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Consolidated text: Regulation (EC) No 2160/2003 of the European Parliament and of the Council of 17 November 2003 on the control of salmonella and other specified food-borne zoonotic agents

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This text is meant purely as a documentation tool and has no legal effect. The Union's institutions do not assume any liability for its contents. The authentic versions of the relevant acts, including their preambles, are those published in the Official Journal of the European Union and available in EUR-Lex. Those official texts are directly accessible through the links embedded in this document

►B	REGULATION (EC) No 2160/2003 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 17 November 2003 on the control of salmonella and other specified food-borne zoonotic agents (OJ L 325 12.12.2003, p. 1)

Amended by:

		Official Journal
		No	page	date
►M1	COMMISSION REGULATION (EC) No 1003/2005 of 30 June 2005	L 170	12	1.7.2005
►M2	COUNCIL REGULATION (EC) No 1791/2006 of 20 November 2006	L 363	1	20.12.2006
►M3	COMMISSION REGULATION (EC) No 1237/2007 of 23 October 2007	L 280	5	24.10.2007
►M4	COMMISSION REGULATION (EC) No 213/2009 of 18 March 2009	L 73	5	19.3.2009
►M5	REGULATION (EC) No 596/2009 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 18 June 2009	L 188	14	18.7.2009
►M6	COMMISSION REGULATION (EU) No 517/2011 of 25 May 2011	L 138	45	26.5.2011
►M7	COMMISSION REGULATION (EU) No 1086/2011 of 27 October 2011	L 281	7	28.10.2011
►M8	COUNCIL REGULATION (EU) No 517/2013 of 13 May 2013	L 158	1	10.6.2013
►M9	REGULATION (EU) 2016/429 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 9 March 2016	L 84	1	31.3.2016

Corrected by:

►C1	Corrigendum, OJ L 068, 13.3.2015, p. 90 (517/2011)

▼B

REGULATION (EC) No 2160/2003 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

of 17 November 2003

on the control of salmonella and other specified food-borne zoonotic agents

CHAPTER I

INTRODUCTORY PROVISIONS

Article 1

Subject matter and scope

The purpose of this Regulation is to ensure that proper and effective measures are taken to detect and to control salmonella and other zoonotic agents at all relevant stages of production, processing and distribution, particularly at the level of primary production, including in feed, in order to reduce their prevalence and the risk they pose to public health.

This Regulation shall cover:

(a)

the adoption of targets for the reduction of the prevalence of specified zoonoses in animal populations:

(i)

at the level of primary production; and

(ii)

where appropriate for the zoonosis or zoonotic agent concerned, at other stages of the food chain, including in food and feed;

(b)

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

(c)

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

(d)

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

This Regulation shall not apply to primary production:

(a)

for private domestic use; or

(b)

leading to the direct supply, by the producer, of small quantities of primary products to the final consumer or to local retail establishments directly supplying the primary products to the final consumer.

Member States shall establish, under national law, rules governing the activities referred to in paragraph 3(b). Such national rules shall ensure that the objectives of this Regulation are achieved.

This Regulation shall apply without prejudice to more specific Community provisions on animal health, animal nutrition, food hygiene, communicable human diseases, health and safety in the workplace, gene technology and transmissible spongiform encephalopathies.

Article 2

Definitions

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

the definitions laid down in Regulation (EC) No 178/2002;

the definitions laid down in Directive 2003/99/EC; and

the following definitions:

(a)

‘herd’ means an animal or group of animals kept on a holding as an epidemiological unit; and

(b)

‘flock’ means all poultry of the same health status kept on the same premises or in the same enclosure and constituting a single epidemiological unit; in the case of housed poultry, this includes all birds sharing the same airspace.

Article 3

Competent authorities

Each Member State shall designate a competent authority or competent authorities for the purpose of this Regulation and notify the Commission thereof. If a Member State designates more than one competent authority, it shall:

(a)

notify the Commission of the competent authority that will act as a contact point for contacts with the Commission; and

(b)

ensure that the competent authorities cooperate so as to guarantee the proper implementation of the requirements of this Regulation.

The competent authority or authorities shall be responsible in particular for:

(a)

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

(b)

collecting the data needed to evaluate the means used and the results obtained in carrying out the national control programmes provided for in Article 5 and for submitting those data and results yearly, including the results of any surveys undertaken, to the Commission, having regard to the rules laid down pursuant to Article 9(1) of Directive 2003/99/EC;

(c)

carrying out regular checks on the premises of food and, if needed, feed businesses for the purpose of checking compliance with this Regulation.

CHAPTER II

COMMUNITY TARGETS

Article 4

Community targets for the reduction of the prevalence of zoonoses and zoonotic agents

Community targets shall be established for the reduction of the prevalence of zoonoses and zoonotic agents listed in Annex I, column 1, in the animal populations listed in Annex I, column 2, taking account, in particular, of:

(a)

the experience gained under existing national measures; and

(b)

information forwarded to the Commission or to the European Food Safety Authority under existing Community requirements, in particular in the framework of information provided for in Directive 2003/99/EC, in particular Article 5 thereof.

▼M5

The targets, and any amendments thereto, shall be established by the Commission. Those measures, designed to amend non-essential elements of this Regulation, inter alia, by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 14(3).

▼B

The targets referred to in paragraph 1 shall consist at least of:

(a)

a numerical expression of:

(i)

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

(ii)

the minimum percentage of reduction in the number of epidemiological units remaining positive;

(b)

the maximum time limit within which the target must be achieved;

(c)

the definition of the epidemiological units referred to in (a);

(d)

the definition of the testing schemes necessary to verify the achievement of the target; and

(e)

the definition, where relevant, of serotypes with public health significance or of other subtypes of zoonoses or zoonotic agents listed in Annex I, column 1, having regard to the general criteria listed in paragraph 6(c) and any specific criteria laid down in Annex III.

Community targets shall be established for the first time before the relevant dates indicated in Annex I, Column 4.

(a)

When defining each Community target, the Commission shall provide an analysis of its expected costs and benefits. This analysis shall take account, in particular, of the criteria laid down in paragraph 6(c). Member States shall, on request, provide the Commission with all the assistance necessary to enable it to prepare the analysis.

(b)

Before proposing each Community target, the Commission shall consult Member States within the committee referred to in Article 14(1) on the results of its analysis.

(c)

In the light of the results of that analysis and the consultation of Member States, the Commission shall propose Community targets where appropriate.

However, by way of derogation from paragraphs 2(e) and 4, the following rules shall apply to poultry for a transitional period.

The Community target established for breeding flocks of Gallus gallus for this transitional period shall cover the five most frequent salmonella serotypes in human salmonellosis, which shall be identified on the basis of data collected through EC monitoring systems. The Community targets established for laying hens, broilers and turkeys for the transitional period shall cover Salmonella enteritidis and Salmonella typhimurium. However, if necessary, these targets may be extended to other serotypes on the basis of the results of an analysis carried out in accordance with paragraph 4.

The transitional period shall apply to each Community target for the reduction of the prevalence of salmonella in poultry. It shall last for three years in each case, starting on the date mentioned in column 5 of Annex I.

►M5

(a)

Annex I may be amended by the Commission for the purposes listed in point (b), after taking account in particular of the criteria listed in point (c). Those measures, designed to amend non-essential elements of this Regulation, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 14(3).

◄

(b)

Amendments to Annex I may alter the scope of the requirements regarding the establishment of Community targets by supplementing, restricting or modifying:

(i)

the zoonoses or zoonotic agents;

(ii)

the stages of the food chain; and/or

(iii)

the animal populations concerned.

(c)

The criteria to be considered before amending Annex I include, with respect to the zoonosis or zoonotic agent concerned:

(i)

its frequency in animal and human populations, feed and food;

(ii)

the gravity of its effects for humans;

(iii)

its economic consequences for animal and human health care and for feed and food businesses;

(iv)

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

(v)

scientific advice;

(vi)

technological developments, particularly relating to the practicality of the available control options; and

(vii)

requirements and trends concerning breeding systems and production methods.

▼M5

Annex III may be amended or supplemented by the Commission. Those measures, designed to amend non-essential elements of this Regulation, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 14(3).

▼B

The Commission shall review the implementation of Community targets and take account of this review when proposing further targets.

Measures taken to reduce the prevalence of zoonoses and zoonotic agents listed in Annex I shall be implemented in accordance with the rules laid down in this Regulation and any rules adopted pursuant thereto.

CHAPTER III

CONTROL PROGRAMMES

Article 5

National control programmes

To achieve the Community targets provided for in Article 4, Member States shall establish national control programmes for each zoonosis and zoonotic agent listed in Annex I. National control programmes shall have regard to the geographical distribution of zoonoses within each Member State and to the financial implications for primary producers and feed and food business operators of establishing effective controls.

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

National control programmes shall:

(a)

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

(b)

define the respective responsibilities of competent authorities and food and feed business operators;

(c)

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

(d)

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

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

(a)

feed production;

(b)

primary production of animals;

(c)

processing and preparation of food 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.

▼M5

The requirements and minimum sampling rules laid down in Annex II may be amended, adapted or supplemented by the Commission, after taking account in particular of the criteria listed in Article 4(6)(c). Those measures, designed to amend non-essential elements of this Regulation, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 14(3).

▼B

Within six months of 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.

▼M2

For Bulgaria and Romania, where the date of submission of the national control programmes for other Member States has already passed, the date of submission shall be the date of accession.

▼M8

For Croatia, where the date of submission of the national control programmes for other Member States has already passed, the date of submission shall be the date of accession.

▼B

Article 6

Approval of the national control programmes

After a Member State submits a national control programme in accordance with Article 5, the Commission shall have two months within which to request any further relevant and necessary information from that Member State. The Member State shall provide such further information within two months of receiving such a request. The Commission shall, within two months of receiving such further information or, if it did not request further information, within six months of the submission of the control programme, establish whether it complies with relevant rules, including this Regulation in particular.

When the Commission has established the conformity of a national control programme, or at the request of the Member State that submitted it, the programme shall be considered without undue delay with a view to approval in accordance with the procedure referred to in Article 14(2).

Amendments to a programme previously approved pursuant to paragraph 2 may be approved, in accordance with the procedure referred to in Article 14(2), 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).

Article 7

Food and feed business operators' control programmes

Food and feed business operators, or organisations representing such operators, may establish control programmes, covering, as far as possible, all stages of production, processing and distribution.

If they wish their control programmes to form part of a national control programme, food and feed business operators, or their representative organisations, shall submit their control programmes, and any amendments thereto, to the competent authority of the Member State in which they are located for approval. If the operations concerned take place in different Member States, the programmes shall be approved separately for each Member State.

The competent authority may approve control programmes submitted pursuant to paragraph 2 only if it is satisfied that the control programmes comply with the relevant requirements set out in Annex II and with the objectives of the relevant national control programme.

Member States shall maintain up-to-date lists of approved control programmes of food and feed business operators or their representative organisations. The lists shall be made available to the Commission upon request.

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

CHAPTER IV

CONTROL METHODS

Article 8

Specific control methods

►M5 At the initiative of the Commission or at the request of a Member State: ◄

(a)

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

(b)

rules may be adopted concerning the conditions for the use of the methods referred to in subparagraph (a);

(c)

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

(d)

it may be decided that certain specific control methods shall not be used as a part of control programmes.

▼M5

Those measures, designed to amend non-essential elements of this Regulation by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 14(3).

▼B

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, 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 provided for in Community legislation.

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 regards salmonella as those laid down under its approved 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.

The special measures concerning salmonella that applied to live animals dispatched to Finland and Sweden prior to the entry into force of this Regulation shall continue to apply as if they had been authorised in accordance with paragraph 2.

▼M9

Those special measures shall include measures based on the provisions contained in Decision 95/410/EC in its last version prior to its repeal and Commission Decisions 2003/644/EC ( 1 ) and 2004/235/EC ( 2 ) in the versions thereof at the time of the repeal of Directive 90/539/EEC.

▼M5

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 of this Article may be laid down by the Commission. Those measures, designed to amend non-essential elements of this Regulation by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 14(3).

▼B

Article 10

Imports from third countries

As from the dates mentioned in Annex I, column 5, admission to or retention on 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 and its approval in accordance with this Article. 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. The Food and Veterinary Office of the Commission shall be closely involved in monitoring to verify whether equivalent control programmes exist in third countries.

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) 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, column 2, shall be tested prior to any dispatching of the live animals or hatching eggs from the food business of origin. Flocks and herds shall be tested for the zoonoses and zoonotic agents listed in Annex I, column 1, or, if necessary to achieve the objective of equivalent guarantees laid down in paragraph 1, such zoonoses and zoonotic agents as may be specified in accordance with the procedure referred to in Article 14(2). 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.

▼M5

The Member State of final destination may be authorised, in accordance with the regulatory procedure referred to in Article 14(2), to require for a transitional period that the results of the testing referred to in paragraph 4 of this Article fulfil the same criteria as those laid down under its national programme, in accordance with Article 5(5). The authorisation may be withdrawn and, without prejudice to Article 5(6), specific rules concerning such criteria may be laid down by the Commission. Those measures, designed to amend non-essential elements of this Regulation by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 14(3).

▼B

Admission to or retention on 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, column 1, shall be designated in accordance with the procedure referred to in Article 14(2).

▼M5

The responsibilities and tasks of the Community reference laboratories, in particular with regard to coordination of their activities and those of the national reference laboratories, shall be laid down by the Commission. Those measures, designed to amend non-essential elements of this Regulation by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 14(3).

▼B

Member States shall designate national reference laboratories for the analysis and testing of zoonoses and zoonotic agents listed in Annex I, column 1. The names and addresses of laboratories shall be communicated to the Commission.

▼M5

Certain responsibilities and tasks of the national reference laboratories, in particular with regard to coordination of their activities and those of the relevant laboratories in the Member States designated under Article 12(1)(a), may be laid down by the Commission. Those measures, designed to amend non-essential elements of this Regulation by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 14(3).

▼B

Article 12

Approval of laboratories, quality requirements and approved testing methods

Laboratories participating in control programmes pursuant to Articles 5 and 7 shall, for the purposes of analysing samples to test for the presence of zoonoses and zoonotic agents referred to in Annex I, column 1:

(a)

be designated by the competent authority; and

(b)

apply quality assurance systems that conform to the requirements of the current EN/ISO standard at the latest within 24 months of entry into force of this Regulation or within 24 months of the addition of new zoonoses or zoonotic agents to Annex I, column 1.

Laboratories shall regularly participate in collaborative testing organised or coordinated by the national reference laboratory.

Testing for the presence of zoonoses and zoonotic agents referred to in Annex I, column 1, shall be carried out using the methods and protocols recommended by international standardisation bodies, as reference methods.

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

▼M5

Where necessary, other methods for testing may be approved by the Commission. Those measures, designed to amend non-essential elements of this Regulation by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 14(3).

▼B

CHAPTER VII

IMPLEMENTATION

▼M5

Article 13

Implementing and transitional measures

Appropriate transitional or implementing measures, including the necessary amendments to the relevant health certificates, may be adopted by the Commission. Transitional measures of general scope designed to amend non-essential elements of this Regulation, including those supplementing it with new non-essential elements, in particular further specifications of the requirements laid down in the provisions of this Regulation, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 14(3).

Other implementing or transitional measures may be adopted in accordance with the regulatory procedure referred to in Article 14(2).

▼B

Article 14

Committee procedure

The Commission shall be assisted by the Standing Committee on the Food Chain and Animal Health instituted by Regulation (EC) No 178/2002 (hereinafter referred to as ‘the Committee’).

Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.

The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months.

▼M5

Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.

▼B

Article 15

Consultation of the European Food Safety Authority

The Commission shall consult the European Food Safety Authority on any matter within the scope of this Regulation that could have a significant impact on public health and, in particular, before proposing Community targets in accordance with Article 4 or specific control methods in accordance with Article 8.

Article 16

Report on financial arrangements

The Commission shall, within three years of the entry into force of this Regulation, submit a report to the European Parliament and to the Council.

The report shall discuss:

(a)

the arrangements in place, at Community and national level, to finance measures taken to control zoonoses and zoonotic agents; and

(b)

the effect that such arrangements have on the effectiveness of those measures.

The Commission shall, if appropriate, accompany its report with relevant proposals.

Member States shall, on request, provide the Commission with all the assistance necessary to enable it to prepare its report.

CHAPTER VIII

GENERAL AND FINAL PROVISIONS

Article 17

Community controls

Experts from the Commission shall carry out on-the-spot checks, in cooperation with the competent authorities of Member States, in order to ensure that the provisions of this Regulation, rules adopted pursuant thereto and any safeguard measures are applied uniformly. A Member State on whose territory checks are made shall provide the experts with all the assistance necessary for carrying out their duties. The Commission shall inform the competent authority of the results of the checks made.

▼M5

Practical arrangements for the implementation of this Article, in particular those governing the procedure for cooperation with national competent authorities, shall be laid down under the regulatory procedure referred to in Article 14(2).

▼B

Article 18

Entry into force

This Regulation shall enter into force on the day of its publication in the Official Journal of the European Union.

It shall apply as from six months following its entry into force.

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

ANNEX I

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

1. Zoonosis or zoonotic agent	2. Animal population	3. Stage of food chain	4. Date by which target must be established (*1)	5. Date from which testing must take place
All salmonella serotypes with public health significance	Breeding flocks of Gallus gallus	Primary production	►M1 18 months after the date of entry into force of this Regulation. ◄	18 months after the date referred to in column 4
All salmonella serotypes with public health significance	Laying hens	Primary production	24 months after the date of entry into force of this Regulation.	18 months after the date referred to in column 4
All salmonella serotypes with public health significance	Broilers	Primary production	36 months after the date of entry into force of this Regulation.	18 months after the date referred to in column 4
All salmonella serotypes with public health significance	Turkeys	Primary production	48 months after the date of entry into force of this Regulation.	18 months after the date referred to in column 4
All salmonella serotypes with public health significance	Herds of slaughter pigs	Slaughter	48 months after the date of entry into force of this Regulation.	18 months after the date referred to in column 4
All salmonella serotypes with public health significance	Breeding herds of pigs	Primary production	60 months after the date of entry into force of this Regulation.	18 months after the date referred to in column 4
(*1) These dates are based on the assumption that comparable data on prevalence will be available at least six months before the establishment of the target. If such data were not available, the date for the establishment of the target would be postponed accordingly.

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.

1. Zoonosis or zoonotic agent	2. Animal population	3. Phases of production which sampling must cover
All salmonella serotypes with public health significance	Breeding flocks of Gallus gallus:
	— rearing flocks	— day-old chicks
		— four-week-old birds
		— two weeks before moving to laying phase or laying unit
	— adult breeding flocks	— every second week during the laying period
All salmonella serotypes with public health significance	Laying hens:
	— rearing flocks	— day-old chicks
	— rearing flocks	— pullets two weeks before moving to laying phase or laying unit
	— laying flocks	— every 15 weeks during the laying phase
All salmonella serotypes with public health significance	Broilers	— birds leaving for slaughter (*1)
All salmonella serotypes with public health significance	Turkeys	— birds leaving for slaughter (*1)
All salmonella serotypes with public health significance	Herds of pigs:
	— breeding pigs	— animals leaving for slaughter or carcases at the slaughterhouse
	— slaughter pigs	— animals leaving for slaughter or carcases at the slaughterhouse
(*1) The results of the analysis on the samples must be known before the animals leave for the slaughterhouse.

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.

▼M4

C. Specific requirements concerning breeding flocks of Gallus gallus and breeding turkeys

The measures laid down in points 3 to 5 must be taken whenever the analysis of samples taken in accordance with part B, or in accordance with the testing schemes set out in the Annexes to Commission Regulations (EC) No 1003/2005 ( 3 ) and (EC) No 584/2008 ( 4 ), indicates the presence of Salmonella Enteritidis or Salmonella Typhimurium in a breeding flock of Gallus gallus or breeding turkeys in the circumstances set out in point 2.

▼B

(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.

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 ( 5 ).

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.

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6.	All references in this section to ‘ Salmonella Typhimurium ’ shall also include monophasic Salmonella Typhimurium with the antigenic formula ►C1 1,4,[5],12:i:- ◄ .

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D. Specific requirements concerning flocks of laying hens

1. Eggs shall not be used for direct human consumption as table eggs unless they originate from a commercial flock of laying hens subject to a national control 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 that are infected with Salmonella serotypes for which a target for reduction has been set or which were identified as the source of infection in a specific human foodborne outbreak, may be used for human consumption only if treated in a manner that guarantees the destruction of all Salmonella serotypes with public health significance in accordance with Community legislation on food hygiene.

Eggs originating from flocks with unknown health status, that are suspected of being infected or that are infected with Salmonella serotypes for which a target for reduction has been set or which were identified as the source of infection in a specific human foodborne outbreak, shall be:

(a)

considered as Class B eggs as defined in Article 2(4) of Commission Regulation (EC) No 557/2007 laying down detailed rules for implementing Council Regulation (EC) No 1028/2006 on marketing standards for eggs ( 6 );

(b)

marked with the indication referred to in Article 10 of Commission Regulation (EC) No 557/2007 which clearly distinguishes them from Class A eggs prior to being placed on the market;

(c)

prohibited access to packaging centres unless the competent authority is satisfied with the measures to prevent possible cross-contamination of eggs from other flocks.

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 shall 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.

4. In order to exclude false-positive initial results, the competent authority may lift the restrictions laid down in point 2 of this Part:

(a)

when the flock of layers is not the source of infection for humans by the consumption of eggs or egg products as a result of the epidemiological investigation of food-borne outbreaks in accordance with Article 8 of Directive 2003/99/EC; and

(b)

where the flock is subjected to a national control programme established under Article 5 and Salmonella serotypes for which a target for reduction has been set, is not confirmed by the following sampling protocol carried out by the competent authority:

(i)

the technical specifications referred to in Article 5 of Commission Decision 2004/665/EC (seven samples); however, a sub-sample of 25 grams must be collected of each faecal material and dust sample for analysis; all samples must be analysed separately;

(ii)

bacteriological investigation of the caeca and oviducts of 300 birds;

(iii)

bacteriological investigation of the shell and the content of 4 000 eggs of each flock in pools of maximum 40 eggs.

In addition to the sampling in point (b), the competent authority shall verify the absence of the use of antimicrobials, potentially affecting the result of the analyses of the sampling.

▼B

E. Specific requirement concerning fresh meat

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1. From 1 December 2011, fresh poultry meat from animal populations listed in Annex I shall meet the relevant microbiological criterion set out in Row 1.28 of Chapter 1 of Annex I to Commission Regulation (EC) No 2073/2005 ( 7 ).

▼B

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.

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:

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

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

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

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

( 1 ) Commission Decision 2003/644/EC of 8 September 2003 establishing additional guarantees regarding salmonella for consignments to Finland and Sweden of breeding poultry and day-old chicks for introduction into flocks of breeding poultry or flocks of productive poultry (OJ L 228, 12.9.2003, p. 29).

( 2 ) Commission Decision 2004/235/EC of 1 March 2004 establishing additional guarantees regarding salmonella for consignments to Finland and Sweden of laying hens (OJ L 72, 11.3.2004, p. 86).

( 3 ) OJ L 170, 1.7.2005, p. 12.

( 4 ) OJ L 162, 21.6.2008, p. 3.

( 5 ) 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).

( 6 ) OJ L 132, 24.5.2007, p. 5.

( 7 ) OJ L 338, 22.12.2005, p. 1.

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