CHAPTER IINTRODUCTORY PROVISIONS
Article 1Subject matter and scope
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 F7competent 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 F8exports 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 F10retained EU law provisions on animal health, animal nutrition, food hygiene, communicable human diseases, health and safety in the workplace, gene technology and transmissible spongiform encephalopathies.
Article 2Definitions
For the purposes of this Regulation the following definitions shall apply:
- 1.
the definitions laid down in Regulation (EC) No 178/2002 F11other 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; F12...
- (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)
F13‘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.
- (a)
Article 2AF2Definition of appropriate authority
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.
Article 3Competent authorities
1
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
c
carrying out regular checks on the premises of food and, if needed, feed businesses for the purpose of checking compliance with this Regulation.
F183.
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 IIF4...TARGETS
Article 4F19... Targets for the reduction of the prevalence of zoonoses and zoonotic agents
F201
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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F224
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
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b
c
F27Before 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.
F287
The appropriate authority may, by regulations, amend Annex 3.
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CHAPTER IIICONTROL PROGRAMMES
Article 5F31... Control programmes
1
F32To achieve a target set in accordance with Article 4, the competent authority must establish a control programme.F33... Control programmes shall have regard to the geographical distribution of zoonoses within F34the constituent territory and to the financial implications for primary producers and feed and food business operators of establishing effective controls.
2
F35... Control programmes shall be continuous and cover a period of at least three consecutive years.
3
F36... 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
F37... 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
F38... 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 F39constituent territory, as part of the official controls provided for in Annex II, part A.
F406
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).
Article 6F43Approval of control programmes
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).
Article 7Food and feed business operators' control programmes
1
Food and feed business operators, or organisations representing such operators, may establish F44operator control programmes, covering, as far as possible, all stages of production, processing and distribution.
2
If they wish their F45operator control programmes to form part of a F46... control programme, food and feed business operators, or their representative organisations, shall submit their F45operator control programmes, and any amendments thereto, to the competent authority of the F47constituent territory in which they are located for approval. If the operations concerned take place in F48more than one constituent territory, the programmes shall be approved separately for F49each territory.
3
The competent authority may approve F50operator control programmes submitted pursuant to paragraph 2 only if it is satisfied that the F51operator control programmes comply with the relevant requirements set out in Annex II and with the objectives of the relevant F52control programme established under Article 5.
4
5
Food and feed business operators or their representative organisations shall communicate regularly the results of their F56operator control programmes to the competent authorities.
CHAPTER IVCONTROL METHODS
Article 8Specific control methods
F571
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.
CHAPTER VTRADE
F60Article 9Intra-Community trade
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Article 10Imports from third countries
1
F61... Admission to or retention on the lists of third countries provided for in F62retained EU law, for the relevant species or category, from which F63importation of animals or hatching eggs covered by this Regulation F64is authorised shall be subject to submission to the F65Secretary 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. F66...
F672
The Secretary of State may, by regulations, amend the list of third countries provided for in retained EU 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 F69.... F70The 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.
F714.
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 F73retained EU law, for the relevant category of products, from which F74importation of those products covered by this Regulation F75is authorised shall be subject to submission to the F76Secretary of State by the third country concerned of guarantees equivalent to those provided for by this Regulation.
CHAPTER VILABORATORIES
Article 11Reference laboratories
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3
F824
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).
Article 12Approval of laboratories, quality requirements and approved testing methods
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
2
Laboratories shall regularly participate in collaborative testing organised or coordinated by the F85... reference laboratory.
3
F86Subject 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.
F87...
F884.
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.
F5CHAPTER VIIIMPLEMENTATION
Ch. 7 omitted (31.12.2020) by virtue of The Zoonotic Disease Eradication and Control (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/740), regs. 1, 3(16); 2020 c. 1, Sch. 5 para. 1(1)
Article 13F1Implementing and transitional measures
F5. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Other implementing or transitional measures may be adopted in accordance with the regulatory procedure referred to in Article 14(2).
F5Article 14Committee procedure
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F5Article 15Consultation of the European Food Safety Authority
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F5Article 16Report on financial arrangements
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CHAPTER VIIIGENERAL AND FINAL PROVISIONS
F89Article 17Community controls
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Article 17AF3Regulations: devolved legislative functions
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.
Article 17BF3Regulations: consent required
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.
Article 18Entry 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.
F6...
Word in Ch. 2 heading omitted (31.12.2020) by virtue of The Zoonotic Disease Eradication and Control (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/740), regs. 1, 3(6); 2020 c. 1, Sch. 5 para. 1(1)