Regulation (EC) No 2160/2003 of the European Parliament and of the Council
of 17 November 2003
on the control of salmonella and other specified food-borne zoonotic agents
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty establishing the European Community, and in particular Article 152(4)(b) thereof,
After consulting the Committee of the Regions,
Whereas:
Live animals and food of animal origin appear on the list in Annex I to the Treaty. Livestock farming and the placing on the market of food of animal origin constitute an important source of income for farmers. The implementation of veterinary measures aimed at raising the level of public and animal health in the Community assists the rational development of the farming sector.
The protection of human health against diseases and infections transmissible directly or indirectly between animals and humans (zoonoses) is of paramount importance.
Zoonoses transmissible through food may cause human suffering, as well as economic losses to food production and the food industry.
Zoonoses transmitted through sources other than food, especially from wild animal and pet animal populations, are also a matter of concern.
Zoonoses present at the level of primary production must be adequately controlled to ensure that the objectives of this Regulation are achieved. However, in the case of primary production leading to the direct supply of small quantities of primary products, by the food business operator producing them, to the final consumer or to local shops, it is appropriate to protect public health through national law. In this case there is a close relationship between the producer and the consumer. Such production should not make a significant contribution to the average prevalence of zoonoses in animal populations in the Community as a whole. The general requirements for sampling and analysis may not be practical or appropriate for producers with very small numbers of animals who may be located in regions suffering from special geographical constraints.
Several Member States have already submitted their plans for the monitoring of salmonella, which the Commission has approved. Moreover, all Member States were required, with effect from 1 January 1998, to fulfil the minimum measures laid down for salmonella in Annex III, Section I, to Directive 92/117/EEC, and to establish rules specifying the measures to be taken to avoid the introduction of salmonella on to a farm.
Those minimum measures focused on monitoring and controlling salmonella in breeding flocks of the species Gallus gallus. When serotypes Salmonella enteritidis or Salmonella typhimurium were detected and confirmed in samples taken, Directive 92/117/EEC laid down specific measures to control the infection.
Moreover, future Community legislation on food hygiene should cover specific elements necessary for the prevention, control and monitoring of zoonoses and zoonotic agents and include specific requirements for the microbiological quality of food.
Directive 92/117/EEC provided for the collection of data on the occurrence of zoonoses and zoonotic agents in feedingstuffs, animals, food and humans. That data collection system, although not harmonised and therefore not allowing comparison between Member States, does provide a basis for evaluating the current situation concerning zoonoses and zoonotic agents in the Community.
The results of the data collection system show that certain zoonotic agents, namely Salmonella spp. and Campylobacter spp., cause the majority of cases of zoonoses in humans. There seems to be a decreasing trend of human cases of salmonellosis, in particular due to Salmonella enteritidis and Salmonella typhimurium, thus reflecting the success of related control measures taken in the Community. Nevertheless, it is assumed that many cases remain unreported and therefore the data collected do not necessarily give the full picture of the situation.
In its opinion on zoonoses adopted on 12 April 2000, the Scientific Committee on Veterinary Measures relating to Public Health considered that the measures in place at that time to control food-borne zoonotic infections were insufficient. It further considered that the epidemiological data that Member States were collecting were incomplete and not fully comparable. As a consequence, the Committee recommended improved monitoring arrangements and identified risk management options.
In principle, controls should cover the whole food chain, from farm to table.
The rules governing such controls should generally be those laid down under Community legislation on feedingstuffs, animal health and food hygiene.
However, for certain zoonoses and zoonotic agents it is necessary to lay down specific requirements for controls.
Those specific requirements should be based on targets for the reduction of the prevalence of zoonoses and zoonotic agents.
The targets should be established for zoonoses and zoonotic agents in animal populations taking account, in particular, of their frequency and epidemiological trends in animal and human populations, feed and food, their gravity for humans, their potential economic consequences, scientific advice and the existence of appropriate measures to reduce their prevalence. Targets may be established in respect of other parts of the food chain, where necessary.
To ensure the achievement of the targets in good time, Member States should set up specific control programmes, which the Community should approve.
The main responsibility for the safety of food should lie with food and feed business operators. Member States should, therefore, encourage the creation of business-wide control programmes.
Within their control programmes, Member States and food and feed business operators may wish to use specific control methods. However, certain methods may not be acceptable, in particular if they hamper the achievement of the target in general, interfere specifically with necessary testing systems or give rise to potential threats to public health. Appropriate procedures should therefore be laid down enabling the Community to decide that certain control methods should not be used as part of control programmes.
Control methods may also exist or be developed which, as such, do not fall under any specific Community legislation on product approval but would help to achieve the targets for the reduction of the prevalence of specified zoonoses and zoonotic agents. It should, therefore, be possible to approve the use of such methods at Community level.
Third countries exporting to the Community must implement equivalent measures for the control of zoonoses at the same time as measures are applied in the Community.
As regards control of salmonella, available information tends to show that poultry products are a major source of human salmonellosis. Control measures should, therefore, be applied to production of those products, thus extending the measures initiated under Directive 92/117/EEC. As regards the production of table eggs, it is important to establish specific measures concerning the placing on the market of products originating from flocks that have not been tested free of relevant salmonella. As regards poultry meat, the aim is to place on the market poultry meat with reasonable assurance that it is free from relevant salmonella. A transitional period is necessary for food business operators to adapt to the measures envisaged, which may be adapted further in particular in the light of scientific risk assessment.
It is appropriate to designate national and Community reference laboratories to give guidance and assistance on matters falling within the scope of this Regulation.
To ensure the uniform application of this Regulation, provision should be made for the organisation of Community audits and inspections in accordance with other Community legislation in this field.
Appropriate procedures should be laid down for amending certain provisions of this Regulation to take account of technical and scientific progress and for the adoption of implementing and transitional measures.
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