
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 
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 Commission,
Having regard to the opinion of the European Economic and Social Committee,
After consulting the Committee of the Regions,
Acting in accordance with the procedure laid down in Article 251 of the Treaty,
Whereas:

(1) Live animals and food of animal origin appear on the list in Annex I to the Treaty. Livestock farming and the placing on the market of food of animal origin constitute an important source of income for farmers. The implementation of veterinary measures aimed at raising the level of public and animal health in the Community assists the rational development of the farming sector.

(2) The protection of human health against diseases and infections transmissible directly or indirectly between animals and humans (zoonoses) is of paramount importance.

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

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

(5) Zoonoses present at the level of primary production must be adequately controlled to ensure that the objectives of this Regulation are achieved. However, in the case of primary production leading to the direct supply of small quantities of primary products, by the food business operator producing them, to the final consumer or to local shops, it is appropriate to protect public health through national law. In this case there is a close relationship between the producer and the consumer. Such production should not make a significant contribution to the average prevalence of zoonoses in animal populations in the Community as a whole. The general requirements for sampling and analysis may not be practical or appropriate for producers with very small numbers of animals who may be located in regions suffering from special geographical constraints.

(6) 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 intoxications provided for the establishment of monitoring systems for certain zoonoses and controls on salmonella in certain poultry flocks.

(7) That Directive required Member States to submit to the Commission the national measures that they had taken to achieve the objectives of the Directive and to draw up plans for monitoring salmonella in poultry. However, Council Directive 97/22/EC amending Directive 92/117/EEC suspended the requirement pending the review provided for in Article 15a of Directive 92/117/EEC.

(8) 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 to avoid the introduction of salmonella on to a farm.

(9) Those minimum measures focused on monitoring and controlling salmonella in breeding flocks of the species Gallus gallus. When serotypes Salmonella enteritidis or Salmonella typhimurium were detected and confirmed in samples taken, Directive 92/117/EEC laid down specific measures to control the infection.

(10) Other Community legislation provides for the monitoring and control of certain zoonoses in animal populations. In particular Council Directive 64/432/EEC of 26 June 1964 on animal health problems affecting intra-Community trade in bovine animals and swine deals with bovine tuberculosis and bovine brucellosis. Council Directive 91/68/EEC of 28 January 1991 on animal health conditions governing intra-Community trade in ovine and caprine animals deals with ovine and caprine brucellosis. This Regulation should not create any unnecessary duplication of these existing requirements.

(11) Moreover, future Community legislation on food hygiene should cover specific elements necessary for the prevention, control and monitoring of zoonoses and zoonotic agents and include specific requirements for the microbiological quality of food.

(12) 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.

(13) 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 do not necessarily give the full picture of the situation.

(14) In its opinion on zoonoses adopted on 12 April 2000, the Scientific Committee on Veterinary Measures relating to Public Health considered that the measures in place at that time to control food-borne zoonotic infections were insufficient. It further considered that the epidemiological data that Member States were collecting were incomplete and not fully comparable. As a consequence, the Committee recommended improved monitoring arrangements and identified risk management options.

(15) It is therefore necessary to improve the existing control systems for specific zoonotic agents. Simultaneously, the rules laid down in 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 will replace the monitoring and data collection systems established by Directive 92/117/EEC.

(16) In principle, controls should cover the whole food chain, from farm to table.

(17) The rules governing such controls should generally be those laid down under Community legislation on feedingstuffs, animal health and food hygiene.

(18) However, for certain zoonoses and zoonotic agents it is necessary to lay down specific requirements for controls.

(19) Those specific requirements should be based on targets for the reduction of the prevalence of zoonoses and zoonotic agents.

(20) The targets should be established for zoonoses and zoonotic agents in animal populations taking account, in particular, of their frequency and epidemiological trends in animal and human populations, feed and food, their gravity for humans, their potential economic consequences, scientific advice and the existence of appropriate measures to reduce their prevalence. Targets may be established in respect of other parts of the food chain, where necessary.

(21) To ensure the achievement of the targets in good time, Member States should set up specific control programmes, which the Community should approve.

(22) The main responsibility for the safety of food should lie with food and feed business operators. Member States should, therefore, encourage the creation of business-wide control programmes.

(23) Within their control programmes, Member States and food and feed business operators 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 Community to decide that certain control methods should not be used as part of control programmes.

(24) 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 the prevalence of specified zoonoses and zoonotic agents. It should, therefore, be possible to approve the use of such methods at Community level.

(25) 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 purchasers 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. Directive 64/432/EEC, Council Directive 72/462/EEC of 12 December 1972 on health and veterinary inspection problems upon importation of bovine animals and swine and fresh meat from third countries 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 eggs should be amended accordingly.

(26) The adoption of this Regulation should not affect the additional guarantees agreed for Finland and Sweden on their accession to the Community and confirmed by Commission Decisions 94/968/EC, 95/50/EC, 95/160/EC, 95/161/EC, 95/168/EC and by Council Decisions 95/409/EC, 95/410/EC and 95/411/EC. This Regulation should provide a procedure for the granting, for a transitional period, of guarantees to any Member State that has an approved national control programme exceeding the minimum Community requirements in relation to salmonella. The results of tests on live animals and hatching eggs traded with such a Member State should meet the criteria laid down in its national control programme. Future Community legislation on hygiene rules for food of animal origin should provide a similar procedure in respect of meat and table eggs.

(27) Third countries exporting to the Community must implement equivalent measures for the control of zoonoses at the same time as measures are applied in the Community.

(28) 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 food business operators to adapt to the measures envisaged, which may be adapted further in particular in the light of scientific risk assessment.

(29) It is appropriate to designate national and Community reference laboratories to give guidance and assistance on matters falling within the scope of this Regulation.

(30) To ensure the uniform application of this Regulation, provision should be made for the organisation of Community audits and inspections in accordance with other Community legislation in this field.

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

(32) To take account of technical and scientific progress, close and effective cooperation should be ensured between the Commission and the Member States within the Standing Committee set up by Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority, and laying down procedures in matters of food safety.

(33) The measures necessary for the implementation of this Regulation should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission,
HAVE ADOPTED THIS REGULATION:

CHAPTER I
INTRODUCTORY PROVISIONS
Subject matter and scope
Article 1 

1. 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.
2. 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  competent authorities  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  exports to member States  and imports from third countries of certain animals and products thereof.
3. 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.
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5. This Regulation shall apply without prejudice to more specific  assimilated law  provisions on animal health, animal nutrition, food hygiene, communicable human diseases, health and safety in the workplace, gene technology and transmissible spongiform encephalopathies.
Definitions
Article 2 
For the purposes of this Regulation the following definitions shall apply:

1.. the definitions laid down in Regulation (EC) No 178/2002 other than the definitions of  ‘appropriate authority’ and  ‘third country’;
2.. the definitions laid down in Directive 2003/99/EC; and
3.. the following definitions:

((a)) ‘herd’ means an animal or group of animals kept on a holding as an epidemiological unit; ...
((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;
((c)) ‘the appropriate authority’ has the meaning given by Article 2A;
((d))  ‘constituent territory’ means England, Wales or Scotland, as the case may be;
((e))  ‘third country’ means a country or territory outside the British Islands.
Definition of appropriate authority
Article 2A 

(1.) Subject to paragraph 2,  ‘the appropriate authority’ means—
(a) in relation to England, the Secretary of State;
(b) in relation to Scotland, the Scottish Ministers;
(d) in relation to Wales, the Welsh Ministers.
(2.) But the appropriate authority is the Secretary of State if consent is given by—
(a) in relation to Scotland, the Scottish Ministers;
(c) in relation to Wales, in respect of the power to make regulations under Articles 4, 5, 8 11 and 12, the Welsh Ministers.
Competent authorities
Article 3 

1. The appropriate authority must  designate a competent authority or competent authorities for the purpose of this Regulation ....
2. 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 ... control programmes provided for in Article 5 ...;
(c) carrying out regular checks on the premises of food and, if needed, feed businesses for the purpose of checking compliance with this Regulation.
(3.) The competent authorities must cooperate with the competent authorities in other constituent territories so as to secure the proper implementation of the requirements of this Regulation.
CHAPTER II
...TARGETS
... Targets for the reduction of the prevalence of zoonoses and zoonotic agents
Article 4 

1. The appropriate authority may, by regulations, set, modify or omit a target for the reduction of the prevalence of the zoonoses and zoonotic agents listed in Annex 1, column 1, in the animal populations listed in Annex 1, column 2.
2. 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.
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4. Before making regulations under paragraph 1, the appropriate authority must—
(a) publish an analysis of the expected costs and benefits of any new target, taking into account the criteria laid down in paragraph 6(c);
(b) take into account data collected in accordance with Article 3(2)(b).
(4A.) The competent authority must, if requested to do so by the appropriate authority, assist in the preparation of the analysis referred to in paragraph 4(a).
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6. 
(a) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
(b) The appropriate authority may, by regulations, amend Annex 1 to alter  the requirements regarding the establishment of ... 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) Before making regulations under point (b), the appropriate authority must take into account, 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.
7. The appropriate authority may, by regulations, amend Annex 3.
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CHAPTER III
CONTROL PROGRAMMES
... Control programmes
Article 5 

1. To achieve a target set in accordance with Article 4, the competent authority must establish a control programme.... Control programmes shall have regard to the geographical distribution of zoonoses within  the constituent territory  and to the  financial implications for primary producers and feed and food business operators of establishing effective controls.
2. ... Control programmes shall be continuous and cover a period of at least three consecutive years.
3. ... 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.
4. ... 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.
5. ... 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  constituent  territory, as part of the official controls provided for in Annex II, part A.
6. The appropriate authority may, by regulations, amend the requirements and minimum sampling rules laid down in Annex 2.
(6A.) Before making regulations under paragraph 6, the appropriate authority must take into account the criteria listed in Article 4(6)(c).
7. Within six months of the establishment of a target under Article 4, the competent authority must submit its control programme to the appropriate authority and set out the measures to be implemented....
Approval of control programmes
Article 6 

1. After the competent authority submits a control programme in accordance with Article 5, the appropriate authority must establish whether it complies with this Regulation.
2. After establishing the conformity of a control programme, the appropriate authority must approve the programme.
3. Amendments to a previously approved programme may be approved to take account of the evolution of the situation in the constituent territory, in particular in the light of the results referred to in Article 5(3)(d).
Food and feed business operators' control programmes
Article 7 

1. Food and feed business operators, or organisations representing such operators, may establish  operator control programmes, covering, as far as possible, all stages of production, processing and distribution.
2. If they wish their  operator control programmes to form part of a ... control programme, food and feed business operators, or their representative organisations, shall submit their  operator control programmes, and any amendments thereto, to the competent authority of the  constituent territory  in which they are located for approval. If the operations concerned take place in  more than one constituent territory, the programmes shall be approved separately for  each territory.
3. The competent authority may approve  operator control programmes submitted pursuant to paragraph 2 only if it is satisfied that the  operator control programmes comply with the relevant requirements set out in Annex II and with the objectives of the relevant  control programme established under Article 5.
4. The competent authority must  maintain up-to-date lists of approved  operator control programmes of food and feed business operators or their representative organisations. The lists shall be made available to  the appropriate authority  upon request.
5. Food and feed business operators or their representative organisations shall communicate regularly the results of their  operator control programmes to the competent authorities.
CHAPTER IV
CONTROL METHODS
Specific control methods
Article 8 

1. The appropriate authority may, by regulations—
(a) require or permit specific control methods for the reduction of prevalence of zoonoses and zoonotic agents to be applied at the stage of the primary production of animals and other stages in the food chain;
(b) prescribe certain specific control methods that may not be used as part of control programmes.
(1A.) Regulations under paragraph 1(a) may, in respect of those specific control methods—
(a) set conditions for their use;
(b) specify documents, procedures and minimum requirements.
2. The provisions referred to in  paragraphs 1(a) and 1A do  not apply to methods using substances or techniques covered by  assimilated law  on animal nutrition, food additives or veterinary medicinal products.
CHAPTER V
TRADE
Intra-Community trade
Article 9 
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Imports from third countries
Article 10 

1. ... Admission to or retention on the lists of third countries provided for in  assimilated law, for the relevant species or category, from which  importation of  animals or hatching eggs covered by this Regulation  is authorised shall be subject to submission to the  Secretary of State  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. ...
2. The Secretary of State may, by regulations, amend the list of third countries provided for in assimilated law referred to in paragraph 1.
(2A.) Before making regulations under paragraph 2 to add to the list, the Secretary of State must be satisfied that the programme which has been submitted meets the requirements set out in paragraph 1.
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4. 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 ....  The date and result of testing must be included in any import certificates which are required for the importation into   Great Britain  of live animals or hatching eggs.
(4.) The Secretary of State may by regulations specify additional zoonoses or zoonotic agents which, for the purposes of paragraph 4, are to be treated as if they are listed in Annex 1, column 1.
(4B.) The Secretary of State may not make regulations under paragraph 4A unless satisfied it is necessary to do so in order to achieve the objective of equivalent guarantees laid down in paragraph 1.
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6. Admission to or retention on the lists of third countries provided for in  assimilated law, for the relevant category of products, from which  importation of  those products covered by this Regulation  is authorised shall be subject to submission to the  Secretary of State  by the third country concerned of guarantees equivalent to those provided for by this Regulation.
CHAPTER VI
LABORATORIES
Reference laboratories
Article 11 

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3. The appropriate authority may  designate ... reference laboratories for the analysis and testing of zoonoses and zoonotic agents listed in Annex I, column 1. ...
4. The appropriate authority may, by regulations, make provision regarding—
(a) the responsibilities and tasks of reference laboratories;
(b) coordination between reference laboratories and laboratories designated under Article 12(1)(a).
Approval of laboratories, quality requirements and approved testing methods
Article 12 

1. 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  ISO  standard at the latest ... within 24 months of the addition of new zoonoses or zoonotic agents to Annex I, column 1.
2. Laboratories shall regularly participate in collaborative testing organised or coordinated by the ... reference laboratory.
3. Subject to paragraph 4, 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....
(4.) Where in the opinion of the appropriate authority it is necessary to do so, the appropriate authority may, by regulations, approve other methods for testing.
CHAPTER VII
IMPLEMENTATION
Implementing and transitional measures
               
Article 13 
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Other implementing or transitional measures may be adopted in accordance with the regulatory procedure referred to in Article 14(2).
Committee procedure
Article 14 
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Consultation of the European Food Safety Authority
Article 15 
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Report on financial arrangements
Article 16 
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CHAPTER VIII
GENERAL AND FINAL PROVISIONS
Community controls
Article 17 
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Regulations: devolved legislative functions
Article 17A 

(1.) This Article applies to regulations made under Article 4, 5, 8, 11 or 12.
(2.) Regulations made by the Secretary of State or the Welsh Ministers are to be made by statutory instrument.
(3.) For regulations made by the Scottish Ministers, see section 27 of the Interpretation and Legislative Reform (Scotland) Act 2010.
(5.) A statutory instrument containing regulations made by the Secretary of State is subject to annulment in pursuance of a resolution of either House of Parliament.
(6.) A statutory instrument containing regulations made by the Welsh Ministers is subject to annulment in pursuance of a resolution of the  Welsh Parliament.
(7.) Regulations made by the Scottish Ministers are subject to the negative procedure (see section 28 of the Interpretation and Legislative Reform (Scotland) Act 2010).
(9.) Such regulations may—
(a) contain consequential, incidental, supplementary, transitional or saving provision (including provision amending, repealing or revoking enactments (which has the meaning given by section 20(1) of the European Union (Withdrawal) Act 2018));
(b) make different provision for different purposes.
Regulations: consent required
Article 17B 

(1.) This Article applies to regulations made under Article 10.
(2.) The Secretary of State may only make regulations in relation to the whole of   Great Britain.
(3.) The Secretary of State may not make regulations without the consent of—
(a) in relation to Wales, the Welsh Ministers;
(b) in relation to Scotland, the Scottish Ministers.
(4.) Where  either of the parties mentioned in paragraph (a) or (b)  requests that the Secretary of State make regulations to which this Article applies, the Secretary of State must have regard to that request.
(5.) Regulations made by the Secretary of State are to be made by statutory instrument.
(6.) A statutory instrument containing regulations is subject to annulment in pursuance of a resolution of either House of Parliament.
(7.) Such regulations may—
(a) contain consequential, incidental, supplementary, transitional or saving provision (including provision amending, repealing or revoking enactments (which has the meaning given by section 20(1) of the European Union (Withdrawal) Act 2018));
(b) make different provision for different purposes.
Entry into force
Article 18 
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.
...
ANNEX I

Specified zoonoses and zoonotic agents for which ... targets for the reduction of prevalence  may  be established pursuant to Article 41. Zoonosis or zoonotic agent 2. Animal population 3. Stage of food chain ...
                            ...
All salmonella serotypes with public health significance Breeding flocks of Gallus gallus Primary production . . . . . .
All salmonella serotypes with public health significance Laying hens Primary production . . . . . .
All salmonella serotypes with public health significance Broilers Primary production . . . . . .
All salmonella serotypes with public health significance Turkeys Primary production . . . . . .
All salmonella serotypes with public health significance Herds of slaughter pigs Slaughter . . . . . .
All salmonella serotypes with public health significance Breeding herds of pigs Primary production . . . . . .
. . .
ANNEX II
CONTROL OF ZOONOSES AND ZOONOTIC AGENTS LISTED IN ANNEX I
A. General requirements for ... control programmes 

The programme must take into account the nature of the zoonosis and/or zoonotic agent concerned and the specific situation in the  constituent territory. 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. General 
 1.1. The occurrence of the zoonosis or zoonotic agent concerned in the  constituent territory.
 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  legislation  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 ... 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

 — 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

All salmonella serotypes with public health significance Turkeys  — birds leaving for slaughter

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


 2. The requirements laid down in point 1 are without prejudice to the requirements of   assimilated  law  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
                     
                      and breeding turkeys
                   
 1. 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 200/2010 and (EC) No 1190/2012, 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.
 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   assimilated  law  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   assimilated  law  on food hygiene. Products derived from such birds may be placed on the market for human consumption in accordance with  assimilated law  on food hygiene and ... part E. If not destined for human consumption, such products must be used or disposed of in accordance with  Regulation (EC) No 1069/2009 of the European Parliament and of the Council laying down health rules as regards animal by-products and derived products not intended for human consumption.
 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  1069/2009.
 6. All references in this section to ‘
                              Salmonella Typhimurium
                           ’ shall also include monophasic 
                              Salmonella Typhimurium
                            with the antigenic formula 1
                           ,4,[5],12:i:-.

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 ... 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  assimilated  law  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 589/2008 laying down detailed rules for implementing Council Regulation (EC) No 1234/2007 as regards marketing standards for eggs;
((b)) marked with the indication referred to in Article 10 of Commission Regulation (EC) No  589/2008  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  assimilated  law  on food hygiene. Products derived from such birds may be placed on the market for human consumption in accordance with  assimilated law  on food hygiene and ... part E. If not destined for human consumption, such products must be used or disposed of in accordance with Regulation (EC) No  1069/2009.
 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 ...; and
((b)) where the flock is subjected to a ... 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  that were presented at the meeting of the Standing Committee on the Food Chain and Animal Health on 15 July 2004; 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;
or
((ii)) bacteriological investigation of the caeca and oviducts of 300 birds;
or
((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.

E. Specific requirement concerning fresh meat 
 1. ... 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.
 2. ...
 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   assimilated  law  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  targets  apply, account must be taken of the following criteria:

1.. the most frequent salmonella serotypes in human salmonellosis on the basis of data collected  by the appropriate authority's  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.
