
Article 1 
This Regulation lays down rules for the application of preventive health measures for the control of Echinococcus multilocularis infection in dogs intended for non-commercial movement into the territory or parts of the territory of certain Member States.
Article 2 

1. Member States may apply to the Commission for the categorisation with respect to preventive health measures under the conditions laid down in paragraphs 2, 3 and 4.
2. Where a Member State can demonstrate that the infection with the Echinococcus multilocularis parasite has not been established because of the absence of wild red foxes in the whole of its territory, it shall submit to the Commission documentation attesting compliance with the following conditions:
(a) it has implemented for three consecutive 12-month periods prior to the date of application, a national observation programme, which describes:
((i)) the techniques allowing the detection of a species' presence, the type and frequency of surveys implemented, the different categories of actors involved and record-keeping of results of surveys,
((ii)) the procedures for monitoring the implementation of the programme;
(b) it has not recorded the presence of wild red foxes in any part of its territory.
3. Where a Member State can demonstrate that wild definitive host animals likely to harbour the Echinococcus multilocularis parasite are present in the whole or parts of its territory and that occurrence of the infection with this parasite has not been recorded in those animals, it shall submit to the Commission documentation attesting compliance with at least one of the following conditions:
(a) it has declared, in accordance with the procedures for self-declaration set out in the Terrestrial Animal Health Code of the World Organisation for Animal Health, the whole or part of its territory free from Echinococcus multilocularis infection in wild definitive host animals, and rules are in place for Echinococcus multilocularis infection in wild definitive host animals to be compulsorily notifiable under national law;
(b) during the 15 years prior to the date of application and without applying a pathogen-specific surveillance programme it has not recorded any occurrence of Echinococcus multilocularis infection in wild definitive host animals provided that during the 10 years prior to the date of application the following conditions have been met:
((i)) rules have been in place for Echinococcus multilocularis infection in wild definitive host animals to be compulsorily notifiable under national law,
((ii)) an early detection system for Echinococcus multilocularis infection in wild definitive 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 definitive host animals on their territory;
(c) it has implemented, for three consecutive 12-month periods prior to the date of application, a pathogen-specific surveillance programme which complies with the requirements of Annex I to this Regulation and has not recorded any occurrence of Echinococcus multilocularis infection in wild definitive host animals, and such occurrences are compulsorily notifiable under national law.
4. Where a Member State has drawn up a compulsory programme for the eradication of Echinococcus multilocularis infection in wild definitive host animals within a defined timescale for the whole or parts of its territory, it shall submit to the Commission documentation outlining in particular:
(a) the rules that are in place for Echinococcus multilocularis infection in wild definitive host animals to be compulsorily notifiable under national law;
(b) the distribution of the infection in its territory;
(c) the reasons for undertaking the programme, taking into account the significance of the disease in humans and its impact on public health;
(d) the geographical area in which the programme is to be implemented;
(e) the programme monitoring procedures, including the extent of the hunters' involvement in implementing the programme;
(f) the measures to be taken if the results of the tests carried out under the programme are positive.
Article 3 

1. Following the examination of the application by a Member State in accordance with Article 2(1), the Commission shall determine whether that Member State complies with the rules for the categorisation for the whole or parts of its territory, and the Commission shall include, where compliant, that Member State or parts thereof in the appropriate list to be established in accordance with the procedure provided for in Article 20 of Regulation (EU) No 576/2013.
2. A Member State or parts thereof in a list referred to in paragraph 1 are eligible for the application of the preventive health measures provided for in this Regulation.
Article 4 

1. Member States categorised as compliant with the rules laid down in Article 2(2) for the whole of their territory shall remain eligible for the application of the preventive health measures where the following conditions are met:
(a) they have a national observation programme in place to detect the presence of wild red foxes;
(b) they immediately notify the Commission and the other Member States of the detection of the presence of wild red foxes during each 12-month observation period;
(c) they report to the Commission the results of the national programme referred to in point (a) by 31 May following the end of each 12-month observation period.
2. Member States categorised as compliant with the rules laid down in Article 2(3) for the whole or parts of their territory shall remain eligible for the application of the preventive health measures where the following conditions are met:
(a) they have in place rules for Echinococcus multilocularis infection in wild definitive host animals to be compulsorily notifiable under national law;
(b) they have in place an early detection system for Echinococcus multilocularis infection in wild definitive host animals;
(c) they implement a pathogen-specific surveillance programme in wild definitive host animals that is drawn up and carried out in accordance with the requirements set out in Annex I;
(d) they immediately notify to the Commission and the other Member States the detection of any Echinococcus multilocularis parasite in samples taken from wild definitive host animals during each 12-month surveillance period;
(e) they report to the Commission the results of the pathogen-specific surveillance programme referred to in point (c) by 31 May following the end of each 12-month surveillance period.
3. Member States categorised as compliant with the rules laid down in Article 2(4) for the whole or parts of their territory shall remain eligible for the application of the preventive health measures for not more than five consecutive 12-month surveillance periods where the following conditions are met:
(a) they have in place rules for Echinococcus multilocularis infection in wild definitive host animals to be compulsorily notifiable under national law;
(b) they have in place an early detection system for Echinococcus multilocularis infection in wild definitive host animals;
(c) after the first two consecutive 12-month surveillance periods following the beginning of the compulsory eradication programme provided for in Article 2(4),
((i)) they implement a pathogen-specific surveillance programme in wild definitive host animals that is drawn up and carried out in accordance with the requirements set out in Annex I;
((ii)) they immediately notify to the Commission and the other Member States of the detection of any Echinococcus multilocularis parasite in samples taken from wild definitive host animals during each 12-month surveillance period;
((iii)) they report to the Commission the results of the pathogen-specific surveillance programme referred to in point (i) by 31 May following the end of each 12-month surveillance period.
4. Member States referred to in paragraph 3 shall remain eligible for the application of the preventive health measures after not more than five consecutive 12-month surveillance periods if they have presented an application to the Commission documenting compliance with the rules for the categorisation laid down in point (c) of Article 2(3) for the whole or parts of their territory and until the Commission has determined in accordance with Article 3 that they comply with those rules for the whole or parts of their territory.
Article 5 

1. Member States categorised as compliant with the rules laid down in Article 2(2) are no longer eligible for the application of the preventive health measures to dogs moved into their territory where:
(a) the condition laid down in point (a) of Article 4(1) is no longer met; or
(b) the presence of at least one wild red fox has been detected during the 12-month observation periods referred to in point (b) of Article 4(1) and the Member State concerned has not presented to the Commission an application documenting compliance with the rules for categorisation laid down in point (c) of Article 2(3) for the whole or parts of its territory; or
(c) the report referred to in point (c) of Article 4(1) has not been supplied to the Commission within the set deadline.
2. Member States categorised as compliant with the rules laid down in Article 2(3) are no longer eligible for the application of the preventive health measures to dogs moved into their territory or into parts of their territory where:
(a) any of the conditions laid down in points (a), (b) and (c) of Article 4(2) are no longer met; or
(b) the occurrence of any Echinococcus multilocularis infection in wild definitive host animals has been detected during the surveillance periods referred to in point (d) of Article 4(2); or
(c) the report referred to in point (e) of Article 4(2) has not been supplied to the Commission within the set deadline.
3. Member States categorised as compliant with the rules laid down in Article 2(4) are no longer eligible for the application of the preventive health measures to dogs moved into their territory or into parts of their territory where:
(a) any of the conditions laid down in points (a) and (b) of Article 4(3) and point (i) of Article 4(3)(c) are no longer met; or
(b) the occurrence of any Echinococcus multilocularis infection in wild definitive host animals has been detected during the surveillance periods referred to in point (ii) of Article 4(3)(c); or
(c) the report referred to in point (iii) of Article 4(3)(c) has not been supplied to the Commission within the set deadline; or
(d) the compulsory eradication programme provided for in Article 2(4) has ended and the Member State concerned has not presented to the Commission an application documenting compliance with the rules for categorisation laid down in point (c) of Article 2(3) for the whole or parts of its territory.
4. In any of the cases referred to in paragraphs 1, 2 and 3, the Commission shall adapt the list of Member States referred to in Article 3.
Article 6 

1. The owner or authorised person as defined in points (c) and (d) of Article 3 of Regulation (EU) No 576/2013 shall ensure that dogs moved into the territory or into the parts of the territory of a Member State referred to in Article 3 of this Regulation have undergone a treatment against mature and immature intestinal forms of the Echinococcus multilocularis parasite.
2. The treatment referred to in paragraph 1 shall be carried out within a period of not more than 120 hours and not less than 24 hours before the time of the dog's scheduled entry into the territory or into parts of the territory of such Member State in accordance with paragraphs 3 and 4 of this Article.
3. The treatment referred to in paragraph 1 shall be administered by a veterinarian and shall consist of a medicinal product:
(a) which contains the appropriate dose of:
((i)) praziquantel, or
((ii)) other 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 dogs at least as effectively as praziquantel; and
(b) which has been granted:
((i)) a marketing authorisation in accordance with Article 5 of Directive 2001/82/EC of the European Parliament and of the Council or Article 3 of Regulation (EC) No 726/2004 of the European Parliament and of the Council, or
((ii)) an approval or a licence by the competent authority of the third country of dispatch of the dog intended for non-commercial movement.
4. The treatment referred to in paragraph 1 shall be certified by:
(a) the administering veterinarian in the relevant section of the passport laid down in accordance with the model set out in:
((i)) Part 1 of Annex III to Commission Implementing Regulation (EU) No 577/2013, in the case of non-commercial movements of dogs into the territory or into parts of the territory of a Member State referred to in Article 3 of this Regulation from another Member State or entry into a Member State after movement to or transit through a territory or a third country from a Member State in accordance with point (b) of Article 27 of Regulation (EU) No 576/2013; or
((ii)) Part 3 of Annex III to Implementing Regulation (EU) No 577/2013, in the case of non-commercial movements of dogs into the territory or into parts of a Member State referred to in Article 3 of this Regulation from a territory or third country listed in Part 1 of Annex II to that Implementing Regulation; or
(b) an official veterinarian of the territory or third country of provenance, or an authorised veterinarian and subsequently endorsed by the competent authority of the territory or third country of provenance, in the relevant section of the animal health certificate laid down in accordance with the model set out in Part 1 of Annex IV to Implementing Regulation (EU) No 577/2013, in the case of non-commercial movement of dogs into the territory or into parts of a Member State referred to in Article 3 of this Regulation from a territory or third country other than those listed in Part 1 of Annex II to that Implementing Regulation.
Article 7 

1. By way of derogation from Article 6, a Member State referred to in Article 3 shall authorise the non-commercial movement into its territory or into parts of its territory of dogs which have not been subjected to the preventive health measures provided those dogs are moved directly from:
(a) the territory of another Member State referred to in Article 3 that complies with the rules for the categorisation laid down in Article 2(2) for the whole of its territory; or
(b) the territory or part of the territory of another Member State referred to in Article 3 that complies with the rules for the categorisation laid down in Article 2(3) for the whole or parts of its territory.
2. By way of derogation from Article 6(2) a Member State referred to in Article 3 may authorise the non-commercial movement into its territory or into parts of its territory of dogs which have been subjected to the preventive health measures provided for:
(a) in Article 6(3) and in point (a) of Article 6(4), 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 6(3) and (4), not less than 24 hours before the time of entering, and not more than 28 days prior to the date of leaving the Member State referred to in Article 3, in which case those dogs must enter and leave that Member State through a travellers' point of entry designated by that Member State for the purposes of the checks referred to in Article 34(1) of Regulation (EU) No 576/2013.
3. Member States referred to in Article 3 making use of the derogation provided for in paragraph 2 shall establish the conditions for the control of such movements and make them publicly available.
Article 8 
Delegated Regulation (EU) No 1152/2011 is repealed.
References to the repealed Regulation shall be construed as references to this Regulation and shall be read in accordance with the correlation table in Annex II.
Article 9 
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
Article 8 shall apply from 1 July 2018.
This Regulation shall be binding in its entirety and directly applicable in all Member States.Done at Brussels, 21 November 2017.
For the Commission
The President
Jean-Claude JUNCKER
ANNEX I
1. The pathogen-specific surveillance programme, using appropriate risk-based or representative sampling, shall be designed to detect per epidemiologically relevant geographical unit in the Member State or part thereof the Echinococcus multilocularis parasite in the wild definitive host population, if present in any part of the Member State at a prevalence of not more than 1 % at a confidence level of at least 95 %.

2. The pathogen-specific surveillance programme shall describe the target wild definitive host population, including the density, age structure, geographical and gender distribution, taking into account the relative risks of infection with the Echinococcus multilocularis parasite in different species and subpopulations of the target wild definitive host population.

3. 

((a)) the sedimentation and counting technique (SCT), or a technique of equivalent sensitivity and specificity, by examination of intestinal contents for the detection of the Echinococcus multilocularis parasite; or
((b)) polymerase chain reaction (PCR) methods, or a technique of equivalent sensitivity and specificity, by examination of intestinal contents or faeces for the detection of species-specific deoxyribonucleic acid (DNA) from tissue or eggs of the Echinococcus multilocularis parasite.

ANNEX II

Delegated Regulation (EU) No 1152/2011 This Regulation
Article 1 Article 1
Article 2(1) Article 3
Article 2(2) Article 7(1)(b)
Article 2(3) Article 7(1)(b)
Article 3(a) Article 2(3)(a)
Article 3(b) Article 2(3)(b)
Article 3(c) Article 2(3)(c)
Article 4 Articles 2(4) and 4(3)
Article 5(1)(a) Article 4(2)(a)
Article 5(1)(b) Article 4(2)(b)
Article 5(2) Article 4(2)(c)
Article 5(3)(a) Article 4(2)(d)
Article 5(3)(b) Article 4(3)(c)
Article 5(4) Article 4(2)(e)
Article 6(a) Article 5(2)(a)
Article 6(b) Article 5(2)(b)
Article 6(c) Article 5(2)(c)
Article 6(d) Article 5(3)(d)
Article 7(1) Article 6(1) and (2)
Article 7(2) Article 6(3)
Article 7(3)(a) Article 6(4)(a)(i)
Article 7(3)(b) Article 6(4)(b)
Article 8(1) Article 7(2)
Article 8(2) Article 7(3)
Article 9 —
Article 10 Article 9
Annex I —
Annex II Annex I