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

(presented by the Commission)

EXPLANATORY MEMORANDUM

1. 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

1. A. Chapter I (Introductory 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.

1. B. Chapter II (Monitoring of zoonoses and zoonotic agents)

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 [1], which entered into force on 1.1.1999, creates a framework for this data collection. Furthermore, Decision 2000/96/EC [2] 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.

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

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

In the light of the increasing importance of antibiotic resistance in zoonotic organisms, it is proposed to include its monitoring within the proposed Directive.

1.C. Chapter III (Food-borne outbreaks)

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.

1.D. Chapter IV (Exchange of information)

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.

1.E. Chapter V (Laboratories)

The proposal establishes the framework for designating the Community Reference Laboratories and National Reference Laboratories and to define their respective tasks.

1.F. Chapter VI (Implementation)

It lays down the regulatory procedure and transposition provisions.

1.G. Chapter VII (final 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 [3].

[3] 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).

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

2.A. Chapter I (Introductory provisions)

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.

2.B. Chapter II (Community targets)

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.

2.C. Chapter III (Control programmes)

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.

2.D. Chapter IV (Control methods)

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.

2.E. Chapter V (Trade)

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 [4] and 90/539/EEC [5]) 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.

[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 303, 31.10.1990, p. 6. Directive as last amended by Directive 1999/90/EC (OJ L 300, 23.11.1999, p. 19).

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.

2.F. Chapter VI (Laboratories)

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.

2.G. Chapter VII (Implementation)

It lays down the regulatory procedure.

2.H. Chapter VIII (General and final provisions)

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.

2001/0177 (COD)

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

(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 152 (4)(b) thereof,

Having regard to the proposal from the Commission [6],

[6] OJ C ...

Having regard to the opinion of the Economic and Social Committee [7],

[7] OJ C ...

Having regard to the opinion of the Committee of the Regions [8],

[8] OJ C ...

Acting in accordance with the procedure laid down in Article 251 of the Treaty [9],

[9] OJ C ...

Whereas:

(1) The protection of human health against diseases and infections transmissible directly or indirectly from animals to man (zoonoses) is of paramount importance.

(2) Zoonoses transmissible through food may cause human suffering, as well as economic losses to food production and food industry.

(3) Zoonoses transmitted through sources other than food, especially from wild animal and pet animal populations, are also a matter of concern.

(4) Council Directive 92/117/EEC of 17 December 1992 concerning measures for protection against specified zoonoses and specified zoonotic agents in animals and products of animal origin in order to prevent outbreaks of food-borne infections and intoxications [10] was adopted in order to establish monitoring systems for certain zoonoses and to establish controls on Salmonella in poultry flocks.

[10] OJ L 62, 15.3.1993, p. 38. Directive as last amended by Directive 1999/72/EC of the European Parliament and of the Council (OJ L 210, 10.8.1999, p. 12).

(5) Directive 92/117/EEC required the Member States to submit to the Commission the national measures that they are taking to achieve the objectives of the Directive. Member States were also required to draw up plans for monitoring salmonella in poultry. That requirement was, however, suspended by Council Directive 97/22/EC [11] amending Directive 92/117/EEC, pending the review provided for in Article 15a of Directive 92/117/EEC.

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

(6) 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 in order to avoid the introduction of salmonella onto a farm.

(7) Those minimum measures focused on monitoring and control of salmonella in breeding flocks of the species Gallus gallus. When serotypes Salmonella Enteritidis or Salmonella Typhimurium were detected and confirmed in samples taken, specific measures to control the infection were required by Directive 92/117/EEC.

(8) Monitoring and control of certain zoonoses in animal populations has been provided for by other Community legislation, in particular Council Directive 64/432/EEC of 26 June 1964 on animal health problems affecting intra-Community trade in bovine animals and swine [12] as regards bovine tuberculosis and bovine brucellosis and Council Directive 91/68/EEC of 28 January 1991 on animal health conditions governing intra-Community trade in ovine and caprine animals [13] as regards ovine and caprine brucellosis.

[12] OJ 121, 29.7.1964, p. 1977. Directive as last amended by Directive 2000/20/EC (OJ L 163, 4.7.2000, p. 35).

[13] OJ L 46, 19.2.1991 p. 19. Directive as last amended by Commission Decision 94/953/EC (OJ L 371, 31.12.1994, p. 14).

(9) Moreover, Regulation (EC) No..../... of the European Parliament and of the Council of .... [on the hygiene of foodstuffs] [14] covers specific elements necessary for the prevention, control and monitoring of zoonoses and zoonotic agents, and includes specific requirements for the microbiological quality of food.

[14] OJ L ...

(10) 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.

(11) 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 does not necessarily give the full picture of the situation.

(12) The Scientific Committee on Veterinary Measures relating to Public Health has, in its Opinion on zoonoses adopted on 12 April 2000, considered that the current measures to control food-borne zoonotic infections are insufficient and that the epidemiological data as currently collected by Member States are incomplete and not fully comparable. On that basis, the Committee recommended improved monitoring arrangements and identified risk management options.

(13) It is, therefore, necessary to improve the existing control systems for specific zoonotic agents. Simultaneously, the monitoring and data collection systems established by Directive 92/117/EEC will be replaced by the rules laid down in Directive .../... of the European Parliament and of the Council of ..... [on the monitoring of zoonoses and zoonotic agents, amending Council Decision 90/424/EEC and repealing Council Directive 92/117/EEC] [15].

[15] OJ L

(14) The principle should be established of controls covering the whole food chain from farm to table.

(15) The rules governing such controls should generally be those laid down under Community legislation on feedingstuffs, animal health and food hygiene.

(16) However, for certain zoonoses and zoonotic agents it is necessary to lay down specific requirements for controls.

(17) Those specific requirements should be based on targets for the reduction of the prevalence of zoonoses and zoonotic agents.

(18) The targets should be established for zoonoses and zoonotic agents in animal population taking into account in particular their incidence and epidemiological trend in animal and human populations, their gravity for humans, their potential economical consequences for health care and for food businesses, and the existence of appropriate measures to reduce their prevalence. Targets may also be established in respect of other parts of the food chain, where necessary.

(19) To ensure the achievement of the targets in good time, the Member States should set up specific control programmes, which should be approved by the Community.

(20) The main responsibility for the safety of food should lie with food businesses. Member States should, therefore, encourage the creation of business-wide control programmes.

(21) Within their control programmes Member States or food businesses 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 Commission to decide that certain control methods should not be used as part of control programmes.

(22) 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 prevalences of specified zoonoses and zoonotic agents. The Commission should, therefore, have the authority to approve the use of such methods at Community level.

(23) It will be essential to ensure that restocking of animals takes place from flocks or herds that have been subject to controls in accordance with the requirements of this Regulation. When a specific control programme is in force, the results of testing should be forwarded to the purchaser of animals. To that end, specific requirements should be added to the corresponding Community legislation on intra-Community trade and imports from third countries, in particular as regards consignments of live animals and hatching eggs. Council Directive 64/432/EEC of 26 June 1964 on animal health problems affecting intra-Community trade in bovine animals and swine, Council Directive 72/462/EEC of 12 December 1972 on health and veterinary inspection problems upon importation of bovine, ovine, caprine animals and swine, fresh meat or meat products from third countries [16] and Council Directive 90/539/EEC of 15 October 1990 on animal health conditions governing intra-Community trade in, and imports from third countries of, poultry and hatching eggs [17] should be amended accordingly.

[16] 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).

[17] 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).

(24) 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 the food business operators to adapt to the foreseen measures, which may be adapted further in particular in the light of scientific risk assessment. Equivalent guarantees should be required from third countries, in due course.

(25) It is appropriate to designate National and Community Reference Laboratories for giving guidance and assistance on matters falling within the scope of this Regulation.

(26) In order to ensure the uniform application of the provisions of this Regulation, provision should be made for the organisation of Community audits and inspections in accordance with Commission Decision 98/139/EC of 4 February 1998 laying down certain detailed rules concerning on-the-spot checks carried out in the veterinary field by Commission experts in the Member States [18] and Commission Decision 98/140/EC of 4 February 1998 laying down certain detailed rules concerning on-the-spot checks carried out in the veterinary field by Commission experts in third countries [19].

[18] OJ L 38, 12.2.1998, p. 10.

[19] OJ L 38, 12.2.1998, p. 14.

(27) Appropriate procedures should be laid down for the amendment of certain provisions of this Regulation taking into account technical and scientific progress, and for the adoption of implementing and transitional measures.

(28) Since the said measures are measures of general scope within the meaning of Article 2 of Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission [20], they should be adopted by use of the regulatory procedure provided for in Article 5 of that Decision. The Commission should be assisted by the Committee on Food Safety and Animal Health set up by Regulation (EC) No .../... of the European Parliament and of the Council of ... [laying down the general principles and requirements of food law, establishing the European Food Authority, and laying down procedures in matters of food] [21],

[20] OJ L 184, 17.7.1999, p. 23.

[21] OJ L ...

HAVE ADOPTED THIS REGULATION:

Chapter I Introductory provisions

Article 1 Subject-matter and scope

1. The purpose of this Regulation is to ensure that proper and effective measures are taken to control salmonella and other zoonotic agents in order to reduce their prevalence and the risk they pose to public health.

2. This Regulation covers:

a) the adoption of targets for the reduction of prevalences of specified zoonoses, in animal populations, in particular at the stage of primary production of animals, but also, where necessary, at other stages in the food chain;

b) the approval of specific control programmes established by Member States and food business operators;

c) the adoption of specific rules concerning certain control methods applied in the reduction of prevalences of zoonoses and zoonotic agents;

d) the adoption of rules concerning intra-Community trade and imports from third countries of certain animals and products thereof.

Article 2 Definitions

For the purposes of this Regulation the following definitions shall apply:

1. "zoonosis" means any disease and/or infection which is naturally transmissible directly or indirectly from animals to humans;

2. "zoonotic agent" means any virus, bacterium, fungus, parasite or other biological entity which is likely to cause a zoonosis;

3. "food business" means a business as defined in Article 2 of Regulation (EC) No .../... [on the hygiene of foodstuffs];

4. "food business operator" means the person or persons responsible for ensuring that the requirements of this Regulation are met within the food business under his/her or their supervision;

5. "prevalence" means the number of cases of epidemiological units tested positive for a given zoonosis or zoonotic agent in a given population over a clearly defined period of time;

6. "herd" means an animal or group of animals as defined in Article 2(2)(a) of Directive 64/432/EEC;

7. "flock" means an animal or group of animals as defined in Article 2(2)(7) of Directive 90/539/EEC;

8. "primary production" means production as defined in Article 2 of Regulation (EC) No .../... [on the hygiene of foodstuffs].

Article 3 Competent authorities

1. Each Member State shall designate its competent authority for the purpose of this Regulation and notify the Commission thereof.

2. The competent authority shall be responsible in particular for:

a) drawing up the programmes provided for in Article 5(1) and preparing any amendments thereto which prove necessary, in particular in the light of data and results obtained;

b) collecting the data needed to evaluate the means used and the results obtained in carrying out the national control programmes provided for in Article 5 and for submitting those data and results yearly, including the results of any surveys undertaken, to the Commission and to the European Food Authority by 31 May of the following year, having regard to the rules laid down pursuant to Article 9(1) of Directive .../.../EC [on the monitoring of zoonoses and zoonotic agents, amending Council Decision 90/424/EEC and repealing Council Directive 92/117/EEC];

c) carrying out regular checks on the premises of food business operators for the purpose of checking compliance with this Regulation.

Chapter II Community targets

Article 4 Community targets for the reduction of prevalences of zoonoses and zoonotic agents

1. Community targets shall be established for the reduction of prevalences of zoonoses and zoonotic agents listed in Annex I, Part A, Column 1 in the animal populations listed in Annex I, Part A, Column 2, taking into account:

a) the experience gained under existing national measures,

b) information forwarded to the Commission or to the European Food Authority under existing Community requirements, in particular in the framework of reports provided for in Article 9(1) of Directive .../.../EC [on the monitoring of zoonoses and zoonotic agents, amending Council Decision 90/424/EEC and repealing Council Directive 92/117/EEC],

c) the criteria laid down in Annex I, Part B.

When necessary, in accordance with the procedure laid down in Article 14(2), Annex I may be amended and it may be decided that Community targets shall be established for other stages in the food-chain.

2. Community targets shall at least include the details set out in Annex I, Part C.

3. Community targets shall be established for the first time before the respective dates indicated in Annex I, Part A, Column 4. The targets, as well as any amendments to them, shall be established in accordance with the procedure referred to in Article 14(2), and after consultation of the European Food Authority.

4. Without prejudice to Community rules on animal nutrition, animal health, or food hygiene, the reduction of prevalences of zoonoses and zoonotic agents listed in Annex I shall be conducted in accordance with the rules laid down in this Regulation and any other rules adopted pursuant to it.

Chapter III Control programmes

Article 5 National control programmes

1. Member States shall, in particular in the light of the Community targets provided for in Article 4 and the geographical distribution of zoonoses in their territory, establish national control programmes for each zoonosis and zoonotic agent listed in Annex I.

2. National control programmes shall be continuous and cover a period of at least three consecutive years.

3. National control programmes shall:

a) provide for the detection of zoonoses and zoonotic agents in accordance with the requirements and minimum sampling rules laid down in Annex II;

b) define the responsibilities of food business operators concerned, especially in terms of their control programmes as provided for in Article 7;

c) specify the control measures to be taken following the detection of zoonoses and zoonotic agents, in particular to protect public health, including implementation of the specific measures laid down in Annex II;

d) allow for the progress under their provisions to be evaluated and for those programmes to be reviewed, in particular in the light of results obtained from the detection of zoonoses and zoonotic agents.

4. National control programmes shall cover at least the following stages of the food chain:

a) feedingstuff production;

b) primary production of animals;

c) processing and preparation of foodstuffs of animal origin.

5. National control programmes shall contain, where relevant, the provisions laid down in relation to testing methods and criteria against which the results of these tests shall be assessed, for testing animals and hatching eggs despatched within the national territory, as part of the official controls provided for in Annex II, Part A, point 1.6.

6. The requirements and minimum sampling rules laid down in Annex II may be amended in accordance with the procedure referred to in Article 14(2).

7. Within 6 months after the establishment of the Community targets provided for in Article 4, Member States shall submit their national control programmes to the Commission and set out the measures to be implemented.

Article 6 Approval of the national control programmes

1. The Commission shall, within six months after submission of a national control programme, establish whether it complies with the relevant rules including this Regulation in particular. The Commission may ask Member States to modify or supplement programmes to bring them into conformity. When the Commission has established the conformity of the programmes, they shall be approved in accordance with the procedure referred to in Article 14(2).

2. Amendments to a programme previously approved pursuant to paragraph 1, in order to take account of the evolution in the situation in the Member State concerned, in particular in the light of the results referred to in Article 5(3)(d), may be approved in accordance with the procedure referred to in Article 14(2).

3. Where the Commission has requested further information from a Member State, the six month time-limit referred to in paragraph 1 shall be suspended until that information is provided.

Article 7 Control programmes of food business operators

1. Member States shall encourage food business operators or organisations representing such operators, which have full responsibility for the production of certain animals or products of animal origin to establish one or more control programmes.

Those control programmes shall cover at least feedingstuff production and primary production of animals.

2. Food business operators or their representative organisations shall submit their control programmes and any amendments thereto for the approval of the competent authority of the Member State in which they are located. If the primary production of animals takes place in different Member States, these programmes shall be approved individually for each Member State.

3. The Competent authority shall approve the control programmes submitted pursuant to paragraph 2 only if they are satisfied, after an inspection visit, that the control programmes comply with the minimum requirements set out in Annex II whenever these requirements are relevant, and with the objectives of the relevant national control programme.

4. Member States shall maintain up-to-date lists of approved control programmes of food business operators or their representative organisations.

Those lists shall be made available to the Commission upon request.

5. Food business operators or their representative organisations shall communicate regularly the results of their control programmes to the competent authorities.

Chapter IV Control methods

Article 8 Specific control methods

1. At the initiative of the Commission or at the request of a Member State and, where necessary, after consultation of the European Food Authority, the following may be adopted in accordance with the procedure referred to in Article 14(2):

a) decisions that specific control methods may or shall be applied for the reduction of prevalence of zoonoses and zoonotic agents at the stage of the primary production of animals and other stages in the food chain;

b) rules concerning the conditions for the use of the methods referred to in (a);

c) detailed rules concerning necessary documents and procedures as well as minimum requirements for the methods referred to in (a);

d) decisions that certain specific control methods shall not be used as a part of control programmes.

2. The provisions referred to in paragraph 1(a), (b) and (c) shall not apply to methods using substances or techniques covered by Community legislation on animal nutrition, food additives or veterinary medicinal products.

Chapter V Trade

Article 9 Intra-Community trade

1. As from the dates mentioned in Annex I, Part A, column 5 at the latest, flocks and herds of origin of the species listed in Column 2 shall be tested for the zoonoses and zoonotic agents listed in Column 1 prior to any dispatching of the live animals, or hatching eggs, from the food business of origin. The date and the result of testing shall be included in the relevant health certificates, as laid down in Directive 64/432/EEC or Directive 90/539/EEC.

2. Without prejudice to the specific requirements concerning the control of salmonella in certain flocks, as laid down in Annex II, the Member State of destination may, in accordance with the procedure referred to in Article 14(2), be authorised for a transitional period to require that the results of the tests to be referred to in the relevant health certificates for consignments of animals and hatching eggs subject to testing in the Member State of dispatch, fulfil the same criteria as those laid down under its national programme, in accordance with Article 5(5), for consignments despatched within its territory.

The authorisation may be withdrawn in accordance with the same procedure.

3. Without prejudice to Article 5(6), specific rules concerning the setting by Member States of the criteria referred to in Article 5(5) and in paragraph 2 above, may be laid down in accordance with the procedure referred to in Article 14(2).

4. The provisions of paragraphs 1 and 2 shall not apply to dispatching of eggs for packaging or processing.

Article 10 Imports from third countries

1. As from the dates mentioned in Annex I, Part A, Column 5, admission to or retention from the lists of third countries provided for in Community legislation, for the relevant species or category, from which Member States are authorised to import those animals or hatching eggs covered by this Regulation shall be subject to submission to the Commission by the third country concerned of a programme equivalent to those provided for under Article 5. The programme shall give details of the guarantees offered by that country as regards inspections and controls for zoonoses and zoonotic agents. Those guarantees must be at least equivalent to the guarantees provided for by this Regulation.

2. These programmes shall be approved in accordance with the procedure referred to in Article 14(2), provided that the equivalence of the measures described under the programme, with the relevant requirements applicable under Community rules, is objectively demonstrated. Alternative guarantees to those provided for in this Regulation may be allowed in accordance with that procedure, provided that they are not more favourable than those applicable to intra-Community trade.

3. For third countries with which a regular trade flow is established, the provisions of Article 5(7) and Article 6(1) and (3) concerning time periods for the submission and approval of programmes shall apply. For third countries establishing or resuming a trade flow, the time periods provided for in Article 6 shall apply.

4. Flocks and herds of origin of species listed in Annex I, Part A, Column 2 shall be tested for the zoonoses and zoonotic agents listed in Column 1, prior to any dispatching of the live animals or hatching eggs from the food business of origin. The date and the result of testing shall be included in the relevant import certificates, for which the models laid down by Community legislation shall be amended accordingly.

5. The Member State of final destination may be authorised, in accordance with the procedure referred to in Article 14(2), to require for a transitional period that the results of the testing referred to in Paragraph 4 fulfil the same criteria as those laid down under its national programme, in accordance with Article 5(5). The authorisation may be withdrawn and, without prejudice to Article 5(6), specific rules concerning such criteria may be laid down, in accordance with the procedure referred to in Article 14(2).

6. Admission to or retention from the lists of third countries provided for in Community legislation, for the relevant category of products, from which Member States are authorised to import those products covered by this Regulation shall be subject to submission to the Commission by the third country concerned of guarantees equivalent to those provided for by this Regulation.

Chapter VI Laboratories

Article 11 Reference laboratories

1. Community Reference Laboratories for the analysis and testing of zoonoses and zoonotic agents listed in Annex I shall be designated in accordance with the procedure referred toin Article 14(2).

2. The responsibilities and tasks of the Community Reference Laboratories, in particular with regard to co-ordination of their activities and those of the National Reference Laboratories, shall be laid down in accordance with the procedure referred to in Article 14(2).

3. Member States shall designate national reference laboratories for zoonoses and zoonotic agents referred to in Annex I. The names and addresses of laboratories shall be communicated to the Commission.

4. Certain responsibilities and tasks of the National Reference Laboratories, in particular with regard to co-ordination of their activities and those of the relevant Laboratories in the Member States, may be laid down in accordance with the procedure referred to in Article 14(2).

Article 12 Approval of laboratories, quality requirements and approved testing methods

1. Laboratories participating in control programmes pursuant to Articles 5 and 7 at which samples are analysed for the testing of the presence of zoonoses and zoonotic agents referred to in Annex I shall be approved by the competent authority.

2. At the latest from 1 January 2005, each Member State shall ensure that laboratories referred to in paragraph 1 apply quality assurance systems which conform to the requirements of Standard EN/ISO 17025.

Laboratories shall regularly participate in collaborative testing organised or co-ordinated by the national reference laboratory.

3. Testing for the presence of zoonoses and zoonotic agents referred to in Annex I shall be carried out using the methods and protocols recommended by international standardisation bodies, as reference methods.

Alternative methods may be used if they have been validated in accordance with internationally recognised rules and offer equivalent results to those obtained by the relevant reference method.

Where necessary, other methods for testing may be approved in accordance with the procedure referred to in Article 14(2).

Chapter VII Implementation

Article 13 Amendments to Annexes, implementing and transitional measures

Where appropriate after consultation of the European Food Authority, the Annexes may be amended or appropriate transitional or implementing measures, including the necessary amendments to the relevant health certificates, may be adopted in accordance with the procedures referred to in Article 14(2).

Article 14 Committee

1. The Commission shall be assisted by the Committee on Food Safety and Animal Health instituted by Regulation (EC) No .../... 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].

2. Where reference is made to this paragraph, the regulatory procedure laid down in Article 5 of Council Decision 1999/468/EC shall apply, in compliance with Article 7 and Article 8 thereof.

3. The period provided for in Article 5(6) of Decision 1999/468/EC shall be three months.

Chapter VIII General and final provisions

Article 15 Community controls

The Commission shall carry out on-the-spot checks in accordance with Decisions 98/139/EC and 98/140/EC in the Member States and in third countries in order to ensure that the provisions of this Regulation, rules adopted pursuant thereto and any safeguard measures are applied uniformly.

Article 16 Amendment of Directive 64/432/EEC

In Article 3(2) of Directive 64/432/EEC, the following point (f) is added:

"f) they have been subject, where relevant, to controls in accordance with the requirements of Regulation (EC) No ..../.... of the European Parliament and of the Council* [this Regulation],

* OJ L ...".

Article 17 Amendment of Directive 72/462/EEC

In Article 6 of Directive 72/462/EEC, the following paragraph 7 is added:

"7. Live animals must originate from third countries with rules equivalent to the requirements on the control of zoonoses and zoonotic agents set out in Regulation (EC) No .../... of the European Parliament and of the Council* [this Regulation]

* OJ L ....".

Article 18 Amendment of Directive 90/539/EEC

Directive 90/539/EEC is amended as follows:

1. In Article 6(1), the following point (d) is added:

"d) they have been subject to controls in accordance with the requirements of Regulation (EC) ..../.... of the European Parliament and of the Council [this Regulation]*

* OJ L ...".

2. In Article 10, the following point (e) is added:

"e) which has been subject to controls in accordance with the requirements of Regulation (EC) ..../.... of the European Parliament and of the Council [this Regulation]."

3. In Article 21(2), the following point (h) is added:

"h) compliance with Community rules on the control of zoonoses and zoonotic agents".

Article 19 Entry into force

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Communities.

It shall apply as from 1 January 2003.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels,

For the European Parliament For the Council

The President The President

ANNEX I

A. Specified zoonoses and zoonotic agents for which Community targets for the reduction of prevalence shall be established pursuant to Article 4

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a Serotypes shall be defined when the target is established.

B. Criteria for laying down the list of zoonoses and stages in the food chain in Part A above

When necessary, zoonoses or zoonotic agents may be added in or deleted, or different stages in the food chain may be specified, taking into account especially

- their occurrence in animal and human populations, feed and food,

- their gravity in humans,

- their economic consequences for health care and food businesses,

- epidemiological trends in animal and human populations, feed and food, and

- management options foreseen at the relevant stage of the target.

C. Details of targets

The Community targets referred to in Article 4(1) shall consist at least of:

1. A numerical expression of either

a) the maximum percentage of epidemiological units remaining positive, and / or

b) the minimum percentage of reduction in a number of positive epidemiological units,

2. The maximum time limit within which the target shall be achieved,

3. Definition of epidemiological units referred to in point 1, and

4. Definition of the testing schemes necessary to verify the achievement of the target.

ANNEX II Control of zoonoses and zoonotic agents listed in Annex I

A. General requirements for national control programmes

The programme shall take into account the nature of the zoonosis and / or agent thereof concerned and the specific situation in the Member State and it shall:

a) state the aim of the programme taking into consideration the importance of the zoonosis concerned;

b) specify

1. General

1.1 The occurrence of the zoonosis concerned in the Member State with specific reference to the results obtained in the framework of monitoring according to Article 4 of Directive .../.../EC [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],

1.2 the geographical area or, where appropriate, the epidemiological units, in which the programme will be implemented,

1.3 the infrastructure of the relevant competent authorities,

1.4 a list of approved laboratories, where samples collected within the programme are analysed,

1.5 the methods used in the examination of the zoonotic agents,

1.6 official controls (including sampling schemes) at feedingstuff, flock and / or herd level,

1.7 official controls (including sampling schemes) at other stages of the food chain, and at feedingstuffs level

1.8 the type of measures laid down by the competent authorities with regard to animals or products in which zoonoses and zoonotic agents have been detected, in particular to protect public health,

1.9 relevant national legislation;

2. Concerning food businesses covered by the programme

2.1 the structure of the production of the given species and products thereof,

2.2 the structure of the production of feedingstuffs,

2.3 relevant guides for good animal husbandry practices or other guidelines (mandatory or voluntary) defining at least

- hygiene management at farms,

- measures to prevent incoming infections carried by animals, feed material, drinking water, people working at farm,

- hygiene in transporting animals to and from farms,

2.4 routine veterinary supervision of farms,

2.5 registration of farms,

2.6 record keeping at farms,

2.7 documents to accompany animals when dispatched,

2.8 other relevant measures to ensure the traceability of animals;

c) comply with the minimum sampling rules and levels laid down in Part B;

d) where relevant, comply with the specific requirements laid down in Parts C to E.

B. Minimum requirements of sampling

1. After the respective control programme referred to in Article 5 has been approved, the food business operator must, at his own expense, have samples taken for analysis for the detection of zoonosis or zoonotic agents listed in Annex I, with the minimum scope of sampling indicated below being respected.

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a Serotypes shall be defined when the target is established.

2. The data collected shall be accompanied with the following information:

a) Date and place of sampling;

b) Identification of the flock / herd.

3. Immunological testing may not be used if the animals have been vaccinated unless it has been proved the vaccine used does not interfere with the testing method applied.

C. Specific requirements concerning breeding flocks of Gallus gallus

Where, as a result of an investigation carried out in accordance with Point 1 of the Table in Part B.1, the presence of Salmonella Enteritidis or Salmonella Typhimurium is confirmed in the birds in a breeding flock of Gallus gallus, the following measures must be taken:

Non-incubated eggs from the flock must be destroyed or be intended for the manufacture of egg products or subject to an equivalent treatment to guarantee the elimination of Salmonella Enteritidis and Salmonella Typhimurium, in accordance with Regulation (EC) No .../... [on the hygiene of foodstuffs];

Without prejudice to the requirements under Part E below, all the birds - including day-old chicks - in the flock must be slaughtered or destroyed so as to reduce as much as possible the risk of spreading salmonella. Slaughtering must be carried out in accordance with [Annex II, Section II, Chapter IV, point 11] (the relevant provisions) of Regulation (EC) No .../... of the European Parliament and of the Council of ...[laying down specific hygiene rules for food of animal origin] [22], and with [Annex II, Chapter III, Section I, point 5] (the relevant provisions) of Regulation (EC) No .../... of the European Parliament and of the Council [laying down detailed rules for the organisation of official controls on products of animal origin intended for human consumption] [23].

[22] OJ L ...

[23] OJ L ...

Where eggs for hatching from flocks in which the presence of Salmonella Enteritidis or Salmonella Typhimurium has been confirmed are still present in a hatchery, they must be destroyed or treated as category 3 material in accordance with Regulation (EC) No .../... of the European Parliament and of the Council of ... [laying down the health rules concerning animal by-products not intended for human consumption] [24].

[24] OJ L ...

D. Specific requirements concerning flocks of laying hens

As from 1 January 2008, eggs shall not be used for direct human consumption (table eggs) unless they originate from a commercial flock of laying hens subject to the testing scheme in accordance with Point 2 in the Table of Part B.1 and subsequently found non contaminated.

The eggs originating from flocks with unknown status, suspected to be contaminated or from contaminated flocks must be intended for the manufacture of egg products or subject to an equivalent treatment to guarantee the elimination of Salmonella Enteritidis and Salmonella Typhimurium, in accordance with Regulation (EC) No .../... [on the hygiene of foodstuffs]:.

Without prejudice to the requirements under Part E below, all the birds in the flock must be slaughtered or destroyed so as to reduce as much as possible the risk of spreading salmonella. Slaughtering must be carried out in accordance with [Annex II, Section II, Chapter IV, point 11] (the relevant provisions) of Regulation (EC) No .../... of the European Parliament and of the Council of ...[laying down specific hygiene rules for food of animal origin] and with [Annex II, Chapter III, Section I, Point 5] (the relevant provisions) of Regulation (EC) No .../... of the European Parliament and of the Council [laying down detailed rules for the organisation of official controls on products of animal origin intended for human consumption].

E. Specific requirements concerning flocks of broilers

As from 1 January 2009, the following criterion will apply for placing on the market of fresh poultry meat, unless it is destined for an industrial heat treatment or another treatment able to eliminate salmonella, in accordance with Regulation (EC) No .../... [on the hygiene of foodstuffs]:

"Salmonella: absence in 25 grammes"

These requirements may be revised in accordance with the procedure referred to in Article 14(2) and after consulting the appropriate Scientific Committee.

LEGISLATIVE FINANCIAL STATEMENT

Policy area(s): Health and Consumer Protection

Activity(ies): veterinary public health

Title of action:

1. 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

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

1. BUDGET LINE(S) + HEADINGS

B1-330 Animal disease eradication and monitoring programmes and monitoring of the physical conditions of animals that could pose a public-health risk linked to an external factor.

This Chapter will cover co-ordinated monitoring programmes as referred to in Article 6 of the above proposal for a Directive and certain actions under national control programmes to be implemented in Member States, pursuant to the above proposal for a Regulation. The financial provisions are established in the new Chapter on zoonoses of Council Decision 90/424/EEC on expenditure in the veterinary field [25], as revised pursuant to the above proposal for a Directive.

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

B1-331 Other measures in the veterinary, animal welfare and public health field.

This Chapter will cover financing of the relevant Community Reference Laboratories.

2. OVERALL FIGURES

2.1 Total allocation for action (Part B): 2.4 EUR millions in EC

2.2 Period of application: 2003-

The existing Zoonosis Directive (92/117/EEC) is reviewed. The aim is to enhance the monitoring and control of zoonoses in the Community in order to protect public health. Expenses are due to

- activities of Community Reference Laboratories

- co-financing of Community co-ordinated monitoring programmes

- co-financing of certain specified control measures.

As regards financing of specified control measures, Community financing will be continued on the basis of the existing rules in Directive 92/117/EEC. See also 5.1.2 below.

Only co-financing of co-ordinated monitoring programmes is a technical measure additional to the measures already established under existing Council Directive 92/117/EEC and financed under Council Decision 90/424/EEC. For this measure, it is foreseen to allocate yearly 0.4 MioEUR. That is why financing of this new measure only is included in the estimate for the proposals.

2.3 Overall multiannual estimate on expenditure :

a) Schedule of commitment appropriations/payment appropriations (financial intervention) (see point 6.1.1)

EUR million (to 3rd decimal place)

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b) Technical and administrative assistance and support expenditure (see point 6.1.2)

NO

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c) Overall financial impact of human resources and other administrative expenditure (see points 7.2 and 7.3)

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These resources in the Commission services will be used for the overall management of the implementation of the proposals. It will consist in particular in technical management of the programmes to be submitted by Member States and non-Member Countries and to be approved by the Commission, and in supervision/management of the (co-)financing of actions in Member States.

2.4 Compatibility with the financial programming and the financial perspective

|X| Proposal compatible with the existing financial programming

| | This proposal will entail reprogramming of the relevant heading in the financial perspective

| | This may entail application of the provisions of the Interinstitutional Agreement.

2.5 Financial impact on revenue

No

| | No financial implications (involves technical aspects regarding implementation of a measure)

OR

| | Financial impact - the effect on revenue is as follows:

Note: All details and observations pertaining to the method of calculating the effect on revenue should be included in a separate annex.

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(Please state each budget line involved, adding the appropriate number of rows to the table if there is an effect on more than one budget line)

3. BUDGET CHARACTERISTICS

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*: only co-ordinated monitoring programmes

4. LEGAL BASIS

Legal basis for the proposals: Article 152 of Treaty.

Financial instrument: Council Decision 90/424/EEC of 26 June 1990 on expenditure in the veterinary field.

5. DESCRIPTION AND GROUNDS

5.1 Need for Community intervention [26]

[26] For further information see a separate guidance paper .

5.1.1 Objectives pursued

Preliminary: a revision of the current legislation on the prevention of zoonoses (Directive 92/117/EEC) was foreseen pursuant to article 15a of the Directive and in that framework, expansion of controls to laying hens was foreseen. The proposals are part of the programme foreseen in the White paper on Food Safety adopted by the Commission on 12 January 2000. It is essential that the proposals respect the main principles of the White paper on Food Safety, in particular: assuring a high standard of food safety; creating an integrated policy from 'farm to table'; being based on risk analysis, including possibilities to take into account the precautionary principle and other legitimate factors.

The essential aim is to increase protection of public health, essentially by decreasing seriously the number of human cases of salmonellosis, due to food consumption. This will be achieved by decreasing prevalence of salmonella in the main animal populations source of salmonella (breeding flocks of Gallus gallus, then commercial flocks, then turkeys and breeding herds of pigs). Decreasing the prevalence in animal populations will decrease the concentration in primary products and further down the food chain.

The cost of food-borne salmonellosis (impact of human disease) is estimated to yearly 560-2840MioEUR. 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/infections is justified. The need for a Community dimension to financial support is also clear. Community financial participation provides a means for ensuring that all Member States affected by a given disease/infection 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. As regards financing of certain specified control measures, Community financing will be continued on the basis of the existing rules in Directive 92/117/EEC, as established in the proposals.

The only new measure for Community co-financing in the proposals is relating to co-ordinated monitoring programmes, which are an important element to enhance monitoring and define baseline values of pathogens (salmonella). It will be a preliminary step for setting or reviewing pathogen reduction targets as required under the proposals.

5.1.2 Measures taken in connection with ex ante evaluation

As indicated above, public financing of measures to reduce or eliminate the diseases/infections is justified. 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. Even if progress in reducing or eliminating diseases/infections 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.

Only co-financing of co-ordinated monitoring programmes is a technical measure additional to the measures already established under existing Council Directive 92/117/EEC and financed under Council Decision 90/424/EEC. For this new measure, it is foreseen to allocate yearly 0.4 EUR millions.

As regards financing of certain specified control measures, Community financing will be continued on the basis of the existing rules in Directive 92/117/EEC. It is likely that more and more Member States will present a request for co-financing of their plans. Financing of the plans will be handled in the framework of the budgetary procedures and the yearly programming. A maximum limit of 50% for co-financing of certain measures has been included in the proposed revision of the Chapter on zoonoses of the financial instrument (Council Decision 90/424/EEC).

5.1.3 Measures taken following ex post evaluation

5.2 Actions envisaged and arrangements for budget intervention

Three areas:

- Community Reference Laboratories (CRL): 100% Community financing of the CRL, as already established under Council Decision 90/424/EEC. The yearly technical work-programmes and estimated costs to be discussed, before a Commission Decision is adopted each year. Payment to the competent authorities in the relevant Member States.

- Co-ordinated monitoring programmes: Community co-financing (50%), pursuant to Council Decision 90/424/EEC. Programmes to be established in Commission Decisions.

- Certain specified control measures: the beneficiaries are the farmers, when their flocks or products thereof have to be slaughtered or disposed of under specified conditions, to prevent risks for public health. Financing of programmes is subject to the procedures in Council Decision 90/424/EEC: in particular, programmes for financing have to be submitted by Member States on a yearly basis; a technical and financial evaluation is carried out by the Commission services before adoption by Commission Decision. Payment to the competent authorities in the Member States. Maximum limit of 50% for co-financing.

5.3 Methods of implementation

Direct management of technical and financial approval of the actions by Commission staff. Payment of actions subject to the procedures in Council Decision 90/424/EEC. Reimbursement of expenses in Member States by payment to the Competent authorities. See also 5.2 above.

6. FINANCIAL IMPACT

6.1 Total financial impact on Part B - (over the entire programming period)

(The method of calculating the total amounts set out in the table below must be explained by the breakdown in Table 6.2.)

6.1.1 Financial intervention in EUR million (to the 3rd decimal place)

Only financing of new measures in the proposals, i.e. co-ordinated monitoring programmes is included.

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6.2. Calculation of costs by measure envisaged in Part B (over the entire programming period) [27]

[27] For further information see a separate guidance paper.

Only financing of new measures in the proposals, i.e. co-ordinated monitoring programmes is included. See calculation example in Annex

Commitments in EUR million (to the 3rd decimal place)

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See calculation in the annex

7. IMPACT ON STAFF AND ADMINISTRATIVE EXPENDITURE

7.1. Impact on human resources

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7.2 Overall financial impact of human resources

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The amounts are total expenditure for twelve months.

7.3 Other administrative expenditure deriving from the action

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The amounts are total expenditure for twelve months.

(1) Specify the type of committee and the group to which it belongs.

I. Annual total (7.2 + 7.3)

II. Duration of action

III. Total cost of action (I x II) // EUR

Years

EUR

8. FOLLOW-UP AND EVALUATION

8.1 Follow-up arrangements

- Financing of Community Reference Laboratories (CRL): The yearly technical work-programmes and estimated costs are evaluated between the Commission services and the relevant CRL; they are revised if necessary, before a Commission Decision is adopted each year.

- Co-ordinated monitoring programmes: the programme, as established through Commission Decisions will be performed whenever possible during one year. It is very likely that the authorities in the Member States will have to perform sampling and examinations themselves. The industry may be involved.

- Co-financing of certain specified control measures: the financial contribution will be introduced as part of a national plan submitted to and approved by the Commission. Financing of the control measures is subject to the procedures in Council Decision 90/424/EEC: in particular, the national plans containing measures for financing have to be submitted by Member States on a yearly basis; a technical and financial evaluation is carried out by the Commission services before adoption by Commission Decision. Rules are foreseen at Article 5.3.(d) of the proposed Regulation to allow progress with the control plans to be evaluated. When the pathogen reduction targets are established, the Commission decides on the timeframe within which the target shall be achieved.

To verify the implementation of the relevant national plans, Article 16 lays down that the Commission shall carry out on-the-spot checks.

8.2 Arrangements and schedule for the planned evaluation

For Community Reference Laboratories as well as for control plans implemented by Member States, a documentary evaluation is performed on a yearly basis (see above). In addition, the EU Food and Veterinary Office performs on-the-spot missions to assess implementation of Community legislation, including the national plans. The frequency of the missions will depend on the priority set for the relevant issue. So far, missions for major animal diseases control programmes have been carried out regularly, up to once per year. In addition, financial audit missions are carried out by the relevant service in Directorate General for Health and Consumer Protection. A prioritisation system is in place. Corrections are made in case of deficiencies.

9. ANTI-FRAUD MEASURES

See 8.1 and 8.2 above.

Also, OLAF may intervene on its own initiative or following information from different sources, in particular those mentioned under 8.2 above.

ANNEX TO FINANCIAL STATEMENT

Method of calculation of the estimated costs:

1. Co-ordinated monitoring programmes

Article 6 of the proposal for a Directive on the monitoring of zoonoses creates the possibility for establishing co-ordinated monitoring programmes. These programmes will serve to create sets of harmonised data which will be used as a reference when pathogen reduction targets are established according to the proposal for a Regulation on control of salmonella and other food-borne zoonotic agents. Since the Commission would need to request the Member States to carry out specified sampling and testing schemes, which possibly differ from the procedures of the national monitoring system, it is deemed necessary that the Community could finance such co-ordinated programmes.

For example, a single study on the exact prevalence of salmonella in the poultry population in the different member States would need testing of a representative number of samples. On the basis of around 35,000 samples within the EU and taking into account the estimated cost of a salmonella bacteriological test: EUR 24, it is estimated that the financing of such a study would be yearly EUR 800 000, of which the Community would co-finance 50%. It is foreseen that such studies would be needed yearly, in conjunction with the establishment of pathogen reduction targets for specified combinations of pathogen/commodities.

IMPACT ASSESSMENT FORM

THE IMPACT OF THE PROPOSAL ON BUSINESS WITH SPECIAL REFERENCE TO SMALL AND MEDIUM-SIZED ENTERPRISES( SMEs)

Title of proposal

1. 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

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

Document reference number

The proposal

1. Taking account of the principle of subsidiarity, why is Community legislation necessary in this area and what are its main aims-

The aim of the proposals is to increase the protection of public health by enhancing the monitoring and control of zoonoses (diseases transmissible from animals to man). Since zoonoses may spread from one Member State to another directly or indirectly through food or other sources, action at the Community level is necessary. The control of zoonoses may also have an impact on trade with third countries.

The impact on business

2. Who will be affected by the proposal-

- which sectors of business: The specific rules on the control of zoonoses will cover

- breeders of Gallus gallus as from 2004,

- producers of laying hens as from 2005,

- producers of broilers as from 2006,

- producers of turkeys as from 2007, and

- producers of breeding pigs as from 2007.

- which sizes of business (what is the concentration of small and medium-sized firms): the proposals will affect all farms irrespective of their size

- are there particular geographical areas of the Community where these businesses are found: the production of animals referred above takes place in all Member States.

3. What will business have to do to comply with the proposal-

The businesses have to comply with the requirements of the respective national control programmes (including sampling of flocks or herds) and the specific requirements laid down in the Regulation. The businesses may create their own control programmes.

4. What economic effects is the proposal likely to have-

- on employment: neutral

- on investment and the creation of new businesses: the needs for enhanced control of zoonoses at the primary production may necessitate new investments on farming buildings. Control programmes, which include sampling and testing regimes, would increase the demand of appropriate test systems and laboratories.

- on the competitiveness of businesses: the control programmes envisaged in the proposal would create additional costs to the businesses. The amount of these costs will be defined when specific Commission Decisions based on the proposal will be made. On the other hand, the aim of the proposal is to increase the consumer health protection and therefor it can be stated that the businesses can benefit from the increased consumer reliance on the products concerned.

5. Does the proposal contain measures to take account of the specific situation of small and medium-sized firms (reduced or different requirements etc)-

It is the purpose of the national control programmes, that they take account of the size of enterprises in the sector.

Consultation

6. List the organisations which have been consulted about the proposal and outline their main views.

Farming, food production and consumer organisations, in particular in the framework of the Advisory Committee on Livestock Products. The representatives of food businesses have been anxious about the potentially high costs incurred due to the control programmes foreseen.