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 movement of pet animals {SEC(2009)776} {SEC(2009)777}
Date: 2009-06-16
Institutions: European Commission
Subjects: animal disease, domestic animal, health control, transport of animals, veterinary inspection

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COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 16.6.2009 
COM(2009) 268 final 

2009/0077 (COD) 

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 movement of pet animals 

{SEC(2009)776} 
{SEC(2009)777} 

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EXPLANATORY MEMORANDUM 

The purpose of this Commission proposal is to amend 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/EEC1. 

This  Commission  proposal  is  supported  by  the  Commission  staff  working  document  on  the 
impact assessment of the review of Regulation (EC) No 998/2003.  

Legal background 

In  accordance  with  Regulation  (EC)  No  998/2003,  pet  dogs,  cats  and  ferrets  travelling  with 
their owner to another Member State must be accompanied by a passport, or when imported 
by  a  certificate,  providing  proof  of  a  valid  anti-rabies  vaccination  ('general  regime').  As  of 
3 July 2011 electronic identification of dogs, cats and ferrets will be mandatory. 

In order to take account of the particular situation of Ireland, Malta, Sweden and the United 
Kingdom  ('the  UK')  with  regard  to  rabies,  Regulation  (EC)  No  998/2003  provides  for  a 
transitional  period  during  which  the  entry  of  pet  dogs  and  cats  into  those  Member  States  is 
subjected to more stringent requirements. 

For the same transitional period, Finland, Ireland, Malta, Sweden and the UK are allowed to 
make  the  entry  of  pet  animals  into  their  territory  subject  to  additional  requirements  for  the 
tapeworm echinococcus and ticks. 

Initially the transitional period lasted until 3 July 2008. As recommended by the Commission 
report adopted on 8 October 2007 pursuant to Article 23 of Regulation (EC) No 998/2003, the 
transitional  period  was  extended  to  30  June  2010  by  Regulation  (EC)  No  454/2008  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 period2. 

The issue 

In view of determining the regime to be applied from 1 July 2010 for Articles 6, 8 and 16 of 
Regulation (EC) No 998/2003, as required by Article 23 of that Regulation, the Commission 
carried  out  an  impact  assessment  on  the  basis  of  its  report,  that  takes  into  account  various 
opinions  of  the  European  Food  Safety  Authority  (EFSA)  on  the  risk  of  introducing  rabies, 
echinococcus and ticks into the five Member States if national rules were abandoned, and of 
various recent consultations of interested parties.  

The  opinions adopted by EFSA identified that certain Member States have a non negligible 
prevalence of rabies in their pet population, which is related to the rabies situation in wildlife. 
In  addition,  EFSA  recommended  that  risk  mitigating  measures  should  be  implemented  with 
respect to movement of pet animals from those Member States.  

Rabies  in  those  Member  States  is  primarily  of  sylvatic  nature.  Field  evidence  demonstrated 
that  with  the  elimination  of  sylvatic  rabies  as  a  result  of  intensive  programmes  of  oral 

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OJ L 146, 13.6.2003, p. 1. 
OJ L 145, 4.6.2008, p. 238. 

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vaccination  of  wildlife,  the  disease  occurrence  in  domestic  animals  diminishes.  The 
Commission  has  approved  a  number  of  programmes  for  the  eradication  of  rabies  in  those 
Member States and envisages ending EU  support to national programmes in the territory of 
those Member States by the end of 2011. 

In view of the EFSA opinions and of the Community-supported programmes, the transitional 
measure provided for in Article 6 of Regulation (EC) No 998/2003 should be extended until 
31 December 2011.  

Moreover,  from  the  opinions  adopted  by  EFSA  with  regard  to  echinococcosis  and  ticks,  it 
results that the data available did not allow EFSA to demonstrate a particular status of the five 
Member States applying the transitional regime with regard to certain ticks and the tapeworm 
Echinococcus  multilocularis  and  to  quantify  the  risk  of  pathogen  introduction  through  the 
non-commercial movement of pet animals. 

For reasons of consistency however, it is appropriate to extend also the transitional measure 
provided for in Article 16 of Regulation (EC) No 998/2003 until 31 December 2011. 

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2009/0077 (COD) 

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 movement of pet animals 

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, 

Having  regard  to  the  Treaty  establishing  the  European  Community,  and  in  particular 
Article 37 and Article 152(4)(b) thereof, 

Having regard to the proposal from the Commission, 

Having regard to the opinion of the European Economic and Social Committee3, 

After consulting the Committee of the Regions, 

Acting in accordance with the procedure laid down in Article 251 of the Treaty4, 

Whereas: 

(1) 

(2) 

(3) 

(4) 

Regulation (EC) No 998/20035 lays down the animal health requirements applicable to 
the  non-commercial  movement  of  pet  animals  and  the  rules  applying  to  checks  on 
such movements. 

Article  5  of  that  Regulation  lays  down  provisions  applicable  to  movement  between 
Member States of dogs, cats and ferrets as listed in Parts A and B of Annex I thereto. 
Pursuant to Article 5(1)(a), the animals must be identified by means of an electronic 
identification  system  (transponder).  For  an  eight-year  transitional  period  from  the 
entry into force of that Regulation, those pet animals are to be regarded as identified 
also where they bear a clearly readable tattoo.  

Article  4(1)  and Article 14 of Regulation (EC) No 998/2003 provide that, where the 
transponder does not comply with ISO Standard 11784 or Annex A to ISO Standard 
11785, the owner or the natural person responsible for the pet animal on behalf of the 
owner must provide the means necessary for reading the transponder at the time of any 
inspection. 

In order to avoid any unnecessary disturbances, in particular as regards the movements 
from third countries, it is necessary to make more precise the references to those ISO 
Standards,  before  the  use  of  transponders  becomes  mandatory.  Due  to  the  technical 

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OJ C […], […], p. […]. 
OJ C 325, 24.12.2002, p. 133. 
OJ L 146, 13.6.2003, p. 1. 

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(5) 

(6) 

(7) 

(8) 

(9) 

nature  of  those  references,  it  is  appropriate  to  include  them  in  an  Annex  and  amend 
Articles 4 and 14 accordingly.  

In addition, Article 5(1)(b) of Regulation (EC) No 998/2003 provides that dogs, cats 
and ferrets must be accompanied by a passport issued by a veterinarian authorised by 
the  competent  authority,  certifying  valid  anti-rabies  vaccination,  in  accordance  with 
the  recommendations  of  the  manufacturing  laboratory,  carried  out  on  the  animal  in 
question,  with  an  inactivated  rabies  vaccine  of  at  least  one  antigenic  unit  per  dose 
(WHO  standard).  Since  the  adoption  of  Regulation  (EC)  No  998/2003,  recombinant 
vaccines have also become available for the purposes of anti-rabies vaccination. 

In order to allow the movement of dogs, cats and ferrets vaccinated with recombinant 
vaccines,  in  particular  from  third  countries,  provision  should  be  made  to  also 
authorise, for the purpose of Regulation (EC) No 998/2003, the use of such vaccines in 
accordance  with  certain  technical  requirements  laid  down  in  an  Annex  to  that 
Regulation. 

If administered in a Member State, the vaccines must have been granted a marketing 
authorisation  in  accordance  with  either  Directive  2001/82/EC  of  the  European 
Parliament and of the Council of 6 November 2001 on the Community code relating to 
veterinary  medicinal  products6  or  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 Agency7. 

If  administered  in  a  third  country,  the  vaccines  should  comply  with  the  minimum 
standards for safety as laid down in the relevant Chapter of the Manual of Diagnostic 
Tests  and  Vaccines  for  Terrestrial  Animals  of  the  World  Organisation  for  Animal 
Health (OIE).  

In addition, the Commission should be empowered to lay down science based rules of 
a similar kind as those laid down for rabies and providing for preventive measures for 
the movement of pet animals regarding other diseases that may affect those animals, 
where  those  preventive  measures  are  proportionate  to  the  risk  of  spreading  those 
diseases  due  to  such  movement.  Since  those  measures  are  of  general  scope  and  are 
designed  to  amend  non-essential  elements  of  Regulation  (EC)  No  998/2003,  by 
supplementing it with new non-essential elements, they must be adopted in accordance 
with  the  regulatory  procedure  with  scrutiny  provided  for  in  Article  5a  of  Council 
Decision  1999/468/EC  of  28  June  1999  laying  down  procedures  for  the  exercise  of 
implementing powers conferred on the Commission8. 

(10)  Article 6 of Regulation (EC) No 998/2003 provides that the entry of dogs and cats into 
Ireland,  Malta,  Sweden  and  the  United  Kingdom  is  to  be  subject  to  additional 
requirements, in view of the particular situation in those Member States with regard to 
rabies. That provision is to be applied until 30 June 2010, as a transitional measure.  

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OJ L 311, 28.11.2001 p. 1. 
OJ L 136, 30.4.2004, p. 1. 
OJ L 184, 17.7.1999, p. 23. 

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(11)  According to those additional requirements, those pet animals entering the territory of 
those Member States must be identified by means of a transponder unless the Member 
State  of  destination  also  recognises  that  the  animal  may  be  identified  by  means  of  a 
clearly readable tattoo. In addition, those requirements include the mandatory antibody 
titration before  entry of the  pet animals into the  territory of  those  Member States, to 
confirm a protective level of anti-rabies antibodies.  

(12)  Article 8 of Regulation (EC) No 998/2003 lays down the conditions for the movement 
of  dogs,  cats  and  ferrets  from  third  countries  depending  on  the  prevailing  rabies 
situation in the third country of origin and in the Member State of destination. 

(13)  Article 8(1)(a)(ii) of Regulation (EC) No 998/2003 provides that, in cases where pet 
animals  are  moved  from  certain  third  countries  to  Ireland,  Malta,  Sweden  and  the 
United  Kingdom,  the  additional  requirements  provided  for  in  Article  6  are  to  apply. 
Those  third  countries  are  listed  in  Section  2  of  Part  B  and  in  Part  C  of  Annex  II  to 
Regulation (EC) No 998/2003. 

(14)  Article 8(1)(b)(ii) of Regulation (EC) No 998/2003 provides that, in cases where pet 
animals  are  moved  from  other  third  countries,  they  are  to  be  placed  in  quarantine 
unless they have been brought into conformity with the  requirements of Article 6 of 
that Regulation after their entry into the Community.  

(15) 

In addition, Article 16 of Regulation (EC) No 998/2003 provides that Finland, Ireland, 
Malta, Sweden and the United Kingdom as regards echinococcosis, and Ireland, Malta 
and the United Kingdom as regards ticks, may make the entry of pet animals into their 
territory subject to compliance with the special rules in place on the date on which that 
Regulation  came  into  force.  That  provision  is  to  be  applied  until  30  June  2010,  as  a 
transitional measure. 

(16)  Article  23  of  Regulation  (EC)  No  998/2003  provides  that  the  Commission,  after 
receipt of the opinion of the European Food Safety Authority (EFSA) on the need to 
maintain the serological test, and based on experience gained and on a risk evaluation, 
is  to  submit  to  the  European  Parliament  and  to  the  Council  a  report,  together  with 
appropriate proposals for determining the regime to be applied with effect from 1 July 
2010 for Articles 6, 8 and 16 of that Regulation.  

(17) 

In order to determine that regime, the Commission carried out an impact assessment 
based on various recent consultations and on the report that was adopted on 8 October 
20079 pursuant to Article 23 of Regulation (EC) No 998/2003 and took into account 
the recommendations made by EFSA. 

(18)  On 11 December 2006, EFSA adopted an Opinion "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"10.  

(19)  Based on 2005 data, EFSA identified that certain Member States have a non negligible 
prevalence  of  rabies  in  pet  animals.  In  addition  EFSA  recommended  that  risk 

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http://ec.europa.eu/food/animal/liveanimals/pets/petreport_en.htm 
The EFSA Journal (2006) 436, p. 1-54. 

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mitigating  measures  should  be  implemented  with  respect  to  the  movement  of  pet 
animals from countries with non negligible prevalence in pet animals.  

(20)  Rabies  in  those  Member  States  is  primarily  of  sylvatic  nature.  Field  evidence 
demonstrated  that  with  the  elimination  of  sylvatic  rabies  as  a  result  of  intensive 
programmes  of  oral  vaccination  of  wildlife,  the  disease  occurrence  in  domestic 
animals diminishes.  

(21)  The  Community  has  approved  a  number  of  programmes  for  the  eradication,  control 
and monitoring of rabies in those Member States, pursuant to Article 24(5) of Council 
Decision  90/424/EEC  on  expenditure  in  the  veterinary  field11.  The  Commission 
envisages ending EU support to national programmes in the territory of those Member 
States by the end of 2011.  

(22) 

In  view  of  the  EFSA  Opinion  and  of  the  Community-supported  programmes  for  the 
eradication of rabies in certain Member States, the transitional measure provided for in 
Article  6  of  Regulation  (EC)  No  998/2003  should  be  extended  until  31  December 
2011.  

(23)  On  18  January  2007,  EFSA  adopted  an  Opinion  "Assessment  of  the  risk  of 
echinococcosis  introduction  into  the  UK,  Ireland,  Sweden,  Malta  and  Finland  as  a 
consequence of abandoning the national rules"12.  

(24)  On  8  March  2007,  EFSA  adopted  an  Opinion  "Assessment  of  the  risk  of  tick 
introduction  into  the  UK,  Ireland,  and  Malta  as  a  consequence  of  abandoning  the 
national rules"13. 

(25)  From  those  opinions,  it  results  that  the  data  available  did  not  allow  EFSA  to 
demonstrate  a  particular  status  of  the  Member  States  applying  the  transitional 
measures  with  regard  to  certain  ticks  and  the  tapeworm  Echinococcus  multilocularis 
and  to  quantify  the  risk  of  pathogen  introduction  through  the  non-commercial 
movement of pet animals.  

(26) 

In order to ensure consistency as regards the transitional measures, it is appropriate to 
extend the transitional measure provided for in Article 16 until 31 December 2011.  

(27)  Regulation (EC) No 998/2003 should therefore be amended accordingly, 

HAVE ADOPTED THIS REGULATION: 

Regulation (EC) No 998/2003 is hereby amended as follows: 

Article 1 

(1) 

In Article 4(1), the second subparagraph shall be replaced by the following: 

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OJ L 224, 18.8.1990, p. 19. 
The EFSA Journal (2006) 441, p. 1-54. 
The EFSA Journal (2007) 469, p. 1-102. 

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'In the case referred to in point (b), where the transponder does not comply with the 
requirements set out in Annex Ia, the owner or the natural person responsible for the 
pet animal on behalf of the owner must provide the means necessary for reading the 
transponder at the time of any inspection.' 

(2) 

In Article 5(1), point (b) shall be replaced by the following: 

'(b)  be  accompanied  by  a  passport  issued  by  a  veterinarian  authorised  by  the 

competent authority certifying that: 

(i) 

a valid anti-rabies vaccination was carried out on the animal in question 
pursuant to Annex Ib, 

(ii)  where  necessary,  preventive  measures  regarding  other  diseases  were 

carried out on the animal in question.' 

(3) 

In Article 5(1), the following subparagraph shall be added: 

'The  preventive  measures  referred  to  in  point  (b)(ii)  may  be  laid  down  by  the 
Commission.  Those  measures,  designed  to  amend  non-essential  elements  of  this 
Regulation by supplementing it, shall be adopted in accordance with the regulatory 
procedure with scrutiny referred to in Article 24(4).' 

(4) 

In the first subparagraph of Article 6(1), the introductory phrase and the first indent 
shall be replaced by the following: 

‘1.  Until  31  December  2011,  the  entry  of  the  pet  animals  listed  in  Part  A  of 
Annex I into the territory of Ireland, Malta, Sweden and the United Kingdom 
shall be subject to the following requirements: 

– 

they  must  be  identified  in  accordance  with  point  (b)  of  the  first 
subparagraph  of  Article  4(1),  unless,  until  the  end  of  the  eight-year 
transitional  period  provided  for  in  Article  4(1),  the  Member  State  of 
destination also recognises identification in accordance with point (a) of 
the first subparagraph of Article 4(1), and’; 

(5) 

Article 8(1) shall be amended as follows: 

(a) 

In point (a), point (ii) shall be replaced by the following: 

'(ii)  until  31  December  2011,  one  of  the  Member  States  listed  in  part  A  of 
Annex  II,  either  directly  or  after  transit  through  one  of  the  territories 
listed in part B of Annex II, satisfy the requirements of Article 6.' 

(b) 

In point (b), point (ii) shall be replaced by the following: 

'(ii)  until  31  December  2011,  one  of  the  Member  States  listed  in  part  A  of 
Annex II, either immediately or after transit through one of the territories 
listed in part B of Annex II, be placed in quarantine.' 

(6) 

In Article 14, the second paragraph shall be replaced by the following: 

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'In the case referred to in point (b) of the first subparagraph of Article 4(1), where the 
transponder does not comply with the requirements set out in Annex Ia, the owner or 
the natural person responsible for the pet animal on behalf of the owner must provide 
the means necessary for reading the transponder at the time of any inspection.' 

(7) 

Article 16 shall be amended as follows: 

(a) 

in  the  first  paragraph,  the  date  '30  June  2010'  shall  be  replaced  by 
'31 December 2011'; 

(b) 

the second and third paragraphs shall be deleted. 

(8) 

Article 19 shall be replaced by the following: 

'Article 19 

1. 

Part C of Annex I, Annex Ib and parts B and C of Annex II may be amended 
by  the  Commission  to  take  account  of  developments  in  the  situation  within 
Community  territory  or  in  third  countries  as  regards  diseases  affecting  the 
species  of  animals  covered  by  this  Regulation,  in  particular  rabies.  Those 
measures,  designed  to  amend  non-essential  elements  of  this  Regulation,  shall 
be adopted in accordance with the regulatory procedure with scrutiny referred 
to in Article 24(4). 

Annex  Ia  may  be  amended  in  accordance  with  the  regulatory  procedure 
referred to in Article 24(2) to take account of technological developments. 

2.  Where necessary, provisions may be laid down by the Commission, to specify 
the  maximum  number  of  pet  animals  which  may  be  the  subject  of  non-
commercial movement, pursuant to this Regulation. Those measures, designed 
to amend non-essential elements of this Regulation by supplementing it, shall 
be adopted in accordance with the regulatory procedure with scrutiny referred 
to in Article 24(4).'  

(9) 

Two  new  Annexes,  Annex  Ia  and  Annex  Ib,  the  texts  of  which  are  set  out  in  the 
Annex to the present Regulation, shall be inserted. 

This Regulation shall enter into force on the twentieth day following that of its publication in 
the Official Journal of the European Union. 

Article 2 

This Regulation shall be binding in its entirety and directly applicable in all Member States. 

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Done at Brussels, 

For the European Parliament 
The President 

For the Council 
The President 

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ANNEX 

'ANNEX Ia 

Technical requirements for the identification 

For the purposes of Article 4(1), the standard electronic identification system shall be a read-
only passive radio frequency identification device ('transponder'): 

1. 

2. 

complying with standard ISO 11784 and applying HDX or FDX-B technology; 

capable of being read by a reading device compatible with ISO 11785. 

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ANNEX Ib 

Technical requirements for the anti-rabies vaccination (Referred to in Article 5(1)(b)(i)) 

For  the  purpose  of  Article  5(1)  of  Regulation (EC) No 998/2003, an  anti-rabies vaccination 
shall be considered valid provided that the following requirements are complied with: 

1. 

The anti-rabies vaccine must: 

(a) 

be  a  vaccine  other  than  a  live  modified  vaccine  and  fall  within  one  of  the 
following categories: 

(i) 

an  inactivated  vaccine  of  at  least  one  antigenic  unit  per  dose  (WHO 
standard); or 

(ii) 

a  recombinant  vaccine  expressing  the  immunising  glycoprotein  of  the 
rabies virus in a live virus vector; 

(b) 

if administered in a Member State, have been granted a marketing authorisation 
in accordance with: 

(i)  Directive 2001/82/EEC, or  

(ii)  Regulation (EC) No 726/2004; 

(c) 

if administered in a third country, meet at least the requirements laid down in 
Part C of Chapter 2.1.13 of the Manual of Diagnostic Tests and Vaccines for 
Terrestrial  Animals,  2008  Edition,  of  the  World  Organisation  for  Animal 
Health. 

2. 

An  anti-rabies  vaccination  may  only  be  considered  valid,  if  it  meets  the  following 
conditions: 

(a) 

the vaccine was administered on a date indicated in: 

(i) 

Section IV of the passport; or  

(ii) 

the appropriate section of the accompanying animal health certificate; 

(b) 

the  date  referred  to  in  point  (a)  must  not  precede  the  date  of  microchipping 
indicated in: 

(i) 

Section III(2) of the passport; or  

(ii) 

the appropriate section of the accompanying animal health certificate; 

(c) 

at  least  21  days  must  have  elapsed  since  the  completion  of  the  vaccination 
protocol  required  by  the  manufacturer  for  the  primary  vaccination  in 
accordance  with  the  technical  specification  of  the  marketing  authorisation 
referred to in point 1(b) for the anti-rabies vaccine in the Member State or third 
country in which the vaccination is administered; 

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(d) 

the  period  of  validity  of  the  vaccination,  as  prescribed  in  the  technical 
specification  of  the  marketing  authorisation  for  the  anti-rabies  vaccine  in  the 
Member  State  or  third  country  where  the  vaccine  is  administered,  must  has 
been entered by the authorised veterinarian in: 

(i) 

Section IV of the passport; or  

(ii) 

the appropriate section of the accompanying animal health certificate; 

(e) 

a revaccination (booster) must be considered a primary vaccination if it was not 
carried  out  within  the  period  of  validity  referred  to  in  point  (d)  of  a  previous 
vaccination.' 

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