COMMISSION IMPLEMENTING REGULATION (EU) No 497/2012
of 7 June 2012
amending Regulation (EU) No 206/2010 as regards the requirements for imports of animals susceptible to bluetongue
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Council Directive 2004/68/EC of 26 April 2004 laying down animal health rules for the importation into and transit through the Community of certain live ungulate animals, amending Directives 90/426/EEC and 92/65/EEC and repealing Directive 72/462/EEC (1), and in particular Article 6(1), Article 7(e), and Article 13(1) thereof,
Whereas:
(1)
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 (2) lays down the list of third countries, territories or parts thereof from which live ungulate animals, including those susceptible to bluetongue, may be introduced into the Union and the veterinary certification requirements for such introduction.
(2)
In particular, with regard to animals susceptible to bluetongue, certificates BOV-X, BOV-Y, OVI-X, OVI-Y and RUM set out in Part 2 of Annex I to Regulation (EU) No 206/2010 include inter alia the requirement that the animals come from a territory which, at the date of issue of the certificate accompanying them had been free from bluetongue for a period of twelve months.
(3)
As a result of new technical developments, "inactivated vaccines" against bluetongue have become available which do not pose the risk of undesired local circulation of the vaccine virus to unvaccinated cattle, sheep and goats. It is now widely accepted that vaccination with inactivated vaccines is the preferred tool for the control of bluetongue and for the prevention of clinical disease in such animals in the Union.
(4)
To ensure better control of the spread of the bluetongue virus and to reduce the burden on the agricultural sector posed by that disease, the rules on vaccination laid down in Council Directive 2000/75/EC of 20 November 2000 laying down specific provisions for the control and eradication of bluetongue (3) were recently amended by Directive 2012/5/EU of the European Parliament and of the Council (4) to take account of the recent technological developments in vaccine production.
(5)
Accordingly, Directive 2000/75/EC now provides for the use of inactivated vaccines in all parts of the EU.
(6)
As a result of the evolving epidemiological situation as regards bluetongue, and to align with the World Organisation for Animal Health (OIE) standards, Commission Regulation (EC) No 1266/2007 of 26 October 2007 on implementing rules for Council Directive 2000/75/EC as regards the control, monitoring, surveillance and restrictions on movements of certain animals of susceptible species in relation to bluetongue (5) was amended recently. The EU standards require the absence of virus circulation for a minimum period of two years in order to consider a territory free from bluetongue. The period of twelve months referred to in the relevant certificates set out in Part 2 of Annex I to Regulation (EU) No 206/2010 should therefore be amended accordingly.
(7)
Directive 2000/75/EC and Regulation (EC) No 1266/2007 apply to intra-Union movements of live ungulates of species susceptible to bluetongue. It is appropriate that the models of veterinary certificates BOV-X, BOV-Y, OVI-X, OVI-Y and RUM set out in Part 2 of Annex I to Regulation (EU) No 206/2010 be amended to align the animal health requirements for imports into the Union, as regards bluetongue, to the requirements for intra-Union movement in animals susceptible to that disease.
(8)
Regulation (EU) No 206/2010 should therefore be amended accordingly.
(9)
The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,
HAS ADOPTED THIS REGULATION:
Article 1
Annex I to Regulation (EU) No 206/2010 is amended in accordance with the Annex to this Regulation.
Article 2
For a transitional period until 30 June 2012, consignments of live ungulates accompanied by a certificate issued before the date of entry into force of this Regulation in accordance with the models BOV-X, BOV-Y, OVI-X, OVI-Y or RUM set out in Part 2 of Annex I to Regulation (EU) No 206/2010 before the amendments introduced by this Regulation may continue to be introduced into the Union.
Article 3
This Regulation shall enter into force on the the twentieth day following that of its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
I, the undersigned official veterinarian, hereby certify, that the animals described in this certificate:
II.1.1. come from holdings which have been free from any official prohibition on health grounds, for the past 42 days in the case of brucellosis, for the past 30 days in the case of anthrax and for the past six months in the case of rabies, and, have not been in contact with animals from holdings which did not satisfy these conditions;
II.1.2. have not received:
any stilbene or thyrostatic substances,
estrogenic, androgenic, gestagenic or β- agonist substances for purposes other than therapeutic or zootechnic treatment (as defined in Directive 96/22/EC);
II.1.3. with regard to bovine spongiform encephalopathy (BSE):
(1) (2) either [(a) the animals are identified by a permanent identification system enabling them to be traced back to the dam and herd of origin, and are not exposed bovine animals as described in Chapter C, part I, point (4) (b) (iv) of Annex II of Regulation (EC) No 999/2001;
(b) if there have been BSE indigenous cases in the country concerned, the animals were born after the date from which the ban on the feeding of ruminants with meat-and-bone meal and greaves derived from ruminants had been effectively enforced or after the date of birth of the last BSE indigenous case if born after the date of the feed ban.]
(1) (3) or [(a) the animals are identified by a permanent identification system enabling them to be traced back to the dam and herd of origin, and are not exposed bovine animals as described in Chapter C, Part II, point (4) (b) (iv) of Annex II of Regulation (EC) No 999/2001;
(b) the animals were born after the date from which the ban on the feeding of ruminants with meat-and-bone meal and greaves derived from ruminants had been effectively enforced or after the date of birth of the last BSE indigenous case if born after the date of the feed ban.]
(1) (4) or [(a) the animals are identified by a permanent identification system enabling them to be traced back to the dam and herd of origin, and are not exposed bovine animals as described in Chapter C, Part II, point (4) (b) (iv) of Annex II of Regulation (EC) No 999/2001;
(b) the animals were born at least two years after the date from which the ban on the feeding of ruminants with meat-and-bone meal and greaves derived from ruminants had been effectively enforced or after the date of birth of the last BSE indigenous case if born after the date of the feed ban.]
II.2. Animal Health attestation:
I, the undersigned official veterinarian, hereby certify, that the animals described above meet the following requirements:
II.2.1. they come from the territory with code: … (5) which, at the date of issuing this certificate:
(1) either [(a) has been free for 24 months from foot-and-mouth disease]
(1) or [(a) has been considered free from foot-and-mouth disease since … (dd/mm/yyyy), without having had cases/outbreaks after that date, and authorised to export these animals by Commission Implementing Regulation (EU) No …/…, of … (dd/mm/yyyy),]
(b) has been free for 12 months from rinderpest, Rift valley fever, contagious bovine pleuropneumonia, lumpy skin disease and epizootic haemorrhagic disease, and for six months from vesicular stomatitis,
(c) where during the last 12 months, no vaccination against the diseases mentioned in points (a) and (b) has been carried out and imports of domestic cloven-hoofed animals vaccinated against these diseases are not permitted;
(1) either [(d) has been free for 24 months from bluetongue;]
(1) (9) or [(d) has been free for 24 months from bluetongue, and the animals have reacted negatively to a serological test for the detection of antibody for bluetongue and epizootic haemorrhagic disease, carried out on two occasions on samples of blood taken at the beginning of the isolation/quarantine period and at least 28 days later, on … (dd/mm/yyyy) and on … (dd/mm/yyyy), the second of which must have been taken within 10 days before export;]
(1) or [(d) has not been free for 24 months from bluetongue, and the animals have been vaccinated with an inactivated vaccine, at least 60 days before the date of dispatch to the Union, against all bluetongue serotype/s … (insert serotype/s) which are those present in the source population as demonstrated through a surveillance programme (12) in an area with a 150 km radius around the holding(s) of origin described under box reference I.11, and the animals are still within the immunity period of time guaranteed in the specifications of the vaccine;]
II.2.2. they have remained in the territory described under point II.2.1 since birth, or for at least the last six months before dispatch to the Union and without contact with imported cloven-hoofed animals for the last 30 days;
II.2.3. they have remained since birth or at least 40 days before dispatch in the holding(s) of origin described under box reference I.11.:
(a) in and around which, in an area with a 150 km radius, there has been no case/outbreak of epizootic haemorrhagic disease during the previous 60 days,
(b) in and around which, in an area with a 10 km radius, there has been no case/outbreak of foot-and-mouth disease, rinderpest, Rift valley fever, bluetongue, contagious bovine pleuropneumonia, lumpy skin disease and, vesicular stomatitis during the previous 40 days;
II.2.4. they are not animals to be killed under a national programme for the eradication of diseases, nor have they been vaccinated against the diseases referred to under point II.2.1,(a) and (b);
II.2.5. they come from herds that are not restricted under the national legislation pertaining to the eradication of tuberculosis, brucellosis and enzootic bovine leukosis;
II.2.6. they come from herds recognised as officially tuberculosis-free (6);
and (1) (7) either [come from a region which is recognised as officially tuberculosis-free (6);]
(1) or [have been subjected to an intradermal tuberculin test (8) carried out with negative results within the past 30 days before dispatch to the Union;]
(1) or [are less than six weeks old;]
II.2.7. they have not been vaccinated against brucellosis and come from herds recognised as officially brucellosis-free (6);
and (1) (7) either [come from a region which is recognised as officially brucellosis-free (6);]
(1) or [have been subjected to at least one test for bovine brucellosis (8) carried out on samples taken within the past 30 days before dispatch to the Union,]
(1) or [are less than 12 months old,]
(1) or [are castrated males of any age,]
(1) either [II.2.8. they come from herds included in an official system for the control of enzootic bovine leukosis, and in which there has been no evidence either clinical or as a result of a laboratory test of this disease during the past two years,]
(1) or [II.2.8. they come from herds recognised as officially enzootic-bovine-leukosis-free (6) (6a),]
and (1) (7) either [come from a region which is recognised as officially enzootic-bovine-leukosis-free (6);]
(1) or [have been subjected to an individual test for enzootic bovine leukosis (8) carried out with negative result on samples taken within the past 30 days before dispatch to the Union;]
(1) or [are less than 12 months old;]
II.2.9. they are/were (1) dispatched from their holding(s) of origin, without passing through any market:
(1) either [directly to the Union,]
(1) or [to the officially authorised assembly centre described under box reference I.13 situated within the territory described under point II.2.1,]
(a) they did not come in contact with other cloven-hoofed animals not complying with the health requirements as described in this certificate,
(b) they were not at any place where, or around which, within a 10 km radius, during the previous 30 days there has been a case/outbreak of any of the diseases referred to in point II.2.1.;
II.2.10. any transport vehicles or containers in which they were loaded were cleaned and disinfected before loading with an officially authorised disinfectant;
II.2.11. they were examined by an official veterinarian within 24 hours of loading and showed no clinical sign of disease;
II.2.12. they have been loaded for dispatch to the Union on … (dd/mm/yyyy) (10) in the means of transport described under box reference I.15 above that were cleaned and disinfected before loading with an officially authorised disinfectant and so constructed that faeces, urine, litter or fodder could not flow or fall out of the vehicle or container during transportation.
II.3. Animal transport attestation
I, the undersigned official veterinarian, hereby certify, that the animals described above have been treated before and at the time of loading in accordance with the relevant provisions of Regulation (EC) No 1/2005, in particular as regards watering and feeding, and they are fit for the intended transport.
(1) (11) [II.4. Specific requirements
II.4.1. According to official information, no clinical or pathological evidence of infectious bovine rhinotracheitis (IBR) has been recorded in the holding(s) of origin referred to in box reference I.11, for the last 12 months;
II.4.2. the animals referred to in box reference I.28.:
(a) have been isolated in accommodation approved by the competent authority for the last 30 days immediately prior to dispatch for export,
(b) have been subjected to a serological test for IBR on sera taken at least 21 days after entry into isolation, with negative results, and all animals in isolation have also given negative results to this test,
(c) have not been vaccinated against IBR.]
Notes
This certificate is meant for domestic bovine animals (including Bubalus and Bison species and their cross-breeds) intended for breeding and/or production.
After importation the animals must be conveyed without delay to the holding of destination where they shall remain for a minimum period of 30 days before further movement outside the holding, except in the case of a dispatch to a slaughterhouse.
Part I:
Box reference I.8.: Provide the code of territory as appearing in Part 1 of Annex I to Regulation (EU) No 206/2010.
Box reference I.13.: The assembly centre, if any, must fulfil the conditions for its approval, as laid down in Part 5 of Annex I to Regulation (EU) No 206/2010.
Box reference I.15.: Registration number (railway wagons or container and lorries), flight number (aircraft) or name (ship) is to be provided. In case of unloading and reloading, the consignor must inform the BIP of entry into the Union.
Box reference I.23.: For containers or boxes, the container number and the seal number (if applicable) should be included.
Box reference I.28.: Identification system: The animals must bear:
An individual number which permits tracing of their premises of origin. Specify the identification system (such as tag, tattoos, brand, chip, transponder).
An ear tag that includes the ISO code of the exporting country. The individual number must permit tracing of their premises of origin.
Species: Select amongst “Bos”, “Bison” and “Bubalus” as appropriate.
Age: Date of birth (dd/mm/yy).
Sex (M = male, F = female, C = castrated).
Breed: select purebred, crossbreed.
Part II:
(1) Keep as appropriate.
(2) Only if the animals were born and continuously reared in a country or region categorised in accordance with Article 5(2) of Regulation (EC) No 999/2001 as a country or region posing a negligible BSE risk and listed as such in Decision 2007/453/EC.
(3) Only if the country or region of origin is categorised in accordance with Article 5(2) of Regulation (EC) No 999/2001 as a country or region posing a controlled BSE risk and is listed as such in Decision 2007/453/EC.
(4) Only if the country or region of origin has not been categorised in accordance with Article 5 (2) of Regulation (EC) No 999/2001 or has been categorised as a country or region with undetermined BSE risk and listed as such in Decision 2007/453/EC.
(5) Code of the territory as it appears in Part 1 of Annex I to Regulation (EU) No 206/2010.
(6) Officially tuberculosis/brucellosis-free regions and herds as laid down in Annex A to Directive 64/432/EEC; and enzootic-bovine-leukosis-free regions and herds as laid down in Chapter I of Annex D to Directive 64/432/EEC.
(6a) Only for officially enzootic-bovine-leukosis-free herds recognised as equivalent to the requirements as laid down in Chapter I of Annex D to Directive 64/432/EEC for the purpose of exports to the EU of live animals according to the model certificate BOV-X from the territory that, in column 6 of Part 1 of Annex I to Regulation (EU) No 206/2010, appears with the entry “IVb” as regards enzootic bovine leukosis.
(7) Only for a territory that, in column 6 of Part 1 of Annex I to Regulation (EU) No 206/2010, appears with the entry “II”, as regards tuberculosis, “III”, as regards brucellosis, and/or “IVa” as regards enzootic bovine leukosis.
(8) Tests carried out in accordance with the protocols that, for the disease concerned, are described in Part 6 of Annex I to Regulation (EU) No 206/2010.
(9) Supplementary guarantees to be provided when required in column 5 “SG” of Part 1 of Annex I to Regulation (EU) No 206/2010, with the entry “A”.
Tests for bluetongue and for epizootic haemorrhagic disease in accordance with Part 6 of Annex I to Regulation (EU) No 206/2010.
(10) Date of loading. Imports of these animals shall not be allowed when the animals were loaded either prior to the date of authorisation for exportation to the Union of the third country, territory or part thereof referred to in Boxes I.7 and I.8, or during a period where restrictive measures have been adopted by the Union against imports of these animals from this third country, territory or part thereof.
(11) When required by the EU Member State of destination or Switzerland, in accordance with Decision 2004/558/EC and in accordance with the Agreement between the Community and the Swiss Confederation on trade in agricultural products (OJ L 114, 30.4.2002, p. 132.).
(12) Surveillance programme as laid down in Annex I to Commission regulation (EC) No 1266/2007 (OJ L 283, 27.10.2007, p. 37.).
I, the undersigned official veterinarian, hereby certify, that the animals described in this certificate:
II.1.1. come from holdings which have been free from any official prohibition on health grounds, for the last 42 days in the case of brucellosis, for the last 30 days in the case of anthrax, for the last six months in the case of rabies, and, have not been in contact with animals from holdings which did not satisfy these conditions;
II.1.2. have not received:
any stilbene or thyrostatic substances,
oestrogenic, androgenic, gestagenic or β- agonist substances for purposes other than therapeutic or zootechnic treatment (as defined in Directive 96/22/EC).
II.1.3. with regard to bovine spongiform encephalopathy (BSE):
(1) (2) either [(a) the animals are identified by a permanent identification system enabling them to be traced back to the dam and herd of origin, and are not exposed bovine animals as described in Chapter C, part I, point (4) (b) (iv) of Annex II of Regulation (EC) No 999/2001;
(b) if there have been BSE indigenous cases in the country concerned, the animals were born after the date from which the ban on the feeding of ruminants with meat-and-bone meal and greaves derived from ruminants had been effectively enforced or after the date of birth of the last BSE indigenous case if born after the date of the feed ban.]
(1) (3) or [(a) the animals are identified by a permanent identification system enabling them to be traced back to the dam and herd of origin, and are not exposed bovine animals as described in Chapter C, Part II, point (4) (b) (iv) of Annex II of Regulation (EC) No 999/2001;
(b) the animals were born after the date from which the ban on the feeding of ruminants with meat-and-bone meal and greaves derived from ruminants had been effectively enforced or after the date of birth of the last BSE indigenous case if born after the date of the feed ban.]
(1) (4) or [(a) the animals are identified by a permanent identification system enabling them to be traced back to the dam and herd of origin, and are not exposed bovine animals as described in Chapter C, Part II, point (4) (b) (iv) of Annex II of Regulation (EC) No 999/2001;
(b) the animals were born at least two years after the date from which the ban on the feeding of ruminants with meat-and-bone meal and greaves derived from ruminants had been effectively enforced or after the date of birth of the last BSE indigenous case if born after the date of the feed ban.]
II.2. Animal Health Attestation
I, the undersigned official veterinarian, hereby certify, that the animals described above meet the following requirements:
II.2.1. they come from the territory with code: … (5) which, at the date of issuing this certificate:
(1) either [(a) has been free for 24 months from foot-and-mouth disease]
(1) or [(a) has been considered free from foot-and-mouth disease since … (dd/mm/yyyy), without having had cases/outbreaks after that date, and authorised to export these animals by Commission Implementing Regulation (EU) No …/…, of … (dd/mm/yyyy);]
(b) has been free for 12 months from rinderpest, Rift valley fever, contagious bovine pleuropneumonia, lumpy skin disease and epizootic haemorrhagic disease, and for six months from vesicular stomatitis,
(c) where during the last 12 months, no vaccination against the diseases mentioned in points (a) and (b) has been carried out and imports of domestic cloven-hoofed animals vaccinated against these diseases are not permitted;
(1) either [(d) has been free for 24 months from bluetongue;]
(1) or [(d) has not been free for 24 months from bluetongue, and the animals have been vaccinated with an inactivated vaccine, at least 60 days before the date of dispatch to the Union, against all bluetongue serotype/s … (insert serotype/s) which are those present in the source population as demonstrated through a surveillance programme (9) in an area with a 150 km radius around the holding(s) of origin described under box reference I.11, and the animals are still within the immunity period of time guaranteed in the specifications of the vaccine;]
II.2.2. they have remained in the territory described under point II.2.1 since birth, or for at least the last three months before dispatch to the Union and without contact with imported cloven-hoofed animals for the last 30 days;
II.2.3. they have remained since birth or at least 40 days before dispatch in the holding(s) described under box reference I.11:
(a) in and around which, in an area with a 150 km radius, there has been no case/outbreak of epizootic haemorrhagic disease during the previous 60 days, and
(b) in and around which, in an area with a 10 km radius, there has been no case/outbreak of foot-and-mouth disease, rinderpest, Rift valley fever, bluetongue, contagious bovine pleuropneumonia, lumpy skin disease and, vesicular stomatitis during the previous 40 days;
II.2.4. they are not animals to be killed under a national programme for the eradication of diseases, nor have they been vaccinated against the diseases referred to in point II.2.1(a) and (b);
II.2.5. they come from herds:
(a) included in an official system for the control of enzootic bovine leukosis, and
(b) that are not restricted under the national legislation regarding eradication of tuberculosis and brucellosis, and
(c) recognised as officially tuberculosis free; (6)
II.2.6. they have not been vaccinated against brucellosis and they:
(1) either [come from herds which are recognised as officially brucellosis free;] (6)
(1) or [are castrated males of any age;]
II.2.7. they are individually marked on at least two places on their hindquarters as to show that they are exclusively intended for immediate slaughter; (7)
II.2.8. they are/were (1) dispatched from their holding(s) of origin, without passing through any market:
(1) either [directly to the Union,]
(1) or [to the officially authorised assembly centre described under box reference I.13 situated within the territory described under point II.2.1]
and, until dispatched to the Union:
(a) they did not come in contact with other cloven-hoofed animals not complying with the health requirements as described in this certificate, and
(b) they were not at any place where, or around which within a 10 km radius, during the previous 30 days there has been a case/outbreak of any of the diseases referred to in point II.2.1;
II.2.9. any transport vehicles or containers in which they were loaded were cleaned and disinfected before loading with an officially authorised disinfectant;
II.2.10. they were examined by an official veterinarian within 24 hours of loading and showed no clinical sign of disease;
II.2.11. they have been loaded for dispatch to the Union on … (dd/mm/yyyy) (8) in the means of transport described under box reference I.15 above that were cleaned and disinfected before loading with an officially authorised disinfectant and so constructed that faeces, urine, litter or fodder could not flow or fall out of the vehicle or container during transportation.
I, the undersigned official veterinarian, hereby certify, that the animals described above have been treated before and at the time of loading in accordance with the relevant provisions of Regulation (EC) No 1/2005, in particular as regards watering and feeding, and they are fit for the intended transport.
Notes
This certificate is meant for live bovine animals (including Bubalus and Bison species and their cross-breeds) intended for immediate slaughter.
After importation the animals must be conveyed without delay to the slaughterhouse of destination to be slaughtered within five working days.
Part I:
Box reference I.8: Provide the code of territory as appearing in Part 1 of Annex I to Regulation (EU) No 206/2010.
Box reference I.13: The assembly centre, if any, must fulfil the conditions for its approval, as laid down in Part 5 of Annex I to Regulation (EU) No 206/2010.
Box reference I.15: Registration number (railway wagons or container and lorries), flight number (aircraft) or name (ship) is to be provided. In case of unloading and reloading, the consignor must inform the BIP of entry into the Union.
Box reference I.23: For containers or boxes, the container number and the seal number (if applicable) should be included.
Box reference I.28: Identification system: the animals must bear:
An individual number which permits tracing of their premises of origin. Specify the identification system (such as tag, tattoos, brand, chip, transponder).
An ear tag that includes the ISO code of the exporting country. The individual number must permit tracing of their premises of origin.
Species: Select amongst “Bos”, “Bison” and “Bubalus” as appropriate.
Age: Date of birth (dd/mm/yy).
Sex (M = male, F = female, C = castrated).
Part II:
(1) Keep as appropriate.
(2) Only if the animals were born and continuously reared in a country or region categorised in accordance with Article 5(2) of Regulation (EC) No 999/2001 as a country or region posing a negligible BSE risk and listed as such in Decision 2007/453/EC.
(3) Only if the country or region of origin is categorised in accordance with Article 5(2) of Regulation (EC) No 999/2001 as a country or region posing a controlled BSE risk and is listed as such in Decision 2007/453/EC.
(4) Only if the country or region of origin has not been categorised in accordance with Article 5(2) of Regulation (EC) No 999/2001 or has been categorised as a country or region with undetermined BSE risk and is listed as such in Decision 2007/453/EC.
(5) Code of the territory as it appears in Part 1 of Annex I to Regulation (EU) No 206/2010.
(6) Officially tuberculosis/brucellosis free regions and herds as laid down in Annex A to Directive 64/432/EEC.
(7) This mark shall take the form of “L” having 13 cm in the left side and 7 cm in the bottom side with 1 cm of strength in both lines. It shall be applied using the technique known as “freeze-branding”.
(8) Date of loading. Imports of these animals shall not be allowed when the animals were loaded either prior to the date of authorisation for exportation to the Union of the third country, territory or part thereof referred to in boxes I.7 and I.8, or during a period where restrictive measures have been adopted by the Union against imports of these animals from this third country, territory or part thereof.
(9) Surveillance programme as laid down in Annex I to Commission regulation (EC) No 1266/2007 (OJ L 283, 27.10.2007, p. 37.).