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

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.

Article 2

Definitions

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

(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.

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).

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.

(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.

(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.

CHAPTER III

CONTROL PROGRAMMES

Article 5

National control programmes

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.

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.

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.

Article 6

Approval of the national control programmes

Article 7

Food and feed business operators' control programmes

CHAPTER IV

CONTROL METHODS

Article 8

Specific control methods

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.

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).

CHAPTER V

TRADE

Article 9

Intra-Community trade

The authorisation may be withdrawn in accordance with the same procedure.

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.

Article 10

Imports from third countries

CHAPTER VI

LABORATORIES

Article 11

Reference laboratories

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.

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 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).

CHAPTER VII

IMPLEMENTATION

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).

Article 14

Committee procedure

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

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 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.

CHAPTER VIII

GENERAL AND FINAL PROVISIONS

Article 17

Community controls

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

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	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

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:

1.1.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;

2.1.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.