Proposal for a EUROPEAN PARLIAMENT AND COUNCIL DIRECTIVE amending Directive 92/117/EEC 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

(presented by the Commission)

EXPLANATORY MEMORANDUM

Council Directive 92/117/EEC 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) lays down that the Commission shall submit to the Council a report on the measures to be applied for the control and prevention of zoonoses. This obligation has been imposed on the Commission since it became apparent after the entry into force of the Directive that an amendment was necessary. The experience of the implementation of the provisions of Directive 92/117/EEC had shown the necessity to review certain technical provisions of the Directive. At the same time, reflection was needed on other measures needed at Community level to prevent zoonoses posing a threat to human health.

(1) OJ L 62, 15.3.1993, p. 38

Such a review deals with a range of complex and difficult issues and was expected to take an extended period of time. Upon a proposal from the Commission, the Council granted the Commission, through Directive 97/22/EC, a period of 18 months to come up with new proposals. At the same time, certain time limits that were imposed on the Member States for implementing control programmes have been extended.

In the meanwhile, the Commission services have proceeded to a number of consultations with interested parties. It appeared from these consultations that establishing solid rules for controlling zoonoses is a complex issue and requires an in depth scientific assessment. A revision of Directive 92/117/EEC within the time limit prescribed by Directive 97/22/EC was therefore not possible. It is therefore proposed to extend the period for the Commission to present appropriate proposals once more. At the same time it is proposed that the deadline of 31 December 1998 for third countries to submit a zoonoses control programme to the Commission be postponed until a scientifically based system is implemented in the Community.

It is the intention of the Commission services to hold working group discussions before a new text is drafted by end of June 1999. Requests for scientific opinions will be sent to the Commission's scientific committees by end of June 1999. Third parties will be able to give their comments on the proposal until the end of 1999. A report and a proposal for revision of Directive 92/117/EEC should then be sent to Council and Parliament by 31 March 2000.

The interim report joined herewith gives information on the state of progress of the dossier, and on possible policy options for future Community legislation on the control of zoonoses.

INTERIM REPORT ON THE MEASURES TO BE PUT IN FORCE FOR THE CONTROL AND PREVENTION OF ZOONOSES

Council Directive 92/117/EEC 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 (2) seeks to establish a reliable reporting system on the incidence 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 programmes for other zoonotic agents than Salmonellosis.

(2) OJ L 62, 15.3.1993, p. 38

1. Control of zoonoses

a) Introduction

Currently the control measures cover only salmonella in poultry breeding flocks since at late 1980's the increasing number 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 S.Enteritidis (and S.Typhimurium) in breeding flocks to reduce the vertical transmission to commercial flocks. Measures in commercial flocks were foreseen in the future.

However, it was soon realised that not all Member States were able to fully implement the system foreseen by the Zoonosis Directive. Indeed, only four Member States have fully implemented the provisions on salmonella control of breeding flocks.Because of the unsatisfyingunsatisfactory results inbreeding Even though certain deadlines of the Zoonosis 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 Zoonosis Directive nor implemented the above provisions. The Commission will take the necessary steps to ensure that the Zoonosis Directive is observed in all Member States, as this is a prerequisite for proposals to improve the measures for controlling zoonoses.

Poultry products, in particular table eggs, remain the main sources of human salmonellosis in most of the Member States. On a national basis some Member States have extended their measures to commercial flocks. Because of the unsatisfactory results in implementing the provisions concerning breeding flocks, it has not been possible to introduce any Community measures to control salmonella in commercial poultry.

The consequences for public health in the Community impose a strict timetable for submitting a report together with a fundamental review of the Zoonosis Directive. The necessary resources will have to be assigned to this important task to meet the envisaged deadlines.

The objective of eradicating salmonella from poultry flocks in the Community with a strategy based on ensuring disease freedom from the breeding parent stock, although still sound, needs to be reviewed especially as regards to steps which must be taken to achieve this aim. Compulsory total slaughter and destruction of parent flocks without prior action to reduce the general pathogen prevalence level by other control measures presents serious difficulties in many Member States. The Commission considers it necessary to review the strategy currently laid down in the Council Directive concerned.

b) New approach for the control measures

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

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

- to give the flexibility needed for the Member States to achieve common objectives;

- to ensure the uniform fulfilment by the Member States;

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

- to be so well scientifically justified that any trade disputes with third countries will be avoided;

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

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

The means of attaining these objectives, and in particular the pathogen reduction schemes need to be set according to scientifically based risk assessments. In order to allow the Commission to follow-up the progress of such schemes, Member States would need to submit national plans concerning the achievement of these objectives. However, an individual Member State would have the possibility to choose the tools which it deems necessary to obtain the objectives. Since actions to control zoonotic agents start at primary production, the implementation of principles of Good Animal Husbandry Practises will play a key role.

While the current zoonoses Directive includes only control measures for certain types of Salmonella, the new approach would allow for the establishment of control objectives 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 cytotoxic E. coli should be addressed.

The new approach would mean the improvement of the safety of consumers especially having regard to the pathogens with the greatest importance to health. At the same time consumers have to accept that a zero level risk is not achievable and even feasible. Further reflection is needed in order to evaluate the economical impact of the new approach but it might be expected that such impact will be considerable and will depend on the level of prevalence of the zoonotic agents of concern in the Member States. The possibility to grant financial assistance to those plans, which fulfil the required options, must be examined.

It should also be noted, that increased safety of foodstuffs will increase the trust of consumers and thus help to avoid food scares. Perhaps most of all, a scientifically based Community level policy on zoonoses and zoonotic agents will also be a tool in trade with third countries.

2. Epidemiological data of zoonoses

A critical issue for the optimal implementation of the Community strategy will be the collection of epidemiological data on zoonoses. In co-operation with the Community Reference Laboratory on 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 currently the report for 1997 is under preparation. 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.

In the future the measures intended to combat zoonoses should be based on risk assessments. This will increase the importance of accurate information on zoonoses and zoonotic agents from all stages of the food chain. Efforts should be directed to harmonise the reporting system by introducing certain fixed criteria for e.g. the case definitions. At the moment there are several initiatives at Community level, which include also measures on the reporting of zoonoses, like the Decision of the European Parliament and of the Council setting up a network for the epidemiological surveillance and control of communicable diseases in the Community (2119/98/EC) (3). Close co-operation within the Commission and between the Commission and the Member States is needed to enable the most efficient use of the data collected and to avoid any duplicate work.

(3) OJ L 268, 3.10.1998, p. 1

3. Conclusions

It is clear from the above that establishing a long term strategy for the control of zoonosis is a complicated issue, for which many aspects must be taken into account. Apart from the paramount objective of public health and consumer protection, aspects such as scientific assessments, practicability of the proposed measures, follow-up of the efficiency of pathogen reduction programmes and the financial impact of such measures play a role in any future policy for controlling zoonoses. It is to be regretted that due to this complicated nature of the problem, the Commission has not been able to come forward with proposal earlier in time. In view of the above, it is believed however that, before submitting proposals on the subject, more reflection is needed. The Commission therefore requests, through an amendment of Article 15a of Directive 92/117/EEC, more time to finalise its ongoing efforts for finding the most appropriate solutions with regard to public health and consumer protection. In the meanwhile, the Commission will endeavour to ensure that Member States apply, with the tools available at present, the highest level of public health and consumer protection possible. Once a scientifically based pathogen control and reduction policy is introduced in the Community and implemented by the Member States, the respect of guarantees equivalent to the ones resulting from such policy can be requested from third countries. It is therefore proposed to report the time limit referred to in Article 14(2) of Directive 92/117/EEC.

Proposal for a

EUROPEAN PARLIAMENT AND COUNCIL DIRECTIVE

amending Directive 92/117/EEC 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 (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 100A thereof,

Having regard to the proposal from the Commission (4),

(4) OJ C

Having regard to the opinion of the Economic and Social Committee (5),

(5) OJ C

Acting in accordance with the procedure laid down in Article 189B of the Treaty,

Whereas in the light of the experience acquired and the importance accorded to the prevention and control of zoonoses it is necessary to carry out a substantial review of the provisions of Council Directive 92/117/EEC of 17 December 1992 concerning measures for the 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 (6), as last amended by Directive 97/22/EC (7);

(6) OJ L 62, 15.3.1993, p. 38

(7) OJ L 113, 30.4.1997, p. 9

Whereas such substantial review consists of introducing new provisions for the reporting system for zoonoses, improved rules for the control and eradication of salmonellosis in poultry flocks, and a system to control other zoonoses than salmonellosis and in particular campylobacter and cytotoxic strains of E. coli;

Whereas a substantial review requires consultation of and consideration by all the parties concerned, and in particular the consumer organisations, the farming industry and the scientific world;

Whereas, pending this substantial review of Directive 92/117/EEC, it is appropriate to provide for a postponement of the deadlines for plans to be submitted by third countries and for the requirement to submit to the European Parliament and the Council proposals on new provisions;

Whereas this Directive aims directly public health: whereas it is therefore appropriate to retain Article 100A as the legal basis,

HAVE ADOPTED THIS DIRECTIVE:

Article 1

Directive 92/117/EEC is amended as follows:

1. In Article 14(2), "31 December 1998" is replaced by "one year after the entry into force of the acts pursuant to the proposals referred to in paragraph 2 of Article 15a".

2. In Article 15a,

(a) In paragraph 1, "1 November 1997" is replaced by "31 March 2000";

(b) In paragraph 2, "1 June 1998" is replaced by "31 December 2000".

Article 2

Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 31 May 2001. They shall forthwith inform the Commission thereof.

When Member States adopt these provisions, they shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States.

Member Sates shall communicate to the Commission the provisions of national law they adopted in the field governed by this Directive. The Commission shall inform the other Member States thereof.

Article 3

This Directive shall enter into force from the third day following its publication in the Official Journal of the European Communities.

Article 4

This Directive is addressed to the Member States.

Done at Brussels,

For the European Parliament

The President

For the Council

The President