Amended 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 pursuant to Article 250(2) of the EC-Treaty)

EXPLANATORY MEMORANDUM

A. Procedure

In August 2001 the Commission submitted proposals for a Directive of the European Parliament and the Council on the monitoring of zoonoses and zoonotic agents, amending Council Decision 90/424/EEC and repealing Council Directive 92/117/EEC and for a Regulation of the European Parliament and 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 (COM(2001) 452 final - 2001/0176(COD)-2001/0177(COD)) for adoption by the co-decision procedure laid down in Article 251 of the Treaty establishing European Community.

On 15 May 2002 the European Parliament took position in the first reading. The Parliament adopted 66 Amendments (respectively 30 on the proposed Directive and 36 on the proposed Regulation), of which 54 (respectively 28 and 26) were accepted by the Commission in the entirety or in part or on conditions or after reformulation.

In the light of these developments, the Commission has drafted these amended proposals. The amendments are in 'bold' and 'underlined', where adding or modifying, and in "bold" and "strikeout', where deleting text. Only extensive linguistic changes will be mentioned below. Editorial changes made pursuant to B III below are not marked in the text.

B. Explanations of the amendments

I. Proposed Directive on monitoring of zoonoses and zoonotic agents

1. Scope to cover products of plant origin (and mixtures)

The European Parliament's amendments 1, 6 and 12 wholly or partly require zoonotic agents to be monitored not only in animals, feed and food of animal origin as foreseen in the Commission proposals, but also in food of plant origin and food of mixed origin. The Commission has accepted these amendments. Monitoring of products of plant origin is a useful addition, as vegetables and fruits are increasingly found to harbour zoonotic agents and to form a source of human infections. The new wording in these revised proposals is not the same as the European Parliament's amendments, but is consistent with them: it refers to "food", which according to Regulation (EC) No 178/2002 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, means any substance or product intended to be, or reasonably expected to be ingested by humans.

2. Collection of comparable data

The European Parliament's amendments 5, 12, 14, 28 and 31 wholly or partly aiming to strengthen the collection of comparable and uniform data on zoonoses from the Member States, have been taken into account by amending the relevant articles. These amendments follow the objective of the proposal and are largely along the lines followed by the Council working group.

3. Co-operation between national authorities

The European Parliament's amendments 9 and 10 ask for a non-exhaustive list of authorities (including competent authorities for legislation on animal feed) and organisations to be included in the co-operation required in the collecting of zoonoses data at the national level. The Commission has introduced these amendments in the relevant article. The amendments improve the proposal from a technical and editorial point of view and they are globally in line with the developments in the Council working group.

4. Reporting and publication of reports

The European Parliament's amendments 4, 8 and part of amendment 20 requesting that the national reports on zoonoses should be published without delay, are incorporated in the relevant articles. The other part of the amendment 20 seeking to shorten the time allowed for the Member States to submit their reports to the Commission is not accepted. Although the tightening of the reporting schedule would be desirable as such, it is unrealistic in the light of the experience with the existing Directive. However amendment 29 and 32, which would shorten the time for the European Food Safety Authority to compile the Community report, seems to be realistic and this amendment is included in the new proposal. Finally, the revised proposal lays down that the Member States will send their national reports to the Commission only, which will then send them to the European Food Safety Authority. The latter will produce the general report.

5. Responsibilities of food business operators to keep samples and testing results

The European Parliament's amendments 17 and 19 tightening the responsibilities of food businesses to keep relevant food samples in case of food-borne outbreaks and the testing results on zoonotic agents are included in the proposed text. The amendments are largely along the lines followed by the Council working group.

6. Broadening the scope of monitoring of anti-microbial resistance

The European Parliament's amendments 28-33 wholly or partly broadening the scope of the monitoring of antimicrobial resistance to agents other than zoonotic ones are included in the proposed text, subject to editorial change in the light of the development in the Council.

7. Comitology procedure

The European Parliament's amendment 23 requests that the Committee on the Communicable Diseases Network should also be consulted where appropriate, in addition to the Standing Committee on the Food Chain and Animal Health. Although it would create stronger linkage between the veterinary matters and public health, it would not be consonant with the principles and rules laid down in Council Decision 1999/468/EC, as required by Article 202, third indent, of the Treaty. Only one committee may assist the Commission in the exercise of the powers that the Council has delegated to it. Therefore, the wording of the relevant article has been revised, so that the Commission shall be assisted by the Standing Committee on the Food Chain and Animal Health, or where appropriate, by the other Committee.

8. Criteria for zoonoses and other agents to be included in monitoring

The European Parliament's amendments 13, 25, 26, 28 and 31 transferring certain criteria from annexes to articles have been taken into account in the proposal. The amendments would enable the European Parliament and the Council to be involved if further amendments would be proposed to the criteria. These criteria concern the addition and deletion of zoonoses subject to monitoring or to the need for the monitoring of anti-microbial resistance to complement the monitoring of human isolates.

9. Consultation of European Food Safety Authority

The European Parliament's amendment 16 making the consultation of the European Food Safety Authority compulsory when establishing co-ordinated monitoring programmes is incorporated in the proposal. This type of scientific input would always be useful. However, the amendment 22 seeking for systematic prior consultation before amending the annexes or taking transitional measures is rejected. This is because scientific advice is not necessary when establishing purely administrative measures.

10. Various topics

The European Parliament's amendment 18 is rejected as it would require systematic microbiological studies (instead of "as far as possible") during investigation of food-borne outbreaks. This may not always be possible if the suspected food is not available any longer.

European Parliament's amendments 2, 3, 6, 7, 11, 24, 27 improve the proposal from a technical and editorial point of view. They have been taken into account in the revised proposal.

II. Proposed Regulation on the control of salmonella and other food-borne zoonotic agents

11. Overall objective of Regulation

The European Parliament's amendment 7 adding an overriding long-term objective to avoid completely the presence of zoonotic agents in the feed and food chain, is rejected. This kind of objective is unrealistic; it is impossible to achieve total absence of zoonotic agents in the food and feed chain irrespective the control measures taken.

12. Involvement of the feed business operators in controls

The European Parliament's amendments 11, 15, 17, 18, 19 and 20 involving feed industry together with the food industry in the control measures to combat zoonoses, are taken into account in the proposal. The amendments clarify and strengthen the Regulation and are in line with the developments in the Council working groups.

13. Exclusion of production for own use from the scope

The European Parliament's amendment 8 exempting the production for domestic use from the scope of the Regulation is introduced in the proposal. This is in line with Article 1.3 of Regulation (EC) No 178/2002 of 28 January 2002.

14. Inclusion of products (food) of plant origin in the scope

The European Parliament's amendments 1 and 16 seeking to add controls of food and other products of plant origin in the scope of controls, is rejected. Feed of plant origin is already covered by the Regulation. The control measures similar to those in animal populations foreseen in this Regulation are not possible in plant production. The controls of food of plant origin is tackled in the recast of food hygiene legislation (COM(2000) 438).

15. National control programmes to take into account economic repercussions

The European Parliament's amendment 14 requiring Member States, when drawing up their national control programmes, to take into account the cost and benefits in order to achieve appropriate distribution of costs, is introduced in the relevant article.

16. Prohibition on use of antibiotics

The European Parliament's amendment 3 adding an objective to prohibit the use of any antibiotics for preventive purposes or to promote growth in animals is rejected. The Commission already announced the total phasing out of antimicrobials used for growth promoting purposes in a separate proposal. The use of antibiotics as veterinary medicines for preventive purposes does not fall into the scope of this Regulation. However, the Commission intends to ask for a scientific opinion on the risks and benefits of the use of antimicrobials to control salmonella in animal populations.

17. Additional guarantees in intra-Community trade

The European Parliament's amendments 2 and 22 aiming to grant transitional additional guarantees for regions with lower prevalence of zoonotic agents were rejected. These additional guarantees would have applied to all zoonotic agents in live animals, hatching eggs and foodstuffs. The proposal already includes the possibility to set additional guarantees for salmonella as regards the trade of live animals and hatching eggs. However, extending this option to cover also other zoonotic agents may create barriers to trade and would be premature as no pathogen reduction targets and control programmes are proposed for them in the current proposal. Additional guarantees for food fall under the recast of food hygiene legislation (COM(2000) 438) currently subject to first reading in co-decision procedure. However, amendment 23 is taken into account as it has no impact on the implementation of the Regulation.

18. Sanctions in intra-Community trade

The European Parliament's amendment 24 requiring Member States without an approved control programme to be excluded from intra-Community trade in the relevant animals or products is rejected. Sanctions will be dealt with in a separate proposal for a Regulation on official feed and food control.

19. Importation from third countries

The European Parliament's amendment 25 requiring the European Food Safety Authority (EFSA) and the Food and Veterinary Office (FVO) to be closely involved in monitoring that equivalent control programmes exist in third countries, is taken into account only as regards the FVO. This is because such a task would not fall within the remit of EFSA.

20. Salmonella reduction targets, sampling schemes and timetable to implement them

The European Parliament's amendments 29, 32, 36 and 38 aiming to tighten and add salmonella reduction targets are partly taken into account in the proposal. The target for laying hens is extended to cover all salmonella serotypes with public health significance and a new target for slaughter pigs is added. The possibility to adopt a progressive approach for pigs is foreseen. These changes are in accordance with the developments in the Council. The European Parliament's proposal to add new targets for calves, other cattle, sheep is dismissed. Before setting such targets scientific advice is needed. Especially as cattle and sheep seem to be minor contributors to human salmonellosis. The amendment seeking to change the minimum sampling frequency for laying hens from every 9 weeks to every 15 weeks is introduced. The new frequency would still ensure an adequate level of control and is in line with a past opinion of the EC Scientific Veterinary Committee. As regards slaughter pigs, the sampling scheme needs further work on the issue and it is proposed to decide on it when the salmonella reduction target is established. Finally, the column titled "data" in Annex II.B.1 of the proposal is deleted from the original text as it did not establish substantial requirements and discussions in the Council showed that it may lead to confusion.

21. Specific measures in infected poultry flocks

The European Parliament's amendment 34 broadening certain predefined control measures for salmonella positive flocks of laying hens is taken into account in the proposal. The corresponding amendment 33 as regards breeding flocks is rejected.

22. Reporting and publication of reports

The European Parliament's amendment 10 seeking to shorten the time allowed for the Member States to submit their reports to the Commission is not accepted.

The experience of the existing data collection system has shown that the Member States have difficulties to meet the current deadline, which is the same as the one in the proposal.

23. Laboratories

European Parliament's amendment 26 shortening the deadline for laboratories to apply international standards for quality assurance schemes is rejected. Shortening the deadline seems unrealistic, considering the time needed to prepare and reach accreditation and because laboratories have not been warned adequately in advance.

24. Criteria for zoonoses and other agents to be included in monitoring

The European Parliament's amendments 12, 13, 30 and 31 transferring certain criteria from annexes to articles have been taken into account in the proposal. The amendments would enable the European Parliament and the Council to be involved if further amendments would be proposed to the criteria. These criteria concern the addition and deletion of pathogen reduction targets for zoonotic agents.

25. Consultation of the European Food Safety Authority

The European Parliament's amendment 21 making the consultation of the European Food Safety Authority compulsory before adopting decisions concerning specific control measures has been introduced in the proposal. Scientific advice is necessary for the preparation of such decisions. However, amendment 27 seeking systematic consultation before amending the annexes or taking transitional measures is rejected. This is because scientific advice is not necessary when adopting purely administrative measures.

26. Editorial amendments

The European Parliament's amendments 4, 5, 6, 9, 17 and 28 improve the proposal from the technical and editorial point of view. They include also the re-wording of the provisions for on-the-spot checks by the Commission. They have been taken into account in the revised proposal.

III. Other changes

Certain technical changes have been made to the text to ensure its conformity with the Interinstitutional Agreement of 22 December 1998 on common guidelines for the quality of drafting of Community legislation (OJ C 73, 17.3.1999, p. 1), drawn up pursuant to Declaration No 39 annexed to the Final Act of Amsterdam on the quality of the drafting of Community legislation. In accordance with points (b) and (g) of that Agreement, the text has been revised to take account of the common guidelines and the Joint Practical Guide drawn up under point (a) thereof.

2001/0176 (COD)

Amended 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 [1],

[1] OJ C ...

Having regard to the opinion of the Economic and Social Committee [2],

[2] OJ C ...

Having regard to the opinion of the Committee of the Regions [3],

[3] OJ C ...

Acting in accordance with the procedure laid down in Article 251 of the Treaty [4],

[4] 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 [5] provided for the establishment of a monitoring system for certain zoonoses both at the level of Member States and at Community level.

[5] 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 particular Council Directive 64/432/EEC of 26 June 1964 on animal health problems affecting intra-Community trade in bovine animals and swine [6], 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 [7], as regards ovine and caprine brucellosis.

[6] OJ L 121, 29.7.1964, p. 1977. Directive as last amended by Commission Regulation (EC) No 1226/2002 (OJ L 179, 9.7.2002, p. 13).

[7] OJ L 46, 19.2.1991, p. 19. Directive as last amended by Commission Decision 2002/261/EC (OJ L 91, 6.4.2002, p. 31).

(7) Moreover, Regulation (EC) No..../... of the European Parliament and of the Council of .... [on the hygiene of foodstuffs] [8] covers specific elements necessary for prevention, control and monitoring of zoonoses and zoonotic agents, and includes specific requirements for the microbiological quality of food.

[8] 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 [9] 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.

[9] 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 and plant 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 specified food-borne zoonotic agents] [10]. Directive 92/117/EEC should therefore be repealed.

[10] OJ L ...

(12) The new framework for scientific advice and scientific support in matters of food safety set up by 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 [11] should be used to collect and analyse the relevant data.

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

(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 agents.

(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 zoonoses and zoonotic agents.

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

(16) In accordance with the principle of proportionality, it is necessary and appropriate for the achievement of the basic objective of monitoring zoonoses and zoonotic agents of importance at Community level, to lay down rules on the provision of data in a harmonised way and monitoring measures. This Directive does not go beyond what is necessary in order to achieve the objectives pursued in accordance with the third paragraph of Article 5 of the Treaty.

(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 to Regulation (EC) No..../... [on the control of salmonella and other specified food-borne zoonotic agents].

(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 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 [12]. Therefore they should be excluded from the scope of this Directive.

[12] OJ L 147, 31.5.2001, p. 1. Regulation as last amended by Commission Regulation (EC) No 1494/2002 (OJ L 225, 22.8.2002, p. 3).

(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 Safety Authority in the form of reports, which should also be made available to the public in an appropriate way without delay.

(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 [13], should be amended as regards the detailed rules governing the Community's financial contribution towards certain actions relating to the monitoring and control of zoonoses and zoonotic agents.

[13] OJ L 224, 18.8.1990, p. 19. Decision as last amended by Decision 2001/572/EC (OJ L 203, 28.7.2001, p. 16).

(24) Appropriate procedures should be laid down for amending certain provisions of this Directive and for the adoption of implementing and transitional measures.

(25) The EFSA should be consulted as appropriate, and particular on matters having significant impact on public health.

(26) The measures necessary for the implementation of this Directive should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission [14].

[14] 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 , zoonotic agents, foodborne outbreaks and antimicrobial resistance of zoonotic agents are properly monitored so that the necessary information may be collected in the Community to evaluate their trends and sources . Those evaluations shall provide a basis for effective risk assessment and 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, in connection with the primary production of animals, and at other stages of the food chain, including the production of feedingstuffs and further preparation and production of food;

(b) the monitoring of antimicrobial resistance;

(c) the epidemiological investigation of foodborne outbreaks;

(d) the exchange of information related to zoonoses and zoonotic agents.

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

Article 2 Definitions

For the purposes of this Directive, the definitions set out in Article 2 and Article 3 of Regulation (EC) No 178/2002 shall apply.

The following definitions shall also apply:

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

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

(c) "antimicrobial resistance" means the ability of micro-organisms 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;

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

(e) "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;

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

Article 3 General obligations

1. Member States shall ensure that data on the occurrence of zoonoses and zoonotic agents, food-borne outbreaks, and antimicrobial resistance are collected, analysed and published without delay 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 (hereinafter referred to as "the competent authority") 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 and:

(a) the competent authorities designated for the purpose of Community legislation on feed;

(b) the competent authorities designated for the purposes of the Community legislation on animal health;

(c) the competent authorities designated for the purposes of the Community legislation on food hygiene;

(d) the structures and/or authorities referred to in Article 1 of Decision No 2119/98/EC;

(e) other authorities and organisations concerned.

4. Each Member State shall ensure that the relevant officials of the competent authority designated for the purposes of this Directive are suitably qualified to undertake their duties and, where necessary, are trained in microbiology and epidemiology and receive regular up-to-date training which reflects scientific progress in those areas.

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 and comparable 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 food.

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

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

3. The monitoring shall be based on the systems in place in Member States. Where necessary to make the data easier to compile and compare, 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 populations 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, in accordance with the requirements set out in Annex II, ensure that the monitoring provides comparable data on the occurrence of antimicrobial resistance in zoonotic agents and, insofar as they present a threat to public health, other agents.

Monitoring shall be coordinated with the surveillance of antimicrobial resistance conducted in accordance with Decision No 2119/98/EC.

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), after consultation of the European Food Safety 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 to Regulation (EC) No .../... [on the control of salmonella and other specified food-borne zoonotic agents].

3. The minimum rules concerning the establishment of co-ordinated monitoring programmes shall be those set out in Annex III.

4. The results of the co-ordinated monitoring programmes shall be provided to the European Food Safety 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, or has reason to believe, 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 a relevant number of samples thereof, shall be preserved in a way which neither impedes its investigation in a laboratory, nor a further epidemiological 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 epidemiological investigation shall provide data on the epidemiological profile, the foodstuffs potentially implicated and the potential causes of the food-borne outbreak. The epidemiological 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 Safety Authority a summary report on the results of the epidemiological investigations carried out, containing the information referred to in Annex IV, Part E, to this Directive.

Detailed rules concerning the epidemiological 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 more specific Community provisions on product safety, early warning and response systems for the prevention and control of communicable diseases and food hygiene.

Chapter IV Exchange of information

Article 8 Examinations for zoonotic agents at the level of food business operators

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

Article 9 Assessment of trends and sources of zoonoses, zoonotic agents, food-borne outbreaks and antimicrobial resistance

1. Member States shall assess trends and sources of zoonoses, zoonotic agents, food-borne outbreaks and antimicrobial resistance in their territory.

Each Member State shall transmit to the Commission every year by the end of May a report on trends and sources of zoonoses, zoonotic agents, food-borne outbreaks and antimicrobial resistance , covering the data collected pursuant to Articles 4 to 7 during the previous year. The reports, and summaries of them, shall be made publicly available without delay.

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 specified food-borne zoonotic agents].

The minimum requirements concerning the reports shall be those set out 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 Commission shall send the reports referred to in paragraph 1 to the European Food Safety Authority.

Within six months of receipt of those reports, the European Food Safety Authority shall publish a summary report on the trends and sources of zoonoses, zoonotic agents, food-borne outbreaks and antimicrobial resistance in the Community.

When preparing the summary report, the European Food Safety Authority may take into consideration other data on zoonoses, zoonotic agents, food-borne outbreaks and antimicrobial resistance 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 [15];

[15] 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 may be designated in accordance with the procedure referred to in Article 12(2).

2. 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 and implementing measures

The Annexes may be amended or any appropriate transitional or implementing measures may be adopted in accordance with the procedure referred to in Article 12(2).

The Commission shall consult the European Food Safety Authority on any matter that could have a significant impact on public health.

Amendments to Annex I shall take into account in particular the following:

(a) the occurrence of the relevant zoonosis or zoonotic agent in animal and human populations, feed and food;

(b) its gravity in humans;

(c) its economic consequences for health care and feed and food businesses;

(d) epidemiological trends in animal and human populations, feed and food.

Article 12 Committee

1. The Commission shall be assisted by the Standing Committee on the Food Chain and Animal Health instituted by Article 58 of Regulation (EC) No 178/2002 or, where appropriate, by the Committee instituted by Article 7 of Decision No 2119/98/EC.

2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.

The period laid down 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 and Transitional provisions

Article 14 Repeal and transitional provisions

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 specified food-borne zoonotic agents].

Article 15

Amendment of Decision 90/424/EEC

Decision 90/424/EEC is amended as follows:

1. Article 29 is replaced by the following

"Article 29

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 specified food-borne zoonotic agents] [*].

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 specified food-borne zoonotic agents] 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 specified food-borne zoonotic agents]."

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

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

Influenza virus

Rabies

Viruses spread by arthropods

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

ANNEX II

Requirements for monitoring of antimicrobial resistance pursuant to Article 5

A. General requirements

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

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

8. the production system from which data was collected

B. Specific requirements

Member States shall ensure that the monitoring as set out in Part A 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 provided for 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

Minimum requirements for the reports to be submitted pursuant to Article 9 (1)

The report as provided for in Article 9(1) shall provide at least for the following information:

A. Initially the following shall be described for each zoonosis and zoonotic agent (subsequently only changes are required 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 Member State.

B. Each year the report shall include the following:

(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 methods of characterization used 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 Communitylevel 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 during the 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 why it is impossible 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.