Annexes to COM(2001)452-3 - Control of salmonella and other food-borne zoonotic agents

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dossier COM(2001)452-3 - Control of salmonella and other food-borne zoonotic agents.
document COM(2001)452 EN
date November 17, 2003
ANNEX I


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

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ANNEX II


CONTROL OF ZOONOSES AND ZOONOTIC AGENTS LISTED IN ANNEX I

A. General requirements for national control programmes

The programme must take into account the nature of the zoonosis and/or zoonotic agent concerned and the specific situation in the Member State. It must:

(a) state the aim of the programme taking into consideration the importance of the zoonosis or zoonotic agent concerned;

(b) comply with the minimum sampling requirements laid down in part B;

(c) where relevant, comply with the specific requirements laid down in parts C to E; and

(d) specify the following points:

1. General

1.1. The occurrence of the zoonosis or zoonotic agent concerned in the Member State with specific reference to the results obtained in the framework of monitoring in accordance with Article 4 of Directive 2003/99/EC.

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

1.3. The structure and organisation of the relevant competent authorities.

1.4. Approved laboratories where samples collected within the programme are analysed.

1.5. Methods used in the examination of the zoonosis or zoonotic agent.

1.6. Official controls (including sampling schemes) at feed, flock and/or herd level.

1.7. Official controls (including sampling schemes) at other stages of the food chain.

1.8. Measures taken by the competent authorities with regard to animals or products in which zoonoses or zoonotic agents have been detected, in particular to protect public health; and any preventive measures taken, such as vaccination.

1.9. Relevant national legislation, including any national provisions concerning the activities referred to in Article 1(3)(b).

1.10. Any financial assistance provided to food and feed businesses in the context of the national control programme;

2. Concerning food and feed businesses covered by the programme

2.1. The structure of the production of the given species and products thereof.

2.2. The structure of the production of feed.

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, drinking water, people working at farms, and

- hygiene in transporting animals to and from farms.

2.4. Routine veterinary supervision of farms.

2.5. Registration of farms.

2.6. Record-keeping at farms.

2.7. Documents to accompany animals when dispatched.

2.8. Other relevant measures to ensure the traceability of animals.

B. Minimum sampling requirements

1. After the relevant control programme referred to in Article 5 has been approved, food business operators must have samples taken and analysed to test for the zoonoses and zoonotic agents listed in Annex I, column 1, respecting the minimum sampling requirements set out in the following table.

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2. The requirements laid down in point 1 are without prejudice to the requirements of Community legislation concerning ante mortem inspection.

3. The results of the analysis must be recorded, together with the following information:

(a) date and place of sampling; and

(b) identification of the flock/herd.

4. Immunological testing may not be used if the animals have been vaccinated, unless it has been proven that the vaccine used does not interfere with the testing method applied.

C. Specific requirements concerning breeding flocks of Gallus gallus

1. The measures laid down in points 3 to 5 must be taken whenever the analysis of samples carried out in accordance with part B indicates the presence of Salmonella enteritidis or Salmonella typhimurium in a breeding flock of Gallus gallus in the circumstances set out in point 2.

2. (a) If the competent authority has approved the method of analysis used for samples taken in accordance with part B, it may require that the measures laid down in points 3 to 5 be taken when such analysis detects the presence of Salmonella enteritidis or Salmonella typhimurium.

(b) Otherwise, the measures laid down in points 3 to 5 must be taken whenever the competent authority confirms a suspicion of the presence of Salmonella enteritidis or Salmonella typhimurium arising from the analysis of samples carried out in accordance with part B.

3. Non-incubated eggs from the flock must be destroyed.

However, such eggs may be used for human consumption if they are treated in a manner that guarantees the elimination of Salmonella enteritidis and Salmonella typhimurium in accordance with Community legislation on food hygiene.

4. All 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 Community legislation on food hygiene. Products derived from such birds may be placed on the market for human consumption in accordance with Community legislation on food hygiene and, once applicable, part E. If not destined for human consumption, such products must be used or disposed of in accordance with Regulation (EC) No 1774/2002 of the European Parliament and of the Council of 3 October 2002 laying down health rules concerning animal by-products not intended for human consumption(1).

5. Where eggs for hatching from flocks in which Salmonella enteritidis or Salmonella typhimurium is present are still present in a hatchery, they must be destroyed or treated in accordance with Regulation (EC) No 1774/2002.

D. Specific requirements concerning flocks of laying hens

1. With effect from 72 months after entry into force of this Regulation, eggs must not be used for direct human consumption (as table eggs) unless they originate from a commercial flock of laying hens subject to a national programme established under Article 5 and not under official restriction.

2. Eggs originating from flocks with unknown health status, that are suspected of being infected or from infected flocks may be used for human consumption only if treated in a manner that guarantees the elimination of all salmonella serotypes with public health significance in accordance with Community legislation on food hygiene.

3. When birds from infected flocks are slaughtered or destroyed, steps must be taken to reduce the risk of spreading zoonoses as far as possible. Slaughtering must be carried out in accordance with Community legislation on food hygiene. Products derived from such birds may be placed on the market for human consumption in accordance with Community legislation on food hygiene and, once applicable, part E. If not destined for human consumption, such products must be used or disposed of in accordance with Regulation (EC) No 1774/2002.

E. Specific requirement concerning fresh meat

1. With effect from 84 months after entry into force of this Regulation, fresh poultry meat from animals listed in Annex I may not be placed on the market for human consumption unless it meets the following criterion:

"Salmonella: absence in 25 grams"

2. Within 72 months of entry into force of this Regulation, detailed rules for this criterion will be laid down in accordance with the procedure referred to in Article 14(2). These will specify, in particular, sampling schemes and analytical methods.

3. The criterion laid down in paragraph 1 does not apply to fresh poultry meat destined for industrial heat treatment or another treatment to eliminate salmonella in accordance with Community legislation on food hygiene.


(1) OJ L 273, 10.10.2002, p. 1. Regulation as last amended by Commission Regulation (EC) No 808/2003 (OJ L 117, 13.5.2003, p. 1).


ANNEX III


Specific criteria to determine salmonella serotypes with public health significance

When determining which are the salmonella serotypes with public health significance to which Community targets will apply, account must be taken of the following criteria:

1. the most frequent salmonella serotypes in human salmonellosis on the basis of data collected through EC monitoring systems;

2. the route of infection (that is, the presence of the serotype in relevant animal populations and feed);

3. whether any serotype shows a rapid and recent ability to spread and to cause disease in humans and animals;

4. whether any serotypes show increased virulence, for instance as regards invasiveness, or resistance to relevant therapies for human infections.