Commission Delegated Regulation (EU) 2018/772Show full title

Commission Delegated Regulation (EU) 2018/772

of 21 November 2017

supplementing Regulation (EU) No 576/2013 of the European Parliament and of the Council with regard to preventive health measures for the control of Echinococcus multilocularis infection in dogs, and repealing Delegated Regulation (EU) No 1152/2011

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EU) No 576/2013 of the European Parliament and of the Council of 12 June 2013 on the non-commercial movement of pet animals and repealing Regulation (EC) No 998/2003(1), and in particular the first subparagraph of Article 19(1) thereof,

Whereas:

(1) Regulation (EU) No 576/2013 lays down animal health requirements applicable to the non-commercial movement of pet animals. In particular, it lays down rules applicable to non-commercial movements into Member States of dogs, cats and ferrets. It also provides, where necessary, for preventive health measures to be adopted by means of delegated acts for controlling diseases or infections other than rabies that are likely to be spread due to movements of those animals. Those measures are to be based on adequate, reliable and validated scientific information and are to be applied proportionately to the risk to public or animal health of spreading those diseases or infections via cross-border movements of dogs, cats or ferrets.

(2) In addition, the categorisation of Member States in view of their eligibility to apply those preventive health measures is to be based on compliance with certain requirements with respect to the animal health status of the country and the surveillance and reporting systems with regard to certain diseases or infections other than rabies.

(3) Regulation (EU) No 576/2013 also provides that dogs, cats or ferrets moved into Member States are to be accompanied by an identification document attesting, inter alia, compliance with any preventive health measures for diseases or infections other than rabies adopted pursuant to that Regulation.

(4) Echinococcus multilocularis infection in dogs falls under the category of diseases or infections other than rabies that require preventive health measures for its control to be adopted by the Commission by means of a delegated act in accordance with Regulation (EU) No 576/2013. Echinococcus multilocularis is a tapeworm which in its larval stage causes alveolar echinococcosis, a zoonotic disease considered as one of the most severe human parasitic diseases in non-tropical areas. Where the disease is established, the typical transmission cycle of the parasite in Europe involves wild carnivores, notably red foxes, as definitive hosts and small rodents, as intermediate hosts.

(5) Domestic dogs and cats having access to outdoors may sporadically contract the infection when predating on infected rodents. However, current knowledge suggests that the contribution of cats to the Echinococcus multilocularis life cycle is low, and there are no reports of ferrets being definitive hosts. Echinococcus multilocularis infection in animals has so far not been detected, despite ongoing surveillance, in definitive hosts in Ireland, Malta, Finland and the United Kingdom.

(6) Since the movement of domestic definitive hosts with a pre-patent or patent infection is considered an important introduction pathway, the treatment of dogs prior to entry into countries where no findings of the parasite have been recorded and where appropriate definitive and intermediate hosts exist to support the Echinococcus multilocularis cycle is recommended in order to mitigate the risk of introducing the infection into such countries through the movement of dogs.

(7) The Commission adopted Delegated Regulation (EU) No 1152/2011(2) pursuant to Regulation (EC) No 998/2003 of the European Parliament and of the Council(3) in order to ensure continuous protection of Ireland, Malta, Finland and the United Kingdom that claimed to be free of the parasite Echinococcus multilocularis as a result of applying national rules until 31 December 2011 in accordance with Article 16 of Regulation (EC) No 998/2003. Delegated Regulation (EU) No 1152/2011 has remained in force after Regulation (EC) No 998/2003 was repealed and replaced by Regulation (EU) No 576/2013.

(8) Delegated Regulation (EU) No 1152/2011 provides that the Commission is to review that 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, and to submit the results of its review to the European Parliament and to the Council. The review is in particular to assess the proportionality and the scientific justification of the preventive health measures. In this respect, the Commission asked for the opinion of the European Food Safety Authority (EFSA)(4)

(9) The results of the Commission's review show that Delegated Regulation (EU) No 1152/2011 provides an adequate framework for the effective protection of Member States claiming freedom from Echinococcus multilocularis parasite. For that reason the main provisions of Delegated Regulation (EU) No 1152/2011 should be taken into account in this Regulation. In particular, the timely and documented treatment of dogs with an effective approved or licensed medicinal product prior to movement into the territory of Member States which have demonstrated continuous absence of the parasite or of those Member States with low prevalence which have implemented for a strictly limited period of time a programme for the eradication of the parasite in the suitable animal population, as well as the conditions for granting derogations from that treatment, should be incorporated in this Regulation.

(10) Moreover, according to EFSA's opinion on Echinococcus multilocularis infection in animals(4), there is no evidence that dogs can maintain the Echinococcus multilocularis life cycle in the absence of red foxes. Therefore, in Member States where the dog is reported as the only candidate definitive host, the Echinococcus multilocularis infection cannot become established.

(11) However, the introduction of contaminated dog faeces through the movement of dogs from endemic areas into Member States where the infection cannot become established constitutes a risk of human infection which otherwise would not exist in that location and which can be mitigated by the application of preventive health measures on dogs entering such Member States. In order to be eligible for such preventive health measures, Member States claiming absence of red foxes likely to harbour the Echinococcus multilocularis parasite should however provide regular evidence of that absence by implementing a programme for the early detection of the presence of red foxes in any part of the Member State.

(12) The review also highlights the importance of surveillance activities to be implemented in Member States claiming freedom from the parasite. The review found that certain aspects regarding the surveillance activities should be reconsidered. Therefore, the existing rules in Delegated Regulation (EU) No 1152/2011 on surveillance activities should be adapted accordingly.

(13) Article 14(1) of Council Directive 92/65/EEC(5) sets out certain elements regarding the documentation to be provided for the recognition of a compulsory programme of a Member State for the eradication of the disease. Provision should be made in order to include those elements in this Regulation.

(14) The Terrestrial Animal Health Code of the World Organisation for Animal Health should be used for the declarations by Member States which claim that their territory is free of Echinococcus multilocularis parasite.

(15) The models of animal identification documents should be used for documenting the preventive health measures.

(16) To ensure legal certainty it is necessary to repeal Delegated Regulation (EU) No 1152/2011,

HAS ADOPTED THIS REGULATION:

Article 1 U.K. Subject matter and scope

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 [F1 Great Britain].

Textual Amendments

F1 Words in Art. 1 substituted (E.W.S.) (31.12.2020) by The Animals, Aquatic Animal Health, Invasive Alien Species, Plant Propagating Material and Seeds (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1388), regs. 1(2)(c), 17(2)

[F2 Article 1a U.K. Interpretation

In this Regulation, “the Commission Implementing Regulation” means “Commission Implementing Regulation (EU) No 577/2013 on the model identification documents for the non-commercial movement of dogs, cats and ferrets, the establishment of lists of territories and third countries and the format, layout and language requirements of the declarations attesting compliance with certain conditions provided for in Regulation (EU) No 576/2013 of the European Parliament and the Council.]

Textual Amendments

F2 Art. 1a inserted (E.W.S.) (31.12.2020) by The Animals, Aquatic Animal Health, Invasive Alien Species, Plant Propagating Material and Seeds (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1388), regs. 1(2)(c), 17(3)

F3 Article 2 U.K. Rules for the categorisation of Member States in view of their eligibility for preventive health measures

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Textual Amendments

F3 Arts. 2-5 omitted (E.W.S.) (31.12.2020) by virtue of The Animals, Aquatic Animal Health, Invasive Alien Species, Plant Propagating Material and Seeds (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1388), regs. 1(2)(c), 17(4)

F3 Article 3 U.K. Eligibility for preventive health measures

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Textual Amendments

F3 Arts. 2-5 omitted (E.W.S.) (31.12.2020) by virtue of The Animals, Aquatic Animal Health, Invasive Alien Species, Plant Propagating Material and Seeds (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1388), regs. 1(2)(c), 17(4)

F3 Article 4 U.K. Conditions to be fulfilled in order to remain eligible for preventive health measures

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Textual Amendments

F3 Arts. 2-5 omitted (E.W.S.) (31.12.2020) by virtue of The Animals, Aquatic Animal Health, Invasive Alien Species, Plant Propagating Material and Seeds (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1388), regs. 1(2)(c), 17(4)

F3 Article 5 U.K. Failure to fulfil the conditions provided for in Article 4

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Textual Amendments

F3 Arts. 2-5 omitted (E.W.S.) (31.12.2020) by virtue of The Animals, Aquatic Animal Health, Invasive Alien Species, Plant Propagating Material and Seeds (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1388), regs. 1(2)(c), 17(4)

Article 6 U.K. Preventive health measures

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 [F4 Great Britain] 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 [F5 Great Britain] 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 [F6 regulation 4 of the Veterinary Medicines Regulations 2013] or Article 3 of Regulation (EC) No 726/2004 of the European Parliament and of the Council(6) [F7 as it has effect in European Union law, as amended from time to time], 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.

[F8 4. The treatment referred to in paragraph 1 must be certified in the relevant section of the identification document by:

(a) where paragraph 4A applies, the administering veterinarian;

(b) where paragraph 4B applies—

(i) an official veterinarian of the third country of departure; or

(ii) an authorised veterinarian, provided an official veterinarian of the third country of departure subsequently endorses the certification.

4A. This paragraph applies in the case of non-commercial movements of dogs into Great Britain from a third country listed in Part 1 of Annex 2 to the Commission Implementing Regulation, after movement to or transit through a third country which is not so listed.

4B. This paragraph applies in the case of non-commercial movements of dogs into Great Britain from a third country not listed in Part 1 of Annex 2 to the Commission Implementing Regulation.]

Textual Amendments

F4 Words in Art. 6(1) substituted (E.W.S.) (31.12.2020) by The Animals, Aquatic Animal Health, Invasive Alien Species, Plant Propagating Material and Seeds (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1388), regs. 1(2)(c), 17(5)(a)

F5 Words in Art. 6(2) substituted (E.W.S.) (31.12.2020) by The Animals, Aquatic Animal Health, Invasive Alien Species, Plant Propagating Material and Seeds (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1388), regs. 1(2)(c), 17(5)(b)

F6 Words in Art. 6(3)(b)(i) substituted (E.W.S.) (31.12.2020) by The Animals, Aquatic Animal Health, Invasive Alien Species, Plant Propagating Material and Seeds (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1388), regs. 1(2)(c), 17(5)(c)(i)

F7 Words in Art. 6(3)(b)(i) inserted (E.W.S.) (31.12.2020) by The Animals, Aquatic Animal Health, Invasive Alien Species, Plant Propagating Material and Seeds (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1388), regs. 1(2)(c), 17(5)(c)(ii)

F8 Art. 6(4)-(4B) substituted for Art. 6(4) (E.W.S.) (31.12.2020) by The Animals, Aquatic Animal Health, Invasive Alien Species, Plant Propagating Material and Seeds (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1388), regs. 1(2)(c), 17(5)(d)

Article 7 U.K. Derogation from the application of the preventive health measures

1. By way of derogation from Article 6, [F9 the appropriate authority] shall authorise the non-commercial movement into its [F10 constituent territory] of dogs which have not been subjected to the preventive health measures provided those dogs are moved directly from:

(a) the territory of [F11 a member State listed in Part 1 of the Annex to Regulation 2018/878]; or

(b) the territory or part of the territory of [F12 a member State listed in Part 2 of the Annex to Regulation 2018/878].

2. By way of derogation from Article 6(2) [F13 the appropriate authority] may authorise the non-commercial movement into its [F14 constituent 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 [F15 leaving the constituent territory, in which case those dogs must enter and leave that constituent territory through a travellers’ point of entry designated by the appropriate authority for the purposes] of the checks referred to in Article 34(1) of Regulation (EU) No 576/2013.

3. [F16 If the appropriate authority makes] use of the derogation provided for in paragraph 2 [F17 , it] shall establish the conditions for the control of such movements and make them publicly available.

[F18 4. For the purposes of this Article, “Regulation 2018/878” means Commission Implementing Regulation (EU) 2018/878 adopting the list of Member States, or parts of the territory of Member States, that comply with the rules for categorisation laid down in Article 2(2) and (3) of Delegated Regulation (EU) 2018/772 concerning the application of preventative health measures for the control of Echinococcus multilocularis infection in dogs, as it has effect in European Union law, as amended from time to time.]

Textual Amendments

F9 Words in Art. 7(1) substituted (E.W.S.) (31.12.2020) by The Animals, Aquatic Animal Health, Invasive Alien Species, Plant Propagating Material and Seeds (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1388), regs. 1(2)(c), 17(6)(a)(i)(aa)

F10 Words in Art. 7(1) substituted (E.W.S.) (31.12.2020) by The Animals, Aquatic Animal Health, Invasive Alien Species, Plant Propagating Material and Seeds (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1388), regs. 1(2)(c), 17(6)(a)(i)(bb)

F11 Words in Art. 7(1)(a) substituted (E.W.S.) (31.12.2020) by The Animals, Aquatic Animal Health, Invasive Alien Species, Plant Propagating Material and Seeds (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1388), regs. 1(2)(c), 17(6)(a)(ii)

F12 Words in Art. 7(1)(b) substituted (E.W.S.) (31.12.2020) by The Animals, Aquatic Animal Health, Invasive Alien Species, Plant Propagating Material and Seeds (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1388), regs. 1(2)(c), 17(6)(a)(iii)

F13 Words in Art. 7(2) substituted (E.W.S.) (31.12.2020) by The Animals, Aquatic Animal Health, Invasive Alien Species, Plant Propagating Material and Seeds (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1388), regs. 1(2)(c), 17(6)(b)(i)(aa)

F14 Words in Art. 7(2) substituted (E.W.S.) (31.12.2020) by The Animals, Aquatic Animal Health, Invasive Alien Species, Plant Propagating Material and Seeds (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1388), regs. 1(2)(c), 17(6)(b)(i)(bb)

F15 Words in Art. 7(2)(b) substituted (E.W.S.) (31.12.2020) by The Animals, Aquatic Animal Health, Invasive Alien Species, Plant Propagating Material and Seeds (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1388), regs. 1(2)(c), 17(6)(b)(ii)

F16 Words in Art. 7(3) substituted (E.W.S.) (31.12.2020) by The Animals, Aquatic Animal Health, Invasive Alien Species, Plant Propagating Material and Seeds (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1388), regs. 1(2)(c), 17(6)(c)(i)

F17 Word in Art. 7(3) inserted (E.W.S.) (31.12.2020) by The Animals, Aquatic Animal Health, Invasive Alien Species, Plant Propagating Material and Seeds (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1388), regs. 1(2)(c), 17(6)(c)(ii)

F18 Art. 7(4) inserted (E.W.S.) (31.12.2020) by The Animals, Aquatic Animal Health, Invasive Alien Species, Plant Propagating Material and Seeds (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1388), regs. 1(2)(c), 17(6)(d)

Article 8 U.K. Repeal

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 U.K. Entry into force and application

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.

F19 ...

Done at Brussels, 21 November 2017.

For the Commission

The President

Jean-Claude Juncker

Textual Amendments

F19 Words in Signature omitted (E.W.S.) (31.12.2020) by virtue of The Animals, Aquatic Animal Health, Invasive Alien Species, Plant Propagating Material and Seeds (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1388), regs. 1(2)(c), 17(7)

F20 ANNEX I U.K. Requirements for the pathogen-specific surveillance programme provided for in Articles 2(3)(c), 4(2)(c) and Article 4(3)(c)(i)

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Textual Amendments

F20 Annex 1 omitted (E.W.S.) (31.12.2020) by virtue of The Animals, Aquatic Animal Health, Invasive Alien Species, Plant Propagating Material and Seeds (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1388), regs. 1(2)(c), 17(8)

ANNEX II U.K. Correlation table referred to in Article 8

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

(1)

OJ L 178, 28.6.2013, p. 1.

(2)

Commission Delegated Regulation (EU) No 1152/2011 of 14 July 2011 supplementing Regulation (EC) No 998/2003 of the European Parliament and of the Council as regards preventive health measures for the control of Echinococcus multilocularis infection in dogs (OJ L 296, 15.11.2011, p. 6).

(3)

Regulation (EC) No 998/2003 of the European Parliament and of the Council of 26 May 2003 on the animal health requirements applicable to the non-commercial movement of pet animals and amending Council Directive 92/65/EEC (OJ L 146, 13.6.2003, p. 1).

(4)

http://www.efsa.europa.eu/sites/default/files/scientific_output/files/main_documents/4373.pdf

(5)

Council Directive 92/65/EEC of 13 July 1992 laying down animal health requirements governing trade in and imports into the Community of animals, semen, ova and embryos not subject to animal health requirements laid down in specific Community rules referred to in Annex A (I) to Directive 90/425/EEC (OJ L 268, 14.9.1992, p. 54).

(6)

Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ L 136, 30.4.2004, p. 1).