Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on official feed and food controls

(presented by the Commission)

EXPLANATORY MEMORANDUM

I. SUMMARY

1. This proposal is a follow-up of the Commission's announcement in the White Paper on Food Safety [1] that it would submit to the European Parliament and the Council a proposal for a Regulation on official feed and food safety controls. It lays down the rules to be respected by the competent authorities responsible for carrying out official controls as well as the tasks of the Commission with regard to the organisation of those controls. It is the result of a review of the existing Community rules on the subject, which were adopted separately for the animal feed sector, the food sector and the veterinary sector. It covers the entire range of activities covered by feed and food law, which includes feed and food safety but also other aspects that relate to consumer protection, such as feed and food labelling.

[1] Document COM (1999) 719.

Special attention is paid to enforcement measures and in particular the imposition of sanctions at national and Community level. For that purpose, the proposal contains minimum requirements on criminal sanctions to be imposed by the Member States with regard to serious offences that are committed intentionally or through serious negligence. The proposal also contains new tools for the Commission to enforce the implementation of Community feed and food law by the Member States.

II. INTRODUCTION

2. The motives for the Commission to present this proposal can be summarised as follows:

- The existing sectoral approach has lead to repetition or to situations whereby requirements of a similar nature are covered in a different way for the different sectors concerned. For certain sectors, some control aspects are lacking, thus leaving loopholes in legislation.

- Recent feed and food emergencies have highlighted deficiencies in national control systems. At the heart of the problem is the lack of a harmonised Community approach to the design and development of national control systems.

- There is a need to properly define the role of the Commission's own control services so as to ensure the most efficient use of available resources.

3. As stated in the White Paper on Food Safety it follows that:

"There is therefore a clear need for a Community framework of national control systems, which will improve the quality of controls at Community level and consequently raise food safety standards across the European Union. The operation of such control systems would remain a national responsibility. This Community framework would have three core elements.

- The first element would be operational criteria set up at Community level, which national authorities would be expected to meet. These criteria would form the key reference points against which the competent authorities would be audited by the FVO, thereby allowing it to develop a consistent, complete approach to the audit of national systems.

- The second element would be the development of Community control guidelines. These would promote coherent national strategies, and identify risk-based priorities and the most effective control procedures. A Community strategy would take a comprehensive, integrated approach to the operation of controls. These guidelines would also provide advice on the development of systems to record the performance and results of control actions, as well as setting Community indicators of performance.

- The third element of the framework would be enhanced administrative co-operation in the development and operation of control systems. There would be a reinforced Community dimension to the exchange of best practice between national authorities. This would also include promoting mutual assistance between the Member States by integrating and completing the existing legal framework."

The present proposal aims to create such Community framework of national control systems by merging and completing existing rules for national and Community controls within the EU, at the borders and in third countries.

4. The proposal takes into account the principles of food safety that are spelled out in the Commission's White Paper on Food Safety, and in particular that:

- Food safety policy must be based on a comprehensive, integrated approach,

- Feed and food businesses operators have the prime responsibility for feed and food safety, whilst the competent authorities monitor and enforce this responsibility through the operation of national surveillance and control systems; the Commission's control services concentrate on evaluating the ability of competent authorities to deliver these systems through audits and inspections,

- Feed and food safety policy must be risk-based,

- The farm to table policy, covering all sectors of the food chain, including feed production and animal feeding, primary production, food processing, storage and distribution, animal health and animal welfare, needs to be systematically implemented.

5. Based on the above observations, the proposal contains the following main elements:

- The official controls by Member States shall enable them to verify and enforce compliance with national and Community feed and food law; for that purpose, official controls shall be carried out regularly and must be defined on the basis of risk.

- The authorities in the Member States that are competent for performing official controls shall meet operational criteria that guarantee their efficiency, effectiveness and impartiality.

- Staff performing official controls shall have received adequate training in order for them to undertake their duties competently.

- Specific control tasks may be delegated to an independent body only under strict conditions.

- Methods of sampling and analysis shall be validated in accordance with internationally accepted protocols, including those based on performance criteria, and be carried out by laboratories accredited for that purpose.

- Where non-compliance is identified during official controls, appropriate measures shall be taken, including administrative measures and criminal sanctions. These measures and sanctions shall be effective, dissuasive and proportionate.

- Contingency plans shall be drawn up setting out measures to be implemented in case of feed and food emergencies.

- Member States shall proceed to regular controls of feed and food imports.

- Where official controls require action by more than one Member State, the competent authorities of the Member States concerned shall afford each other administrative assistance. This assistance may be extended to active co-operation including on-the-spot controls of Member State experts in another Member State.

- In co-operation with the Member States, a Community framework for the development and operation of national control systems shall be developed taking account of existing best practices and of the experience of the Commission's control services. It will be based on agreed criteria for the performance of these systems, and lead to clear guidelines on their operation. Community guidelines will be developed for that purpose.

- Inspections and audits by the Commission's Food and Veterinary Office (FVO) shall be organised to verify the effectiveness of national control systems.

- Additional tools for the Commission to enforce implementation of Community feed and food law by Member States must be made available.

- There must be a Community framework for the training of control staff in the Member States in order to ensure a uniform level of decision taken by such staff.

- There is a need to take special account of the needs of developing countries.

6. The basic principles related to responsibilities of the Member States authorities are already laid down in the Regulation (EC) No 178/2002 laying down the general principles of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety [2]. This Regulation stipulates in particular that "Member States shall enforce food law and monitor and verify that the relevant requirements of food law are fulfilled by feed and food business operators at all stages of production, processing and distribution. For that purpose they shall maintain a system of official controls and other activities as appropriate to the circumstances, including public communication on feed and food safety and risk, feed and food safety surveillance and other monitoring activities covering all stages of production, processing and distribution. Member States shall also lay down the rules on measures and penalties applicable to infringements of feed and food law. The measures and penalties provided for shall be effective, proportionate and dissuasive".

[2] OJ L 31, 1.2.2002, p. 1.

The present proposal describes in more detail how these basic principles must be interpreted and implemented.

III. GENERAL ANALYSIS OF EXISTING COMMUNITY LEGISLATION

7. Community legislation on official controls in the areas of feed and food safety has been developed over a period of several decades and on a sectoral basis. As a result, it is contained in several Directives and Decisions. The situation can be summarised as follows:

Feed

8. Council Directive 95/53/EC of 25 October 1995 [3] fixes the principles governing the organisation of official controls in the field of animal nutrition.

[3] OJ L 265, 8.11.1995, p. 17.

The main purpose of this Directive is to harmonise official controls carried out by the Member States' competent authorities as regards both imports and trade within the Community.

The Directive covers all products and substances used in animal nutrition. The following elements constitute the basic provisions:

(a) Uniform principles for the organisation of checks.

(b) Reinforcement of checks at source and organisation of checks at the place of destination in the context of the single market.

(c) Systematic documentary checks and random identity and physical checks on feed imports and a procedure for improving the harmonisation of these checks.

(d) Procedures for the co-operation between Member States when infringements are detected.

(e) A requirement for the Member States to set up national annual control programs.

(f) A requirement for the Member States to transmit a report on the implementation of the national programs to the Commission commencing in April 2000.

(g) Based on the above information, a requirement for the Commission to present each year an overall summary report and a proposal for a recommendation concerning a co-ordinated Community control program.

(h) A procedure for carrying out Commission on-the-spot controls both in the Member States and in third countries.

(i) The possibility for the Commission, when confronted by a serious risk, to adopt safeguard measures on products originating in third countries.

(j) Provisions to set up specific control plans when appropriate in addition to the annual and general control plan.

(k) A requirement for Member States to have adequate contingency plans to deal with serious feed risks.

(l) A requirement for Member States to inform the Commission as soon as a serious contamination or risk is detected and has spread.

9. The financing of official controls in the animal feed sector is organised by Council Decision 98/728/EC [4]. This Decision provides for a Community system for fees to be levied for the examination of dossiers of specified additives and for the approval of certain establishments and intermediaries. The Decision fixes an exclusive list of costs that can be taken into account when calculating control fees. This includes staff costs, administrative costs and technical costs. Based on these criteria, Member States may apply flat-rate amounts for financing expenses for official controls in specific areas. The direct or indirect refund of the fees to the feed or food business operators is not allowed.

[4] OJ L 346 , 22.12.1998, p. 51.

Although this Decision has only recently become applicable, it seems to function properly. Contrary to the system that is applied in the veterinary sector, no difficulties in implementing it have been notified to the Commission.

10. Community methods of sampling and analysis for the official control of feedingstuffs are laid down in Council Directive 70/373/EEC [5]. This Directive empowers the Commission to establish such methods for the purpose of checking compliance with quality and compositional requirements, taking into account current scientific and technical knowledge.

[5] OJ L 170 , 3.8.1970, p. 2.

That has allowed to establish a number of analytical methods, such as Commission Directive 98/88/EC of 13 November 1998 establishing guidelines for the microscopic identification and estimation of constituents of animal origin for the official control of feedingstuffs [6]. Directive 70/373/EEC does however not lay down criteria with which methods of analysis shall comply, as it is the case for foodstuffs (Council Directive 85/591/EEC). There is a need to harmonise both areas.

[6] OJ L 318, 27.11.1998, p. 45.

Food

11. Two Directives apply to official controls in the food area:

- Council Directive 89/397/EEC on the official control of foodstuffs [7],

[7] OJ L 186, 30.6.1989, p. 23.

- Council Directive 93/99/EEC on the subject of additional measures concerning the official controls of foodstuffs [8].

[8] OJ L 290, 24.11.1993, p. 14.

The scope of these Directives covers all food, without prejudice to the application of requirements in veterinary legislation described below. They lay down, in a general way, the general principles that must be applied by the control services in the Member States to ensure compliance of foodstuffs, food additives, vitamins, mineral salts, trace elements and other additives as well as materials and articles intended to come into contact with foodstuffs. These include in particular rules on the organisation of the official controls in the Member States, sampling and analysis, the right of appeal against measures taken by the competent authority, the organisation of controls in accordance with in advance established plans, Community controls in the Member States and mutual assistance.

These Directives do not include however common rules on the control of foodstuffs imported into the Community nor on the organisation of Community controls in third countries. Neither do they include procedures to be implemented in case of food emergencies or on the financing of official controls. They do not specify the measures to be taken when the official controls disclose irregularities.

Veterinary checks

12. There is a comprehensive set of rules to be applied by the controlling authorities in the Member States to checks on products of animal origin and for verifying their compliance with Community veterinary rules. These include the following Directives that are of a general nature and thus applicable to all food of animal origin:

- Council Directive 89/662/EEC concerning veterinary checks in intra-Community trade with a view to the completion of the internal market [9],

[9] OJ L 395, 30.12.1989, p. 13.

- Council Directive 97/78/EC laying down the principles governing the organisation of veterinary checks on products entering the Community from third countries [10].

[10] OJ L 24, 30.1.1998, p. 9.

13. The first Directive was adopted at the time of the establishment of the single market. It aims to ensure that veterinary checks on goods that are intended for the EU market are carried out at the place of dispatch and no longer at the internal borders of the Community. It contains elements on the organisation of the controlling services in the Member States, the measures to be taken in case of food emergencies and the establishment of control plans.

14. The second Directive fixes in detail all the checks that must be carried out on goods coming from third countries. It lays down in particular that such goods must be cleared in advance through a border inspection post, which must be included on the list of Commission approved Border Inspection Posts, and that they must be submitted to a documentary, identity and physical check. It describes the procedures that must be followed in case of non-compliance of the goods with Community veterinary rules.

15. In addition to these two Directives, a number of product specific Directives exist. Each of these Directives contains obligations for the competent authorities to perform controls on the products concerned. They include meat, meat products, egg products, fishery products, milk and dairy products etc.

16. Two other Directives in the veterinary sector are of major importance with regard to the organisation of official controls:

- Directive 89/608/EEC contains detailed rules on mutual assistance between the administrative authorities of the Member States and co-operation between the latter and the Commission to ensure the correct application of legislation on veterinary and zootechnical matters [11],

[11] OJ L 351, 2.12.1989, p. 34.

- Directive 96/43/EC amending and consolidating Directive 85/73/EEC in order to ensure financing of veterinary inspections and controls on live animals and certain animal products [12]. It covers, for products of animal origin and for live animals, the financing of veterinary controls.

[12] OJ L 162, 1.7.1996, p. 1.

17. Finally, Regulation (EC) N° 999/2001 of the European Parliament and the Council laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies is of major importance for the organisation of official controls in veterinary sector, as well as the recently adopted Regulation (EC) No 1774/2002 of the European Parliament and of the Council of 3 October 2002 laying down the health rules concerning animal by-products not intended for human consumption [13].

[13] OJ L 273, 10.10.2002, p. 1.

18. The veterinary legislation lays down, for food of animal origin, common rules on the organisation of official controls, the control of foodstuffs imported into the Community, procedures to be implemented in case of food emergencies, specific measures to be taken when the official controls disclose irregularities, detailed rules on mutual assistance and on the financing of veterinary inspections and controls on live animals and certain animal products. It also covers the organisation of Community controls in Member States and third countries. An issue that is not covered in a comprehensive way under veterinary legislation is the question of official sampling and analysis of food.

Other sectors

19. In the areas of animal health and animal welfare, official control requirements proper to these sectors have been developed. However, bearing in mind its horizontal character and general nature, the proposal on official feed and food controls can be fully applied to these sectors. This is in line with the White Paper on Food Safety stating that animal health and animal welfare are important factors that contribute to feed and food safety.

IV. COMMISSION CONTROL RESPONSIBILITIES UNDER CURRENT LEGISLATION

Commission powers and obligations in relation to activities in Member States

20. Controls fall within the wider guardianship role of the Commission to ensure that Community legislation is effectively applied and enforced within the Community as laid down in Article 211 of the EC Treaty. There is also the requirement in Article 152 that "Community action ... shall be directed towards improving public health, preventing human illness and diseases, and obviating sources of danger to human health". Control obligations contained in legislative texts are subject to these broader duties to ensure that legislation is effectively enforced and that dangers to health are obviated.

21. There are only a few instances where Community legislation requires the Commission to carry out controls in the Member States. In the vast majority of cases the legislation provides an authorisation to inspect without imposing an obligation to do so. Thus the Commission has discretion as to whether to carry out controls or to use other means of securing enforcement of the legislation. Currently there are two exceptions to this:

(a) Commission Decision 97/778/EC requires the Commission to inspect border inspection posts normally on an annual basis (there are about 290 posts in the Community);

(b) Several Commission Decisions in recent years relating to BSE have specifically called for controls by the Commission to verify compliance.

The obligation under (a) has never been fully met due to resource constraints. Moreover, the frequency of inspections currently prescribed is not essential to ensure a high level of protection. Ensuring the proper functioning of these facilities should be primarily the responsibility of the Member States' controlling services, whilst the Commission's control services should integrate their control element into their general audits of the Member States' control systems in line with the ideas expressed in this memorandum. The Commission considers that the existing rules should therefore be reviewed and adapted accordingly. This will be subject of separate proposals.

Commission powers and obligations in relation to third countries

22. As regards third countries, Community legislation generally imposes major obligations to inspect only in the veterinary sector, where the vertical hygiene Directives provide that Community controls "shall" be carried out with a view to verifying whether the standards applied by the relevant third country comply or offer an equivalent level of protection to that applied within the Community. In so far as the hygiene Directives include an obligation to inspect, a derogation from this obligation was introduced by Council Decision 95/408 for all animals and products, except cattle, sheep, pigs and goats and their products. In relation to the latter, Commission Decision 86/474/EEC requires the Commission to carry out controls in a large number of countries and establishments annually. Due to resource constraints, only a small fraction of these countries and establishments are in fact visited each year in relation to the products concerned. It is clear that the rules as existing at present must be adapted so as to take account of these constraints and apply an audit approach to third countries as soon as practicable.

V. THE ROLE OF THE COMMUNITY

The changing context

23. The context for the Commission's control activities has changed in a number of important respects in recent years.

Food safety has moved to and remains at the top of the Community's agenda. Part of the present Commission's response to the continuing concerns of European consumers about food safety was to bring together in 1999, within the Directorate General for Health and Consumer Protection, all the services responsible for feed and food safety issues. In this way it aims to focus all its available resources, in a concerted and efficient manner, on the main priorities for ensuring food safety at Community level. Thus, the control and legislative services of the Commission work in close co-operation to ensure that food safety legislation is up-to-date, comprehensive and practicable, and that it is being properly implemented and enforced.

24. In Member States too, new institutional arrangements are being put in place. Food safety agencies have been or are being set up in a number of Member States to help meet consumers' food safety concerns. Some of these new bodies have major control responsibilities.

25. The range of control responsibilities at both national and Community level is becoming wider. Community controls have tended in the past to concentrate on the initial stages of food processing, especially of food of animal origin. Much of the existing detailed legislation on food safety relates to controls in these areas. However, control authorities must cover the whole food chain for an ever-expanding number of products and sectors. The food production chain is also becoming more complex and sophisticated, with foods being manufactured by new processes not foreseen in existing legislation. Control systems need to adapt accordingly. They need to be based upon an approach that is targeted at critical points at each level of control: Community, national, regional, local and at the level of the individual enterprise.

26. The Commission has also an ever growing responsibility to ensure that Community requirements are met in relation to all imports of food, animals, plants and their products from third countries. The EU now imports such products from over 200 countries around the world. These countries range from the highly developed to the poorest countries in the world. They have very different control methods and standards. Balancing the demands of Community legislation on food safety, animal health, animal welfare and plant health issues against the Community's trade and humanitarian obligations concerning so many countries is complex and delicate.

The future enlargement of the Union will also add a new dimension to the Commission's responsibilities. It is clear that many of the applicant countries face a serious challenge in bringing their control systems up to the standards required within the Community. The Commission will have to play its part in helping them to achieve this goal.

Community framework for national control systems

27. The White Paper on Food Safety identified the need for a more harmonised approach to the operation of the systems in Member States to monitor and enforce Community legislation. It therefore proposed the development of a Community framework for national control systems in order to raise standards of food safety across the EU.

28. In this Regulation the Commission proposes the introduction of a new approach under which the three aspects of control - verifying transposition, receiving reports from Member States, and carrying out on-the-spot controls - will be combined into one integrated control process for all feed and food. The control cycle under this new approach will involve four main stages.

Stage 1:

Broad guidelines will be drawn up by the Commission, in consultation with the Member States and taking into account the principle of subsidiarity, on the structure and organisation of integrated national control systems, and on the scope, content and operation of national control plans. These guidelines will aim to promote a harmonised approach to controls, covering the full range of Community legislation, and embracing all product sectors and all stages of the feed and food chain. They will encourage the adoption of best practices in respect of the key principles outlined above at all levels of the control system in each Member State and will indicate the main performance indicators to be applied in assessing and auditing national control plans.

Stage 2:

Member States will be required, within six months of the entry into force of the Regulation, to prepare an integrated multi-annual national control plan, to maintain this plan and to present it to the Commission upon request. The plans shall be implemented for the first time one year after the entry into force of the Regulation.

Stage 3:

On the basis of the multi-annual national control plan the Commission will conduct, on a regular basis, a general audit of the control activities of each Member State which may include selected controls at regional, local/district and establishment level to verify aspects of the control system. This general audit may be supplemented by further audits of specific sectors or particular critical control points, including the investigation of emergencies or new developments, as considered appropriate.

Stage 4:

One year after the implementation of the control plans and annually thereafter, Member States will be required to present a report to the Commission which will, where necessary, update their initial plan in relation to (a) what new legislation has been introduced or modified to meet Community requirements, (b) what important changes have been made to the structure and functioning of control systems, and (c) adjustments made to their control plans. Subsequent Commission audits of the Member States will be based on their updated plans.

A general report on the overall operation of national control systems in the Member States, based on the Member States reports, the outcome of Commission audits and other relevant information, will be prepared by the Commission and submitted to the European Parliament and Council and published.

29. This new approach to controls will have a number of important advantages. For Member States it will enable them to plan and implement their control activities with a clear understanding of what is expected at Community level and within an overall, integrated Community framework. Existing Community legislation on food safety, animal nutrition, animal health, animal welfare and plant health sets out a very broad and diverse range of requirements. Member States sometimes express concerns that the criteria and benchmarks by which their control systems are checked and assessed by the Commission are not always clear and consistently applied. The new approach will respond to these concerns.

For the Commission, it will be able to apply its available resources more effectively by combining its various existing control activities into one overall integrated process. This approach will also ensure that all the main requirements set down in Community legislation are regularly checked and that no important gaps are left in the control process.

For consumers, the new approach will be more transparent and understandable. The publication of reports on the overall operation of national control plans in the Member States and the results of audits by experts from the Commission will provide a very clear view of how Community legislation on food safety is being implemented and what the Commission and Member States are doing to ensure adequate consumer protection and to improve feed and food safety, animal health, animal welfare and plant health.

Community controls in third countries

30. The European Union imports feed, food, plants and animals from over 200 countries around the world. Under current legislation, the Commission is required

(a) to verify that the competent authorities in these countries are capable of ensuring that Community requirements are met in respect of all products exported to the EU,

(b) in the case of certain products, to inspect individual production establishments, of which there are currently around 13.500 approved for export to the Community,

(c) to monitor on a regular basis the operation of around 290 existing inspection posts that carry out specified checks on all imports of animals, animal products and food of animal origin at their point of entry into the EU, and to inspect new inspection posts for their individual approval.

31. This represents an enormous range of responsibilities for the Commission. Given the limits on its resources, a major effort of prioritisation is needed. It is considered that adopting a more integrated approach to controls whereby third countries would be audited on the basis of control plans similar to those foreseen for the Member States, would facilitate this process. For this purpose, third countries can be classified into four broad categories:

- the applicant countries currently negotiating to join the European Union,

- the countries that have negotiated veterinary and phytosanitary agreements with the EU (Canada, USA, New Zealand, Chile and Switzerland). Under these agreements the contracting parties have accepted that certain legislative requirements on food safety and animal health provide an equivalent level of consumer and animal health protection,

- the three countries that have special agreements with the EU (Norway, Iceland and the Faroe Islands) which provide that imports of all or specified products (e.g. fishery products from Iceland) will be treated in accordance with the relevant agreement,

- all other third countries, many of which have only a very small volume of exports to the EU.

32. Applicant countries

The Commission has intensified its control activities in applicant countries in anticipation of enlargement. At present its control responsibilities relate only to those sectors and establishments approved for export to the EU, which are generally small relative to the national sectors as a whole. However, agreement has been reached with most applicant countries that controls of the FVO should now extend to all areas of feed, food, animal and plant production. The Commission's role in relation to the applicant countries has therefore already changed substantially in recent years, requiring it to take on major additional responsibilities, and to extend its controls to cover the whole production chain in these countries in the same way as in Member States.

The applicant countries already account for a large proportion of the feed, food, plants and animals currently imported from outside the Community, in particular the higher risk products of animal origin and live animals.

33. Countries with a bilateral agreement

Veterinary agreements have been concluded with the USA, Canada, New Zealand, Chile and Switzerland. These agreements provide a framework under which the parties to each agreement may agree that for certain animals and products their respective legislation offers an equivalent level of protection for trade purposes.

With respect to Mercosur, it was agreed at the recent EU-Mercosur Summit held in Madrid on 17 May 2002, to start negotiations on sanitary and phytosanitary measures between the EU and the Mercosur countries. These negotiations will be part of the single undertaking of the future bi-regional association agreement.

At present, each agreement covers sanitary measures applied to most live animals and commodities containing products of animal origin, with the exception of certain issues specified in the agreements (e.g. certain residues, additives, labelling). Currently limitations exist with regard to the number of items for which full equivalency has been agreed. Thus the Commission is required to apply two different standards when verifying the operation of control systems in relation to trade with these countries. For the products for which full equivalence has been agreed, the Commission must verify that the control systems in these countries are operated in accordance with and deliver the standards laid down in their own domestic legislation. For other products, it carries out inspections to verify whether control systems in place can ensure that the requirements of Community legislation are met in relation to those aspects where equivalency has not yet been agreed. The increasing demands arising from this dual system of control needs to be addressed.

It seems appropriate therefore to conduct one general, comprehensive audit of each of these countries which would cover all the main sectors which export products to the EU. As with the Member States, the authorities in countries that are party to the agreements would have available a plan setting out the structure, organisation and functioning of control systems in relation to the main products they export to the EU. The audits would then be carried out against this background. If particular issues emerge from these general audits, they may subsequently be the subject of additional more specific audits as appropriate.

Broadly the same approach will apply to the three other countries with which the Community has special agreements.

34. Other Third Countries

Around 190 other third countries export feed, food, plants or animals to the EU. With the limits on its resources, the Commission cannot meet all its current obligations in relation to the evaluation of competent authorities and the checking of establishments in these countries.

It seems appropriate therefore to organise audits in these countries on the basis of control plans similar to those foreseen for Member States, in respect of the products they export to the EU.

Currently the Commission verifies the guarantees given by third countries through exchanges of correspondence, questionnaires, reports on the implementation of controls and on-the-spot inspections in respect of each commodity sector for which the third country is approved to export to the Community. This exchange of information corresponds with the actions provided for in Articles 4 and 7 and point 3 of Annex B of the Agreement on the Application of Sanitary and Phytosanitary Measures (SPS Code) adopted in the framework of the World Trade Organisation.

Under the new arrangement, exporting third countries shall be required to maintain a control plan which provides accurate and up-to-date information on the general organisation and management of the relevant control systems, and to maintain up-to-date records on the implementation of these systems, all of which shall be made available to the Commission on request. The control plan and records will replace the system of pre-mission questionnaires except in specific instances where supplementary information, not covered by the standard plan or records, is required. The control plan shall be proportionate and technically and economically feasible taking account of specific situation of the third country and the nature of the products exported to the Community. Guidelines will be established specifying how these control plans and records should be drawn up and presented to facilitate third countries in complying with this requirement. Commission audits will then be carried out against these plans by a multidisciplinary team covering the main sectors exporting to the EU. The frequency of these controls should be determined on the basis of risk: where, on the basis of an assessment involving the nature of the products, the guarantees given by a third country and possible records on compliance history, a higher risk is perceived, the frequency of the audits shall be higher. If particular issues emerge from these general audits, they may be the subject of subsequent more specific audits as appropriate.

Experience has shown that competent authorities in some of the less developed countries can have major difficulties in organising their control systems in a manner that is required to meet Community standards. The Commission is often presented with a dilemma in these circumstances. To follow the letter of the law requires the Commission to propose closing down imports from these countries in accordance with the precautionary approach. But the products in question may often be one of the few sources of foreign revenue available to them and an import ban often has very serious economic consequences, not just for the establishments in question, but for the whole country.

The Commission will seek to identify means of helping countries in these circumstances while ensuring that consumer health protection will not be compromised. For example, additional assistance could be given through Community aid and training programmes to third countries in order to provide guidance on the best methods of achieving Community standards and to identify particular control solutions that more precisely reflect the level of risk posed by particular products.

VI. ANALYSIS OF THE PROPOSAL

35. The proposal attached herewith aims to review the existing Community rules on official controls. Such a review will eliminate discrepancies between the different parts of existing Community legislation and to fill loopholes in feed and food law in certain areas. The resulting harmonisation across all sectors of feed and food law will increase transparency.

36. With the adoption of Regulation (EC) No 178/2002 laying down the general principles of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety, a number of issues have now been resolved for all areas of feed and food law. These do not therefore need further attention in the present proposal. This is the case for:

- The basic definitions of feed and food law.

- The basic responsibility of the Member States with regard to official feed and food controls.

- Procedures for the implementation of emergency measures.

- Information to be made available to the Commission and the other Member States in the event of feed and food posing a serious threat to health.

Official controls by the Member States

37. Objectives and general obligations

The objective of official controls carried out by the Member States shall be to enforce feed and food law and to reveal whether feed and food business operators at all stages of production, processing and distribution fulfil the relevant requirements of such law. For these purposes, the different control techniques that are available such as inspections, monitoring, verification, audits, sampling and the analysis of samples must be implemented. The intensity of these controls depends on many factors: in addition to a basic routine monitoring programme, account must be taken of identified risks associated with particular feed and food commodities or businesses, the performance of feed and food businesses with regard to in-house controls, the suspicion of non-compliance and possible fraudulent practices.

38. Competent authorities

Member States shall designate the authorities that are competent for carrying out official controls. These competent authorities shall meet a number of operational criteria that must guarantee their efficiency, effectiveness and impartiality. They shall in particular have or have access to a sufficient number of suitably qualified staff. It must be ensured that these staff can function properly also in extreme conditions of possible feed and food emergencies. This requires contingency plans to be established and staff to be properly trained to implement these plans. Audits subject to independent scrutiny shall be carried out to ensure that competent authorities achieve the objective of this regulation.

Suitable co-ordination procedures shall also be established in order to ensure that different departments involved in official controls are acting effectively together. This is particularly important in Member States with a decentralised structure, where it is essential that there is effective and efficient co-ordination between the central competent authority and the authority or authorities to which the competence for performing official controls has been delegated.

39. The delegation of control tasks to non-governmental control bodies

Several Member States have delegated certain control tasks to non-governmental bodies. This is in particular the case for the laboratory examination of official samples. It does not exclude however that other tasks are delegated to such bodies. Where Member States practice such delegation of competence, it must be ensured that a high level of consumer protection is maintained. For that purpose, the proposal lays down that bodies to which competence for performing official controls is delegated must operate in accordance with strictly defined conditions and in accordance with internationally recognised rules that must ensure their competence and independence.

It must also be envisaged that certain control tasks cannot be delegated to non-governmental bodies. A procedure is therefore provided to define at Community level the tasks that can (or cannot) be delegated to such bodies.

40. Sampling and analysis

There is an urgent need to ensure that results following official sampling and sample analysis are obtained on the basis of common principles. This is not always ensured in the Community legislation in force. Although ideally all methods of sampling and analysis should be harmonised, it is not feasible to reach this goal in the short term. The proposal instead introduces requirements for laboratories to implement, where they are available, methods of analysis that are validated in accordance with international protocols, including those based on performance criteria, such as those accepted by the European Committee for Standardisation (CEN), the International Organisation for Standardisation (ISO) and the International Union of Pure and Applied Chemistry (IUPAC). There should also be a procedure that allows the Commission to establish methods of sampling and analysis. The laboratories that are designated to analyse official samples shall be accredited in accordance with the relevant international standards established for that purpose.

In developing, harmonising and validating methods of sampling and analysis or for establishing performance criteria for such methods, the Commission's Framework programme and Joint Research Centre (JRC) play already a prominent role and their capacities could even better be exploited in the future, whether or not in co-operation with the international bodies referred to above.

For ensuring a high standard of sampling and analysis, the proposal relies to a certain extent on the work of the CEN. This standardisation body has developed activities in the food sector. This involvement has so far been restricted to the development of analytical methods, a number of which emanate from ISO. A number of EN Standards developed by CEN relate to the organisation of controls. This is in particular the case for the validation of methods of analysis and to the operation and accreditation of control bodies. These standards have a recognised international status fully justifying their use in this context.

41. Contingency plans

Experience has shown that the prompt handling and management of emergency situations requires the availability of infrastructures, material and human resources that can be mobilised in the short term and for a certain period in time. It also requires a high degree of co-ordination where responsibilities are shared between different services or departments. The present proposal introduces an obligation to ensure effective emergency management of feed and food emergencies through the establishment of contingency plans.

42. Feed and food imports

Certain sectors, and in particular the veterinary sector, already implement detailed rules to ensure that imported products are effectively controlled. The products covered by that sector (products of animal origin) must be presented at an approved EU border inspection post and be submitted to a documentary check as well as to an identity and physical check in accordance with a scheme the principles of which are laid down at EU level. There are also requirements for products in transit and for products that are temporarily stored on the territory of the Community. It functions properly, and there is no reason to amend the system.

For feed and food other than that of animal origin, there is no harmonised Community approach towards import controls. The present proposal aims to introduce a control system for these products based on the following principles:

(a) The Member States shall proceed to regular controls of feed and food that will be released for free circulation in the Community. These controls shall be organised using a statistically based sampling plan. They can take place at any point of the distribution of the goods: before release for free circulation or afterwards, e.g. at the importer's premises, during processing or at the point of retail sale. There shall in any way be a close co-operation between the customs services and the authority that is competent for controlling feed and food imports.

(b) In addition it is proposed to establish at Community level a list of priority feed and foodstuffs for which experience has shown that hazards may occur (e.g. aflatoxins in certain foods). Such feed and food shall be presented at specially designated and equipped inspection posts for the carrying out of the necessary checks. These controls must be carried out before the goods are released for free circulation.

Additionally and in order to allow for the possibility of controls on feed and food from third countries that enters into free zones and free warehouses or is placed in transit, customs warehousing, inward processing, processing under customs control or temporary admission, the proposal foresees a possibility for performing official controls of feed and food kept under these different customs approved treatments or uses.

The present proposal aims also to better define the essential controls that are needed to ensure feed safety along the same lines as those that are developed for food.

43. Financing of official controls

A system of control fees is applied at present in two sectors: the veterinary sector and the feed sector. The system in the veterinary sector relies on a flat rate from which departures can be made in order to take account of local differences with regard to the elements that have been taken into account to calculate the flat rate (wages, transport costs etc.) Although the fees in the veterinary sector have been introduced to avoid differences between Member States that may lead to distortions, experience has shown that important differences between and in certain cases within Member States continue to exist. The system has not always attained the desired objective.

In the feed sector, fees can be levied for particular well-specified control tasks. The Directive that governs this sector does not fix a Community flat rate, but leaves this to the Member States who must observe certain criteria in fixing flat rates. The rules that fix these principles have been adopted relatively recently (Council Decision 98/728 of 14 December 1998 concerning a Community system of fees in the animal feed sector).

Taking into account the experience gained so far, it is proposed to lay down the principles that underlie the financing of official controls and in particular that:

- Member States must ensure that adequate financial resources are available for organising official controls;

- if inspection fees are imposed to feed and food business operators, common principles must be observed for setting the level of such fees,

- where official controls reveal non-compliance with feed and food law, the extra costs that result from more intensive controls possibly linked to such non-compliance be borne by the feed and food business operator concerned,

- there is a need for flexibility in order to take into account the interests of small businesses.

44. Official certification

Within the EU, where there is free circulation of goods, there is no need to provide for consignments of feed and food to be systematically accompanied by official certificates issued by the competent authority.

Two areas can be identified however where official certification can be envisaged: (a) in exceptional circumstances when a feed or food emergency occurs within the EU, and (b) in order to obtain confirmation from the authorities in exporting third countries that the goods comply with the EU standards or with standards equivalent thereto.

In order to cover these areas the proposal provides for a procedure for specifying the cases and conditions under which official certification must be ensured.

Reference laboratories

45. A number of Community Reference Laboratories (CRLs) have been established under Community legislation in force. They are operating with Community financial support. These laboratories have an important role in ensuring a high level of consumer protection. They must provide the national reference laboratories, for example, with details of analytical methods, organise comparative testing, co-ordinate within their area of competence the practical and scientific activities needed to obtain new analytical methods, conduct training courses and provide technical assistance to the Commission. CRLs exist at present for residue testing (four laboratories), milk testing, the quantification of biotoxins in molluscs, for testing molluscan shellfish for the absence of harmful viruses, for the control of zoonoses (salmonella) and for transmissible spongiform encephalopathies (TSEs).

The present proposals lays down procedures to ensure that these laboratories can continue their work and for establishing new laboratories should the need arise.

For each CRL, a national reference laboratory must be established in each Member State. Such laboratories function as the point of communication between the CRL and all the official laboratories in the Member States. The national reference laboratories play therefore an important role in ensuring that a uniform level with regard to analytical results of official samples is achieved.

Mutual assistance

46. Mutual assistance between the controlling authorities of the Member States is an essential element of Community legislation. It must ensure effective co-ordination where action is required by more than one Member State (e.g. feed and food emergencies or non-compliance that affect two or more Member States).

Although this aspect is covered in the legislation affecting the different sectors concerned, it is conceived in different ways resulting in unnecessary differences. The present proposal fixes a uniform system based on the following principles:

(a) Member States shall designate a liaison body the role of which shall be to assist and co-ordinate communication, transmission and reception of requests for assistance.

(b) Upon receiving a reasoned request, the liaison body shall contact the relevant authorities who shall ensure that the requesting party is provided with all necessary information and documents enabling it to verify compliance with feed and food law.

(c) If necessary, the different parties shall seek together ways and means of remedying the situation.

The procedure applies to the exchange of all information, except that which cannot be released because of it being the subject of legal proceedings.

National control plans

47. As set out above, the proposal provides for the establishment of national control plans that set out the national control system and activities in a global and comprehensive way. These plans will have to be developed along the lines that are contained in guidelines to be established by the Commission in consultation with the Member States.

48. The Member States are requested to report annually on the results of the controls that have been carried out the previous year. If necessary, the control plans must be adapted in function of these results. The Commission will then, on a regular basis, audit the Member States on the basis of their updated plans.

Community activities

49. Community controls in the Member States

Until now, Community controls in the Member States were organised in function of the mandates the Commission has in the different sectoral Directives. This system has not always permitted to evaluate Member State control systems in a global way.

The creation of a single legal basis with the present proposal and the establishment of control plans will allow the Community control services to perform a general audit of the Member States' control systems globally. These audits will be carried out globally in order to verify the continuous achievement of the required level of control by the competent services in the Member States. If needed, these can be supplemented by more specific audits and inspections for a particular sector or problem.

50. Community controls in third countries

The volume of imported feed and food is substantial. Given the available resources, it is excluded that all of the operators in third countries involved in feed and food exports are individually controlled in a systematic way by FVO inspectors. The proposal therefore establishes a system that obliges the controlling authorities in third countries to guarantee that feed and food that is exported to the EU complies with EU feed and food law or with requirements that are judged equivalent to those.

For that purpose, the proposal requires third countries to have a control plan available, similar to those foreseen for Member States, in respect of the products they export to the EU. These plans will form the basis for subsequent Commission audits and inspections that will be carried out within a multidisciplinary framework covering the main sectors exporting to the EU. Where necessary more specific inspections and audits of particular sectors can be carried by the Community control teams. The same principles shall apply to live animals and plants.

51. Third country controls in the Community

In the same way as the FVO is entitled to perform controls in third countries to verify compliance or equivalence of the third requirements with EU feed and food law, third country authorities are entitled to organise controls in the Member States. Experience has shown that it is beneficial in some cases to ensure that representatives of the FVO accompany the third country teams that visit Member States. These representatives can assist Member States by providing information and data that are available at Community level and that may be useful in the context of the third country control carried out. The present proposal provides for a procedure to ensure such assistance.

The training of control officials

52. The integrated and global approach towards feed and food safety requires high levels of competence and expertise from the controlling authorities: they need to have a broad knowledge of different hazards (chemical, biological and physical) that can occur along the feed and food chain. They must also understand the mechanisms of the market in which ingredients for composite products can be obtained from different sources. At the same time, they need to be informed about very specific problems that are inherent to specific production methods. They must be able to identify non-compliance with feed and food safety requirements and to detect fraudulent practices.

Modern control techniques require feed and food control officials to be highly skilled so that controls are efficient, objective and adequate. This is in particular the case where the performance of hazard analysis and control techniques applied by food operators must be assessed.

Control of feed and food production and marketing requires therefore a multidisciplinary approach. Feed and food inspectors will need continuing training and updating of their knowledge. It is essential that the necessary legal provisions are made to facilitate such training. The present proposal therefore requires the establishment of proper training programmes both at national and Community level.

In this context, special attention has been paid to the organisation of training programmes at Community level and provision is made for organising such training. It must be ensured for example that the assessment of the implementation of the HACCP principles and the decisions that are subsequently taken by the assessor reflect an approach that is based on a standard procedure that applies in a uniform way in all Member States. The organisation of training courses is left to a future decision, but a possibility could be the establishment of a training centre under the aegis of the Commission, within the limits of the human and financial resources available to it. Leading experts in the area of feed and food controls and the different control techniques could be invited. Control officials from the Member States, but also from third countries and in particular from developing countries could be invited to follow the courses.

Enforcement of feed and food law

53. National enforcement measures

In order to guarantee and maintain a high level of public health and consumer protection, adequate enforcement measures must be available to the competent authorities and effectively used by them in order to tackle non-compliance with feed and food law.

The responsibility for implementing and enforcing community legislation lies primarily with the Member States. According to Article 10 of the EC Treaty, Member States must take all measures necessary to guarantee the application and effectiveness of Community law. Such measures include, in any event, effective proportionate and dissuasive penalties (judgement of the Court of 10 July 1990 in case C-326/88). Such measures may consist of administrative measures or criminal sanctions to be imposed by the competent authorities in the Member States.

54. Administrative enforcement measures

Administrative enforcement measures are to a greater or lesser extent spelled out in certain Community acts such as the veterinary legislation (Directives 89/662/EEC and 97/78/EEC), the feedingstuffs legislation (Article 13 of Directive 95/53/EEC) and the food legislation (Article 10 of Directive 89/397/EEC). In these Community acts, these measures extend from a simple requirement "to take the requisite measures" (Article 10 of Directive 89/397/EEC) to take action at the level of the products (withdrawal from the market, destruction, product sanitation etc.) or of the food business concerned (taking of corrective action, temporary or permanent closure of a food business). National legislation may also, of course, provide for further, different administrative sanctions.

Such administrative measures, having direct effect on operators, are a powerful tool and, if properly used, also have an important dissuasive effect. The present proposal therefore re-confirms the need for the Member States to take administrative enforcement measures. It also aims to ensure that a requirement to that effect applies to all feed and food businesses at all levels of the feed and food chain.

55. Criminal sanctions

There is a lack of certainty in Community law with regard to the Member States' obligation to provide criminal penalties. In addition, there is no minimum standard with regard to the constituent elements of offences to the detriment of feed and food safety.

In many cases, only criminal penalties will provide a strong dissuasive effect. The provision for such sanctions demonstrates social disapproval of a qualitatively different nature compared to administrative enforcement measures. There is also an additional guarantee of impartiality of investigating authorities, because other authorities than those who have granted exploitation licences will be involved in a criminal investigation.

Therefore, a common minimum set of serious offences under EU feed and food law, or under rules adopted by the Member States in order to comply with such law, for which Member States are required to impose criminal penalties, must be established. This takes the form of a list of serious offences against Community feed and food law committed intentionally or through serious negligence, for which Member States must provide for criminal sanctions. These are the offences that could threaten most feed and food safety and therefore public health.

The proposal aims to set a minimum standard of feed and food safety protection, including animal health and animals welfare, through criminal law. It does not cover all activities regulated by Community feed and food law, but only important offences that may lead to the placing on the market of feed or food that are unsafe in the sense of Articles 14 and 15 of Regulation (EC) No 178/2002.

The offences listed in the present proposal are offences that may eventually lead to the placing on the market of unsafe feed or food. Considering the seriousness of the threat they pose to public health, it is important that these offences are made punishable "per se", whether they eventually lead or not to the placing on the market of unsafe feed or food.

Member States may, of course, establish additional offences and/or provide for different additional types of enforcement measures and penalties. For instance, they may consider to provide for disqualification of natural persons from engaging in an activity of founding or directing a company or other form of enterprise.

The nature of the sanctions can only be determined under national law by the Member States. For the same reason, the Regulation does not regulate questions of criminal investigations and prosecutions, nor questions of criminal procedure. It is up to the authorities in the Member States to decide whether the offences listed in the Regulation must be prosecuted in any case or whether the competent authority may refrain from providing for criminal penalties in minor cases where the impact on feed and food safety is insignificant.

As to natural persons, the proposal would oblige Member States to provide for effective, dissuasive and proportionate criminal penalties against the defined breaches of Community law. In order to ensure a high level of feed and food safety, it is important also to include sanctions against complicity (participation and instigation) in the offences that are listed. In serious cases, Member States would have to provide for the possibility of imprisonment but would have a broad discretion in defining such serious cases.

As to legal persons, it is essential for effective enforcement of Community feed and food law that they can be held liable and that sanctions against legal persons are taken. However, for some Member States it might be difficult to provide for criminal sanctions against legal persons without changing fundamental principles of their national legal systems. Therefore, Member States would be able to foresee sanctions other than those of a criminal nature as long as they are effective, proportionate and dissuasive. For instance, they could provide for non-criminal fines, judicial supervision, judicial winding-up orders or exclusion from entitlement to public benefits or aid.

The Commission believes that such a measure is justified in order to ensure that feed and food safety rules are respected throughout the EU by means of a harmonised approach in all Member States. This objective is best achieved by a Community approach in accordance with Article 5, paragraph 2 of the EC Treaty.

56. Community safeguard measures

The procedure referred to in Article 226 of the Treaty (infraction procedure) offers a tool for the Commission to proceed against Member States that fail to implement Community law.

Although this procedure is a powerful instrument, the time constraints imposed on it render it impractical where a failure to implement Community law requires prompt action to safeguard feed and food safety. The safeguard measure adopted under Regulation (EC) No 178/2002 allows the taking of measures only where there is evidence that feed or food that is placed on the market is likely to constitute a serious risk to human health, animal health or the environment, and that such risk cannot be contained satisfactorily by means of measures taken by the Member State(s) concerned. This measure does not allow the Commission to take action when there is clear evidence that a Member State's control system shows serious shortcomings and is inadequate to implement Community law properly thus possibly compromising feed and food safety in a more general way.

The present proposal adds a new dimension to the existing safeguard measure in Regulation (EC) No 178/2002. It introduces a tool that would allow the Commission to take measures when there is proof that a Member State's control system is inadequate. These may include the suspension, for the Member State in question, of the placing on the market of certain feed or foodstuffs, laying down special conditions for certain feed or foodstuffs or the taking of any other interim measure required to ensure protection of human health, animal health and animal welfare.environment

Special and Differential treatment

57. Article 10 of the agreement on the application of Sanitary and Phytosanitary Measures (SPS Code) adopted by the World Trade Organisation lays down that, in the preparation of sanitary or phytosanitary measures, Members shall take account of the special needs of developing country Members, and in particular of the least-developed country Members.

The EU imports large quantities of feed and food from developing countries. These countries fall within the same general requirements laid down in Regulation (EC) No 178/2002 that third countries must ensure that feed or food exported towards the EU complies with the relevant requirements of feed and food law, or with conditions recognised by the Community to be at least equivalent thereto or, where a specific agreement exists between the Community and the exporting country, with the requirements contained therein.

Whilst it is not possible to grant derogations on the health standards that are established under Community feed and food law, it is possible to consider a number of activities to assist developing countries to provide the requisite guarantees. The proposal therefore introduces procedures to that effect. These concern, for example, a phased introduction of the requirement to present a control programme, assistance with the establishment of a control programme, the promotion of twining projects between developing countries and Member States, sending Community experts on the spot so as to assist in the organisation of official controls.

Financial support

58. The proposal includes a number of activities that require a financial input from the Community. These are in particular:

- the designation of new reference laboratories;

- the creation of a database on country profiles;

- the participation of national experts in FVO missions;

- the standardisation of methods of analysis and sampling, in particular by the establishment of criteria based performance standards;

- the support for developing countries;

- the creation of training facilities for control staff of the Member State and third countries;

- feed and food safety studies, conferences and publications.

At the moment, feed and food safety controls account for about EUR 3 Mio in the annual Community budget. Implementing all of the above proposed measures would increase this amount to approximately EUR 16 Mio annually or EUR 95 Mio over six years. EUR 7.5 Mio out of those EUR 16 Mio are foreseen for training of control officials from Member States, Candidate Countries and third countries on the (new) EU feed and food control measures.

This action must be considered as the completion of action 79 of the White Paper on Food Safety which aims to provide for a legal basis to ensure adequate Community financial support of actions necessary to enhance food safety.

Implementing measures

59. The proposed rules cover an extensive area including official controls of all feed and food at all stages of the food chain within the Community or presented at the Community border for import. These rules cannot cover all the details that characterise official controls. They must therefore be considered as a framework containing the essential requirements on the basis of which more detailed rules to ensure uniform implementation by the Member States can be developed if necessary. It is for that reason that provision is made for the development of such implementing rules in accordance with the procedure provided for in Article 5 of Council Decision 1999/468/EC.

Scope of the proposed Regulation

60. The principles set out in this proposal are generally applicable to all feed and food law, and to animal health and animal welfare legislation. However, bearing in mind that for certain areas of food law there are already comprehensive and specific control measures in place, the proposed Regulation should therefore take account of this acquis.

The scope of the proposal does therefore not extend to the verification of compliance with the rules on the common organisation of the markets of agricultural products (arable crops, wine, olive oil, fruit and vegetables, hops, milk and milk products, beef and veal, sheepmeat and goatmeat and honey) for which a well established and specific control system is already in place. In addition, the purpose and objectives of the proposal are different from the purpose and objectives of the controls that apply to the common organisation of the agricultural markets.

The following contain specific measures for the verification of compliance with the requirements contained therein:

- Council Directive 2000/29/EC of 8 May 2000 on protective measures against the introduction into the Community of organisms harmful to plants or plant products and against their spread within the Community [14],

[14] OJ L 169, 10.7.2000, p. 1.

- Council Regulation (EEC) No 2092/91 of 24 June 1991 on organic production of agricultural products and indications referring thereto on agricultural products and foodstuffs [15],

[15] OJ L 198, 22.7.1991, p. 1.

- Council Regulation (EC) No 2081/92 of 14 July 1992 on the protection of geographical indications and designations of origin for agricultural products and foodstuffs [16], and

[16] OJ L 208, 24.7.1992, p. 1.

- Council Regulation (EC) No 2082/92 of 14 July 1992 on certificates of specific character for agricultural products and foodstuffs [17].

[17] OJ L 208, 24.7.0992, p. 9.

This proposal should be flexible enough so as to take account of the specificity of these areas.

The structure of future Community rules on feed and food controls

61. The proposal joined herewith provides for the general rules applicable to the official controls of all feed and food at any stage of production, processing and distribution, whether produced within the EU, exported to or imported from third countries. In addition to these general rules, it must be envisaged that particular problems need particular solutions. There must therefore be room for more specific control measures in order to maintain a high level of protection. Within this context it is clear that existing more specific control rules must be kept in place. These are for example:

- Council Directive 96/22/EC of 29 April 1996 concerning the prohibition on the use in stockfarming of certain substances having a hormonal or thyrostatic action and of beta-agonists, and repealing Directives 81/602/EEC, 88/146/EEC and 88/299/EEC [18],

[18] OJ L 125, 23.5.1996, p. 3.

- Council Directive 96/23/EC of 29 April 1996 on measures to monitor certain substances and residues thereof in live animals and animal products and repealing Directives 85/358/EEC and 86/469/EEC and Decisions 89/187/EEC and 91/664/EEC [19],

[19] OJ L 125, 23.5.1996, p. 10.

- Regulation (EC) N° .../... of the European Parliament and of the Council laying down specific rules for the organisation of official controls on products of animal origin intended for human consumption [20],

[20] COM (2000) 438, doc. 2000/0180 (COD).

- Regulation (EC) N° 999/2001 of the European Parliament and of the Council of 22 May 2001 laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies [21],

[21] OJ L 147, 31.5.2001, p. 1.

- Regulation (EC) N°.../... of the European Parliament and of the Council on the control of salmonella and other food-borne zoonotic agents and amending Council Directives 64/432/EEC, 72/462/EEC and 90/539/EEC [22],

[22] COM (2001).

- Council Directives 86/362/EEC of 24 July 1986 on the fixing of maximum levels for pesticide residues in and on cereals [23] and 90/642/EEC of 27 November 1990 on the fixing of maximum levels for pesticide residues in and on certain products of plant origin, including fruit and vegetables [24] and the implementing rules resulting therefrom,

[23] OJ L 221, 7.8.1986, p. 37.

[24] OJ L 350, 14.12.1990, p. 71.

- Commission Directives 92/1 of 13 January 1992 on the monitoring of temperatures in the means of transport, warehousing and storage of quick-frozen foodstuffs intended for human consumption [25] and 92/2 of 13 January 1992 laying down the sampling procedure and the Community method of analysis for the official control of the temperatures of quick-frozen foods intended for human consumption [26].

[25] OJ L 34, 11.2.1992, p. 29.

[26] OJ L 34, 11.2.1992, p. 30.

Likewise, it is not excluded that in future new rules must be developed where special problems arise. In that event, proposals will be made to that effect.

2003/0030 (COD)

Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of on official feed and food controls

(Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, and in particular Articles 37, 95 and 152(4)(b) thereof,

Having regard to the proposal from the Commission [27],

[27] OJ C , , p. .

Having regard to the opinion of the Economic and Social Committee [28],

[28] OJ C , , p. .

Having regard to the opinion of the Committee of the Regions [29]

[29] OJ C [...], [...], p. [...].

Acting in accordance with the procedure laid down in Article 251 of the Treaty,

Whereas:

(1) Feed and Food should be safe and wholesome. Community legislation comprises a set of rules to ensure that this objective is attained. These rules extend to the production and the placing on the market of both feed and food.

(2) The basic rules with regard to feed and food law are laid down in Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority, and laying down procedures in matters of food safety [30].

[30] OJ L 31, 1.2.2002, p. 1.

(3) In addition to those basic rules, more specific feed law and food law cover different areas such as animal nutrition including medicated feedingstuffs, feed and food hygiene, zoonoses, animal by-products, residues and contaminants, control and eradication of animal diseases with a public health impact, feed and food labelling, pesticides, feed and food additives, vitamins, mineral salts, trace elements and other additives, materials in contact with food, quality and compositional requirements, drinking water, ionisation, novel foods and genetically modified organisms (GMOs).

(4) Animal health and animal welfare are also important factors that contribute to the quality and safety of food.

(5) Community feed and food law is based on the principle that feed and food business operators at all stages of production, processing and distribution within the businesses under their control are responsible for ensuring that feed and food satisfy the requirements of feed and food law which are relevant to their activities.

(6) The Member States should enforce feed and food law and monitor and verify that the relevant requirements of food law are fulfilled by feed and food business operators at all stages of production, processing and distribution. Official controls should be organised for that purpose.

(7) A Community framework should be established for the organisation of official controls covering all the areas of feed and food law, including animal health and welfare.

(8) As a general rule this Community framework should not include official controls with regard to organisms harmful to plants and plant products since these controls are already adequately covered by Council Directive 2000/29/EC of 8 May 2000 on protective measures against the introduction into the Community of organisms harmful to plants or plant products and against their spread within the Community [31]. Certain aspects of this Regulation should however also apply to the plant health sector and in particular those concerning the establishment of national control plans and Community inspections within the Member States and in third countries. It is therefore appropriate to amend Directive 2000/29/EC accordingly.

[31] OJ L 169, 10.7.2000, p. 1. Directive as last amended by Commission Directive 2002/36/EC (OJ L 116, 3.5.2002, p. 16).

(9) Council Regulations (EEC) No 2092/91 of 24 June 1991 on organic production of agricultural products and indications referring thereto on agricultural products and foodstuffs [32], (EEC) No 2081/92 of 14 July 1992 on the protection of geographical indications and designations of origin for agricultural products and foodstuffs [33], and (EEC) No 2082/92 of 14 July 1992 on certificates of specific character for agricultural products and foodstuffs [34] contain specific measures for the verification of compliance with the requirements contained therein. These requirements of this Regulation should be flexible enough so as to take account of the specificity of these areas.

[32] OJ, L 198, 22.7.1991, p. 1. Regulation as last amended by Commission Regulation (EC) No 436/2001 (OJ L 63, 3.3.2001, p. 16).

[33] OJ L 208, 24.7.1992, p. 1. Regulation as last amended by Commission Regulation (EC) No 2796/2000 (OJ L 324, 21.12.2000, p. 26).

[34] OJ L 208, 24.7.1992, p. 9. Regulation as last amended by the Act of accession of Austria, Finland and Sweden.

(10) For the verification of compliance with the rules on the common organisation of the markets of agricultural products (arable crops, wine, olive oil, fruit and vegetables, hops, milk and milk products, beef and veal, sheepmeat and goatmeat and honey) a well established and specific control system is already in place. This Regulation should therefore not apply to these areas, all the more since the objectives of this Regulation differ from the objectives pursued by the control mechanisms for the common organisation of the markets of agricultural products.

(11) The competent authorities for performing official controls should meet a number of operational criteria so as to ensure their impartiality and effectiveness. They should have a sufficient number of suitably qualified and experienced staff and possess adequate facilities and equipment to carry out their duties properly.

(12) The official controls should be carried out using appropriate techniques developed for that purpose, including routine surveillance checks and more intensive controls such as inspections, verifications, audits, sampling and the testing of samples. The correct implementation of those techniques requires appropriate training of the staff performing official controls. Training is also required in order to ensure that the competent authorities take decisions in a uniform way, in particular with regard to the implementation of the Hazard Analysis and Critical Control Points (HACCP) principles.

(13) The frequency of official controls should be regular and proportionate to the risk, taking into account the results of the checks carried out by feed and food business operators under HACCP based control programmes or Quality Assurance Programmes, where these are designed to meet requirements of feed and food law. Where necessary, ad hoc controls must be carried out in case of suspicion of non-compliance with feed and food law.

(14) Official controls should take place on the basis of documented procedures so as to ensure that these controls are carried out uniformly and are of consistent high quality.

(15) The competent authorities should ensure that where different control units are involved in carrying out official controls, appropriate co-ordination procedures are in place and effectively implemented.

(16) The competent authorities should also ensure that, where the competence to carry out official controls has been delegated from the central level to a regional or local level, there is effective and efficient co-ordination between the central level and that regional or local level.

(17) Laboratories involved in the analysis of official samples should work in accordance with internationally approved procedures or criteria based performance standards and use methods of analysis that have as far as possible been validated.

(18) The designation of Community and national reference laboratories should contribute to a high quality and uniformity of analytical results. This objective can be achieved by activities such as the application of validated analytical methods, ensuring that reference materials are available, the organisation of comparative testing and the training of staff from laboratories.

(19) The activities of reference laboratories should cover all the areas of feed and food law, in particular those areas where there is a need for precise analytical and diagnostic results. This includes animal health given the importance of this sector with regard to feed and food law.

(20) For a number of activities related to official controls, the European Committee for Standardisation (CEN) has developed European Standards (EN Standards) appropriate for the purpose of this Regulation. These EN Standards relate in particular to the operation and assessment of testing laboratories and to the operation and accreditation of control bodies. International standards have also been elaborated by the International Organisation for Standardisation (ISO) and the International Union of Pure and Applied Chemistry (IUPAC). These Standards might, in certain well defined cases, be appropriate for the purposes of this Regulation, taking into account that performance criteria are laid down in feed and food law in order to ensure flexibility and cost effectiveness.

(21) Provision should be made for delegating competence for performing specific control tasks from the competent authority to a non-governmental body, and for the conditions under which such delegation can take place.

(22) Appropriate procedures should be available for the co-operation of the competent authorities in and between the Member States, in particular when official controls reveal that feed and food problems extend to more than one Member State. In order to facilitate such co-operation, Member States should designate one or more liaison bodies with the role of co-ordinating the transmission and reception of requests for assistance.

(23) In accordance with Article 50 of Regulation 178/2002, the Member States shall inform the Commission where information relating to the existence of a serious direct or indirect risk to human health deriving from food or feed is available.

(24) It is important to create uniform procedures for the control of feed and food from third countries introduced into the territory of the Community, taking into account that harmonised import procedures are already established for:

- food of animal origin by virtue of Council Directive 97/78/EC of 18 December 1997 laying down the principles governing the organisation of veterinary checks on products entering the Community from third countries [35];

[35] OJ L 24, 30.1.1998, p. 9.

- for live animals by virtue of Council Directive 91/496/EEC of 15 July 1991 laying down the principles governing the organisation of veterinary checks on animals entering the Community from third countries and amending Directives 89/662/EEC, 90/425/EEC and 90/675 [36].

[36] OJ L 268, 24.9.1991, p. 56. Directive as last amended by Directive 96/43/EC (OJ L 162, 1.7.1996, p. 1).

These procedures function properly and should be maintained.

(25) The checks on feed and food from third countries referred to in Directive 97/78/EEC are limited to veterinary aspects. It is necessary to supplement these checks with official controls on aspects that are not covered by veterinary checks, such as those on additives, labelling, traceability, irradiation of food and materials in contact with food.

(26) Community legislation also provides for procedures for the control of imported feed by virtue of Council Directive 95/53/EC of 25 October 1995 fixing the principles governing the organisation of official inspections in the field of animal nutrition [37]. That Directive contains principles and procedures that must be applied by the Member States when releasing imported feed for free circulation.

[37] OJ L 265, 8.11.1995, p. 17. Directive as last amended by Directive 2001/46/EC (OJ L 234, 1.9.2001, p. 55).

(27) It is appropriate to establish Community rules in order to ensure that feed and food from third countries is submitted to official controls before release for free circulation in the Community. Special attention should be paid to import controls of feed and food for which there may be an increased risk of contamination.

(28) Provision should also be made for the organisation of official controls of feed and food that is introduced into the territory of the Community under customs procedures other than free circulation, and in particular those introduced under the customs procedures referred to in points (b) to (f) of article 4(16) of Regulation (EC) No 2913/92 of 12 October 1992 establishing the Community Customs Code [38], as well as their entry into a free zone or free warehouse. This includes the introduction of feed and food from third countries by passengers of international means of transport and through parcels sent by mail.

[38] OJ L 311, 12.12.2000, p. 17.

(29) For the purpose of official controls on feed and food, it is necessary to define the territory of the Community in which the rules apply in order to ensure that feed and food that is introduced in this territory is submitted to the controls prescribed by this Regulation. This territory is not necessarily the same as provided for in Article 299 of the Treaty, or as defined in Article 3 of Council Regulation (EEC) No 2913/92.

(30) In order to ensure a more efficient organisation of the official controls on feed and food from third countries and in order to facilitate commercial flows, it may be necessary to designate specific points of entry for feed and food from third countries into the territory of the Community. Likewise, it may be necessary to require advance notice of the arrival of goods at the territory of the Community.

(31) In establishing rules on the official controls of feed and food from third countries, it should be ensured that that the competent authorities and the customs services work together, taking into account that rules to that effect already exist in Council Regulation (EEC) No 339/93 of 18 February 1993 on checks for conformity with the rules on product safety in the case of products from third countries [39].

[39] OJ L 40, 17.2.1993, p. 1.

(32) Adequate financial resources should be available for organising official controls. Where for that purpose fees are imposed on feed and food business operators, common principles should apply. It is appropriate therefore to lay down the criteria for setting the level of inspection fees. With regard to fees applicable for import controls, it is appropriate to establish directly the rates for main import items with a view to ensure their uniform application and to avoid trade distortions.

(33) Community food law and feed law provide for the registration or approval of certain feed and food businesses by the competent authority. This is in particular the case in:

- Regulation (EC) No .../... of the European Parliament and of the Council on the hygiene of foodstuffs [40];

[40] OJ L

- Regulation (EC) No .../... of the European Parliament and of the Council on the laying down specific hygiene rules for food of animal origin [41];

[41] OJ L

- Council Directive 95/69/EC of 22 December 1995 laying down the conditions and arrangements for approving and registering certain establishments and intermediaries operating in the animal feed sector and amending Directives 70/524/EEC, 74/63/EEC, 79/373/EEC and 82/471/EEC [42].

[42] OJ L 332, 30.12.1995, p. 5. Directive as last amended by Directive 1999/20/EC (OJ L 80, 25.3.1999, p. 20).

Procedures should be put in place in order to ensure that registration and approval of feed and food businesses are carried out in an efficient and transparent way.

(34) In order to have a global and uniform approach with regard to official feed and food controls, Member States should establish and implement national control plans in accordance with broad guidelines elaborated at Community level. These guidelines should promote coherent national strategies, and identify risk-based priorities and the most effective control procedures. A Community strategy should take a comprehensive, integrated approach to the operation of controls.

(35) The national control plans should cover food law and feed law, and the legislation on animal health and animal welfare.

(36) The national control plans should establish a solid basis for the Commission inspection services to carry out controls in the Member States. The control plans should enable the Commission inspection services to verify whether the official controls in the Member States are organised in accordance with the criteria laid down in the this Regulation. Where appropriate and in particular where the audit of the Member States against the national control plans shows weaknesses or failures, detailed inspections and audits should be carried out.

(37) Member States should be required to present an annual report to the Commission with information on the implementation of the national control plans. This report should provide the results of the official controls and audits carried out during the previous year and, where necessary, an update of the initial control plan in response to these results.

(38) Community controls in the Member States should allow the Commission control services to verify whether feed and food law, and the legislation on animal health and animal welfare are implemented in a uniform and correct way throughout the Community.

(39) Community controls in third countries are required in order to verify compliance or equivalence with Community feed and food law as well as with the legislation on animal health. Third countries may also be requested to establish control plans similar to those intended for Member States, in respect of the feed and food exported by them. These plans, which should be established on the basis of Community guidelines, should form the basis for subsequent Commission controls, which should be carried out within a multidisciplinary framework covering the main sectors exporting to the Community. This evolution should allow a simplification of the current regime, enhance effective control co-operation, and consequently facilitate trade flows.

(40) In order to ensure that imported feed and food comply with or are equivalent to Community food law and feed law, it is necessary to establish procedures that allow the definition of import conditions and certification requirements as appropriate.

(41) Breaches of feed and food law may constitute a threat to human health, animal health, and animal welfare. Such breaches should therefore be subject to effective, dissuasive and proportionate measures at national level throughout the Community.

(42) Such measures should include administrative action by the competent authorities in the Member States who should have procedures in place for that purpose. The advantage of such procedures is that quick action can be undertaken in order to restore the situation.

(43) Experience has shown that the existing systems of sanctions have not always been sufficient to achieve compliance with Community law. Such compliance can and should be strengthened by the application of criminal penalties, which demonstrate a social disapproval of a qualitatively different nature compared to administrative measures or a compensation mechanism under civil law.

(44) Entrusting to judicial authorities, rather than to administrative authorities the task of imposing penalties, entails giving responsibility for investigating and enforcing the respect of animal health rules and feed and food law to authorities which are independent of those which grant exploitation licences.

(45) Certain offences should therefore be considered criminal offences when they are committed intentionally or through negligence, and should be subject to criminal penalties, involving in serious cases deprivation of liberty.

(46) Legal persons should also be subject to effective, dissuasive and proportionate penalties, because breaches of Community law to a large extent are committed in the interest of legal persons or for their benefit.

(47) Feed and food business operators should have a right to appeal against the decisions taken by the competent authority as a result of the official controls, and be informed about such right.

(48) It is appropriate to take account of the special needs of developing countries, and in particular of the least-developed countries, and to introduce measures to that effect.

(49) The rules contained in this Regulation underpin the integrated and horizontal approach necessary to implement a coherent control policy on feed and food safety. There must be room however to develop specific control rules where required. Likewise, more specific rules existing in the area of feed and food controls should be kept in place. These include in particular the following acts:

- Council Directive 96/22/EC of 29 April 1996 concerning the prohibition on the use in stockfarming of certain substances having a hormonal or thyrostatic action and of beta-agonists, and repealing Directives 81/602/EEC, 88/146/EEC and 88/299/EEC [43],

[43] OJ L 125, 23.5.1996, p. 3.

- Council Directive 96/23/EC of 29 April 1996 on measures to monitor certain substances and residues thereof in live animals and animal products and repealing Directives 85/358/EEC and 86/469/EEC and Decisions 89/187/EEC and 91/664/EEC [44],

[44] OJ L 125, 23.5.1996, p. 10.

- Regulation (EC) No .../... of the European Parliament and of the Council of [...] laying down specific rules for the organisation of official controls on products of animal origin intended for human consumption [45],

[45] COM (2000) 438, doc. 2000/0180 (COD).

- Regulation (EC) No 999/2001 of the European Parliament and of the Council of 22 May 2001 laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies [46],

[46] OJ L 147, 31.5.2001, p. 1. Regulation as last amended by Commission Regulation (EC) No 270/2002 (OJ L 45, 15.2.2002, p. 24).

- Regulation (EC) No.../... of the European Parliament and of the Council of [...] on the control of salmonella and other food-borne zoonotic agents and amending Council Directives 64/432/EEC, 72/462/EEC and 90/539/EEC [47],

[47] COM (2001)452 final-2001/0177 (COD).

- Council Directive 86/362/EEC of 24 July 1986 on the fixing of maximum levels for pesticide residues in and on cereals [48],

[48] OJ L 221, 7.8.1986, p. 37. Directive as last amended by Commission Directive 2002/42/EC (OJ L 134, 22.3.2002, p. 29).

- Council Directive 90/642/EEC of 27 November 1990 on the fixing of maximum levels for pesticide residues in and on certain products of plant origin, including fruit and vegetables [49] and the implementing rules resulting therefrom,

[49] OJ L 350, 14.12.1990, p. 71. Directive as last amended by Directive 2002/42/EC.

- Commission Directive 92/1/EEC of 13 January 1992 on the monitoring of temperatures in the means of transport, warehousing and storage of quick-frozen foodstuffs intended for human consumption [50],

[50] OJ L 34, 11.2.1992, p. 28.

- Commission Directive 92/2/EEC of 13 January 1992 laying down the sampling procedure and the Community method of analysis for the official control of the temperatures of quick-frozen foods intended for human consumption [51].

[51] OJ L 34, 11.2.1992, p. 30.

(50) This Regulation covers areas that are already covered in certain D