation referred to in Article 1(2) of the OCR would be considered neither ‘official controls’ nor ‘other official activities’ within the meaning of the Article 2 of the OCR.

In general, all the steps necessary to complete an activity should be considered part of that activity. This includes documentation steps, such as writing official control reports or recording the outcome of an activity in electronic systems (e.g., finalizing and signing a CHED). By contrast, for example, the issuance of an official certificate is a separate activity that results in the production of a document with legal effect, which is based on the outcomes of a finalised and documented official control but is itself not part of the official control. Some other examples of ‘other official activities’, in line with the views expressed by the Member States during the drafting of the OCR and during the discussions in the Council, are:

—	management of lists of registered/approved operators;

—	guidance/advice to operators on Union agri-food chain legislation and its implementation;

—	surveys on the presence of pests of plants;

—	surveillance for the detection of animal diseases;

—	epidemiological investigations of food-borne outbreaks;

—	notification of animal diseases or pests of plants;

—	eradication and containment of animal diseases or pests of plants;

Where an established non-compliance gives rise to the suspicion of further non-compliances (Article 137(2) of the OCR), or elicits investigations aimed at determining the extent or origin of the non-compliance or the responsibility of the operator (Article 138(1)(a) of the OCR), such activities are itself aimed at verifying compliance and should therefore be considered ‘official controls’.

Some activities may be either official controls or other official activities, depending on their purpose. For example, the verification of the presence of a disease in the context of an eradication programme qualifies as an ‘other official activity’ in accordance with Article 2(2) of the OCR, while the verification of the presence of the same disease can be an ‘official control’, if it is performed in order to verify compliance with the rules referred to in Article 1(2) of the OCR. In particular, some of the methods and techniques for official controls mentioned in Article 14 of the OCR are equally used during surveillance and epidemiological investigations (e.g., examination of documents and traceability records, interviews, sampling, analysis, diagnosis and tests, etc.). For those activities, if necessary, a differentiation between the two contexts can be made based on the characteristics described above.

Some practical examples of ‘official controls’ and ‘other official activities’ are included in Table 1 below.

Table 1

Examples of official controls (OC) and other official activities (OOA)

	Activity	OC	OOA	Comment / reasoning
1	Checking the list of prior notifications of consignments entering the Union for the planning of border controls		OOA	Preparation prior to performance of official controls
2	Establishing an eradication program		OOA	Eradication and containment of diseases or pests (cf. recital 25 of the OCR)
3	Making use of the results of surveillance conducted by operators		OOA	Data analysis informing/assisting preparation of official controls, not itself verification of compliance
4	Drafting of written procedures for the performance of official controls		OOA	Preparation/assistance prior to official controls
5	Checking records of transit consignments	OC		Verification of compliance (with Article 19(e) of Commission Delegated Regulation (EU) 2019/2124 (8))
6	Taking samples of consignments entering the Union according to TRACES-NT	OC		Verification of compliance with the rules referred to in Article 1(2) of the OCR
7	Carrying out checks on animals and goods entering the Union.	OC		Verification of compliance with the rules referred to in Article 1(2) of the OCR
8	Checking whether a CHED has been correctly filled in by the operator	OC		Verification of compliance with the rules referred to in Article 1(2) of the OCR
9	Sampling and analysis of a consignment at a Border Control Post	OC		Verification of compliance with the rules referred to in Article 1(2) of the OCR
10	Sampling and analysis of a consignment at the place of destination after cross-border trade	OC		Verification of compliance with the rules referred to in Article 1(2) of the OCR
11	Check if the movement restrictions have been complied with by an operator	OC		Verification of compliance with the rules referred to in Article 1(2) of the OCR
12	Sampling and analysis of a consignment in a quarantine establishment, as required by Union rules	OC		Verification of compliance with the rules referred to in Article 1(2) of the OCR
13	Sampling and analysis for an emerging disease		OOA	Epidemiological surveillance; cf. OCR recital 25
14	Sampling of wild animals to survey for a listed disease		OOA	Surveillance programme to verify presence of disease; cf. OCR recital 25
15	Checking if an operator complies with specific requirements prescribed by an eradication programme for a listed disease	OC		Verification of compliance with the rules referred to in Article 1(2) of the OCR
16	Assistance to an operator on biosecurity measures to prevent the spread of listed diseases, provided by the competent authorities, or by the delegated bodies or the natural persons to which certain other official activities have been delegated in accordance with the OCR and with the rules referred to in Article 1(2) of the OCR		OOA	Assistance, not verification of compliance with the rules referred to in Article 1(2) of the OCR
17	Checking production data to verify if the operator notifies abnormal mortalities, significant decreased production rates with undetermined cause or suspicions of certain listed diseases etc. as required by Union rules	OC		Verification of compliance with the rules referred to in Article 1(2) of the OCR
18	Sampling and analysis to maintain status of a Member State, zone or establishment as free from a listed disease/pest		OOA	Surveillance programme to verify presence of disease
19	Carrying out risk-based surveys to check for the presence of pests		OOA	cf. Article 2(2) and recital 25 of the OCR
20	Assessing compliance of organic food and feed products prior to placing on the market	OC		Verification of compliance with the rules referred to in Article 1(2) of the OCR
21	Verification of compliance with Maximum Residue Levels	OC		Verification of compliance with the rules referred to in Article 1(2) of the OCR
22	Epidemiological investigation to determine the extent of the spread of a disease		OOA	cf. Article 2(2) and recital 25 of the OCR
23	Regular or risk-based controls in an approved establishment to check if the operator continues to comply with the approval requirements	OC		Verification of compliance with the rules referred to in Article 1(2) of the OCR
24	Actions (e.g., inspection, documentary scrutiny etc.) in relation to an establishment which applied for approval as required by Union rules (e.g., an assembly centre, an aquaculture establishment, a germinal product establishment)	OC		Verification of compliance with the rules referred to in Article 1(2) of the OCR
25	Auditing of slaughterhouses/cutting plants for good hygiene practices and procedures based on the HACCP principles	OC		Verification of compliance with rules referred to in Article 1(2) of the OCR
26	Verifying (including sampling and analysis) if the necessary investigations into abnormal mortalities or significantly decreased production are duly done by a private veterinarian in accordance with Article 18(1)(c) of Regulation (EU) 2016/429 (9)	OC		Verification of compliance of operators and private veterinarians with the rules referred to in Article 1(2) of the OCR
27	Verifying compliance with the rules referred to in Article 1(2) of the OCR of animals and goods entering the Union	OC		Verification of compliance with the rules referred to in Article 1(2) of the OCR
28	Taking a decision and signing the CHED	OC		Part of finalization of official control
29	Inserting the results of checks on animals and goods entering the Union in TRACES-NT	OC		Part of finalization of official control
30	Issuing a permit for the entry into the Union of animals, including permits on the basis of entry rules that are not fully harmonised at Union level		OOA	Activity based on the outcomes of official controls (in analogy to the issuance of an official certificate or attestation (Article 2(2) of the OCR). Article 1(2) of the OCR refers to rules established both at Union and at national level.
31	Sampling and analysis done to check the compliance of an animal/consignment with requirements to be certified for cross-border trade	OC		Verification of compliance with the rules referred to in Article 1(2) of the OCR
32	Checks performed by competent authorities or delegated bodies/persons on lots of plants or plant products for the presence of Union quarantine pests or regulated non-quarantine pests for the purpose of issuing a phytosanitary certificate	OC		Verification of compliance with the rules referred to in Article 1(2)(g) of the OCR
33	Checks performed by competent authorities or delegated bodies/persons on lots of plants or plant products for the presence of Union quarantine pests or regulated non-quarantine pests for the purpose of issuing a plant passport	OC		Verification of compliance with the rules referred to in Article 1(2)(g) of the OCR
34	Checks performed by competent authorities or delegated bodies/persons on lots of plants or plant products for the presence of Union quarantine pests or regulated non-quarantine pests	OC		Verification of compliance with the rules referred to in Article 1(2) of the OCR
35	Issuance of a phytosanitary certificate or plant passport		OOA	Activity based on the outcome of an official control
36	Survey activities intended for detecting the presence of plant pests.		OOA	Activity not directly aimed at verification of compliance with the rules referred to in Article 1(2) of the OCR
37	Sampling and analyses performed in the context of surveys for the presence of Union quarantine pests		OOA	Epidemiological surveillance and monitoring; cf. OCR recital 25
38	Ordering the disposal of animal by-products after an outbreak to contain the spread of animal diseases		OOA	Containing the spread of animal diseases (cf. Article 2(2) of the OCR)
39	Ordering movement restrictions as part of an eradication programme or due to a certain established status (infected, free etc.)		OOA	Eradicating animal diseases (cf. Article 2(2) of the OCR)
40	Ordering movement restrictions due to an epidemic outbreak		OOA	Containing the spread of animal diseases (cf. Article 2(2) of the OCR)
41	Culling of animals in the context of an eradication programme		OOA	Eradicating animal diseases (cf. Article 2(2) of the OCR)
42	Notification of the presence of a listed disease (via ADNS, to OIE, to trading countries etc.)		OOA	Activity following official control (or following other official activity)
43	Informing the public about certain risks (e.g., an epidemic disease, nature thereof, measures taken etc.)		OOA	Informing, not verifying compliance
44	Issuing approval of an establishment		OOA	Activity following verification of compliance (Article 148 of the OCR); cf. recital 25
45	Checks in an EU establishment to verify compliance with export requirements that are laid down in the rules referred to in Article 1(2) of the OCR	OC		Verification of compliance with rules referred to in Article 1(2) of the OCR
46	Investigatory actions to determine the extent of a non-compliance	OC		Article 138(1) of the OCR; verification of compliance with the rules referred to in Article 1(2) of the OCR;
47	Verification of compliance with the rules referred to in Article 1(2) of the OCR for the purpose of issuing an official certificate or official attestation	OC		Verification of compliance with the rules referred to in Article 1(2) of the OCR (cf. Article 2(1)(b) of the OCR)
48	Issuance of an official certificate or an official attestation on the basis of the outcomes of official controls		OOA	Activity based on completed official control (cf. Article 2(2) of the OCR)
49	Preparing inspection/audit/laboratory report (outcome of official control)	OC		Integral part of official control activity
50	Monitoring of contaminants in food or feed (10) performed in order to verify compliance with a regulatory level established by Union or national rules, or to verify compliance of an operator with mitigation measures established by Union or national rules	OC		Activity aimed at verification of compliance with the rules referred to in Article 1(2) of the OCR
51	Monitoring of contaminants in food or feed for which no regulatory level has been established, performed in order to verify the presence of contaminants in food or feed or with the objective to collect data in accordance with Article 33 of Regulation (EC) No 178/2002 of the European Parliament and of the Council (11)		OOA	Non-targeted monitoring activity not aimed at verifying compliance with the rules referred to in Article 1(2) of the OCR

1.2.   The official veterinarian (Article 3 of the OCR)

Article 3 of the OCR Definitions For the purposes of this Regulation, the following definitions apply: [..] (32) ‘official veterinarian’ means a veterinarian appointed by a competent authority, either as staff or otherwise, and appropriately qualified to perform official controls and other official activities in accordance with this Regulation and the relevant rules referred to in Article 1(2); (49) ‘official auxiliary’ means a representative of the competent authorities trained in accordance with the requirements established under Article 18 and employed to perform certain official control tasks or certain tasks related to other official activities; [..]

As mentioned in recital 44 of the OCR, the performance of certain official controls requires the use of the specific skills of official veterinarians to ensure a sound outcome, without this requirement limiting their work solely to those types of official controls.

It follows from the definition of Article 3(32) of the OCR, that official veterinarians can be staff of the competent authorities, or otherwise. To the latter category could belong a veterinarian from the private sector, therefore the appointment of an official veterinarian is not necessarily linked to an employment contract as staff of the competent authority.

Article 5(2) of the OCR specifies that the competent authorities appoint official veterinarians in writing and that this appointment includes a description of the specific official controls and other official activities and related tasks that they are going to perform. Rules on the delegation of tasks laid down in Articles 28 to31 of the OCR are unrelated to this appointment, as the notion of delegation is not appropriate in this case where the legislation specifically attributes certain control tasks to the official veterinarian.

The OCR stipulates the role of official veterinarians in two separate Chapters of Title II:

(a)

Regarding the production of products of animal origin intended for human consumption, in Articles 17 and 18 (Chapter II) on official controls, the OCR establishes among others, a framework on the types of cooperation between the official veterinarian and the official auxiliary during the performance of certain official control tasks and on the terms for the contribution of slaughterhouse staff to the official control tasks.

(b)

Regarding consignments referred to in Article 47(1) which are subject to official controls at the border control posts upon entry into the Union, Articles 49 and 55 (Chapter V) differentiate animals and goods as regards the role of the official veterinarian. More specifically, the OCR distinguishes animals and goods as to whether the official veterinarians must carry out the physical checks and make the relevant decisions on consignments’ compliance with rules referred to in Article 1(2), in person, or whether trained staff can substitute them. This distinction is illustrated in Figure 1.

Figure 1

Role of the official veterinarian and of specifically trained and designated staff on physical checks and decisions made on animals and goods entering the Union, under Articles 49 and 55 of the OCR

It results from Article 5(2) of the OCR, that the requirements applied to the staff of the competent authorities are also imposed to all appointed official veterinarians. At this point, OCR underlines the importance of freedom from any conflict of interest for official veterinarians. To ensure this absence of conflict of interest, competent authorities are required to have procedures or arrangements in place according to Article 5(1)(c) of the OCR.

Article 5(1), (4) and (5) of the OCR apply to all official veterinarians. The same stands for requirements of Article 8 of the OCR on confidentiality and requirements of Article 91(3) on impartiality and freedom of conflict of interest, which in this case, refers to the supervision of the issuance of the official attestation by the official veterinarian.

The obligation of the competent authorities to perform official controls based on documented procedures, as provided for in Article 12 of the OCR, also applies to official veterinarians. Operators are to assist and cooperate with official veterinarians when they perform official controls or tasks related to other official activities, according to the provisions of Article 15(6) of the OCR.

As regards training, the official veterinarians are subject to general training requirements of Article 5(4) of the OCR, training for the issuance of official attestations referred to in Article 91(3) of the OCR and training provided by the European reference centres for animal welfare referred to in Article 96(e) of the OCR.

In relation to products of animal origin intended for human consumption, Articles 13 and 14 of and Annex II to Commission Delegated Regulation (EU) 2019/624 (12) list the training requirements for the official veterinarian, official auxiliary, slaughterhouse staff and staff designated by competent authorities to perform official controls in cutting plants.

Staff assisting the official veterinarian in performing physical checks or performing physical checks at the BCPs for animals and products laid down in Article 49(2) of the OCR, is subject to the specific training requirements laid down in Commission Delegated Regulation (EU) 2019/1081 (13).

2.   TITLE II - OFFICIAL CONTROLS AND OTHER OFFICIAL ACTIVITIES IN MEMBER STATES

2.1.   CHAPTER II – Official controls

2.1.1.    Official controls of e-commerce

Member States have the general obligation to establish a system of risk-based official controls (Article 9 of the OCR). To the extent necessary to ascertain compliance with the rules referred to in Article 1(2) of the OCR, competent authorities have to perform official controls on ‘animals and goods at any stage of production, processing, distribution and use’; ‘substances, materials or other objects which may influence the characteristics or health of animals and goods and their compliance with applicable requirements, at any stage of production, processing, distribution and use’; and ‘operators as regards activities, including the keeping of animals, equipment, means of transport, premises and other places under their control and their surroundings and on related documentation’ (Article 10(1) of the OCR). The official controls may therefore concern animals and goods offered for sale by means of distance communication and operators as regards activities undertaken by means of distance communication.

‘ Means of distance communication ’ (referred to in Article 15(5) and Article 36 of the OCR) may be understood as including the internet, but also other mechanisms of distance ordering, such as by mail or phone from a catalogue. However, e-commerce activities, in particular online sales of agri-food products, are the most relevant in terms of volume and exposure to citizens to be considered for the purposes of official controls.

E-commerce activities in the agri-food sector may include:

—	business-to-consumer and business-to-business sales;

—	online product presentation and information;

—	operations using both stationary and online channels as well as online-only channels;

—	different modes of purchase for online goods (e.g., payment online or upon delivery/pick-up);

—	activities involving digital service providers, including online marketplaces and platforms;

—	online-specific business models, such as ‘virtual restaurants’ (i.e., food preparation facilities operating solely for delivery or takeaway orders placed on websites, apps or platforms);

—	cross-border sales, including imports from operators located in third countries directly to EU citizens.

In general, competent authorities are to perform regular, risk-based controls on operators and on animals or goods at any stage of production, processing, distribution and use in accordance with Articles 9 and 10 of the OCR. This requirement applies in the same way to e-commerce activities as to conventional activities.

2.1.1.1.   Registration of e-commerce operators

Article 10(2) of the OCR requires competent authorities to keep up-to-date lists of operators (see also section 2.1.2). For this purpose, Article 15(5) of the OCR requires operators to provide competent authorities with updated information regarding their name and legal form as well as the activities carried out, ‘ including activities undertaken by means of distance communication, and the places under their control’. It should contain specific information about all the channels of distance communication used by the operator, including whether the operator makes use of intermediary services such as social networks and online market places, and should enable competent authorities to perform official controls on operators’ ‘ activities, including the keeping of animals, equipment, means of transport, premises and other places under their control and their surroundings and on related documentation ’ in accordance with Article 10(1)(c) of the OCR.

Operators established in one Member State may operate websites that target customers in another Member State (e.g., by using the language of the other Member State and/or offering delivery options).

Online search strategies used by Member States to identify websites or goods sold online usually also reveal operators established outside their jurisdiction. Member States may use the mechanisms of administrative assistance and cooperation (Articles 102 to 108 of the OCR) to inform each other of cross-border activities of operators.

Operators in third countries may be subject to specific requirements for registration or authorisation laid down in the rules referred to in Article 1(2) of the OCR, depending on their activities and the categories of goods exported to the EU.

2.1.1.2.   Sampling and analysis of animals and goods sold online

Competent authorities may perform samplings and analyses to verify compliance during risk-based controls of animals and goods in accordance with Article 14(h) of the OCR. This may concern animals and goods offered online. Samples may be taken during the inspection of premises of operators offering products online. Another effective way of sampling (in particular in cross-border situations) is to order goods online and to take samples of those goods upon delivery. For this purpose, and in order to be able to perform official controls without prior notice in accordance with Article 9(4) of the OCR, competent authorities may have to conceal their identity during the ordering process. Article 36 of the OCR provides the legal basis for competent authorities to use animals and goods ordered online (or by other means of distance communication) without identifying themselves as samples for the purposes of official controls. Competent authorities, once they are in possession of the samples, are to inform operators that goods have been ordered for the purposes of official sampling and/or analysis (Article 36(2)(a) of the OCR). Operators whose animals and goods are subject to sampling and analysis have the right to a second expert opinion (see more details in Chapter 2.3.2 on Article 35 of the OCR).

2.1.1.3.   Action in the event of non-compliance and risk

The responsibility to enforce Union agri-food chain legislation lies with Member States (recital 15 of the OCR), whose competent authorities take action in accordance with Articles 137 and 138 of the OCR. Where non-compliances of animals and goods offered or sold online are found or suspected that have relevance for other Member States, or the responsible operator is located in another Member State, the mechanisms for administrative assistance and cooperation laid down in Articles 102 to 108 of the OCR and implemented in the IT system iRASFF as a component of the Information Management System for Official Controls (IMSOC) are to be used, in order to allow for efficient and consistent enforcement action across all Member States.

Where non-compliant goods offered or sold online are found to present a health risk within the meaning of Article 50 of Regulation (EC) No 178/2002, the RASFF procedure implemented in the iRASFF system should be used accordingly.

The Commission will inform third countries that do not have access to the iRASFF or TRACES systems about products that are subject to RASFF notifications (alert, information or border rejection notification) originating in or distributed to those third countries; in the case of non-compliance notifications and food fraud notifications, the Commission may inform concerned third countries that do not have access to iRASFF or TRACES (Article 27 of Implementing Regulation (EU) 2019/1715).

Further information on the practical use of iRASFF to notify products offered online can be found in the RASFF Standard Operating Procedures (14).

2.1.1.4.   Digital service providers

Regulation (EU) 2022/2065 (15) (Digital Services Act - DSA) already applies to online platforms and online search engines designated by the Commission as very large online platforms and very large online search engines (16). It applies to all intermediary service providers active in the Union from 17 February 2024. The DSA lays down rules regarding the exemption from liability of and diligence obligations imposed upon intermediary service providers.

Article 3(g) of the DSA defines different categories of intermediary services, of which ‘ hosting ’ is the most relevant from a product safety and compliance point of view. Hosting is a service whereby a service provider stores on its server information provided by the user of the service, i.e., an independent third party. An ‘online platform’ service is a specific sub-category of hosting that includes services where the information stored is, in addition, disseminated to the public at the request of the user of the service, such as online social networks or online platforms allowing consumers to conclude distance contracts with traders.

Intermediary service providers carrying out hosting activities have no general obligation to monitor the use of their services for illegal activity and are conditionally exempted of liability for illegal content provided by third parties using their services. The notion of illegal content in this context also covers the offer of unsafe and/or non-compliant goods.

The liability exemption is not absolute. According to Article 6(1) of the DSA, it only applies under the condition that the service provider:

(a)	does not have actual knowledge of illegal activity or illegal content and, as regards claims for damages, is not aware of facts or circumstances from which the illegal activity or illegal content is apparent; or

(b)	upon obtaining such knowledge or awareness, acts expeditiously to remove or to disable access to the illegal content.

Therefore, in order to benefit from the liability exemption laid down in Article 6 of the DSA, hosting service providers must act upon obtaining specific information on illegal activity or content, obtained either as a result of voluntary own-initiative investigations (17) or obtained through notification by external individuals or entities. In accordance with Article 16 of the DSA, hosting service providers must put mechanisms in place that allow any individual or entity to notify them of the presence on their service of specific items of information that the individual or entity considers to be illegal content (‘notice and action mechanisms’).

Furthermore, providers of online platforms that allow consumers to conclude distance contracts with traders are obliged to implement ‘compliance by design’. This means that they should ensure that their ‘ online interface is designed in a way that enables traders to comply with their obligations regarding pre-contractual information, compliance and product safety information under applicable Union law ’ (Article 31(1) of the DSA).

In addition, and in any case, Articles 9 and 10 of the DSA require providers of intermediary services to inform without undue delay the relevant authorities of any effect given to any order to act against illegal content or to provide information, adopted by the relevant national judicial or administrative authorities on the basis of the applicable Union law or national law in compliance with Union law. For this purpose, Article 11 of that Regulation requires providers of intermediary services to designate a single point of contact for the communication with Member States’ authorities, the Commission and the European Board for Digital Services (Article 61 of the DSA).

2.1.1.5.   E-commerce control strategies – best practices

Based on the above and on experiences in the Member States, the following measures should be considered as best practices for e-commerce controls:

(i)	Official controls by competent authorities of Member States should be supported by conducting web searches to identify online sellers located in the Member State’s territory that are not yet known to competent authorities, with the aim of subjecting them to risk-based controls.

(ii)	Web searches should also be used to identify online offers of goods that have been identified during official controls as non-compliant or presenting a risk, or where there is a suspicion of non-compliance, including goods notified in the iRASFF system.

(iii)

Control of e-commerce activities should include the control of websites and their compliance with product information requirements. For example, online offers of food are to comply with food information requirements laid down in Regulation (EU) No 1169/2011 (18). According to Article 1 of that Regulation, food information requirements apply to food business operators in all stages of the food chain where their activities concern the provision of food information to consumers, all foods intended for the final consumer, and foods delivered by or supplied to mass caterers. Fair commercial practices must be ensured through the provision of food information, also through advertising, according to Article 7 of Regulation (EU) No 1169/2011.

(iv)	E-commerce controls should be performed using suitable hard- and software to allow for web searches and online purchases without revealing the competent authority’s identity.

(v)

Competent authorities should establish contacts with the contact points of intermediary service providers, as relevant including online social networks, online marketplaces, digital payment service providers and top-level domain name registries to, among others, facilitate the timely removal of online offers of non-compliant or counterfeit goods or identifying operators or users of digital services if necessary for enforcement purposes.

(vi)

For an efficient performance of official controls, competent authorities should be empowered to request information or take appropriate measures with regard to other relevant operators that are not subject to the OCR(this may be the case for some intermediary service providers or financial institutions, for example), or, depending on national administrative structures, should ensure close cooperation with other national authorities which oversee the activities of those other operators.

(vii)

In conformity with their constitutional requirements, Member States may consider establishing central e-commerce control units for the above-mentioned tasks, for reasons of efficiency and harmonisation as regards procedures, equipment, and external contacts.

2.1.2.    Listing of operators (Article 10(2) and (3) of the OCR)

Article 10(2) of the OCR requires competent authorities to keep up-to-date lists of operators. This provision concerns ‘ operators ’ within the meaning of Article 3(29) of the OCR.

Article 10(2) and (3) of the OCR 2. Without prejudice to the rules concerning existing lists or registers established on the basis of the rules referred to in Article 1(2), the competent authorities shall draw up and keep up-to-date a list of operators. Where such a list or register already exists for other purposes, it may also be used for the purposes of this Regulation. 3. The Commission shall adopt delegated acts in accordance with Article 144 to amend this Regulation concerning the setting out of categories of operators to be exempted from the list of operators referred to in paragraph 2 of this Article where their inclusion in such a list would constitute a disproportionate administrative burden for them compared to the risk related to their activities.

Article 3(29) of the OCR: ‘operator’ means any natural or legal person subject to one or more of the obligations provided for in the rules referred to in Article 1(2);

The definition of operators in Article 3(29) of the OCR includes natural persons, if those are subject to one or more of the obligations provided for in the rules referred to in Article 1(2). For example, Article 1 of Regulation (EC) No 178/2002 excludes ‘ domestic preparation, handling or storage of food for private domestic consumption’ from the scope of that Regulation. Therefore, in relation to Regulation (EC) No 178/2002, domestic consumers would not be considered operators within the meaning of Article 3(29) of the OCR and do not need to be included in the lists referred to in Article 10(2) of the OCR.

The requirements for listing and registration of operators in Article 10(2) and (3) of the OCR apply to all the areas referred to in Article 1(2) of the OCR. Where sector-specific rules establish rules for the inclusion or exclusion of certain categories of operators, taking into account the needs in terms of risk management specific to that sector, registers drawn up on the basis of those rules may be used for the purpose of the OCR in accordance with Article 10(2), second sentence, of the OCR.

For example, in the plant health area, Article 65 of Regulation (EU) 2016/2031 (19) requires the competent authorities to keep and update a register containing several categories of professional operators who operate in the territory of the Member State concerned. Thus, under these sector-specific rules, only the registration of professional operators is required. Moreover, Article 65 of Regulation (EU) 2016/2031 lays down certain exemptions from this requirement to draw up a register and empowers the Commission to add further categories of professional operators to be exempted, where registration would constitute an administrative burden for operators disproportionate to the low pest risk related to their professional activities. In line with Article 10(2), second sentence of the OCR, in the area of plant health, the registers of professional operators established pursuant to Article 65 of Regulation (EU) 2016/2031 may also be used for the purposes of the OCR. Similarly, in the organic area, the lists of operators and groups of operators kept in accordance with Article 34(6) of Regulation (EU) 2018/848 (20) may be used for the purposes of the OCR.

TRACES network contact points of the Member States may be required to keep up-to-date lists of certain operators as reference data in the TRACES system in accordance with Article 45 of Commission Implementing Regulation (EU) 2019/1715 (IMSOC Regulation). Such lists may also be used for the purpose of Article 10 of the OCR.

2.1.3.    Methods and techniques for official controls: inspections and audits (Article 14 of the OCR)

2.1.3.1.   Inspections

Article 14 of the OCR lists methods and techniques of official controls that are to be used, as appropriate, by competent authorities to verify compliance of operators and animals or goods with the rules referred to in Article 1(2). Two important techniques listed in that article are ‘ inspections’ and ‘ audits’.

In the context of official controls within the scope of the OCR, the purpose of an inspection is to verify the (current) compliance of an object of inspection with specific requirements laid down in the rules referred to in Article 1(2) of the OCR.

The term ‘ inspection’ is not defined in the OCR and can be understood, by its dictionary meaning, to refer to a close examination of an object, or certain aspects thereof (e.g., equipment, facilities, places, animals, goods, materials, data, activities, processes). An inspection involves mostly direct observations that can be made at a specific moment by the person carrying out the examination. Inspections are often performed with the help of checklists of the specific requirements to be complied with. This understanding of the term is analogous to the definition of ‘ inspection ’ in the international standard ISO/IEC 17000 ‘Conformity assessment – Vocabulary and general principles’.

Elements to be examined, as appropriate, by ‘ inspection ’ as part of official controls are listed in Article 14(b) of the OCR:

Article 14 of the OCR: Official control methods and techniques shall include the following as appropriate: [..] (b) an inspection of: (i) equipment, means of transport, premises and other places under their control and their surroundings; (ii) animals and goods, including semi-finished goods, raw materials, ingredients, processing aids and other products used for the preparation and production of goods or for feeding or treating animals; (iii) cleaning and maintenance products and processes; (iv) traceability, labelling, presentation, advertising and relevant packaging materials including materials intended to come into contact with food;

It is possible that inspections overlap with or additionally involve other methods listed in Article 14 of the OCR. For example, an inspection of the ‘ traceability ’ of an animal or good (Article 14(b)(iv) of the OCR) typically involves the examination of traceability records, as referred to in Article 14(e) of the OCR.

2.1.3.2.   Audits

The term ‘ audit ’ is defined in Article 3(30) of the OCR:

Article 3(30) of the OCR ‘audit’ means a systematic and independent examination to determine whether activities and the related results of such activities comply with planned arrangements and whether these arrangements are applied effectively and are suitable to achieve the objectives;

This definition has three elements:

(i)	compliance with planned arrangements;

(ii)	effective application of those arrangements;

(iii)

suitability of those arrangements to achieve objectives.

Therefore, an audit, as compared to an inspection, goes beyond the verification of compliance with specific requirements; it also examines whether predefined outcomes (objectives) can be achieved.

This definition of an audit is comparable to the definition of audits in international standards such as ISO/IEC 17000 ‘Conformity assessment – Vocabulary and general principles’ and ISO 19011 ‘Guidelines for auditing management systems’.

An audit is typically applied when the subject of controls is an activity such as a procedure or a management system, which needs to be assessed with regard to its suitability to systematically achieve compliant outcomes. An audit therefore requires a broader and systematic assessment of different stages of a process.

When used as a technique during official controls, auditing may involve several or all of the other methods and techniques listed in Article 14 of the OCR, such as the examination of documents or other records, interviews with staff, etc.

Furthermore, some of the elements listed in Article 14 of the OCR may involve auditing as a method, for example:

—	an examination of the controls that operators have put in place and of the results obtained (Article 14(a) of the OCR);

—	an assessment of procedures on good manufacturing practices, good hygiene practices, good farming practices, and of procedures based on the principles of hazard analysis critical control points (HACCP) (Article 14(d) of the OCR).

Although official controls are in general to be performed without prior notice (Article 9(4) of the OCR), audits can often only be performed with prior notice, because of the necessary preparation of the auditor and the audited entity (cf. recital 33 of the OCR).

Apart from the use of auditing in official controls, auditing as a technique is also relevant for the performance of:

—	Internal or external audits on competent authorities (Article 6 of the OCR) (21);

—	Audits organised by the competent authorities of delegated bodies and persons (Article 33(a) of the OCR), official laboratories (Article 39 of the OCR) and of national reference laboratories (Article 100(2) of the OCR);

—	Accreditation assessments by national accreditation bodies, for example, of delegated bodies (Article 29(b)(iv) of the OCR) or official laboratories (Article 37(4)(e) and (5) of the OCR);

—	Commission controls in Member States (Article 116 of the OCR).

2.1.4.    Official controls for the production of products of animal origin for human consumption

Article 17 of the OCR lays down specific definitions applicable in the controls on the production of products of animal origin. The definitions ‘under the responsibility of the official veterinarian’ and ‘under the supervision of the official veterinarian’ specify the type of cooperation between the official veterinarian and the official auxiliary during veterinary controls, as foreseen in the OCR.

In both cases, the official veterinarian assigns an action to the official auxiliary, the difference being that in the case of the supervision, the official veterinarian is present on the premises during the time of the performance of the action by the official auxiliary.

Furthermore, Article 17 defines the activities that fall into the scope of ‘ante-mortem inspection’ and ‘post-mortem inspection’.

Article 18 of the OCR lays down specific requirements for official controls on the production of products of animal origin. In paragraph 2, it presents the framework for the verification of compliance with Union legislation for the production of products of animal origin intended for human consumption and specifies the official controls and the role of the official veterinarian and of the official auxiliary that perform these controls, as illustrated in Figure 2.

Figure 2

Staff performing the official controls for the production of products of animal origin for human consumption, under Article 17 and 18(2), and (4), 18(7) (a), (b), (e) of the OCR  (22)

It should be underlined that, as it results from Article 18(5) of the OCR, when actions are assigned to the official auxiliaries, the responsibility on relevant decisions remains with the official veterinarians, irrespective of their presence at the premises.

In addition, Article 18(3) of the OCR, provides for the possibility of the slaughterhouse staff to:

(a)	assist in the performance of tasks relating to the official controls referred to in Article 18(2) in slaughterhouses of poultry or lagomorphs,

(b)	carry out sampling and testing in slaughterhouses of other species.

As a prerequisite for the participation of the slaughterhouse staff to the official controls, a risk-based analysis of the competent authority must demonstrate that the same level of protection of human health, animal health and welfare is ensured during the performance of these official controls in the slaughterhouse. Moreover, the above possibility exists provided the competent authority ensures that this staff is appropriately trained, acts independently from the production staff of the slaughterhouse and carries out the tasks in the presence and under the instructions of the official veterinarian or auxiliary. Under the same conditions, slaughterhouse staff can also apply the health mark.

Paragraphs 7 and 8 of Article 18 of the OCR form the legal base for the adoption of delegated acts supplementing the OCR and implementing acts providing practical arrangements for the performance of official controls.

The assignment of tasks to the official auxiliary, either under the supervision or the responsibility of the official veterinarian, or to staff designated by the competent authorities, is subject to certain criteria and conditions that are set out in the relevant delegated acts.

More specifically, Delegated Regulation (EU) 2019/624 stipulates the roles of the official veterinarian and the official auxiliary concerning specific control tasks and provides for derogations from the rules of the OCR. Official control tasks reserved exclusively for the official veterinarian by Delegated Regulation (EU) 2019/624, are shown in Figure 3.

Figure 3

Ante-mortem and post-mortem inspections exclusively carried out by the official veterinarian, as provided for in Delegated Regulation (EU) 2019/624

Provisions of Articles 3, 6, 7 and 9 of Delegated Regulation (EU) 2019/624 complement the roles of the official veterinarian and auxiliary concerning ante-mortem and post-mortem inspection and other official controls.

Furthermore, this Regulation introduces the definition of the staff designated by the competent authorities to conduct specific tasks at cutting plants.

Article 2 of Commission Delegated Regulation (EU) 2019/624 Definitions The following definitions shall apply for the purpose of this Regulation: [..] (5) ‘staff designated by the competent authorities’ means a person other than the official auxiliary and the official veterinarian, who is qualified in accordance with this Regulation to act in such a capacity in cutting plants and to whom the competent authorities assign the performance of specific actions;[..]”

According to Article 10 of Delegated Regulation (EU) 2019/624, as a derogation to the provisions of the OCR, in cutting plants, other staff designated by the competent authorities can perform the official controls referred to in Article 18(2)(d) of the OCR including auditing activities. These staff are subject to specific training requirements and to regular checks of their performance.

Commission Implementing Regulation (EU) 2019/627 (23) lays down detailed rules on the performance of official controls on products of animal origin. It contains directions for the tasks of staff participating in these official controls. In the following tables, the tasks in the performance of official controls of products of animal origin have been summarised with reference to the relevant provisions of the OCR, Delegated Regulation (EU) 2019/624 and Implementing Regulation (EU) 2019/627, allowing for a conclusion to be drawn as to the staff permitted to perform each task.

STAFF PERFORMING OFFICIAL CONTROL TASKS FOR THE PRODUCTION OF PRODUCTS OF ANIMAL ORIGIN

Table 2

Tasks performed by the official veterinarian

No	Tasks		OCR	Reg. (EU) 2019/624	Reg. (EU) 2019/627
1	Ante-mortem [definition in Art. 17 (c) OCR]	Ante-mortem inspection of domestic ungulates outside the slaughterhouse in case of emergency slaughter according to Article 4 of Commission Delegated Regulation (EU) 2019/624	Art. 18(7)(c)	Art. 4	-
2		Ante-mortem inspection and checks at the holding of provenance for all species according to Article 5(2)(a), (b) and (c) of Commission Delegated Regulation (EU) 2019/624	Art. 18(7)(d)	Art. 5(2)	-
3		Clinical inspection of isolated animals for more thorough ante-mortem inspection. Ante-mortem inspection of animals suspected of having a disease or condition that may adversely affect human or animal health	Art. 18(2)(a)	Art. 3(3)(b)-(f)	Art. 11(5) Art. 43(4)

No	Tasks		OCR	Reg. (EU) 2019/624	Reg. (EU) 2019/627
4	Post-mortem inspection [definition in Art. 17 (d) OCR]	In the case of the emergency slaughter of the domestic ungulates outside the slaughterhouse in accordance with Chapter VI of Section I of Annex III to Regulation (EC) 853/2004 Examination of the animal health certificate of Chapter 5 of Annex IV of Commission Implementing Regulation (EU) 2020/2235 (24)	Art. 18(2)(c), Art. 18(7)(f)	Art. 8(a)	- Art. 10(3)
5		Inspection of Animals suspected of having a disease or condition that may adversely affect human health	Art. 18(2)(c)	Art. 8(b)	-
6		Inspection of Bovine animals from herds that have not been declared officially free of tuberculosis		Art. 8(c)	-
7		Inspection of Bovine, ovine and caprine animals from herds that have not been declared officially free of brucellosis		Art. 8(d)	-
8		Inspection in the case of an outbreak of animal diseases for which animal health rules are laid down in Union legislation, for animals susceptible to the particular disease in question that come from all areas covered by: — EU emergency measures [certain Cat A: Highly pathogenic avian influenza (HPAI), sheep pox etc.]; — national measures linked to any Cat A disease eradication measures; — additional EU special (additional) disease control measures [certain Cat A: African swine fever (ASF), infection with lumpy skin disease virus (LSD) etc.]; — compulsory approved eradication programmes for Cat B diseases and listed in Annex I-II of Commission Implementing Regulation (EU) 2021/620 (25) [Brucellosis and Mycobacterium tuberculosis complex (MTBC)]		Art. 8(e)	-
9	Post-mortem inspection	Inspection when stricter controls are necessary to take account of emerging diseases or particular diseases listed by the World Organisation for Animal Health		Art. 8(f)	-
10		Post-mortem inspection delayed by no more than 24 hours from slaughter or arrival at the game handling establishment, in low-capacity slaughterhouses or low-capacity game handling establishments in accordance with Article 13 of Commission Implementing Regulation (EU) 2019/627		Art. 8(g)	Art. 13
11		Performance of the additional post-mortem inspection procedures referred to in Articles 18(3), 19(2), 20(2), 21(2), 22(2) and 23(2) of Commission Implementing Regulation (EU) 2019/627 using incision and palpation of the carcase and offal where there is a possible risk in relation to cases referred to in Article 8 of Commission Delegated Regulation (EU) 2019/624		Art. 8	Art. 24
12	Declaration of meat unfit for human consumption	Non-compliance with requirements for fresh meat	Art.18(5)	-	Art.45
13		Meat infected with cysticerci or trichinae		-	Art. 30, 31
14		Meat of solipeds in which glanders have been diagnosed		-	Art. 32(3)
15		Where animals have reacted positively or inconclusively to tuberculin or there are other grounds for suspecting infection		-	Art. 33
16		Where animals have reacted positively or inconclusively to a brucellosis test or there are other grounds for suspecting infection		-	Art. 34
17	Other	Verification of compliance of performance of the official auxiliary carrying out ante-mortem tasks under the supervision or responsibility of the official veterinarian	-	Art. 3(1)(c) and (2)(c)	-
18		Verification of compliance of performance of food business operators carrying out slaughter and bleeding of farmed game at the holding of provenance	-	Art. 6(4)(b)	-
19		Assessment of the operator’s system for the detection and separation of birds with abnormalities, contamination, or defects	-	-	Art. 25(2)(a)
20		Ensuring that additional laboratory testing for the needs of Article 18(2) of the OCR takes place	Art. 18(5)	-	Art. 37(2)

No	Tasks		OCR	Reg. (EU) 2019/624	Reg. (EU) 2019/627
21	Other	Evaluation of the results of official controls carried out in accordance with Article 7 to 38 of Commission Implementing Regulation (EU) 2019/627	Art. 18(5)	-	Art. 39(1)
22		Communication of control results where inspections reveal the presence of any disease or condition that might affect human or animal health or compromise animal welfare		-	Art. 39(2)
23		Verification of compliance with the health requirements for raw milk and colostrum production as laid down in Part I of Chapter I of Section IX of Annex III to Regulation (EC) No 853/2004	-	-	Art. 49(1), (3)

Table 3

Tasks performed by the official veterinarian or by the official auxiliary under the supervision of the OV

No	Tasks		OCR	Reg. (EU) 2019/624	Reg. (EU) 2019/627
1	Ante-mortem [definition in Art. 17 (c) OCR]	Ante-mortem inspection at the slaughterhouse on species other than poultry and lagomorphs (including verification of compliance with rules on animal welfare (26)), regarding food chain information, animal’s identity check and preselection of animals with abnormalities under the conditions defined in Article 3(1) of Commission Delegated Regulation (EU) 2019/624 except for cases referred to in Article 3(3) of that Delegated Regulation	Art. 18(2)(a) Art. 18(7)(a)	Art. 3(1)	Art. 10(1), Art. 11, Art. 38, Art. 40
2		Ante-mortem inspection of poultry and lagomorphs including verification of compliance with rules on animal welfare.	Art. 18(2)(b)	-	Art. 38

No	Tasks		OCR	Reg. (EU) 2019/624	Reg. (EU) 2019/627
3	Post-mortem [definition in Art. 17 (d) OCR] (27)	Examination of certificates of animals slaughtered at the holding of provenance	Art. 18(2)(c)	-	Art. 10(2)
4		Examination of: i. declarations (of the trained person) accompanying large wild game issued in accordance with point 4 (a) of Chapter II of Section IV of Annex III to Regulation (EC) 853/2004; ii. the official certificate of Chapter 2 of Annex II of Commission Implementing Regulation (EU) 2020/2235 for the movement between Member States of unskinned large wild game intended for human consumption.		-	Art. 10(4), Art. 28
5		Post-mortem inspection of carcases and accompanying offal, including specific practical arrangements, laboratory testing and verification of compliance with rules on animal welfare		-	Articles 12,14 (unless not authorised by other specific Articles), 15, 17, 18 (1) & (2), 19(1), 20(1), 21(1), 22(1), 23(1), 25, 26, 27, 28 (1), (2), (3), & (4), 29 (removal from the carcase of specified risk material), 30, 31, 32, 33, 34, 35, 36, 37, 38
6		Performance of the additional post-mortem inspection procedures referred to in Articles 18(3), 19(2), 20(2), 21(2), 22(2) and 23(2) of Commission Implementing Regulation (EU) 2019/627 using incision and palpation of the carcase and offal where there is a possible risk. Additional post-mortem inspection under the supervision of the official veterinarian is not possible in cases referred to in Article 8 of the Delegated Regulation (see Table 2 row 11)		-	Art. 24
7	Other	Official controls in relation to TSEs according to Regulation (EC) No 999/2001 (28), as regards the handling and disposal of specified risk material according to Regulation (EC) No 1069/2009 (29) on animal by products	Art. 18(2)(d)(iv), (v)	-	Art. 29
8		Sampling for analysis and any additional sampling	Art. 18(2)(d)(ii), (iii) and (iv)	-	Art. 35, Art. 36, Art. 37

Table 4

Tasks performed by the official veterinarian or by the official auxiliary under the supervision or the responsibility of the OV

No	Tasks		Art. OCR	Reg. (EU) 2019/624	Reg. (EU) 2019/627
1	Ante-mortem [definition in Art. 17 (c) OCR]	Ante-mortem inspection at the slaughterhouse on all species (including verification of compliance with rules on animal welfare) in case an ante-mortem inspection has already been performed by the official veterinarian at the holding of provenance, under the conditions defined in Article 3(2) of Commission Delegated Regulation (EU) 2019/624 with the exception of cases referred to in Article 3(3) of that Delegated Regulation Examination of model animal health certificate of live animals transported to the slaughterhouse in the case of ante-mortem inspection has taken place at the holding of provenance [Chapter 1 of Annex IV of Commission Implementing Regulation (EU) 2020/2235]	18(2)(a), (b)	3(2) 5(2)(f)	11(6) 10(2) 38
2		Additional checks on animal identification and animal welfare rules at the slaughterhouse following ante-mortem inspection at the holding of provenance according to Article 5(3) and Article 3 of Commission Delegated Regulation (EU) 2019/624		3(2), 5(3)	-
3	Post-mortem [definition in Art. 17 (d) OCR]	Post-mortem inspection of tasks of Table 3 in low-capacity establishments fulfilling the conditions of Article 7 of Commission Delegated Regulation (EU) 2019/624	18(2)(c), 18(7)(e)	7	-
4		Post-mortem inspection of viscera, genital organs and udder as specified in Article 12(1)(c) of Commission Delegated Regulation (EU) 2019/624, of Rangifer tarandus tarandus (reindeer) from areas of Sweden and Finland laid down in Annex I of that Delegated Regulation (30)		12(1)(c)	-

No	Tasks		Art. OCR	Reg. (EU) 2019/624	Reg. (EU) 2019/627
5	Other	Collection of information on sampling and the results of sampling for Salmonella by food business operators of slaughterhouses as provided for in Article 35(1)(b) of Commission Implementing Regulation (EU) 2019/627	18(2)(d)(iii),18(7)(e)	9	35
6		Collection of information for sampling and the results of sampling for Campylobacter by food business operators of slaughterhouses as provided for in Article 36(1)(b) of Commission Implementing Regulation (EU) 2019/627			36
7		Collection of information of official controls as regards good hygiene practices and procedures based on HACCP principles in slaughterhouses and game handling establishments			39
8		Adoption of appropriate measures in cases of non-compliances with animal welfare rules on the protection of animals during transport laid down in Council Regulation (EC) No 1/2005	18(2)(d)(vi)	-	44 (31)
9		Verification of operator’s corrective and preventive actions in cases of non-compliances with rules on the protection of animals at the time of slaughter or killing laid down in Articles 3 to 9 and Articles 14 to 17 and 19 of Regulation (EC) No 1099/2009		-
10		Enforcement actions in cases of non-compliances with animal welfare rules on the protection of animals at the time of killing laid down in Regulation (EC) No 1099/2009		-
11		Communication of identified problems in relation to animal welfare to the competent authorities, where appropriate		-
12		Application of health mark on domestic ungulates, farmed game mammals other than lagomorphs and large wild game (32)	18(4)	-	48

2.2.   CHAPTER III – Delegation of certain tasks of the competent authorities (Articles 28 to 33 of the OCR)

Chapter III of Title II of the OCR lays down, on the one hand, conditions for delegating certain official control tasks (Articles 28 to 30 of the OCR) and, on the other hand, conditions for delegating tasks related to other official activities (Article 31 of the OCR). Article 32 of the OCR lays down rules concerning obligations of the delegated bodies and natural persons. Article 33 of the OCR establishes the obligations of the delegating competent authorities.

Additional rules on the delegation of official control tasks and tasks related to other official activities may be laid down in specific EU rules. For example, in the area of organic production, additional rules on the delegation of official control tasks and tasks related to other official activities to ‘control bodies’ are laid down in Article 40 of Regulation (EU) 2018/848 on organic production and labelling of organic products.

2.2.1.    Conditions for delegating certain official control tasks

Articles 29 and 30 of the OCR lay down conditions for delegating certain official control tasks to delegated bodies and natural persons, respectively.

Competent authorities should grant the delegation of official controls tasks based on on-site controls of the candidate delegated bodies or natural persons. In the case of delegated bodies, the official controls should be performed independently of their accreditation in accordance with Article 29(b)(iv) of the OCR.

Competent authorities that have delegated certain official control tasks to delegated bodies or natural persons must organise audits or inspections of such bodies or persons, as necessary. They must withdraw the delegation fully or partly without delay in the case of non-compliance (Article 33(b) of the OCR).

Therefore, the conditions for delegating certain official control tasks laid down in Articles 29 and 30 of the OCR, and the mechanisms of verification and follow-up measures of non-compliance laid down in Article 33 of the OCR must be understood as a continuous process of monitoring of compliance.

While organising audits and inspections, the competent authorities must consider the outcome of the relevant accreditation audits carried out by the National Accreditation bodies, defined in Article 2(11) of Regulation (EC) No 765/2008 (33) (Article 33(a) of the OCR). In respect of those different types of controls, duplication should be avoided (Article 33(a) of the OCR). Consequently, communication with National Accreditation bodies and coordination regarding the timing of the controls, is necessary.

Rules adopted in Member States that allow a provisional delegation of tasks to delegated bodies not yet accredited in accordance with Article 29(b)(iv) of the OCR, could be considered compatible with the OCR subject to conditions. This is the case if:

i)	such provisional delegation is not excluded by the rules referred to in Article 1(2) of the OCR establishing specific provisions on the delegation of tasks;

ii)	on-site controls show that all other conditions for the delegation established in Article 29 of the OCR are fulfilled (34);

iii)	the provisional delegation is granted for a limited period of time, having regard to the length of the accreditation procedure, the risks in the concerned area and the protection of consumers interests;

iv)	the body applying for delegation proves that it has already applied for the accreditation.

During such provisional delegation, the competent authority must fully or partially withdraw the delegation without delay in the cases referred to in Article 33(b) of the OCR.

For delegated bodies, accreditation in accordance with Article 29, point (b)(iv) of the OCR is of particular importance to ensuring that the impartiality, quality and consistency of official controls are preserved (cf. recital 46 of the OCR).

Competent authorities should consider the relevance of a standard to the delegated tasks to determine its suitability for use by and accreditation of the delegated body according to Article 29(b)(iv) of the OCR. National Accreditation bodies will subsequently assess whether the delegated body operates in accordance with the requirements of the defined standard, in the context of accreditation.

Member States should ensure consistency across competent authorities when identifying the relevant standard for the delegation of a given control task.

EN ISO/IEC 17020 ‘Requirements for the operation of various types of bodies performing inspection’, is one of the relevant standards that has to be used for the operation and accreditation of delegated bodies, according to the OCR. This is the reference standard for inspection tasks unless another standard is referred to in sectoral legislation under the OCR, or another standard corresponds better to the nature of the delegated tasks (for example: certifications of products, management systems, etc.).

Other standards that can be relevant to the delegated tasks, are:

—	EN ISO/IEC 17065 ‘Conformity assessment — Requirements for bodies certifying products, processes and services’;

—	EN ISO/IEC 17021-1: ‘Conformity assessment – Requirements for bodies providing audit and certification of management systems – Part 1: Requirements’;

—	ISO 22003-1 ‘Food safety — Part 1: Requirements for bodies providing audit and certification of food safety management systems’.

The designation of official laboratories to carry out laboratory analyses, tests and diagnoses on samples taken during official controls and other official activities falls under the rules of Articles 34 to 42 (Chapter IV) of the OCR. In this case, EN ISO/IEC 17025 is mandatory for the operation and accreditation of the designated official laboratory (Article 37(4) of the OCR).

Accreditation of a delegated body in accordance with more than one standard for the same activity is not advisable. It should be noted that EN ISO/IEC 17065 provides the possibility to include in the applicable requirements for the delegated body, all relevant requirements of the other accreditation standards. In this respect, it can be used as an ‘umbrella’ standard.

Further rules on the identification of the relevant standards can be laid down in:

—

Union legislation on areas referred to in Article 1(2) of the OCR: — in the area of organic products, Article 40(3) of Regulation (EU) 2018/848, provides that the relevant standard for the delegation of certain official control tasks to verify compliance with that Regulation is the most recently notified version of the standard for ‘Conformity assessment – Requirements for bodies certifying products, processes and services’, the reference of which has been published in the  Official Journal of the European Union, i.e. of standard EN ISO/IEC 17065; — in the area of geographical indications for wine, spirit drinks and agricultural products, as well as traditional specialities guaranteed and optional quality terms for agricultural products, Articles 41 (1) and 73(1) of Regulation (EU) 2024/1143 (35), provide that the delegated bodies and the product certification bodies shall comply with and be accredited in accordance with Standard EN ISO/IEC 17065 ‘Conformity assessment — Requirements for bodies certifying products, processes and services’ or Standard EN ISO/IEC 17020 ‘Conformity assessment — Requirements for the operation of various types of bodies performing inspection’.

—	national legislation of Member States.

2.3.   CHAPTER IV – Sampling, Analyses, tests and diagnoses (Articles 34 to 42 of the OCR)

2.3.1.    Methods used for sampling, analysis, tests and diagnosis (Article 34 of the OCR)

Article 34 of the OCR lays down requirements for methods used in the context of both official controls and other official activities. In particular, a hierarchy of criteria is established which is to be applied when choosing among available methods in the absence of applicable Union rules (‘method cascade’).

The hierarchical relationship between the options listed in paragraphs (1) to (3) of Article 34 of the OCR is indicated by the use of phrases such as ‘ in the absence of’ and ‘ if no such [..] exists’ . Within the hierarchy, some options are established as equal alternatives, as indicated by the use of the conjunction ‘ or’ .

Article 34(1) of the OCR establishes that methods used for sampling or for laboratory analyses, tests and diagnoses in the context of official controls or other official activities shall comply with Union rules, if such rules exist. These rules may either establish specific methods or lay down performance criteria to be applied for the methods used. Sector-specific Union laws may also lay down different method preferences that deviate from the basic hierarchy established in Article 34 of the OCR, which would then take precedence (lex specialis) over the general hierarchy established in Article 34 of the OCR. For example, while Article 34(2)(a) of the OCR presents methods that comply with ‘relevant internationally recognised rules or protocols’ as an equal option to methods recommended by European Reference Laboratories (EURLs), Article 6(1) of Commission Delegated Regulation (EU) 2020/689 (36) gives priority to methods recommended by EURLs over methods recommended by the World Organisation for Animal Health (OIE) in the context of disease surveillance. The requirement laid down in Article 34(1) of the OCR applies to methods of laboratory analysis, test or diagnosis, as well as to methods used for sampling, irrespective of whether those methods are used by competent authorities (or delegated bodies or persons), or by official laboratories.

Article 34(2) of the OCR lays down a hierarchy of methods to be used by official laboratories in the absence of Union rules as referred to in paragraph 1. The methods referred to in paragraph 2 therefore include methods of laboratory analysis, test or diagnosis as well as methods used for sampling or sample preparation, where such methods are used by official laboratories in the context of official controls and other official activities (including, for example, cases where aggregated sample material is divided into samples for analysis in the laboratory).

Article 34(2)(a) of the OCR lays down that in the absence of Union rules as referred to in paragraph 1, methods recommended by relevant internationally recognised rules or protocols (e.g., CEN, OIE), or methods developed or recommended by EU reference laboratories and validated in accordance with internationally accepted scientific protocols shall be used by official laboratories. These two options in Article 34(2)(a) of the OCR are stipulated as equal alternatives that can both be applied in the absence of Union rules.

Article 34(2)(b) of the OCR lists methods that may only be applied when no Union rules as referred to in paragraph 1 and no international protocols or EURL methods as referred to in point (a) of paragraph 2 exist. Within the options listed under Article 34(2)(b) of the OCR, priority shall be given to methods prescribed by national rules over methods recommended by national reference laboratories. However, other validated methods can be applied as an equal alternative to both of the aforementioned options.

Article 34(3) of the OCR refers only to methods of laboratory analysis, test or diagnosis and not to methods of sampling. It allows the use of non-validated methods only when none of the methods referred to in paragraphs 1 and 2 exist and if laboratory analyses, tests or diagnoses are urgently needed. With regard to the first of these conditions, it should be noted that the availability of a method in a given laboratory or Member State is not a relevant criterion in the context of Article 34(3) of the OCR, given the possibility for competent authorities to designate official and reference laboratories in other Member States or EEA countries. Under the conditions established in Article 34(3) of the OCR, non-validated methods may be used by national reference laboratories, and by official laboratories only in the absence of a national reference laboratory.

Article 34(4) of the OCR establishes the baseline requirement for methods of laboratory analysis in the context of official controls and other official activities that methods should be characterised wherever possible using the criteria set out in Annex III of the OCR.

Article 34(5) of the OCR requires that samples are taken, handled and labelled in such a way as to ensure their legal, scientific and technical validity. This requirement applies to the processing of samples both during sampling itself, whether performed by competent authorities (or delegated bodies or persons) or by official laboratories, during transfer of the samples to the laboratory and during the performance of laboratory analyses, tests or diagnoses performed by official laboratories or national reference laboratories.

Figure 4 provides an overview of the paragraphs of Article 34 of the OCR as regards their applicability to sampling methods and/or methods of laboratory analysis, test or diagnosis.

Figure 4

Applicability of Article 34(1) to (5) of the OCR to i) methods of sampling used by competent authorities (or delegated bodies or natural persons to which certain tasks have been delegated), ii) methods of sampling used by official laboratories and iii) methods of laboratory analyses, tests and diagnoses used by official laboratories. (CA = competent authority (or delegated body or natural person to which certain tasks have been delegated); OL = official laboratory)