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Document 02003L0099-20130701
Directive 2003/99/EC of the European Parliament and of the Council of 17 November 2003 on the monitoring of zoonoses and zoonotic agents, amending Council Decision 90/424/EEC and repealing Council Directive 92/117/EEC
Consolidated text: Directive 2003/99/EC of the European Parliament and of the Council of 17 November 2003 on the monitoring of zoonoses and zoonotic agents, amending Council Decision 90/424/EEC and repealing Council Directive 92/117/EEC
Directive 2003/99/EC of the European Parliament and of the Council of 17 November 2003 on the monitoring of zoonoses and zoonotic agents, amending Council Decision 90/424/EEC and repealing Council Directive 92/117/EEC
In force
02003L0099 — EN — 01.07.2013 — 003.001
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DIRECTIVE 2003/99/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 17 November 2003 (OJ L 325 12.12.2003, p. 31) |
Amended by:
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Official Journal |
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L 363 |
352 |
20.12.2006 |
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REGULATION (EC) No 219/2009 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 11 March 2009 |
L 87 |
109 |
31.3.2009 |
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L 155 |
30 |
18.6.2009 |
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L 158 |
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10.6.2013 |
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DIRECTIVE 2003/99/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
of 17 November 2003
on the monitoring of zoonoses and zoonotic agents, amending Council Decision 90/424/EEC and repealing Council Directive 92/117/EEC
CHAPTER I
INTRODUCTORY PROVISIONS
Article 1
Subject matter and scope
This Directive covers:
the monitoring of zoonoses and zoonotic agents;
the monitoring of related antimicrobial resistance;
the epidemiological investigation of food-borne outbreaks; and
the exchange of information related to zoonoses and zoonotic agents.
Article 2
Definitions
For the purposes of this Directive, the following definitions shall apply:
the definitions laid down in Regulation (EC) No 178/2002, and
the following definitions:
‘zoonosis’ means any disease and/or infection which is naturally transmissible directly or indirectly between animals and 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;
‘food-borne outbreak’ means an incidence, observed under given circumstances, of two or more human cases of the same disease and/or infection, or a situation in which 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.
Article 3
General obligations
Each Member State shall designate a competent authority or competent authorities for the purposes of this Directive and notify the Commission thereof. If a Member State designates more than one competent authority, it shall:
notify the Commission of the competent authority that will act as a contact point for contacts with the Commission; and
ensure that the competent authorities cooperate so as to guarantee the proper implementation of the requirements of this Directive.
Each Member State shall ensure that effective and continuous cooperation based on free exchange of general information and, where necessary, of specific data, is established between the competent authority or authorities designated for the purposes of this Directive and:
the competent authorities for the purposes of Community legislation on animal health;
the competent authorities for the purposes of Community legislation on feed;
the competent authorities for the purposes of Community legislation on food hygiene;
the structures and/or authorities referred to in Article 1 of Decision No 2119/98/EC;
other authorities and organisations concerned.
CHAPTER II
MONITORING OF ZOONOSES AND ZOONOTIC AGENTS
Article 4
General rules on monitoring of zoonoses and zoonotic agents
Monitoring shall take place at the stage or stages of the food chain most appropriate to the zoonosis or zoonotic agent concerned, that is:
at the level of primary production; and/or
at other stages of the food chain, including in food and feed.
►M2 Annex I may be amended by the Commission to add zoonoses or zoonotic agents to, or delete them from, the lists therein, taking account in particular of the following criteria: ◄
their occurrence in animal and human populations, feed and food;
the gravity of their effects for humans;
their economic consequences for animal and human health care and for feed and food businesses;
epidemiological trends in animal and human populations, feed and food.
Those measures, designed to amend non-essential elements of this Directive, shall be adopted in accordance with the urgency procedure referred to in Article 12(4).
Such detailed rules shall lay down minimum requirements for the monitoring of certain zoonoses or zoonotic agents. They may, in particular, specify:
the animal population or subpopulations or stages in the food chain to be covered by monitoring;
the nature and type of data to be collected;
case definitions;
sampling schemes to be used;
laboratory methods to be used in testing; and
the frequency of reporting, including guidelines for reporting between local, regional and central authorities.
Article 5
Coordinated monitoring programmes
Article 6
Food business operators' duties
Member States shall ensure that, when food business operators carry out examinations for the presence of zoonoses and zoonotic agents subject to monitoring under Article 4(2), they:
keep the results and arrange for the preservation of any relevant isolate for a period to be specified by the competent authority; and
communicate results or provide isolates to the competent authority on request.
CHAPTER III
ANTIMICROBIAL RESISTANCE
Article 7
Monitoring of antimicrobial resistance
CHAPTER IV
FOOD-BORNE OUTBREAKS
Article 8
Epidemiological investigation of food-borne outbreaks
CHAPTER V
EXCHANGE OF INFORMATION
Article 9
Assessment of trends and sources of zoonoses, zoonotic agents and antimicrobial resistance
Each Member State shall transmit to the Commission every year by the end of May, for Bulgaria and Romania, for the first time, by the end of May 2008, and for Croatia, for the first time, by the end of May 2014, a report on trends and sources of zoonoses, zoonotic agents and antimicrobial resistance, covering the data collected pursuant to Articles 4, 7, and 8 during the previous year. Reports, and any summaries of them, shall be made publicly available.
Reports shall also contain the information referred to in Article 3(2)(b) of Regulation (EC) No 2160/2003.
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 that 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.
When preparing the summary report, the European Food Safety Authority may take into consideration other data provided for in the framework of Community legislation, such as:
CHAPTER VI
LABORATORIES
Article 10
Community and national reference laboratories
CHAPTER VII
IMPLEMENTATION
Article 11
Amendments to the Annexes and transitional or implementing measures
Annexes II, III and IV may be amended by the Commission. Those measures, designed to amend non-essential elements of this Directive, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 12(3).
Transitional measures of general scope designed to amend non-essential elements of this Directive, inter alia, by supplementing it with new non-essential elements, in particular further specifications of the requirements laid down in this Directive, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 12(3).
Other implementing or transitional measures may be adopted in accordance with the regulatory procedure referred to in Article 12(2).
Article 12
Committee procedure
The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months.
Article 13
Consultation of the European Food Safety Authority
The Commission shall consult the European Food Safety Authority on any matter within the scope of this Directive that could have a significant impact on public health, in particular before proposing any amendment to Annexes I or II or before establishing any coordinated monitoring programme in accordance with Article 5.
Article 14
Transposition
They shall apply those measures by 12 June 2004.
When Member States adopt those measures, 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.
CHAPTER VIII
FINAL PROVISIONS
Article 15
Repeal
Directive 92/117/EEC shall be repealed with effect from 12 June 2004.
However, measures which Member States have adopted pursuant to Article 8(1) of Directive 92/117/EEC and those 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 5 of Regulation (EC) No 2160/2003.
▼M3 —————
Article 17
Entry into force
This Directive shall enter into force on the day of its publication in the Official Journal of the European Union.
Article 18
Addressees
This Directive is addressed to the Member States.
ANNEX I
A. Zoonoses and zoonotic agents to be included in monitoring
B. List of zoonoses and zoonotic agents to be monitored according to the epidemiological situation
1. Viral zoonoses
2. Bacterial zoonoses
3. Parasitic zoonoses
4. Other zoonoses and zoonotic agents
ANNEX II
Requirements for monitoring of antimicrobial resistance pursuant to Article 7
A. General requirements
Member States must ensure that the monitoring system for antimicrobial resistance provided for in Article 7 provides at least the following information:
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 must ensure that the monitoring system provides relevant information at least with regard to a representative number of isolates of Salmonella spp., Campylobacter jejuni and Campylobacter coli from cattle, pigs and poultry and food of animal origin derived from those species.
ANNEX III
Coordinated monitoring programmes as referred to in Article 5
When a coordinated monitoring programme is established, at least the following characteristics of the programme must be defined:
ANNEX IV
Requirements for the reports to be submitted pursuant to Article 9(1)
The report referred to in Article 9(1) must provide at least the following information. Parts A to D apply to reports on monitoring carried out in accordance with Article 4 or 7. Part E applies to reports on monitoring carried out in accordance with Article 8.
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A. |
Initially the following must 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)
vaccination policy and other preventive actions;
(c)
control mechanism and, where relevant, programmes;
(d)
measures in case of positive findings or single cases;
(e)
notification systems in place;
(f)
history of the disease and/or infection in the country. |
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B. |
Each year the following must be described:
(a)
relevant susceptible animal population (together with the date the figures relate to):
—
number of herds or flocks,
—
total number of animals, and
—
where relevant, methods of production involved;
(b)
number and general description of the laboratories and institutions involved in monitoring. |
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C. |
Each year the following details on each zoonotic agent and data category concerned must be described with their consequences:
(a)
changes in the systems already described;
(b)
changes in previously described methods;
(c)
results of the investigations and of further typing or other method of characterisation in laboratories (for each category reported on separately);
(d)
national evaluation of the recent situation, the trend and the sources of infection;
(e)
relevance as zoonotic disease;
(f)
relevance to human cases, as a source of human infection, of findings in animals and food;
(g)
control strategies recognised that could be used to prevent or minimise transmission of the zoonotic agent to humans;
(h)
if necessary, any specific action decided in the Member State or suggested for the Community as a whole on the basis of the recent situation. |
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D. |
Reporting of results of examinations Results shall be given by stating the number of epidemiological units investigated (flocks, herds, samples, batches) and the number of positive samples according to the case definition. The results shall, when necessary, be presented in a way which shows the geographical distribution of the zoonosis or the zoonotic agent. |
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E. |
For food-borne outbreak data:
(a)
total number of outbreaks over a year;
(b)
number of human deaths and illnesses in these outbreaks;
(c)
the causative agents of the outbreaks, including, where possible, serotype or other definitive description of the agents. Where the identification of the causative agent is not possible, the reason for such unidentifiability should be stated;
(d)
foodstuffs implicated in the outbreak and other potential vehicles;
(e)
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. |
( 1 ) OJ C 304 E, 30.10.2001, p. 250.
( 2 ) OJ C 94, 18.4.2002, p. 18.
( 3 ) Opinion of the European Parliament of 15 May 2002 (OJ C 180 E, 31.7.2003, p. 161), Council common position of 20 February 2003 (OJ C 90 E, 15.4.2003, p. 9) and position of the European Parliament of 19 June 2003 (not yet published in the Official Journal).
( 4 ) OJ L 62, 15.3.1993, p. 38. Directive as last amended by Regulation (EC) No 806/2003 (OJ L 122, 16.5.2003, p. 1).
( 5 ) OJ 121, 29.7.1964, p. 1977. Directive as last amended by Commission Regulation (EC) No 1226/2002 (OJ L 179, 9.7.2002, p. 13).
( 6 ) OJ L 46, 19.2.1991, p. 19. Directive as last amended by Commission Decision 2003/708/EC (OJ L 258, 10.10.2003, p. 11).
( 7 ) OJ L 268, 3.10.1998, p. 1.
( 8 ) See page 1 of this Official Journal.
( 9 ) OJ L 31, 1.2.2002, p. 1.
( 10 ) OJ L 147, 31.5.2001, p. 1. Regulation as last amended by Commission Regulation (EC) No 1494/2002 (OJ L 225, 22.8.2002, p. 3).
( 11 ) OJ L 224, 18.8.1990, p. 19. Decision as last amended by Decision 2001/572/EC (OJ L 203, 28.7.2001, p. 16).
( 12 ) OJ L 184, 17.7.1999, p. 23.
( 13 ) Council Directive 89/397/EEC of 14 June 1989 on the official control of foodstuffs (OJ L 186, 30.6.1989, p. 23).