Report from the Commission to the European Parliament and the Council in connection with Article 23 of Regulation (EC) No 998/2003 of the European Parliament and of the Council on the animal health requirements applicable to the non-commercial movement of pet animals {COM(2007)572}
Date: 2007-10-08
Institutions: European Commission
Subjects: animal disease, domestic animal, health control, rabies, transport of animals, veterinary legislation

COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 8.10.2007 
COM(2007) 578 final 

REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND 
THE COUNCIL 

in connection with Article 23 of Regulation (EC) No 998/2003 of the European 
Parliament and of the Council on the animal health requirements applicable to the non-
commercial movement of pet animals 

{COM(2007)572} 

EN 

   EN 

 
 
 
  
 
 
TABLE OF CONTENTS 

1. 

1.1. 

1.2. 

1.3. 

General aspects............................................................................................................. 4 

Introduction .................................................................................................................. 4 

Background .................................................................................................................. 5 

EC legislation regarding non-commercial movements of pet animals – short 
description of the regime currently in place................................................................. 5 

1.3.1.  General provisions ....................................................................................................... 5 

1.3.2.  Rabies........................................................................................................................... 6 

1.3.2.1.  Entry into Member States other than the UK, Malta, Ireland and Sweden.................. 6 

1.3.2.2.  Entry into the UK, Malta, Ireland and Sweden............................................................ 6 

1.3.3.  Echinococcosis............................................................................................................. 7 

1.3.3.1.  Entry into the UK and Ireland (except pets coming from the UK or Ireland) ............. 7 

1.3.3.2.  Rules applying to entry into Sweden, Finland and Malta: ........................................... 7 

1.3.4.  Ticks ............................................................................................................................ 8 

1.3.4.1.  Entry into the UK and Ireland (except pets coming from the UK or Ireland) ............. 8 

1.3.4.2.  Entry into Malta ........................................................................................................... 8 

2. 

2.1. 

2.2. 

Outcomes of the Member State consultation on experience gained so far with the 
implementation of Articles 6, 8 and 16 of the Regulation ........................................... 8 

Introduction .................................................................................................................. 8 

Issues identified............................................................................................................ 8 

2.2.1.  Comments from Member States other than the UK, Ireland, Sweden, Finland and 

Malta ............................................................................................................................ 9 

2.2.2.  Comments from Member States which have retained their national requirements ..... 9 

3. 

3.1. 

Scientific reports from EFSA- conclusions................................................................ 10 

Risk of rabies introduction into the UK, Ireland, Sweden, Malta as a consequence of 
abandoning the serological test measuring protective antibodies to rabies ............... 10 

3.1.1.  Terms of reference and Method ................................................................................. 10 

3.1.2.  Main elements of EFSA’s conclusions ...................................................................... 10 

3.2. 

Risk of Echinococcus introduction into the UK, Ireland, Sweden, Malta and Finland 
as a consequence of abandoning national rules.......................................................... 11 

3.2.1.  Terms of reference and Method ................................................................................. 11 

3.2.2.  Main elements of the opinion..................................................................................... 12 

EN 

2 

   EN 

 
3.3. 

Assessment of the risk of ‘ticks’ introduction into UK, Ireland and Malta as a 
consequence of abandoning national rules................................................................. 13 

3.3.1.  Terms of reference and Method ................................................................................. 13 

3.3.2.  Main elements of the opinion..................................................................................... 13 

4. 

4.1. 

4.2. 

Overall conclusions.................................................................................................... 14 

Commission conclusions from consultation of Member States................................. 14 

Commission conclusions from EFSA opinions ......................................................... 14 

4.2.1.  Rabies......................................................................................................................... 14 

4.2.2.  Echinococcosis........................................................................................................... 15 

4.2.3.  Ticks .......................................................................................................................... 15 

4.3. 

4.4. 

5. 

Available options ....................................................................................................... 15 

Subsequent steps ........................................................................................................ 16 

Annexes...................................................................................................................... 17 

EN 

3 

   EN 

 
REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND 
THE COUNCIL 

in connection with Article 23 of Regulation (EC) No 998/2003 of the European 
Parliament and of the Council on the animal health requirements applicable to the non-
commercial movement of pet animals 

1. 

GENERAL ASPECTS 

1.1. 

Introduction 

Regulation  (EC)  No  998/20031  of  the  European  Parliament  and  the  Council  on  the 
animal  health  requirements  applicable  to  the  non-commercial  movements  of  pet 
animals  and  amending  Council  Directive  92/65/EEC  (‘the  Regulation’)  was 
published on 13 June 2003 and entered into force on 3 July 2003. 

The  Regulation  harmonises  the  rules  for  the  non  commercial  movement  of  pet 
animals between Member States and from third countries into the EU in order to ease 
pet travelling. 

It  however  allows  Ireland,  Malta,  Sweden  and  the  United  Kingdom  ('the  UK'),  to 
maintain  for  a  transitional  period  ending  3  July  2008  their  national  rabies 
requirements for the entry of pet animals, and Finland its national anti-parasite pre-
entry treatment requirement, as they were in force on the date the Regulation came 
into force. 

According to Article 23 of the Regulation, the Commission is required to submit to 
the European Parliament and to the Council, before the 1st February 2007, a report 
on  the  need  to  maintain  the  serological  test,  and  with  appropriate  proposals  for 
determining the regime to be applied at the end of transitional period for movement 
between Member States (Articles 6), entry from third countries (Article 8) and anti-
parasitic pre-entry treatment (Article 16). 

The  report  to  the  European  Parliament  and  to  the  Council  shall  be  based  on  the 
experience  gained  so  far  with  the  implementation  of  those  Articles  and  on  a  risk 
analysis,  following  receipt  of  a  scientific  opinion  of  the  European  Food  Safety 
Authority (EFSA). 

1 

OJ L 146, 13.6.2003, p. 1. Regulation as last amended by Commission Regulation (EC) No 1467/2006 
(OJ L 274, 5.10.2006, p. 3). 

EN 

4 

   EN 

 
                                                 
1.2. 

Background 

EFSA's assessment of the risk of rabies introduction into the UK, Ireland, Sweden, 
Malta,  as  a  consequence  of  abandoning  the  serological  test  measuring  protective 
antibodies to rabies was published on 28 February 20072. 

As regards echinococcosis and ticks and according to Article 16 of the Regulation, 
the Member States concerned were required to send a report on their situation with 
regard  to  the  diseases  in  question,  setting  out  grounds  for  the  need  for  additional 
guarantees to prevent the risk of introduction of the disease. 

Finland sent its report on 25 February 2004 updated on 1st December 2006, Sweden 
on  22  November  2006,  Ireland  on  7  December  2006  and  the  UK  on  11  December 
2006. To date no report has been received from Malta. 

EFSA's  assessment  of  the  risk  of  echinococcosis  introduction  into  the  UK,  Ireland, 
Sweden,  Malta  and  Finland  as  a  consequence  of  abandoning  national  rules  was 
adopted on 18 January 20073. 

EFSA's assessment of the risk of tick introduction into the UK, Ireland, and Malta as 
a consequence of abandoning National rules was adopted on 8 March 20074. 

As some aspects of these two mandates on the risk of "rabies" and "echinococcosis" 
introduction  deal  respectively  with  issues  which  fall  under  the  competence  of  the 
Committee  for  Medicinal  Products  for  Veterinary  Use  (CVMP),such  as  efficacy  of 
rabies vaccination in pets or medicinal products information and the scientific basis 
for  recommending  treatment  schemes,  ,  the  European  Medicines  Agency  (EMEA) 
was officially consulted by EFSA. 

Moreover, in view of producing a comprehensive report, the Commission asked the 
Member  States  on  20  October  2006  to  provide  information  on  experience  gained 
with the implementation of Articles 6, 8 and 16 of the Regulation. 

1.3. 

EC  legislation  regarding  non-commercial  movements  of  pet  animals  –  short 
description of the regime currently in place 

1.3.1.  General provisions 

The  Regulation  introduced  the  pet  passport  for  cats,  dogs  and  ferrets  when  being 
moved from one Member State to another, which provides proof that the animal has 
been  vaccinated  against  rabies.  An  electronic  microchip  (transponder)  -  to  be 
introduced progressively by the Member States - shall allow for easy identification of 
the  animals,  connecting  the  passport  to  the  pet.  During  a  transitional  period  of  8 
years (ending in 2011), a tattoo is also allowed as a way to mark the animal, except 

2 

3 
4 

http://www.efsa.europa.eu/etc/medialib/efsa/science/ahaw/ahaw_opinions/ej436_rabies.Par.0001.File. 
dat/ahaw op_ej436_rabies_en.pdf 
http://www.efsa.europa.eu/en/science/ahaw/ahaw_opinions/ej441_echinoccocus.html 
http://www.efsa.europa.eu/en/science/ahaw/ahaw_opinions/ej469_ticks.Par.001.File.dat/ahaw  op  ej469 
ticks en.pdf 

EN 

5 

   EN 

 
                                                 
for  some  Member  States  which  already  now  require  the  transponder  as  the  sole 
obligatory mark. 

The passport is issued by a veterinarian authorised by the competent authority, who 
certifies the valid anti-rabies vaccination carried out on the animal in question with 
an  inactivated  vaccine  in  accordance  with  the  recommendations  of  the  vaccine's 
manufacturer. 

Member  States  may  authorise  the  movement  of  cats,  dogs  and  ferrets,  which  are 
under three months old and unvaccinated (Article 5. 2). 

However the Regulation allows Finland, Ireland, Malta, Sweden and the UK to retain 
pre-entry  measures  such  as  anti-parasite  treatment  and  blood  testing.  In  the  latter 
case, rabies neutralising antibody titration is carried out by a laboratory approved by 
AFSSA  Nancy  (France),  which  in  accordance  with  Council  Decision  2000/258/EC 
was  designated  as  the  specific  institute  responsible  for  establishing  the  criteria 
necessary for standardising the serological test to monitor the effectiveness of rabies 
vaccines. 

1.3.2.  Rabies 

1.3.2.1.  Entry into Member States other than the UK, Malta, Ireland and Sweden  

From Member States, certain European (non EU) countries and third countries with a 
favourable  rabies  situation  (listed  in  Annex  II,  part  C  of  the  Regulation):  a  valid 
rabies vaccination - Article 5. 

From third countries not listed in Annex II, part C of the Regulation: in addition to a 
valid rabies vaccination, a rabies antibody titration prior to movement is to be carried 
out  by  an  approved  laboratory  on  a  blood  sample  taken  at  least  30  days  after 
vaccination and three months before being moved - Article 8. 

1.3.2.2.  Entry into the UK, Malta, Ireland and Sweden  

1.3.2.2.1 From  Member  States  other  than  the  UK,  Malta,  Ireland  and  Sweden  and  third 
countries listed in Annex II, part C of the Regulation: National legislation requires in 
addition  to  a  valid  rabies  vaccination,  an  antibody  titration  carried  out  by  an 
approved laboratory six months prior to travel in case of UK, Ireland and Malta and 
between 4 and 12 months after vaccination in case of Sweden. 

1.3.2.2.2 From third countries not listed in Annex II, part C of the Regulation: placement into 

a quarantine facility before entry - Article 8. 

1.3.2.2.3 For the entry into Malta only the EU-15 Member States and Cyprus, and a number of 
non-rabies-free  third  countries  are  listed  as  countries  qualifying  for  the  pet-travel 
scheme, pets of other provenances must undergo mandatory quarantine.5 

5 

http://www.veterinary.gov.mt/page.asp?p=6107&l=1 

EN 

6 

   EN 

 
                                                 
1.3.3.  Echinococcosis 

National  legislation  has  been  made  available  to  the  public  by  the  competent 
authorities of the five Member States concerned. 

1.3.3.1.  Entry into the UK and Ireland (except pets coming from the UK or Ireland) 

On each occasion within 24 to 48 hours before check-in with the approved transport 
company, dogs and cats travelling or returning to the UK6 or Ireland7 must be treated 
by  a  veterinarian  against 
tapeworm  Echinococcus  multilocularis  by 
administering,  in  accordance  with  the  manufacturer’s  instructions,  a  product 
containing praziquantel. 

the 

1.3.3.2.  Rules applying to entry into Sweden, Finland and Malta: 

Sweden8 requires a treatment against tapeworm (Echinococcus) 1 to 10 days before 
entering the country. Finland9 requires a certificate issued by a veterinarian showing 
that the animal has been given, not more than 30 days before arrival, an appropriate 
dosage of an authorised medicine containing praziquantel. 

6 
7 
8 

9 

http://www.defra.gov.uk/animalh/quarantine/pets/procedures/support-info/treatment.htm 
http://www.agriculture.gov.ie/index.jsp?file=pets/travel.xml 
http://www.sjv.se/download/18.1adbfde10e558aac1580002148/Ny+broschyr+fr%C3%A5n+3+juli+ 
2004+OVR76ENG.pdf 
http://www.evira.fi/portal/en/animals_and_health/import_and_export/dogs__cats_and_ferrets/import_ 
from_eu_countries_and_norway/ 

EN 

7 

   EN 

 
                                                 
The  medication  is  not  required  for  animals  less  than  three  months  old  and  those 
introduced directly from Sweden, Norway (other than Svalbard), the UK or Ireland, 
or if the animal returns to Finland within 24 hours. 

Malta10 requires a certified treatment with praziquantel within 24 to 48 hours before 
departure. 

1.3.4.  Ticks 

National  legislation  has  been  made  available  to  the  public  by  the  competent 
authorities of all the Member States concerned. 

1.3.4.1.  Entry into the UK and Ireland (except pets coming from the UK or Ireland) 

Before entering or re-entering the UK or Ireland, dogs and cats must be treated by a 
veterinarian against ticks within 24 to 48 hours before check-in. 

The tick treatment must be a veterinary product which has marketing authorisation in 
the country of use and is licensed for use against ticks. A tick collar is not acceptable. 

1.3.4.2.  Entry into Malta 

Malta  requires  a  certified  treatment  with  Fiprinol  within  24  to  48  hours  before 
starting the journey for Malta. 

2. 

OUTCOMES  OF  THE  MEMBER  STATE  CONSULTATION  ON  EXPERIENCE  GAINED  SO 
FAR WITH THE IMPLEMENTATION OF ARTICLES 6, 8 AND 16 OF THE REGULATION 

2.1. 

Introduction  

A  total  of  twenty  Member  States  responded  to  the  Commission’s  request  for 
information  in  connection  with  Article  23  of  the  Regulation,  submitting  from 
detailed reports based on external surveys to short statements.  

Some Member States used this response to raise concerns about issues not covered 
by  the  consultation  (commercial  movements,  identification,  pets  younger  than  3 
months  of  age  and  order  of  preparation)  to  be  considered  when  carrying  out  the 
forthcoming revision process to determine the regime to be applied from 1 January 
2008. 

2.2. 

Issues identified 

While in general the Regulation is considered to be an improvement compared to the 
previous  situation,  the  various  additional  requirements  maintained  by  the  UK, 
Ireland,  Sweden,  Finland  and  Malta  continue  to  cause  confusion  and  discomfort 
amongst travellers. 

10 

http://www.veterinary.gov.mt/page.asp?n=documentation&l=1 

EN 

8 

   EN 

 
                                                 
2.2.1.  Comments  from  Member  States  other  than  the  UK,  Ireland,  Sweden,  Finland  and 

Malta 

From the Member States consultation, the following could be extracted as the main 
concerns: 

– 

– 

– 

– 

unjustified  differences  in  protection  measures  between  Member  States  of 
different history of rabies freedom; 

unfounded differences in sanitary requirements and time limits for vaccination 
and treatments complicate pet travel unnecessarily and increase the costs;  

different vaccination protocols complicate veterinary checks; 

harmonised requirements have effectively prevented the introduction of rabies 
into the majority of Member States. 

2.2.2.  Comments from Member States which have retained their national requirements 

The Regulation is considered a popular and successful alternative to quarantine and 
has enabled pet owners to travel with their pets with minimal difficulty.  

The UK, Finland and Ireland wish that the current regimes covered by Article 6, 8 or 
16  of  the  Regulation  be  continued  as  a  permanent  measure.  Malta  has  not 
commented. Sweden is in favour of: 

– 

abolishing  the  rabies  blood  testing  within  the  EU  and  for  introduction  from 
other  low-risk  countries,  if  EFSA  concludes  that  this  can  be  done  without 
increasing the risk of spreading rabies and if regular oral vaccination of foxes 
is performed under EU control in the Baltic States, Poland, Slovakia, Hungary, 
Romania and Bulgaria; 

EN 

9 

   EN 

 
– 

maintaining  the  obligation  of  national  quarantine  for  pets  coming  from  high 
risk  third  countries  until  scientific  evidence  is  presented  that  introduction 
without quarantine is possible without increasing the rabies risk. 

3. 

SCIENTIFIC REPORTS FROM EFSA- CONCLUSIONS 

3.1. 

Risk  of  rabies  introduction  into  the  UK,  Ireland,  Sweden,  Malta  as  a 
consequence of abandoning the serological test measuring protective antibodies 
to rabies  

3.1.1.  Terms of reference and Method 

In  line  with  the  terms  of  reference  detailed  on  page  8  of  the  opinion,  EFSA 
conducted  a  quantitative  risk  assessment  on  the  risk  reducing  capacity  of  protocols 
with or without application of a serological test following vaccination. Bat rabies has 
been excluded from the scope of the risk evaluation. 

3.1.2.  Main elements of EFSA’s conclusions 

A  rabies  vaccination  using  an  authorised  vaccine  administered  according  to  the 
approved  vaccination  schedule  is  considered  to  be  the  key  requirement  for  pet 
movement between and into Member States, provided that protective immunity has 
been established and is maintained. 

A serological titre of 0.5 IU/ml of neutralising antibodies measured in a sample taken 
after  the  prescribed  period  following  primo-vaccination  with  a  single  dose,  is 
considered  to  be  indicative  of  a  high  probability  of  protection  and  is  used  as 
threshold titre. 

Because  this  assumption  is  not  related  to  the  efficacy  of  any  vaccine  but  to  the 
definition  of  a  certain  level  of  risk,  the  following  issues  must  be  specifically 
addressed: 

– 

– 

– 

as  a  function  of  time,  vaccinating  an  already  rabies  incubating  animal  may 
have limited or no effect on subsequent development of the disease; 

no discriminatory methods are available to detect infection in a live vaccinated 
animal; 

due  to  biological  individual  variations,  a  small  fraction  of  vaccinated  pets 
especially animals younger than 1 year ("low-responders") may not achieve the 
threshold titre after a single dose primary vaccination. 

EN 

10 

   EN 

 
From  the  above  issues  it  is  possible  to  identify  two  risk  scenarios  which  require 
additional risk mitigating measures to prevent spread of the disease: 

– 

– 

the animal was vaccinated while incubating the disease (type A risk), and 

a  low-responder  becomes  infected  and  incubates  the  disease  despite  positive 
vaccination record (type B risk). 

A protocol including the following risk mitigating measures would be the best way to 
deal with the risk of rabies introduction: 

– 

– 

a  waiting  time  (time  spent  between  vaccination  and  movement)  following 
primo-vaccination with a single dose would allow to develop clinical disease if 
the animal was infected before primo-vaccination. EFSA’s risk assessment has 
modelled the effect of the waiting time on the probability of developing clinical 
signs  before  the  end  of  the  waiting  time,  for  the  two  risk  scenarios.  As  an 
example, an animal has a 95.2% probability to develop clinical signs before the 
end of a waiting period of 60 days.  

serological  testing  or  administration  of  a  second  injection  of  vaccine  4  to  6 
weeks after the first vaccination, to overcome the problem of low-responders, 
provided  that  approved  vaccination  schedules  are  amended  to  include  such 
option in the marketing authorisation. 

There is no rationale for including a waiting time beyond the time where protective 
immunity  has  been  reached  for  animals  coming  from  countries  with  a  negligible 
incidence of rabies in pets (lower than 1 case per million pets per year). According to 
EFSA's opinion, the highest rabies prevalence in pets in 2005 within EU is found in 
Baltic States. 

Very  little  published  data  are  available  to  support  the  positive  impact  of  a  second 
injection  and  the  assumption  is  mainly  based  on  expert  advice  from  laboratories 
authorised  to  do  serological  tests.  Consequently  the  number  of  true  non-responders 
after two injections is considered negligible. 

3.2. 

Risk  of  Echinococcus  introduction  into  the  UK,  Ireland,  Sweden,  Malta  and 
Finland as a consequence of abandoning national rules  

3.2.1.  Terms of reference and Method 

In  line  with  the  terms  of  reference  detailed  on  page  5  of  the  opinion,  EFSA 
conducted its risk assessment in the light of the reports sent by Finland, Ireland, the 
UK  and  Sweden.  These  reports  should  set  out  grounds  for  the  need  for  additional 
guarantees to prevent the risk of introduction of the disease. 

EN 

11 

   EN 

 
Taking  into  account  the  epidemiological  situation  in  the  Member  States  concerned 
and  the  absence  of  background  information  in  the  mandate  on  which  particular 
species  the  risk  assessment  should  be  conducted,  EFSA  suggested  restricting  its 
assessment to E. multilocularis. The Commission accepted this suggestion. 

Due to a lack of harmonised surveillance programs for E. multilocularis in pets and 
wildlife  in  the  EU  (variety  of  sampling  strategies  and  diagnostic  methods),  the 
limited  availability  of  data  on  the  prevalence  or  incidence  of  infections  with  E. 
multilocularis in pets and based on the nature of the data submitted by the Member 
States concerned, EFSA conducted a qualitative risk assessment. 

In  addition,  EFSA  also  considered  data  from  the  EFSA's  Community  Summary 
Report  on  Zoonoses,  Zoonotic  Agents,  Antimicrobial  resistance  and  Food  Borne 
Outbreaks in the European Union in 200511 which are based on the annual Member 
States' reports. 

3.2.2.  Main elements of the opinion 

The various isolated surveys in wildlife show a great variability from one country to 
another  and  even  between  regions  in  the  same  country.  Therefore  comparisons 
between  various  epidemiological  situations  are  extremely  difficult.  This  variability 
has  to  be  considered  for  any  definition  of  the  status  (free/endemic)  of  the  country 
which depends on numerous factors yet to be defined.  

To  date,  surveys  conducted  in  Finland  to  detect  E.  multilocularis  in  dogs  (the 
sampling strategy was not indicated) have yielded negative results. The UK, Ireland, 
Sweden  and  Malta  did  not  provide  any  information  on  surveillance  in  domestic 
animals. 

From a reduced number of published surveys on infection in pets in Europe, it seems 
that  infection  rates  in  domestic  carnivores  are  low  most  likely  because  of  low 
exposure to the parasite and to routine de-worming of domestic pets. Dogs and cats 
appear  to  be  of  secondary  importance  for  the  life  cycle  which  is  typically  wildlife-
based. However, due to close contact they may play a role in transmission to humans, 
in which the disease may have serious consequences. The role of cats as final host is 
at present inconclusive. 

From the three current treatment protocols used by the UK, Ireland, Malta, Finland 
and  Sweden  it  was  concluded  that  the  probability  of  re-infection  in  the  country  of 
origin,  and  the  probability  of  viable  egg  dissemination  in  the  importing  country  is 
reduced  to  a  negligible  level  when  a  suitable  treatment  with  praziquantel  is  given 
between 24 to 48 hours prior to departure. 

11 

http://www.efsa.europa.eu/en/science/monitoring_zoonoses/reports/zoonoses_report_2005.html 

EN 

12 

   EN 

 
                                                 
Echinococcosis  is  notifiable  in  humans  in  those  Member  States  that  provided 
information,  except  in  Denmark,  France,  the  Netherlands  and  the  UK.  Cyprus, 
Luxembourg, Malta and Poland did not provided information on the notifiability of 
echinococcosis  in  humans.  These  data  are  collected  and  published  as  the  EFSA’s 
Community Summary Report on Trends and Sources of Zoonoses, Zoonotic Agents, 
Antimicrobial  resistance  and  Food  Borne  Outbreaks  in  the  European  Union. 
However, for the year 2005, Luxembourg, Malta, Belgium, Estonia, Finland, Greece, 
Ireland, Italy and Slovenia did not contribute to the report (EFSA, 2006). 

In  animals,  Echinococcus  detection  is  notifiable  in  most  Member  States  except  in 
Czech  Republic,  Hungary  and  the  UK,  while  Cyprus,  France,  Germany,  Ireland, 
Luxembourg, Malta and Poland provided no information (EFSA, 2006). Notifiability 
would be considered necessary to prove absence of infestation in its autochthonous 
animal or human population. 

3.3. 

Assessment of  the risk  of ‘ticks’ introduction  into  UK,  Ireland  and  Malta  as  a 
consequence of abandoning national rules 

3.3.1.  Terms of reference and Method 

In line with the terms of reference on page 4 of the opinion, EFSA conducted its risk 
assessment  in  the  light  of  the  reports  sent  by  Ireland  and  the  review  produced  by 
DEFRA (UK). EFSA considered that a complete review of the situation in Malta and 
Ireland was needed. 

EFSA did not address ticks and tick borne diseases of livestock/agriculture animals 
but  focused  on  ticks  hosted  by  pet  animals.  The  report  reviews  the  geographical 
distribution  of  these  ticks,  including  the  current  situation  in  the  UK,  Ireland  and 
Malta,  and  their  role  as  vectors  for  disease  agents  that  can  be  responsible  for 
important exotic diseases with potential zoonotic impacts. 

3.3.2.  Main elements of the opinion 

Throughout  the  world  ticks,  together  with  fleas,  are  the  most  widespread 
ectoparasites  affecting  pets.  Up  to  now  there  are  866  described  species  of  ticks 
worldwide, out of which approximately 54 affect pets. Ticks may be classified on the 
basis  of  the  number  of  animal  species  they  infect.  Most  species  of  ticks  affecting 
dogs  and  cats  worldwide  are  three-host  telotropic  tick  species  feeding  on  small 
carnivores, sheep, cattle or horses. 

The distribution of some species of ticks is probably underestimated due to the lack 
of  comprehensive  surveillance  and  collection  of  specimens  further  complicated  by 
the  difficulties  that  may  occur  in  their  identification.  Some  of  the  available 
information  is  either  anecdotal  or  historic.  The  considerations  above  lead  to  the 
conclusion  that  the  absence  of  evidence  does  not  mean  the  evidence  of  absence  of 
ticks in a given area. 

EN 

13 

   EN 

 
Tick species harboured by pets (i.e. dogs, cats, ferrets) and their distribution through 
Europe have been itemised. No reports were found for tick species presence and/or 
distribution  in  Malta.  The  existing  reports  and  literature  indicate  the  presence  of 
selected tick species in the UK and Ireland; no data are available for Malta. 

Ticks  as  hematophagous  parasites  are  recognised  to  transmit  to  their  host/s  a  wide 
variety of pathogens which may cause tick borne diseases (TBDs) affecting wild and 
domestic animals including pets and humans. 

However,  some  of  these  TBDs  are  not  notifiable  or  reportable  in  several  countries 
and therefore overall data are lacking. TBDs are numerous and are hazard for human 
and animal health. Most of these diseases are underestimated due to common clinical 
signs and symptoms that are common to several diseases. Furthermore co-infection 
exists  in  many  of  these  diseases.  There  is  lack  of  reliable  diagnostic  measures  for 
most of these TBDs. 

Reports  provided  by  the  UK  and  Ireland  did  not  conduct  a  comprehensive 
assessment to determine the risk of the introduction of ticks to these countries due to 
the  lack  of  sufficient  required  data.  The  evaluation  of  the  effectiveness  of  the 
treatment  to  prevent  the  infestation  by  ticks  requires  prior  knowledge  about  the 
distribution of ticks but cannot be performed given the scarce data presented in the 
reports. 

4. 

OVERALL CONCLUSIONS  

4.1. 

Commission conclusions from consultation of Member States 

The majority of Member States, except the UK, Ireland, Malta, Sweden and Finland, 
is  in  favour  of  fully  harmonised  rules  for  pet  movement  into  Member  States.  They 
wish to minimise any annoyance to people travelling with pets without jeopardising 
the control of the disease concerned. 

The UK, Ireland and Finland are more in favour of keeping the current rules. Sweden 
is prepared to review the current rules subject to the favourable outcome of an EFSA 
risk assessment. 

4.2. 

Commission conclusions from EFSA opinions 

4.2.1.  Rabies 

Provided  that  protective  immunity  has  been  established  and  maintained  by 
administration  of  an  authorised  vaccine  according  to  the  approved  vaccination 
schedule, a valid vaccination should be the sole requirement for pets to travel to all 
Member States. 

EN 

14 

   EN 

 
In order to reduce the risk that unprotected animals be moved while incubating the 
disease,  it  is  necessary  to  introduce  in  addition,  complementary  risk  mitigating 
measures following primo-vaccination with a single dose, including: 

– 

– 

the implementation of a waiting time to allow the development of clinical signs 
if the animal was infected before protective immunity has been reached; 

a procedure to ensure protective immunity by either a test against the threshold 
titre of 0.5 IU/ml for neutralising antibodies or a booster vaccination, subject to 
modifications of approved vaccination schedules forming part of the marketing 
authorisation of the vaccine. 

4.2.2.  Echinococcosis 

The  risk  of  introducing  E.  multilocularis  from  endemic  areas  into  countries,  where 
the intermediate host (rodents) is present, but considered free from the disease on the 
basis of national surveys conducted is greater than negligible and could be reduced if 
pets are treated before movements.  

However, the estimation of the risk is, notwithstanding the zoonotic potential of the 
disease, impaired by absence of reliable data. Because there are various surveillance 
strategies  in  place  and  the  disease  is  not  notifiable  in  human  and  animals  in  most 
countries, any evaluation of the epidemiology can only be an approximation. 

Moreover certain countries border affected countries and are therefore more exposed 
to  the  risk  of  introduction  of  E.  multilocularis  through  trans-boundary  wildlife 
movements than through movements of infected pets. 

4.2.3.  Ticks 

Tick  species  harboured  by  pets  are  widespread  in  Europe,  including  in  the  UK, 
Ireland and probably Malta. They are indiscriminate feeders as they parasitize a large 
range of small mammals, companion and economic animals and humans. 

Surveillance systems for tick species and tick transmitted diseases are limited and not 
comprehensive.  The  current  available  data  indicate  a  lack  of  systematic  specimen 
collection, epidemiological background and effective control measures. 

EFSA's  opinion  did  not  correlate  the  extension  of  the  geographical  distribution  of 
many  tick  species  to  the  increased  mobility  of  dogs  and  cats  but  rather  to  the 
potential impacts of climatic changes. 

The  opinion  has  clearly  indicated  the  lack  of  sufficient  evidence  over  the 
epidemiological  situation  in  the  UK,  Ireland  and  Malta  to  refute  or  accept  the 
justifications of additional guarantees currently applied by these countries. 

4.3. 

Available options 

To  decide  on  the  possibility  of  reviewing  the  current  regime,  the  Commission  is 
currently considering the options available, which can be summarised as follows: 

EN 

15 

   EN 

 
1.  Continuation  on  a  permanent  basis  of  the  current  conditional  pre-entry 
measures for the UK, Ireland, Malta, Finland and Sweden. This option will not 
take  account  of  the  scientific  opinions  provided  by  EFSA,  which  do  not 
demonstrate  a  particular  status  of  the  five  Member  States  with  regard  to  the 
diseases  concerned.  This  option  would  not  remove  the  confusion  and 
discomfort experienced by certain travellers and is far from intentions of other 
Member  States  to  achieve  harmonisation  and  simplification  considering  the 
relative  homogenous  animal  health  situation  in  Europe  with  regard  to  the 
diseases concerned. 

2. 

3. 

Extension  of  the  transitional  period  for  the  current  conditional  pre-entry 
measures  for  the  UK,  Ireland,  Malta,  Finland  and  Sweden  until  scientific 
evidence  is  presented  stating  that  the  withdrawal  of  the  current  measures  is 
possible without increasing the risks of introduction of the diseases: this option 
should  be  retained  if  it  is  considered  that  the  scientific  opinions  provided  by 
EFSA  do  not  sufficiently  substantiate  the  modification  of  the  measures  and 
until further scientific evidence is obtained. 

Lifting  of  the  current  conditional  pre-entry  measures  for  the  UK,  Ireland, 
Malta, Finland and Sweden: this option would correspond to full harmonisation 
of  the  rules  in  the  EU,  but  would  not  take  into  account  all  of  the  concerns 
raised by the UK, Ireland, Finland, Malta and Sweden and would not take into 
account all of the elements in the EFSA opinions. 

4.  Adjustment  of  the  current  rules  applicable  to  all  Member  States,  except  the 
UK, Ireland, Finland, Malta and Sweden, in line with the consultations of the 
Member  States  and  the  EFSA  opinions,  and  subsequent  withdrawal  of  the 
specific conditions applied by those five Member States would benefit all EU 
citizens  when  travelling  with  their  pets  throughout  EU  territory  and  abroad 
while enhancing the safety of these pet movements. 

4.4. 

Subsequent steps 

According to Article 23 of the Regulation, the Commission shall submit appropriate 
proposals  for  determining  the  regime  to  be  applied  at  the  end  of  the  transitional 
period for Articles 6, 8 and 16 of the Regulation.  

However,  because  the  scientific  assessment  has  taken  longer  than  envisaged, 
delaying  the  completion  of  the  Commission  report,  and  the  prepared  Commission 
proposal amending Regulation (EC) No 998/2003 will cause discussions within the 
framework of the co-decision procedure, it is unlikely to meet the above deadline. 

Therefore, before taking into account further consideration of the identified options 
presented in this report, the Commission will put forward a legislative proposal for a 
Regulation  of  the  European  Parliament  and  of  the  Council  amending  Regulation 
(EC)  No  998/2003  on  the  animal  health  requirements  applicable  to  the  non-
commercial  movements  of  pet  animals  as  regards  the  extension  of  the  transitional 
period. 

EN 

16 

   EN 

 
5. 

ANNEXES 

5.1. 

Regulation (EC) No 998/2003 of the European Parliament and 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. 

http://eur-lex.europa.eu/LexUriServ/site/en/consleg/2003/R/02003R0998-
20061025-en.pdf  

http://eur-
lex.europa.eu/LexUriServ/site/en/oj/2007/l_073/l_07320070313en00090009.pdf  

5.2. 

Assessment of the risk of rabies introduction into the UK, Ireland, Sweden and 
Malta as a consequence of abandoning the serological test measuring protective 
antibodies to rabies (EFSA-Q-2006-014) 

http://www.efsa.europa.eu/EFSA/efsa_locale-
1178620753812_1178620772660.htm  

5.3. 

Assessment  of  the  risk  of  echinococcosis  introduction  into  the  UK,  Ireland, 
Sweden,  Malta  and  Finland  as  a  consequence  of  abandoning  national  rules 
(EFSA-Q-2006-112) 

http://www.efsa.europa.eu/EFSA/efsa_locale-
1178620753812_1178620772901.htm 

5.4. 

Assessment of the risk of ticks introduction into the UK, Ireland and Malta as a 
consequence of abandoning national rules (EFSA-Q-2006-326) 

http://www.efsa.europa.eu/EFSA/efsa_locale-
1178620753812_1178620771045.htm  

EN 

17 

   EN