Commission Notice on a guidance document on the implementation of the requirements for the multi-annual national control plans as set out in Articles 109 to 111 of Regulation (EU) 2017/625 2021/C 78/01
Date: 2021-03-04
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: animal feedingstuffs, animal welfare, eco-label, food inspection, genetically modified organism, information system, labelling, market approval, plant health control, veterinary inspection








C_2021078EN.01000101.xml










8.3.2021   


EN


Official Journal of the European Union


C 78/1






Commission Notice on a guidance document on the implementation of the requirements for the multi-annual national control plans as set out in Articles 109 to 111 of Regulation (EU) 2017/625
(2021/C 78/01)

Foreword

Union legislation provides for a set of harmonised rules to ensure that food and feed are safe and wholesome, and that activities which might have an impact on the safety of the agri-food chain or on the protection of consumers’ interests in relation to food and food information are performed in accordance with specific requirements. Union rules exist also to ensure a high level of human, animal and plant health as well as animal welfare along the agri-food chain and in all those areas of activity where a key objective is the fight against the possible spread of animal diseases, in some cases transmissible to humans, or of pests injurious to plants or plant products, and to ensure the protection of the environment from risks that might arise from genetically modified organisms (GMOs) or plant protection products. The correct application of those rules, hereinafter collectively referred to as ‘Union agri-food chain legislation’, contributes to the functioning of the internal market.
Regulation (EU) 2017/625 of the European Parliament and of the Council (1)establishes a harmonised Union framework for the organisation of official controls, and official activities other than official controls, along the entire agri-food chain.
Article 109 of Regulation (EU) 2017/625 provides that Member States shall ensure that official controls governed by that Regulation are performed by the competent authorities on the basis of a multi-annual national control plan (MANCP), the preparation and implementation of which are coordinated across their territory.
Article 110(1) of Regulation (EU) 2017/625 provides that the MANCP shall be prepared so as to ensure that official controls are planned in all the areas governed by the rules referred to in Article 1(2) and in accordance with the criteria laid down in Article 9 and with the rules provided for in Articles 18 to 27.
Article 110(2) of Regulation (EU) 2017/625 lays down principles for the general information to be contained in the MANCP and Article 111(2) for the preparation, update and review of the MANCP.
In the light of experience gained from the implementation of MANCPs, from audits of the competent authorities in the Member States in accordance with Article 4(6) of Regulation (EC) No 882/2004 of the European Parliament and of the Council (2), and by Commission experts under Article 45 of that Regulation as well as from the information included in the annual reports submitted by the Member States under Article 44 of that Regulation, it is appropriate to create this guidance document for the preparation of MANCPs.
Therefore, this guidance document should concentrate on the elements of the MANCP which are to be in place in the Member States in order to meet the requirements of Regulation (EU) 2017/625, and in particular the requirements of Article 111 which sets out the principles for the preparation, update and review of the MANCP.
The purpose of the MANCP is also to establish a solid basis for the audits of competent authorities in accordance with Article 6 of Regulation (EU) 2017/625 and for the Commission to carry out controls in the Member States, in accordance with Article 116 of that Regulation.
The Commission will keep this guidance document under review and update it, as necessary, following the receipt and examination of the MANCPs and in light of the experience of the Member States in implementing Regulation (EU) 2017/625.
This guidance document is intended to assist national authorities in the application of Articles 109 to 111 of Regulation (EU) 2017/625. Only the Court of Justice of the European Union is competent to authoritatively interpret Union law.


Table of Contents









A.

Purpose of the guidance document
4










B.

Definitions
4










C.

Guidance on legal requirements for the MANCP
5










1.

Scope of the MANCP
5










2.

The single integrated MANCP
5










3.

Collection of information during MANCP implementation and reporting
6










4.

Periodicity (length of planning cycle)
6










5.

General requirements for the MANCP
7










D.

General guidance on the content of the MANCP
7










1.

Strategy and context
7










1.1.

Strategic objectives of the MANCP
7










1.2.

Risk categorisation
8










2.

Structural framework for official controls
8










2.1.

Designation of competent authorities
8










2.2.

Delegation to delegated bodies (or natural persons)
9










3.

General organization and management of official controls
9










3.1.

Control systems and coordination activities
10










3.2.

Compliance with operational criteria
11










3.3.

Training of staff performing official controls
12










3.4.

Documented procedures
12










4.

Incident/emergency management
12










4.1.

Operational contingency plans
12










4.2.

Organisation of cooperation and mutual assistance
13



A.   Purpose of the guidance document

The purpose of this guidance document is to assist Member States in preparing the multi-annual national control plan (MANCP) provided for in Article 109 of Regulation (EU) 2017/625. It provides guidance on the implementation of the requirements for the MANCP as set out in Article 110(2) of that Regulation.
Therefore, Section C of this guidance document focuses on guidance on the legal requirements for the MANCP and Section D provides guidance on the content of the MANCP. This guidance document also includes an optional template for the MANCP. It is however up to the Member States to choose in which format they want to present their MANCP.
B.   Definitions

For the purposes of this guidance document, reference is made to the definitions laid down in Articles 2 and 3 of Regulation (EU) 2017/625 and other relevant Union agri-food chain legislation.
In particular, the following definitions set out in Regulation (EU) 2017/625 should be noted:






(a)


‘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:






—


compliance by the operators with this Regulation and with the rules referred to in Article 1(2),










—


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;














(b)


‘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;










(c)


‘competent authorities’ means:






—


the central authorities of a Member State responsible for the organisation of official controls and of other official activities, in accordance with this Regulation and the rules referred to in Article 1(2),










—


any other authority to which that responsibility has been conferred;














(d)


‘organic control authority’ means a public administrative organisation for organic production and labelling of organic products of a Member State to which the competent authorities have conferred, in whole or in part, their competences in relation to the application of Council Regulation (EC) No 834/2007 (3);










(e)


‘delegated body’ means a separate legal person to which the competent authorities have delegated certain official control tasks or certain tasks related to other official activities;










(f)


‘control plan’ means a description established by the competent authorities containing information on the structure and organisation of the official control system, and of its operation and the detailed planning of official controls to be performed, over a period of time, in each of the areas governed by the rules referred to in Article 1(2);










(g)


‘risk’ means a function of the probability of an adverse effect on human, animal or plant health, animal welfare or the environment and of the severity of that effect, consequential to a hazard.




In addition to the definitions above, reference is made to the following ones for the purposes of this guidance document:






(a)


‘coordination’ means any action(s) taken to ensure that the competent authorities are planning and implementing their official controls in a coherent and consistent manner in order to effectively contribute to the common objective(s) of achieving effective implementation of the MANCP and of Union law.










(b)


‘areas’ means the areas established in Articles 1(2) of Regulation (EU) 2017/625.




C.   Guidance on legal requirements for the mancp

1.   
Scope of the MANCP



Legal requirement

Article 109(1) of Regulation (EU) 2017/625

Guidance

The MANCP should cover official controls governed by Regulation (EU) 2017/625, provided for in its Article 1(2) to (4). Further information meant as guidance on the rules that contain provisions for the above official controls is given in Annex 1.
Member States are not required to include information in their MANCP about other official activities that the competent authorities, the delegated bodies or the natural persons carry out (4).
However, Member States may still wish to include such information in their MANCP if it is felt that the information is relevant or would aid understanding the MANCP.
Information on other official controls, which are not within the scope of Regulation (EU) 2017/625, such as, for example official controls on the basis of other EU legislation (e.g. on veterinary medicinal products), or information related to the World Organisation for Animal Health (OIE) Performance of Veterinary Services (PVS) tool (5), could be included in the MANCP.
2.   
The single integrated MANCP



Legal requirement

Article 109(1) and (2)(a) and (b) of Regulation (EU) 2017/625

Guidance

Article 109(1) of Regulation (EU) 2017/625 provides that Member States are to coordinate across their territory the preparation and implementation of the MANCP. Article 109(2) provides that Member States are to designate a single body tasked with coordinating the preparation of the MANCP across all competent authorities responsible for the official controls and ensuring that the MANCP is coherent and complete.
The designation of a single body by a Member State should not be perceived as an obligation to create a new department within a competent authority, a new organisation or institution, for complying with Article 109(2) of Regulation (EU) 2017/625. Existing structures in Member States may be designated as a single body.
The MANCP covers official controls by all competent authorities at all levels (central, regional and local), according to national arrangements for official controls.
For Member States with decentralised administrations, the MANCP should outline how coordination between the various administrations is ensured in order to arrive at a single integrated MANCP.
Competent authorities should devise appropriate systems for the integrated planning, development and coordination of activities regarding the MANCP. A single integrated MANCP should not be a simple compilation of plans per individual competent authority or per area. Such compilation would not address the integration and coordination of official controls within and across competent authorities and areas, with regard to related official controls.
3.   
Collection of information during MANCP implementation and reporting



Legal requirement

Articles 109(2)(c), 111(1) to (3) and 113 of Regulation (EU) 2017/625
Commission Implementing Regulation (EU) 2019/723 (6)


Guidance

Member States should, during the MANCP implementation, gather evidence of its implementation, retain it and make it available to any organisation involved in carrying out audits to allow verification of the MANCP's effective implementation. Such evidence should include written procedures, documentation and records of official controls.
Article 109(2)(c) of Regulation (EU) 2017/625 provides that Member States' single bodies collect the information on the implementation of the MANCP in view of submitting the annual reporting referred to in Article 113 and of its review and update as necessary in accordance with Article 111(2) of that Regulation.
Annual reports relating to the MANCP are to be compiled and submitted in accordance with Commission Implementing Regulation (EU) 2019/723 laying down rules for the application of Regulation (EU) 2017/625 of the European Parliament and of the Council as regards the standard model form to be used in the annual reports submitted by Member States. The guidance document (7) on how to fill in the standard model form in the Annex to Regulation (EU) 2019/723 will further assist Member States.
Article 111(1) of Regulation (EU) 2017/625 provides that Member States shall ensure that the MANCP is made available to the public, with the exception of those parts of the plan the disclosure of which could undermine the effectiveness of official controls. Member States can choose the means of publication of the MANCP.
Article 111(3) of Regulation (EU) 2017/625 provides that Member States shall provide the Commission, upon request, with the latest up-to-date version of their respective MANCP.
This is without prejudice to other Commission requests for specific information in order to perform Commission controls, including audits, in Member States in accordance with Article 116 of Regulation (EU) 2017/625.
4.   
Periodicity (length of planning cycle)



Guidance

The period of validity/duration of the MANCP is a matter for the Member State to decide and may be set to correspond with other national planning activities, such as, the budgetary cycle. The reasons for selecting the chosen duration should be briefly stated in the MANCP.
It is suggested that in order to be multi-annual, the plan should cover a minimum period of three years. In view of the difficulty for planning ahead in an evolving environment, it is suggested that the period of a single planning cycle should not exceed five years.
Uncertainties and constraints dictate the level of detail on official controls that can be provided for in each year of the plan. In particular, operational goals/objectives for official controls may have to be set provisionally for the later years of the MANCP and updated on a regular basis in conjunction with the preparation of the annual report required under Article 113(1) of Regulation (EU) 2017/625. In that respect, please refer to Section D.1.1.
5.   
General requirements for the MANCP



Legal requirement

Articles 110, 111(2) and 119 of Regulation (EU) 2017/625

Guidance

The MANCP is required to contain general information on the structure and organisation of the Member State's systems of official controls covering all areas of the Union agri-food chain. Although general in nature, the MANCP is required to include information on the specific issues provided for in Article 110(2)(a) to (k) of Regulation (EU) 2017/625. Guidance on those specific issues is set out in Section D of this guidance document.
Member States are reminded of their obligation to review, and consider adjustments of, the MANCP during its implementation in the light of the factors set out in Articles 111(2) and 119(a) of Regulation (EU) 2017/625 and for the inclusion of any subsequent adjustments in the annual report provided for in Article 113(1) of that Regulation.
The MANCP should therefore describe:






(a)


the process for the annual review of the operation of the MANCP, as a contribution to the annual report on the implementation of the MANCP;










(b)


how the outcome of the audits of national competent authorities required under Article 6 of Regulation (EU) 2017/625 feeds into this process.




D.   General guidance on the content of the MANCP

1.   
Strategy and context


1.1.   Strategic objectives of the MANCP


Legal requirement

Article 110(2)(a) of Regulation (EU) 2017/625

Guidance

Taking into account that the main objective of Regulation (EU) 2017/625 is to ensure a more harmonised and coherent approach to official controls and relevant enforcement actions along the entire Union agri-food chain and the general obligation on Member States to enforce Union law, Member States should develop appropriate objectives and strategies to achieve that purpose. Those objectives and strategies are to form the basis of and be briefly set out in the MANCP (8).
The strategy adopted by the Member State for the different activities, areas and stages of the Union agri-food chain should include a brief description of, and the reasons for, the:






—


focus of the official controls,










—


prioritisation of the official controls, and










—


allocation of resources.




1.2.   Risk categorisation


Legal requirement

Article 110(2)(b) of Regulation (EU) 2017/625

Guidance

Taking into account that with regard to Union agri-food chain legislation, Article 9(1) and (2) of Regulation (EU) 2017/625 requires competent authorities to perform official controls on all operators regularly, on a risk basis and with an appropriate frequency, the MANCP is to contain information on the risk categorisation, if any, assigned to the various activities subject to official controls. This is without prejudice to Union legislation specifying minimum frequencies of official controls.
A brief description of the process of risk categorisation used by the Member State may be included in the MANCP (9).
2.   
Structural framework for official controls


2.1.   Designation of competent authorities


Legal requirement

Article 110(2)(c) of Regulation (EU) 2017/625

Guidance

The MANCP should provide a comprehensive overview of the structure and tasks of the competent authorities. The MANCP should:






(a)


identify the authorities, or, where appropriate, the level of such authorities (10), that are designated as competent authorities responsible for official controls for all areas listed in Article 1(2) of Regulation (EU) 2017/625. All competent authorities, and where appropriate level of competent authority (central, regional and local level) should be identified, as should all delegated bodies or natural persons to which certain tasks have been delegated;










(b)


describe the allocation of official control tasks and responsibilities for the entire agri-food chain;










(c)


indicate the resources available to the competent authorities;










(d)


list the national reference laboratories designated in accordance with Article 100(1) of Regulation (EU) 2017/625 and the areas for which they are designated.




The information referred to in points (a) to (d) may be illustrated in the form of an integrated national-level organisational chart of the competent authorities and their respective tasks and responsibilities.
The description of resources available to the competent authorities should include the human resources and supporting facilities and services, such as specialist IT systems and laboratory, diagnostic, research and training facilities and services, as applicable.
Human resources should be described in terms of number of full-time or ‘full-time equivalent’ posts. The facilities and services available may be quantified in terms of level of service, laboratory capacity and range of analytical activities and, if appropriate, the information may be provided on a national or regional level indicating the number of competent authorities sharing the facilities.
A full list of official laboratories designated to carry out analysis on samples taken during official controls is not required to be included in the plan, but should be maintained by the competent authority.
Where the lists of national reference laboratories and official laboratories are not included in the MANCP, (a) link(s) to the relevant web page(s) where those lists can be found should be included.
2.2.   Delegation to delegated bodies (or natural persons)


Legal requirement

Article 110(2)(d) of Regulation (EU) 2017/625

Guidance

The MANCP should where appropriate:






(a)


identify the competent authorities that delegate official control tasks to delegated bodies;










(b)


list the specific tasks delegated to each category of delegated body;










(c)


include a general description of the arrangements in place to ensure that delegating competent authorities and delegated bodies meet the requirements of:






(i)


Articles 29 and 33 of Regulation (EU) 2017/625;










(ii)


Annex II, Chapter II, point 2 of Regulation (EU) 2017/625.








Points (a) to (c)(i) above may also apply when there is a delegation of tasks to natural persons (Articles 30 and 33 of Regulation (EU) 2017/625).
Where the same official control tasks are delegated to a number of delegated bodies or natural persons, the delegation of such tasks may, for the purposes of the MANCP be described in terms of categories of delegated body or natural person. In this case, a comprehensive and up-to-date list of delegated bodies or natural persons to whom official control tasks are delegated is not required to be included in the plan, but should be maintained by the relevant competent authorities.
3.   
General organisation and management of official controls



Legal requirement

Article 110(2)(e) to (i) of Regulation (EU) 2017/625

Guidance

Article 110(2)(e) of Regulation (EU) 2017/625 provides for the MANCP to contain information on the general organisation and management of official controls at national, regional and local level, including official controls in individual establishments.
A general description of the organisation and structure of each organisation, designated as competent authority, at all levels, should be included in the MANCP. A generic description may be provided for the same category of competent authority at regional and/or local level when the organisation and structure of the competent authorities is essentially the same. The MANCP should describe how official controls, including import and export controls, are organised and managed at national, regional and local level.
The MANCP should include a general description of:






(a)


the organisation of the competent authorities;










(b)


the hierarchical relationships and reporting (and/or governance) arrangements within and between competent authorities and with delegated bodies or natural persons;










(c)


the arrangements for verification to ensure the quality, impartiality, consistency and effectiveness of official controls at all levels within and across competent authorities including across all regional and/or local authorities as provided for by Article 5(1)(b) of Regulation (EU) 2017/625;










(d)


the relationship and arrangements between competent authorities and designated official and national reference laboratories to ensure that such laboratories conform to and operate in accordance with Articles 38 and 100(1) of Regulation (EU) 2017/625, respectively;










(e)


the arrangements for carrying out the audits of competent authorities, to ensure effectiveness and suitability of official controls, as provided for by Article 6 of Regulation (EU) 2017/625. The arrangements (11) should indicate how it is ensured that the audits are subject to independent scrutiny and are carried out in a transparent manner and that competent authorities take appropriate measures in the light of the results of such audits.




3.1.   Control systems and co/dination activities

The organisation of official control systems should take account of:






(a)


the need to determine the nature, frequency, time and point of the official control, in order to maximise compliance with Union agri-food chain legislation;










(b)


the role of prioritisation in determining the balance between tasks and resources, cost-efficiency and cost-effectiveness;










(c)


the specific national control plans or programmes provided for by Union agri-food chain legislation;










(d)


any specific national disease control or eradication plans;










(e)


any relevant risk categorisations.




The MANCP should therefore describe:






(a)


the official control systems applied to different areas, in particular:






(i)


the official control methods and techniques used, such as, monitoring, surveillance, verification, audit, inspection, sampling and analysis, taking account of the requirements of Articles 14, 34 and 35 of Regulation (EU) 2017/625, and where and when such official control methods and techniques are used;










(ii)


the frequency, or as appropriate, the criteria for determining the frequency and nature of the official controls;










(iii)


the extent and operation of official controls on imports and exports of all animals and goods;














(b)


how the risk categories referred to in Section D.1.2 are applied to target official controls effectively;










(c)


how the official control arrangements for horizontally applicable Union agri-food legislation are integrated into the official controls applicable to each relevant area; where more than one area is involved appropriate ‘linkages’ should be established between the different areas.




Arrangements should be in place to ensure coordination of activities and cooperation within and between competent authorities. Those arrangements should also contribute to ensuring the quality, impartiality, consistency and effectiveness of official controls.
In particular, information should be provided on the general measures to manage the relationship between the different competent authorities responsible for different areas or different stages of the Union agri-food chain and on the arrangements where competence is conferred on, or shared with regional and/or, local competent authorities.
The MANCP should therefore describe:






(a)


the arrangements to ensure effective and efficient cooperation and coordination of activities:






—


within a competent authority, between two or more competent authorities involved in the same area (in particular, where a Member State confers competence to carry out official controls on: an authority other than a central competent authority between the relevant central, regional and local authorities, as laid down in Article 4(2) of Regulation (EU) 2017/625),










—


on other authorities (where cooperation is required as laid down in Articles 75 and 76 of Regulation (EU) 2017/625), and










—


where competent authorities delegate official controls to delegated bodies or natural persons as laid down in and Articles 28(1), 29, 30 and 33 of Regulation (EU) 2017/625.




For example, formal arrangements for coordination of activities and ensuring consistency of official controls such as meetings, joint committees and liaison groups and requirements for joint agreements or actions;










(b)


shared training initiatives for staff involved in official controls, e.g. in the areas of technical skills, supervision of control services, quality management and auditing, if applicable;










(c)


sharing access to laboratory and diagnostic facilities if applicable;










(d)


management and use of shared national databases where applicable;










(e)


the areas where coordination and communication between competent authorities is an important issue, including:






(i)


the measures in place to ensure the effective operation of such activity so there is no breakdown in official controls;










(ii)


how the necessary information is exchanged between competent authorities to ensure the continuity and consistency of official controls and to enable traceability systems to operate effectively.








3.2.   Compliance with operational criteria

The MANCP should describe the methods employed to ensure that organisations designated as competent authorities or organic control authorities are effectively implementing the requirements of Article 5(1)(a) and (c) to (i) of Regulation (EU) 2017/625.
In particular, the MANCP should describe the procedures and/or arrangements in place to ensure the following, in respect of all competent authorities and organic control authorities:






(a)


the effectiveness and appropriateness of official controls;










(b)


that measures are in place to ensure that staff performing official controls (12) are free from any conflict of interest, which could impair their objectivity and independence or compromise their professional judgement and to deal with any potential conflict of interest which may arise;










(c)


that all authorities have, or have access to, an adequate laboratory capacity for analysis, testing and diagnosis;










(d)


that all authorities have, or have access to, a sufficient number of suitably qualified and experienced staff so that official controls can be performed efficiently and effectively;










(e)


that all authorities have appropriate and properly maintained facilities and equipment to ensure that staff can perform official controls efficiently and effectively;










(f)


that all authorities have the legal powers to perform official controls and to take the actions provided for in Regulation (EU) 2017/625 and in the rules referred to in Article 1(2), including the power to access operators’ premises, to inspect animals and goods, records or other documents including computing systems, to take samples, and to take appropriate actions in the case of suspicion or detection of non-compliances including the imposition of effective, proportionate and dissuasive sanctions or initiating appropriate procedures for the imposition of such sanctions;










(g)


that all authorities have contingency plans in place and be prepared to operate such plans in the event of an emergency, where appropriate, in accordance with the rules referred to in Article 1(2).




3.3.   Training of staff performing official controls

The MANCP should describe the systems or arrangements in place to ensure that staff performing official controls receive, or have received the training, provided for in Article 5(4) of Regulation (EU) 2017/625.
The MANCP should also describe the arrangements to ensure that all staff performing official controls have the necessary qualifications, training and competencies to perform such controls in an effective manner.
The MANCP should, for all areas, set out the systems or arrangements in place to:






(a)


identify the training needs for staff performing official controls;










(b)


provide and evaluate such training;










(c)


document such training for audit purposes.




Arrangements for the delegation of official control tasks to delegated bodies or natural persons, should ensure that the staff of such delegated bodies or natural persons, have the necessary training, qualification and competencies to perform those tasks in an effective manner (see also guidance at Section D.2.2).
3.4.   Documented procedures

The MANCP should describe the systems or arrangements in place to ensure the effective implementation of the requirements of Article 12(1) to (3) of Regulation (EU) 2017/625, regarding documented procedures and Article 13 of that Regulation regarding written records of official controls.
The documented procedures are to cover the areas for control procedures set out in Chapter II of Annex II to Regulation (EU) 2017/625 and contain instructions for staff performing official controls.
For all areas, the MANCP should describe the systems or arrangements in place to ensure that:






(a)


the relevant documented procedures are readily accessible to (13):






(i)


all staff performing official controls;










(ii)


the competent authorities concerned;










(iii)


the central competent authority;














(b)


documented procedures are reviewed and updated at appropriate intervals.




A comprehensive list or index of documented procedures is not required to be included in the plan, but should be maintained by the competent authority.
For all areas, the MANCP should describe the systems or arrangements in place to provide for the recording of the performance and outcome of official controls, as provided for by Article 13(1) and (2) of Regulation (EU) 2017/625, the filing of such records and for ensuring that such records are readily accessible to:






(a)


all staff performing those official controls;










(b)


the competent authority concerned;










(c)


the central competent authority;










(d)


any organisation involved in carrying out audits;










(e)


the Commission upon request.




4.   
Incident/emergency management


4.1.   Operational contingency plans


Legal requirement

Article 110(2)(j) of Regulation (EU) 2017/625

Guidance

This Section provides guidance, in particular, on the information that should be provided in relation to the contingency plans referred to in Articles 5(1)(i) and 115 of Regulation (EU) 2017/625, and, in general, on other contingency plans required under relevant Union legislation, such as:






—


Regulation (EU) 2016/429 of the European Parliament and of the Council (14), and










—


Regulation (EU) 2016/2031 of the European Parliament of the Council (15).




The MANCP should:






(a)


indicate each of the areas for which specific contingency plans are in place;










(b)


indicate the scope of each such contingency plan;










(c)


in relation to each such contingency plan, identify the body or bodies responsible for their preparation and maintenance;










(d)


the system or arrangements in place for dissemination of the contingency plans and for appropriate training in relation to their implementation.




However, it is not necessary to attach a copy of the individual contingency plans but (a) link(s) to the relevant web page(s) should be provided.
If appropriate, those arrangements may be described using an organisational chart or table or other easily presented format.
4.2.   Organisation of cooperation and mutual assistance

Legal requirement

Article 110(2)(k) of Regulation (EU) 2017/625

Guidance

The MANCP should:






(a)


describe the general arrangements in place to ensure that the requirements of Articles 102 to 107 of Regulation (EU) 2017/625 are met;










(b)


identify the designated liaison body or bodies and their respective areas of responsibility or competence.




The description of the general arrangements could include information on how competent authorities exchange and disseminate information on serious direct or indirect risks to human, animal or plant health, animal welfare or, as regards GMOs and plant protection products, also to the environment for the purpose of enabling rapid measures to be taken to counter those serious risks.
Mechanisms for cross border assistance and cooperation between competent authorities should be in place to ensure that cases of non-compliance with Union agri-food chain legislation, which have a cross-border dimension, are effectively pursued not only in the Member State where the non-compliance is first detected but also in the Member State where the non-compliance originated.
A brief explanation of how competent authorities interact with and use the different components of the computerised information management system for official controls (IMSOC) (16) could be used to demonstrate Member States' timely actions to counter certain serious risks along the Union agri-food chain and how they are prepared to take effective and proportionate actions to pursue cross-border violations of Union agri-food chain legislation also in cases where potential fraudulent or deceptive practices have or could have a cross-border dimension.
Requests for administrative assistance, cooperation and all notifications should be given appropriate follow-up. To facilitate this, Member States should designate one or more liaison bodies to assist and coordinate communication flows between competent authorities in different Member States.


(1)  Regulation (EU) 2017/625 of the European Parliament and of the Council of 15 March 2017 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, amending Regulations (EC) No 999/2001, (EC) No 396/2005, (EC) No 1069/2009, (EC) No 1107/2009, (EU) No 1151/2012, (EU) No 652/2014, (EU) 2016/429 and (EU) 2016/2031 of the European Parliament and of the Council, Council Regulations (EC) No 1/2005 and (EC) No 1099/2009 and Council Directives 98/58/EC, 1999/74/EC, 2007/43/EC, 2008/119/EC and 2008/120/EC, and repealing Regulations (EC) No 854/2004 and (EC) No 882/2004 of the European Parliament and of the Council, Council Directives 89/608/EEC, 89/662/EEC, 90/425/EEC, 91/496/EEC, 96/23/EC, 96/93/EC and 97/78/EC and Council Decision 92/438/EEC (Official Controls Regulation) (OJ L 95, 7.4.2017, p. 1).

(2)  Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules (OJ L 165, 30.4.2004, p. 1).

(3)  Council Regulation (EC) No 834/2007 of 28 June 2007 on organic production and labelling of organic products and repealing Regulation (EEC) No 2092/91 (OJ L 189, 20.7.2007, p. 1).

(4)  According to Article 1(5) of Regulation (EU) 2017/625, Articles 109 to 111 of the same regulation do not apply to other official activities.

(5)  The work of the Joint OIE-EU Working group might be a useful source of information.

(6)  Commission Implementing Regulation (EU) 2019/723 of 2 May 2019 laying down rules for the application of Regulation (EU) 2017/625 of the European Parliament and of the Council as regards the standard model form to be used in the annual reports submitted by Member States (OJ L 124, 13.5.2019, p. 1).

(7)  Commission Notice on a guidance document on how to fill in the standard model form in the Annex to Commission Implementing Regulation (EU) 2019/723 laying down rules for the application of Regulation (EU) 2017/625 of the European Parliament and the Council as regards the standard model form to be used in the annual reports submitted by Member States (OJ C 71, 1.3.2021, p. 1) [C(2021) 1136].

(8)  The work of the MANCP Network might be a useful source of information.

(9)  Idem footnote 8.

(10)  For example: ‘Länder’, ‘county councils’, ‘municipalities’, ‘départements’.

(11)  Those arrangements should take account of the Commission Notice on a guidance document on the implementation of the provisions for the conduct of audits under Article 6 of Regulation (EU) 2017/625 (OJ C 66, 26.2.2021, p. 22).

(12)  Where external or contract staff are performing official controls, that measures are in place to ensure they have the same degree of independence and accountability as permanent staff in the performance of their official control duties.

(13)  See also section C.3.

(14)  Regulation (EU) 2016/429 of the European Parliament and of the Council of 9 March 2016 on transmissible animal diseases and amending and repealing certain acts in the area of animal health (‘Animal Health Law’) (OJ L 84, 31.3.2016, p. 1).

(15)  Regulation (EU) 2016/2031 of the European Parliament of the Council of 26 October 2016 on protective measures against pests of plants, amending Regulations (EU) No 228/2013, (EU) No 652/2014 and (EU) No 1143/2014 of the European Parliament and of the Council and repealing Council Directives 69/464/EEC, 74/647/EEC, 93/85/EEC, 98/57/EC, 2000/29/EC, 2006/91/EC and 2007/33/EC (OJ L 317, 23.11.2016, p. 4).

(16)  Commission Implementing Regulation (EU) 2019/1715 of 30 September 2019 laying down rules for the functioning of the information management system for official controls and its system components (‘the IMSOC Regulation’) (OJ L 261, 14.10.2019, p. 37).




ANNEX 1
Guidance on the scope of the MANCP
The arrangements for all official controls coming within the scope of Regulation (EU) 2017/625 should be addressed in the MANCP. Further information meant as guidance on the rules that contain provisions for the above official controls is provided below, in the form of non-exhaustive indicative lists, for each area under Article 1(2) and for Article 1(3) of Regulation (EU) 2017/625.
REGARDING AREAS REFERRED TO IN ARTICLE 1(2) OF REGULATION (EU) 2017/625:











(a)


Food and food safety, integrity and wholesomeness at any stage of production, processing and distribution of food, including rules aimed at ensuring fair practices in trade and protecting consumer interests and information, and the manufacture and use of materials and articles intended to come into contact with food








Regulation (EEC) No 315/93 laying down Community procedures for contaminants in food




Directive 96/22/EC concerning the prohibition on the use in stockfarming of certain substances having a hormonal or thyrostatic action and of beta-agonists




Directive 96/23/EC on measures to monitor certain substances and residues thereof in live animals and animal products - provisions which remain applicable in accordance with the transitional provision in Article 150 of Regulation (EU) 2017/625




Decision 97/747/EC fixing the levels and frequencies of sampling provided for by Council Directive 96/23/EC for the monitoring of certain substances and residues thereof in certain animal products




Directive 98/83/EC on the quality of water intended for human consumption (relevant rules for bottled water)




Directive 1999/2/EC on the approximation of the laws of the Member States concerning foods and food ingredients treated with ionising radiation




Directive 1999/3/EC on the establishment of a Community list of foods and food ingredients treated with ionising radiation




Regulation (EC) No 178/2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety




Directive 2002/46/EC on the approximation of the laws of the Member States relating to food supplements




Directive 2002/99/EC laying down the animal health rules governing the production, processing, distribution and introduction of products of animal origin for human consumption




Directive 2003/40/EC establishing the list, concentration limits and labelling requirements for the constituents of natural mineral waters and the conditions for using ozone-enriched air for the treatment of natural mineral waters and spring waters




Regulation (EC) No 1829/2003 on genetically modified food and feed




Regulation (EC) No 1830/2003 concerning the traceability and labelling of genetically modified organisms and the traceability of food and feed products produced from genetically modified organisms




Regulation (EC) No 852/2004 on the hygiene of foodstuffs




Regulation (EC) No 853/2004 laying down specific hygiene rules for food of animal origin




Regulation (EC) No 641/2004 on detailed rules for the implementation of Regulation (EC) No 1829/2003 as regards the application for the authorisation of new genetically modified food and feed, the notification of existing products and adventitious or technically unavoidable presence of genetically modified material which has benefited from a favourable risk evaluation




Regulation (EC) No 1935/2004 on materials and articles intended to come into contact with food




Regulation (EC) No 396/2005 on maximum residue levels of pesticides in or on food and feed of plant or animal origin




Regulation (EC) No 2073/2005 on microbiological criteria for foodstuffs




Regulation (EC) No 2074/2005 laying down implementing measures for certain products under Regulation (EC) No 853/2004 and for the organisation of official controls under Regulation (EC) No 854/2004




Regulation (EC) No 1881/2006 setting maximum levels for certain contaminants in foodstuffs




Regulation (EC) No 1924/2006 on nutrition and health claims made on foods




Regulation (EC) No 1925/2006 on the addition of vitamins and minerals and of certain other substances to foods




Regulation (EC) No 2023/2006 on good manufacturing practice for materials and articles intended to come into contact with food




Regulation (EC) No 1332/2008 on food enzymes




Regulation (EC) No 1333/2008 on food additives




Regulation (EC) No 1334/2008 on flavourings and certain food ingredients with flavouring properties for use in and on food




Directive 2009/32/EC on the approximation of the laws of the Member States on extraction solvents used in the production of foodstuffs and food ingredients




Directive 2009/39/EC on foodstuffs intended for particular nutritional uses




Directive 2009/54/EC on the exploitation and marketing of natural mineral waters




Regulation (EU) No 37/2010 on pharmacologically active substances and their classification regarding maximum residue limits in foodstuffs of animal origin




Regulation (EU) No 115/2010 laying down the conditions for use of activated alumina for the removal of fluoride from natural mineral waters and spring waters




Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food




Regulation (EU) No 931/2011 on the traceability requirements set by Regulation (EC) No 178/2002 for food of animal origin




Regulation (EU) No 1169/2011 on the provision of food information to consumers




Regulation (EU) No 29/2012 on marketing standards for olive oil




Regulation (EU) No 1151/2012 on quality schemes for agricultural products and foodstuffs (Title IV: optional quality terms)




Regulation (EU) No 228/2013 laying down specific measures for agriculture in the outermost regions of the Union




Regulation (EU) No 609/2013 on food intended for infants and young children, food for special medical purposes, and total diet replacement for weight control




Regulation (EU) No 1306/2013 on the financing, management and monitoring of the common agricultural policy




Regulation (EU) No 1308/2013 establishing a common organisation of the markets in agricultural products (articles 73 to 91)




Regulation (EU) No 1337/2013 laying down rules for the application of Regulation (EU) No 1169/2011 as regards the indication of the country of origin or place of provenance for fresh, chilled and frozen meat of swine, sheep, goats and poultry




Regulation (EU) No 1379/2013 on the common organisation of the markets in fishery and aquaculture products




Regulation (EU) No 179/2014 supplementing Regulation (EU) No 228/2013 with regard to the register of operators, the amount of aid for the marketing of products outside the region, the logo, the exemption from import duties for certain bovine animals and the financing of certain measures relating to specific measures for agriculture in the outermost regions of the Union




Regulation (EU) 2015/1375 laying down specific rules on official controls for Trichinella in meat




Regulation (EU) 2015/2283 on novel foods




Regulation (EU) 2019/624 concerning specific rules for the performance of official controls on the production of meat and for production and relaying areas of live bivalve molluscs in accordance with Regulation (EU) 2017/625




Regulation (EU) 2019/627 laying down uniform practical arrangements for the performance of official controls on products of animal origin intended for human consumption in accordance with Regulation (EU) 2017/625 and amending Regulation (EC) No 2074/2005 as regards official controls




Regulation (EU) 2019/1139 amending Regulation (EC) No 2074/2005 as regards official controls on food of animal origin in relation to requirements concerning food chain information and fishery products and to the reference to recognised testing methods for marine biotoxins and to testing methods for raw milk and heat-treated cow's milk




Regulation (EU) 2019/2090 supplementing Regulation (EU) 2017/625 regarding cases of suspected or established non-compliance with Union rules applicable to the use or residues of pharmacologically active substances authorised in veterinary medicinal products or as feed additives or with Union rules applicable to the use or residues of prohibited or unauthorised pharmacologically active substances


















(b)


Deliberate release into the environment of Genetically Modified Organisms (GMOs) for the purpose of food and feed production.








Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms




Regulation (EC) 1829/2003 on genetically modified food and feed




Regulation (EC) No 1830/2003 concerning the traceability and labelling of genetically modified organisms and the traceability of food and feed products produced from genetically modified organisms




Regulation (EC) 1946/2003 on transboundary movements of genetically modified organisms




Recommendation 2004/787/EC on technical guidance for sampling and detection of genetically modified organisms and material produced from genetically modified organisms as or in products in the context of Regulation (EC) No 1830/2003




Regulation (EC) No 65/2004 establishing a system for the development and assignment of unique identifiers for genetically modified organisms




Regulation (EC) No 641/2004 on detailed rules for the implementation of Regulation (EC) No 1829/2003 as regards the application for the authorisation of new genetically modified food and feed, the notification of existing products and adventitious or technically unavoidable presence of genetically modified material which has benefited from a favourable risk evaluation




Regulation (EU) 619/2011 laying down the methods of sampling and analysis for the official control of feed as regards presence of genetically modified material for which an authorisation procedure is pending or the authorisation of which has expired




Directive (EU) 2015/412 amending Directive 2001/18/EC as regards the possibility for the Member States to restrict or prohibit the cultivation of genetically modified organisms (GMOs) in their territory




All legal acts on authorisation for individual products, as can be found in the EU GMO Register: Genetically Modified Organisms - European Commission (http://ec.europa.eu/food/dyna/gm_register/index_en.cfm)


















(c)


Feed and feed safety at any stage of production, processing and distribution of feed and the use of feed, including rules aimed at ensuring fair practices in trade and protecting consumer health, interests and information.








Directive 90/167/EEC laying down the conditions governing the preparation, placing on the market and use of medicated feedingstuffs in the Community (until 27 January 2022)




Regulation (EC) No 178/2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety




Directive 2002/32/EC on undesirable substances in animal feed




Regulation (EC) 1829/2003 on genetically modified food and feed




Regulation (EC) No 1830/2003 concerning the traceability and labelling of genetically modified organisms and the traceability of food and feed products produced from genetically modified organisms




Regulation (EC) No 1831/2003 on additives for use in animal nutrition




Regulation (EC) No 641/2004 on detailed rules for the implementation of Regulation (EC) No 1829/2003 as regards the application for the authorisation of new genetically modified food and feed, the notification of existing products and adventitious or technically unavoidable presence of genetically modified material which has benefited from a favourable risk evaluation




Regulation (EC) No 183/2005 laying down requirements for feed hygiene




Regulation (EC) No 396/2005 on maximum residue levels of pesticides in or on food and feed of plant or animal origin




Directive 2008/38/EC establishing a list of intended uses of animal feedingstuffs for particular nutritional purposes




Regulation (EC) No 152/2009 laying down the methods of sampling and analysis for the official control of feed




Regulation (EC) No 767/2009 on the placing on the market and use of feed




Regulation (EU) No 619/2011 laying down the methods of sampling and analysis for the official control of feed as regards presence of genetically modified material for which an authorisation procedure is pending or the authorisation of which has expired




Regulation (EU) No 68/2013 on the Catalogue of feed materials




Regulation (EU) 2019/4 on the manufacture, placing on the market and use of medicated feed (from 28 January 2022)




Regulation (EU) 2019/2090 supplementing Regulation (EU) 2017/625 regarding cases of suspected or established non-compliance with Union rules applicable to the use or residues of pharmacologically active substances authorised in veterinary medicinal products or as feed additives or with Union rules applicable to the use or residues of prohibited or unauthorised pharmacologically active substances


















(d)


Animal health requirements.








List of acts in Article 270(2) of Regulation (EU) 2016/429 (until 20 April 2021), in particular:






—


Directive 88/407/EEC laying down the animal health requirements applicable to intra-Community trade in and imports of deep-frozen semen of domestic animals of the bovine species










—


Directive 89/556/EEC on animal health conditions governing intra-Community trade in and importation from third countries of embryos of domestic animals of the bovine species










—


Directive 90/429/EEC laying down the animal health requirements applicable to intra-Community trade in and imports of semen of domestic animals of the porcine species










—


Directive 92/65/EEC laying down animal health requirements governing trade in and imports into the Community of animals, semen, ova and embryos not subject to animal health requirements laid down in specific Community rules referred to in Annex A (I) to Directive 90/425/EEC










—


Regulation (EC) No 21/2004 establishing a system for the identification and registration of ovine and caprine animals










—


Directive 2006/88/EC on animal health requirements for aquaculture animals and products thereof, and on the prevention and control of certain diseases in aquatic animals








Regulation (EC) No 1255/97 concerning Community criteria for control posts and amending the route plan referred to in the Annex to Directive 91/628/EEC




Regulation (EC) No 494/98 laying down detailed rules for the implementation of Regulation (EC) No 820/97 as regards the application of minimum administrative sanctions in the framework of the system for the identification and registration of bovine animals




Regulation (EC) No 1760/2000 establishing a system for the identification and registration of bovine animals and regarding the labelling of beef and beef products




Regulation (EC) No 999/2001 laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies




Regulation (EC) No 1082/2003 laying down detailed rules for the implementation of Regulation (EC) No 1760/2000 as regards the minimum level of controls to be carried out in the framework of the system for the identification and registration of bovine animals




Regulation (EC) No 1505/2006 implementing Regulation (EC) No 21/2004 as regards the minimum level of checks to be carried out in relation to the identification and registration of ovine and caprine animals




Regulation (EU) 2016/429 on transmissible animal diseases and amending and repealing certain acts in the area of animal health (‘Animal Health Law’) (from 21 April 2021)


















(e)


Prevention and minimisation of risks to human and animal health arising from animal by-products and derived products.








Regulation (EC) No 1069/2009 laying down health rules as regards animal by-products and derived products not intended for human consumption




Regulation (EU) No 142/2011 implementing Regulation (EC) No 1069/2009 and implementing Directive 97/78/EC as regards certain samples and items exempt from veterinary checks at the border under that Directive


















(f)


Welfare requirements for animals.








Regulation (EC) No 1255/97 concerning Community criteria for control posts and amending the route plan referred to in the Annex to Directive 91/628/EEC




Directive 98/58/EC concerning the protection of animals kept for farming purposes




Directive 1999/74/EC laying down minimum standards for the protection of laying hens




Regulation (EC) No 1/2005 on the protection of animals during transport and related operations




Directive 2007/43/EC laying down minimum rules for the protection of chickens kept for meat production




Directive 2008/119/EC laying down minimum standards for the protection of calves




Directive 2008/120/EC laying down minimum standards for the protection of pigs




Regulation (EC) No 1099/2009 on the protection of animals at the time of killing


















(g)


Protective measures against pests of plants.








Regulation (EU) 2016/2031 on protective measures against pests of plants




Regulation (EU) 2019/66 on rules on uniform practical arrangements for the performance of official controls on plants, plant products and other objects in order to verify compliance with Union rules on protective measures against pests of plants applicable to those goods


















(h)


Requirements for the placing on the market and use of plant protection products and the sustainable use of pesticides, with the exception of pesticides application equipment.








Regulation (EC) No 1107/2009 concerning the placing of plant protection products on the market




Directive 2009/128/EC establishing a framework for Community action to achieve a sustainable use of pesticides


















(i)


Organic production and labelling of organic products.








Regulation (EC) No 834/2007 on organic production and labelling of organic products (until 31 December 2020)




Regulation (EC) No 889/2008 laying down detailed rules for the implementation of Regulation (EC) No 834/2007 on organic production and labelling of organic products with regard to organic production, labelling and control




Regulation (EC) No 1235/2008 laying down detailed rules for implementation of Regulation (EC) No 834/2007 as regards the arrangements for imports of organic products from third countries




Regulation (EU) No 392/2013 amending Regulation (EC) No 889/2008 as regards the control system for organic production




Regulation (EU) No 1308/2013 establishing a common organisation of the markets in agricultural products




Regulation (EU) 2018/848 on organic production and labelling of organic products and repealing Council Regulation (EC) No 834/2007 (from 1 January 2021)


















(j)


Use and labelling of protected designations of origin, protected geographical indications and traditional specialities guaranteed.








Regulation (EC) No 178/2002 (Article 53)




Regulation (EC) No 110/2008 on the definition, description, presentation, labelling and the protection of geographical indications of spirit drinks




Regulation (EU) No 1151/2012 on quality schemes for agricultural products and foodstuffs




Regulation (EU) No 251/2014 on the definition, description, presentation, labelling and the protection of geographical indications of aromatised wine products




Regulation (EU) No 664/2014 supplementing Regulation (EU) No 1151/2012 with regard to the establishment of the Union symbols for protected designations of origin, protected geographical indications and traditional specialities guaranteed and with regard to certain rules on sourcing, certain procedural rules and certain additional transitional rules




Regulation (EU) No 668/2014 laying down rules for the application of Regulation (EU) No 1151/2012




REGARDING ARTICLE 1(3) OF REGULATION (EU) 2017/625:





Regulation (EC) No 1235/2008 laying down detailed rules for implementation of Regulation (EC) No 834/2007 as regards the arrangements for imports of organic products from third countries




Implementing acts adopted in accordance with Article 53 of Regulation (EC) No 178/2002 related to emergency measures for food and feed of Community origin or imported from a third country




Regulation (EU) 2019/478 amending Regulation (EU) 2017/625 of the European Parliament and of the Council as regards the categories of consignments to be subjected to official controls at border control posts




Regulation (EU) 2019/625 supplementing Regulation (EU) 2017/625 of the European Parliament and of the Council with regard to requirements for the entry into the Union of consignments of certain animals and goods intended for human consumption




Regulation (EU) 2019/1012 supplementing Regulation (EU) 2017/625 by derogating from the rules on the designation of control points and from the minimum requirements for border control posts




Regulation (EU) 2019/1013 on prior notification of consignments of certain categories of animals and goods entering the Union




Regulation (EU) 2019/1014 to lay down detailed rules on minimum requirements for border control posts, including inspection centres, and for the format, categories and abbreviations to use for listing border control posts and control points




Regulation (EU) 2019/1081 establishing rules on specific training requirements for staff for performing certain physical checks at border control posts




Regulation (EU) 2019/1666 supplementing Regulation (EU) 2017/625 as regards conditions for monitoring the transport and arrival of consignments of certain goods from the border control post of arrival to the establishment at the place of destination in the Union




Regulation (EU) 2019/1793 on the temporary increase of official controls and emergency measures governing the entry into the Union of certain goods from certain third countries implementing Regulations (EU) 2017/625 and (EC) No 178/2002 and repealing Regulations (EC) No 669/2009, (EU) No 884/2014, (EU) 2015/175, (EU) 2017/186 and (EU) 2018/1660




Regulation (EU) 2019/1873 on the procedures at border control posts for a coordinated performance by competent authorities of intensified official controls on products of animal origin, germinal products, animal by-products and composite products




Regulation (EU) 2019/2074 supplementing Regulation (EU) 2017/625 as regards rules on specific official controls on consignments of certain animals and goods originating from, and returning to the Union following a refusal of entry by a third country




Regulation (EU) 2019/2122 supplementing Regulation (EU) 2017/625 as regards certain categories of animals and goods exempted from official controls at border control posts, specific controls on passengers’ personal luggage and on small consignments of goods sent to natural persons which are not intended to be placed on the market and amending Commission Regulation (EU) No 142/2011




Regulation (EU) 2019/2123 supplementing Regulation (EU) 2017/625 as regards rules for the cases where and the conditions under which identity checks and physical checks on certain goods may be performed at control points and documentary checks may be performed at distance from border control posts




Regulation (EU) 2019/2124 supplementing Regulation (EU) 2017/625 as regards rules for official controls of consignments of animals and goods in transit, transhipment and onward transportation through the Union, and amending Regulations (EC) No 798/2008, (EC) No 1251/2008, (EC) No 119/2009, (EU) No 206/2010, (EU) No 605/2010, (EU) No 142/2011, (EU) No 28/2012, Regulation (EU) 2016/759 and Decision 2007/777/EC




Regulation (EU) 2019/2125 supplementing Regulation (EU) 2017/625 as regards rules concerning the performance of specific official controls of wood packaging material, notification of certain consignments and measures to be taken in cases of non-compliance




Regulation (EU) 2019/2126 supplementing Regulation (EU) 2017/625 as regards rules for specific official controls for certain categories of animals and goods, measures to be taken following the performance of such controls and certain categories of animals and goods exempted from official controls at border control posts




Regulation (EU) 2019/2129 establishing rules for the uniform application of frequency rates for identity checks and physical checks on certain consignments of animals and goods entering the Union




Regulation (EU) 2019/2130 establishing detailed rules on the operations to be carried out during and after documentary checks, identity checks and physical checks on animals and goods subject to official controls at border control posts









ANNEX 2
Guidance on the format of the MANCP
In order to promote a consistent and comprehensive approach to the organisation and implementation of official controls, Member States may choose to present their MANCP in accordance with the following optional format.
1.   Title

Multi-annual national control plan, in accordance with Articles 109 to 111 of Regulation (EU) 2017/625, presented by (country name) for the period from (year) to (year) (1).
2.   Single body in Member State (for communication regarding the plan)

Single body (may be a unit or office of a named administration):






Address:


 




Email address:


 




Telephone:


 




Website


 




3.   Content of the MANCP

3.1   
Strategy and context


3.1.1   Strategic objectives of the MANCP (Reference Guidance: Section D.1.1)

List the strategic objectives, e.g.








Areas


Objectives


Indicators


Comment




Area 1


Objective 1


Indicator 1


 




 


 


Indicator 2


 




 


 


Indicator n


 




3.1.2   Risk categorisation (Reference Guidance: Section D.1.2)

Risk Categorisation per activity, e.g.









 


Risk 1


Risk 2


Risk 3


Risk n




Activity 1


 


 


 


 




Activity 2


 


 


 


 




Activity 3


 


 


 


 




3.2   
Structural framework for official controls


3.2.1   Designation of competent authorities (Reference Guidance: Section D.2.1)

For designated competent authorities (designation, structure and organisation on a national basis), provide an overview of the:






—


areas of competence/scope of responsibilities,










—


reporting and communication channels.




Organisational charts or tables may be used to describe the structure, responsibilities, reporting or communication channels, etc.
National reference laboratories:









National reference laboratory


Accreditation number


Competent authority responsible


Designated analytical activities


Proficiency/ring tests programmes




 


 


 


 


 




Or provide a link to where this list can be found.
Describe:






—


the quality control or management systems applied in each national reference laboratory,










—


the arrangements for the planning and conduct of proficiency/ring tests and the programme for proficiency/ring tests during the duration of the MANCP as applicable,










—


the arrangements to ensure that national reference laboratories designated in accordance with Article 100(1) of Regulation (EU) 2017/625 conform to and operate in accordance with Article 100 of that Regulation.




3.2.2   Delegation to delegated bodies or natural persons (Reference Guidance: Section D.2.2)









Delegating competent authority


Delegated bodies or natural persons or category of delegated body or natural person as appropriate


Official control tasks delegated


Accreditation number or type of accreditation required




 


 


 


 




Describe the arrangements to ensure that the legislative requirements regarding delegation of control tasks to delegated bodies or natural persons are met.
Describe the arrangements in place to ensure efficient and effective coordination between the competent authorities and the delegated bodies or natural persons.
If not included in the list above, provide (a) link(s) to where the list of delegated bodies or natural persons can be found.
3.3   
General organisation and management of official controls (Reference Guidance: Sections D.3 and C.2 to C.5)


3.3.1   Competent authority

Describe, as applicable, the:






—


internal organisation and structure in general terms,










—


human resources available for the purpose of performing official controls (full-time equivalents),










—


resources supporting official control actions,










—


laboratory facilities,










—


other resources/infrastructure.




Complete individually for each designated competent authority. However, this information may be aggregated at national or regional level for the same category of regional or local competent authorities. The information on competent authorities may be presented per area, for example as in the following manner:
‘Area 1 - Food and food safety, integrity and wholesomeness at any stage of production, processing and distribution of food, including rules aimed at ensuring fair practices in trade and protecting consumer interests and information, and the manufacture and use of materials and articles intended to come into contact with food
Central Competent Authorities (CCA)






Competent Authority CCA 1


 




Competent Authority CCA 2


 




Etc.


 







Regional (for example, Federal/Provincial) Competent Authorities (RCA)






Competent Authority RCA 1 or Category 1


 




Competent Authority RCA 2 or Category 2


 




Competent Authority RCA 3 or Category 3


 




Etc.


 




Local (for example, District/Municipal) Competent Authorities (LCA)






Competent Authority LCA 1 or Category 1


 




Competent Authority LCA 2 or Category 2


 




Competent Authority LCA 3 or Category 3


 




Etc.


 




For laboratories (other than national reference laboratories), describe the procedures for:






—


designation of laboratories,










—


ensuring that requirements which apply to official laboratories are met.




Provide (a) link(s) to where the lists of designated official laboratories can be found.
Area 2 - Deliberate release into the environment of Genetically Modified Organisms (GMOs) for the purpose of food and feed production
…’
3.3.2   Control systems (by area, including horizontal arrangements where applicable)

For each of the control systems below describe the measures to:






—


manage coordination between competent authorities with related responsibilities,










—


ensure efficient and effective cooperation both within and between competent authorities,










—


ensure that all areas where coordination and cooperation are required, both within and between competent authorities, are addressed.




Describe the arrangements to ensure the following:






—


impartiality, quality and consistency of official controls,










—


staff are free from conflict of interest,










—


adequate laboratory capacity,










—


sufficient number of suitably qualified & experienced staff,










—


adequate facilities & equipment,










—


adequate legal powers,










—


operators cooperate with staff performing official controls,










—


documented procedures are available,










—


records are maintained,










—


transparency of official controls.




For each of the control systems describe:






—


the control methods and techniques used and where and when applied,










—


control priorities, resource allocation and how they relate to risk categorisation,










—


verification of planned arrangements including reporting arrangements,










—


arrangements for the application of horizontal legislation across different areas,










—


how specific control plans or programmes required by Union legislation are integrated into the control systems for the relevant areas as appropriate.






‘1.


Control system for food and food safety, integrity and wholesomeness at any stage of production, processing and distribution of food, including rules aimed at ensuring fair practices in trade and protecting consumer interests and information, and the manufacture and use of materials and articles intended to come into contact with food






Coordination and cooperation


 




 


 




Quality and transparency of official controls


 




 


 




Implementation and Supervision of official controls


 




 


 




Arrangements for the application of horizontal legislation


 




 


 




Specific control plans or programmes


 














2.


Control system for deliberate release into the environment of Genetically Modified Organisms (GMOs) for the purpose of food and feed production.










—


…’








3.3.3   Training arrangements

These may be included under each competent authority or per category of competent authority where there are equivalent systems, as appropriate. If appropriate, the training arrangements may be described per area.
Describe the arrangements for:






—


identification of training needs,










—


implementing training plan(s),










—


recording and evaluating training.




3.3.4   Describe the process for the adjustment and review of the MANCP.

Describe the arrangements for:






—


audits of competent authorities including the frequency and nature of the audits,










—


ensuring that competent authorities take appropriate measures in the light of results of these audits,










—


ensuring that these audits are subject to independent scrutiny and are carried out in a transparent manner.




3.4   
Incident/emergency management (Reference Guidance: Sections D.4.1 and D.4.2))


This section should be completed on a national basis.
For contingency plans, describe the:






—


sectors/subjects/areas where contingency plans are in place,










—


scope of each contingency plan,










—


competent authority or authorities responsible,










—


arrangements for dissemination and training to ensure effective implementation including simulation exercises.
Arrangements for mutual assistance:






Liaison body/bodies


Area(s) of responsibility




 


 




Use of EU databases:






RASFF


 




AAC


 




EUROPHYT


 




TRACES


 




BOVEX


 




ADNS


 










(1)  Period of validity of the plan.