Proposal for a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on the monitoring of zoonoses and zoonotic agents, amending Council Decision 90/424/EEC and repealing Council Directive 92/117/EEC

(presented by the Commission)

EXPLANATORY MEMORANDUM

1. Proposal for a Directive of the European Parliament And of the Council on the monitoring of zoonoses and zoonotic agents, amending Council Decision 90/424/EEC and repealing Council Directive 92/117/EEC

1. A. Chapter I (Introductory provisions)

The proposed Directive would cover the monitoring aspects provided for in Directive 92/117/EEC. In principle, no zoonoses are excluded from the scope of the Directive. However, because a specific set of rules is foreseen for transmissible spongiform encephalopathies, these are excluded from the scope of this Directive. The monitoring activity proposed should take place in animal populations and, where necessary, at other stages of food chain. Member States should nominate a competent authority for the purposes of the Directive and ensure sufficient co-operation between authorities responsible for animal health, food hygiene, communicable diseases and zoonoses monitoring.

1. B. Chapter II (Monitoring of zoonoses and zoonotic agents)

The proposal would oblige the Member States to undertake action in monitoring zoonotic organisms in general. The list of organisms covered by the monitoring is mainly based on the opinion on zoonoses of 12 April 2000 of the Scientific Committee on Veterinary Measures relating to Public Health. The monitoring systems would be primarily based on existing systems in Member States. However, there would be procedures available to establish common criteria for data collection. Also as a new element it is proposed to create a basis for co-ordinated Community monitoring programmes. These co-ordinated monitoring programmes would last for a relevant, but limited time period (1-3 years), and the results of surveys could be used as the basis for possible modification of the pathogen reduction targets. However, any control action based on this monitoring data is, in principle, regulated by Member States themselves.

The collection of human data on the incidence of zoonotic diseases is of paramount importance to base food safety legislation on scientific advice and to obtain feedback on the effectiveness of the control applied and, when necessary, to redirect these measures. Decision 2119/98/EC [1], which entered into force on 1.1.1999, creates a framework for this data collection. Furthermore, Decision 2000/96/EC [2] defines those zoonoses to be progressively covered. Thiscommunicable diseases network should also be used for the purposes of zoonoses monitoring and control. Therefore the proposed Directive requires close co-operation between human, veterinary and food safety authorities in Member States.

[1] OJ L 268, 3.10.1998, p. 1.

[2] OJ L 28, 3.2.2000, p. 50.

In the light of the increasing importance of antibiotic resistance in zoonotic organisms, it is proposed to include its monitoring within the proposed Directive.

1.C. Chapter III (Food-borne outbreaks)

As a separate requirement, the monitoring of foodborne outbreaks is proposed. At the moment, epidemiological outbreak data is collected by a WHO-based Europe-wide system, which is a slow way to gather this data. The monitoring and associated reporting of outbreaks would give important information on the main causes of foodborne diseases. However, the measures concerning suspected foods and their production environment lie outside the scope of this Directive.

1.D. Chapter IV (Exchange of information)

Food business operators would be obliged to keep the results of testing of zoonoses and to communicate these results to the competent authority upon request. Member States shall prepare a yearly report on trends and sources of zoonoses, which they must transmit to the Commission and to the European Food Authority set up following the proposal for a Regulation of the European Parliament and of the Council laying down the general principles and requirements of food law, establishing the European Food Authority (EFA), and laying down procedures in matters of food (COM(2000) 716 final). The EFA shall compile a synthesis report, which may include also relevant information from other Community-wide sources, like animal disease eradication programmes and communicable disease networks.

1.E. Chapter V (Laboratories)

The proposal establishes the framework for designating the Community Reference Laboratories and National Reference Laboratories and to define their respective tasks.

1.F. Chapter VI (Implementation)

It lays down the regulatory procedure and transposition provisions.

1.G. Chapter VII (final provisions)

The proposal encompasses provisions for repealing Directive 92/117/EEC and for amending Council Decision 90/424/EEC of 26 June 1990 on expenditure in the veterinary field [3].

[3] OJ L 224, 18.8.1990, p. 19. Decision as last amended by Council Decision 2001/12/EC (OJ L 3, 6.1.2001, p. 27).

Since the provisions of Directive 92/117/EEC will be covered by the proposed Directive and the proposed Regulation on the control of salmonella and other food-borne zoonotic agents agents and amending Council Directives 64/432/EEC, 72/462/EEC and 90/539/EEC, it is proposed to repeal the current Council Directive. However, to ensure a smooth transition and continuous control it is proposed that certain obligations based on Directive 92/117/EEC would remain in force until corresponding provisions laid down in the proposed Regulation will take effect.

The proposal lays down certain provisions relating to Community's financial contribution towards certain actions relating to the monitoring and control of zoonoses and zoonotic agents, by amending the Chapter on "zoonoses" in Decision 90/424/EEC.

2. Proposal for a Regulation 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

2.A. Chapter I (Introductory provisions)

The proposal encompasses a fundamental review concerning the approach towards the control of zoonotic diseases. It follows the principles of the White Paper on Food Safety (COM(1999) 719 final) adopted by the Commission on 12 January 2000. Account is also taken of the opinion on zoonoses issued by the Scientific Committee on Veterinary Measures relating to Public Health on 12 April 2000.

The proposal for a Regulation 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 would cover, in principle, all zoonoses. However, the specific control requirements are covering only certain types of salmonella. Further extension to cover other pathogens, would be possible, when the epidemiological situation so warrants. The control activities are foreseen to take place primarily at the primary production of animals, and where necessary, at the subsequent stages at the food chain.

2.B. Chapter II (Community targets)

The proposal creates a framework for a pathogen reduction policy. The practical form of this policy would be the establishment of Community pathogen reduction targets for selected zoonotic agents in selected farming animal populations. Before the adoption of pathogen reduction targets, scientific - and political - scrutiny is needed. Therefore it is proposed that the Commission within a fixed timeframe will establish the targets.

The proposal enables future modification of pathogen reduction targets. The targets would progressively be set for certain salmonella serotypes in laying hens, broilers, and their breeders, and for turkey and pig breeders. Other emerging pathogens could be selected as targets, based on scientific evidence and a sufficient knowledge on the potential means to reduce their prevalence in animal populations. It would be also possible to establish separate targets for the different stages of food chain.

2.C. Chapter III (Control programmes)

The level of details of the prescriptive rules concerning control measures at breeder flocks would be minimised compared to the existing Zoonosis Directive. However, this would not mean lowering the required level of safety. The concrete method for implementing pathogen reduction systems would be the establishment of national control programmes. The Commission shall approve the programmes, but to be effective, it is clear that national authorities should bear the greatest responsibility. However, taking into consideration that animal production systems are nowadays more and more integrated (i.e. the same company or organisation governs the supply of feedingstuffs, breeding and/or production animals, and even slaughter) there should be a possibility for own-initiative private sector actions. Therefore it is proposed that the Member States should encourage food businesses to establish their own control programmes.

2.D. Chapter IV (Control methods)

The proposal lays down the possibility for the Commission to decide that certain control methods should not be used as part of control programmes, or to decide on certain conditions for their use. In particular, the use of antibiotics or vaccination may in future need to be further reflected upon. Further control methods may need to be considered in the future.

2.E. Chapter V (Trade)

The basic element in the proposal is to ensure that the purchaser of live animals or hatching eggs knows the status of the holding of origin of the animals. Nationally this can be achieved through national control programmes. However, concerning intra-Community trade there is a need to use a health certification system. Since the existing certificates based on animal health legislation (Directives 64/432/EEC [4] and 90/539/EEC [5]) can be amended by comitology procedure (for Directive 64/432/EEC, a proposal to that effect has been prepared by the Commission), these will be amended by Commission Decisions in due course, in orderto add information concerning zoonosis control into these certificates. After a certain transitional period, the results of testing for salmonella in the flock or herd of origin should be presented in the certificate. With the approval of the Commission, for a transitional period, the Member State of destination could decide that for dispatches from other Member States it could apply the same results requirements as are applied domestically as a part of the respective control programme.

[4] OJ 121, 29.7.1964, p. 1977. Directive as last amended by Directive 2000/20/EC (OJ L 163, 4.7.2000, p. 35).

[5] OJ L 303, 31.10.1990, p. 6. Directive as last amended by Directive 1999/90/EC (OJ L 300, 23.11.1999, p. 19).

For table eggs, once the transitional period before full implementation of the control measures concerning laying hens has elapsed, table eggs will only be allowed to be marketed for direct consumption when originating from flocks tested negative for S. Enteritidis and S. Typhimurium. For poultry meat, a criterion of "absence of salmonella in 25g" will apply after a transitional period.

As regards third countries, equivalent measures would be required for importation of relevant live animals and hatching eggs into the Community. Where appropriate, control programmes should be required. The certification requirements presented above would apply to imports from third countries and specific certificates for third country trade shall be established or amended, in due course, by Commission Decisions. Certification requirements for products like table eggs or poultry meat will also be established in due course.

2.F. Chapter VI (Laboratories)

The proposal establishes the framework for designating the Community Reference Laboratories and National Reference Laboratories and to define their respective tasks. It also lays down the quality requirements for laboratories participating in control programmes.

2.G. Chapter VII (Implementation)

It lays down the regulatory procedure.

2.H. Chapter VIII (General and final provisions)

The proposal encompasses provisions for Community controls and for amending certain Directives on health conditions governing intra-Community trade and/or importation from third countries.

The proposal encompasses provisions for Community controls and for amending certain Directives on health conditions governing intra-Community trade and/or importation from third countries.

2001/0176 (COD)

Proposal for a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on the monitoring of zoonoses and zoonotic agents, amending Council Decision 90/424/EEC and repealing Council Directive 92/117/EEC

(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 Article 152(4)(b) thereof,

Having regard to the proposal from the Commission [6],

[6] OJ C ...

Having regard to the opinion of the Economic and Social Committee [7],

[7] OJ C ...

Having regard to the opinion of the Committee of the Regions [8],

[8] OJ C ...

Acting in accordance with the procedure laid down in Article 251 of the Treaty [9],

[9] OJ C ...

Whereas:

(1) The protection of human health against diseases and infections directly or indirectly transmissible from animals to man (zoonoses) is of paramount importance.

(2) Zoonoses transmissible through food may cause human suffering, as well as economic losses to food production and food industry.

(3) Zoonoses transmitted through sources other than food, especially from wild animal and pet animal populations, are also a matter of concern.

(4) Council Directive 92/117/EEC of 17 December 1992 concerning measures for protection against specified zoonoses and specified zoonotic agents in animals and products of animal origin in order to prevent outbreaks of food-borne infections and intoxications [10] provided for the establishment of a monitoring system for certain zoonoses both at the level of Member States and at Community level.

[10] OJ L 62, 15.3.1993, p. 38. Directive as last amended by Directive 1999/72/EC of the European Parliament and of the Council (OJ L 210, 10.8.1999, p. 12).

(5) The results of the monitoring are collected yearly from the Member States and compiled by the Commission, with the assistance of the Community Reference Laboratory for the epidemiology of zoonoses. The results have been published yearly since 1995 and they provide a basis for the evaluation of the current situation concerning zoonoses and zoonotic agents. However, the data collection systems are not harmonised and therefore do not permit comparisons between Member States.

(6) Monitoring and control of certain zoonoses in animal populations has been provided for by other Community legislation, in particularCouncil Directive 64/432/EEC of 26 June 1964 on animal health problems affecting intra-Community trade in bovine animals and swine [11], as regards bovine tuberculosis and bovine brucellosis and Council Directive 91/68/EEC of 28 January 1991 on animal health conditions governing intra-Community trade in ovine and caprine animals [12], as regards ovine and caprine brucellosis.

[11] OJ 121, 29.7.1964, p. 1977. Directive as last amended by Directive 2000/20/EC (OJ L 163, 4.7.2000, p. 35).

[12] OJ L 46, 19.2.1991, p. 19. Directive as last amended by Commission Decision 94/953/EC (OJ L 371, 31.12.1994, p. 14).

(7) Moreover, Regulation (EC) No..../... of the European Parliament and of the Council of .... [on the hygiene of foodstuffs] [13] covers specific elements necessary for prevention, control and monitoring of zoonoses and zoonotic agents, and includes specific requirements for the microbiological quality of food.

[13] OJ L ...

(8) Directive 92/117/EEC provides for collection of data on human cases of zoonoses. Decision No 2119/98/EC of the European Parliament and of the Council of 24 September 1998 setting up a network for the epidemiological surveillance and control of communicable diseases in the Community [14] was adopted in order to reinforce the collection of such data and to contribute to improving the prevention and control, in the Community, of communicable diseases.

[14] OJ L 268, 3.10.1998, p. 1.

(9) The collection of data on the occurrence of zoonoses and zoonotic agents in feedingstuffs, animal populations, products of animal origin and in humans is necessary to determine the trends and sources of zoonoses.

(10) The Scientific Committee on Veterinary Measures relating to Public Health has, in its Opinion on zoonoses adopted on 12 April 2000, considered that the current measures to control food-borne zoonotic infections are insufficient and that the epidemiological data as currently collected by Member States are incomplete and not fully comparable. On that basis, the Committee recommended improved monitoring arrangements and identified risk management options. In particular, the Committee identified Salmonella spp., Campylobacter spp., verotoxigenic Escherichia coli (VTEC), Listeria monocytogenes, Cryptosporidium spp., Echinococcus granulosus / multilocularis and Trichinella spiralis as public health priorities.

(11) It is, therefore, necessary to improve the existing monitoring and data collection systems established by Directive 92/117/EEC. Simultaneously, the specific control measures established by Directive 92/117/EEC will be replaced by the rules laid down in 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] [15]. Directive 92/117/EEC should therefore be repealed.

[15] OJ L ...

(12) The new framework for scientific advice and scientific support in matters of food safety set up by Regulation (EC) No .../... of the European Parliament and of the Council of ... [laying down the general principles and requirements of food law, establishing the European Food Authority, and laying down procedures in matters of food] [16] should be used to collect and analyse the relevant data.

[16] OJ L ...

(13) Where necessary, procedures should be created which provide data on a harmonised basis, making it possible to evaluate trends and sources of zoonoses and zoonotic agents within the Community. The data collected, together with data from other sources, should form the basis for risk assessment of zoonotic organisms.

(14) Priority should be given to those zoonoses posing the greatest risk to human health. However, the monitoring systems should also facilitate the detection of emerging or newly emerging zoonotic diseases.

(15) Alongside emerging new zoonoses and zoonotic agents, known zoonotic organisms may be converted into new strains. The emergence of resistance to antimicrobial agents is a characteristic that should be monitored.

(16) Since providing data in a harmonised way, to form the basis for risk assessment of zoonotic organisms of importance at Community level cannot be sufficiently achieved by the Member States and can therefore, be better achieved at Community level, the Community may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Directive does not go beyond what is necessary in order to achieve those objectives. The responsibility for establishing and maintaining monitoring systems should lie with Member States.

(17) In addition to general monitoring, specific needs may be recognised which may necessitate the establishment of co-ordinated monitoring programmes. Attention should be paid in particular to zoonoses listed in Annex I, part A of Regulation (EC) No..../... [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].

(18) Food-borne outbreaks of zoonoses, if thoroughly investigated, provide the opportunity to identify the pathogen, the food vehicle involved and the factors in the food preparation and handling that contributed to the outbreak. It is, therefore, appropriate to make provision for such investigations and for a close co-operation between the various authorities.

(19) Transmissible spongiform encephalopathies are subject to Regulation (EC) No .../... of the European Parliament and of the Council of ...[laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies] [17].

[17] OJ L ...

(20) In order to ensure that information collected on zoonoses and zoonotic agents can be used effectively, appropriate rules should be laid down concerning the exchange of all relevant information. That information should be collected in Member States and transmitted to the Commission and to the European Food Authority in the form of reports, which should also be made available to the public in an appropriate way.

(21) The reports should be submitted on an annual basis. However, additional reports may be appropriate, when warranted by circumstances.

(22) It may be appropriate to designate National and Community Reference Laboratories for giving guidance and assistance for analysis and testing in relation to zoonoses and zoonotic agents falling within the scope of this Directive.

(23) Council Decision 90/424/EEC of 26 June 1990 on expenditure in the veterinary field [18], should be amended in so far as concerns the detailed rules governing the Community's financial contribution towards certain actions relating to the monitoring and control of zoonoses and zoonotic agents.

[18] OJ L 224, 18.8.1990, p. 19. Decision as last amended by Council Decision 2001/12/EC (OJ L 3, 6.1.2001, p. 27).

(24) Appropriate procedures should be laid down for amending certain provisions of this Directive to take account of technical and scientific progress and for the adoption of implementing and transitional measures.

(25) Since the said measures are measures of general scope within the meaning of Article 2 of Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission [19], they should be adopted by use of the regulatory procedure provided for in Article 5 of that Decision. The Commission should be assisted by the Committee on Food Safety and Animal Health set up by Regulation (EC) No .../... of the European Parliament and of the Council [laying down the general principles and requirements of food law, establishing the European Food Authority, and laying down procedures in matters of food],

[19] OJ L 184, 17.7.1999, p. 23.

HAVE ADOPTED THIS DIRECTIVE:

Chapter I Introductory provisions

Article 1 Subject-matter and scope

1. The purpose of this Directive is to ensure that zoonoses and zoonotic agents are properly monitored so that the necessary information may be collected in the Community to evaluate trends and sources of zoonoses and zoonotic agents. That evaluation shall provide a basis for the action to be taken to prevent and control zoonoses and zoonotic agents relevant to the Community.

2. This Directive covers:

a) the monitoring of zoonoses and zoonotic agents, taking into account specific features such as antimicrobial resistance related to zoonotic agents, in animal populations at the stage of primary production of animals, and, where necessary, at other stages of food chain, including the production of feedingstuffs and further preparation and production of products of animal origin;

b) the epidemiological investigation of foodborne outbreaks;

c) the exchange of information related to zoonoses and zoonotic agents;

d) the adoption of specific rules on monitoring.

3. This Directive shall apply without prejudice to more specific Community provisions on animal health, animal nutrition, food hygiene, communicable diseases, health and safety at workplace and gene technology.

4. This Directive shall not apply to transmissible spongiform encephalopathies.

Article 2 Definitions

For the purposes of this Directive, the following definitions shall apply:

1. "zoonosis" means any disease and/or infection which is naturally transmissible directly or indirectly from animals to humans;

2. "zoonotic agent" means any virus, bacterium, fungus, parasite or other biological entity which is likely to cause a zoonosis;

3. "antimicrobial resistance" means the ability of micro-organisms of certain species to survive or even to grow in the presence of a given concentration of an antimicrobial agent, that is usually sufficient to inhibit or kill micro-organisms of the same species;

4. "communicable diseases" means diseases caused by zoonotic agents occurring in humans which are covered by Decision No 2119/98/EC;

5. "food business" means a business as defined in Article 2 of Regulation (EC) No .../... [on the hygiene of foodstuffs];

6. "food business operator" means the person or persons responsible for ensuring that the requirements of this Directive are met within the food business under his/her or their supervision;

7. "foodborne outbreak" means the observation under given circumstances of an incidence of two or more human cases of the same disease and/or infection, or the situation when the observed number of cases exceeds the expected number and where the cases are linked, or are probably linked, to the same food source;

8. "monitoring" means a system of collecting, analysing and disseminating data on the occurrence of zoonoses, zoonotic agents and antimicrobial resistance related thereto;

9. "primary production" means production as defined in Article 2 of Regulation (EC) No .../... [on the hygiene of foodstuffs].

Article 3 General obligations

1. Member States shall ensure that data on the occurrence of zoonoses and zoonotic agents and antimicrobial resistance related thereto are collected, analysed and disseminated in accordance with the requirements of this Directive and of any provision adopted pursuant to it.

2. Each Member State shall designate its competent authority for the purposes of this Directive and notify the Commission thereof.

3. Each Member State shall ensure that effective and continuous co-operation based on a free exchange of general information and, where necessary, of specific data, shall be established between its competent authority designated for the purposes of this Directive and:

a) the competent authorities for the purposes of the Community legislation on animal health,

b) the competent authorities for the purposes of the Community legislation on food hygiene,

c) the structures and/or authorities referred to in Article 1 of Decision No 2119/98/EC.

4. Each Member State shall ensure that the relevant officials of the competent authority for the purposes of this Directive are suitably qualified to undertake their duties and, where necessary, are trained in microbiology and epidemiology.

Chapter II Monitoring of zoonoses and zoonotic agents

Article 4 General rules on monitoring of zoonoses and zoonotic agents

1. The Member States shall collect data that is relevant in order to identify and characterise hazards, to assess exposures and to characterise risks related to zoonoses and zoonotic agents. The monitoring shall take place in animal populations, especially at the stage of primary production but also, where necessary, at the other stages in the food chain including the production of feedingstuffs and further preparation and production of products of animal origin.

2. The monitoring shall cover zoonoses and zoonotic agents listed in Annex I, part 1.A.

Where the epidemiological situation in a Member State so warrants, zoonoses and zoonotic agents listed in Annex I, part 1.B shall also be monitored.

3. The monitoring shall be based on the systems in place in Member States. Where necessary, detailed rules for the monitoring of zoonoses and zoonotic agents listed in Annex I may be laid down in accordance with the procedure referred to in Article 12(2) and taking into consideration other Community rules laid down in the fields of animal health, food hygiene and communicable diseases. Those detailed rules shall specify in particular:

a) the animal population or sub-populations or stages in the food chain to be covered by monitoring;

b) the nature and type of data to be collected;

c) case definitions;

d) sampling methods to be used;

e) laboratory methods to be used in testing;

f) the frequency of reporting, including guidelines for reporting between local, regional and central authorities.

Article 5 Monitoring of antimicrobial resistance

1. Member States shall ensure that the monitoring provides data on the occurrence of antimicrobial resistance in zoonotic agents in accordance with the requirements set out in Annex II.

2. Detailed rules for the implementation of paragraph 1 shall be laid down in accordance with the procedure referred to in Article 12(2).

Article 6 Co-ordinated monitoring programmes

1. Co-ordinated monitoring programmes concerning one or more zoonoses and/or zoonotic agents may be established in accordance with the procedure referred to in Article 12(2), where appropriate after consultation of the European Food Authority. Co-ordinated monitoring programmes may be established especially when specific needs are identified to assess risks, or in order to establish base-line values related to zoonoses and/or zoonotic agents at the level of Member States and/or at Community level.

2. Where a co-ordinated monitoring programme is established, special reference shall be made to zoonoses and zoonotic agents in animal populations referred to in Annex I, part A, of Regulation (EC) No .../... [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].

3. Minimum rules concerning the establishment of co-ordinated monitoring programmes are laid down in Annex III.

4. The results of the co-ordinated monitoring programmes shall be provided to the European Food Authority.

Chapter III Food-borne outbreaks

Article 7 Epidemiological investigation of food-borne outbreaks

1. Member States shall ensure that when a food business operator becomes aware that a foodstuff produced or processed by him has caused, or is likely to cause, a foodborne outbreak, he shall inform the competent authority without delay. The foodstuff, or an appropriate sample thereof, shall be preserved in a way which neither impede its investigation in a laboratory, nor a further investigation of the suspected outbreak.

2. When a competent authority receives information pursuant to paragraph 1 or is otherwise informed of a food-borne outbreak, it shall investigate the outbreak in co-operation with the authorities referred to in Article 1 of Decision No 2119/98/EC. The investigation shall provide data on the epidemiological profile, the foodstuffs potentially implicated and the potential causes of the outbreak. The investigation shall include, as far as possible, adequate epidemiological and microbiological studies. The competent authority shall transmit to the Commission and to the European Food Authority a summary report on the results of the investigations carried out, containing the information referred to in Annex IV, Part E, to this Directive. Detailed rules concerning the investigation of food-borne outbreaks may be laid down in accordance with the procedure referred to in Article 12(2).

3. Paragraphs 1 and 2 shall apply without prejudice to Community provisions on product safety, early warning and response systems for the prevention and control of communicable diseases and food hygiene.

4. Measures concerning the suspected foods and their production environment shall be laid down in accordance with Article 12 of Regulation (EC) No ...../..... [on the hygiene of foodstuffs].

Chapter IV Exchange of information

Article 8 Examinations for zoonoses at the level of food business operators

Member States shall ensure that food business operators keep, for a period to be specified by the competent authority, and communicate to the latter at its request, the results of examinations for the presence of the zoonoses and zoonotic agents listed in Annex I, part 1.A.

Article 9 Assessment of trends and sources of zoonoses, zoonotic agents and antimicrobial resistance

1. Member States shall assess trends and sources of zoonoses, zoonotic agents and antimicrobial resistance related thereto in their territory.

Each Member State shall transmit to the Commission and to the European Food Authority every year by the end of May a report on trends and sources of zoonoses, zoonotic agents and antimicrobial resistance related thereto, covering the data collected pursuant to Articles 4 to 7 during the previous year. The reports, or summaries of them, shall be made publicly available.

The reports shall also contain the information referred to in Article 3(2)(b) of Regulation (EC) No ..../... [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].

The minimum requirements concerning the reports are laid down in Annex IV. Detailed rules concerning the assessment of those reports, including the formats and the minimum information which they must include, may be laid down in accordance with the procedure referred to in Article 12(2).

Where the circumstances warrant it, the Commission may request specific additional information and the Member States shall submit reports to the Commission upon such request, or on their own initiative.

2. The European Food Authority shall each year examine the reports referred to in paragraph 1 and within nine months after receiving them shall publish a summary report on the trends and sources of zoonoses, zoonotic agents and antimicrobial resistance related thereto in the Community.

When preparing the summary report, the European Food Authority may take into consideration other data on zoonoses, zoonotic agents and antimicrobial resistance related thereto such as those provided for in the framework of the Community legislation on animal health, food control, food hygiene and communicable diseases, and in particular:

- Article 8 of Directive 64/432/EEC,

- Article 14(2) of Council Directive 89/397/EEC [20],

[20] OJ L 186, 30.6.1989, p. 23. (to be replaced in due course by a Regulation on official food and feed safety controls; referred to as Action No 4 in the White Paper on Food Safety (COM(1999) 719 final)).

- Article 24 of Decision 90/424/EEC,

- Article 4 of Decision 2119/98/EC.

Chapter V Laboratories

Article 10 Community and national reference laboratories

1. One or more Community Reference Laboratories for the analysis and testing of zoonoses and zoonotic agents and antimicrobial resistance related thereto may be designated in accordance with the procedure referred to in Article 12(2).

2. Without prejudice to the relevant provisions in Decision 90/424/EEC, the responsibilities and tasks of the Community Reference Laboratories, in particular with regard to co-ordination of their activities and those of the National Reference Laboratories, shall be laid down in accordance with the procedure referred to in Article 12(2).

3. Member States shall designate National Reference Laboratories for each field where a Community Reference Laboratory has been established and inform the Commission thereof.

4. Certain responsibilities and tasks of the National Reference Laboratories, in particular with regard to co-ordination of their activities and those of the relevant Laboratories in the Member States, may be laid down in accordance with the procedure referred to in Article 12(2).

Chapter VI Implementation

Article 11 Amendments to the annexes and transitional measures

Where appropriate after consultation of the European Food Authority, the Annexes may be amended or any appropriate transitional measures may be adopted in accordance with the procedure referred to in Article 12(2).

Article 12 Committee

1. The Commission shall be assisted by the Committee on Food Safety and Animal Health instituted by Regulation (EC) No .../... of the European Parliament and of the Council [laying down the general principles and requirements of food law, establishing the European Food Authority, and laying down procedures in matters of food].

2. Where reference is made to this paragraph, the regulatory procedure laid down in Article 5 of Decision 1999/468/EC shall apply, in compliance with Article 7 and Article 8 thereof.

3. The period provided for in Article 5(6) of Decision 1999/468/EC shall be three months.

Article 13

Transposition

1 Member States shall adopt and publish before 1 November 2002 the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith inform the Commission thereof.

They shall apply those provisions from 1 January 2003.

When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.

2. Member States shall communicate to the Commission the text of the provisions of national law that they adopt in the field covered by this Directive.

Chapter VII Final provisions

Article 14 Repeal

Directive 92/117/EEC is repealed with effect from 1 January 2003.

However, measures which Member States have adopted pursuant to Article 8(1) of that Directive and implemented in accordance with Article 10(1) thereof and plans approved in accordance with Article 8(3) thereof shall remain in force until corresponding control programmes have been approved in accordance with Article 6 of Regulation (EC)..../.... [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].

Article 15

Amendment of Decision 90/424/EEC

Decision 90/424/EEC is amended as follows:

1. Article 29 is replaced by the following:

"1. A Community financial contribution may be requested by Member States for the monitoring and control of the zoonoses specified in the Annex, Group 2, in the framework of the provisions referred to in Article 24 (2) to (11).

2. As regards control of zoonoses, the Community financial contribution shall be introduced as part of a national plan referred to in Article 6 of Regulation (EC) No ..../... 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] [*].

The level of Community financial participation for measures provided for in Annex II, point C, to Regulation (EC) No ..../... [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] shall be fixed at a maximum of 50% of the cost incurred in the Member State by way of compensation for owners for the slaughter and destruction measures of breeding flocks of Gallus gallus because of the infection concerned.

- - -

* OJ L ....".

2. The following Article 29a is inserted:

"Article 29a

Member States may seek from the Community the financial contribution referred to in Article 29(2) for a national plan which was approved on the basis of Directive 92/117/EEC, until the date on which corresponding control programmes have been approved in accordance with Article 6 of Regulation (EC) No ..../... [Regulation 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]."

3. In the Annex, the following indents are added to the list under Group 2:"

- Campylobacteriosis

- Cryptosporidiosis

- Listeriosis

- Salmonellosis (zoonotic salmonella)

- Trichinellosis

- Verotoxigenic Escherichia coli."

Article 16 Entry into force

This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Communities.

Article 17 Addressees

This Directive is addressed to the Member States.

Done at Brussels,

For the European Parliament For the Council

The President The President

ANNEX I

Part 1. Zoonoses and zoonotic agents to be monitored pursuant to Article 4

A. Zoonoses and zoonotic agents to be included in monitoring

Brucellosis and agents thereof

Campylobacteriosis and agents thereof

Cryptosporidiosis and agents thereof

Echinococcosis and agents thereof

Listeriosis and agents thereof

Salmonellosis and agents thereof

Trichinellosis and agents thereof

Tuberculosis due to Mycobacterium bovis

Verotoxigenic Escherichia coli

B. List of zoonoses and zoonotic agents to be monitored according to the epidemiological situation

1. Viral zoonoses

Calicivirus

Hepatitis A virus

Influenzavirus

Rabies

Tick borne viruses

2. Bacterial zoonoses

Borreliosis and agents thereof

Botulism and agents thereof

Leptospirosis and agents thereof

Psittacosis and agents thereof

Tuberculosis other than in Point A

Vibriosis and agents thereof

Yersiniosis and agents thereof

3. Parasitic zoonoses

Anisakiasis and agents thereof

Cysticercosis and agents thereof

Toxoplasmosis and agents thereof

4. Other zoonoses and zoonotic agents

Part 2. Criteria for addition or deletion of zoonoses in the list in Part 1

When necessary, zoonoses or zoonotic agents may be added or deleted as regards the list in Part 1 taking into account especially

- their occurrence in animal and human populations, feed and food

- their gravity in humans,

- their economic consequences for health care and food businesses,

- epidemiological trends in animal and human populations, feed and food.

ANNEX II Requirements for monitoring of antimicrobial resistance pursuant to Article 5

A. General requirements

Monitoring of antimicrobial resistance should provide relevant information to detect the emergence of and to identify the trends in antimicrobial resistance in zoonotic agents.

Monitoring should be complementary to the monitoring of human isolates conducted according to Council Decision 2119/98/EC.

The Member States shall ensure that the monitoring system for antimicrobial resistance provided for in Article 5 provides at least following information:

1. animal species included in monitoring

2. bacterial species and/or strains included in monitoring

3. sampling strategy used in monitoring

4. antimicrobials included in monitoring

5. laboratory methodology used for the detection of resistance

6. laboratory methodology used for the identification of microbial isolates

7. methods used for the collection of the data

B. Specific requirements

Member States shall ensure that the above monitoring provides relevant information at least with regard to:

- Antibiograms for a representative number of isolates of Salmonella spp., Campylobacter jejuni and Campylobacter coli from cattle, pigs and poultry.

ANNEX III Co-ordinated monitoring programmes as referred to in Article 6

When a co-ordinated monitoring programme is established, at least the following characteristics of the programme shall be defined:

- its purpose

- its time period

- its geographical area or region

- the zoonoses and / or zoonotic agents concerned

- the type of samples and other data units requested

- minimum sampling schemes

- the type of laboratory testing methods

- the responsibility of competent authorities

- the resources to be allocated

- the estimation of its costs and how they will be covered

- the method and time of reporting the results to the Commission and to other Member States.

ANNEX IV Requirements for the reports to be submitted pursuant to Article 9

The report referred to in Article 9(1) must provide at least for the following information:

A. Initially the following shall be described for each zoonosis and zoonotic agent (later only changes have to be reported):

a) Monitoring systems (sampling strategies, frequency of sampling, kind of specimen, case definition, diagnostic methods used)

b) Vaccination policy and other preventive actions

c) Control programmes

d) Measures in case of positive findings or single cases

e) Notification systems in place

f) History of the disease and/or infection in the country

B. Each year shall be reported:

a) Relevant susceptible animal population (and date the figures are related to)

- Number of herds or flocks

- Total number of animals

b) Laboratories and institutions involved in reporting

C. Each year the following details on each zoonotic agent and data category concerned shall be described with their consequences:

a) Changes in the systems already described

b) Changes in previously described methods

c) Results of the investigations and of further typing or other method of characterization in laboratories (for each category reported on separately)

d) National evaluation of the recent situation, the trend and the sources of infection

e) Relevance as zoonotic disease

f) Relevance of findings in animals and foodstuff to human cases, source of human infection

g) Control strategies recognized that could be used to prevent or minimize transmission of the zoonotic agent to humans

h) Need of any specific action in the Member State or at EU level on the basis of the recent situation

D. Reporting of results of examinations

Results shall be given by stating the number of investigated epidemiological units (flocks, herds, samples, batches) and the number of positive samples according to the case definition. The results shall be, when necessary, presented in a way which shows the geographical distribution of the zoonosis or the zoonotic agent.

E. For food-borne outbreak data:

a) Total number of outbreaks over a year.

b) Number of ill and dead persons in these outbreaks.

c) The causative agents of the outbreaks, including, where possible, serotype or other definitive description of the agent. Where the identification of the causative agent is not possible, the reason for that should be stated.

d) Foodstuffs implicated in the outbreak and other potential vehicles.

e) Identification of the type of place where the foodstuff incriminated was produced / purchased / acquired/ consumed.

f) Contributory factors, for example, deficiencies in food processing hygiene.