Article 1U.K.Subject matter and scope
This Regulation establishes preventive health measures for the control of Echinococcus multilocularis infection in dogs intended for non-commercial movements into the territories of the Member States or parts thereof, which are determined on the basis of:
(a)
the absence of the Echinococcus multilocularis parasite in definitive host animals; or
(b)
the implementation of a programme for the eradication of the Echinococcus multilocularis parasite in wild definitive host animals, within a defined timescale.
Article 2U.K.Geographical application of preventive health measures
1.Member States listed in Annex I shall apply the preventive health measures provided for in Article 7 (‘the preventive health measures’) to dogs intended for non-commercial movements entering into the territory of those Member States or parts thereof listed in that Annex.
2.Member States listed in Part A of Annex I shall not apply the preventive health measures to the dogs intended for non-commercial movements coming directly from another Member State or parts thereof listed in that Part.
3.Member States listed in Part B of Annex I shall not apply the preventive health measures to dogs intended for non-commercial movements coming directly from another Member State or parts thereof listed in Part A.
Article 3U.K.Conditions for listing Member States or parts thereof in Part A of Annex I
Member States shall be listed in Part A of Annex I, for the whole or parts of their territory, where they have submitted to the Commission an application documenting compliance with at least one of the following conditions:
(a)
they have declared, in accordance with the procedure recommended in paragraph 3 of Article 1.4.6 of Chapter 1.4 of the Terrestrial Animal Health Code, 2010 Edition, Volume 1, of the World Organisation for Animal Health (OIE), the whole or part of their territory to be free from Echinococcus multilocularis infection in definitive host animals, and rules are in place for Echinococcus multilocularis infection in host animals to be compulsorily notifiable under national law;
(b)
during the 15 years prior to the date of that application and without applying a pathogen-specific surveillance programme they have not recorded any occurrence of Echinococcus multilocularis infection in host animals provided that during the 10 years prior to the date of that application the following conditions have been met:
(i)
rules have been in place for Echinococcus multilocularis infection in host animals to be compulsorily notifiable under national law;
(ii)
an early detection system for Echinococcus multilocularis infection in host animals has been in place;
(iii)
appropriate measures to prevent the introduction of the Echinococcus multilocularis parasite through domestic definitive host animals have been in place;
(iv)
infection with the Echinococcus multilocularis parasite has not been known to be established in the wild host animals on their territory;
(c)
they have implemented, for three 12-month periods prior to the date of that application, a pathogen-specific surveillance programme which complies with the requirements of Annex II and has not recorded any occurrence of Echinococcus multilocularis infection in wild definitive host animals, and such occurrences are compulsorily notifiable under national law.
Article 4U.K.Conditions for listing Member States or parts thereof in Part B of Annex I
Member States shall be listed in Part B of Annex I for not more than five 12-month surveillance periods where they have submitted to the Commission an application documenting that:
(a)
a compulsory programme, in line with the indents in Article 14(1) of Directive 92/65/EEC, for the eradication of Echinococcus multilocularis infection in wild definitive host animals has been implemented in the whole or part of their territory to be listed in that Part;
(b)
rules are in place for Echinococcus multilocularis infection in host animals to be compulsorily notifiable under national law.
Article 5U.K.Obligations of Member States listed in Annex I
1.Member States listed in Annex I shall have in place:
(a)rules for Echinococcus multilocularis infection in host animals to be compulsorily notifiable under national law;
(b)an early detection system for Echinococcus multilocularis infection in host animals.
2.Member States listed in Annex I shall implement a pathogen-specific surveillance programme which is drawn up and carried out in accordance with Annex II.
3.Member States listed in Annex I shall immediately notify to the Commission and the other Member States the detection of any Echinococcus multilocularis infection in samples taken from wild definitive host animals:
(a)during the previous 12-month surveillance period, in the case of Member States or parts thereof listed in Part A of Annex I; or
(b)after the first 24-month period following the beginning of the compulsory programme provided for in Article 4 for the eradication of Echinococcus multilocularis infection in wild definitive host animals in Member States or parts thereof listed in Part B of Annex I.
4.Member States listed in Annex I shall report to the Commission the results of the pathogen-specific surveillance programme referred to in paragraph 2 by 31 May following the end of each 12-month surveillance period.
Article 6U.K.Conditions for delisting Member States or parts thereof from Annex I
The Commission shall remove Member States or parts thereof from the respective list set out in Annex I when:
(a)
the conditions set up in Article 5(1) no longer apply; or
(b)
the occurrence of any Echinococcus multilocularis infection in definitive host animals has been detected during the surveillance periods referred to in Article 5(3); or
(c)
the report referred to in Article 5(4) has not been supplied to the Commission within the set deadline provided for in Article 5(4); or
(d)
the eradication programme provided for in Article 4 has been terminated.
Article 7U.K.Preventive health measures
1.Dogs intended for non-commercial movements into Member States or parts thereof listed in Annex I shall be treated against mature and immature intestinal forms of the Echinococcus multilocularis parasite within a period of not more than 120 hours and not less than 24 hours before the time of their scheduled entry into such Member States or parts thereof.
2.The treatment provided for in paragraph 1 shall be administered by a veterinarian and shall consist of a medicinal product:
(a)which contains the appropriate dose of:
(ii)
pharmacologically active substances, which alone or in combination, have been proven to reduce the burden of mature and immature intestinal forms of the Echinococcus multilocularis parasite in the host species concerned;
(b)which has been granted:
(i)
a marketing authorisation in accordance with Article 5 of Directive 2001/82/EC or Article 3 of Regulation (EC) No 726/2004; or
(ii)
an approval or a licence by the competent authority of the third country of provenance of the dog intended for non-commercial movement.
3.The treatment provided for in paragraph 1 shall be certified by:
(a)the administering veterinarian in the relevant section of the model passport established by Decision 2003/803/EC, in the case of intra-Union non-commercial movements of dogs; or
(b)an official veterinarian in the relevant section of the model animal health certificate established by Decision 2004/824/EC, in the case of non-commercial movements of dogs from a third country.
Article 8U.K.Derogation from the application of the preventive health measures
1.By way of derogation from Article 7(1), the non-commercial movement into Member States or parts thereof listed in Annex I shall be permitted for dogs which have been subjected to the preventive health measures as provided for:
(a)in Article 7(2) and Article 7(3)(a), at least twice at an interval of a maximum of 28 days and the treatment is repeated thereafter at regular intervals not exceeding 28 days;
(b)in Article 7(2) and (3), not less than 24 hours before the time of entering, and not more than 28 days prior to the date of completing the transit, in which case those dogs must pass through a travellers’ point of entry listed by that Member State in accordance with Article 13 of Regulation (EC) No 998/2003.
2.The derogation provided for in paragraph 1 shall only apply to movements of dogs entering those Member States or parts thereof listed in Annex I which have:
(a)notified the Commission of the conditions for the control of such movements; and
(b)made such conditions publicly available.
Article 9U.K.Revision
The Commission shall:
(a)
review this Regulation no later than 5 years following the date of its entry into force in the light of scientific developments regarding Echinococcus multilocularis infection in animals;
(b)
submit the results of its review to the European Parliament and to the Council.
The review shall, in particular, assess the proportionality and the scientific justification of the preventive health measures.
Article 10U.K.Entry into force and application
This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union.
It shall apply from 1 January 2012.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 14 July 2011.
For the Commission
The President
José Manuel Barroso