Explanatory Memorandum to COM(2001)452-2 - Monitoring of zoonoses and zoonotic agents - Main contents
Please note
This page contains a limited version of this dossier in the EU Monitor.
| dossier | COM(2001)452-2 - Monitoring of zoonoses and zoonotic agents. |
|---|---|
| source | COM(2001)452  |
| date | 01-08-2001 |
Contents
- 1. A. Chapter I (Introductory provisions)
- 1. B. Chapter II (Monitoring of zoonoses and zoonotic agents)
- 1.C. Chapter III (Food-borne outbreaks)
- 1.D. Chapter IV (Exchange of information)
- 1.E. Chapter V (Laboratories)
- 1.F. Chapter VI (Implementation)
- 1.G. Chapter VII (final provisions)
- 2.A. Chapter I (Introductory provisions)
- 2.B. Chapter II (Community targets)
- 2.C. Chapter III (Control programmes)
- 2.D. Chapter IV (Control methods)
- 2.E. Chapter V (Trade)
- 2.F. Chapter VI (Laboratories)
- 2.G. Chapter VII (Implementation)
- 2.H. Chapter VIII (General and final provisions)
The proposed Directive would cover the monitoring aspects provided for in Directive 92/117/EEC. In principle, no zoonoses are excluded from the scope of the Directive. However, because a specific set of rules is foreseen for transmissible spongiform encephalopathies, these are excluded from the scope of this Directive. The monitoring activity proposed should take place in animal populations and, where necessary, at other stages of food chain. Member States should nominate a competent authority for the purposes of the Directive and ensure sufficient co-operation between authorities responsible for animal health, food hygiene, communicable diseases and zoonoses monitoring.
The proposal would oblige the Member States to undertake action in monitoring zoonotic organisms in general. The list of organisms covered by the monitoring is mainly based on the opinion on zoonoses of 12 April 2000 of the Scientific Committee on Veterinary Measures relating to Public Health. The monitoring systems would be primarily based on existing systems in Member States. However, there would be procedures available to establish common criteria for data collection. Also as a new element it is proposed to create a basis for co-ordinated Community monitoring programmes. These co-ordinated monitoring programmes would last for a relevant, but limited time period (1-3 years), and the results of surveys could be used as the basis for possible modification of the pathogen reduction targets. However, any control action based on this monitoring data is, in principle, regulated by Member States themselves.
The collection of human data on the incidence of zoonotic diseases is of paramount importance to base food safety legislation on scientific advice and to obtain feedback on the effectiveness of the control applied and, when necessary, to redirect these measures. Decision 2119/98/EC i, which entered into force on 1.1.1999, creates a framework for this data collection. Furthermore, Decision 2000/96/EC i defines those zoonoses to be progressively covered. Thiscommunicable diseases network should also be used for the purposes of zoonoses monitoring and control. Therefore the proposed Directive requires close co-operation between human, veterinary and food safety authorities in Member States.
In the light of the increasing importance of antibiotic resistance in zoonotic organisms, it is proposed to include its monitoring within the proposed Directive.
As a separate requirement, the monitoring of foodborne outbreaks is proposed. At the moment, epidemiological outbreak data is collected by a WHO-based Europe-wide system, which is a slow way to gather this data. The monitoring and associated reporting of outbreaks would give important information on the main causes of foodborne diseases. However, the measures concerning suspected foods and their production environment lie outside the scope of this Directive.
Food business operators would be obliged to keep the results of testing of zoonoses and to communicate these results to the competent authority upon request. Member States shall prepare a yearly report on trends and sources of zoonoses, which they must transmit to the Commission and to the European Food Authority set up following the proposal for a Regulation of the European Parliament and of the Council laying down the general principles and requirements of food law, establishing the European Food Authority (EFA), and laying down procedures in matters of food (COM(2000) 716 final). The EFA shall compile a synthesis report, which may include also relevant information from other Community-wide sources, like animal disease eradication programmes and communicable disease networks.
The proposal establishes the framework for designating the Community Reference Laboratories and National Reference Laboratories and to define their respective tasks.
It lays down the regulatory procedure and transposition provisions.
The proposal encompasses provisions for repealing Directive 92/117/EEC and for amending Council Decision 90/424/EEC of 26 June 1990 on expenditure in the veterinary field i.
Since the provisions of Directive 92/117/EEC will be covered by the proposed Directive and the proposed Regulation on the control of salmonella and other food-borne zoonotic agents agents and amending Council Directives 64/432/EEC, 72/462/EEC and 90/539/EEC, it is proposed to repeal the current Council Directive. However, to ensure a smooth transition and continuous control it is proposed that certain obligations based on Directive 92/117/EEC would remain in force until corresponding provisions laid down in the proposed Regulation will take effect.
The proposal lays down certain provisions relating to Community's financial contribution towards certain actions relating to the monitoring and control of zoonoses and zoonotic agents, by amending the Chapter on 'zoonoses' in Decision 90/424/EEC.
2. Proposal for a Regulation of the European Parliament and of the Council on the control of Salmonella and other food-borne zoonotic agents and amending Council Directives 64/432/EEC, 72/462/EEC and 90/539/EEC
The proposal encompasses a fundamental review concerning the approach towards the control of zoonotic diseases. It follows the principles of the White Paper on Food Safety (COM(1999) 719 final) adopted by the Commission on 12 January 2000. Account is also taken of the opinion on zoonoses issued by the Scientific Committee on Veterinary Measures relating to Public Health on 12 April 2000.
The proposal for a Regulation of the European Parliament and of the Council on the control of salmonella and other food-borne zoonotic agents and amending Council Directives 64/432/EEC, 72/462/EEC and 90/539/EEC would cover, in principle, all zoonoses. However, the specific control requirements are covering only certain types of salmonella. Further extension to cover other pathogens, would be possible, when the epidemiological situation so warrants. The control activities are foreseen to take place primarily at the primary production of animals, and where necessary, at the subsequent stages at the food chain.
The proposal creates a framework for a pathogen reduction policy. The practical form of this policy would be the establishment of Community pathogen reduction targets for selected zoonotic agents in selected farming animal populations. Before the adoption of pathogen reduction targets, scientific - and political - scrutiny is needed. Therefore it is proposed that the Commission within a fixed timeframe will establish the targets.
The proposal enables future modification of pathogen reduction targets. The targets would progressively be set for certain salmonella serotypes in laying hens, broilers, and their breeders, and for turkey and pig breeders. Other emerging pathogens could be selected as targets, based on scientific evidence and a sufficient knowledge on the potential means to reduce their prevalence in animal populations. It would be also possible to establish separate targets for the different stages of food chain.
The level of details of the prescriptive rules concerning control measures at breeder flocks would be minimised compared to the existing Zoonosis Directive. However, this would not mean lowering the required level of safety. The concrete method for implementing pathogen reduction systems would be the establishment of national control programmes. The Commission shall approve the programmes, but to be effective, it is clear that national authorities should bear the greatest responsibility. However, taking into consideration that animal production systems are nowadays more and more integrated (i.e. the same company or organisation governs the supply of feedingstuffs, breeding and/or production animals, and even slaughter) there should be a possibility for own-initiative private sector actions. Therefore it is proposed that the Member States should encourage food businesses to establish their own control programmes.
The proposal lays down the possibility for the Commission to decide that certain control methods should not be used as part of control programmes, or to decide on certain conditions for their use. In particular, the use of antibiotics or vaccination may in future need to be further reflected upon. Further control methods may need to be considered in the future.
The basic element in the proposal is to ensure that the purchaser of live animals or hatching eggs knows the status of the holding of origin of the animals. Nationally this can be achieved through national control programmes. However, concerning intra-Community trade there is a need to use a health certification system. Since the existing certificates based on animal health legislation (Directives 64/432/EEC i and 90/539/EEC i) can be amended by comitology procedure (for Directive 64/432/EEC, a proposal to that effect has been prepared by the Commission), these will be amended by Commission Decisions in due course, in orderto add information concerning zoonosis control into these certificates. After a certain transitional period, the results of testing for salmonella in the flock or herd of origin should be presented in the certificate. With the approval of the Commission, for a transitional period, the Member State of destination could decide that for dispatches from other Member States it could apply the same results requirements as are applied domestically as a part of the respective control programme.
For table eggs, once the transitional period before full implementation of the control measures concerning laying hens has elapsed, table eggs will only be allowed to be marketed for direct consumption when originating from flocks tested negative for S. Enteritidis and S. Typhimurium. For poultry meat, a criterion of 'absence of salmonella in 25g' will apply after a transitional period.
As regards third countries, equivalent measures would be required for importation of relevant live animals and hatching eggs into the Community. Where appropriate, control programmes should be required. The certification requirements presented above would apply to imports from third countries and specific certificates for third country trade shall be established or amended, in due course, by Commission Decisions. Certification requirements for products like table eggs or poultry meat will also be established in due course.
The proposal establishes the framework for designating the Community Reference Laboratories and National Reference Laboratories and to define their respective tasks. It also lays down the quality requirements for laboratories participating in control programmes.
It lays down the regulatory procedure.
The proposal encompasses provisions for Community controls and for amending certain Directives on health conditions governing intra-Community trade and/or importation from third countries.
The proposal encompasses provisions for Community controls and for amending certain Directives on health conditions governing intra-Community trade and/or importation from third countries.