HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"L 296/6
EN
Official Journal of the European Union
15.11.2011
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
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
There are no reports of ferrets being definitive hosts and
according to the current knowledge, the contribution of
cats to the transmission cycle is doubtful.
Having regard to the Treaty on the Functioning of the European
Union,
(5) Where
humans
are
affected
as
aberrant
intermediate
hosts by the larval form of the tapeworm, severe
Having regard to Regulation (EC) No 998/2003 of the European
clinical and pathological signs of the disease are
Parliament and of the Council of 26 May 2003 on the animal
observed after a long incubation period and in
health requirements applicable to the non-commercial
untreated or in inadequately treated patients, mortality
movement of pet animals and amending Council Directive
may be more than 90 %. The increasing prevalence of
92/65/EEC ( 1 ), and in particular the second subparagraph of
the disease in wildlife, and in parallel in humans, in
Article 5(1) thereof,
certain parts of Europe causes serious concern for
public health authorities in many Member States.
Whereas:
(6) While Echinococcus multilocularis infection in animals
occurs in the northern hemisphere, including central
(1) Regulation
(EC)
No
998/2003
lays
down
animal
health
and northern parts of Europe, Asia and North America,
requirements applicable to the non-commercial
it has never been recorded in domestic and wild
movement of pet animals. In particular, it lays down
definitive hosts in certain areas of the European Union
rules applicable to non-commercial movements into
despite ongoing surveillance of wildlife and unrestricted
Member States of dogs, cats and ferrets and provides,
access of dogs.
where necessary, for preventive health measures to be

adopted by means of delegated acts to ensure the
control of diseases, other than rabies, likely to be
(7) The
transboundary
movement
of
infected
wildlife
has
spread due to the movement of those animals. Those
been identified by the European Food Safety Authority
measures are to be scientifically justified and propor
(EFSA), in a scientific opinion on the Assessment of the
tionate to the risk of the spread of those diseases by
risk of echinococcosis introduction into the United
such movements.
Kingdom, Ireland, Sweden, Malta and Finland as a conse
quence of abandoning national rules ( 2 ), as the main
potential route of incursion of the Echinococcus multi
(2) In
addition,
Regulation
(EC)
No
998/2003
provides
that
locularis parasite, especially in areas lacking effective
pet animals are to be accompanied by a passport issued
physical barriers, such as open seas. The EFSA
by a veterinarian authorised by the competent authority
considers that the epidemiological role of dogs in
certifying, where necessary, that preventive health
endemic settings is of limited importance for the life
measures regarding diseases other than rabies were
cycle of the parasite.
carried out on the animal in question.
(8)
However, the EFSA considers that the risk of the trans
(3) Alveolar
echinococcosis
is
a
parasitic
disease
caused
by
mission cycle of the Echinococcus multilocularis parasite
the tapeworm Echinococcus multilocularis. Where the
being established in suitable wild intermediate and
disease is established, the typical transmission cycle of
definitive hosts in previously parasite-free areas is
the parasite in Europe is wildlife-based and involves
greater than negligible, where the parasite is introduced
wild carnivores as definitive hosts and several species
through the movement of infected dogs shedding eggs of
of mammals, notably small rodents, as intermediate
the tapeworm.
hosts which become infected by ingesting eggs
disseminated with the faeces of definitive hosts into the
environment.
(9) According
to
the
EFSA,
the
risk
of
introducing
the Echi
nococcus multilocularis parasite into previously parasite-free
areas could be mitigated if dogs from endemic areas are
(4) Although
of
secondary
importance
for
the
persistence
of
treated. In order to prevent re-infection, such treatment
the life cycle of the parasite in endemic settings, dogs can
should be applied as soon as possible prior to entry into
be infested by ingesting infected rodents. As potential
the areas free of that parasite. However, a minimum post-
definitive hosts and due to close contacts to human,
treatment period of 24 hours is necessary to prevent the
they may serve as a source of infection for humans as
shedding of residual amounts of infectious eggs in the
well as a source of contamination of the environment,
environment of the parasite-free area.
including parasite-free areas behind natural barriers.
( 2 ) The EFSA Journal (2006) 441, 1-54 (http://www.efsa.europa.eu/en/
( 1 ) OJ L 146, 13.6.2003, p. 1.
efsajournal/doc/441.pdf).

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EN
15.11.2011 Official
Journal
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the
European
Union
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(10) To
ensure
their
effectiveness
for
the
control
of Echino
certificate established by Commission Decision
coccus multilocularis infection in dogs, the medicinal
2004/824/EC of 1 December 2004 establishing a
products should have been granted a marketing authori
model health certificate for non-commercial movements
sation in accordance with either Directive 2001/82/EC of
of dogs, cats and ferrets from third countries into the
the European Parliament and of the Council of
Community ( 4 ).
6 November 2001 on the Community code relating to
veterinary medicinal products ( 1 ) or Regulation (EC) No
726/2004 of the European Parliament and of the Council
(16) Considering
that the preventive health measures are
of 31 March 2004 laying down Community procedures
burdensome, they should be applied proportionately to
for the authorisation and supervision of medicinal
the risk of the spread of Echinococcus multilocularis
products for human and veterinary use and establishing
infection through the non-commercial movements of
the European Medicines Agency ( 2 ), or should have been
pet dogs. Therefore, it is appropriate to mitigate such
approved or licensed by the competent authority of the
risks by applying the preventive health measures
third country of origin of the animal.
provided for in this Regulation to non-commercial
movements of dogs entering the territory of Member
States or parts thereof in which the infection was not
(11) Article
16
of
Regulation
(EC)
No
998/2003
provides
that
recorded, namely those Member States listed in Part A of
Finland, Ireland, Malta, Sweden and the United Kingdom,
Annex I to this Regulation.
as regards echinococcosis, may make the entry of pet
animals into their territory subject to compliance with
the special rules applicable on the date of entry into force
(17) In
addition,
and
for
a
strictly
limited
period
of
time,
the
of that Regulation. Because Article 16 of that Regulation
preventive health measures should be also applied to
applies only until 31 December 2011, it is necessary to
prevent the re-introduction of the Echinococcus multi
adopt measures before that date, in order to ensure
locularis parasite into Member States or parts thereof
continuous protection of those Member States
with a low prevalence of that parasite and where a
mentioned in that Article that claim to have remained
compulsory programme for its eradication in wild
free of the parasite as a result of applying national rules.
definitive hosts is being implemented, namely those
Member States listed in Part B of Annex I to this Regu
lation.
(12) Experience has shown that the 24 to 48 hour treatment
window required by some Member States under national
rules in accordance with Article 16 of Regulation (EC)
(18) Council
Directive
92/65/EEC
of
13
July
1992
laying
No 998/2003 may be very burdensome or even not
down animal health requirements governing trade in
feasible for pet owners especially when the treatment
and imports into the Community of animals, semen,
has to be carried out during weekends and public
ova and embryos not subject to animal health
holidays or when the departure after treatment is
requirements laid down in specific Community rules
delayed for reasons beyond the control of the owner.
referred to in Annex A(I) to Directive 90/425/EEC ( 5 )
lays down, amongst others, animal health rules for
trade in and imports from third countries of dogs. The
(13) Given
the
experience
of
some
other
Member
States
which
health requirements in Articles 10 and 16 of that
permit a longer treatment window under national rules
Directive refer to Regulation (EC) No 998/2003.
in accordance with Article 16 of Regulation (EC) No
Therefore, in the interests of consistency of Union legis
998/2003 and have remained free from the parasite, a
lation, it is appropriate that the programmes for the
reasonable increase in that treatment window to a 24 to
eradication of Echinococcus multilocularis infection in wild
120 hour period should not significantly enhance the
definitive hosts be drawn up and presented to the
risk of re-infection of treated dogs from endemic areas
Commission outlining in particular the elements in
with the Echinococcus multilocularis parasite.
Article 14(1) of Directive 92/65/EEC.
(14) The
preventive
health
measures
for
the
control
of Echi
(19) As the movement of dogs from an area free of the
nococcus multilocularis infections in dogs should therefore
Echinococcus multilocularis parasite presents a negligible
consist in the documented administration by a
risk of spreading the disease, the preventive health
veterinarian of an effective authorised or licensed
measures should not be required for dogs coming from
medicinal product which guarantees the timely elim
Member States or parts thereof listed in Part A of Annex
ination of the intestinal forms of the Echinococcus multi
I to this Regulation.
locularis parasite.
(20) Sweden
has
reported
cases
of Echinococcus multilocularis
(15) The treatment should be documented in the relevant
infection in wildlife since January 2011, while Ireland,
section of the passport as established by Commission
Finland and the United Kingdom have submitted to the
Decision 2003/803/EC of 26 November 2003 estab
Commission results of their surveillance for the Echino
lishing a model passport for the intra-Community
coccus multilocularis parasite in wild definite hosts which
movements of dogs, cats and ferrets ( 3 ) or the health
support their claim of the absence of the parasite in their
respective ecosystems.
( 1 ) OJ L 311, 28.11.2001, p. 1.
( 2 ) OJ L 136, 30.4.2004, p. 1.
( 4 ) OJ L 358, 3.12.2004, p. 12.
( 3 ) OJ L 312, 27.11.2003, p. 1.
( 5 ) OJ L 268, 14.9.1992, p. 54.

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L 296/8
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Official Journal of the European Union
15.11.2011
(21) Malta
has submitted evidence that suitable definitive
3. Member
States
listed
in
Part
B
of
Annex
I
shall
not
apply
wildlife host animals are missing on the island, that the
the preventive health measures to dogs intended for non-
Echinococcus multilocularis parasite has never been recorded
commercial movements coming directly from another
in indigenous domestic definitive hosts and that the
Member State or parts thereof listed in Part A.
environment does not support a significant population
of potential intermediate host animals.
Article 3
Conditions for listing Member States or parts thereof in
(22) From the information submitted by Ireland, Malta,
Part A of Annex I
Finland and the United Kingdom, it is clear that those
Member States comply with one of the conditions for
Member States shall be listed in Part A of Annex I, for the
being listed in Part A of Annex I to this Regulation for
whole or parts of their territory, where they have submitted
the whole of their territory. Accordingly, they should be
to the Commission an application documenting compliance
permitted to apply the preventive health measures
with at least one of the following conditions:
provided for in this Regulation from 1 January 2012,
when the transitional measure provided for in
(a) they have declared, in accordance with the procedure
Article 16 of Regulation (EC) No 998/2003 expires.
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
(23) According to the EFSA’s opinion of 2006, the shedding
of infectious eggs of the Echinococcus multilocularis parasite
(OIE), the whole or part of their territory to be free from
does not commence until 28 days after ingestion of an
Echinococcus multilocularis infection in definitive host animals,
infected intermediate host. Therefore, this Regulation
and rules are in place for Echinococcus multilocularis infection
should lay down the conditions for granting derogations
in host animals to be compulsorily notifiable under national
in the case of dogs residing for less than 28 days
law;
following the application of preventive health measures
on the territory of Member States or parts thereof listed
(b) during the 15 years prior to the date of that application
in Annex I to this Regulation, since those dogs do not
and without applying a pathogen-specific surveillance
represent a risk of introducing that parasite,
programme they have not recorded any occurrence of Echi
nococcus multilocularis infection in host animals provided that
during the 10 years prior to the date of that application the
HAS ADOPTED THIS REGULATION:
following conditions have been met:
Article 1
(i) rules have been in place for Echinococcus multilocularis
infection in host animals to be compulsorily notifiable
Subject matter and scope
under national law;
This Regulation establishes preventive health measures for the
control of Echinococcus multilocularis infection in dogs intended
(ii) an early detection system for Echinococcus multilocularis
for non-commercial movements into the territories of the
infection in host animals has been in place;
Member States or parts thereof, which are determined on the
basis of:
(iii) appropriate measures to prevent the introduction of the
Echinococcus multilocularis parasite through domestic
(a) the absence of the Echinococcus multilocularis parasite in
definitive host animals have been in place;
definitive host animals; or
(iv) infection with the Echinococcus multilocularis parasite has
(b) the implementation of a programme for the eradication of
not been known to be established in the wild host
the Echinococcus multilocularis parasite in wild definitive host
animals on their territory;
animals, within a defined timescale.
(c) they have implemented, for three 12-month periods prior to
the date of that application, a pathogen-specific surveillance
Article 2
programme which complies with the requirements of
Geographical application of preventive health measures
Annex II and has not recorded any occurrence of Echino
coccus multilocularis infection in wild definitive host animals,
1. Member
States
listed
in
Annex
I
shall
apply
the
preventive
and such occurrences are compulsorily notifiable under
health measures provided for in Article 7 (‘the preventive health
national law.
measures’) to dogs intended for non-commercial movements
entering into the territory of those Member States or parts
thereof listed in that Annex.
Article 4
Conditions for listing Member States or parts thereof in
Part B of Annex I
2. Member
States
listed
in
Part
A
of
Annex
I
shall
not
apply
the preventive health measures to the dogs intended for non-
Member States shall be listed in Part B of Annex I for not more
commercial movements coming directly from another Member
than five 12-month surveillance periods where they have
State or parts thereof listed in that Part.
submitted to the Commission an application documenting that:

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15.11.2011 Official
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European
Union
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(a) a compulsory programme, in line with the indents in
Article 7
Article 14(1) of Directive 92/65/EEC, for the eradication
of Echinococcus multilocularis infection in wild definitive
Preventive health measures
host animals has been implemented in the whole or part
1. Dogs
intended
for
non-commercial
movements
into
of their territory to be listed in that Part;
Member States or parts thereof listed in Annex I shall be
treated against mature and immature intestinal forms of the
(b) rules are in place for Echinococcus multilocularis infection in
Echinococcus multilocularis parasite within a period of not more
host animals to be compulsorily notifiable under national
than 120 hours and not less than 24 hours before the time of
law.
their scheduled entry into such Member States or parts thereof.
Article 5
2. The
treatment
provided
for
in
paragraph
1
shall
be
admin
istered by a veterinarian and shall consist of a medicinal
Obligations of Member States listed in Annex I
product:
1. Member States listed in Annex I shall have in place:
(a) which contains the appropriate dose of:
(a) rules for Echinococcus multilocularis infection in host animals
(i) praziquantel; or
to be compulsorily notifiable under national law;
(ii) pharmacologically active substances, which alone or in
(b) an early detection system for Echinococcus multilocularis
combination, have been proven to reduce the burden of
infection in host animals.
mature and immature intestinal forms of the Echinococcus
multilocularis parasite in the host species concerned;
2. Member
States
listed
in
Annex
I
shall
implement
a
pathogen-specific surveillance programme which is drawn up
(b) which has been granted:
and carried out in accordance with Annex II.
(i) a marketing authorisation in accordance with Article 5
3. Member
States
listed
in
Annex
I
shall
immediately
notify
of Directive 2001/82/EC or Article 3 of Regulation (EC)
to the Commission and the other Member States the detection
No 726/2004; or
of any Echinococcus multilocularis infection in samples taken from
wild definitive host animals:
(ii) an approval or a licence by the competent authority of
the third country of provenance of the dog intended for
non-commercial movement.
(a) during the previous 12-month surveillance period, in the
case of Member States or parts thereof listed in Part A of
3. The treatment provided for in paragraph 1 shall be
Annex I; or
certified by:
(b) after the first 24-month period following the beginning of
(a) the administering veterinarian in the relevant section of the
the compulsory programme provided for in Article 4 for
model passport established by Decision 2003/803/EC, in
the eradication of Echinococcus multilocularis infection in wild
the case of intra-Union non-commercial movements of
definitive host animals in Member States or parts thereof
dogs; or
listed in Part B of Annex I.
(b) an official veterinarian in the relevant section of the model
4. Member
States
listed
in
Annex
I
shall
report
to
the
animal health certificate established by Decision
Commission the results of the pathogen-specific surveillance
2004/824/EC, in the case of non-commercial movements
programme referred to in paragraph 2 by 31 May following
of dogs from a third country.
the end of each 12-month surveillance period.
Article 8
Article 6
Derogation from the application of the preventive health
Conditions for delisting Member States or parts thereof
measures
from Annex I
1. By
way
of
derogation
from
Article
7(1),
the
non-
The Commission shall remove Member States or parts thereof
commercial movement into Member States or parts thereof
from the respective list set out in Annex I when:
listed in Annex I shall be permitted for dogs which have
been subjected to the preventive health measures as provided
(a) the conditions set up in Article 5(1) no longer apply; or
for:
(a) in Article 7(2) and Article 7(3)(a), at least twice at an
(b) the occurrence of any Echinococcus multilocularis infection in
interval of a maximum of 28 days and the treatment is
definitive host animals has been detected during the
repeated thereafter at regular intervals not exceeding 28
surveillance periods referred to in Article 5(3); or
days;
(c) the report referred to in Article 5(4) has not been supplied
(b) in Article 7(2) and (3), not less than 24 hours before the
to the Commission within the set deadline provided for in
time of entering, and not more than 28 days prior to the
Article 5(4); or
date of completing the transit, in which case those dogs
must pass through a travellers’ point of entry listed by
(d) the eradication programme provided for in Article 4 has
that Member State in accordance with Article 13 of Regu
been terminated.
lation (EC) No 998/2003.

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Official Journal of the European Union
15.11.2011
2. The
derogation
provided
for
in
paragraph
1
shall
only (b) submit the results of its review to the European Parliament
apply to movements of dogs entering those Member States or
and to the Council.
parts thereof listed in Annex I which have:
(a) notified the Commission of the conditions for the control of
such movements; and
The review shall, in particular, assess the proportionality and the
scientific justification of the preventive health measures.
(b) made such conditions publicly available.
Article 9
Article 10
Revision
Entry into force and application
The Commission shall:
This Regulation shall enter into force on the 20th day following
its publication in the Official Journal of the European Union.
(a) review this Regulation no later than 5 years following the
date of its entry into force in the light of scientific devel
opments regarding Echinococcus multilocularis infection in
animals;
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

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15.11.2011 Official
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Union L
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ANNEX I
PART A
List of Member States or parts thereof complying with the conditions laid down in Article 3
ISO code Member
State Part
of
territory
FI FINLAND Whole
territory
GB UNITED
KINGDOM Whole
territory
IE IRELAND Whole
territory
MT MALTA Whole
territory
PART B
List of Member States or parts thereof complying with the conditions laid down in Article 4
ISO code Member
State Part
of
territory

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L 296/12
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Official Journal of the European Union
15.11.2011
ANNEX II
Requirements for the pathogen-specific surveillance programme provided for in point (c) of Article 3
1. The pathogen-specific surveillance programme shall be designed to detect per epidemiologically relevant geographical
unit in the Member State or part thereof a prevalence of not more than 1 % at confidence level of at least 95 %.
2. The pathogen-specific surveillance programme shall use appropriate sampling, either risk-based or representative, that
ensures detection of the Echinococcus multilocularis parasite if present in any part of the Member State at the design
prevalence specified at point 1.
3. The pathogen-specific surveillance programme shall consist in the ongoing collection, during the 12-month
surveillance period, of samples from wild definitive hosts or, in the case where there is evidence of the absence of
wild definitive hosts in the Member State or part thereof, from domestic definitive hosts, to be analysed by exam
ination of:
(a) intestinal contents for the detection of the Echinococcus multilocularis parasite by the sedimentation and counting
technique (SCT), or a technique of equivalent sensitivity and specificity; or
(b) faeces for the detection of species-specific deoxyribonucleic acid (DNA) from tissue or eggs of the Echinococcus
multilocularis parasite by polymerase chain reaction (PCR), or a technique of equivalent sensitivity and specificity.

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