REPORT TO THE EUROPEAN PARLIAMENT AND TO THE COUNCIL on the measures to be put in force for the control and prevention of zoonoses

(presented by the Commission)

A. Summary

The report describes the current situation as regards the presence of zoonoses (diseases transmissible from animals to man) and zoonotic organisms and the legislative framework in force in the Community to combat zoonoses. Experiences gained during the implementation of specific zoonoses legislation are particularly referred to. It is concluded that although certain progress has been observed in the monitoring and controlling of zoonoses, these measures need to be intensified. The review of the current legislation should lead to a system where more appropriate and comparable data on the occurrence of zoonoses is available to be used, for example, in risk assessments. The policy of controlling zoonoses, in particular in farm animal populations, should be changed in a manner whereby Member States are obliged to reach certain common targets for the reduction of zoonotic pathogens. The means of attaining the targets should be selected and expressed in a national control programme. Finally, the impacts of the proposed new approach are discussed.

B. Introduction

Article 15a of Council Directive 92/117/EEC of 17 December 1992 concerning measures for protection against specified zoonoses and specific zoonotic agents in animals and products of animal origin in order to prevent outbreaks of food-borne infections and intoxications [1], as amended by Directive 97/22/EC [2], provides for the Commission to submit a report to the Council concerning the measures to be implemented for the control and prevention of zoonoses. This report shall refer in particular to:

[1] OJ L 62, 15.3.1993, p. 38.

[2] OJ L 113, 30.4.1997, p. 9.

- the new rules for the reporting system for zoonoses,

- the methods for collecting samples and for examinations in approved national laboratories,

- the control of salmonella in poultry laying flocks,

- the control of salmonella in poultry breeding flocks and in compound feedingstuffs for poultry, and

- any measures to combat zoonoses other than salmonellosis.

The report shall be accompanied by proposals concerning zoonoses, especially in the context of the review of the Directive. As amended by Directive 97/22/EC, the Directive required that the Council should act on the proposals by a qualified majority before 1 June 1998. Later on, Directive 92/117/EEC was amended for the second time by Directive 1999/72/EC [3], which provided for the Commission to present the report and accompanying proposals by 30 March 2000.

[3] OJ L 210, 10.8.1999, p. 12.

This report and the accompanying two proposals are part of the programme foreseen in the White Paper on Food Safety (COM(1999) 719 final) adopted by the Commission on 12 January 2000. It is essential that the proposals concerning monitoring and control of zoonoses respect the main principles of the White Paper, in particular

- assuring a high standard of food safety,

- laying the responsibility for food safety primarily with food businesses, including feed manufacturers and farmers,

- creating an integrated policy from 'farm to table',

- permitting traceability,

- ensuring transparency, and

- being based on risk analysis, including possibilities to take into account the precautionary principle and other legitimate factors.

The report and proposals accompanying this report, a proposal for a Parliament and Council Directive on the monitoring of zoonoses and zoonotic agents and a proposal for a Parliament and Council Regulation on the control of specified zoonoses and zoonotic agents, are submitted somewhat later than provided for in Directive 92/117/EEC. However, the extra time taken has enabled the Commission to take into consideration the opinion of the Scientific Committee on Veterinary Measures relating to Public Health on Zoonoses adopted on 12 April 2000, as well as the proposal for a Regulation of the European Parliament and of the Council laying down the general principles and requirements of food law, establishing the European Food Authority, and laying down procedures in matters of food (COM(2000) 716 final).

C. Present situation on the control and prevention of zoonoses

C.1. Epidemiological situation on zoonoses in the EU

In co-operation with the Community Reference Laboratory for the Epidemiology of Zoonoses, the Commission has prepared the Annual Report on Trends and Sources of Zoonotic Agents in animals, feeding stuff, food and man in the European Union. The first report covered year 1994 and the report concerning the year 1999 was presented in March 2001. The goals regarding the collection of epidemiological data have been achieved with increasing success each year and currently all 15 Member States submit their annual reports. However, the quality of the data still suffers from unharmonised surveillance systems, rendering it difficult at present to draw valuable conclusions on the trends of zoonotic agents within the EU.

All Member States provided a report on trends and sources of zoonotic agents in 1999 according to Article 5 of Directive 92/117/EEC, which contained at least some information on the zoonotic situation in animals, feedingstuffs, food and man. Community rules forming a basis for comparable data were in force for bovine tuberculosis, bovine, ovine and caprine brucellosis, Salmonella Enteritidis and Salmonella Typhimurium in poultry breeding flocks, Trichinella and Echinococcus sp. (meat inspection). For other zoonoses, a valuable overview is available on the national approaches to tackle zoonoses and the results thereof.

As regards human illnesses, two zoonoses caused the major part of the reported cases: Salmonella and Campylobacter, with 165 659 and 126 981 reported cases in 1999, respectively. Of the other zoonoses, for which information is collected, 8309 cases were reported for Yersinia, 3843 for Brucella, 665 for Listeria, 554 for Echinococcus, 309 for Toxoplasma, 155 for Mycobacterium bovis and 48 for Trichinella,. No human rabies cases occurred in 1999. The EU report of 1999 included also information on human cases of verotoxigenic E.coli (VTEC) infections with 1892 cases.

However, these figures have to be interpreted carefully, since it is likely that many human infections go unrecorded with either patients failing to present to health services, or no laboratory diagnosis being made, or the diagnosis not being reported centrally. The cases reported may in fact only represent the severe end of the spectrum of the disease. Despite this underreporting, it appears that the magnitude of these human health problems is significant.

As regards details on the gravity of these zoonoses, the total number of fatalities is not recorded. However, certain data are known:

- According to the SCVPH opinion on zoonoses of 12 April 2000, in approximately 5% of salmonellosis cases, sequellae (like reactive arthritis) arise. In around 2% of these complicated cases (i.e. 1 in every 1000 salmonellosis cases), the patient dies. This ratio would lead to an estimate of around 200 fatalities per year in the EU. Reduced sensitivity of certain salmonella strains to antibiotics may not only prolong the duration of clinical disease but also affect the incidence of sequellae or death.

- Still according to the above scientific opinion, Campylobacter has shown to cause a serious disease, Guillain-Barré syndrome, a disorder resulting in acute neuromuscular paralysis. It is estimated to occur about once in every 1000 cases of campylobacteriosis.

- As regards listeriosis, the incidence is much lower than for the two other zoonoses above, but the case fatality rate (proportion of cases that die) is reported being between 20 and 40%. In immuno-compromised individuals, the reported case fatality rates may approach 75% according to the above scientific opinion.

- As regards VTEC (verotoxigenic E.coli) infections, around 5% of cases progress into haemolytic uraemic syndrome and of these cases, 3-5% die and a similar proportion develop major sequellae.

As regards the sources of salmonella, the principal reservoir of the common Salmonella spp. is the gastrointestinal tract of mammals and birds. S. Enteritidis and S. Typhimurium are by far the most common serotypes in human isolates in the EU: according to the data forwarded by the Member States through the zoonoses reporting system in 1998, both serotypes represented between 60 and over 90% of all notified human cases (S. Enteritidis being No1 in all but one member States). S. Enteritidis and S. Typhimurium are the serotypes most frequently associated with eggs or poultry and other farm animals respectively.

C.2. The Community legislation regarding the control of zoonotic infections

C.2.1. Directive 92/117/EEC

Council Directive 92/117/EEC seeks to establish a reliable reporting system on the occurrence of zoonoses generally, and to bring about also monitoring, control, and ultimately eradication of some invasive serotypes of salmonella in poultry breeding flocks. It also provides for the development of control measures for other zoonotic agents than salmonella.

Currently the control measures cover only salmonella in poultry breeding flocks since in the late 1980's the increasing number of the cases of human salmonellosis caused by Salmonella Enteritidis derived from table eggs was regarded as the most alarming issue. A top-down approach was adopted by firstly providing for measures to eradicate Salmonella Enteritidis (and Salmonella Typhimurium) in breeding flocks to reduce the vertical transmission to commercial flocks. Measures in commercial flocks were foreseen for the future.

C.2.2. Other legislation

Reduction of the incidence of zoonoses and zoonotic agents in order to prevent food-borne infections requires a concerted multi-disciplinary approach including control measures at all stages of the food chain:

- in animal waste and feed processing,

- at farm level,

- in processing and distribution of foodstuffs of animal origin, and

- at consumer level.

Directives 90/667/EEC [4] and 92/118/EEC [5] and the corresponding Commission Decisions cover the control of zoonotic agents in animal waste and feed processing. These provisions cover substances with ingredients of animal origin. A proposal for a fundamental review of this legislation has been adopted by the Commission (COM(2000) 574 final). No rules concerning zoonotic organisms exist yet in the Community legislation for feedingstuffs comprising solely ingredients of vegetable origin. The establishment of such legislation is however foreseen as a part of the legislative programme of the White Paper on Food Safety since it is evident that feedingstuffs of vegetable origin can harbour zoonotic agents.

[4] OJ L 363, 27.12.1990, p. 51.

[5] OJ L 62, 15.3.1993, p. 49.

Provisions on the control of certain zoonoses at farm level have been laid down in various directives regarding animal health conditions in trade of live animals, e.g. provisions on bovine tuberculosis and brucellosis in Directive 64/432/EEC [6]. Furthermore, there are rules in certain hygiene directives providing for the control of zoonoses at farm level, e.g. in Directive 92/46/EEC [7] regarding dairy herds.

[6] OJ 121, 29.7.1964, p. 1977.

[7] OJ L 268, 14.9.1992, p. 1.

Measures on the control of zoonotic agents in processing and distribution of foodstuffs of animal origin are provided in the corresponding hygiene directives. These provisions range from the specific, for example, ante and post mortem inspection of animals in abattoirs, through to the general, for example, requirements for hygienic construction and operation of food processing premises and provisions for minimum processing conditions and storage/transport temperatures.

Control of zoonoses at consumer level is mainly beyond the scope of legislative actions. Progress in that field may be achieved by intensifying general consumer advice on hygienic food handling and increasing the awareness of certain specific risk groups, like pregnant women.

The Community legislation on food hygiene is currently being restructured and revised in order to establish a coherent and consistent body of hygiene rules based on an integrated approach covering the whole food chain "from stable to table". This approach will be realised by proposing a legal instrument on food hygiene covering the entire production chain of all foodstuffs both of animal and of plant origin. One of the main objectives of the new legislation is to prevent food-borne infections. Efforts will be directed to highlighting producers' liability in ensuring food safety and establishing HACCP-type principles in controls. Risk-based systems are intended to cover primary agricultural production at farm level. A general obligation will be proposed providing for the Member States to ensure that Good Animal Husbandry Practices (GAHP) are complied with in the production of animals. From the point of view of zoonoses control this means that an individual farmer will be obliged to take the necessary preventive actions against zoonotic infections.

The European Parliament and the Council adopted on 24 September 1998 Decision 2119/98/EC setting up a network for the epidemiological surveillance and control of communicable diseases in the Community [8]. Thus, the Commission shall facilitate close co-operation among the authorities responsible for public health in the Member States. One of the main activities foreseen in Decision 2119/98/EC is the establishment of an information system for the surveillance, prevention and control of communicable diseases at Community level. To that end, the Commission adopted Decision 2000/96/EC of 22 December 1999 on the communicable diseases to be progressively covered by the Community network [9]. In the Decision a number of food- and water-borne and other zoonoses are listed. In particular it is stipulated that where specific surveillance networks are put in place for zoonoses for which surveillance of human cases is required under Directive 92/117/EEC, surveillance shall be performed in accordance with Decision 2119/98/EC and such data required for the implementation of Directive 92/117/EEC shall be made fully available for that purpose. To this end, case definitions and surveillance methods for human disease shall be drawn up, as far as possible, in such a way that the data collected serve also Directive 92/117/EEC.

[8] OJ L 282, 20.10.1998, p. 76.

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

C.3. The experience gained under the current provisions

Community legislation on the monitoring and control of zoonoses has been developed gradually. It was, however, soon realised that not all Member States were able to fully implement the system foreseen by the Zoonoses Directive. Indeed, only six Member States have been recognised as fully implementing the provisions on salmonella control of breeding flocks (Table 1). However, pending the review of Directive 92/117/EEC, the obligation to submit plans for monitoring and control of salmonella in fowl flocks has been suspended through Directive 97/22/EC, for those Member States which have not yet submitted such plans. Even though certain deadlines of the Directive were postponed by Directive 97/22/EC, a number of Member States still have not submitted their national plans for attaining the objectives of the Directive nor implemented the above provisions. Nevertheless, it should be noted that authorities have taken effective measures against salmonella and other zoonotic organisms in all Member States either alone or in co-operation with private businesses. The Commission will continue to take the necessary steps to ensure that the current Directive is implemented in all Member States, as this is a prerequisite for proposals to improve the measures for controlling zoonoses.

Table 1. National salmonella control plans submitted and approved according to Directive 92/117/EEC.

Member State // Reference of approval

Denmark // 94/507/EC, 96/692/EC

Ireland // 96/389/EC

Finland // 96/390/EC

Sweden // 96/502/EC

Austria // 2000/60/EC

France // 2000/629/EC

Several advantages have followed the implementation of the Directive. Firstly, the obligation to monitor certain zoonoses and subsequently to report the findings at the national level and to the Commission has created new activity in this field. In many Member States the co-operation between responsible authorities for feedingstuffs control, animal and public health, and human medicine has developed favourably, creating also better possibilities to combat zoonoses. As the result of monitoring, the awareness of the presence of zoonotic agents in different parts of the food chain, as well as in wild and pet animal populations, has increased, necessitating preventive and control measures.

Secondly, the incidence of salmonella, the major target of the controls laid down by Directive 92/117/EEC, in human population in many Member States seems to be stabilised and even decreasing. Although it is difficult to speculate on what has been the direct effect of the specific control requirements towards Salmonella Enteritidis and Salmonella Typhimurium in the breeding flocks of domestic fowl, it may be stated that the action taken throughout the Community, based on both mandatory and voluntary programmes, has brought success.

One important aspect of the implementation of the control provisions of Directive 92/117/EEC has been the possibility for the co-financing of national control programmes. The co-financing corresponds to 50 % of the costs incurred from the measures for slaughter and destruction and official sampling. Since 1995, the Community has co-financed the control of salmonella in poultry, as indicated in Table 2.

Table 2. The Community's financial contribution towards the measures for slaughter and destruction and official sampling according to Article 9 of Directive 92/117/EEC

>TABLE POSITION>

Financial contributions have been awarded to Member States also in the framework of the programmes for the eradication and monitoring of animal diseases, based on Council Decision 90/424/EEC on expenditure in the veterinary field [10]. This co-financing has contributed to the control and monitoring of several zoonoses, notably bovine, ovine and caprine brucellosis, bovine tuberculosis and rabies, and periodically hydatidosis (echinococcosis) and enterohaemmoragic E. coli (EHEC). The maximum Community financial contributions towards co-financing of bovine brucellosis, ovine and caprine brucellosis, bovine tuberculosis and rabies for the year 2000 are EUR 14 250 000, EUR 14 000 000, EUR 8 235 000, and EUR 2 895 000, respectively.

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

The difficulties in the implementation of Directive 92/117/EEC were recognised by the Commission and subsequently modifications to the Directive were proposed, which lead to two sets of amendments, in Directive 97/22/EC and Directive 1999/72/EC. According to provisions laid down in Directive 97/22/EC, Member States should have implemented as from 1 January 1998 the minimum measures laid down for salmonella control in poultry breeding flocks. Most Member States seem to have implemented the main features of these requirements by 1999. The Commission's Food and Veterinary Office (FVO) has recently finalised a series of missions on the production of poultry meat and in that context also salmonella control was evaluated. A general report is due to be issued subsequently.

A number of other factors call for the review of Directive 92/117/EEC. Trends in food-borne infections show that the current situation is far from satisfactory. The numbers of human infections caused by "traditional" pathogens like salmonella remain high and, in addition, there are emerging "new" pathogens (e.g. Campylobacter, VTEC). Although these trends may be partially explained by improved diagnostic methods and reporting systems, it is obvious that effective and strict measures at Community level are needed to respond to the increasing threat posed by food-borne infections to human health.

Community legislation on food hygiene will cover in the future the entire food production chain "from stable to table" and will also introduce certain obligations at farm level. One of its main objectives is to safeguard human health from food-borne infections. This new environment necessitates ensuring the coherence between the specific zoonoses legislation and the general food hygiene and food control legislation.

Various situations and attitudes in various Member States as regards food-borne pathogens could seriously jeopardise the intra-Community market in the future. There could be pressure in Member States with high standards to introduce unilateral measures to protect their obtained level. To prevent such a threat, more uniform measures offering sufficient guarantees to protect animal populations from zoonotic organisms, and thus protecting consumer health from food-borne infections, should be introduced at Community level.

Food safety issues are of increasing importance in world trade. A clear policy in the Community is needed when these issues are addressed in trade negotiations with third countries.

D. New approach towards control and prevention of zoonoses

D.1. Basic elements of the approach

With a view to preparing a proposal to improve the measures for monitoring and controlling zoonoses, the Commission together with the experts of the Member States and other interested parties has reflected upon a fundamental change to the current policy and on the objectives of possible future strategies. As a result, a number of objectives and concerns have been identified such as to:

- create a system of monitoring of zoonoses based on harmonised rules, when necessary,

- develop measures according to "farm to table" principle, by producing safe food from healthy animals,

- take account of the level of prevalence of zoonotic agents in the Member States,

- give guarantees for the improvement of the safety of consumers by introducing pathogen reduction programmes to be implemented by the Member States,

- give the flexibility needed for the Member States to achieve common targets, and

- take account of concerns with regard to the spreading of zoonotic agents through animal trade.

The means of attaining these objectives and in particular the pathogen reduction schemes need to be set up according to scientifically based risk assessments. However, even if such risk assessments have not yet been undertaken for certain zoonoses or zoonotic agents, this should not justify that no action is taken in that respect. In order to allow the Commission to follow-up the progress of such schemes, Member States have to submit national programmes concerning the pursuance and achievement of these targets. However, an individual Member State will have the possibility to choose the tools that it deems necessary to obtain the targets. Since actions to control zoonotic agents start with primary production, the implementation of principles of Good Animal Husbandry Practices will play a key role.

D.2. Intensified monitoring and extended control

A critical issue for the optimal implementation of the Community strategy will be the continuing collection of epidemiological data on zoonoses: in the future the measures intended to combat zoonoses should be based on risk assessments and this will increase the importance of accurate information on zoonoses and zoonotic agents at all stages of the food chain. The new framework for scientific advice and scientific support in matters of food safety set up following the proposal for a Regulation of the European Parliament and of the Council laying down the general principles and requirements of food law, establishing the European Food Authority, and laying down procedures in matters of food (COM(2000) 716 final) and subsequent collection and analysis of data relating to biological risks, will be used. Moreover, efforts should be directed to build on the existing monitoring provisions under the current Directive 92/117/EEC and harmonise, where necessary, the reporting system by introducing certain fixed criteria concerning, for example, the case definitions. Since zoonotic agents can present new and emerging features, like antimicrobial resistance, which are making them more harmful, their monitoring should in particular be emphasised. To permit targeted monitoring which could lay the basis, for example, for base-line values capable of being used as starting prevalences for pathogen reduction, co-ordinated monitoring programmes may be needed.

While Directive 92/117/EEC includes only control measures for certain types of salmonella, the new approach would allow for the establishment of control targets for other food-borne pathogens too. With regard to the impact on human health and the feasibility to target the control measures at the farm level, bacteria like Campylobacter and verotoxigenic E. coli could be addressed, once the necessary scientific basis for controlling them has been established.

The new approach would mean an improvement in the safety of consumers especially having regard to the pathogens with the greatest importance to health. As regards salmonella, the data tend to show that S.Enteritidis and S. Typhimurium are the prominent serotypes in human food-borne salmonellosis and the main sources are poultry products, followed by other meat products, pork in particular. In order to improve the level of safety for consumers, and prolong the actions already initiated under Directive 92/117/EEC, there is a need to take appropriate measures, starting from egg and poultry meat production.

D.3. Impacts of the approach

The main impact expected of the proposal would be the amelioration of public health by decreased number of human cases of zoonoses, in particular salmonellosis.

Although the measures envisaged to reduce the prevalence of zoonotic agents would incur costs both to authorities and to food businesses, the selected approach would profit businesses. The gain is expected to follow from increased confidence in both live animals and food produced from animals covered by control programmes. The EU food business would also gain from increased exports to world market due to a clearer and more comprehensive zoonoses control policy and high quality live animals and foods. Moreover, on the medium-term, the reduced level of pathogens means less need for product recalls, and a preventive approach will also help to reduce the need to use antibiotics.

This chapter aims to describe the benefits and costs of the approach proposed. Particular attention is paid to the effects on trade.

D.3.1. Health costs

Within certain Member States and third countries cost-benefit analyses on specific control programmes have been undertaken, in particular for salmonella. In general, these analyses have shown that the economic impact of human disease caused by salmonella is considerable. A recent study made in the USA (Frentzen, P.D. et al. Food Review, 22 (2), 1999, 10-15) estimates that the cost of a single case of salmonellosis varies from EUR 24 (case recovering without medical care) to EUR 3.8 million (fatal case calculated using so-called labour market approach). Assuming that the incidence of the disease and the share of different categories of the gravity are similar in Europe, it can be estimated that the costs of human salmonellosis in the EU are yearly MEUR 620 - 3160. It is generally assumed that 90 % of cases of salmonellosis are food-borne. Thus, the cost of food-borne salmonellosis would be yearly MEUR 560 - 2840.

D.3.2. Costs of financing of monitoring and control

Given the very 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. Moreover, even if progress in that direction has been uneven and too limited, measures taken have proved to be effective in many cases and show that, where these are properly managed, substantial improvements are feasible. The need for a Community dimension to financial support is also clear. The effectiveness of programmes in a Member State can be limited or undermined where in others higher levels of infection persist either directly through contamination across borders or indirectly due to economic pressures resulting from unequal financial efforts of authorities and operators in different States. Moreover, for geographical and historical reasons, national priorities are not the same. Community financial participation provides a means for ensuring that all Member States affected by a given disease make co-ordinated efforts which, taken together, will be much more effective at reducing or eliminating that threat throughout the Community, while at the same time permitting States to continue to address problems that are particularly important on their territory. In the absence of Community participation, they will naturally tend to prefer to address only their own priorities.

At the same time, the question of how to use limited Community funds most effectively is far from straightforward. Every effort needs to be made to maximise the return on the Community's investment in effective disease reduction. This means not only identifying priorities for concentrated common efforts but also providing incentives for authorities and operators to manage programmes as rigorously as possible. Possibilities include raising the level of Community support where programmes are proving their effectiveness by reference to properly controlled benchmarks for the reduction of infection levels. The same might apply where Member States have ensured a certain financial participation from operators, including perhaps the development of insurance regimes to address acute outbreaks.

Such possibilities require further study and discussion with all concerned and the Commission will shortly launch a consultation exercise on the subject in relation to both zoonoses and other animal diseases. Once the consultation exercise is complete, it intends to amend those rules if it appears, as seems likely, that there are possibilities for improving the effectiveness of Community spending.

In the meantime, it is proposed to continue Community financing on the basis of the existing rules, not least to allow programmes already launched to be funded as expected. Provisions in this respect, established in Council Decision 90/424/EEC on expenditure in the veterinary field, need to be amended.

D.3.3. Impact on trade

One of the main objectives of the proposal on the control of zoonoses is to ensure that any contamination or re-contamination carried by live animals or hatching eggs transferred from one holding to another can be eliminated. Also, information concerning animals for slaughter will be necessary. As to the purchases within a country, Member States should create necessary tools for that purpose within their national control programmes. But to ensure that live animals or hatching eggs purchased from other Member States or from third countries comply with the objectives of the corresponding national programme, it is proposed that in the appropriate health certificates the status of the flock or herd of origin should be stated. The appropriate amendments to the relevant health certificates will be established in due course by Commission Decisions. For breeding flocks of Gallus gallus infected by Salmonella Enteritidis or Salmonella Typhimurium, no eggs or birds shall leave the establishment other than for slaughter, special treatment or destruction. Ultimately, when the prevalence of a given zoonosis in a certain animal population is reasonably low, it is nonetheless necessary to require that animals or hatching eggs purchased for production purposes derive from flocks or herds with a negative status. Therefore it is proposed that a Member State, with the approval of the Commission, could require certain criteria to be observed, based on the results of testing, to preserve the low level of prevalence which has been obtained.

Since such a provision could affect the free circulation of goods, it is necessary that the Commission has the power to decide on common criteria which the Member States could apply. Moreover, it is foreseen that when the results of the improved monitoring activities are available, the differences in prevalences will be such as to create a stronger demand to improve the situation.

Also for table eggs, once the transitional period before full implementation of the control measures concerning laying hens has elapsed, eggs will not be allowed to be marketed for direct human consumption unless they originate from a flock subject to relevant testing, and subsequently found free of S. Enteritidis and S. Typhimurium. For poultry meat, a criterion of "absence of salmonella in 25g" will apply after a transitional period.

Concerning laying hens and broilers, until the transitional period before full implementation of the control measures has elapsed, the proposal would have no impact on the additional guarantees given to Finland and Sweden upon their accession, as regards salmonella in those categories of production.

As to trade with third countries, the Agreement on the Application of Sanitary and Phytosanitary Measures (SPS Agreement) plays a key role. The Agreement provides that Members shall ensure that any sanitary or phytosanitary measure:

- is applied only to the extent necessary to protect human, animal or plant life or health,

- is based on scientific principles, and

- is not maintained without scientific evidence.

Measures based on international standards, guidelines or recommendations, where they exist, are presumed to be consistent with the relevant provision of the Agreement.

Since such international standards do not exist, sanitary or phytosanitary measures shall be based on an assessment, appropriate to the circumstances, of the risks to human, animal or plant life or health. In the assessment of specific risks, Member States shall take into account, in accordance with the SPS agreement: available scientific evidence; relevant process and production methods; relevant inspection, sampling and testing methods; prevalence of specific diseases or pests; existence of pest- or disease-free areas; relevant ecological and environmental conditions and quarantine or other treatment. The Appellate Body report in the Hormones case stated that the risk that is to be evaluated in a risk assessment is not only risk ascertainable in a science laboratory operating under strictly controlled conditions, but also factors not susceptible of quantitative analysis. Such risk assessment regarding food-borne bacteria along the food chain in particular, belongs to that category of risk assessment that is more qualitative than quantitative.

In order to maintain the high level of protection required by the Treaty in the Community, equivalent measures should be required from exporting third countries including the presentation of control programmes and health certification, where relevant. Although the evaluation of programmes presented by third countries will cause a heavy workload for the Commission services, the experience gathered with similar mechanisms shows that this approach is feasible.

E. Conclusions

The provisions of Directive 92/117/EEC need to be revised in the light of the experiences gained in their implementation. Poultry products still host a major source of human salmonellosis. Nevertheless, in the future the results of risk assessment may reveal other important sources of zoonotic agents, or new types of organisms may emerge. Therefore a global framework for control of zoonoses must be established.

The policy against zoonotic infections needs to be based on risk analysis including three elements: risk assessment, risk management and risk communication. The Commission makes two proposals for a new legislative framework in this field:

- 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 and

- Proposal for a Regulation of the European Parliament and of the Council on the control of salmonella and other food-borne zoonotic agents and amending Council Directives 64/432/EEC, 72/462/EEC and 90/539/EEC.

Of these proposals, the first proposal aims to cover the areas of data collection in relation to incidence and prevalence of biological risks and transparency of these data, while the second proposal deals mainly with the aspects of risk management. Separating these issues into two legal texts should facilitate their practical implementation. However, it is necessary to stress that these proposals form an inseparable unity. The European Food Authority will play an essential role in the area of data collection in relation to food safety and in the communication of these data.