Chwilio Deddfwriaeth

Chwiliad Uwch

Commission Regulation (EU) No 206/2010Dangos y teitl llawn

Commission Regulation (EU) No 206/2010 of 12 March 2010 laying down lists of third countries, territories or parts thereof authorised for the introduction into the European Union of certain animals and fresh meat and the veterinary certification requirements (Text with EEA relevance)

Help about advanced features

Nodweddion Uwch

Help about UK-EU Regulation

Legislation originating from the EU

When the UK left the EU, legislation.gov.uk published EU legislation that had been published by the EU up to IP completion day (31 December 2020 11.00 p.m.). On legislation.gov.uk, these items of legislation are kept up-to-date with any amendments made by the UK since then.

Close

Mae hon yn eitem o ddeddfwriaeth sy’n deillio o’r UE

Mae unrhyw newidiadau sydd wedi cael eu gwneud yn barod gan y tîm yn ymddangos yn y cynnwys a chyfeirir atynt gydag anodiadau.Ar ôl y diwrnod ymadael bydd tair fersiwn o’r ddeddfwriaeth yma i’w gwirio at ddibenion gwahanol. Y fersiwn legislation.gov.uk yw’r fersiwn sy’n weithredol yn y Deyrnas Unedig. Y Fersiwn UE sydd ar EUR-lex ar hyn o bryd yw’r fersiwn sy’n weithredol yn yr UE h.y. efallai y bydd arnoch angen y fersiwn hon os byddwch yn gweithredu busnes yn yr UE. EUR-Lex Y fersiwn yn yr archif ar y we yw’r fersiwn swyddogol o’r ddeddfwriaeth fel yr oedd ar y diwrnod ymadael cyn cael ei chyhoeddi ar legislation.gov.uk ac unrhyw newidiadau ac effeithiau a weithredwyd yn y Deyrnas Unedig wedyn. Mae’r archif ar y we hefyd yn cynnwys cyfraith achos a ffurfiau mewn ieithoedd eraill o EUR-Lex. The EU Exit Web Archive legislation_originated_from_EU_p3

Status:

Point in time view as at 01/07/2022.

Changes to legislation:

There are currently no known outstanding effects for the Commission Regulation (EU) No 206/2010. Help about Changes to Legislation

Close

Changes to Legislation

Revised legislation carried on this site may not be fully up to date. At the current time any known changes or effects made by subsequent legislation have been applied to the text of the legislation you are viewing by the editorial team. Please see ‘Frequently Asked Questions’ for details regarding the timescales for which new effects are identified and recorded on this site.

[X1ANNEX I U.K. UNGULATES

Editorial Information

[F1PART 1 U.K.

List of third countries F2...a

a

Without prejudice to specific certification requirements provided for by any relevant agreement between the [F3United Kingdom] and third countries.

b

Exclusively for live animals other than animals belonging to the cervidae species.

c

F4. . .

d

Not including Kosovo under UNSCR 1244/99.

e
f
F6. . .
ISO code and name of third country F7... F8... Veterinary certificate F9...
Model(s) F10...
1 2 3 4 5 6
F5
[F11CA — Canada POR-X, BOV-X, OVI-X, OVI-Y, RUM]b
CH – Switzerland F4. . .
CL – Chile BOV-X,OVI-X, RUM
POR-X, SUI
[F12EU member States, Liechtenstein and Norway F6. . .BOV-X, BOV-Y, OVI-X, OVI-Y, POR-X, POR-Y, RUM, SUI]
GL – Greenland OVI-X, RUM
F13
IS – Iceland BOV-X, BOV-Y RUM, OVI-X, OVI-Y
POR-X, POR-Y
ME – Montenegro
[F14MK-The Republic of North Macedonia
[F15NZ – New Zealand

BOV-X, BOV-Y,

RUM,

POR-X, POR-Y

OVI-X, OVI-Y]

F16. . .
RS – Serbia d
RU – Russia
BOV-X-TRANSIT-RU
[F17US – United States POR-X]

Textual Amendments

F12Words in Annex 1 Pt. 1 table inserted (31.12.2020) by The Import of, and Trade in, Animals and Animal Products (Miscellaneous Amendments) (EU Exit) Regulations 2020 (S.I. 2020/1462), regs. 1(3), 56(28)(a)(i) (with regs. 69-71)

Specific Conditions (see footnotes in each certificate) U.K.

F18...

:

‘II’

:

territory recognised as having an official tuberculosis-free status for the purposes of exports to [F19Great Britain] of live animals certified according to the model of certificate BOV-X.

‘III’

:

territory recognised as having an official brucellosis-free status for the purposes of exports to [F19Great Britain] of live animals certified according to the model of certificate BOV-X.

‘IVa’

:

territory recognised as having an official enzootic-bovine-leukosis (EBL) free status for the purposes of exports to [F19Great Britain] of live animals certified according to the model of certificate BOV –X.

‘IVb’

:

recognised as having officially enzootic-bovine-leukosis (EBL)-free herds equivalent to the requirements set out in Annex D to Directive 64/432/EEC for the purposes of exports to [F19Great Britain] of live animals certified according to the model of certificate BOV–X.

‘V’

:

territory recognised as having an official brucellosis-free status for the purposes of exports to [F19Great Britain] of live animals certified according to the model of certificate OVI-X.

‘VI’

:

Geographical constraints:

‘VII’

:

territory recognised as having an official tuberculosis-free status for the purposes of exports to [F19Great Britain] of live animals certified according to the model of certificate RUM.

‘VIII’

:

territory recognised as having an official brucellosis-free status for the purposes of exports to [F19Great Britain] of live animals certified according to the model of certificate RUM.

‘IX’

:

territory recognised as having an official Aujeszky’s disease -free status for the purposes of exports to [F19Great Britain] of live animals certified according to the model of certificate POR-X.

F18...

:

‘[F20XI’

:

holdings or compartments recognised as applying controlled housing conditions in accordance with Article 8 of [F21Commission Implementing Regulation (EU) 2015/1375].]

‘[F22XII’

:

territory recognised as having officially tuberculosis-free bovine herds equivalent to those recognised based on the conditions laid down in paragraphs 1 and 2 of Annex A.I to Directive 64/432/EEC, for the purposes of exports to [F19Great Britain] of live animals certified according to the model of veterinary certificate BOV-X or BOV-Y.]

‘[F14XIII’

:

territory recognised as having an official bluetongue and epizootic haemorrhagic disease seasonally free status, for the purpose of exports to [F19Great Britain] of live animals certified according to the model of veterinary certificate BOV-X, OVI-X, OVI-Y or RUM.]]]

Textual Amendments

F18Words in Annex 1 Pt. 1 table omitted (31.12.2020) by virtue of The Import of, and Trade in, Animals and Animal Products (Miscellaneous Amendments) (EU Exit) Regulations 2020 (S.I. 2020/1462), regs. 1(3), 56(28)(a)(iii)(aa) (with regs. 69-71)

F19Words in Annex 1 Pt. 1 table substituted (31.12.2020) by The Import of, and Trade in, Animals and Animal Products (Miscellaneous Amendments) (EU Exit) Regulations 2020 (S.I. 2020/1462), regs. 1(3), 56(28)(a)(iii)(bb) (with regs. 69-71)

F21Words in Annex 1 Pt. 1 table substituted (31.12.2020) by The Import of, and Trade in, Animals and Animal Products (Miscellaneous Amendments) (EU Exit) Regulations 2020 (S.I. 2020/1462), regs. 1(3), 56(28)(a)(iii)(cc) (with regs. 69-71)

Textual Amendments

Modifications etc. (not altering text)

F23 PART 2 U.K. Models of Veterinary Certificates

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F24 PART 3 U.K. Addendum for transport of animals by sea (To be completed and attached to the veterinary certificate when transport to the Union frontier includes, even for part of the journey, transportation by ship.)

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F24Annex 1 Pt. 3 omitted (31.12.2020) by virtue of The Import of, and Trade in, Animals and Animal Products (Miscellaneous Amendments) (EU Exit) Regulations 2020 (S.I. 2020/1462), regs. 1(3), 56(28)(b) (with regs. 69-71)

F25 PART 4 U.K. Addendum for transport of animals by air (To be completed and attached to the veterinary certificate when transport to the Union frontier includes, even for part of the journey, transportation by air.)

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F25Annex 1 Pt. 4 omitted (31.12.2020) by virtue of The Import of, and Trade in, Animals and Animal Products (Miscellaneous Amendments) (EU Exit) Regulations 2020 (S.I. 2020/1462), regs. 1(3), 56(28)(b) (with regs. 69-71)

PART 5 U.K. Conditions for the approval of assembly centres (referred to in Article 4)

In order to be approved, assembly centres must meet the following requirements:

I.

They must be supervised by an official veterinarian.

II.

They must each be situated at the centre of an area of at least 20 km in diameter in which, according to official findings, there has been no case of foot-and-mouth disease for at least a period of 30 days prior to their use as approved assembly centres.

III.

They must, before each use as approved assembly centres, be cleansed and disinfected with a disinfectant officially authorised in the exporting country as effective for the control of foot-and-mouth disease.

IV.

They must have, taking into account their animal capacity:

(a)

a facility dedicated exclusively for use as an assembly centre;

(b)

appropriate facilities, that are easy to clean and disinfect, for loading, unloading and adequate housing of a suitable standard for the animals, for watering and feeding them, and for giving them any necessary treatment;

(c)

appropriate facilities for inspection and isolation;

(d)

appropriate equipment for cleaning and disinfecting rooms and trucks;

(e)

an appropriate storage area for fodder, litter and manure;

(f)

an appropriate system for collecting and disposal of waste water;

(g)

an office for the official veterinarian.

V.

When operating, they must have sufficient veterinarians to carry out all duties set out in Part 5;

VI.

They must only admit animals that are individually identified so as to guarantee traceability. To this end, when animals are admitted the owner or the person in charge of the centre must ensure that the animals are properly identified and accompanied by health documents or certificates for the species and categories involved.

In addition, the owner or the person in charge of the assembly centre must record on a register or in a data base, and retain for at least three years the name of the owner, the origin of the animals, the dates of entry and exit, the identification number of the animals or registration number of the herd of origin and the holding of destination, and, the registration number of the carrier and the registration number of the lorry delivering or collecting animals from that assembly centre.

VII.

All animals passing through the assembly centre must fulfil the health conditions established for the introduction of the relevant category of animal into [F26Great Britain].

VIII.

Animals to be introduced into [F26Great Britain] which pass through an assembly centre must, within six days of arrival at the assembly centre, be loaded and dispatched directly to the border of the exporting country:

(a)

without coming into contact with cloven-hoofed animals other than animals which fulfil the health conditions established for the introduction of the relevant category of animal into [F26Great Britain];

(b)

segregated into consignments so that no consignment contains both animals for breeding or production and animals for immediate slaughter;

(c)

in transport vehicles or containers which have first been cleansed and disinfected with a disinfectant officially authorised in the exporting country as effective for the control of foot-and-mouth disease and which are so constructed that faeces, urine, litter or fodder cannot flow or fall out during transportation.

IX.

Where the conditions for the export of animals to [F26Great Britain] require that a test is carried out within a specified period before loading, that period must include any period of assembly, up to six days, from the date of arrival of the animals at the approved assembly centre.

X.

The exporting third country must designate the centres which are approved for animals for breeding and production and those centres which are approved for animals for slaughter and must notify the [F27appropriate authority] of the names and addresses of such premises. That information must be updated regularly.

XI.

The exporting third country shall determine the procedure for official supervision of approved assembly centres and shall ensure that such supervision is carried out.

XII.

The approved assembly centres must be regularly inspected by the competent authority of the third country in order to check that the requirements for approval set out in points I to XI continue to be fulfilled.

If those inspections show that those conditions are no longer complied with, the approval of the centre must be suspended. The approval may be restored only when the competent authority of the third country is satisfied that the centre fully complies with the conditions set out in points I to XI.

Textual Amendments

PART 6 U.K. Protocols for the standardisation of materials and testing procedures (referred to in Article 5)

Tuberculosis (TBL) U.K.

The single intradermal tuberculin test using bovine tuberculin shall be carried out [F28in a manner equivalent to the standards in] Annex B to Directive 64/432/EEC. In the case of Suidae animals, the single intradermal tuberculin test using avian tuberculin shall be carried out [F28in a manner equivalent to the standards in] Annex B to 64/432/EEC, except that the site of injection shall be the loose skin at the base of the ear.

Textual Amendments

[F29Brucellosis ( Brucella abortus ) (BRL) U.K.

The serum agglutination test, complement fixation test, buffered brucella antigen test, enzyme-linked immunosorbent assays (ELISA) and fluorescence polarisation assay (FPA) shall be carried out [F28in a manner equivalent to the standards in] Annex C to Directive 64/432/EEC.]

Textual Amendments

Brucellosis (Brucella melitensis) (BRL) U.K.

Tests shall be carried out [F28in a manner equivalent to the standards in] Annex C to Directive 91/68/EEC.

Enzootic Bovine Leukosis (EBL) U.K.

The agar gel immuno-diffusion test and the enzyme linked immuno-absorbent assay test (ELISA) shall be carried out [F28in a manner equivalent to the standards in] paragraphs A and C of Chapter II of Annex D to Directive 64/432/EEC.

Bluetongue (BTG) U.K.

A.

The blocking or competitive ELISA test shall be carried out according to the following protocol: U.K.

The competitive ELISA using monoclonal antibody 3-17-A3 is capable of identifying antibodies to all known serotypes of bluetongue virus (BTV).

The principle of the test is the interruption of the reaction between BTV antigen and a group-specific monoclonal antibody (3-17-A3) by the addition of test serum. Antibodies to BTV present in the test serum block the reactivity of the monoclonal antibody (Mab) and result in a reduction in the expected colour development after the addition of enzyme labelled anti-mouse antibody, and chromogen/ substrate. Sera can be tested at a single dilution of 1:5 (spot test – Appendix 1) or may be titrated (serum titration – Appendix 2) to give dilution end-point. Inhibition values higher than 50 % may be regarded as positive.

Material and Reagents: U.K.
1.

Appropriate ELISA microtitre plates.

2.

Antigen: supplied as a cell extracted concentrate, prepared as described below, and stored at either – 20 °C or – 70 °C.

3.

Blocking buffer: phosphate buffered saline (PBS) containing 0,3 % BTV negative adult bovine serum, 0,1 % (v/v) Tween-20 (supplied as polyoxyethylene sorbiton monolaurate syrup) in PBS.

4.

Monoclonal antibody: 3-17-A3 (supplied as hybridoma tissue-culture supernatant) directed against the group-specific polypeptide VP7, stored at - 20 °C or freeze-dried and diluted 1/100 with blocking buffer before use.

5.

Conjugate: rabbit anti-mouse globulin (adsorbed and eluted) conjugated to horseradish peroxidase and kept in the dark at 4 °C.

6.

Chromogen and substrate: Orthophenylene diamine (OPD-chromogen) at a final concentration of 0,4 mg/ml in sterile distilled water. Hydrogen peroxide (30 %w/v-substrate) 0,05 % v/v added immediately before use (5μl H 2 O 2 per 10 ml OPD). ( Handle OPD with care - wear rubber gloves - suspected mutagen ).

7.

1 Molar sulphuric acid: 26,6 ml of acid added to 473,4 ml of distilled water. ( Remember Acid must be added to water, never water to acid .)

8.

Orbital shaker.

9.

ELISA plate reader ( the test may be read visually ).

Test format U.K.

Cc: conjugate control (no serum/ no monoclonal antibody); C++: strong positive serum control; C+: weak positive serum control; C-: negative serum control; Cm: monoclonal antibody control (no serum).

APPENDIX 1:

Spot dilution (1:5) format (40 sera/plate)

Controls Test Sera
1 2 3 4 5 6 7 8 9 10 11 12
A Cc C- 1 2 3 4 5 6 7 8 9 10
B Cc C- 1 2 3 4 5 6 7 8 9 10
C C++ C++
D C++ C++
E C+ C+
F C+ C+
G Cm Cm 40
H Cm Cm 40
APPENDIX 2:

Serum titration format (10 sera/plate)

Controls Test Sera
1 2 3 4 5 6 7 8 9 10 11 12
A Cc C- 1:5 1:5
B Cc C- 1:10 1:10
C C++ C++ 1:20 1:20
D C++ C++ 1:40 1:40
E C+ C+ 1:80 1:80
F C+ C+ 1:160 1:160
G Cm Cm 1:320 1:320
H Cm Cm 1:640 1:640
Test protocol: U.K.
Conjugate control (Cc)

:

Wells 1A and 1B are a blank control consisting of BTV antigen and conjugate. This may be used to blank the ELISA reader.

Mab control (Cm)

:

Columns 1 and 2, rows G and H are the monoclonal antibody control and contain BTV antigen, monoclonal antibody and conjugate. These wells represent maximum colour. The mean of the optical density readings from this control represents the 0 % inhibition value.

Positive control (C++, C+)

:

Columns 1 and 2, rows C-D-E-F. These wells contain BTV antigen, BTV strong and weak positive antiserum respectively, Mab and conjugate.

Negative control (C-)

:

Wells 2A and 2B are the negative controls, which contain BTV antigen, BTV negative antiserum, Mab and conjugate.

Test sera

:

For large-scale serological surveys and rapid screening, sera may be tested at a single dilution of 1:5 (Appendix 1). Alternatively, 10 sera may be tested over a dilution range from 1:5 to 1:640 (Appendix 2). This will give some indication of the titre of antibody in the test sera.

Procedure: U.K.
1.

Dilute BTV antigen to pre-titrated concentration in PBS, sonicate briefly to disperse aggregated virus (if sonicator is not available, pipette vigorously) and add 50 μl to all wells of the ELISA plate. Tap sides of plate to disperse antigen.

2.

Incubate at 37 °C for 60 minutes on an orbital shaker. Wash plates three times by flooding and emptying the wells with non-sterile PBS and blot dry on absorbent paper.

3.

Control wells: Add 100 μl of blocking buffer to Cc wells. Add 50 ul of positive and negative control sera, at a dilution of 1:5 (10 μ l sera + 40 μl blocking buffer), to respective wells C-, C+ and C++. Add 50μl blocking buffer to Mab control wells.

Spot titration method: Add a 1:5 dilution of each test serum in blocking buffer to duplicate wells of columns 3 to 12 (10 μl sera + 40 μl blocking buffer),

or

Serum titration method: Prepare a two-fold dilution series of each test sample (1:5 to 1:640) in blocking buffer across eight wells of single columns 3 to 12.

4.

Immediately after the addition of the test sera, dilute Mab 1:100 in blocking buffer and add 50 μl to all wells of the plate except for the blank control.

5.

Incubate at 37 °C for 60 minutes on an orbital shaker. Wash three times with PBS and blot dry.

6.

Dilute rabbit anti-mouse concentrate to 1/ 5 000 in blocking buffer and add 50 μl to all wells of the plate.

7.

Incubate at 37 °C for 60 minutes on an orbital shaker. Wash three times with PBS and blot dry.

8.

Thaw the O-Phenylenediamine dihydrochloride (OPD) and immediately before use add 5 μl of 30 % hydrogen peroxide to each 10 ml of OPD. Add 50 μl to all wells of the plate. Allow colour to develop for approximately 10 minutes and stop the reaction with 1 Molar sulphuric acid (50 μl per well). Colour should develop in the Mab control wells and in those wells containing sera with no antibody to BTV.

9.

Examine and record the plates either visually or using a spectrophotometric reader.

Analysis of results: U.K.

Using the software package print out the optical density (OD) values, and the percentage inhibition (PI) for test and control sera based on the mean value recorded in the antigen control wells. The date expressed as OD and PI values are used to determine whether the test has performed within acceptable limits. The upper control limits (UCL) and lower control limits (LCL) for the Mab control (antigen plus Mab in the absence of test sera) are between OD values 0,4 and 1.4. Any plate that fails to conform to the above criteria must be rejected.

If a computer software package is not available print out the OD values using the ELISA printer. Calculate the mean OD value for the antigen control wells, which is equivalent to the 100 % value. Determine the 50 % OD value and manually calculate the positivity and negativity of each sample.

Percentage inhibition (PI) value = 100 – (OD of each test control/Mean OD of Cm) × 100.

The duplicate negative control serum wells and the duplicate blank wells must record PI values between + 25 % and – 25 %, and between + 95 % and + 105 %, respectively. Failure to be within these limits does not invalidate the plate but does suggest that background colour is developing. The strong and weak positive control sera must record PI values between + 81 % and + 100 %, and between + 51 % and + 80 %, respectively.

The diagnostic threshold for test sera is 50 % (PI 50 % or OD 50 %). Samples recording PI values >50 % are recorded negative. Samples that record PI values above and below the threshold for the duplicate wells are considered doubtful; such samples may be re-tested in the spot test and/or titration. Positive samples may also be titrated to provide an indication of the degree of positivity.

Visual reading: Positive and negative samples are easily discernible by eye; weakly positive or strong negative samples may be more difficult to interpret by eye.

Preparation of BTV ELISA antigen: U.K.
1.

Wash 40-60 roux of confluent BHK-21 cells three times with serum-free Eagle's medium and infect with bluetongue virus serotype 1 in serum-free Eagle's medium.

2.

Incubate at 37 °C and examine daily for cytopathic effect (CPE).

3.

When CPE are complete in 90 % to 100 % of the cell sheet of each roux, harvest the virus by shaking any still-attached cells from the glass.

4.

Centrifuge at 2 000 to 3 000 rpm to pellet the cells.

5.

Discard the supernatant and re-suspend the cells in approximately 30 ml of PBS containing 1 % ‘ Sarkosyl ’ and 2 ml phenylmethylsulphonyl fluoride (lysis buffer). This may cause the cells to form a gel and more lysis buffer may be added to reduce this effect. (NB: phenylmethylsulphonyl fluoride is harmful - handle with extreme caution.)

6.

Disrupt the cells for 60 seconds using an ultrasonic probe at an amplitude of 30 microns.

7.

Centrifuge at 10 000 rpm for 10 minutes.

8.

Store the supernatant at + 4 °C and re-suspend the remaining cell pellet in 10 to 20 ml of lysis buffer.

9.

Sonicate and clarify, storing the supernatant at each stage, a total of three times.

10.

Pool the supernatants and centrifuge at 24 000 rpm (100,000 g) for 120 minutes at + 4 °C over a 5 ml cushion of 40 % sucrose (w/v in PBS) using 30 ml Beckmann centrifuge tubes and an SW 28 rotor.

11.

Discard the supernatant, drain the tubes thoroughly and re-suspend the pellet in PBS by sonication. Store the antigen in aliquots at – 20 °C.

Titration of BTV ELISA antigen: U.K.

Bluetongue ELISA antigen is titrated by the indirect ELISA. Twofold dilutions of antigen are titrated against a constant dilution (1/100) monoclonal antibody 3-17-A3. The protocol is as follows:

1.

Titrate a 1:20 dilution of BTV antigen in PBS across the microtitre plate in a twofold dilution series (50 μl/well) using a multichannel pipette.

2.

Incubate for one hour at 37 °C on an orbital shaker.

3.

Wash plates three times with PBS.

4.

Add 50 μl of monoclonal antibody 3-17-A3 (diluted 1/100) to each well of the microtitre plate.

5.

Incubate for one hour at 37 °C on an orbital shaker.

6.

Wash plates three times with PBS.

7.

Add 50 μl of rabbit anti-mouse globulin conjugated to horseradish peroxidase, diluted to a pre-titrated optimal concentration, to each well of the microtitre plate.

8.

Incubate for one hour at 37 °C on an orbital shaker.

9.

Add substrate and chromogen as described previously. Stop the reaction after 10 minutes by the addition of 1 Molar sulphuric acid (50 μl/well).

In the competitive assay, the monoclonal antibody must be in excess, therefore a dilution of antigen is chosen which falls on the titration curve (not on the plateau region) which gives approximately 0,8 OD after 10 minutes.

B.

The agar gel immuno-diffusion test shall be carried out according to the following protocol: U.K.

Antigen: U.K.

Precipitating antigen is prepared in any cell culture system that supports the rapid multiplication of a reference strain of bluetongue virus. BHK or Vero cells are recommended. Antigen is present in the supernatant fluid at the end of virus growth but requires 50 to 100-fold concentration to be effective. This may be achieved by any standard protein concentration procedure; virus in the antigen may be inactivated by the addition of 0,3 % (v/v) beta-propiolactone.

Known positive control serum: U.K.

Using the international reference serum and antigen a national standard serum is produced, standardised for optimal proportion against the international reference serum, freeze-dried and used as the known control serum in each test.

Test serum U.K.
Procedure

:

1 % agarose prepared in borate or sodium barbitol buffer, pH 8,5 to 9,0, is poured into a petri dish to a minimum depth of 3,0 mm. A test pattern of seven moisture-free wells, each 5,0 mm in diameter, is cut in the agar. The pattern consists of one centre well and six wells arranged round it in a circle of radius 3 cm. The central well is filled with the standard antigen. Peripheral wells 2, 4 and 6 are filled with known positive serum, wells 1, 3 and 5 are filled with test sera. The system is incubated for up to 72 hours at room temperature in a closed humid chamber.

Interpretation

:

A test serum is positive if it forms a specific precipitin line with the antigen and forms a complete line of identity with the control serum. A test serum is negative if it does not form a specific line with the antigen and it does not bend the line of the control serum. Petri dishes must be examined against a dark background and using indirect illumination.

Epizootic haemorrhagic disease (EHD) U.K.

The agar gel immuno-diffusion test shall be carried out according to the following protocol: U.K.

Antigen: U.K.

Precipitating antigen is prepared in any cell culture system that supports the rapid multiplication of the appropriate serotype(s) of epizootic haemorrhagic disease virus. BHK or Vero cells are recommended. Antigen is present in the supernatant fluid at the end of virus growth but requires 50 to 100-fold concentration to be effective. This may be achieved by any standard protein concentration procedure; virus in the antigen may be inactivated by the addition of 0,3 % (v/v) beta-propiolactone.

Known positive control serum: U.K.

Using the international reference serum and antigen a national standard serum is produced, standardised for optimal proportion against the international reference serum, freeze-dried and used as the known control serum in each test.

Test serum U.K.

Procedure

:

1 % agarose prepared in borate or sodium barbitol buffer, pH 8,5 to 9,0, is poured into a petri dish to a minimum depth of 3,0 mm. A test pattern of seven moisture-free wells, each 5,0 mm in diameter, is cut in the agar. The pattern consists of one centre well and six wells arranged round it in a circle of radius 3 cm. The central well is filled with the standard antigen. Peripheral wells 2, 4 and 6 are filled with known positive serum, wells 1, 3 and 5 are filled with test sera. The system is incubated for up to 72 hours at room temperature in a closed humid chamber.

Interpretation

:

A test serum is positive if it forms a specific precipitin line with the antigen and forms a complete line of identity with the control serum. A test serum is negative if it does not form a specific line with the antigen and it does not bend the line of the control serum. Petri dishes must be examined against a dark background and using indirect illumination.

Infectious bovine rhinotracheitis (IBR) / infectious pustular vulvo-vaginitis (IPV) U.K.

A. The serum neutralisation test shall be carried out according to the following protocol: U.K.

Serum

:

All sera are heat-inactivated at 56 °C for 30 minutes before use.

Procedure

:

The constant virus-varying serum neutralisation test on microtitre plates employs MDBK or other susceptible cells. The Colorado, Oxford or any other reference strain of the virus is used at 100 TCID50 per 0,025 ml; inactivated undiluted serum samples are mixed with an equal volume (0,025 ml) of virus suspension. The virus/serum mixtures are incubated for 24 hours at 37 °C in the microtitre plates before the MDBK cells are added. Cells are used at a concentration which forms a complete monolayer after 24 hours.

Controls

:

(i) virus infectivity assay, (ii) serum toxicity controls, (iii) uninoculated cell culture controls, (iv) reference antisera.

Interpretation

:

The results of the neutralisation test and the titre of the virus used in the test are recorded after three to six days incubation at 37 °C. Serum titres are considered negative if there is no neutralisation at a dilution of 1/2 (undiluted serum).

B. Any other test recognised in the framework of Decision 2004/558/EC (1) . U.K.

Foot-and-mouth disease (FMD) U.K.

A. Collecting oesophageal/pharyngeal samples and testing shall be carried out according to the following protocol: U.K.

Reagents

:

Prior to sampling, transport medium is prepared. Two ml volumes are dispensed in as many containers as there are animals to be sampled. The containers used must withstand freezing over solid CO 2 or liquid nitrogen. Samples are obtained by the use of a specially-designed sputum collector or ‘probang’. To obtain a sample the probang cup is passed through the mouth, over the dorsum of the tongue and down into the upper part of the oesophagus. Attempts are made to scrape the surface epithelium of the upper oesophagus and pharynx by movements directed laterally and dorsally. The probang is then withdrawn, if possible after the animal has swallowed. The cup must be full and contain a mixture of mucus, saliva, oesophageal fluid and cellular debris. Care must be taken to ensure that each specimen contains some visible cellular material. Very rough handling which causes bleeding must be avoided. Samples from some animals may be heavily contaminated with ruminal contents. Such samples must be discarded and the mouth of the animal flushed with water, or preferably physiological saline, before repeat sampling.

Treatmentof samples:

:

Each sample collected in the probang cup is examined for quality and 2 ml added to an equal volume of transport medium in a container which can withstand freezing. The containers are tightly closed, sealed, disinfected and labelled. The samples are kept cool (+ 4 °C) and examined within three to four hours or placed over dry ice (- 69 °C) or liquid nitrogen and kept frozen until examined. Between animals the probang is disinfected and washed in three changes of clean water.

Testing for FMD virus:

:

Samples are inoculated into cultures of primary bovine thyroid cell cultures using at least three tubes per sample. Other susceptible cells such as primary bovine or porcine kidney cells can be used but it must be kept in mind that for some strains of FMD virus they are less sensitive. The tubes are incubated at 37 °C on a roller apparatus and examined daily for 48 hours for the presence of a cytopathic effect (CPE). If negative, cultures are blind passaged onto new cultures and re-examined for 48 hours. The specificity of any CPE must be confirmed.

Recommended transport media:

1.

0,08M phosphate buffer pH 7,2 containing 0,01 % bovine serum albumin, 0,002 % phenol red and antibiotics.

2.

Tissue culture medium (such as Eagle's MEM) containing 0,04 M Hepes buffer, 0,01 % bovine serum albumin and antibiotics, pH 7,2.

3.

Antibiotics (per ml final) must be added to the transport medium such as penicillin 1 000 IU, neomycin sulphate100 IU, polymyxin B sulphate50 IU, mycostatin100 IU.

B. The virus neutralisation test shall be carried out according to the following protocol: U.K.

Reagents

:

Stock FMDV antigen is prepared in cell cultures or on cattle tongues and stored at - 70 °C or less or at - 20 °C after the addition of 50 % glycerol. This is the stock antigen. FMDV is stable under these conditions and titres vary little over a period of months.

Procedure

:

The test is carried out in flat-bottomed tissue culture grade microtitre plates using susceptible cells such as IB-RS-2, BHK-21 or calf kidney cells. Sera for the test are diluted 1/4 in serum-free cell culture medium with the addition of 100 IU/ml neomycin or other suitable antibiotics. Sera are inactivated at 56 °C for 30 minutes and 0.05 ml amounts are used to prepare a twofold series on microtitre plates using 0,05 ml diluting loops. Pre-titrated virus also diluted in serum-free culture medium and containing 100 TCID50/0.05 ml is then added to each well. Following incubation at 37 °C for one hour to allow neutralisation to take place, 0,05 ml of suspension cells containing 0,5 to 1.0 × 10 6 cells per 1 ml in cell culture medium containing serum free of FMD antibody is added to each well and the plates are sealed. Plates are incubated at 37 °C. Monolayers are normally confluent within 24 hours. CPE is usually sufficiently advanced at 48 hours for a microscopic reading of the test. At this time a final microscopic reading may be made or the plates may be fixed and stained for macroscopic reading, for instance using 10 % formol-saline and 0,05 % methylene blue.

Controls

:

Controls in each test include homologous antiserum of known titre, a cell control, a serum toxicity control, a medium control, and a virus titration from which the actual amount of virus in the test is calculated.

Interpretation

:

Wells with evidence of CPE are considered to be infected and neutralisation titres are expressed as the reciprocal of the final dilution of serum present in the serum/virus mixtures at the 50 % end point estimated according to the Spearman-Karber method. (Karber, G., 1931, Archiv fuer Experimentelle Pathologie und Pharmokologie, 162, 480.). Tests are considered to be valid when the actual amount of virus used per well in the test is between 101,5 and 102,5 TCID50 and when the titre of the reference serum is within twofold of its expected titre, estimated from the mode of previous titrations. When the controls are outside these limits the tests are repeated. An end point titre of 1/11 or less is taken as negative.

C. The detection and quantification of antibody by ELISA shall be carried out according to the following protocol: U.K.

Reagents

:

Rabbit antisera to 146S antigen of seven types of foot-and-mouth disease virus (FMDV) used at a predetermined optimum concentration in carbonate/bicarbonate buffer, pH 9,6. Antigens are prepared from selected strains of virus grown on monolayers of BHK-21 cells. The unpurified supernatants are used and pretitrated according to the protocol but without serum, to give a dilution which after the addition of an equal volume of PBST (phosphate buffered saline containing 0,05 % Tween-20 and phenol red indicator) would give an optical density reading of between 1,2 and 1,5. The viruses can be used inactivated. PBST is used as a diluent. Guinea-pig antisera are prepared by inoculating guinea pigs with 146S antigen of each serotype. A predetermined optimum concentration is prepared in PBST containing 10 % normal bovine serum and 5 % normal rabbit serum. Rabbit anti-guinea-pig immunoglobulin conjugated to horseradish peroxidase is used at a predetermined optimum concentration in PBST containing 10 % normal bovine serum and 5 % normal rabbit serum. Test sera are diluted in PBST.

Procedure: U.K.
1.

ELISA plates are coated with 50 μl of rabbit antiviral sera overnight in a humidity chamber at room temperature.

2.

Fifty microlitres of a duplicate, twofold series of each test serum starting at 1/4 are prepared in U-bottomed multiwell plates (carrier plates). Fifty microlitres of a constant dose of antigen are added to each well and the mixtures are left overnight at 4 °C. The addition of the antigen reduces the starting serum dilution to 1/8.

3.

The ELISA plates are washed five times with PBST.

4.

Fifty microlitres of serum/antigen mixtures are then transferred from the carrier plates to the rabbit-serum-coated ELISA plates and incubated at 37 °C for one hour on a rotary shaker.

5.

After washing, 50 μl of guinea-pig antiserum to the antigen used in point 4 is added to each well. The plates are incubated at 37 °C for one hour a rotary shaker.

6.

The plates are washed and 50 μl of rabbit anti-guinea-pig immunoglobulin conjugated to horseradish peroxidase is added to each well. The plates are incubated at 37 °C for one hour on a rotary shaker.

7.

The plates are washed and 50 μl of orthophenylene diamine containing 0,05 % H 2 O 2 (30 %) w/v is added to each well.

8.

The reaction is stopped after 15 minutes with 1,25M H 2 SO 4 .

The plates are read spectrophotometrically at 492 nm on an ELISA reader linked to a microcomputer.

Controls

:

For each antigen used 40 wells contain no serum but contain antigen diluted in PBST. A duplicated twofold dilution series of homologous bovine reference antiserum. A duplicate twofold dilution series of negative bovine serum.

Interpretation

:

Antibody titres are expressed as the final dilution of tests serum giving 50 % of the mean OD value recorded in the virus control wells where test serum is absent. Titres in excess of 1/40 are considered positive.

References

:

Hamblin C, Barnett ITR and Hedger RS (1986) ‘ A new enzyme-linked immunosorbent assay (ELISA) for the detection of antibodies against foot-and-mouth disease virus. I. Development and method of ELISA. ’ Journal of Immunological Methods, 93, 115 to 121.11.

Aujeszky's disease (AJD) U.K.

A. The serum neutralisation test shall be carried out according to the following protocol: U.K.

Serum

:

All sera are heat-inactivated at 56 °C for 30 minutes before use.

Procedure

:

The constant virus-varying serum neutralisation test on microtitre plates employs Vero or other sensitive cell systems. Aujeszky's disease virus is used at 100 TCID50 per 0,025 ml; inactivated undiluted serum samples are mixed with an equal volume (0,025 ml) of virus suspension. The virus/serum mixtures are incubated for two hours at 37 °C in the microtitre plates before the appropriate cells are added. Cells are used at a concentration which forms a complete monolayer after 24 hours.

Controls

:

(i) virus infectivity assay, (ii) serum toxicity controls, (iii) uninoculated cell culture controls, (iv) reference antisera.

Interpretation

:

The results of the neutralisation test and the titre of the virus used in the test are recorded after three to seven days incubation at 37 °C. Serum titres less than 1/2 (undiluted serum) are considered negative.

B. Any other test recognised in the framework of Decision 2008/185/EC (2) . U.K.

Transmissible gastro-enteritis (TGE) U.K.

The serum neutralisation test shall be carried out according to the following protocol:

Serum

:

All sera are heat-inactivated at 56 °C for 30 minutes before use.

Procedure

:

The constant virus-varying serum neutralisation test on microtitre plates employs A72 (dog tumour) cells or other sensitive cell systems. TGE virus is used at 100 TCID50 per 0,025 ml; inactivated undiluted serum samples are mixed with an equal volume (0,025 ml) of virus suspension. The virus/serum mixtures are incubated for 30 to 60 minutes at 37 °C in the microtitre plates before the appropriate cells are added. Cells are used at a concentration which forms a complete monolayer after 24 hours. Each cell receives 0,1 ml of cell suspension.

Controls

:

(i) virus infectivity assay, (ii) serum toxicity controls, (iii) uninoculated cell culture controls, (iv) reference antisera.

Interpretation

:

The results of the neutralisation test and the titre of the virus used in the test are recorded after three to five days incubation at 37 °C. Serum titres less than 1/2 (final dilution) are considered negative. If undiluted serum samples are toxic to the tissue cultures, these sera may be diluted 1/2 before being used in the test. This is equivalent to 1/4 final dilution of serum. Serum titres of less than 1/4 (final dilution) are considered negative in these cases.

Swine vesicular disease (SVD) U.K.

Tests for swine vesicular disease (SVD) shall be carried out according to Decision 2000/428/EC (3) .

Classical swine fever (CSF) U.K.

Tests for classical swine fever (CSF) shall be carried out according to Decision 2002/106/EC (4) .

The performance of tests for CSF must follow the guidelines set out in the relevant chapter of the OIE Manual of Diagnostic Tests and Vaccines for Terrestrial Animals.

The evaluation of sensitivity and specificity of the serological test for CSF must be carried out in a national laboratory with a quality assurance scheme in place. Tests employed must be shown to recognise a range of weak and strong positive reference sera and allow detection of antibody in early phase and convalescence.

[F17Vesicular stomatitis (VS) U.K.

The virus neutralisation (VN) test shall be carried out in accordance with the testing protocols for vesicular stomatitis set out in Chapter 2.1.19 of the OIE Manual of Diagnostic Tests and Vaccines for Terrestrial Animals.

Sera that prevent cytopathic effect (CPE) at dilutions of 1 in 32 or greater shall be considered to contain antibodies to the vesicular stomatitis virus.]

F30 PART 7 U.K. Import and quarantine animal health conditions for animals imported into St. Pierre and Miquelon within a period of less than six months prior to introduction into the Union (referred to in Article 6)

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F30Annex 1 Pt. 7 omitted (31.12.2020) by virtue of The Import of, and Trade in, Animals and Animal Products (Miscellaneous Amendments) (EU Exit) Regulations 2020 (S.I. 2020/1462), regs. 1(3), 56(28)(e) (with regs. 69-71)

ANNEX II U.K. FRESH MEAT

[F29PART 1 U.K.

List of third countries F31... a

Footnotes:
a

Without prejudice to specific certification requirements provided for in [F32agreements between the United Kingdom and third countries].

b

Meat from animals slaughtered on or before the date set out in column 7 may be imported into [F33Great Britain] for 90 days from that date. Consignments carried on vessels on the high seas may be imported into [F33Great Britain] if certified before the date set out in column 7 for 40 days from that date.(N.B.: no date in column 7 means that there are no time restrictions).

c

Only meat from animals slaughtered on or after the date set out in column 8 may be imported into [F33Great Britain] (no date in column 8 means that there are no time restrictions).

d

F34. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

e

Not including Kosovo which is at present under international administration pursuant to United Nations Security Council Resolution 1244 of 10 June 1999 .

f

[F22Hereafter understood as the State of Israel, excluding the territories under Israeli administration since June 1967, namely the Golan Heights, the Gaza Strip, East Jerusalem and the rest of the West Bank.]

g

[F35Only for fresh meat originating from New Zealand, for which New Zealand is authorised for introduction into [F33Great Britain], which is accompanied by the appropriate model of veterinary certificate issued by the competent authority of New Zealand, destined to [F33Great Britain] and being unloaded, with or without storage and reloaded in an approved establishment during transit through Singapore.

h

Upon entry into [F33Great Britain], the consignments should be accompanied both by this model of veterinary certificate issued in TRACES by the competent authority of Singapore and by the appropriate model of veterinary certificate for import of fresh meat issued by the competent authority of New Zealand, which may be attached in TRACES by the competent authority of Singapore.]

i

F34. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

j

[F36Only for transit of consignments of fresh meat of domestic bovine animals via Bulgaria into Turkey.]

F37. . .
*

=

F38...

—

=

No certificates are laid down and fresh meat imports are prohibited (except for those species where indicated in the line comprising the entry for the whole country).

F39. . .

No offal is authorised for introduction into [F33Great Britain] (except, in the case of bovine species, diaphragm and masseter muscles).]

ISO code and name of third country F40... F40... Veterinary certificate F41... F41... F41...
Model(s) F42...
1 2 3 4 5 6 7 8
AL – Albania —
[F14AR-Argentina EQU
[F43BOV, OVI, RUF, RUW]
F44. . .
F45. . .
F46. . .
F47. . .
AU – Australia BOV, OVI, POR, EQU, RUF, RUW, SUF, SUW
[F11BA – Bosnia and Herzegovina j BOV ]
BH – Bahrain —
[F48BR — BRAZIL EQU
[F49BOV]
F50. . .
F51. . .
F52. . .
F53. . .]
[F54BW — Botswana EQU, EQW
[F55BOV, OVI, RUF, RUW]
F56. . .
F57. . .
F58. . .
F59. . .
F60. . .]
BY – Belarus —
BZ – Belize BOV, EQU
CA – Canada BOV, OVI, POR, EQU, SUF, SUW, RUF, RUW
CH – Switzerland F38. . .
CL – Chile BOV, OVI, POR, EQU, RUF, RUW, SUF
CN – China —
CO – Colombia EQU
CR – Costa Rica BOV, EQU
CU – Cuba BOV, EQU
DZ – Algeria —
[F61EU member States, Liechtenstein and Norway F37... BOV, OVI, POR, EQU, RUF, RUW, SUF, SUW [F62, EQW]]
ET – Ethiopia —
FK – Falkland Islands BOV, OVI, EQU
GL – Greenland BOV, OVI, EQU, RUF, RUW
GT – Guatemala BOV, EQU
HK – Hong Kong —
HN – Honduras BOV, EQU
F13. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
[F15IL – Israel f — ]
IN – India —
IS – Iceland BOV, OVI, EQU, RUF, RUW [F63, POR, SUF, SUW, EQW]
[F64JP — Japan BOV]
KE – Kenya —
MA – Morocco EQU
ME – Montenegro BOV, OVI, EQU
MG – Madagascar —
[F14MK-The Republic of North Macedonia BOV, OVI, EQU]
MU – Mauritius —
MX – Mexico BOV, EQU
NA – Namibia EQU, EQW
[F65BOV, OVI, RUF, RUW]
F66. . .
NC – New Caledonia BOV, RUF, RUW
NI – Nicaragua —
NZ – New Zealand BOV, OVI, POR, EQU, RUF, RUW, SUF, SUW
PA – Panama BOV, EQU
[F15PY – Paraguay EQU
[F67BOV]
F68. . .]
RS – Serbia e BOV, OVI, EQU
RU – Russia [F69RUF]
F70. . .
[F35SG — Singapore g NZ-TRANSIT-SG]h
SV – El Salvador —
SZ – Swaziland EQU, EQW
[F71BOV, RUF, RUW]
F72. . .
F73. . .
TH – Thailand —
TN – Tunisia —
TR – Turkey [F74EQU]
F75. . .
UA – Ukraine —
US – United States BOV, OVI, POR, EQU,SUF, SUW, RUF, RUW
[F76UY – Uruguay EQU
[F77BOV, OVI]
F78. . .
F78. . .]
[F79ZA – South Africa EQU, EQW]
F80...
ZW – Zimbabwe — ]

Textual Amendments

F32Words in Annex 2 Pt. 1 table substituted (31.12.2020) by The Import of, and Trade in, Animals and Animal Products (Miscellaneous Amendments) (EU Exit) Regulations 2020 (S.I. 2020/1462), regs. 1(3), 56(29)(a)(ii)(aa) (with regs. 69-71)

F33Words in Annex 2 Pt. 1 table substituted (31.12.2020) by The Import of, and Trade in, Animals and Animal Products (Miscellaneous Amendments) (EU Exit) Regulations 2020 (S.I. 2020/1462), regs. 1(3), 56(29)(a)(ii)(bb) (with regs. 69-71)

F61Words in Annex 2 Pt. 1 table inserted (31.12.2020) by The Import of, and Trade in, Animals and Animal Products (Miscellaneous Amendments) (EU Exit) Regulations 2020 (S.I. 2020/1462), regs. 1(3), 56(29)(a)(i) (with regs. 69-71)

Modifications etc. (not altering text)

F81 PART 2 U.K. Models of veterinary certificates

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F81Annex 2 Pt. 2 omitted (31.12.2020) by virtue of The Import of, and Trade in, Animals and Animal Products (Miscellaneous Amendments) (EU Exit) Regulations 2020 (S.I. 2020/1462), regs. 1(3), 56(29)(b) (with regs. 69-71)

F82 ANNEX III U.K.

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

ANNEX IV U.K. ANIMALS REFERRED TO IN ARTICLE 1(1)(b)

PART 1 U.K. Lists of third countries, territories or parts thereof

SECTION 1 U.K. Parts of third countries or territories referred to in Article 7(2)

a

Suspended from 5 May 2010 . ]]

[F83 Country/territory Code of part of the country/territory Description of part of the country/territory
US – United States US-A The State of Hawaii a

Textual Amendments

F84 PART 2 U.K. Tables of animals and the corresponding model veterinary certificates

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F84Annex 4 Pt. 2 omitted (31.12.2020) by virtue of The Import of, and Trade in, Animals and Animal Products (Miscellaneous Amendments) (EU Exit) Regulations 2020 (S.I. 2020/1462), regs. 1(3), 56(31) (with regs. 69-71)

F85 ANNEX V U.K. Explanatory notes for completing the veterinary certificates (referred to in Article 18)

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

[F86ANNEX VI U.K.

Textual Amendments

PART 1 U.K.

Table 1
‘RUM-A’

:

[F87Model veterinary certificate, in the form published by the appropriate authority from time to time,] for animals of the species listed below that are originating from and intended for an approved body, institute or centre.

Order Family Genera/species
Artiodactyla Antilocapridae Antilocapra ssp.
Bovidae Addax ssp., Aepyceros ssp., Alcelaphus ssp., Ammodorcas ssp., Ammotragus ssp., Antidorcas ssp., Antilope ssp., Bison ssp., Bos ssp. (including Bibos, Novibos, Poephagus), Boselaphus ssp., Bubalus ssp. (including anoa), Budorcas ssp., Capra ssp., Cephalophus ssp., Connochaetes ssp., Damaliscus ssp. (including Beatragus), Dorcatragus ssp., Gazella ssp., Hemitragus ssp., Hippotragus ssp., Kobus ssp., Litocranius ssp., Madoqua ssp., Naemorhedus ssp. (including Nemorhaedus and Capricornis), Neotragus ssp., Oreamnos ssp., Oreotragus ssp., Oryx ssp., Ourebia ssp., Ovibos ssp., Ovis ssp., Patholops ssp., Pelea ssp., Procapra ssp., Pseudois ssp., Pseudoryx ssp., Raphicerus ssp., Redunca ssp., Rupicapra ssp., Saiga ssp., Sigmoceros-Alecelaphus ssp., Sylvicapra ssp., Syncerus ssp., Taurotragus ssp., Tetracerus ssp., Tragelaphus ssp. ( including Boocerus ).
Camelidae Camelus ssp., Lama ssp., Vicugna ssp.
Cervidae Alces ssp., Axis-Hyelaphus ssp., Blastocerus ssp., Capreolus ssp., Cervus-Rucervus ssp., Dama ssp., Elaphurus ssp., Hippocamelus ssp., Hydropotes ssp., Mazama ssp., Megamuntiacus ssp., Muntiacus ssp., Odocoileus ssp., Ozotoceros ssp., Pudu ssp., Rangifer ssp.
Giraffidae Giraffa ssp., Okapia ssp.
Moschidae Moschus ssp.
Tragulidae Hyemoschus ssp., Tragulus-Moschiola ssp.

Textual Amendments

Table 2
‘SUI-A’

:

[F87Model veterinary certificate, in the form published by the appropriate authority from time to time,] for animals of the species listed below that are originating from and intended for an approved body, institute or centre.

Order Family Genera/species
Artiodactyla Suidae Babyrousa ssp., Hylochoerus ssp., Phacochoerus ssp., Potamochoerus ssp., Sus ssp.
Tayassuidae Catagonus ssp., Pecari-Tayassu ssp.
Hippopotamidae Hexaprotodon-Choeropsis ssp., Hippopotamus ssp.
Table 3
‘TRE-A’

:

[F87Model veterinary certificate, in the form published by the appropriate authority from time to time,] for animals of the species listed below that are originating from and intended for an approved body, institute or centre.

Order Family Genera/species
Perissodactyla Tapiridae Tapirus ssp.
Rhinocerotidae Ceratotherium ssp., Dicerorhinus ssp., Diceros ssp., Rhinoceros ssp.
Proboscidea Elephantidae Elephas ssp., Loxodonta ssp.

F88 PART 2 U.K.

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F88Annex 6 Pt. 2 omitted (31.12.2020) by virtue of The Import of, and Trade in, Animals and Animal Products (Miscellaneous Amendments) (EU Exit) Regulations 2020 (S.I. 2020/1462), regs. 1(3), 56(33)(b) (with regs. 69-71)

PART 3 U.K. Requirements concerning bodies, institutes or centres in third countries

The body, institute or centre in a third country must:

(a)

be clearly demarcated and separated from its surroundings;

(b)

have adequate means for catching, confining and isolating animals, and have available adequate quarantine facilities and approved standard operating procedures for animals coming from unknown origin;

(c)

have a vector-protected structure complying with the following requirements:

(i)

it has appropriate physical barriers at entry and exit points;

(ii)

the openings of the vector-protected structure are vector-screened with mesh of appropriate gauge impregnated regularly with an approved insecticide according to the instructions of the manufacturer;

(iii)

vector surveillance and control are carried out within and around the vector-protected structure;

(iv)

measures are taken to limit or eliminate breeding sites for vectors in the vicinity of the vector-protected structure;

(v)

standard operating procedures are in place, including descriptions of back-up and alarm systems, for the operation of the vector-protected structure and for the transport of the animals from that structure to the place of loading;

(d)

keep, for a minimum period of ten years, up-to-date records indicating:

(i)

the number and identity (age, sex, species and individual identification, where appropriate) of the animals of each species present on their premises;

(ii)

the number and identity (age, sex, species and individual identification where appropriate) of animals arriving in or leaving their premises, together with information on their origin or destination, the means of transport, and the health status of those animals;

(iii)

the results of blood tests or any other diagnostic procedures carried out on the animals on their premises;

(iv)

cases of disease and, where appropriate, the treatment administered;

(v)

the results of the post-mortem examinations on animals that have died on their premises, including still-born animals;

(vi)

observations made during any isolation or quarantine period;

(e)

be free from the diseases listed in Annex A to Directive 92/65/EEC or mentioned in the veterinary certificates for the relevant species [F89, in the form published by the appropriate authority from time to time], for at least the previous three years, as evidenced by the records kept pursuant to point (d) and the results of the clinical and laboratory tests carried out on the animals on their premises;

(f)

either have an arrangement with a laboratory approved by the competent authority to perform post-mortem examinations, or have one or more appropriate premises where these examinations may be performed under the authority of the approved veterinarian;

(g)

ensure disposal of the carcasses of animals which die of a disease or are euthanised;

(h)

secure, by contract or legal instrument, the services of a veterinarian approved by and acting under the control of the competent authority, who must perform at least the following tasks:

(i)

ensure that appropriate disease surveillance and control measures are applied in that body, institute or centre. Such measures must be approved by the competent authority of the third country, territory or part thereof where the body, institute or centre is situated, taking into account the disease situation and must include at least the following elements:

  • an annual disease surveillance plan including appropriate control measures concerning zoonoses in the animals present on the premises,

  • clinical, laboratory and post-mortem testing of animals suspected to be affected by transmissible diseases and zoonoses,

  • vaccination of susceptible animals against infectious diseases and zoonoses;

(ii)

ensure that any suspect deaths or the presence of any other symptom suggesting that animals have contracted one or more of the diseases listed in Annex A to Directive 92/65/EEC or mentioned in the veterinary certificates for the relevant species [F90, in the form published by the appropriate authority from time to time,] are notified without delay to the competent authority, where that particular disease is notifiable in the third country, territory or part thereof concerned;

(iii)

ensure that incoming animals have been quarantined as necessary, in accordance with the instructions given by the competent authority;

(iv)

ensure compliance with the animal health requirements which the animals must fulfil in order to be introduced into [F91Great Britain].

Textual Amendments

PART 4 U.K. Conditions concerning the approval of bodies, institutes or centres in third countries

1. Approval must be granted only to those bodies, institutes or centres which comply with the requirements set out in Part 3. U.K.

2. Where vector protection is required, the approval of a structure as vector-protected must be granted only if the criteria in point (c) of Part 3 are met. In order to grant the approval, the competent authority must verify at least three times during the required protection period (at the beginning, during and at the end of the period) the effectiveness of the vector protection measures, by means of a vector trap inside the vector protected structure. U.K.

3. Each approved body, institute and centre must be assigned an approval number. U.K.

4. Approval must be maintained only as long as the following conditions continue to be met: U.K.

the premises are under the control of an official veterinarian, who must perform at least the following tasks:

(i)

inspect the premises of the body, institute or centre at least once per year;

(ii)

audit the activity of the veterinarian referred to in point (h) of Part 3 and the implementation of the annual disease surveillance plan referred to in the first indent of point (h)(i);

(iii)

ensure that the provisions laid down in Parts 3 and 4 are met;

(iv)

verify F92...:

  • compliance with the animal health requirements which the animals must fulfil in order to be introduced into [F93Great Britain];

  • [F94that the results of the clinical, post-mortem and laboratory tests on the animals have revealed no occurrence of the diseases listed in Annex A to Directive 92/65/EEC or mentioned in the veterinary certificates for the relevant species [F95, in the form published by the appropriate authority from time to time].

Textual Amendments

5. The approval must be withdrawn where the competent authority finds that the requirements of Part 3 are no longer being fulfilled. U.K.

6. Where notification is given of the suspicion of the occurrence of one of the diseases listed in Annex A to Directive 92/65/EEC or mentioned in the veterinary certificates for the relevant species [F96, in the form published by the appropriate authority from time to time], the competent authority must suspend the approval of the body, institute or centre, until the suspicion has been officially ruled out. Depending on the disease involved and the risk of disease transmission, the suspension may relate to [F97the body], institute or centre as a whole or only to certain categories of animals susceptible to the disease in question. The competent authority must ensure that the measures necessary to confirm or rule out the suspicion and to avoid any spread of disease are taken. U.K.

Textual Amendments

7. Where the suspected disease referred to in point 6 is confirmed, the approval of the body, institute or centre must be withdrawn. U.K.

8. Where the approval of a body, institute or centre has been withdrawn, it must be restored only where the following conditions are complied with: U.K.

(a)

the disease and the source of infection were eradicated on the premises of the body, institute or centre concerned;

(b)

the premises of the body, institute or centre concerned were appropriately cleaned and desinfected;

(c)

the body, institute or centre concerned complies with the requirements set out in points (a) to (d) and (f) to (h) of Part 3.

9. The competent authority which approved the body, institute or centre must inform the [F98appropriate authority] that included the body, institute or centre on their lists of approved bodies, institutes and centres of the suspension, withdrawal or restoration of that approval.]] U.K.

Textual Amendments

Editorial Information

Yn ôl i’r brig

Options/Help

Print Options

Close

Mae deddfwriaeth ar gael mewn fersiynau gwahanol:

Y Diweddaraf sydd Ar Gael (diwygiedig):Y fersiwn ddiweddaraf sydd ar gael o’r ddeddfwriaeth yn cynnwys newidiadau a wnaed gan ddeddfwriaeth ddilynol ac wedi eu gweithredu gan ein tîm golygyddol. Gellir gweld y newidiadau nad ydym wedi eu gweithredu i’r testun eto yn yr ardal ‘Newidiadau i Ddeddfwriaeth’.

Gwreiddiol (Fel y’i mabwysiadwyd gan yr UE): Mae'r wreiddiol version of the legislation as it stood when it was first adopted in the EU. No changes have been applied to the text.

Pwynt Penodol mewn Amser: This becomes available after navigating to view revised legislation as it stood at a certain point in time via Advanced Features > Show Timeline of Changes or via a point in time advanced search.

Close

Gweler y wybodaeth ychwanegol ochr yn ochr â’r cynnwys

Rhychwant ddaearyddol: Indicates the geographical area that this provision applies to. For further information see ‘Frequently Asked Questions’.

Dangos Llinell Amser Newidiadau: See how this legislation has or could change over time. Turning this feature on will show extra navigation options to go to these specific points in time. Return to the latest available version by using the controls above in the What Version box.

Close

Dewisiadau Agor

Dewisiadau gwahanol i agor deddfwriaeth er mwyn gweld rhagor o gynnwys ar y sgrin ar yr un pryd

Close

Rhagor o Adnoddau

Gallwch wneud defnydd o ddogfennau atodol hanfodol a gwybodaeth ar gyfer yr eitem ddeddfwriaeth o’r tab hwn. Yn ddibynnol ar yr eitem ddeddfwriaeth sydd i’w gweld, gallai hyn gynnwys:

  • y PDF print gwreiddiol y fel adopted version that was used for the EU Official Journal
  • rhestr o newidiadau a wnaed gan a/neu yn effeithio ar yr eitem hon o ddeddfwriaeth
  • pob fformat o’r holl ddogfennau cysylltiedig
  • slipiau cywiro
  • dolenni i ddeddfwriaeth gysylltiedig ac adnoddau gwybodaeth eraill
Close

Llinell Amser Newidiadau

Mae’r llinell amser yma yn dangos y fersiynau gwahanol a gymerwyd o EUR-Lex yn ogystal ag unrhyw fersiynau dilynol a grëwyd ar ôl y diwrnod ymadael o ganlyniad i newidiadau a wnaed gan ddeddfwriaeth y Deyrnas Unedig.

Cymerir dyddiadau fersiynau’r UE o ddyddiadau’r dogfennau ar EUR-Lex ac efallai na fyddant yn cyfateb â’r adeg pan ddaeth y newidiadau i rym ar gyfer y ddogfen.

Ar gyfer unrhyw fersiynau a grëwyd ar ôl y diwrnod ymadael o ganlyniad i newidiadau a wnaed gan ddeddfwriaeth y Deyrnas Unedig, bydd y dyddiad yn cyd-fynd â’r dyddiad cynharaf y daeth y newid (e.e. ychwanegiad, diddymiad neu gyfnewidiad) a weithredwyd i rym. Am ragor o wybodaeth gweler ein canllaw i ddeddfwriaeth ddiwygiedig ar Ddeall Deddfwriaeth.

Close

Rhagor o Adnoddau

Defnyddiwch y ddewislen hon i agor dogfennau hanfodol sy’n cyd-fynd â’r ddeddfwriaeth a gwybodaeth am yr eitem hon o ddeddfwriaeth. Gan ddibynnu ar yr eitem o ddeddfwriaeth sy’n cael ei gweld gall hyn gynnwys:

  • y PDF print gwreiddiol y fel adopted fersiwn a ddefnyddiwyd am y copi print
  • slipiau cywiro

liciwch ‘Gweld Mwy’ neu ddewis ‘Rhagor o Adnoddau’ am wybodaeth ychwanegol gan gynnwys

  • rhestr o newidiadau a wnaed gan a/neu yn effeithio ar yr eitem hon o ddeddfwriaeth
  • manylion rhoi grym a newid cyffredinol
  • pob fformat o’r holl ddogfennau cysylltiedig
  • dolenni i ddeddfwriaeth gysylltiedig ac adnoddau gwybodaeth eraill

The data on this page is available in the alternative data formats listed: