CHAPTER 1SUBJECT MATTER AND DEFINITIONS
Article 1Subject matter
This Regulation lays down rules for the control, monitoring, surveillance and restrictions on movements of animals with the meaning of Article 2(c) of Directive 2000/75/EC, in relation to bluetongue, in and from the restricted zones.
Article 2Definitions
For the purposes of this Regulation, the definitions in Article 2 of Directive 2000/75/EC shall apply.
In addition, the following definitions shall apply:
- (a)
‘case of bluetongue’ means an animal that meets one of the following requirements:
- (i)
it presents clinical signs consistent with the presence of bluetongue;
- (ii)
it is a sentinel animal that had showed negative serological results in a previous test and has seroconverted from negative to positive for antibodies to at least one bluetongue serotype since that test;
- (iii)
it is an animal from which the bluetongue virus has been isolated and identified as such;
- (iv)
it is an animal which has tested positive to bluetongue serological tests or from which viral antigen or viral ribonucleic acid (RNA) specific to one or more of the bluetongue serotypes has been identified.
In addition, a set of epidemiological data must indicate that the clinical signs or results of laboratory tests suggesting bluetongue infection are the consequence of virus circulation in the holding in which the animal is kept and not the result of the introduction of vaccinated or seropositive animals from restricted zones;
- (i)
- (b)
‘outbreak of bluetongue’ means an outbreak of that disease as defined in Article 2(c) of Directive 82/894/EEC;
- (c)
‘primary outbreak of bluetongue’ means an outbreak as defined in Article 2(d) of Directive 82/894/EEC, taking into account that, for the purposes of the application of the first indent of Article 3(1) of that Directive, a case of bluetongue is a primary outbreak in the following cases:
- (i)
if it is not epidemiologically linked with a previous outbreak; or
- (ii)
it implies the demarcation of a restricted zone or a change in an existing restricted zone as referred to in Article 6;
- (i)
- (d)
‘restricted zone’ means a zone consisting of both protection and surveillance zones established pursuant to Article 8(1) of Directive 2000/75/EC;
- (e)
‘bluetongue seasonally-free zone’ means an epidemiological relevant geographical area of a Member State for which, for a part of the year, surveillance demonstrates no evidence of bluetongue virus transmission or of adult Culicoides likely to be competent bluetongue vectors;
- (f)
‘transit’ means the movement of animals:
- (i)
from or through a restricted zone;
- (ii)
from a restricted zone through a non-restricted zone back to the same restricted zone; or
- (iii)
from a restricted zone through a non-restricted zone to another restricted zone.
- (i)
CHAPTER 2MONITORING AND SURVEILLANCE AND EXCHANGE OF INFORMATION
Article 3Notification of bluetongue
Member States shall notify primary outbreaks and outbreaks of bluetongue through the Animal Disease Notification System, using the codified forms and the codes set out in Decision 2005/176/EC.
Article 4Bluetongue monitoring and surveillance programmes
Member States shall implement the following programmes in accordance with the minimum requirements set out in Annex I:
- (a)
bluetongue monitoring programmes in restricted zones (the bluetongue monitoring programmes);
- (b)
bluetongue surveillance programmes outside restricted zones (bluetongue surveillance programmes).
Article 5Epidemiological information
1
Member States shall transmit to the BlueTongue NETwork application (BT-Net system), established by Decision 2007/367/EC, information on bluetongue gathered in the course of the implementation of the bluetongue monitoring and/or surveillance programmes, and in particular:
a
a monthly report, transmitted not later than one month after the end of the reporting month, which shall contain at least:
- (i)
the data on the sentinel animals from the bluetongue monitoring programmes in place in the restricted zones;
- (ii)
the entomological data from the bluetongue monitoring programmes in place in the restricted zones;
b
an intermediate report covering the first six months of the year, and transmitted each year by 31 July at the latest, which shall contain at least:
- (i)
the data from the bluetongue surveillance programmes in place outside the restricted zones;
- (ii)
the vaccination data from the restricted zones;
c
an annual report, transmitted by 30 April of the following year at the latest, which shall contain the information referred to in points (b)(i) and (ii) for the previous year.
2
The information to be transmitted to the BT-Net system is set out in Annex II.
CHAPTER 3RESTRICTIONS ON MOVEMENTS OF ANIMALS AND OF THEIR SEMEN, OVA AND EMBRYOS
Article 6Restricted zones
1
Member States shall notify to the Commission their restricted zones, and any change in the situation of those zones within 24 hours.
2
Before taking any decision to remove an epidemiologically relevant geographical area from a restricted zone, Member States shall provide the Commission with substantiated information demonstrating the absence of bluetongue virus circulation in that area during a period of two years following the implementation of the bluetongue monitoring programme.
3
The Commission shall inform the Member States in the framework of the Standing Committee on the Food Chain and Animal Health of the list of restricted zones.
4
Member States shall draw up and keep updated a list of the restricted zones in their territory and make it available to the other Member States and to the public.
5
The Commission shall publish, for information purposes only, on its website the updated list of restricted zones.
That list shall include information on the bluetongue virus serotypes circulating in each restricted zone, which permits, for the purposes of Articles 7 and 8, the identification of the restricted zones demarcated in different Member States where the same bluetongue virus serotypes are circulating.
Article 7Conditions for movements within the same restricted zone
1
Movements of animals within the same restricted zone where the same bluetongue virus serotype or serotypes are circulating shall be allowed by the competent authority provided that the animals to be moved do not show any clinical signs of bluetongue on the day of transport.
2
However, movements of animals from a protection zone to a surveillance zone may only be allowed if:
a
the animals comply with the conditions set out in Annex III; or
b
the animals comply with any other appropriate animal health guarantees based on a positive outcome of a risk assessment of measures against the spread of the bluetongue virus and protection against attacks by vectors, required by the competent authority of the place of origin and approved by the competent authority of the place of destination, prior to the movement of such animals;
c
the animals are destined for immediate slaughter.
F12a
Member States may, on the basis of the outcome of a risk assessment which must take into account sufficient epidemiological data obtained following the implementation of monitoring with sentinel animals in accordance with point 1.1.2.1 of Annex I, demarcate a part of a protection zone as a ‘restricted zone with vaccination and without circulation of bluetongue virus of a specific serotype or serotypes’ (lower-risk area), subject to the following conditions:
- (i)
vaccination is applied in that part of the protection zone for a specific bluetongue virus serotype or serotypes;
- (ii)
there is no bluetongue virus circulating in that part of the protection zone for that specific bluetongue serotype or serotypes.
A Member State which intends to demarcate a part of a protection zone as a ‘lower-risk area’ shall notify its intention to the Commission. That notification shall be accompanied by all the necessary information and data to justify the demarcation in view of the epidemiological situation of the zone concerned, in particular with regard to the bluetongue monitoring programme in place. It shall also inform the other Member States without delay.
Movements of animals within the same restricted zone from an area where the same bluetongue virus serotype or serotypes are circulating to a part of the same restricted zone demarcated as a ‘lower-risk area’ may only be permitted if:
a
the animals comply with the conditions set out in Annex III; or
b
the animals comply with any other appropriate animal health guarantees based on a positive outcome of a risk assessment of measures against the spread of the bluetongue virus and protection against attacks by vectors, required by the competent authority of the place of origin and approved by the competent authority of the place of destination, prior to the movement of such animals; or
c
the animals are destined for immediate slaughter.
F23
The Member State of origin shall immediately inform the Commission and the other Member States of the animal health guarantees referred to in paragraph 2(b) or 2a(b).
4
For the animals referred to in paragraphs 1, 2 and 2a of this Article, the following additional wording shall be added to the corresponding health certificates laid down in Directives 64/432/EEC, 91/68/EEC and 92/65/EEC, or referred to in Decision 93/444/EEC:
Animals in compliance with … (Article 7(1), or 7(2)(a), or 7(2)(b), or 7(2)(c), or 7(2a)(a) or 7(2a)(b), or 7(2a)(c), indicate as appropriate) of Regulation (EC) No 1266/2007
Article 8Conditions for exemption from the exit ban provided for in Directive 2000/75/EC
1
Movements of animals, their semen, ova and embryos, from a holding or semen collection or storage centre located in a restricted zone to another holding or semen collection or storage centre shall be exempted from the exit ban established pursuant to Article 9(1)(c) and point 1 of Article 10 of Directive 2000/75/EC provided that the animals, their semen, ova and embryos comply with:
a
the conditions set out in Annex III to this Regulation; or
b
comply with any other appropriate animal health guarantees based on a positive outcome of a risk assessment of measures against the spread of the bluetongue virus and protection against attacks by vectors, required by the competent authority of the place of origin and approved by the competent authority of the place of destination, prior to the movement of such animals.
2
The Member State of origin shall immediately inform the Commission and the other Member States of the animal health guarantees referred to in paragraph 1(b).
3
A channelling procedure shall be set up, under the control of the competent authority of the place of destination, to ensure that the animals, their semen, ova and embryos moved in accordance with the conditions provided for in paragraph 1(b), are not subsequently moved to another Member State unless the animals comply with the conditions provided for in paragraph 1(a).
4
Movements of animals from a holding located in a restricted zone for immediate slaughter shall be exempted from the exit ban established pursuant to Article 9(1)(c) and point 1 of Article 10 of Directive 2000/75/EC provided that:
a
no case of bluetongue has been recorded in the holding of origin for a period of at least 30 days prior to the date of dispatch;
F3b
the animals are transported
under veterinary supervision to the slaughterhouse of destination, where they are to be slaughtered within 24 hours of arrival, and
directly, unless a rest period foreseen by Regulation (EC) No 1/200513 takes place in a control post situated in the same restricted zone;
c
the competent authority at the place of dispatch notifies the intended movement of the animals to the competent authority of the place of destination at least 48 hours prior to the loading of the animals.
5
Notwithstanding paragraph 4(b), the competent authority of the place of destination may require, on the basis of a risk assessment, the competent authority of the place of origin to set up a channelling procedure for the transport of the animals referred to therein towards designated slaughterhouses.
Any such designated slaughterhouses shall be identified on the basis of a risk assessment that shall take into account the criteria set out in Annex IV.
Information on the designated slaughterhouses shall be made available to the other Member States and to the public. That information shall also be made available through the BT-Net system.
F45a
Movements of animals not certified in accordance with paragraph 1 from a holding located in a restricted zone directly, to the exit point, as defined in Article 1(2)(a) of Decision 93/444/EEC, for export to a third country shall be exempted from the exit ban established pursuant to Article 9(1)(c) and point 1 of Article 10 of Directive 2000/75/EC provided that:
a
no case of bluetongue has been recorded in the holding of origin for a period of at least 30 days prior to the date of dispatch;
b
the animals are transported to the exit point
under official supervision, and
directly, unless a rest period foreseen by Regulation (EC) No 1/2005 takes place in a control post situated in the same restricted zone.
F36
For the animals, their semen, ova and embryos referred to in paragraphs 1, 4 and 5a of this Article, the following additional wording shall be added to the corresponding health certificates laid down in Directives 64/432/EEC, 91/68/EEC and 92/65/EEC, or referred to in Decision 93/444/EEC:
‘… (Animals semen, ova and embryos indicate as appropriate) in compliance with … (Articles 8(1)(a) or 8(1)(b) or 8(4) or 8(5a), indicate as appropriate) of Regulation (EC) No 1266/2007’.
Article 9Further conditions for the transit of animals
1
The transit of animals shall be allowed by the competent authority provided that:
a
animals from a restricted zone being moved through areas outside a restricted zone and the means in which they are transported are treated with authorised insecticides and/or repellents after adequate cleansing and disinfection at the place of loading and in any case prior to leaving the restricted zone;
b
animals being moved from an area outside a restricted zone through a restricted zone and the means in which they are transported are treated with authorised insecticides and/or repellents after adequate cleansing and disinfection at the place of loading and in any case prior to entry into the restricted zone;
c
when a rest period is foreseen at a control post during the movement through a restricted zone, the animals are protected against any attacks by vectors.
2
For the animals referred to in paragraph 1 of this Article, the following additional wording shall be added to the corresponding health certificates laid down in Directives 64/432/EEC, 91/68/EEC and 92/65/EEC, or referred to in Decision 93/444/EEC:
Insecticide/repellent treatment with … (insert name of the product) on … (insert date) at … (insert time) in conformity with Regulation (EC) No 1266/200714.
3
Paragraph 1 of this Article shall no longer apply in an epidemiologically relevant geographical area of a bluetongue seasonally vector-free zone when more than 60 days have elapsed from the date of commencement of the seasonally vector-free period, defined in accordance with Annex V.
However, that exemption shall no longer apply after the end of the seasonally vector-free period, on the basis of the bluetongue monitoring programme.
Article 9aF5Transitional provisions
1
Until F631 December 2009, by way of derogation from Article 8(1)(a) and based on the outcome of a risk assessment taking into account the entomological and epidemiological conditions of the introduction of animals, Member States of destination may require that the movement of animals, which are covered by the exemption provided for in Article 8(1) and which comply with at least one of the conditions set out in points 1 to 4 of Section A of Annex III but which do not comply with points 5, 6 and 7 of that Section, comply with the following additional conditions:
a
those animals must be less than 90 days old;
b
they must have been kept since birth in vector protected confinement;
c
the tests referred in points 1, 3 and 4 of Section A of Annex III must have been carried out on samples taken not earlier than seven days before the date of the movement.
2
A Member State which intends to apply the additional conditions laid down in paragraph 1 shall notify the Commission in advance.
It shall provide the Commission with all the necessary information and data required to justify the application of those additional conditions in view of its entomological and epidemiological situation, in particular with regard to the vector species and virus serotype involved, climate conditions, and the type of husbandry of the susceptible ruminants.
If the Commission has not opposed the application within a period of seven days from the date of notification, the notifying Member State shall be entitled to apply those additional conditions forthwith. It shall inform the other Member States without delay.
3
The Commission shall make available to the public information regarding the application of additional conditions in accordance with paragraph 2.
CHAPTER 4FINAL PROVISIONS
Article 10Repeal
Decision 2005/393/EC is repealed.
Article 11Entry into force
This Regulation shall enter into force on the fifth 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.