ANNEX

Guidelines for single integrated multi-annual national control plans as provided for in Article 41 of Regulation (EC) No 882/2004

Contents

1.

Purpose of the Guidelines

2.

Definitions

3.

Guidance on the legal requirements for national control plans

3.1.

National control plans

3.2.

General requirements for national control plans

3.3.

Strategic objectives of national control plans

3.4.

Risk categorisation

3.5.

Designation of competent authorities

3.6.

General organisation and management

3.7.

Control systems and coordination of activities

3.8.

Delegation to control bodies

3.9.

Compliance with operational criteria

3.10.

Training of staff performing official controls

3.11.

Documented procedures

3.12.

Operational contingency plans

3.13.

Organisation of cooperation and mutual assistance

3.14.

Adjustment of national control plans

4.

Guidance on the format of single integrated multi-annual national control plans

4.1.

Title

4.2.

Contact point in Member State

4.3.

Content of plan

4.3.1.

Overall national strategic objectives

4.3.2.

Designation of the competent authorities, national reference laboratories and delegated control bodies

4.3.3.

Organisation and management of official controls by competent authorities

4.3.4.

Contingency plans and mutual assistance

4.3.5.

Arrangement for audit of competent authorities

4.3.6.

Measures to ensure compliance with the operational criteria of Regulation (EC) No 882/2004

4.3.7.

Review and adjustment of national control plans

5.

Guidance on the scope of single integrated multi-annual national control plans

1.   PURPOSE OF THE GUIDELINES

These guidelines are to assist Member States in preparing the single integrated multi-annual national control plan provided for in Article 41 of Regulation (EC) No 882/2004 (the national control plan). They provide guidance on the requirements for the national control plans as set out in Article 42(2) of that Regulation.

2.   DEFINITIONS

2.1.   For the purposes of these guidelines, the definitions laid down in Articles 2 and 3 of Regulation (EC) No 178/2002, Article 2 of Regulation (EC) No 882/2004 and other relevant Community legislation shall apply.

In particular, the following definitions set out in those Regulations are to be noted:

(a)

‘food law’ means the laws, regulations and administrative provisions governing food in general, and food safety in particular, whether at Community or national level; it covers any stage of production, processing and distribution of food and also of feed produced for, or fed to, food producing animals. (Point 1 of Article 3 of Regulation (EC) No 178/2002);

(b)

‘feed law’ means the laws, regulations and administrative provisions governing feed in general and feed safety in particular, whether at Community or national level; it covers all stages of production, processing and distribution of feed and the use of feed. (Point 3 of the second paragraph of Article 2 of Regulation (EC) No 882/2004);

(c)	‘official control’ means any form of control that the competent authority or the Community performs for the verification of compliance with feed and food law, animal health and animal welfare rules. (Point 1 of the second paragraph of Article 2 of Regulation (EC) No 882/2004);

(d)

‘competent authority’ means the central authority of a Member State competent for the organisation of official controls or any other authority to which that competence has been conferred; it shall also include, where appropriate, the corresponding authority of a third country. (Point 4 of the second paragraph of Article 2 of Regulation (EC) No 882/2004); With regard to plant health, ‘competent authority’ includes the ‘single authority’ referred to in Article 1(4) of Directive 2000/29/EC and ‘responsible official bodies’ referred to in Article 2(1)(g) of that Directive; With regard to organic production of agricultural products covered by Council Regulation (EEC) No 2092/91 (1), ‘competent authority’ includes the ‘authority’ designated for the reception of notifications provided for in Article 8(2) of Regulation (EEC) No 2092/91 and the authority designated for the approval and supervision of private bodies as provided for in Article 9(4) of that Regulation;

(e)

‘control body’ means an independent third party to which the competent authority has delegated certain control tasks. (Point 5 of the second paragraph of Article 2 of Regulation (EC) No 882/2004); With regard to plant health, ‘control body’ includes ‘legal persons’ with delegated tasks as referred to in Article 2(1)(g) of Directive 2000/29/EC; With regard to organic production of agricultural products covered by Council Regulation (EEC) No 2092/91, ‘control body’ includes ‘approved private bodies’ referred to in Article 9 of Regulation (EEC) No 2092/91;

(f)	‘control plan’ means a description established by the competent authority containing general information on the structure and organisation of its official control system. (Point 20 of the second paragraph of Article 2 of Regulation (EC) No 882/2004);

(g)	‘risk’ means a function of the probability of an adverse health effect and the severity of that effect, consequential to a hazard. (Point 9 of Article 3 of Regulation (EC) No 178/2002); With regard to plant health, ‘risk’ must be interpreted in accordance with Directive 2000/29/EC.

2.2.   In addition to the definitions referred to in 2.1, the following definitions apply for the purpose of these guidelines:

(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 national control plan and of Community law.

(b)	‘production chain’ means the full chain of production incorporating all ‘stages of production, processing and distribution’, as defined in point 16 of Article 3 of Regulation (EC) No 178/2002, including, where appropriate, all stages of non-food chain related animal and plant production.

(c)	‘production stage’ means any stage in the production chain for a commodity, including import, from and including the primary production up to and including processing, manufacture, storage, transport, distribution, sale or supply to the final consumer.

(d)	‘sector’ means the full production chain for a particular commodity or group of commodities and which may involve the activities of one or more competent authorities.

3.   GUIDANCE ON LEGAL REQUIREMENTS FOR NATIONAL CONTROL PLANS

Note regarding references to Community legislation

In these guidelines a reference to a Community act means, unless a contrary intention is indicated, a reference to that act as last amended.

3.1.   NATIONAL CONTROL PLANS

3.1.1.   RELEVANT COMMUNITY LEGISLATION

Article 41 of Regulation (EC) No 882/2004 provides:

Article 27a of Directive 2000/29/EC provides:

3.1.2.   GUIDANCE/DEFINITION OF REQUIREMENT

3.1.2.1.   Scope of the national control plans

National control plans should cover the full legislative scope of Regulation (EC) No 882/2004, including plant health, in so far as provided for in Article 27a of Directive 2000/29/EC. It should be noted that with regard to feed and food law and animal health and animal welfare legislation, national control plans are required to cover all official controls relating to all relevant Community legislation and not just those relating to feed and food hygiene and safety.

Therefore with regard to official controls on feed and food, the national control plans should cover all feed and food law including, for example, feed and food hygiene, materials in contact with food, genetically modified organisms (GMOs), irradiation (2), quality and compositional requirements of feed and food law, labelling, nutritional aspects, organic farming, agricultural products and foodstuffs as traditional specialities guaranteed (3) and protection of geographical indications and designations of origin for agricultural products and foodstuffs (4). In relation to animal health, all diseases and issues regulated by Community law should also be included.

The national control plans should cover all relevant commodities: food, feed, and non-food commodities of both animal and non-animal origin, including animal by-products, and all production stages, (including, as applicable, importation, primary production, processing, manufacture up to and including storage, transport, distribution and sale or supply to the final consumer). With regard to plant health, all controls required under Directive 2000/29/EC should be included in the national control plans.

See Section 5 for further clarification on the scope of the national control plans.

3.1.2.2.   Application to Plant Health

Article 27a of Directive 2000/29/EC provides that Articles 41 to 46 of Regulation (EC) No 882/2004 are to apply to plant health. However, the information required under Articles 42(2)(f) to (k) of that Regulation refers to provisions of the Regulation that are not applicable to plant health.

It should also be noted that as provided for by Articles 42(2)(f), 42(2)(h), 42(2)(i) and 42(2)(k) of Regulation (EC) 882/2004, Directive 2000/29/EC has corresponding or equivalent provisions in respect of plant health. Please refer to:

—	Article 42(2)(f) — delegation of tasks to control bodies for which guidance is set out at Section 3.8 of these Guidelines,

—	Article 42(2)(h) — training of staff performing official controls for which guidance is set out at Section 3.10 of these Guidelines,

—	Article 42(2)(i) — documented procedures for which guidance is set out in Section 3.11 of these Guidelines,

—	Article 42(2)(k) — organisation of cooperation and mutual assistance for which guidance is set out in Section 3.13 of these Guidelines.

Information concerning the arrangements to comply with these matters in respect of Directive 2000/2029 should be included in the national control plans.

These guidelines on the requirements of Article 42(2)(c), (d) and (e) contain some additional references to provisions of Regulation (EC) No 882/2004 which are not applicable to plant health. When addressing these requirements it is not necessary to apply those aspects of these guidelines to plant health. For example, the guidelines at Section 3.6 refer to audits of competent authorities as required by Article 4(6) of Regulation (EC) No 882/2004 which are not applicable to plant health. However, if Member States carry out such audits, or apply other provisions of the guidelines in relation to official controls in respect of plant health they may provide this information on a voluntary basis in their description of their control system for plant health.

3.1.2.3.   Single integrated multi-annual national control plans

Article 41 of Regulation (EC) No 882/2004 provides that each Member State is to prepare a single integrated multi-annual national control plan. Those national control plans should apply to official controls by all competent authorities at all levels (central, regional and local), as applicable according to national arrangements for official controls.

For Member States with decentralised administrations, the national control plan should outline how coordination between the various administrations is ensured in order to arrive at a single integrated national control plan.

A simple compilation of individual competent authority or sectoral plans which does not address the integration and coordination of official controls within and across competent authorities and sectors, with regard to related official controls, does not satisfy the requirement for a single integrated multi-annual national control plan.

Competent authorities should devise appropriate systems for the integrated planning, development and coordination of activities regarding national control plans. This process should include putting in place arrangements for the transmission of a single national control plan to the Commission and the identification of a single contact point in the Member State for communications regarding the national control plan.

When preparing a single national control plan, Member States should provide that during its implementation, evidence of compliance is gathered, retained and made available to any body involved in carrying out audits, and to the Commission upon request, to allow verification of its effective implementation. Such evidence should include written procedures, documentation and records of official controls.

3.1.2.4.   Periodicity (length of planning cycle)

The period of validity/duration of the national control plan 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 national control plan.

It is suggested that in order to be multi-annual, the national control 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 national control plan and updated on an ongoing basis in conjunction with the preparation of the annual report required under Article 44(1) of Regulation (EC) No 882/2004. In that respect, please refer to the provisions regarding the adjustment or amendment of the national control plan as provided for in Article 42(3) of that Regulation.

3.2.   GENERAL REQUIREMENTS FOR NATIONAL CONTROL PLANS

3.2.1.   RELEVANT COMMUNITY LEGISLATION

Article 42(2) of Regulation (EC) No 882/2004 provides:

Article 27a of Directive 2000/29/EC provides that that provision of Regulation (EC) No 882/2004 also applies to plant health.

3.2.2.   GUIDANCE/DEFINITION OF REQUIREMENT

National control plans are required to contain general information on the structure and organisation of the Member States systems of official controls covering all sectors and all stages of the feed and food production chain, animal health, animal welfare and, as is provided for by Article 27a of Directive 2000/29/EC, plant health. Although general in nature, the national control plans are required to include information on the specific issues provided for in Article 42(2)(a) to (k) of Regulation (EC) No 882/2004. Guidance on those specific issues is set out in Sections 3.3 to 3.13 of these Guidelines. In addition, Section 3.14 of these Guidelines contains guidance on adjustments of the national control plans.

Specific control plans, provided for under other relevant Community legislation are not replaced by the national control plans. However, the national control plans should integrate the planning and implementation of such specific control plans into the overall national control plans. A general description of the structure and organisation of the system of official controls for each of these specific areas should be included in the national control plans, and that description may make cross-references to the specific control plans.

3.3.   STRATEGIC OBJECTIVES OF NATIONAL CONTROL PLANS

3.3.1.   RELEVANT COMMUNITY LEGISLATION

Article 42(2)(a) of Regulation (EC) No 882/2004 provides:

Article 27a of Directive 2000/29/EC provides that that provision of Regulation (EC) No 882/2004 also applies to plant health.

3.3.2.   GUIDANCE/DEFINITION OF REQUIREMENT

Taking into account that the main objective of Regulation (EC) No 882/2004 is to ensure effective enforcement of feed and food law and rules applicable to animal health, animal welfare, and plant health as provided for by Article 27a of Directive 2000/29/EC and the general obligation on Member States to enforce Community law, Member States should develop appropriate objectives and strategies to achieve that purpose. Those objectives and strategies should form the basis of and be briefly set out in a single integrated multi-annual national control plan.

The strategy adopted by the Member State may involve the concentration or prioritisation of official controls or the allocation of resources on certain activities or at certain stages of the production chain. Where this is the case, such concentration or priorities and the reasons therefore, should be indicated in the national control plan.

3.4.   RISK CATEGORISATION

3.4.1.   RELEVANT COMMUNITY LEGISLATION

Article 42(2)(b) of Regulation (EC) No 882/2004 provides:

Article 27a of Directive 2000/29/EC provides that that provision of Regulation (EC) No 882/2004 also applies to plant health.

3.4.2.   GUIDANCE/DEFINITION OF REQUIREMENT

Taking into account that with regard to feed and food law and animal health and animal welfare, Article 3(1) of Regulation (EC) No 882/2004 requires official controls to be carried out on a risk basis with appropriate frequency, national control plans should indicate the risk categorisation, if any, assigned to the various activities subject to official controls.

It should be noted that Article 3(1) of Regulation (EC) No 882/2004 does not apply to plant health. However, where Member States assign a risk categorisation for the performance of official controls under Directive 2000/29/EC a description of the risk categorisation, applied for those purposes should be provided in the national control plans.

A brief description of the process of risk categorisation used by the Member State may be included in the national control plan, if desired. That information may, at a future date, contribute to the development of guidelines concerning the identification of risk-based priorities and the most effective official control procedures, as provided for by Article 43(1)(b) of Regulation (EC) No 882/2004.

3.5.   DESIGNATION OF COMPETENT AUTHORITIES

3.5.1.   RELEVANT COMMUNITY LEGISLATION

Article 42(2)(c) of Regulation (EC) No 882/2004 provides:

Article 27a of Directive 2000/29/EC provides that that provision of Regulation (EC) No 882/2004 also applies to plant health.

3.5.2.   GUIDANCE/DEFINITION OF REQUIREMENT

National control plans should provide a comprehensive overview of the structure and tasks of the competent authorities.

The national control plans should:

(a)

identify the organisations, or, where appropriate, the categories of organisations, that are designated as competent authorities responsible for official controls; all competent authorities, or where appropriate the category of competent authority, at all levels, (central, regional and local level) should be identified, as should all control bodies to which certain official control tasks have been delegated in relation to plant health;

(b)	describe the allocation of official control tasks and responsibilities for the entire feed and food production chain, and for animal health, animal welfare and plant health;

(c)	indicate the resources (see guidance at the fourth paragraph of this Section), available to the competent authorities;

(d)	list the national reference laboratories designated in accordance with Article 33(1) of Regulation (EC) No 882/2004, the areas for which they are designated as responsible and the competent authority responsible for the laboratory.

The information referred to in points (a) to (d) may be illustrated in the form of an integrated national-level organigramme 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 authorised 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 and made available for Community audits and inspections.

When addressing this requirement, Member States should include the organisations equivalent to competent authorities under Article 1(4) and Article 2(1)(g) of Directive 2000/29/EC and Article 8(2) of Regulation (EEC) No 2092/91.

3.6.   GENERAL ORGANISATION AND MANAGEMENT

3.6.1.   RELEVANT COMMUNITY LEGISLATION

Article 42(2)(d) of Regulation (EC) No 882/2004 provides:

Article 27a of Directive 2000/29/EC provides that that provision of Regulation (EC) No 882/2004 also applies to plant health.

3.6.2.   GUIDANCE/DEFINITION OF REQUIREMENT

Article 42(2)(d) of Regulation 882/2004 provides for the national control plan to contain a general description of the organisation and structure of each organisation, designated as a competent authority, at all levels taking account of the specific requirements of Regulation (EC) No 882/2004, where applicable. 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 national control plan should describe how official controls, including import controls, are organised and managed at national, regional and local level.

For the purpose of completing the national control plan, the descriptions of the organisation and management of official controls may be provided under the headings of feed and food law, animal health, animal welfare and plant health law.

3.6.2.1.   The national control plans should include a general description of:

(a)	the organisation of the competent authorities;

(b)	the hierarchical relationships and reporting arrangements within and between competent authorities and with control bodies;

(c)	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 4(4) of Regulation (EC) No 882/2004;

(d)	for plant health, the legal and administrative powers that the competent authorities and control bodies have to enforce the applicable legislation, (for other areas, this matter is covered under Section 3.9);

(e)	the procedure for the designation of laboratories for the analysis of samples taken during official controls and the arrangements to ensure that such laboratories conform to and operate in accordance with the European standards referred to in Article 12(2) of Regulation (EC) No 882/2004;

(f)	the arrangements to ensure that national reference laboratories designated in accordance with Article 33(1) of Regulation (EC) No 882/2004, conform to and operate in accordance with the requirements of Article 33 of that Regulation.

The national control plan should describe how the audits of competent authorities, to ensure effectiveness and suitability of official controls, as provided for by Article 4(6) of Regulation (EC) No 882/2004, are organised and managed at national, regional and local level.

3.6.2.2.   The national control plans should include a description of the arrangements in place:

(a)	for internal or external audits of competent authorities;

(b)	to ensure that competent authorities take appropriate measures in the light of the results of the audits referred to in point (a);

(c)	to ensure that the audits referred to in point (a) are subject to independent scrutiny and are carried out in a transparent manner.

Those arrangements should take account of the guidelines laying down the criteria for the conduct of audits as provided for in Commission Decision 2006/677/EC.

3.7.   CONTROL SYSTEMS AND COORDINATION OF ACTIVITIES

3.7.1.   RELEVANT COMMUNITY LEGISLATION

Article 42(2)(e) of Regulation (EC) No 882/2004 provides:

Article 27a of Directive 2000/29/EC provides that that provision of Regulation (EC) No 882/2004 also applies to plant health.

3.7.2.   GUIDANCE/DEFINITION OF REQUIREMENT

3.7.2.1.   Organisation of official controls

3.7.2.1.1.   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 feed and food law, animal health, animal welfare and plant health law;

(b)	the role of prioritisation in determining the balance between tasks and resources;

(c)	the specific national control plans or programmes provided for by Community legislation;

(d)	any specific national disease control or eradication plans;

(e)	any relevant risk categorisations.

3.7.2.1.2.   The national control plan should describe:

(a)

the official control systems applied to different sectors, 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 10 and 11 of Regulation (EC) No 882/2004, 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 of all feed and food, animals and products of animal origin;

(b)	how the risk categories referred to in Section 3.4.1 are applied to target official controls effectively;

(c)

how the official control arrangements for horizontally applicable Community legislation and the specific control plans referred to in Section 3.2.2 are integrated into the official controls applicable to each relevant sector or sub-sector; where more than one sector or sub-sector is involved appropriate ‘linkages’ should be established between the different sectors or sub-sectors.

3.7.2.2.   Coordination and cooperation

Arrangements should be in place to ensure effective coordination of activities and cooperation within and between competent authorities, especially in relation to issues which involve joint action or cooperation between different services within a competent authority or between different 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 sub-sectors or different stages of the production chain and on the arrangements to ensure efficient and effective cooperation where competence is conferred on, or shared with regional and/or, local competent authorities.

National control plans should 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 sector, and 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(3) and Article 5 of Regulation (EC) No 882/2004 and Article 2(1)(g) of Directive 2000/29/EC; for example, formal arrangements for coordination of activities and ensuring consistency of officials 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, such as 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 if 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.

3.8.   DELEGATION TO CONTROL BODIES

3.8.1.   RELEVANT COMMUNITY LEGISLATION

Article 42(2)(f) of Regulation (EC) No 882/2004 provides:

Article 27a of Directive 2000/29/EC provides that that provision of Regulation (EC) No 882/2004 also applies to plant health, as regards responsible official bodies designated under Article 2(1)(g) of that Directive.

3.8.2.   GUIDANCE/DEFINITION OF REQUIREMENT

National control plans should where appropriate:

(a)	identify the competent authorities that delegate official control tasks to control bodies;

(b)	list the specific tasks delegated to each category of control body;

(c)

describe the arrangements in place to ensure that delegating competent authorities and control bodies meet, as applicable, the requirements of: (i) Article 5(2)(b), (c), (d) and (f) and Article 5(3) of Regulation (EC) No 882/2004; (ii) Annex II, Chapter II, point 2 of Regulation (EC) No 882/2004; (iii) Article 2(1)(g) of Directive 2000/29/EC with regard to plant health; (iv) Article 9 of Regulation (EEC) No 2092/91 with regard to organic farming; (v) Article 15 of Regulation (EC) No 509/2006 with regard to agricultural products and foodstuffs as traditional specialities guaranteed; (vi) Article 11 of Regulation (EC) No 510/2006 with regard to protection of geographical indications and designations of origin for agricultural products and foodstuffs.

Where the same official control tasks are delegated to a number of control bodies, the delegation of such tasks may, for the purposes of the national control plan be described in terms of category of control body.

Where that option is taken, the relevant competent authorities should maintain a comprehensive and up-to-date list of control bodies to whom official control tasks are delegated and make this list available for audits and inspections.

3.9.   COMPLIANCE WITH OPERATIONAL CRITERIA

3.9.1.   RELEVANT COMMUNITY LEGISLATION

Article 42(2)(g) of Regulation (EC) No 882/2004 provides:

3.9.2.   GUIDANCE/DEFINITION OF REQUIREMENT

That requirement does not apply to official controls regarding plant health. National control plans should describe the methods employed to ensure that organisations designated as competent authorities are effectively implementing the requirements of Article 4(2) of Regulation (EC) No 882/2004.

In particular, the national control plans should describe the arrangements in place to ensure the following, in respect of all competent authorities:

(a)	that effective and appropriate official controls are applied at all stages of production, processing and distribution of animals, food, feed and plants and the use of feed, as required by Article 4(2)(a) of Regulation (EC) No 882/2004;

(b)

that measures are in place to ensure that staff carrying out official controls 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, as required by Article 4(2)(b) of Regulation (EC) No 882/2004;

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

(d)

that all competent authorities have, or have access to, adequate laboratory capacity for testing and a sufficient number of suitably qualified and experienced staff so that official controls and control duties can be carried out efficiently and effectively, as required by Article 4(2)(c) of Regulation (EC) No 882/2004;

(e)	that all competent authorities have appropriate and properly maintained facilities and equipment to ensure that staff can perform official controls efficiently and effectively, as required by Article 4(2)(d) of Regulation (EC) No 882/2004;

(f)

that there are adequate legal powers to carry out official controls, as required by Article 4(2)(e) and taking account of the requirements of Article 8(2) and Articles 54 and 55 of Regulation (EC) No 882/2004, including the power to enter onto premises, to inspect animals, plants, products, 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;

(g)	that there are contingency plans in place, and competent authorities are prepared to operate such plans in the event of an emergency, as required by Article 4(2)(f) of Regulation (EC) No 882/2004;

(h)	that feed and food business operators are obliged to undergo any inspection carried out in accordance with Regulation (EC) No 882/2004 and to assist staff of the competent authority in the accomplishment of their tasks, as required by Article 4(2)(g) of Regulation (EC) No 882/2004.

3.10.   TRAINING OF STAFF PERFORMING OFFICIAL CONTROLS

3.10.1.   RELEVANT COMMUNITY LEGISLATION

Article 42(2)(h) of Regulation (EC) No 882/2004 provides:

Article 27a of Directive 2000/29/EC provides that provision of Regulation (EC) No 882/2004 also applies to plant health, as regards the requirements of Article 2(1)(i) of Directive 2000/2029/EC and points 1 and 2 of the Annex to Commission Directive 98/22/EC (5).

3.10.2.   GUIDANCE/DEFINITION OF REQUIREMENT

With regard to feed and food law, animal health and animal welfare, national control plans 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 6 of Regulation (EC) No 882/2004.

For all sectors, including plant health, national control plans 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.

With regard to plant health, national control plans should, in particular, describe how the requirements of Article 2(1)(i) of Directive 2000/29/EC and points 1 and 2 of the Annex to Directive 98/22/EC are met.

National control plans should, for all sectors, 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.

The documentation of such training by the competent authorities should include recording the subject and level of training, number of days training, and the number of participants. Those records should be maintained up-to-date and be available for audits and inspections.

Arrangements for the delegation of official control tasks to control bodies, should ensure that the staff of such control bodies have the necessary training, qualification and competencies to perform those tasks in an effective manner (see also guidance at Section 3.8.2).

3.11.   DOCUMENTED PROCEDURES

3.11.1.   RELEVANT COMMUNITY LEGISLATION

Article 42(2)(i) of Regulation (EC) No 882/2004 provides:

Article 27a of Directive 2000/29/EC provides that that provision of Regulation (EC) No 882/2004 also applies to plant health, as regards the requirements of points (a) and (b) of paragraph 1 of the Annex to Directive 98/22/EC.

3.11.2.   GUIDANCE/DEFINITION OF REQUIREMENT

With regard to feed and food law and animal health and animal welfare, the national control plan should describe the systems or arrangements in place to ensure the effective implementation of the requirements of Article 8(1) and (3) of Regulation (EC) No 882/2004, regarding documented procedures and Article 9 of that Regulation regarding reports on official controls.

For plant health, national control plans should, in particular, describe the systems or arrangements in place to ensure the effective implementation of point 1(a) and (b) of the Annex to Directive 98/22/EC.

3.11.2.1.   For all sectors, national control plans should describe the systems or arrangements in place to ensure that:

(a)	the relevant documented procedures are readily accessible to: (i) all staff performing official controls; (ii) the competent authorities concerned; (iii) the central competent authority; (iv) any body involved in carrying out audits; (v) the Commission upon request.

(b)	documented procedures are reviewed and updated at appropriate intervals.

A comprehensive list or index of documented procedures should be maintained by the competent authority and be available for audits and inspections.

3.11.2.2.   For all sectors, national control plans, 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 9(1) and (2) of Regulation (EC) No 882/2004, 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 body involved in carrying out audits;

(e)	the Commission upon request.

3.12.   OPERATIONAL CONTINGENCY PLANS

3.12.1.   RELEVANT COMMUNITY LEGISLATION

Article 42(2)(j) of Regulation (EC) No 882/2004 provides:

3.12.2.   GUIDANCE/DEFINITION OF REQUIREMENT

That requirement does not apply to official controls regarding plant health.

3.12.2.1.   This Section applies, in particular, to the contingency plans referred to in Article 4(2)(f) and Article 13(1) of Regulation (EC) No 882/2004, but reference should also be made to other contingency plans required under relevant Community legislation, such as:

(a)	Council Directive 2001/89/EC of 23 October 2001 on Community measures for the control of classical swine fever (6);

(b)	Council Directive 2003/85/EC of 29 September 2003 on Community measures for the control of foot-and-mouth disease repealing Directive 85/511/EEC and Decisions 89/531/EEC and 91/665/EC and amending Directive 92/46/EEC (7);

(c)	Council Directive 92/119/EEC of 17 December 1992 introducing general Community measures for the control of certain animal diseases and specific measures relating to swine vesicular disease (8).

3.12.2.2.   National control plans should:

(a)	indicate each of the sectors 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)	describe 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.

If appropriate, those arrangements may be described using an organigramme or table or other easily presented format.

3.13.   ORGANISATION OF COOPERATION AND MUTUAL ASSISTANCE

3.13.1.   RELEVANT COMMUNITY LEGISLATION

Article 42(2)(k) of Regulation (EC) No 882/2004 provides:

Article 27a of Directive 2000/29/EC provides that that provision of Regulation (EC) No 882/2004 also applies to plant health as regards the requirements of the second subparagraph of Article 12(4), Article 13c(2)(c) and Article 16(1) and (2) of Directive 2000/29/EC.

3.13.2.   GUIDANCE/DEFINITION OF REQUIREMENT

3.13.2.1.   With regard to feed and food law, the national control plans should:

(a)	describe the general arrangements in place to ensure that the requirements of Articles 34 to 39 of Regulation (EC) No 882/2004 are met;

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

3.13.2.2.   With regard to animal health (veterinary and zootechnical legislation), the national control plans should describe the general arrangements in place to ensure that the requirements of Council Directive 89/608/EEC (9) are met.

3.13.2.3.   With regard to plant health, the national control plans should describe the arrangements in place to comply with the second subparagraph of Article 12(4), Article 13c(2)(c) and Article 16(1) and (2) of Directive 2000/29/EC.

3.14.   ADJUSTMENT OF NATIONAL CONTROL PLANS

3.14.1.   RELEVANT COMMUNITY LEGISLATION

Article 42(3) of Regulation (EC) No 882/2004 provides:

Article 27a of Directive 2000/29/EC provides that that provision of Regulation (EC) No 882/2004 also applies to plant health.

3.14.2.   GUIDANCE/DEFINITION OF REQUIREMENT

Member States are reminded of their obligation to consider adjustments to the national control plan during its implementation in the light of the factors set out in Articles 42(3), 44(5) and 45(5) of Regulation (EC) No 882/2004 and for the inclusion of any subsequent adjustments in the annual report provided for in Article 44(1) of that Regulation.

The national control plan should therefore describe:

(a)	the process for the review of the operation of the national control plan that should take place annually as a contribution to the annual report on the implementation of the national control plan;

(b)	how the outcome of the audits of national competent authorities required under Article 4(6) of Regulation (EC) No 882/2004 shall feed into this process.

4.   GUIDANCE ON FORMAT OF SINGLE INTEGRATED MULTI-ANNUAL NATIONAL CONTROL PLANS

In order to have a consistent and comprehensive approach to the organisation and implementation of official controls the single integrated multi-annual national control plan should be presented in accordance with the following format.

4.1.   TITLE

Single integrated multi-annual national control plan presented by … (Member State) for the period from … to … (period of validity of the plan).

4.2.   CONTACT POINT IN MEMBER STATE (FOR COMMUNICATION REGARDING THE PLAN)

Contact point (may be a unit or office of a named administration and not necessarily a named individual official):
Address:
E-mail address:
Telephone:
Fax:

4.3.   CONTENT OF PLAN

4.3.1.

OVERALL NATIONAL STRATEGIC OBJECTIVES

4.3.2.

DESIGNATION, OF THE COMPETENT AUTHORITIES, NATIONAL REFERENCE LABORATORIES AND CONTROL BODIES

4.3.3.

ORGANISATION AND MANAGEMENT OF OFFICIAL CONTROLS BY COMPETENT AUTHORITIES

4.3.4.

CONTINGENCY PLANS & MUTUAL ASSISTANCE

4.3.5.

ARRANGEMENT FOR AUDIT OF COMPETENT AUTHORITIES

4.3.6.

MEASURES TO ENSURE COMPLIANCE WITH THE OPERATIONAL CRITERIA OF REGULATION (EC) No 882/2004

4.3.7.

REVIEW AND ADJUSTMENT OF THE NATIONAL CONTROL PLAN

4.3.1.   OVERALL NATIONAL STRATEGIC OBJECTIVES

Reference Guidance:	Section 3.1	National control plans
	Section 3.3	Strategic objectives of the national control plan

List Strategic objectives e.g.

Objective 1

Objective 2

Objective 3 etc.

4.3.2.   DESIGNATION OF THE COMPETENT AUTHORITIES, NATIONAL REFERENCE LABORATORIES AND DELEGATED CONTROL BODIES

Reference Guidance:	Section 3.5	Designation of competent authorities
	Section 3.8	Delegation to control bodies

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.

Delegation of official control tasks to control bodies

Competent authority responsible	Control bodies or category of control body as appropriate	Official control tasks delegated

Describe the arrangements to ensure that the legislative requirements regarding delegation of control tasks to control bodies are met.

National reference laboratories (10):

This requirement does not apply to official controls regarding plant health.

National reference laboratories	Competent authority responsible	Designated analytical activities

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

Describe arrangements for the planning and conduct of proficiency/ring tests and the programme for proficiency/ring tests during the duration of the national control plan as applicable.

Describe the arrangements to ensure that national reference laboratories designated in accordance with Article 33(1) of Regulation (EC) No 882/2004 conform to and operate in accordance with Article 33 of that Regulation.

4.3.3.   ORGANISATION AND MANAGEMENT OF OFFICIAL CONTROLS BY COMPETENT AUTHORITIES

Reference Guidance:	Section 3.2	General requirements for national control plans
	Section 3.4	Risk categorisation
	Section 3.6	General organisation and management
	Section 3.7	Control systems and coordination of activities
	Section 3.9	Compliance with operational criteria
	Section 3.10	Training of staff performing official controls
	Section 3.11	Documented procedures

Competent authority (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).

Describe 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

as applicable

The information on competent authorities may be presented on a sectoral basis (Food/Feed/Animal Health/Animal Welfare/Plant Health) for example as in the following manner:

Sector (namely the Food/Feed/Animal Health/Animal Welfare/Plant Health as appropriate)

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, 2, 3 …, and/or

Competent Authority ‘RCA Category 1, 2, 3 …’

Etc.

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

Competent Authority LCA 1 or Category 1

Competent Authority LCA 2 or Category 2

Etc.

Laboratories (other than national reference laboratories):

Describe procedures for:

—	designation of laboratories

—	ensuring that requirements which apply to official laboratories are met

Control systems (by sector, including horizontal arrangements where applicable)

For each of the following sectors 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 sectors/sub-sectors

—	how specific control plans or programmes required by Community legislation are integrated into the control systems for the relevant sectors or sub-sectors as appropriate.

1.	Control system for food law

2.	Control system for feed law

3.	Control system for animal health law

4.	Control system for animal welfare law

5.	Control system for plant health law

In relation to the control systems 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

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 on a sectoral basis).

Describe the arrangements for:

—	Identification of training needs

—	Implementing training plan(s)

—	Recording and evaluating training

4.3.4.   CONTINGENCY PLANS AND MUTUAL ASSISTANCE

Reference Guidance:	Section 3.12	Operational contingency plans
	Section 3.13	Organisation of cooperation and mutual assistance

This Section should be completed on a national basis

Contingency plans: (not applicable to plant health)

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 of responsibility

4.3.5.   ARRANGEMENTS FOR AUDIT OF COMPETENT AUTHORITIES (NOT APPLICABLE TO PLANT HEALTH)

Reference Guidance:

Section 3.6

General organisation and management

Describe the arrangements for:

—	internal or external 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

4.3.6.   MEASURES TO ENSURE COMPLIANCE WITH THE OPERATIONAL CRITERIA OF REGULATION (EC) No 882/2004 (NOT APPLICABLE TO PLANT HEALTH)

Reference Guidance:	Section 3.9	Compliance with operational criteria
	Section 3.11	Documented procedures

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

—	food & feed business operators cooperate with staff performing official controls

—	documented procedures are available

—	records are maintained

4.3.7.   REVIEW AND ADJUSTMENT OF NATIONAL CONTROL PLANS

Reference Guidance:

Section 3.14

Adjustment of national control plans

Describe the process for the review of the operation of the single integrated multi-annual national control plan.

5.   GUIDANCE ON THE SCOPE OF SINGLE INTEGRATED MULTI-ANNUAL NATIONAL CONTROL PLANS

The arrangements for all official controls coming within the scope of Regulation (EC) No 882/2004 should be addressed in the national control plan. The following tables give an indication of the range of legislation/topics to be addressed in the plan. It is not and does not purport to be, an exhaustive list of all the relevant legislative topics. Requirements of both primary legislation and implementing measures should be taken into account in preparing the national control plan.

ANIMAL HEALTH LAW INCLUDES

Live Animals	Aquaculture Bovine Equine Ovine and Caprine Porcine Poultry and Hatching Eggs Pets Others e.g. wild animals
Semen, Ova and Embryos	Bovine Equine Ovine and Caprine Porcine
Animal Diseases	Control measures — specific diseases — general Eradication and monitoring Animal Disease Notification System Animo/Traces Animal movement and traceability Community Reference Laboratories
Animal by-products
Animal identification	Bovine Equine Ovine and Caprine Porcine Pets
Import controls	all above categories as appropriate

ANIMAL WELFARE LAW INCLUDES

Welfare on farm
Welfare during transport
Welfare at slaughter

PLANT HEALTH LAW INCLUDES

Harmful organisms (within the meaning of Council Directive 2000/29/EC

Control measures required under Council Directive 2000/29/EC

FOOD AND FEED LAW INCLUDES

General Food and Feed Law	Operators responsibilities and procedures Official Controls Traceability Rapid Alert System Import Controls
Food Labelling and Nutrition	General Food Labelling Nutrition and Health Claims Nutrition Labelling Natural Mineral Waters Food Supplements Addition of Vitamins and Minerals Foods for Particular Nutritional Uses (Dietetic Food) Food Intended for Infants and Young Children Food for Weight Reduction Specific Food Products (Dietary foods for special medical purposes)
Hygiene (all food)	Food Hygiene (general all sectors and commodities) — primary production — processing — manufacture — storage — distribution — transport — retail Sampling and analysis Approval of establishments
Biological Safety	Salmonella and food-borne diseases Food Hygiene (food of animal origin) — meat/meat products/preparations etc. (including poultry meat) — game meat/products/preparations etc. — milk and milk products — eggs and egg products — fish/fishery products — aquaculture — bivalve molluscs — other products TSE’s Animal by-products (also animal health issue)
Chemical safety	Food Additives Food Flavourings Novel Foods Contaminants Residues — medicinal products — pesticides Hormones/prohibited substances in products of animal origin Sampling and Analysis Food Contact Materials
Community Reference Laboratories	Laboratories for both chemical and biological analysis
Irradiation	Directive 1999/2/EC of the European Parliament and of the Council
Biotechnology	GM Food and Feed GM Plants and Seeds
Other Food Law	Organic farming Agricultural Products and Foodstuffs as traditional specialities guaranteed Geographical Indications and Designations of Origin of agricultural products and foodstuffs
Fraudulent practices	e.g. false or misleading labelling, quality or compositional claims e.g. food or feed adulteration
Animal Nutrition	Feed Materials Feed Labelling Certain products used in animal nutrition — ‘Bioproteins’ (Council Directive 82/471/EEC (11)) Feed Additives Compound feedingstuffs (including pet food) Animal feedingstuffs for particular nutritional purposes Medicated feed Undesirable substances Methods of sampling and analysis Prohibited Substances Feed Hygiene

---

(1)   OJ L 198, 22.7.1991, p. 1.

(2)  Directive 1999/2/EC of the European Parliament and of the Council of 22 February 1999 on the approximation of the laws of the Member States concerning foods and food ingredients treated with ionising radiation (OJ L 66, 13.3.1999, p. 16).

(3)  Council Regulation (EC) No 509/2006 of 20 March 2006 on agricultural products and foodstuffs as traditional specialities guaranteed (OJ L 93, 31.3.2006, p. 1).

(4)  Council Regulation (EC) No 510 of 20 March 2006 on the protection of geographical indications and designations of origin for agricultural products and foodstuffs (OJ L 93, 31.3.2006, p. 12).

(5)   OJ L 126, 28.4.1998, p. 26.

(6)   OJ L 316, 1.12.2001, p. 5.

(7)   OJ L 306, 22.11.2003, p. 1.

(8)   OJ L 62, 15.3.1993, p. 69.

(9)   OJ L 351, 2.12.1989, p. 34.

(10)  National reference laboratories are not prescribed by Plant Health Law.

(11)  Council Directive 82/471/EEC of 30 June 1982 concerning certain products used in animal nutrition (OJ L 213, 21.7.1982, p. 8).