COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT pursuant to the second subparagraph of Article 251 (2) of the EC Treaty concerning the common position of the Council on the adoption of 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 and the common position of the Council on the adoption of 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

2001/0176 (COD) 2001/0177 (COD)

COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT pursuant to the second subparagraph of Article 251 (2) of the EC Treaty concerning the common position of the Council on the adoption of 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 and the common position of the Council on the adoption of 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

1. BACKGROUND

Date of transmission of the proposals to the EP and the Council (document COM([2001])[452] final - [2001]/[0176](COD) and 2001/0177 (COD)): // 01.08.2001.

Date of the opinion of the European Economic and Social Committee (document CES 191/2002) [1]: // 22.02.2002.

[1] The Committee of the Regions decided not to issue an opinion.

Date of the opinion of the European Parliament, first reading: // 15.05.2002.

Date of transmission of the amended proposals (COM(2002)684 final): // 27.11.2002.

Date of political agreement (qualified majority)

Date of adoption of the common position: // 28.11.2002.

20.02.2003.

2. OBJECTIVES OF THE COMMISSION PROPOSALS

2.1 Objectives of the Directive on the monitoring of zoonoses and zoonotic agents

The objectives of the proposed Directive are to provide for:

- improved monitoring of zoonoses and zoonotic agents, to collect comparable data;

- the monitoring of related antimicrobial resistance;

- the epidemiological investigation of food-borne outbreaks; and

- improved exchange of information related to zoonoses and zoonotic agents.

2.2 Objectives of the Regulation on the control of salmonella and other food-borne zoonotic agents

The aim of the proposed Regulation is to provide for effective measures to be progressively implemented to control specified food-borne zoonotic agents, primarily in specified animal populations but possibly also at other stages of the food chain where appropriate, in order to reduce the risk these agents pose to public health. The primary aim is to control salmonella with public health significance in critical categories of animals. The objectives of the Regulation are to:

- create a framework to implement a pathogen reduction policy, through the progressive setting of Community targets for the reduction of the prevalence of specified zoonotic agents and the implementation of related national control programmes;

- provide for a procedure by which the use of specific control measures may be subject to particular requirements or restrictions;

- provide for rules for trade and imports of live animals and hatching eggs to be set;

- to set specific requirements concerning animal populations covered by control measures and, where appropriate, after transitional periods have elapsed.

3. COMMENTS ON THE COMMON POSITION

3.1 Comments on the common position adopted by the Council with a view to the adoption of a Directive of the European Parliament and of the Council on the monitoring of zoonoses and zoonotic agents (see also point 3.3 below)

3.1.1 General remarks

The Commission accepted nearly all amendments requested by the European Parliament at its first reading and revised its proposal consequently. Nearly all amendments of the European Parliament included in the Commission proposal have been taken into account in the common position. The common position does not incorporate European Parliament amendments that were rejected by the Commission. Additional changes have been included in the common position as a result of discussions in the Council after the first reading of the European Parliament.

There is a similar view between the European Parliament and the Council regarding the principles and most provisions of the Directive.

As regards the recitals of the Directive, amendments 1-4 of the European Parliament, which were incorporated in the Commission proposal, have been included in the common position. The comments below do not cover specifically the other amendments introduced in the recitals of the common position since they are destined to ensure consistency with the body of the legal text.

Date of applicability of the Directive: the Council noted that the date in the Commission proposal (i.e. 1 January 2003) was not realistic considering the state of play of the procedure and it subsequently set a relative date, requiring application within 6 months of entry into force. The Commission acknowledges this.

3.1.2 Scope of monitoring of zoonoses and zoonotic agents (Articles 1, 4-6 and Annex I of the common position)

European Parliament amendments taken into account in the Commission proposal and in the common position: 5, 6, 12 (relevant part), 13-14, 16 (see 3.1.8 below), 19, 24-25

In the common position, certain elements of Article 1 have been transferred to Article 4. Concerning amendment 5, the reference to "effective risk assessment" in the last sentence of Article 1.1, also included in the Commission proposal, is absent from the common position, but reference to the elements of risk assessment are in Article 4.1. The remainder of the last sentence of Article 1.1 was eliminated in the common position due to inter-institutional guidelines on the quality of legal drafting that say that Articles ought not to contain political statements. The Commission agrees on these provisions.

Additional changes incorporated in the common position:

- For certain zoonotic agents it is not appropriate to monitor at all stages of the food chain. The Council therefore introduced flexibility in the additional paragraph 2 of Article 4, which is consistent with the Commission proposal.

- The common position also includes two additional provisions in Article 4.5 and 4.6 to clarify that the harmonised monitoring would set minimum requirements and to ask the Commission to give priority to agents whose monitoring would be mandatory, when setting harmonised rules. The Commission agrees on these refined rules and made a declaration for the Council's minutes to the effect that harmonisation of routine monitoring would be proposed to the extent necessary to ensure that data are comparable (see declarations in the Annex to this Communication).

- The common position also clarifies in Article 5 that co-ordinated monitoring programmes would be established only if data collected through "routine" monitoring performed pursuant to Article 4 were not sufficient. The Commission has no difficulty with this provision.

- As regards Article 6 on food operators' duties, the common position would require that operators arrange for the preservation of any relevant isolate and would provide for detailed rules to be laid down. The Commission supports this further elaboration of the operators' duties.

- Article 1.3 of the common position clarifies that the Directive applies without prejudice to more specific provisions in different areas of Community legislation (including the rules on transmissible spongiform encephalopathies). The Commission agrees on these rules.

- At Annex I, item "cryptosporidiosis and agents thereof" was transferred from part A to part B requiring monitoring depending on the epidemiological situation in each Member State, instead of obligatory monitoring. The Commission can accept this, because the importance of food borne transmission and analytical methods for cryptosporidia are not well developed, it may be better not to require compulsory monitoring until the epidemiological situation is better known.

3.1.3 General obligations (Article 3)

European Parliament amendments included in the Commission proposal and taken into account in the common position: 8-11.

As regards amendment 11, the rewording in the common position is consistent with the European Parliament amendment.

Additional changes incorporated in the common position:

The common position enables a Member State to designate more than one competent authority for the purpose of the Directive, provided that there is co-operation between authorities and a single contact point for the Commission. The Commission has no difficulty with this amendment which is consistent with the mirroring amendment 9 requested by the European Parliament on the Regulation, that the Commission incorporated in its proposal.

3.1.4 Monitoring of anti-microbial resistance (Article 7 and Annex II of the common position)

European Parliament amendments taken into account in the Commission proposal and in the common position: 26-27

Amendment 27 requiring reporting on production systems from which data are collected was included in the Commission proposal. The common position included instead this requirement in Annex IV, so that it applies to all reports, not only to those on anti-microbial resistance. The Commission accepts this view.

European Parliament amendments partly taken into account in the Commission proposal and in the common position: 28, 30, 31 and 33.

Through these amendments, the Parliament requested to provide for monitoring of anti-microbial resistance in zoonotic agents "and other bacteriological agents". Amendments 28 and 31 cover Article 7 and amendments 30 and 33 cover Annex II. The Commission had accepted the amendments, subject to editorial changes. As regards amendments 28 and 31 that cover Article 7, the wording used both in the Commission proposal and the common position refers to zoonotic agents "and, insofar as they present a threat to public health, other agents". This clarifies that collection of data is needed in case of threat to public health. The corresponding sentence in Annex II is deleted from the common position because corresponding provisions are already in Article 7. The Commission accepts this approach.

Additional changes incorporated in the common position:

Annex II would require collection of information from isolates not only from certain animals but also from food derived therefrom. The Commission agrees on these additional rules.

3.1.5 Food-borne outbreaks (Article 8)

European Parliament amendment included in the Commission proposal and taken into account in the common position: 17

As regards amendment 17 on requirements for food business operators, the common position is consistent with the first part of the amendment by referring to Article 19(3) of 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 [2]. The second part of the amendment is not included in the common position. However, the Commission considers that this should have no practical impact because the wording refers to the involved foodstuff or an appropriate sample thereof. A sample may well comprise several sample units.

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

The Commission can accept some further editorial changes that have also been included in the common position.

3.1.6 Exchange of information (Article 9)

European Parliament amendments included in the Commission proposal and taken into account in the common position: 29 and 32

Part of amendment included in the Commission proposal but not in the common position: 20.

As regards this amendment, the reference to making documents publicly available "without delay" is not present in Article 9.1 of the common position. However, this reference is included in recital 21 of the common position and Article 3.1 that lays down the general obligations. There is a slight difference between the Commission proposal that reflects the part of the amendment requesting making publicly available the national reports and summaries of them and the common position that requests this for either of them. The Commission can accept these provisions.

3.1.7 Comitology

European Parliament amendments included in the Commission proposal and taken into account in the common position: 13, 25-26, 28 (relevant part) and 31 (relevant part).

A particular result is that while amendments of the provisions contained in the Annexes will be made by comitology, certain criteria governing such amendments will now appear in Articles instead of the Annexes.

European Parliament amendment partly included in the Commission proposal and in the common position: 23.

The common position, as well as the Commission proposal, takes into account amendment 23 aiming to consult where appropriate the Committee instituted by Article 7 of European Parliament and Council Decision 2119/98/EC of 24 September 1998 setting up a network for the epidemiological surveillance and control of communicable diseases in the Community [3]. The European Parliament suggested consultation of both committees on the same proposal, but this is not legally possible.

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

3.1.8 Consultation of the European Food Safety Authority (EFSA)

European Parliament amendment included in the Commission proposal and taken into account in the common position: 16, relating to consultation of EFSA before proposing the establishment of co-ordinated monitoring programmes.

European Parliament amendment partly included in the Commission proposal and in the common position: 22.

The Commission rejected amendment 22 of the European Parliament that would have required systematic consultation of EFSA before amending the Annexes or taking transitional measures. The reason is that certain "administrative" actions do not need scientific expertise. Instead, the Commission proposal would require consultation of EFSA on any matter that could have a significant impact on public health (in addition to the above paragraph). The common position builds on the Commission proposal to specify additionally consultation at least before proposing any amendment to Annexes I or II. The Commission accepts the wording of the common position.

3.1.9 Definitions (Article 2):

Amendment included in the Commission proposal but not in the common position: 7.

It relates to an editorial change in the definition of anti-microbial resistance. The Commission considers that this should have no practical impact.

The following comments relate to issues not raised by the European Parliament at its first reading. Because the definition of "communicable diseases" was not essential and may even be confusing, it was deleted in the common position. The Commission agrees on this change. For consistency reasons, certain definitions already set in Regulation (EC) No 178/2002 have been removed in the modified proposal as well as in the common position and a cross reference to the definitions in this Regulation added. Thus, in particular, the broad definition of "food" in the above Regulation applies.

3.2 Comments on the common position adopted by the Council with a view to the adoption of a Regulation of the European Parliament and of the Council on the control of salmonella and other food-borne zoonotic agents (see also point 3.3 below)

3.2.1 General remarks

At the first reading of the European Parliament, the Commission stated that it could accept some or parts of the amendments requested by the European Parliament, but had to reject others. The modified Commission proposal was drafted consequently. The common position does not incorporate European Parliament amendments that were rejected by the Commission.

A substantial number of additional changes have been included in the common position as a result of discussions in the Council after the first reading of the European Parliament. They relate in particular to the scope of the Community targets, the timetable for implementation of the Regulation and the financial aspects.

As regards the recitals of the Regulation, amendments 4-6 of the European Parliament, which were incorporated in the Commission proposal, have been taken into account in the common position. The comments below do not cover specifically the other amendments introduced in the recitals of the common position since they are destined to ensure consistency with the body of the legal text.

Date of applicability of the Regulation: the Council noted that the date in the Commission proposal (i.e. 1 January 2003) was not realistic considering the state of play of the procedure and it subsequently set a relative date, requiring application within 6 months of entry into force. The Commission acknowledges this.

3.2.2 Scope (Article 1 and references to feed)

European Parliament amendments included in the Commission proposal and taken into account in the common position: 8 (exclusion of primary production for private domestic use from the scope of the Regulation); 11, 15, 17(relevant part), 18-20 (clarification that the Regulation ought to apply to feed).

The wording of Article 1.2 further strengthens the principle that the Regulation ought to apply to the whole food chain, including feed. Subsequent additional references to feed are also added in other Articles of the Regulation, which are consistent with European Parliament amendments 11, 15, 17(relevant part), 18-20 that were included in the Commission proposal, as well.

Additional change incorporated in the common position:

- To ensure consistency with the principle of subsidiarity and the agreement reached on the proposed Community legislation on the hygiene of foodstuffs (COM(2000) 438 final), the common position leaves the control of zoonoses at the level of primary production to national law when such production takes place on a very small scale (Article 1.3(b)). However, national law would have to achieve the objectives of the Regulation (Article 1.4). The Commission accepts this approach.

As regards the setting of targets for stages of the food chain after primary production, the Commission issued a declaration that these would generally be laid down through comitology pursuant to Article 4 of the proposed Regulation on the hygiene of foodstuffs (see declarations in the Annex to this Communication).

3.2.3 Definitions (Article 2) and competent authorities (Article 3)

European Parliament amendment included in the Commission proposal and taken into account in the common position: 9.

The revised wording of Article 3.1 of the common position is consistent with the amendment and mirrors the wording used in corresponding provisions in Article 3.2 of the above Directive on monitoring.

The following comments on changes to Article 2 (definitions) relate to issues not raised by the European Parliament at its first reading. In the same line as in the Directive, the Commission proposal and the common position ensure consistency with the definitions in Regulation No 178/2002. The definitions already set in the Directive on monitoring of zoonotic agents are not repeated either. This is in line with the Commission proposal as modified for legalistic reasons. In addition, the definition of "prevalence" included in the Commission proposal is absent from the common position, because it was not used in the provisions to be applied. These changes do not pose a problem to the Commission.

3.2.4 Community targets: general aspects (Article 4)

European Parliament amendments included in the Commission proposal and taken into account in the common position: 12-13 and 30-31 (transfer from Annex I to Article 4, of detailed rules regarding certain criteria for setting targets and target components).

Additional changes incorporated in the common position:

- Firstly, the common position further elaborates on amendments 13 and 31. Article 4.2(e) adds to the list of target components the definition of subtypes of zoonotic agents covered and introduces a new Annex III (and related procedure to adapt it at Article 4.7) that lays down specific criteria to determine salmonella serotypes with public health significance. While keeping a reference to general criteria for establishing targets through Article 4.6(c), it clarifies the specific criteria for setting salmonella targets and thus paves the way to establish targets for zoonotic agents other than salmonella. The Commission accepts these provisions.

- Secondly, an additional paragraph (Article 4.4) requires the Commission to carry out cost/benefit analyses before proposing Community targets and requires the Member States to provide all assistance necessary to enable it to prepare such analyses. The Commission is also required to consult Member States on the result of the analysis and propose targets in the light of a favourable cost/benefit analysis and the consultation of Member States. Although such analyses are extremely difficult to perform, the Commission agrees on undertaking this justified effort.

- Thirdly, as regards the setting of the first Community targets, i.e. for different categories of poultry, the common position provides for transitional periods. Thus, each target for poultry would for the first three years apply only to the most prevalent salmonella serotypes (five for breeding hens and two for other poultry). The justification is that on one hand, cost/benefit analyses are unlikely to be available before several years, on the other hand it may avoid creating an excessive burden for primary producers in the first years of application of the Regulation. However, should results of analyses be available in the meantime, it would be possible to extend the requirements to the five most prevalent serotypes during the transitional period. Although the transitional periods will cover a limited number of serotypes, it will target the isolates responsible for a large majority of the human cases of salmonellosis. The Commission can support the progressive approach.

3.2.5 Scope and timetable of the Community targets: table in Annex I

European Parliament amendments taken into account in the Commission proposal and in the common position: 29 (relevant part on laying hens), 36 and 38.

Thus, salmonella serotypes with public health significance are covered in principle for laying hens and targets for slaughter pigs will be established in addition to breeding pigs.

As regards the timetable for setting targets for breeding pigs and slaughter pigs respectively, the Commission had accepted amendments 36 and 38, subject to possibly setting a different timetable for breeding pigs and slaughter pigs. The Commission proposal, the common position and the European Parliament amendments are partly consistent. The European Parliament asked to set both targets at the same time as for turkeys. In the Commission proposal, targets may be set at the same time or consecutively, but the first target shall be set on the same date as for turkeys. The common position refers to setting the first target on slaughter pigs at the same time as for turkeys, and one year later for breeding pigs. However, the Commission made a declaration to the Council's minutes that the order may be reversed if the evaluation of the available evidence indicates that this would be more appropriate (see declarations in the Annex to this Communication). The Commission proposed this flexibility because the approach for pigs is new in the Community and would require consultation of the European Food Safety Authority before fixing the most appropriate measures. This need for flexibility is valid also when it comes to the minimum sampling schemes laid down in Annex II.A (see chapter 3.2.6 below). The Commission accepts the approach set in the common position that may still be amended following scientific consultation.

Additional changes incorporated in the common position:

As regards the timetable, while the Commission had not changed the explicit dates in column 4 and 5 of Annex I, other than for the additional target on slaughter pigs, the common position establishes relative dates linked to the entry into force of the Regulation. The relative dates for setting the targets (column 4 of the table) correspond to the periods in the Commission proposal that includes entry into force on 1 January 2003. With the new relative dates, delays in the adoption of the proposal will lead to delays in the setting of targets. Furthermore, the periods established in column 5 for the Member States to implement the approved national control programmes has been extended from 12 months (Commission proposal) to 18 months and a condition added that comparable data on prevalence will be available at least 6 months before setting each target. The Commission accepts this approach that gives some more time to the Member States and the Commission for the elaboration of the draft programmes, their approval and the establishment of national legislation to implement them.

3.2.6 Specific control requirements: Annex II

European Parliament amendments taken into account in the Commission proposal and taken into account in the common position: 32 (relevant part on laying hens) and 34.

Thus, all measures on laying hens cover in principle salmonella serotypes with public health significance and sampling takes place in adult hens every 15 weeks instead of every 9 weeks.

Additional changes incorporated in the common position:

Besides some editorial changes, a number of substantial further amendments have been introduced in the common position. These are commented upon below.

At Annex II.A, paragraphs 1.8 and 1.9 have been further elaborated and a new paragraph 1.10 relating to financial assistance to operators has been listed. The Commission supports these provisions.

At Annex II.B.1:

- The requirement for business operators to have, at their own expense, samples taken for analysis has been deleted. Therefore, Member States may decide to give financial assistance as long as Community legislation is not infringed (the above new paragraph 1.10 ensures that the Commission is informed).

- Furthermore, the common position as well as the Commission proposal have deleted the column called "data" from the table, as it was perceived as unnecessary and confusing, sampling being set in the last column of the table. A reference to ante-mortem inspection was kept as a note below the table.

- The common position, the Commission proposal and the European Parliament amendment are partly consistent on sampling requirements for pigs. The European Parliament requested through amendment 32 detailed sampling in particular for slaughter pig. The Commission accepted the principle of sampling in pigs, subject to possible revision of the place of sampling. The Commission proposal states that the details shall be established when the target is set, i.e. after consultation of the European Food Safety Authority. The common position refers to testing before slaughter or sampling of carcasses at the slaughterhouses. The Commission accepts the common position but may reassess it in the framework of scientific consultation.

The specific requirements for breeding flocks (Annex II.C) of the common position are consistent with the Commission proposal although the wording has been reviewed. Additionally, a paragraph establishes the conditions under which measures shall be taken because of the presence of (relevant) salmonella, following initial detection or after confirmation. The Commission accepts this approach.

As regards the specific requirement for laying hens (Annex II.D), the date for implementing the measures has been made relative as other dates in the Regulation (see above). While in the Commission proposal, the transitional period between starting to implement the corresponding national control programme and implementing compulsory specific requirements was 24 months, it became 30 months in the common position. Further editorial changes were also made. While the Commission can accept the new provisions, it expects that the Member States will be willing to implement the provisions sooner, once the control programmes are in place.

As regards the specific requirement concerning fresh meat (Annex II.E), the explicit date in the Commission proposal has been changed into a relative date, also extending from 24 to 30 months the transitional period in a way similar to laying hens. Additionally, detailed rules for the implementation of the criterion shall be laid down one year before the criterion applies. The Commission accepts these provisions.

3.2.7 Control programmes and control methods: Articles 5-8

European Parliament amendments included in the Commission proposal and taken into account in the common position: 14-15 and 17-20.

Additional changes incorporated in the common position:

- Firstly, as regards the procedure to approve the national control programmes, more details including deadlines have been added. The procedure is quite comparable to the one used for approving animal disease control/eradication programmes pursuant to Council Decision 90/424/EEC and therefore the Commission can accept it.

- Secondly, Article 7 on control programmes of operators has been reworded so that in particular the competent authorities "may" (rather than "shall") approve the programmes: thus the competent authority may organise a system to ensure that industry programmes are sufficiently representative. This amendment was also introduced in the Commission proposal and the Commission can accept the other editorial changes.

3.2.8 Trade: Article 9-10

European Parliament amendments included in the Commission proposal and taken into account in the common position: 23; 25 (relevant part relating to FVO involvement).

Additional changes incorporated in the common position:

- As regards Article 9 on intra-Community trade, the common position contains further amendments in respect of the additional guarantees. It clarifies that firstly, additional guarantees for animals and hatching eggs will apply to salmonella only (rewording of Article 9.2). Secondly, through the additional Article 9.3, the relevant additional guarantees that currently apply to Sweden and Finland will continue to apply, but they may be updated according to the procedure foreseen by the Regulation. The Commission supports these provisions and made a declaration to the Council's minutes that it would not propose any measure that would reduce the guarantees granted to these two countries upon their accession to the Community (see declarations in the Annex to this Communication).

- As regards Article 10 on importation from third countries, the common position contains further changes. Paragraph 1 was slightly reworded to clarify that approval of the programmes is required. Additionally, paragraph 4 contains a new sentence that would allow targeting of certain "exotic" serotypes of salmonella (or other subtypes of other zoonotic agents) prevalent in third countries, if they are of particular importance for the Community. Paragraph 5 was reworded to mirror the wording in Article 9. The Commission accepts these provisions.

3.2.9 Consultation of the European Food Safety Authority (EFSA)

European Parliament amendments included in the Commission proposal and taken into account in the common position: 21, relating to consultation of EFSA before deciding on specific control methods.

European Parliament amendment partly included in the Commission proposal and in the common position: 27.

The Commission rejected amendment 27 of the European Parliament that would have required systematic consultation of EFSA before amending the Annexes or taking transitional or implementing measures, for the same reason as for the Directive (see 3.1.8 above). The approach taken in the Commission proposal is mirroring the one in the Directive. The common position builds on the Commission proposal to specify additionally consultation at least before proposing Community targets or specific control methods. The Commission accepts the wording of the common position.

3.2.10 Other

As regards laboratories (Articles 11 and 12), the relevant part of European Parliament amendment 26 making a generic reference to EN/ISO standard for quality assurance was accepted by the Commission and introduced in its proposal and in the common position as well. Some further editorial changes were introduced in the common position to make the date for laboratories to comply with this standard, relative (instead of explicit) and to clarify some elements of the provisions. The Commission accepts them.

As regards Community controls, European Parliament amendment 28 was incorporated into the Commission proposal and the common position as well.

As regards Articles 16-18, present in the original Commission proposal and in the common position, they were deleted from the revised Commission proposal, for legalistic reasons: these amendments of Directives 64/432/EEC [4], 72/462/EEC [5] and 90/539/EEC [6] were considered unnecessary in the light of Article 9 and 10. The legal Service of the Council appeared to agree on deleting these Articles for finalising the common position.

[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 302, 31.12.1972, p. 28. Directive as last amended by Directive No 97/79/EC (OJ L 24, 30.1.1998, p. 31).

[6] OJ L 303, 31.10.1990, p. 6. Directive as last amended by Commission Decision 2000/505/EC (OJ L 201, 9.8.2000, p. 8).

3.3 Financial issues

At its first reading, the European Parliament did not ask to amend the financial provisions in the original Commission proposals. However, the explanatory statement accompanying the report on the Regulation by the Committee on the Environment, Public Health and Consumer Policy contained a paragraph on the economic aspects. It indicated in particular that "consideration should therefore perhaps be given to shifting more of the costs associated with this Regulation to where the "gains" will be felt, i.e. the taxpayers, at an appropriate level."

In the Commission proposals, financial provisions are laid down in Article 15 of the proposed Directive on the monitoring of zoonoses and zoonotic agents (Article 16 in the common position). They amend certain provisions of the Chapter on "checks aimed at the prevention of zoonoses" of Council Decision 90/424/EEC (Title III, Chapter 2). The provisions cover both monitoring measures under the Directive and control measures under the Regulation. Community expenses are foreseen for:

- activities of Community Reference Laboratories to be appointed;

- co-financing of Community co-ordinated monitoring programmes;

- co-financing of certain specified control measures.

As regards specified control measures, the proposal provided for a continuation of the co-financing of technical measures already co-financed under the current legislation (Directive 92/117/EEC), i.e. disposal of poultry breeding flocks found infected by Salmonella Enteritidis and Salmonella Typhimurium. The justification was in particular the need for a review of the existing system for Community co-financing of disease control programmes. In its report accompanying the original proposals (COM(2001) 452 final), the Commission had highlighted that "given the high economic costs occasioned by zoonoses, not only to operators but also to society at large, public financing of measures to reduce or eliminate the diseases is justified...The need for a Community dimension to financial support is also clear... At the same time, the question of how to use limited Community funds most effectively is far from straightforward". It was further stated that such possibilities require further study and discussion with all concerned. Pending the result of a consultation exercise to be launched by the Commission, it was proposed to continue Community financing on the basis of the existing rules.

Serious difficulties were raised during the discussions at the Council, especially regarding the Community support to the new zoonoses control measures foreseen pursuant to the Regulation. A majority of Member States demanding clear undertaking as regards Community support for these new measures.

Certain elements connected to financial issues were introduced in the common position on the proposed Regulation: the requirement for cost/benefit analyses (see 3.2.4 above) and the amendment made in Article 5 (following European Parliament amendment 14, incorporated in the Commission proposal) to have regard to the financial implications for operators of establishing effective controls.

Additionally, two important amendments were introduced in the common position specifically in relation to the Community co-financing. Firstly, the Regulation in its new Article 16, provides for the Commission to report on financial issues and if appropriate, to make proposals, within three years of entry into force of the Regulation (i.e. when expenditures will start pursuant to the new compulsory control measures). Secondly, the common position on the Directive includes a modification of the provisions in Article 15, to make eligible for Community co-financing (up to 50%), in the framework of the provisions of Article 24 (3) to (11) of Council Decision 90/424/EEC, the costs incurred implementing mandatory control measures. Thus Community co-financing would apply not only to the above mentioned existing measures to dispose of poultry breeding flocks but also to the new measures. It would however enable the decision on the level of resources to be allocated to Community co-financing to be taken in the light of the Commission's report.

The Commission agreed on the above provisions that are consistent with the objectives highlighted in the above mentioned report accompanying the original proposals, but it highlighted the budgetary constraints and the limited power it has in respect of budgetary resources. The Commission together with the Council, made a joint declaration for the Council's minutes (see declarations in the Annex to this declaration) stating that "The Council and the Commission consider that the resources available need to be sufficient to cover the co-financing of measures to control zoonoses. They agree that the decision on the level of resources to be allocated to Community co-financing should be taken in the light of the Commission's report provided for in Article 16 of the Regulation. This decision must be budget neutral, meaning that it must be implemented within the given financial framework of Chapter 1."

4. COMMISSION DECLARATIONS

The Commission declarations for the Council's minutes and a joint declaration Commission-Council on the financial issues are attached in Annex to this Communication.

5. CONCLUSION

In the light of the above comments, the Commission supports both common positions adopted by the Council with a view to the adoption of:

- 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; and

- 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.

This communication will be submitted to the European Parliament.

ANNEX ON COMMISSION DECLARATIONS

DIRECTIVE

Ad Article 4(5) - Harmonisation of routine monitoring

The Commission will propose the harmonisation of routine monitoring of zoonoses and zoonotic agents, including the harmonisation of laboratory methods to be used in testing, if and to the extent necessary to ensure that data are comparable. When doing so, it will take due account of the principles of subsidiarity and proportionality, and the need to avoid creating undue financial or administrative burdens for competent authorities.

Ad Article 5 - Co-ordinated monitoring

The Commission will propose measures in accordance with existing Community legislation to permit the gathering of the data needed for the adoption of the first control targets under the Regulation before the Directive takes effect.

Ad Article 16(1) - Amendment of Decision 90/424/EC

The Council and the Commission consider that the resources available need to be sufficient to cover the co-financing of measures to control zoonoses. They agree that the decision on the level of resources to be allocated to Community co-financing should be taken in the light of the Commission's report provided for in Article 16 of the Regulation. This decision must be budget neutral, meaning that it must be implemented within the given financial framework of Chapter 1.

REGULATION

Ad Article 9(3) - Additional guarantees

The Commission will not propose any measure that would reduce the guarantees granted to Finland and Sweden upon their accession to the Community.

Ad Annex I and Annex II, Part B - Targets for stages after primary production

The Commission declares that targets for stages of the food chain after primary production will generally be laid down through comitology pursuant to Article 4 of the proposed Regulation on the hygiene of foodstuffs. These will supplement the targets for table eggs and poultry meat contained in the proposed Regulation on the control of zoonoses (which may themselves be modified or supplemented through comitology).

Ad Annex I and Annex II - Targets for pigs

The Commission declares that the envisaged order of the Community targets for pigs may be reversed if the evaluation of the available evidence indicates that this would be more appropriate.