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Q&A notes for enforcement authorities on the animal health and animal welfare elements of Regulation (EC) 882/2004

Important note

These Notes set out Defra’s interpretation of the requirements under Regulation (EC) No 882/2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules (“Regulation 882/2004”). They do not have legal effect but are intended to offer guidance on the Regulation’s requirements. Ultimately, it would fall to the Courts to determine the full legal effect and interpretation of the Regulation.

These Notes should be read in conjunction with Regulation 882/2004 (Official Journal L191, 28.5.2004, 1-52) and, where appropriate, with other enforcement or operational instructions.

Introduction

These Notes relate primarily to the enforcement of animal health and animal welfare official controls in England. They are aimed mainly at those authorities responsible for monitoring and enforcement of animal health and animal welfare rules. For the purposes of these Notes, animal health includes fish health and bee health.

These Notes are not intended to cover the feed law or food law elements of Regulation 882/2004, for which the Food Standards Agency (FSA) has most of the responsibility, or to official controls on animal health and animal welfare in Scotland, Wales or Northern Ireland where the central authorities will be producing their own equivalent documents.

The FSA has published Q&A Notes for enforcement authorities in respect of the feed and food elements of Regulation 882/2004. The FSA’s Notes include coverage of those elements of feed and food law that are the responsibility of Defra, namely:

  • organic foods, including imported organic food products;
  • protected name food products and specified character foods;
  • veterinary medicines residues;
  • pesticide residues;
  • animal by-products (in relation to feed);
  • TSEs in relation to testing (including sampling) controls on bovine, ovine and caprine animals slaughtered for human consumption;
  • the import from third countries of, and intra-Community trade in, products of animal origin; and
  • beef labelling.
 

Regulation 882/2004 covers feed and food law, including plant-related food law in terms of residues, and animal health and animal welfare legislation. Plant health, i.e. diseases in crops and other plants, are not covered by Regulation 882/2004 other than in terms of the national control plan required under Article 41 of the Regulation. The Plant Health Directive, Council Directive 2000/29/EC on protective measures against the introduction into the Community of organisms harmful to plants or plant products and against their spread within the Community, was amended by Article 59 of Regulation 882/2004 to reflect this inclusion.

Although not actually part of the implementation package, an earlier version of these Notes were consulted on as part of the wider consultation on the Official Controls (Animals, Feed and Food) (England) Regulations 2006 providing for implementation in England of the requirements of Regulation 882/2004.

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General Information

General principles for enforcement arrangements in the Member States
General requirements for the competent authorities
Audit requirements for the competent authorities
Requirements in relation to control bodies
Requirements on staff performing official controls
Requirements for transparency
Requirements on control activities and reports
Requirements for sampling and analysis and for designation of official laboratories
Financing of official controls
Reference laboratories
National Controls Plans and Annual Reports to the Commission
Community controls in the Member States
Impact of Regulation 882/2004 on the livestock sector
Impact on consumers
Impact on the plant health regime

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General Information

Q1. What is Regulation 882/2004 about?

A1. It is about arrangements for the verification of compliance with animal health and animal welfare rules (as well as feed and food law). It sets out the general approach to be taken, and the principles to be adopted, by the competent authorities (see Q4 and Q5) in EU Member States that are responsible for organising and undertaking official controls (see Q6). Regulation 882/2004 also provides the legal basis for the European Commission to assess the effectiveness of national monitoring and enforcement arrangements, as well as providing a legal basis for Member States to introduce cost recovery or charging regimes for carrying out official controls.

Q2. Why has the Regulation been introduced?

A2. It has been introduced to address the wide variation in the manner in which Community legislation is implemented and enforced across the EU.

Q3. What are the aims and objectives of the Regulation?

A3. The aim is to create a more comprehensive, integrated, risk-based, EU-wide approach to official controls. The objective is to improve the consistency and effectiveness of official controls across the EU, thereby raising standards of animal health and animal welfare, with concomitant improvements in food safety and quality. It also aims to increase transparency about enforcement arrangements.

Q4. What are competent authorities?

A4. Competent authorities are defined specifically for the purposes of Regulation 882/2004 at Article 2(4). These are the central authority or authorities of a Member State that are responsible for national arrangements for execution and enforcement of feed and food and animal health and welfare law, as well as other authorities to whom such responsibility has been conferred, and who are responsible for organising compliance verification checks (i.e. carrying out official controls).

Q5. Who are the competent authorities in England?

A5. Execution and enforcement of animal health and animal welfare legislation is split between Defra (as central competent authority) and local authorities. Defra operates through its Executive Agencies, e.g. Animal Health - formerly the State Veterinary Service (SVS). Local authorities operate as competent authorities to the extent of their legal powers under relevant animal health and welfare law.

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Q6. What are official controls?

A6. Official controls are specifically defined for the purposes of Regulation 882/2004 at Article 2(1). They include:

  • enforcement checks carried out by the competent authorities in each Member State to monitor compliance with animal health and animal welfare rules (such checks include inspections, surveillance, sampling and analysis etc);
  • checks carried out by the European Commission’s Inspection Services, generally the Food and Veterinary Office (FVO), to evaluate the performance of national control authorities and national control systems.
Q7. What animal health and animal welfare rules are covered by the Regulation?

A7. As a general rule, all Community rules applying to animal health and animal welfare fall within the scope of Regulation 882/2004, along with all national rules that are relied upon to implement Community legislation. Animal health rules within the scope of Regulation 882/2004 cover fish health, fish farming, bee health and the pet travel scheme (PETS). National rules that have no connection with Community legislation, such as those relating to the welfare of companion animals, are outside the scope of this Regulation.

Q8. What are the main elements of the Regulation?

A8. These are:

  • General principles for enforcement arrangements in the Member States (see Q10)
  • General requirements for the competent authorities (see Q11 to Q12)
  • Audit requirements for the competent authorities (see Q13 to Q22)
  • Requirements in relation to control bodies (see Q23 to Q29)
  • Requirements on staff performing official controls (see Q30)
  • Requirements for transparency (see Q31 to Q34)
  • Requirements on control activities and reports (see Q35)
  • Requirements for sampling and analysis and for designation of official laboratories (see Q36 to Q38)
  • Financing of official controls (see Q39 to Q45)
  • Reference laboratories (see Q46 to Q50)
  • National Control Plans and Annual Reports to the Commission (see Q51 to Q58)
  • Community controls in the Member States (see Q59 to Q61)
  • Impact of Regulation 882/2004 on the livestock sector (see Q62 to Q63)
  • Impact on consumers (seeQ64)
  • Impact on the plant health regime (see Q65).
Q9. When do the provisions of the Regulation apply from?

A9. Most of the provisions in Regulation 882/2004 applied from 1 January 2006. The provisions on financing of official controls (Articles 27 and 28) applied from 1 January 2007.

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General principles for enforcement arrangements in the Member States

Q10. What are these principles?

A10. These are included at Article 3 of Regulation 882/2004. They require official controls to be carried out:

  • regularly and in accordance with a risk-based approach;
  • without prior warning unless advance notification is necessary;
  • at all stages of production including farmed animal production, processing and distribution; and
  • with the same care to exports outside the Community and to imports from third countries, as to circulation within the Community.

General requirements for the competent authorities

Q11. What are these requirements?

A11. The main ones, which are set out at Articles 4 to 10, 54 and 55 of Regulation 882/2004, are that competent authorities should:

  • meet certain operational criteria such as, having or having access to, adequate laboratory capacity and a sufficient number of suitably qualified and experienced staff, ensuring that staff are free from any conflict of interest, having contingency plans for emergencies, having appropriate legal powers, having suitable facilities and equipment etc;
  • ensure effective and efficient co-ordination with other competent authorities or between different units of a single authority;
  • carry out internal audits or have external audits undertaken, and have those audits independently scrutinised to ensure that they meet the objectives of the Regulation;
  • ensure specific conditions are met if any control task is delegated to an independent third party, i.e. a ‘control body’ (see Q23);
  • ensure that staff receive appropriate and on-going training;
  • be transparent about its monitoring and enforcement activity;
  • prepare reports of individual controls and provide copies to businesses;
  • have, use and update, as necessary, documented procedures for carrying out controls;
  • official controls to be carried out using appropriate control methods and techniques;
  • take appropriate action where businesses are not complying with the rules to ensure that the situation is remedied; and
  • apply effective, proportionate and dissuasive sanctions in the case of non-compliance.
Q12. Will this mean any changes to the monitoring and enforcement arrangements in England?

A12. Competent authorities already comply with many of the provisions of Regulation 882/2004 in respect of animal health and animal welfare enforcement, either through legislative provision or through administrative measures. Some organisational and administrative changes may need to be addressed by individual competent authorities. Defra is currently reviewing its arrangements; local authorities and Local Authorities Coordinators of Regulatory Services (LACORS) will also be doing so in consultation with Defra.

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Audit requirements for the competent authorities

Q13. What are the audit requirements for competent authorities?

A13. Under Article 4(6) of Regulation 882/2004, competent authorities are required to carry out internal audits, or have external audits carried out. The purpose of these audits is to ensure that competent authorities are carrying out official controls in a consistent manner and on a risk-based approach. These audits, in turn, are to be independently scrutinised. Guidelines produced by the European Commission call for transparency in the audit process, which should be based on a clearly defined planning process, audit criteria, and include report approval and distribution mechanisms.

There will be small impact on farmers and other business operators at whose premises animal health and animal welfare legislation, and the relevant feed and food law, is enforced. They, will be required to allow entry to auditors monitoring competent authorities performance of official controls. These on-site audits will be carried out on a risk-bases and co-ordinated so that any disruption to the farmers or business operators will be minimal.

Q14. What are audits for the purpose of the Regulation?

A14. The term audit in the context of Regulation 882/2004 is specifically defined as “a systematic and independent examination to determine whether activities and related results comply with planned arrangements and whether these arrangements are implemented effectively and are suitable to achieve objectives”. Generally, official controls audits would scrutinise how official controls are carried out, and whether they achieve their purpose.

Q15. What will the audit requirements mean for competent authorities?

A15. Competent authorities will have to ensure that audits carried out under Regulation 882/2004 comply with the requirements of the Regulation, as well as with the Commission guidelines on criteria for audits (see Q16 below). Defra has an internal audit system, although some of the Executive Agencies have external audits carried out. Departmental audits are overseen by an independent Audit and Risk Committee. In addition, internal audit reports are scrutinised by the National Audit Office. Local Authorities already undertake a degree of internal monitoring, and have systems in place to monitor activity. These arrangements might need to be reviewed in the light of Regulation 882/2004 and the guidelines on criteria for audit which the Commission has established.

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Q16. How are these audits to be carried out?

A16. Guidelines on the criteria for the conduct of official control audits have been agreed with the Commission. The guidelines were published in the form of a Commission Decision (2006/677/EC).

Member States are required to take account of the guidelines under Article 43(1) of Regulation 882/2004. The guidelines provide general principles for the conduct of audits, and Defra considers the guidelines to be generally consistent with accepted good practice on the conduct of audits. In particular the Guidelines stress the need for:

  • a systematic approach to the planning, conduct, follow-up and management of audits;
  • documented procedures and clearly defined planning process, criteria and report approval and distribution;
  • independence of the audit bodies insofar as they should have a clear mandate and adequate authority to conduct the audits, and not be actively involved in the area being audited; and
  • the audit process should be subject to independent scrutiny.
Q17. How will the audit requirement be met by Defra?

A17. In England, Defra is the central competent authority for animal health and animal welfare. The Department has an Internal Audit Division (IAD), which operates in line with UK Government Internal Audit Standards (GIAS), and provides an independent appraisal function to examine and evaluate the Department’s activities. IAD reports on the adequacy and effectiveness of governance, risk management and control in relation to Defra’s objectives, and ensures amongst other things compliance with relevant laws and regulations. The Executive Agencies have their own internal audit units, which comply with GIAS and give assurance in the same areas. The results of all audits are monitored by the relevant Audit and Risk Committees, to ensure that the work is to a satisfactory standard, and that management is responding appropriately to recommendations. The assurance gained from the Agency audit units is then fed into the Defra overall assurance process.

Defra Internal Audit currently provides internal audit services to the following agencies under service level agreements: Animal Health (AH), the Pesticide Safety Directorate (PSD), and the Veterinary Medicines Directorate (VMD). If the Agency Internal Audit service is provided by a non-government body, its work will be reviewed periodically by Defra Internal Audit to ensure that its work complies with GIAS.

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Q18. How will the audit requirement be met by other competent authorities?

A18. The audit requirement stems directly from the Regulation 882/2004 to which the Official Controls (Animals, Feed and Food) (England) Regulations 2006 (S.I. No. 2006/3472) give effect. Regulation 882/2004 requires, amongst other things, that competent authorities carry out, or have carried, audits of their official control functions.

Therefore, as designated competent authorities under the Official Controls (Animals, Feed and Food) (England) Regulations 2006 local authorities must carry out audits of their controls systems. Under these Regulations local authorities may carry out audits:

  • autonomously; or
  • under regulation 8(3) the Secretary of State can step in and organise audits of any local authority.

Under regulation 8(1) the Secretary of State can seek information about a local authority's audit arrangements. These powers are there so that Defra has the means to check that the requisite auditing is being carried out by local authorities. On the other hand, the Secretary of State and local authorities may agree that the Secretary of State will take responsibility for audits.

Defra is currently exploring options of audit arrangements for local authorities with Animal Health and LACORS.

Q19. Will audits be carried out on business premises?

A19. The Commission guidance on the conduct of audits carried out under Article 4(6) of Regulation 882/2004 envisages audits being carried out on-site, i.e. on farms and other business premises. The purpose of these on-site audits is to ensure the quality and consistency of the checks carried out by enforcement officers. In order to ensure that any disruption to the farmer or business operator is kept to a minimum, the competent authorities will endeavour to co-ordinate audit visits with visits for other purposes.

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Q20. What powers will auditors have?

A20. When carrying out on-site audits, auditors will have the same powers as an inspector for the purposes of gaining entry to premises, obtaining, examining and, where necessary, copying records. Additionally, in instances when auditors may reasonably require assistance, they will also be able to bring others, such as technical experts, with them. They will not need to be accompanied by an inspector.

Q21. Why is it necessary for auditors to have such powers?

A21. The Commission’s audit guidelines and audit best practice support the case for audits to take place on business premises, and on other premises involved in the official controls which are the subject of the audit, as well as at the offices of the competent authority responsible for the official controls. To ensure that the audit process is robust along the whole length of the control chain, and cannot be compromised by outside influences, it is necessary for auditors to have access to premises, and to the information that they require without relying on an inspector. This can only be done by providing auditors with general independent powers of entry and access to information.

Q22. What other powers have been introduced to support the audit requirement?

A22. As the central competent authority for animal health and welfare legislation, Defra needs to be sure that other competent authorities designated in the Official Controls (Animals, Feed and Food) (England) Regulations 2006, undergo audits as required under Regulation 882/2004. This Regulation provides the Secretary of State with powers to ask local authorities for information about their audits and audit plans, and can appoint an auditor to carry out a local authority’s audits for it, whether by agreement or, if necessary, by compulsion, in which case the local authority can be required to co-operate with the auditor.

Requirements in relation to control bodies

Q23. What is a control body?

A23. A control body is defined for the purposes of Regulation 882/2004 at Article 2.5 as “an independent third party to which the competent authority has delegated certain control tasks”. Control bodies are usually non-governmental organisations, such as privately-owned laboratories undertaking testing, or analysis of samples taken during an official control. In delegating the task, the competent authority retains responsibility for the work. Local Veterinary Inspectors (LVIs) are not control bodies, because they act on behalf of, and with the authority of Defra, i.e. the Secretary of State, as the competent authority.

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Q24. Are there any control bodies in England?

A24. Yes. Any privately-owned laboratory used by a competent authority to undertake testing, for example for the presence of infection, or analysis, or microbiological examination could be considered as a control body under Regulation 882/2004. In practice though, so far as animal health and animal welfare are concerned, the Veterinary Laboratories Agency of Defra usually carries out the laboratory function. Other examples of control bodies are certain carriers or transport companies (airlines, ferry companies etc) who have been approved by Defra to carry dogs, cats and ferrets under the “PETS” scheme.

Q25. What sort of tasks can be delegated to a control body?

A25. Tasks relating to the monitoring of compliance may be delegated to a control body, e.g. testing for the presence of infection or analysis of samples, or ensuring that companion animals brought into the UK meet the necessary requirements under the “PETS” scheme. However, under Article 5(1) of Regulation 882/2004, action in the case of non-compliance with animal health and animal welfare rules, cannot be delegated to control bodies, and remains the responsibility of the competent authority. Article 54 details the activities which cannot be delegated.

Q26. What are the specific conditions for delegating tasks to control bodies?

A26. These are set out in detail at Article 5 of Regulation 882/2004. In summary, there must be an accurate description of the task, and proof that the control body has the necessary expertise, and that it is impartial and free from conflicts of interest in respect of the particular task. Control bodies must operate and be accredited in accordance with appropriate European Standards, and there must be procedures in place to ensure that results of controls are communicated to the competent authority. In addition, the competent authority must arrange audit or inspection of the control body and, if it finds that the control body is not meeting the specified conditions, the delegation of tasks is to be withdrawn.

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Q27. What accreditation do control bodies require?

A27. Any control body undertaking specific tasks for official control purposes needs to be accredited to EN 45004 (EN ISO 17020:2004) standard on “General criteria for the operation of various types of bodies performing inspection” and/or a more relevant standard. If the control body is a laboratory, it must also operate in accordance with the following European Standards:

  • EN ISO/IEC 17025 on general requirements for the competence of testing and calibration laboratories;
  • EN 45002 on general criteria for the assessment of testing laboratories;
  • EN 45003 (replaced by ISO 17011:2004) on calibration and testing laboratory accreditation system – general requirements for operation and recognition.

In the UK, the United Kingdom Accreditation Service (UKAS) operates an official accreditation service. Defra accepts accreditation to these standards by any signatory to the multilateral agreement of the European Co-operation for Accreditation Body (EA).

Q28. Are there any audit requirements on control bodies?

A28. Control bodies are required to be audited or inspected. For the purposes of Regulation 882/2004, where audits are carried out they do not necessarily have to comply with the European Commission’s audit guidelines; however following the guidelines would represent good audit practice. Instead of audits, control bodies can be inspected. Inspections are defined in Regulation 882/2004 as an “examination of any aspect of feed, food, animal health and animal welfare in order to verify that such aspect(s) comply with legal requirements of feed and food law, animal health and animal welfare rules”.

Q29. What happens if a control body fails to carry out its delegated tasks properly?

A29. If audits or inspections identify failings on the part of the control body in carrying out the delegated task(s), the competent authority may withdraw the delegation. If the control body fails to take appropriate remedial action within a reasonable period, the delegated task(s) are to be withdrawn immediately.

Requirements on staff performing official controls

Q30. Are there any requirements on staff carrying out official controls?

A30. Yes. Article 6 of Regulation 882/2004 requires competent authorities to ensure that all staff performing official controls receive appropriate training, keep their knowledge up-to-date, and can operate co-operatively.

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Requirements for transparency

Q31. What are the requirements on transparency?

A31. These are set out at Article 7 of Regulation 882/2004. Competent authorities are required to publish information about official controls carried out and on the effectiveness of them. However, confidential information, including personal details, are not to be made publicly available.

Q32. How will this obligation be met in England?

A32. Defra already publishes a substantial amount of information on animal health and welfare enforcement activity. For example, the Defra Departmental Annual Report provides information on Departmental progress against various key animal health and animal welfare targets. In addition, the Chief Veterinary Officer’s Annual Report catalogues developments in animal health and animal welfare. The annual return to Parliament under Section 80 of the Animal Health Act 1981 (as amended) contains details of prosecutions initiated and compensation paid.

Q33. Will individual inspection reports be published?

A33. No. Regulation 882/2004 does not go as far as that. General information, giving the overall picture only, is required. Reports, of individual official controls, do, however, have to be provided to the business concerned, at least in the case of non-compliance.

Q34. Will the Commission publish reports on Member States official controls?

A34. The Commission is required, under Article 44(4) of Regulation 882/2004 to produce annual reports on the “overall operation of the official controls in Member States”. These Commission reports will be based on the annual reports Member States are required to make to the Commission on implementation of their national control plans (see Q51 to Q56), the results of Commission audits, and any other information the Commission considers relevant. The Commission reports may make recommendations on improvements in Member States’ systems, control activities in certain sectors, and/or plans to address issues of particular interest. These reports will be submitted to the Council, to the European Parliament, and will be made public.

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Requirements on control activities and reports

Q35. Are there any procedural requirements on competent authorities?

A35. Articles 8, 9 & 10 of Regulation 882/2004 require competent authorities to:

  • have documented procedures for carrying out official controls;
  • have appropriate legal powers to carry out the necessary control tasks;
  • have procedures in place to verify the effectiveness of their controls, and to ensure that corrective action is carried out;
  • draw up reports of the controls carried out, and provide copies to the business operator concerned, at least in the case of non-compliance; and
  • carry out official controls using appropriate methods and techniques.

Requirements for sampling and analysis and for designation of official laboratories

Q36. What are the requirements in respect of sampling and analysis?

A36. The requirements are set out at Article 11 and Annex III of Regulation 882/2004. As now, sampling and methods of analysis used for official control purposes should, wherever possible, be recognised by international organisations, and should be validated in accordance with Community legislation, or with internationally accepted protocols.

Q37. What are official laboratories?

A37. These are laboratories that are appointed by the competent authorities to undertake analysis of samples taken for official control purposes. For animal health and welfare purposes in England, this role is usually undertaken by the Veterinary Laboratories Agency. Under certain circumstances, some other laboratories, including private laboratories, are authorised by the competent authority to carry out specific analyses.

Q38. What are the requirements for official laboratories?

A38. These are set out at Article 12 of Regulation 882/2004. Official laboratories must be designated as such by the competent authorities. Designation may only be given if the laboratory meets certain specified standards, i.e. is accredited to the European Standards specified in Regulation 882/2004. These are EN ISO/IEC 17025, EN 45002 and EN 45003 (replaced by ISO 17011:2004). In the UK, the United Kingdom Accreditation Service (UKAS) operates an official accreditation service. Defra accepts accreditation to these standards by any signatory to the multilateral agreement of the European Co-operation for Accreditation Body (EA).

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Financing of official controls

Q39. What are the requirements for financing of controls?

A39. These are detailed at Articles 26 to 29 of Regulation 882/2004. Member States are required to ensure that official controls are properly financed. Member States can decide how, including through the use of general taxation and the introduction of fees or charges, based on principles set out in the Regulation. Some sectors require mandatory charges, in others they are optional.

Q40. When will charges be mandatory?

A40. Article 27 of Regulation 882/2004 provides for where fees are already mandatory under EU legislation they remain in place. These are set out in Section A of Annexes IV and V of Regulation 882/2004. Mandatory charges are also required when additional controls have to be introduced where there has been non-compliance.

Q41. What are the rules on charging in the event of non-compliance?

A41. Article 28 of Regulation 882/2004 obliges competent authorities to charge for the expenses arising from any additional controls that might have to be carried out where there has been non-compliance with animal health or animal welfare legal requirements.

Q42. What are additional controls?

A42. These are extra checks which go beyond normal control activities, that are needed following detection of infringements or non-compliance of animal health or animal welfare rules. Generally, normal controls are the routine controls required under relevant Community or national law, and in particular those controls described in the national control plan. The Commission may establish detailed rules to clarify when these charges should be applied, but generally it is envisaged that the charges should only apply in the case of major or significant incidents resulting from non-compliance.

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Q43. When will these provisions apply?

A43. The provisions on financing under Articles 27 & 28 applied from 1 January 2007.

Q44. Will the rules make a difference to the present charging regime?

A44. The financing provisions came into effect on 1 January 2007. From that point, Regulation 882/2004 became the legal basis for the introduction of charges to cover the costs of official controls, should the decision to do so be made. In November 2005, Defra published “Partners for success – a farm regulation and charging strategy”, which set out Defra’s principles by which charges for services are made. In particular, beneficiary or risk owner pays and polluter pays are the principles that apply to the provision of Government services. The introduction of particular charges will take into account the impact of charges on the sustainability of the sector affected.

The introduction of any charges will also need to take into account the current work being taken forward by Defra on responsibility and cost sharing for animal health and welfare.

Q45. Are there any other charging provisions in Regulation 882/2004?

A45. Yes. Article 40(4) of Regulation 882/2004 requires competent authorities to charge business operators any expenses that arise where repeated non-compliance by a feed or food business causes risks to human, animal or plant health. Expenses arising from a Commission inspection, or from the need to apply intensified official controls, will be charged to the business operator concerned.

Reference laboratories

Q46. Does Regulation 882/2004 make provision for reference laboratories?

A46. Article 32(2) of Regulation 882/2004 establishes the Community Reference Laboratories (CRLs) for animal health and live animals. Details of these CRLs can be found in Commission Regulation (EC) No 776/2006 .

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Q47. What are the responsibilities of the Community Reference Laboratories for animal health?

A47. Community Reference Laboratories for animal health are responsible for:

  • co-ordinating the methods for diagnosing diseases;
  • assisting in the diagnosis of disease outbreaks;
  • facilitating training of experts in laboratory diagnosis;
  • collaborating with competent laboratories in third countries on disease diagnosis; and
  • conducting initial and further training of staff from national reference laboratories and of experts from developing countries.
Q48. What are the requirements on Community Reference Laboratories?

A48. Community Reference Laboratories must:

  • have suitably qualified staff with adequate training in diagnosis and analytic techniques;
  • have the necessary equipment to carry out tasks;
  • have an appropriate administrative infrastructure;
  • ensure confidentiality;
  • have knowledge of international standards and practices;
  • have updated lists of reference substances, reagents and manufacturers and suppliers;
  • take account of research at national and Community level; and
  • have trained personnel available for emergency situations within the Community.
Q49. What are the functions of the National Reference Laboratories?

A49. Within their areas of competence, national reference laboratories are to:

  • collaborate with the relevant CRL;
  • co-ordinate the activities of official laboratories;
  • organise comparative tests;
  • disseminate information from the CRLs;
  • give scientific and technical assistance to the competent authority; and
  • carry out other duties as necessary.
Q50. What are the accreditation requirements for National Reference Laboratories?

A50. Article 33 of Regulation 882/2004 requires Member States to designate at least one national reference laboratory (NRL) for each Community Reference Laboratory. The designated NRLs must be accredited to the following European standards:

  • EN ISO/IEC 17025 on general requirements for the competence of testing and calibration laboratories;
  • EN 45002 on general criteria for the assessment of testing laboratories;
  • EN 45003 (replaced by ISO 17011:2004) on calibration and testing laboratory accreditation system – general requirements for operation and recognition.

National Control Plans and Annual Reports to the Commission

Q51. What is the national control plan?

A51. All Member States are required to prepare a single, integrated multi-annual national control plan in accordance with Articles 41 to 43 of Regulation 882/2004. The plan is essentially a reflection of strategic objectives and priorities. In addition, it sets out the national monitoring and enforcement arrangements, with details of how the various requirements of Regulation 882/2004 are being met. It is to be a single integrated plan, covering arrangements for monitoring and enforcement not only of animal health and animal welfare rules, but also of feed and food law and plant health.

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Q52. Who will produce the UK plan and who needs to contribute?

A52. The single integrated UK-wide national control plan has been prepared by the central competent authorities – for animal health and animal welfare by Defra and the Devolved Administrations, and the Food Standards Agency in respect of the feed and food elements. Information about the enforcement activities of other competent authorities, such as the Local Authorities, is also included. Stakeholders were consulted on the national control plan structure and content during its development.

Q53. What information is included in the national control plan?

A53. The Commission has developed guidelines on what information should be included in the national control plan. In addition, Article 42 of Regulation 882/2004 identifies certain specific areas for inclusion in the plan. The guidelines were finalised in late 2006 and will be published as a Commission Decision.

Q54. Has the UK national control plan been published?

A54. Yes. The FSA published the national control plan on their website on 14 December 2006. Defra and the Devolved Administrations have provided separate links from their own websites to the published plan.

Q55. Do Member States have to send the national control plan to the Commission?

A55. The national control plan is the property of the Member State concerned and it reflects the monitoring and enforcement regimes within that Member State. There is no legal obligation under Regulation 882/2004 for Member States to send their control plans to the Commission. However, the Regulation does oblige Member States to provide the Commission with a copy of the latest version of the plan when requested to do so in advance of a Commission audit.

Q56. What about reporting to the Commission on performance of the national control plan?

A56. Article 44 of Regulation 882/2004 requires Member States to send to the Commission annually a report covering amendments to the national control plan, the results of official controls and audits, the type and number of cases of non-compliance, and actions taken to ensure the national control plan is working effectively.

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Q57. When do the annual reports start?

A57. The first annual report is due one year after the national control plan has been implemented for the first time. Because the reports are meant to be with the Commission within six months of the end of the year they refer to, the first report must be finalised by the end of June 2008.

Q58. What is the level of detail needed for the annual reports?

A58. The Commission and Member States have been involved in discussions on producing guidelines on the structure and level of information to be included in the annual reports. Discussions are continuing. The guidelines will be published in the form of a Commission Decision, and made available via the Defra website, when they have been finalised.

Community controls in the Member States

Q59. How will the European Commission ensure that the national enforcement arrangements of Member States are effective?

A59. The Commission’s Inspection Services, the Food and Veterinary Office (FVO), will undertake two types of assessment as set out at Article 45 of Regulation 882/2004. These are:

  • general audits of the national control plans and annual reports; and, where necessary;
  • supplementary or specific audits, e.g. where there appear to be emerging or recurring problems.
Q60. Will there be any change to the current arrangements for FVO missions?

A60. No. As usual the FVO will publish its inspection programmes in advance, and the central authorities will make appropriate arrangements and draw up the itineraries. Missions may, as now, include visits to local authorities and to businesses, and reports of missions will include recommendations for the Member State concerned. Finalised reports will be published on the Commission’s website.

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Q61. Will there be any change in the frequency of FVO missions?

A61. Perhaps. The Commission has suggested that where it believes control systems in a Member State are sufficiently robust, and provide an acceptable level of assurance, the frequency of on-the-spot inspections might reduce. This is in line with their risk-based approach to official controls, and would allow them to intensify controls on priority areas.

Impact of Regulation 882/2004 on the livestock sector

Q62. Are there any requirements for livestock businesses in the Regulation?

A62. No. Regulation 882/2004 is about the organisation of enforcement arrangements and verification of compliance with legal requirements by enforcement authorities. It does not require increased levels of checks or enforcement, nor does it impose additional administrative burdens on businesses.

Q63. Is the Regulation of any benefit to the livestock sector?

A63. Regulation 882/2004 aims to ensure a risk-based and more consistent approach to enforcement of animal health and welfare rules across the Community. This should lead to improved animal health through the prevention of disease, and to more humane treatment of animals. It should also help to create a more level playing field for UK businesses.

Impact on consumers

Q64. Are the new rules of any benefit to consumers?

A64. Regulation 882/2004 aims to improve the effectiveness of enforcement throughout the Community. This should contribute to improved standards of animal health and animal welfare, which, in turn, should lead to improved food quality and safety. Moreover, the provisions on transparency and publication of information on official controls will ensure that consumers have access to information about enforcement activity and its effectiveness, both within the UK and across the Community.

Impact on the plant health regime

Q65. Does Regulation 882/2004 impact on the EU plant health regime?

A65. There is no direct impact on the plant health regime. Regulation 882/2004 amends the Plant Health Directive (2000/29/EC) in order to include the plant health control regime in the single integrated national control plan that Member States are required to draw up (see Q51).

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Page last modified: December 3, 2008
Page published: 5 February, 2003

Department for Environment, Food and Rural Affairs