Report to the European Parliament and to the Council on the measures to be put in force for the control and prevention of zoonoses
Date: 2001-08-01
Institutions: European Commission
Subjects: animal disease, food inspection, health legislation, health policy, infectious disease, veterinary legislation, zoonosis

COMMISSION OF THE EUROPEAN COMMUNITIES

Brussels, 01.08.2001
COM(2001) 452 final

2001/0176 (COD)
2001/0177 (COD)

REPORT TO THE EUROPEAN PARLIAMENT AND TO THE COUNCIL

on the measures to be put in force for the control and prevention of zoonoses

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

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)

REPORT TO THE EUROPEAN PARLIAMENT AND TO THE COUNCIL

on the measures to be put in force for the control and prevention of zoonoses

A. SUMMARY

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

B. INTRODUCTION

Article 15a of Council Directive 92/117/EEC of 17 December 1992 concerning measures for
protection against specified zoonoses and specific zoonotic agents in animals and products of
animal origin in order to prevent outbreaks of food-borne infections and intoxications1, as
amended by Directive 97/22/EC2, provides for the Commission to submit a report to the Council
concerning the measures to be implemented for the control and prevention of zoonoses. This
report shall refer in particular to:

–

–

–

–

–

the new rules for the reporting system for zoonoses,

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

the control of salmonella in poultry laying flocks,

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

any measures to combat zoonoses other than salmonellosis.

The report shall be accompanied by proposals concerning zoonoses, especially in the context
of the review of the Directive. As amended by Directive 97/22/EC, the Directive required that
the Council should act on the proposals by a qualified majority before 1 June 1998. Later on,
Directive 92/117/EEC was amended for the second time by Directive 1999/72/EC3, which
provided for
the report and accompanying proposals by
30 March 2000.

the Commission to present

1

2

3

OJ L 62, 15.3.1993, p. 38.
OJ L 113, 30.4.1997, p. 9.
OJ L 210, 10.8.1999, p. 12.

2

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

–

–

–

–

–

–

assuring a high standard of food safety,

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

creating an integrated policy from 'farm to table',

permitting traceability,

ensuring transparency, and

being based on risk analysis,
precautionary principle and other legitimate factors.

including possibilities to take into account

the

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

in matters

procedures

laying

down

and

of

C. PRESENT SITUATION ON THE CONTROL AND PREVENTION OF ZOONOSES

C.1. Epidemiological situation on zoonoses in the EU

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

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

3

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

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

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

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

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

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

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

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

4

C.2. THE COMMUNITY LEGISLATION REGARDING THE CONTROL OF ZOONOTIC INFECTIONS

C.2.1. Directive 92/117/EEC

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

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

C.2.2. Other legislation

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

– in animal waste and feed processing,

– at farm level,

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

– at consumer level.

Directives 90/667/EEC4 and 92/118/EEC5 and the corresponding Commission Decisions
cover the control of zoonotic agents in animal waste and feed processing. These provisions
cover substances with ingredients of animal origin. A proposal for a fundamental review of
this legislation has been adopted by the Commission (COM(2000) 574 final). No rules
in the Community legislation for feedingstuffs
concerning zoonotic organisms exist yet
comprising solely ingredients of vegetable origin. The establishment of such legislation is
however foreseen as a part of the legislative programme of the White Paper on Food Safety
since it is evident that feedingstuffs of vegetable origin can harbour zoonotic agents.

Provisions on the control of certain zoonoses at farm level have been laid down in various
directives regarding animal health conditions in trade of live animals, e.g. provisions on
bovine tuberculosis and brucellosis in Directive 64/432/EEC6. Furthermore, there are rules in
certain hygiene directives providing for the control of zoonoses at farm level, e.g. in Directive
92/46/EEC7 regarding dairy herds.

4

5

6

7

OJ L 363, 27.12.1990, p. 51.
OJ L 62, 15.3.1993, p. 49.
OJ 121, 29.7.1964, p. 1977.
OJ L 268, 14.9.1992, p. 1.

5

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

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

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

The European Parliament and the Council adopted on 24 September 1998 Decision
2119/98/EC setting up a network for the epidemiological surveillance and control of
communicable diseases in the Community8. Thus, the Commission shall facilitate close co-
operation among the authorities responsible for public health in the Member States. One of
the main activities foreseen in Decision 2119/98/EC is the establishment of an information
system for the surveillance, prevention and control of communicable diseases at Community
level. To that end, the Commission adopted Decision 2000/96/EC of 22 December 1999 on
the communicable diseases to be progressively covered by the Community network9. In the
Decision a number of food- and water-borne and other zoonoses are listed. In particular it is
stipulated that where specific surveillance networks are put in place for zoonoses for which
surveillance of human cases is required under Directive 92/117/EEC, surveillance shall be
performed in accordance with Decision 2119/98/EC and such data required for
the
implementation of Directive 92/117/EEC shall be made fully available for that purpose. To
this end, case definitions and surveillance methods for human disease shall be drawn up, as
far as possible, in such a way that the data collected serve also Directive 92/117/EEC.

8

9

OJ L 282, 20.10.1998, p. 76.
OJ L 28, 3.2.2000, p. 50.

6

C.3. THE EXPERIENCE GAINED UNDER THE CURRENT PROVISIONS

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

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

Member State

Denmark

Ireland

Finland

Sweden

Austria

France

Reference of approval

94/507/EC, 96/692/EC

96/389/EC

96/390/EC

96/502/EC

2000/60/EC

2000/629/EC

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

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

7

the implementation of

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

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

Year

Member State

Programme

Maximum financial
contribution
from
Community
the
(ECU / EUR)

Amount
paid

finally

(ECU / EUR)

1994

1995

1996

1997

1998

1999

2000

Denmark

Salmonella in poultry

Denmark

Salmonella in poultry

Denmark

Salmonella in poultry

Denmark

Salmonella in poultry

Denmark

Salmonella in poultry

Denmark

Salmonella in poultry

Denmark

Salmonella in poultry

Ireland

Salmonella in poultry

2001

Denmark

Salmonella in poultry

330 000

-

203 476

200 000

48 619

162 989

330 000

660 000

470 000

200 000

500 000

500 000

400 000

50 000

200 000

100 000

Austria

France

Salmonella in poultry

Salmonella in poultry

3 000 000

Financial contributions have been awarded to Member States also in the framework of the
programmes for the eradication and monitoring of animal diseases, based on Council
Decision 90/424/EEC on expenditure in the veterinary field10. This co-financing has
contributed to the control and monitoring of several zoonoses, notably bovine, ovine and
hydatidosis
periodically
rabies,
caprine
(echinococcosis) and enterohaemmoragic E. coli
(EHEC). The maximum Community
financial contributions towards co-financing of bovine brucellosis, ovine and caprine
the year 2000 are EUR 14 250 000,
brucellosis, bovine tuberculosis and rabies for
EUR 14 000 000, EUR 8 235 000, and EUR 2 895 000, respectively.

brucellosis, bovine

tuberculosis

and

and

10

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

8

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

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

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

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

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

D. NEW APPROACH TOWARDS CONTROL AND PREVENTION OF ZOONOSES

D.1. Basic elements of the approach

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

–

–

–

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

develop measures according to “farm to table” principle, by producing safe food
from healthy animals,

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

9

–

–

–

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

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

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

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

D.2.

Intensified monitoring and extended control

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

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

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

10

D.3.

Impacts of the approach

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

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

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

D.3.1. Health costs

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

D.3.2. Costs of financing of monitoring and control

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

11

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

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

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

D.3.3. Impact on trade

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

it

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

12

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

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

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

-

-

-

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

is based on scientific principles, and

is not maintained without scientific evidence.

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

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

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

E. CONCLUSIONS

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

13

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

–

–

Proposal for a Directive of the European Parliament and of the Council on the
monitoring of zoonoses and zoonotic agents,
amending Council Decision
90/424/EEC and repealing Council Directive 92/117/EEC and

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

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

14

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

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

15

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
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.

rules is foreseen for

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 monitoring
co-ordinated Community 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.

programmes. These

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/EC11, which entered into force on 1.1.1999, creates a framework for this data
collection. Furthermore, Decision 2000/96/EC12 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.

11

12

OJ L 268, 3.10.1998, p. 1.
OJ L 28, 3.2.2000, p. 50.

16

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 field13.

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.

13

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).

17

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
the White Paper on Food Safety
of zoonotic diseases.
(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.

follows the principles of

It

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.

18

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/EEC14 and 90/539/EEC15) 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.

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.

14

15

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

19

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.

20

2001/0176 (COD)

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

(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 Commission16,

Having regard to the opinion of the Economic and Social Committee17,

Having regard to the opinion of the Committee of the Regions18,

Acting in accordance with the procedure laid down in Article 251 of the Treaty19,

Whereas:

(1)

(2)

(3)

(4)

16

17

18

19

20

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

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

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

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
intoxications20 provided for the establishment of a monitoring system for certain
zoonoses both at the level of Member States and at Community level.

OJ C ...
OJ C ...
OJ C ...
OJ C ...
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).

21

(5)

(6)

(7)

(8)

(9)

(10)

The results of the monitoring are collected yearly from the Member States and
compiled by the Commission, with the assistance of the Community Reference
Laboratory for the epidemiology of zoonoses. The results have been published yearly
since 1995 and they provide a basis for the evaluation of the current situation
concerning zoonoses and zoonotic agents. However, the data collection systems are
not harmonised and therefore do not permit comparisons between Member States.

Monitoring and control of certain zoonoses in animal populations has been provided
for by other Community legislation, in particularCouncil Directive 64/432/EEC of
26 June 1964 on animal health problems affecting intra-Community trade in bovine
animals and swine21, 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 animals22, as regards ovine and
caprine brucellosis.

Moreover, Regulation (EC) No…./… of the European Parliament and of the Council
foodstuffs]23 covers specific elements necessary for
of …. [on the hygiene of
prevention, control and monitoring of zoonoses and zoonotic agents, and includes
specific requirements for the microbiological quality of food.

Directive 92/117/EEC provides for collection of data on human cases of zoonoses.
Decision No 2119/98/EC of
the Council of
24 September 1998 setting up a network for the epidemiological surveillance and
control of communicable diseases in the Community24 was adopted in order to
reinforce the collection of such data and to contribute to improving the prevention and
control, in the Community, of communicable diseases.

the European Parliament and of

The collection of data on the occurrence of zoonoses and zoonotic agents in
feedingstuffs, animal populations, products of animal origin and in humans is
necessary to determine the trends and sources of zoonoses.

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. In particular, the Committee identified Salmonella
(VTEC), Listeria
spp., Campylobacter
monocytogenes, Cryptosporidium spp., Echinococcus granulosus / multilocularis and
Trichinella spiralis as public health priorities.

spp., verotoxigenic Escherichia coli

21

22

23

24

OJ 121, 29.7.1964, p. 1977. Directive as last amended by Directive 2000/20/EC (OJ L 163, 4.7.2000,
p. 35).
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).
OJ L ...
OJ L 268, 3.10.1998, p. 1.

22

(11)

(12)

It is, therefore, necessary to improve the existing monitoring and data collection
systems established by Directive 92/117/EEC. Simultaneously, the specific control
measures established by Directive 92/117/EEC will be replaced by the rules laid down
in Regulation (EC) No…/… of the European Parliament and of the Council of …..[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]25. Directive 92/117/EEC
should therefore be repealed.

The new framework for scientific advice and scientific support in matters of food
safety 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]26should be used to collect and analyse the relevant data.

(13) Where necessary, procedures should be created which provide data on a harmonised
basis, making it possible to evaluate trends and sources of zoonoses and zoonotic
agents within the Community. The data collected, together with data from other
sources, should form the basis for risk assessment of zoonotic organisms.

(14)

Priority should be given to those zoonoses posing the greatest risk to human health.
However, the monitoring systems should also facilitate the detection of emerging or
newly emerging zoonotic diseases.

(15) Alongside emerging new zoonoses and zoonotic agents, known zoonotic organisms
may be converted into new strains. The emergence of resistance to antimicrobial
agents is a characteristic that should be monitored.

(16)

(17)

(18)

Since providing data in a harmonised way, to form the basis for risk assessment of
zoonotic organisms of importance at Community level cannot be sufficiently achieved
by the Member States and can therefore, be better achieved at Community level, the
Community may adopt measures, in accordance with the principle of subsidiarity as set
out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set
out in that Article, this Directive does not go beyond what is necessary in order to
achieve those objectives. The responsibility for establishing and maintaining
monitoring systems should lie with Member States.

In addition to general monitoring, specific needs may be recognised which may
necessitate the establishment of co-ordinated monitoring programmes. Attention
should be paid in particular to zoonoses listed in Annex I, part A of Regulation (EC)
No…./… [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].

Food-borne outbreaks of zoonoses, if thoroughly investigated, provide the opportunity
to identify the pathogen,
the food vehicle involved and the factors in the food
preparation and handling that contributed to the outbreak. It is, therefore, appropriate
to make provision for such investigations and for a close co-operation between the
various authorities.

25

26

OJ L ...
OJ L ...

23

(19)

(20)

(21)

(22)

Transmissible spongiform encephalopathies are subject to Regulation (EC) No …/…
of the European Parliament and of the Council of …[laying down rules for the
prevention,
spongiform
control
encephalopathies]27.

transmissible

eradication

certain

and

of

In order to ensure that information collected on zoonoses and zoonotic agents can be
used effectively, appropriate rules should be laid down concerning the exchange of all
relevant information. That information should be collected in Member States and
transmitted to the Commission and to the European Food Authority in the form of
reports, which should also be made available to the public in an appropriate way.

The reports should be submitted on an annual basis. However, additional reports may
be appropriate, when warranted by circumstances.

It may be appropriate to designate National and Community Reference Laboratories
for giving guidance and assistance for analysis and testing in relation to zoonoses and
zoonotic agents falling within the scope of this Directive.

(23) Council Decision 90/424/EEC of 26 June 1990 on expenditure in the veterinary
field28, should be amended in so far as concerns the detailed rules governing the
Community's financial contribution towards certain actions relating to the monitoring
and control of zoonoses and zoonotic agents.

(24) Appropriate procedures should be laid down for amending certain provisions of this
Directive to take account of technical and scientific progress and for the adoption of
implementing and transitional measures.

(25)

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 Commission29, 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
food law,
establishing the European Food Authority, and laying down procedures in matters of
food],

[laying down the general principles and requirements of

HAVE ADOPTED THIS DIRECTIVE:

27

28

29

OJ L ...
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).
OJ L 184, 17.7.1999, p. 23.

24

Chapter I
Introductory provisions

Article 1
Subject-matter and scope

1.

The purpose of this Directive is to ensure that zoonoses and zoonotic agents are
properly monitored so that
the necessary information may be collected in the
Community to evaluate trends and sources of zoonoses and zoonotic agents. That
evaluation shall provide a basis for the action to be taken to prevent and control
zoonoses and zoonotic agents relevant to the Community.

2.

This Directive covers:

a)

b)

c)

d)

the monitoring of zoonoses and zoonotic agents, taking into account specific
features such as antimicrobial resistance related to zoonotic agents, in animal
the stage of primary production of animals, and, where
populations at
including the production of
food chain,
necessary, at other stages of
feedingstuffs and further preparation and production of products of animal
origin;

the epidemiological investigation of foodborne outbreaks;

the exchange of information related to zoonoses and zoonotic agents;

the adoption of specific rules on monitoring.

3.

4.

This Directive shall apply without prejudice to more specific Community provisions
on animal health, animal nutrition, food hygiene, communicable diseases, health and
safety at workplace and gene technology.

This Directive shall not apply to transmissible spongiform encephalopathies.

Article 2
Definitions

For the purposes of this Directive, the following definitions shall apply:

1.

2.

3.

“zoonosis” means any disease and/or infection which is naturally transmissible
directly or indirectly from animals to humans;

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

“antimicrobial resistance” means the ability of micro-organisms of certain species to
survive or even to grow in the presence of a given concentration of an antimicrobial
agent, that is usually sufficient to inhibit or kill micro-organisms of the same species;

25

4.

5.

6.

7.

8.

9.

1.

2.

3.

4.

“communicable diseases” means diseases caused by zoonotic agents occurring in
humans which are covered by Decision No 2119/98/EC;

“food business” means a business as defined in Article 2 of Regulation (EC)
No …/… [on the hygiene of foodstuffs];

“food business operator” means the person or persons responsible for ensuring that
the requirements of this Directive are met within the food business under his/her or
their supervision;

“foodborne outbreak” means the observation under given circumstances of an
incidence of two or more human cases of the same disease and/or infection, or the
situation when the observed number of cases exceeds the expected number and
where the cases are linked, or are probably linked, to the same food source;

“monitoring” means a system of collecting, analysing and disseminating data on the
occurrence of zoonoses, zoonotic agents and antimicrobial resistance related thereto;

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

Article 3
General obligations

Member States shall ensure that data on the occurrence of zoonoses and zoonotic
agents and antimicrobial resistance related thereto are collected, analysed and
disseminated in accordance with the requirements of this Directive and of any
provision adopted pursuant to it.

Each Member State shall designate its competent authority for the purposes of this
Directive and notify the Commission thereof.

Each Member State shall ensure that effective and continuous co-operation based on
a free exchange of general information and, where necessary, of specific data, shall
be established between its competent authority designated for the purposes of this
Directive and:

a)

b)

c)

the competent authorities for the purposes of the Community legislation on
animal health,

the competent authorities for the purposes of the Community legislation on
food hygiene,

the structures and/or authorities referred to in Article 1 of Decision
No 2119/98/EC.

Each Member State shall ensure that the relevant officials of the competent authority
for the purposes of this Directive are suitably qualified to undertake their duties and,
where necessary, are trained in microbiology and epidemiology.

26

Chapter II
Monitoring of zoonoses and zoonotic agents

Article 4
General rules on monitoring of zoonoses and zoonotic agents

1.

The Member States shall collect data that
in order to identify and
characterise hazards, to assess exposures and to characterise risks related to zoonoses
and zoonotic agents. The monitoring shall
take place in animal populations,
especially at the stage of primary production but also, where necessary, at the other
stages in the food chain including the production of feedingstuffs and further
preparation and production of products of animal origin.

is relevant

2.

The monitoring shall cover zoonoses and zoonotic agents listed in Annex I, part 1.A.

Where the epidemiological situation in a Member State so warrants, zoonoses and
zoonotic agents listed in Annex I, part 1.B shall also be monitored.

The monitoring shall be based on the systems in place in Member States. Where
necessary, detailed rules for the monitoring of zoonoses and zoonotic agents listed in
Annex I may be laid down in accordance with the procedure referred to in
Article 12(2) and taking into consideration other Community rules laid down in the
fields of animal health, food hygiene and communicable diseases. Those detailed
rules shall specify in particular:

a)

b)

c)

d)

e)

f)

the animal population or sub-populations or stages in the food chain to be
covered by monitoring;

the nature and type of data to be collected;

case definitions;

sampling methods to be used;

laboratory methods to be used in testing;

the frequency of reporting, including guidelines for reporting between local,
regional and central authorities.

Article 5
Monitoring of antimicrobial resistance

Member States shall ensure that the monitoring provides data on the occurrence of
antimicrobial resistance in zoonotic agents in accordance with the requirements set
out in Annex II.

Detailed rules for
accordance with the procedure referred to in Article 12(2).

the implementation of paragraph 1 shall be laid down in

3.

1.

2.

27

1.

2.

3.

4.

1.

2.

Article 6
Co-ordinated monitoring programmes

Co-ordinated monitoring programmes concerning one or more zoonoses and/or
zoonotic agents may be established in accordance with the procedure referred to in
Article 12(2), where appropriate after consultation of the European Food Authority.
Co-ordinated monitoring programmes may be established especially when specific
needs are identified to assess risks, or in order to establish base-line values related to
zoonoses and/or zoonotic agents at the level of Member States and/or at Community
level.

Where a co-ordinated monitoring programme is established, special reference shall
be made to zoonoses and zoonotic agents in animal populations referred to in Annex
I, part A, of Regulation (EC) No …/… [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].

Minimum rules
programmes are laid down in Annex III.

concerning the

establishment

of

co-ordinated monitoring

The results of the co-ordinated monitoring programmes shall be provided to the
European Food Authority.

Chapter III
Food-borne outbreaks

Article 7
Epidemiological investigation of food-borne outbreaks

Member States shall ensure that when a food business operator becomes aware that a
foodstuff produced or processed by him has caused, or is likely to cause, a foodborne
outbreak, he shall inform the competent authority without delay. The foodstuff, or an
appropriate sample thereof, shall be preserved in a way which neither impede its
investigation in a laboratory, nor a further investigation of the suspected outbreak.

When a competent authority receives information pursuant
to paragraph 1 or is
otherwise informed of a food-borne outbreak, it shall investigate the outbreak in co-
operation with the authorities referred to in Article 1 of Decision No 2119/98/EC.
The investigation shall provide data on the epidemiological profile, the foodstuffs
potentially implicated and the potential causes of the outbreak. The investigation
include, as far as possible, adequate epidemiological and microbiological
shall
studies. The competent authority shall
to the Commission and to the
transmit
European Food Authority a summary report on the results of the investigations
carried out, containing the information referred to in Annex IV, Part E, to this
Directive. Detailed rules concerning the investigation of food-borne outbreaks may
be laid down in accordance with the procedure referred to in Article 12(2).

28

3.

4.

Paragraphs 1 and 2 shall apply without prejudice to Community provisions on
product safety, early warning and response systems for the prevention and control of
communicable diseases and food hygiene.

Measures concerning the suspected foods and their production environment shall be
laid down in accordance with Article 12 of Regulation (EC) No …../….. [on the
hygiene of foodstuffs].

Chapter IV
Exchange of information

Article 8
Examinations for zoonoses at the level of food business operators

Member States shall ensure that food business operators keep, for a period to be specified by
the competent authority, and communicate to the latter at
the results of
examinations for the presence of the zoonoses and zoonotic agents listed in Annex I, part 1.A.

its request,

Article 9
Assessment of trends and sources of zoonoses, zoonotic agents and antimicrobial resistance

1.

Member States shall assess trends and sources of zoonoses, zoonotic agents and
antimicrobial resistance related thereto in their territory.

Each Member State shall transmit to the Commission and to the European Food
Authority every year by the end of May a report on trends and sources of zoonoses,
zoonotic agents and antimicrobial resistance related thereto, covering the data
collected pursuant to Articles 4 to 7 during the previous year. The reports, or
summaries of them, shall be made publicly available.

The reports shall also contain the information referred to in Article 3(2)(b) of
Regulation (EC) No …./… [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 minimum requirements concerning the reports are laid down in Annex IV.
Detailed rules concerning the assessment of those reports, including the formats and
the minimum information which they must include, may be laid down in accordance
with the procedure referred to in Article 12(2).

Where the circumstances warrant it, the Commission may request specific additional
information and the Member States shall submit reports to the Commission upon
such request, or on their own initiative.

2.

The European Food Authority shall each year examine the reports referred to in
paragraph 1 and within nine months after receiving them shall publish a summary
report on the trends and sources of zoonoses, zoonotic agents and antimicrobial
resistance related thereto in the Community.

29

When preparing the summary report, the European Food Authority may take into
consideration other data on zoonoses, zoonotic agents and antimicrobial resistance
related thereto such as those provided for in the framework of the Community
legislation on animal health, food control, food hygiene and communicable diseases,
and in particular:

–

–

–

–

Article 8 of Directive 64/432/EEC,

Article 14(2) of Council Directive 89/397/EEC30,

Article 24 of Decision 90/424/EEC,

Article 4 of Decision 2119/98/EC.

Chapter V
Laboratories

Article 10
Community and national reference laboratories

1.

2.

3.

4.

One or more Community Reference Laboratories for the analysis and testing of
zoonoses and zoonotic agents and antimicrobial resistance related thereto may be
designated in accordance with the procedure referred to in Article 12(2).

the
Without prejudice to the relevant provisions
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 12(2).

in Decision 90/424/EEC,

Member States shall designate National Reference Laboratories for each field where
a Community Reference Laboratory has been established and inform the
Commission thereof.

Certain responsibilities and tasks of
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 12(2).

the National Reference Laboratories,

30

OJ L 186, 30.6.1989, p. 23. (to be replaced in due course by a Regulation on official food and feed
safety controls; referred to as Action No 4 in the White Paper on Food Safety (COM(1999) 719 final)).

30

Chapter VI
Implementation

Article 11
Amendments to the annexes and transitional measures

Where appropriate after consultation of the European Food Authority, the Annexes may be
amended or any appropriate transitional measures may be adopted in accordance with the
procedure referred to in Article 12(2).

Article 12
Committee

1.

2.

3.

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].

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

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

Article 13
Transposition

Member States shall adopt and publish before 1 November 2002 the laws,
regulations and administrative provisions necessary to comply with this Directive.
They shall forthwith inform the Commission thereof.

They shall apply those provisions from 1 January 2003.

When Member States adopt those provisions, they shall contain a reference to this
Directive or be accompanied by such a reference on the occasion of their official
publication. Member States shall determine how such reference is to be made.

2.

Member States shall communicate to the Commission the text of the provisions of
national law that they adopt in the field covered by this Directive.

31

Chapter VII
Final provisions

Article 14
Repeal

Directive 92/117/EEC is repealed with effect from 1 January 2003.

However, measures which Member States have adopted pursuant to Article 8(1) of that
Directive and implemented in accordance with Article 10(1) thereof and plans approved in
accordance with Article 8(3) thereof shall remain in force until corresponding control
programmes have been approved in accordance with Article 6 of Regulation (EC)…./…. [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].

Article 15
Amendment of Decision 90/424/EEC

Decision 90/424/EEC is amended as follows:

1.

Article 29 is replaced by the following:

“1. A Community financial contribution may be requested by Member States for
the monitoring and control of the zoonoses specified in the Annex, Group 2, in
the framework of the provisions referred to in Article 24 (2) to (11).

2.

As regards control of zoonoses, the Community financial contribution shall be
introduced as part of a national plan referred to in Article 6 of Regulation (EC)
No …./… 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 level of Community financial participation for measures provided for in
Annex II, point C, to Regulation (EC) No …./… [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] shall be fixed at a maximum of
50% of the cost incurred in the Member State by way of compensation for
owners for the slaughter and destruction measures of breeding flocks of Gallus
gallus because of the infection concerned.

- - -

*

OJ L ….".

32

2.

The following Article 29a is inserted:

"Article 29a

Member States may seek from the Community the financial contribution referred to
in Article 29(2) for a national plan which was approved on the basis of Directive
92/117/EEC, until the date on which corresponding control programmes have been
approved in accordance with Article 6 of Regulation (EC) No …./… [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]."

3.

In the Annex, the following indents are added to the list under Group 2:"

–

–

–

–

–

–

Campylobacteriosis

Cryptosporidiosis

Listeriosis

Salmonellosis (zoonotic salmonella)

Trichinellosis

Verotoxigenic Escherichia coli."

Article 16
Entry into force

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

Article 17
Addressees

This Directive is addressed to the Member States.

Done at Brussels,

For the European Parliament
The President

For the Council
The President

33

ANNEX I

Part 1. Zoonoses and zoonotic agents to be monitored pursuant to Article 4

A.

Zoonoses and zoonotic agents to be included in monitoring

Brucellosis and agents thereof

Campylobacteriosis and agents thereof

Cryptosporidiosis and agents thereof

Echinococcosis and agents thereof

Listeriosis and agents thereof

Salmonellosis and agents thereof

Trichinellosis and agents thereof

Tuberculosis due to Mycobacterium bovis

Verotoxigenic Escherichia coli

B.

1.

List of zoonoses and zoonotic agents to be monitored according to the
epidemiological situation

Viral zoonoses

Calicivirus

Hepatitis A virus

Influenzavirus

Rabies

Tick borne viruses

2.

Bacterial zoonoses

Borreliosis and agents thereof

Botulism and agents thereof

Leptospirosis and agents thereof

Psittacosis and agents thereof

Tuberculosis other than in Point A

Vibriosis and agents thereof

Yersiniosis and agents thereof

34

3.

Parasitic zoonoses

Anisakiasis and agents thereof

Cysticercosis and agents thereof

Toxoplasmosis and agents thereof

4.

Other zoonoses and zoonotic agents

Part 2. Criteria for addition or deletion of zoonoses in the list in Part 1

When necessary, zoonoses or zoonotic agents may be added or deleted as regards the list in
Part 1 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.

35

ANNEX II

Requirements for monitoring of antimicrobial resistance pursuant to Article 5

A.

General requirements

Monitoring of antimicrobial resistance should provide relevant information to detect the
emergence of and to identify the trends in antimicrobial resistance in zoonotic agents.

Monitoring should be complementary to the monitoring of human isolates conducted
according to Council Decision 2119/98/EC.

The Member States shall ensure that the monitoring system for antimicrobial resistance
provided for in Article 5 provides at least following information:

1.

2.

3.

4.

5.

6.

7.

animal species included in monitoring

bacterial species and/or strains included in monitoring

sampling strategy used in monitoring

antimicrobials included in monitoring

laboratory methodology used for the detection of resistance

laboratory methodology used for the identification of microbial isolates

methods used for the collection of the data

B.

Specific requirements

Member States shall ensure that the above monitoring provides relevant information at least
with regard to:

–

Antibiograms
Campylobacter jejuni and Campylobacter coli from cattle, pigs and poultry.

for a representative number of

isolates of Salmonella spp.,

36

ANNEX III

Co-ordinated monitoring programmes as referred to in Article 6

When a co-ordinated monitoring programme is established, at
characteristics of the programme shall be defined:

least

the following

–

–

–

–

–

–

–

–

–

–

–

its purpose

its time period

its geographical area or region

the zoonoses and / or zoonotic agents concerned

the type of samples and other data units requested

minimum sampling schemes

the type of laboratory testing methods

the responsibility of competent authorities

the resources to be allocated

the estimation of its costs and how they will be covered

the method and time of reporting the results to the Commission and to other Member
States.

37

ANNEX IV

Requirements for the reports to be submitted pursuant to Article 9

The report referred to in Article 9(1) must provide at least for the following information:

A.

Initially the following shall be described for each zoonosis and zoonotic agent
(later only changes have to be reported):

a) Monitoring systems (sampling strategies, frequency of sampling, kind of

specimen, case definition, diagnostic methods used)

b)

c)

Vaccination policy and other preventive actions

Control programmes

d) Measures in case of positive findings or single cases

e)

f)

Notification systems in place

History of the disease and/or infection in the country

B.

Each year shall be reported:

a)

Relevant susceptible animal population (and date the figures are related to)

–

–

Number of herds or flocks

Total number of animals

b)

Laboratories and institutions involved in reporting

C.

Each year the following details on each zoonotic agent and data category
concerned shall be described with their consequences:

a)

b)

c)

d)

e)

f)

g)

Changes in the systems already described

Changes in previously described methods

Results of the investigations and of further
characterization in laboratories (for each category reported on separately)

typing or other method of

National evaluation of the recent situation,
infection

the trend and the sources of

Relevance as zoonotic disease

Relevance of findings in animals and foodstuff to human cases, source of
human infection

Control strategies recognized that could be used to prevent or minimize
transmission of the zoonotic agent to humans

38

h)

Need of any specific action in the Member State or at EU level on the basis of
the recent situation

D.

Reporting of results of examinations

Results shall be given by stating the number of investigated epidemiological units
(flocks, herds, samples, batches) and the number of positive samples according to the
case definition. The results shall be, when necessary, presented in a way which
shows the geographical distribution of the zoonosis or the zoonotic agent.

E.

For food-borne outbreak data:

a)

b)

c)

d)

e)

Total number of outbreaks over a year.

Number of ill and dead persons in these outbreaks.

The causative agents of the outbreaks, including, where possible, serotype or
other definitive description of the agent. Where the identification of the
causative agent is not possible, the reason for that should be stated.

Foodstuffs implicated in the outbreak and other potential vehicles.

Identification of the type of place where the foodstuff incriminated was
produced / purchased / acquired/ consumed.

f)

Contributory factors, for example, deficiencies in food processing hygiene.

39

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 Commission31,

Having regard to the opinion of the Economic and Social Committee32,

Having regard to the opinion of the Committee of the Regions33,

Acting in accordance with the procedure laid down in Article 251 of the Treaty34,

Whereas:

(1)

(2)

(3)

(4)

31

32

33

34

35

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

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

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

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
intoxications35 was adopted in order to establish monitoring systems for certain
zoonoses and to establish controls on Salmonella in poultry flocks.

OJ C ...
OJ C ...
OJ C ...
OJ C ...
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).

40

(5)

(6)

(7)

(8)

(9)

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/EC36
amending Directive 92/117/EEC, pending the review provided for in Article 15a of
Directive 92/117/EEC.

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.

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.

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 swine37 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 animals38 as regards ovine and caprine
brucellosis.

Moreover, Regulation (EC) No…./… of the European Parliament and of the Council
of …. [on the hygiene of foodstuffs]39 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.

(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.

36

37

38

39

OJ L 113, 30.4.1997, p. 9.
OJ 121, 29.7.1964, p. 1977. Directive as last amended by Directive 2000/20/EC (OJ L 163, 4.7.2000,
p. 35).
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).
OJ L ...

41

(12)

(13)

(14)

(15)

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.

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]40.

The principle should be established of controls covering 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.

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

requirements for controls.

(17)

(18)

(19)

(20)

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
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.

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.

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.

40

OJ L

42

(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 countries41 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 eggs42 should be amended
accordingly.

(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)

(26)

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

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 States43 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 countries44.

41

42

43

44

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).
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).
OJ L 38, 12.2.1998, p. 10.
OJ L 38, 12.2.1998, p. 14.

43

(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 Commission45, 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]46,

HAVE ADOPTED THIS REGULATION:

Chapter I
Introductory provisions

Article 1
Subject-matter and scope

1.

2.

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.

This Regulation covers:

a)

b)

c)

d)

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;

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

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

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

45

46

OJ L 184, 17.7.1999, p. 23.
OJ L ...

44

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

Article 2
Definitions

1.

2.

3.

4.

5.

6.

7.

8.

1.

2.

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

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

“food business” means a business as defined in Article 2 of Regulation (EC)
No …/… [on the hygiene of foodstuffs];

"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;

"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;

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

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

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

Article 3
Competent authorities

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

The competent authority shall be responsible in particular for:

a)

b)

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;

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];

45

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)

b)

the experience gained under existing national measures,

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.

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

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.

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

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.

3.

4.

1.

46

2.

3.

4.

5.

6.

7.

1.

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

National control programmes shall:

a)

b)

c)

d)

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

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

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

to protect public health,

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.

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

a)

b)

c)

feedingstuff production;

primary production of animals;

processing and preparation of foodstuffs of animal origin.

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.

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).

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

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).

47

2.

3.

1.

2.

3.

4.

5.

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).

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

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.

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.

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.

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.

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

48

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):

2.

1.

2.

a)

b)

c)

d)

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;

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

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

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

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

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.

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.

49

3.

4.

1.

2.

3.

4.

5.

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).

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

Article 10
Imports from third countries

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.

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.

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.

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.

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
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).

its national programme,

50

6.

1.

2.

3.

4.

1.

2.

3.

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

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).

The responsibilities and tasks of
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).

the Community Reference Laboratories,

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.

in
Certain responsibilities and tasks of
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).

the National Reference Laboratories,

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

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.

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.

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.

51

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.

2.

3.

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
food law,
Council [laying down the general principles and requirements of
establishing the European Food Authority, and laying down procedures in matters of
food].

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.

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.

52

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".

53

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
The President

For the Council
The President

54

ANNEX I

A.

Specified zoonoses and zoonotic agents for which Community targets for the

reduction of prevalence shall be established pursuant to Article 4

1. Zoonosis /
zoonotic agent

2. Animal
population

3. Stage of
food-chain

Breeding
flocks
Gallus gallus

of

Primary
production

4. Target to be
established by
(date)

5.Mandatory testing and
certification for trade
shall apply as from

31.12.2003

1.1.2005

All salmonella
serotypes with
public health
significancea

Salmonella
Enteritidis and
Salmonella
Typhimurium

All salmonella
serotypes with
public health
significancea

All salmonella
serotypes with
public health
significancea

All salmonella
serotypes with
public health
significancea

Laying hens

Primary
production

31.12.2004

1.1.2006

Broilers

Primary
production

31.12.2005

1.1.2007

Turkeys

Primary
production

31.12.2006

1.1.2008

Breeding herds
of pigs

Primary
production

31.12.2006

1.1.2008

a

Serotypes shall be defined when the target is established.

55

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)

b)

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

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

2.

3.

4.

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

Definition of epidemiological units referred to in point 1, and

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

56

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)

b)

1.

1.1

1.2

1.3

1.4

1.5

1.6

1.7

1.8

1.9

2.

2.1

2.2

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

specify

General

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],

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

the infrastructure of the relevant competent authorities,

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

the methods used in the examination of the zoonotic agents,

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

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

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,

relevant national legislation;

Concerning food businesses covered by the programme

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

the structure of the production of feedingstuffs,

57

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

2.5

2.6

2.7

2.8

c)

d)

routine veterinary supervision of farms,

registration of farms,

record keeping at farms,

documents to accompany animals when dispatched,

other relevant measures to ensure the traceability of animals;

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

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

58

B.

1.

a

2.

3.

MINIMUM REQUIREMENTS OF SAMPLING

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.

Zoonosis /
zoonotic agent

salmonella
with
health

All
serotypes
public
significancea

Animal species

Data

Sampling shall cover at
least these phases of
production

1. Breeding flocks
of Gallus gallus

1.1 Rearing flocks

1.2. Adult breeding
flocks

a)feedingstuffs

i) Day-old chicks

b) live animals

ii) 4 week old

a) feedingstuffs

b) live animals

iii) 2 weeks before moving to
laying phase or laying unit

i) every second week during
the laying period

Salmonella
Enteritidis
Salmonella
Typhimurium

2.
layers

and

Commercial

a) feedingstuffs

b) live animals

i) Day-old chicks

2.1 Rearing flocks

ii) pullets 2 weeks before
moving to laying phase or
laying unit

2.2 Laying flocks

a) feedingstuffs

b) live animals

i) every 9 weeks during the
laying phase

3. Broilers

a) feedingstuffs

i) Birds leaving for slaughter

b) live animals

c) Ante mortem
inspection

salmonella
with
health

All
serotypes
public
significancea

salmonella
with
health

All
serotypes
public
significancea

4. Turkey

5. Pigs

Ante
inspection

Ante
inspection

mortem

i) Birds leaving for slaughter

mortem

i) Animals
slaughter

leaving

for

Serotypes shall be defined when the target is established.

The data collected shall be accompanied with the following information:

a)

b)

Date and place of sampling;

Identification of the flock / herd.

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.

59

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]47, 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]48.

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]49.

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].

47

48

49

OJ L ...
OJ L ...
OJ L ...

60

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.

61

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 field50, as revised pursuant to the above proposal for a Directive.

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

financing of

the relevant Community Reference

This Chapter will cover
Laboratories.

OVERALL FIGURES

2.

2.1

2.2

Total allocation for action (Part B): 2.4

Period of application: 2003-

€

millions in EC

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.

50

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

62

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 Mio
. That is why financing of this new measure
only is included in the estimate for the proposals.

€

2.3

a)

Overall multiannual estimate on expenditure :

Schedule
commitment
intervention) (see point 6.1.1)

of

appropriations/payment

appropriations

(financial

€

million (to 3rd decimal place)

Year
n

n + 1

n + 2

n + 3

n + 4

Commitments

Payments

0.4

0.4

0.4

0.4

0.4

0.4

0.4

0.4

0.4

0.4

n + 5
and
subs.
years
0.4

0.4

Total

2.4

2.4

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

b)

NO

Commitments/
payments

Subtotal a+b

Commitments

Payments

c)

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

Commitment/
payments

0.432

0.432

0.432

0.432

0.432

0.432

2.592

TOTAL a+b+c

0.432

0.432

0.432

0.432

0.432

0.432

2.592

Commitments

Payments

63

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
(cid:1)

Proposal compatible with the existing financial programming

This proposal will entail reprogramming of the relevant heading in the

financial
(cid:1)

perspective

This may entail application of

the provisions of

the Interinstitutional

Agreement.

2.5

Financial impact on revenue

No
(cid:1)

No financial implications (involves technical aspects regarding implementation

of a measure)

OR

(cid:1)

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.

€

million (to 1 decimal place)

Situation following action

Year n

n+1

n+2

n+3

n+4

n+5

Prior to
action
(Year
n-1)

Budget line

Revenue

a) Revenue in absolute terms

b) Change in Revenue

D

(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

Type of expenditure

New

EFTA
participation

Participation
applicant
countries

Heading
Financial
Perspective

Comp

Non-diff

YES*

NO

NO

N° 1 A

*: only co-ordinated monitoring programmes

64

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.

5.1

DESCRIPTION AND GROUNDS

Need for Community intervention 51

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
560-2840Mio
. 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.

51

For further information see a separate guidance paper .

65

5.1.2 Measures taken in connection with ex ante evaluation

to reduce or

indicated above, public

As
the
financing of measures
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.

eliminate

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

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.

66

5.3

Methods of implementation

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

to the procedures

subject

6.

6.1

FINANCIAL IMPACT

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

€

million (to the 3rd decimal place)

Only financing of new measures in the proposals,
programmes is included.

i.e. co-ordinated monitoring

Year n

n + 1

n + 2

n + 3

n+ 4

0.400

0.400

0.400

0.400

0.400

n + 5 and
subs.
years

0.400

Total

2.400

Breakdown

Action 1

Action 2

Etc.

TOTAL 0.400

0.400

0.400

0.400

0.400

0.400

2.400

67

6.1.2 Technical and administrative assistance, support expenditure and IT expenditure
n + 5 and
subs.
years

Year n

n + 4

n + 2

n + 1

n + 3

Total

1)
administrative assistance

Technical

and

Technical

a)
offices

assistance

b) Other
administrative assistance:

technical

and

- intra muros :

- extra muros :

of which for construction
and
of
maintenance
computerised management
systems

Subtotal 1

2) Support expenditure

a) Studies

b) Meetings of experts

c) Information and
publications

Subtotal 2

TOTAL

68

6.2.

Calculation of costs by measure envisaged in Part B (over the entire
programming period)52

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

Commitments in

€

million (to the 3rd decimal place)

Breakdown

Type
of outputs
(projects, files )

1

(total for years
1…n)
2

Number of
outputs

Average unit
cost

Total cost

(total for years
1…n)

3

4=(2X3)

Action 1
- Measure 1
- Measure 2
Action 2
- Measure 1
- Measure 2
- Measure 3

Etc.

TOTAL COST

See calculation in the annex

tests

6x35.000

50 % of 24

€

2.400 (6x0,400)

2.400

7.

IMPACT ON STAFF AND ADMINISTRATIVE EXPENDITURE

7.1.

Impact on human resources

Types of post

Staff to be assigned to management of the
action using existing and/or additional
resources

Number of
permanent posts

Number of
temporary posts

Total

2

or

Permanent
A
officials
B
Temporary staff
C
Other human resources
Total

1
1

Description of tasks deriving from the
action

If necessary, a fuller description of the
tasks may be annexed.

52

For further information see a separate guidance paper.

69

7.2

Overall financial impact of human resources

Type of human resources

€

Amount

Method of calculation *

Officials
Temporary staff

Other human resources

0.216
0.216

2*0.108
2*0.108

(give budget line)
Total

0.432

The amounts are total expenditure for twelve months.

7.3

Other administrative expenditure deriving from the action

€

Amount

Method of calculation

Budget line
(number and heading)

Overall allocation (Title A7)
A0701 – Missions
A07030 – Meetings
A07031 – Compulsory committees (1)
A07032 – Non-compulsory committees (1)
A07040 – Conferences
A0705 – Studies and consultations
… Other expenditure (state which)

Information systems (A-5001/A-4300)

Other expenditure - Part A (state which)

Total

The amounts are total expenditure for twelve months.

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

I.

II.

III.

8.

8.1

–

–

Annual total (7.2 + 7.3)

Duration of action

Total cost of action (I x II)

FOLLOW-UP AND EVALUATION

Follow-up arrangements

€

Years
€

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.

70

–

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.

71

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
the Member States to carry out specified
Commission would need to request
sampling and testing schemes, which possibly differ from the procedures of the
national monitoring system,
the Community could
finance such co-ordinated programmes.

is deemed necessary that

it

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.

72

IMPACT ASSESSMENT FORM

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

Title of proposal

1.

2.

Proposal for a Directive of the European Parliament and of the Council on the
amending Council Decision
monitoring of zoonoses and zoonotic agents,
90/424/EEC and repealing Council Directive 92/117/EEC

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.

73

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.

74