WORLD TRADE  
ORGANIZATION   
G/SPS/GEN/1159 
29 June 2012 
 (12-3455) 
Committee on Sanitary and Phytosanitary Measures Original:   English 
  
 
APPLICATION OF ARTICLE 6 OF THE AGREEMENT ON SANITARY AND 
PHYTOSANITARY MEASURES AS REGARDS ANIMAL DISEASES 
 
Submission by the European Union 
  
 The following communication, received on 26 June 2012, is being circulated at the request of 
the Delegation of the European Union. 
 
_______________ 
 
 
1. The European Union is pleased to describe how  its zoning, or regionalization, policy for 
animal diseases can be successfully implemented.  It does this by demonstrating in practice that a 
correct application of the zoning principle reduces trade disruption to the minimum, both in terms of 
the geographical area(s) affected and the duration of trade restrictions.  Using the example of avian 
influenza, it shows how this can be done without  posing unacceptable risks to the importing country. 
I. THE SPS AGREEMENT AND THE WORL D ORGANIZATION FOR ANIMAL 
HEALTH 
2. Zoning is a concept whereby an area of a count ry is recognized as being pest- or disease-free 
or with low pest or disease prevalence.  It allows tr ade from such areas even if the health status in the 
rest of the country is not favourable.  It is a risk management option which can be applied in a flexible 
manner, albeit in accordance with a fully harmonized  set of principles and rules established through 
legislation.  The European Union recognises the app lication of this concept by third countries wishing 
to export to the European Union provided that equi valent guarantees are given by the trading partners.  
A. THE SPS  AGREEMENT  
3. Article 6 of the WTO Agreement on the Applica tion of Sanitary and Phytosanitary Measures 
(SPS Agreement) defines regionalization and states th e general conditions that facilitate international 
trade.  In addition, since May 2008 the WTO  SPS Committee has adopted non-binding "Guidelines to 
further the Practical Implementation of Article 6 of the SPS Agreement", in order to facilitate the 
recognition of pest- and disease-free areas or areas of low pest or disease prevalence.1  These 
guidelines are intended to provide assistance to WTO Members in the practical implementation of 
Article 6 by improving transparency, the exchange of information, predictability, confidence and 
credibility between importing and exporting Members.  These guidelines describe in particular the 
information needed for the recognition of regi onalization and the administrative steps an 
exporting/importing country must take. 
                                                      
1 G/SPS/48  G/SPS/GEN/1159 
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  B. T
HE WORLD ORGANIZATION FOR ANIMAL HEALTH  
4. According to the World Organization for Animal Health (OIE), the terms "zone" and "region" 
are synonyms which refer to "a clearly defined part  of a territory containing an animal subpopulation 
with a distinct health status with respect to a specific disease for which required surveillance, control 
and biosecurity measures have been applied for the purpose of international trade".  Chapter 4.3. of 
the OIE Terrestrial Animal Health Code giv es specific guidelines for performing zoning and 
compartmentalization.  Zoning is implemented with  a view to defining subpopulations of distinct 
health status within a territory  for the purpose of disease control and/or international trade.  The 
importing country should recognise the existence of the zone in the exporting country.  The following principles should apply when defining a zone:  
(a) The extent of a zone and its geographical lim its should be established by the Veterinary 
Authority on the basis of natural, artifici al and/or legal boundaries, and made public 
through official channels; 
(b) A protection zone may be established to preserve the health status of animals in a free 
country or zone, from adjacent countries or z ones of different animal health status; 
(c) In the event of limited outbreaks of a specified  disease within an otherwise free country or 
zone, a single containment zone, which includes all cases, can be established for the purpose of minimizing the impact on the entire country or zone; 
(d) Animals and herds belonging to separate subpopulat ions need to be recognisable as such 
through a clear epidemiological separation a nd the Veterinary Authority should document 
in detail the measures taken to  ensure the identification of the subpopulation and the 
establishment and maintenance of its hea lth status through a biosecurity plan; 
(e) Relevant animals within the zone or compartm ent should be identified in such a way that 
their movements are traceable. 
II. ZONING FOR ANIMAL DISEASES IN THE EUROPEAN UNION  
5. Within the European Union, the main goal of z oning is twofold:  (i) to ensure the effective 
control of diseases within the affected area and (ii) to limit the impact of diseases on both the EU 
internal market and on exports. 
A. THE IMPORTANCE OF ZONING FOR THE EUROPEAN UNION  
6. The European Union is a single market comprising the free movement of goods (including 
animal and animal products), persons, services and capital amongst all EU member States.  The 
Single Market dates back to 1993.  To this end,  the European Union has developed a comprehensive 
animal, plant health and food safety policy that en sures a high status of animal and plant health 
throughout the European Union.  This is not only essential to ensure the sustainable development of 
agriculture and profitability for farmers, the protectio n of human health and the welfare of animals, it 
is also fundamental to the functioning of the intern al market and to trade.  The European Union bases 
its policy on international standards not only, for th e purpose of trading internationally, but also, to 
ensure the proper functioning of the single market. 
B. HOW IS ZONING APPLIED WITHIN THE EUROPEAN UNION ? 
7. Given that animal diseases do not respect national boundaries, the concept of zoning has been 
present in EU sanitary and phytosanitary legislati on long before the establishment of the internal 
market.  With the abolition of border controls a nd the creation of a single market between member 
States around twenty years ago, the European Union re inforced and extended this concept to cover all  G/SPS/GEN/1159 
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  the pests and diseases of major concern.  This has le d to a comprehensive body of EU legislation on 
disease control, on intra-EU trade and on imports of animals and their pr oducts.  Zoning is an 
excellent tool to control disease and it is widely applied in the European Union in line with SPS and 
OIE guidelines and standards. 
C. EU HARMONIZED LEGISLATION , NATIONAL CONTINGENCY PLAN S AND PREDICTABILITY OF 
MEASURES  
8. In the European Union, a comprehensive bod y of harmonized legislation is in place, 
establishing the basic measures and actions to be implemented by the competent authorities in the 
member States to contain, and eventual ly eradicate, major animal diseases. 
9. In line with EU requirements, in all EU member States, disease-specific contingency plans 
are also in place for all major animal diseases , so that the actions established in the legislation on 
disease control and trade can be effectively impl emented, while taking into account the local 
circumstances and specific characteristics of each disease outbreak.  This emergency preparedness is 
key to enhance the ability of the European Un ion to rapidly contain disease.  By means of 
contingency plans, rapid implementation of all a ppropriate disease control measures and restrictions 
on trade in animals and their products that could pose a risk, are put in place.  This is fundamental for 
a proper implementation of the concept of zoning when outbreaks of diseases occur. 
10. The size of the area in which disease control measures and trade restrictions apply may vary 
depending on several factors, including the disease in question and local risk factors that are 
considered in each contingency plan. 
11. The disease control measures will also vary depe nding on the same factors.  However, they 
usually include the stamping-out (humane killing and destruction) of animals in the infected farms 
(and if necessary, on other at-risk farms identified by  means of epidemiological investigations) and/or 
vaccination.  Trade restrictions may include a ban on animal movements within and from the infected 
areas. 
12. Control measures and trade restrictions can only be lifted after appropriate disease 
surveillance measures have been applied in the aff ected area, and are modulated on the basis of the 
outcome of epidemiological investigations.  EU legislation and national contingency plans foresee 
precise timetables for these actions.  However, once the appropriate surveillance is carried out and 
persistence of disease agent in the affected area is excluded, measures are lifted without undue delay.  
In this way, the impact of trade restrictions is kept to a minimum. 
13. In the event of disease outbreaks, the European  Commission follows the evolution of the 
disease situation very closely; working in close cooperation with the affected member State - and 
other member States - in the framework of the Standing Committee of the Food Chain and Animal 
Health (SCOFCAH) meetings.  In this way, it en sures maximum transparency with respect to the 
disease situation.  Regular reports are published on the SCOFCAH website, usually within 24 hours 
from the end of the meeting.  Transparency is furt her ensured through audits by the inspection service 
of the Commission of the control measures implemented.  Such audits may be undertaken during a 
prolonged outbreak to also inform the decision-maki ng process or after the lifting of restrictions to 
verify the actions taken. 
D.  MODULATION OF DISEASE CONTROL MEASURES AND OF THE AREAS IN WHICH TRADE 
RESTRICTIONS APPLY  
14. EU legislation and member States continge ncy plans include the necessary flexibility to 
ensure that disease control measures and the size of  the area under restriction are proportionate to the G/SPS/GEN/1159 
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  risk of further disease spread.  Where appropriate, the Commission intervenes with the rapid adoption 
of further legal texts supplementing the existing le gislation and modulating disease control measures, 
including zoning, as appropriate.  In this way, it supports the action undertaken by the affected 
member State and it provides the necessary guarantees to third country partners as regards the zoning 
measures adopted.  If there is a risk that an outbreak will get out of control, the Commission 
intervenes by restricting trade from an area bigger th an that foreseen in the basic legislation.  In 
extreme circumstances, the area under restrictions may include the whole territory of the affected 
member State. 
E. B
ENEFITS FOR THE EU MARKET AND FOR EU TRADE PARTNERS  
15. The concept of zoning is primarily applied in the European Union to prevent disease spread 
from the affected area, for the benefit of the no n-affected EU member States, and to prevent 
disruption to the EU internal market.  The restrict ions to trade that apply in the European Union 
affected area apply both to intra-EU trade and to exports.  The acceptance by non-affected EU 
member States of the way zoning is applied, is one  of the best guarantees that the European Union can 
provide to its trading partners. 
16. The system requires mutual trust and confiden ce.  This has been achieved amongst the EU 
member States, with the European Commission acting as arbiter.  The very high level of transparency 
that is necessary to ensure the functioning of this system within the EU, also serves as a significant 
guarantee from the European Union to its trade partners. 
17. This system is amongst the best proof that a pplication of zoning for SPS measures, in line 
with the provisions of Article 5.6 of the SPS Agreem ent, serves trade well.  By choosing the least 
trade-restrictive measures possible, zoning allo ws to proceed on a safe basis with appropriate 
guarantees provided along the way.  Application of the principle can also be very beneficial to many 
developing countries whose health status is not  necessarily favourable throughout their whole 
territory, but who may, nevertheless, be able to export products from a particular area.   
III. CASE STUDY 
18. The European Union is pleased to provide a cas e study in annex, which refers to avian 
influenza. 
IV. CONCLUSION 
19. The success achieved by the European Union in the  last decade in containing, controlling and 
eradicating outbreaks of diseases such as foot and mouth disease, classical swine fever and avian influenza, and  the experience gained by the European Union in applying zoning, or regionalization, to 
ensure the proper functioning of the EU single mark et, have demonstrated, time and again, the EU's 
ability to meet the dual objectives of maintaini ng a high health status whilst simultaneously 
minimizing barriers to trade. 
Equally, the European Union fully accepts zoning in  third countries exporting to the European Union 
on the basis of the principles of transparency, e quivalency and mutual trust between the competent 
authorities.  The European Union continues to enco urage all third countries' to accept these principles 
and to recognize their benefits, both in terms of disease control and in terms of minimizing trade restrictions. G/SPS/GEN/1159 
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  ANNEX  
CASE STUDY ON ZONING (OR REGIONALISATION) APPLIED FOR  
AVIAN INFLUENZA IN THE EUROPEAN UNION 
  
I. EU LEGISLATION ON AVIAN INFLUENZA CONTROL 
1. In 1999-2000 and then in 2003, the European Union experienced major outbreaks of highly 
pathogenic avian influenza virus (HPAI) origina ting from the uncontrolled circulation of low 
pathogenic avian influenza (LPAI) virus in poultry flocks and the subsequent  mutation of LPAI into 
HPAI viruses.  These experiences, a nd advances in scientific knowledge, in particular on the risks that 
avian influenza viruses may pose to human health and on the role played by wild birds, led to a major 
revision of EU legislation on avian influe nza.  In 2005 Council Directive 2005/94/EC
1 was adopted.  
This legal act lays down surveillance, control a nd eradication measures for HPAI, and LPAI of the H5 
and H7 subtype, when confirmed in poultry and captive birds.  
2. The main objectives of EU legislation on avian influenza control are to: 
(i) reduce the risk of LPAI mutation to HPAI  by control and eradication of LPAI 
infections in poultry; 
(ii) reduce the occurrence of larg e scale HPAI/LPAI outbreaks;  
(iii) limit the spread of both LPAI and HPAI fro m the originally infected poultry farm and 
from areas put under restrictions; 
(iv) minimize the risks for human health by m eans of a rapid detection, control and 
eradication of both LPAI and HPAI; 
(v) minimize the negative impact of avian influenza outbreaks on trade.  
3. In accordance with Directive 2005/94/EC, the cl assical "stamping-out" policy is applied as a 
general rule to control and eradicate avian influen za, by culling infected poultry flocks and those that 
might have had direct or indirect contact with th e infected flock.  However, the legislation also 
foresees the possible use of vaccination, and facilit ates, in principle, the application of a DIVA 
(Differentiating Infected from Vaccinated Animals) vaccination strategy in order to prevent the mass 
killing of birds.  However, vaccine use against avian influenza in the Eu ropean Union has been 
extremely limited. 
4. Directive 2005/94/EC has also been supplem ented with further legal acts so that a very 
comprehensive legal framework ensures a proportionate response to the different risks posed by 
the occurrence of LPAI and HPAI under different situations (LPAI or HPAI; special measures for 
HPAI H5N1, given the major risk that it poses to hum an health; occurrence in wild birds, poultry or 
other captive birds; occurrence of disease in ar eas with high density of poultry; etc.). 
5. In order to ensure the proper implementation of EU legal requirements, all member States 
have put in place contingency plans .  These plans detail the provisions necessary for the practical 
application under the local circumstances of avia n influenza control measures such as legal powers, 
administrative organization for an efficient chai n of command, establishment of local and central 
disease control centres, instructions for laboratories a nd veterinarians and information to stakeholders 
and the public.  Veterinary authorities must also en sure that sufficient financial and human resources 
                                                      
1 http://eur-lex.europa.eu/LexUriServ/LexUri Serv.do?uri=OJ:L:2006:010:0016:0065:EN:PDF  G/SPS/GEN/1159 
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  and equipment are available for the rapid control of a major outbreak.  The plans must be regularly 
updated and simulation exercises carried out. 
6. The European Commission also has the lega l powers to adopt further disease control and 
zoning measures very rapidly if an outbreak in  the European Union gets out of control. 
7. This infrastructure ensures that following the detection of both LPAI and HPAI in their 
territory, EU member States can swiftly establish proper disease control and zoning measures 
around the affected holdings.  In fact, zoning is firstly applied in the European Union to prevent 
unnecessary disruption of the EU Single Market, a nd secondly to provide the necessary guarantees to 
trade partners so that trade can safely conti nue from the non-affected areas of their territory. 
8. Restrictions within the established zones in re lation to avian influenza outbreaks can only be 
lifted after additional surveillance and testing has b een carried out in the poultry holdings (including 
backyards) within the zones in  accordance with the detailed protocols established in the "Avian 
Influenza Diagnostic Manual
2", that takes into account the short in cubation period of avian influenza.  
Once all actions foreseen in the EU legislation incl uding the depopulation of the infected holding(s) 
and the above additional surveillance have been su ccessfully completed and further virus circulation 
has been excluded, restrictions may be lifted in a re latively short period of time, i.e. after a minimum 
of 21 days (LPAI) or 30 days (HPAI) from the completion of cleaning and disinfection on the 
previously infected holding(s). 
9. In the paragraphs below, some more details  are provided on how disease control and zoning 
measures are applied in a synergistic way, under different disease scenarios. 
II. SURVEILLANCE, CONTROL AND ZONING MEASURES FOR LPAI IN POULTRY 
10. Member States must carry out ac tive sero-surveillance in domestic poultry in order to identify 
circulation of LPAI viruses which may easily go undetect ed due to lack of clinical signs.  Surveillance 
enables the CA to adopt measures to possibly prev ent mutation of LPAI to HPAI.  Surveillance shall 
be conducted in a targeted manner taking into account  specific risk factors such as the location of 
holdings close to waterways where migratory wild birds gather or/and a high density of poultry 
holdings in certain areas. 
11. If LPAI is confirmed in poultry, control measu res proportionate to the risk posed by these 
viruses must be implemented.  All poultry present on the holding must be removed i.e. either by 
killing and safe disposal or by slaughtering under stringent precautions and biosecurity measures.  
However, at present member States do not make use of the latter option.  A "restricted zone" of at least one km radius around the infected holding must  be established, where movement restrictions for 
live poultry and eggs apply and epidemiological i nvestigations, enhanced biosecurity and cleaning 
and disinfection must be carried out. 
III. SURVEILLANCE, CONTROL AND ZONING MEASURES FOR HPAI IN POULTRY 
12. In accordance with Directive 200 5/94/EC, the classical "stamping-out" policy for HPAI is 
applied by culling infected poultry flocks and those that  might have had direct or indirect contact with 
the infected flock.  Certain outbreak situations also require the pre-emptive culling of poultry on 
holdings at risk of infection in the surroundings of the affected holding.  Thorough cleaning and disinfection of the premises must be carried out.  Feeding stuffs, contaminated equipment and manure 
are destroyed or treated to render the virus inactive to further prevent virus spread.  Council Directive 
                                                      
2 Commission Decision 2006/437/EC: 
http://eur-lex.europa.eu/LexUriServ/LexUriSe rv.do?uri=OJ:L:2006:237:0001:0027:EN:PDF   G/SPS/GEN/1159 
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  2005/94/EC also foresees the possible use of vaccination,  and facilitates in principle the application of 
a DIVA (Differentiating Infected from Vaccinated Anim als) vaccination strategy in order to prevent 
the mass killing of birds.  However, vaccine use against avian influenza in the European Union has 
been extremely limited. 
13. Immediately after the confirmation of the outbreak member States' competent veterinary 
authorities (CA) must put in place movement rest rictions on affected holdings and on all poultry 
farms located in a radius of at least 3 km (protec tion zone) and of at least 10 km (surveillance zone).  
In these zones graduated measures apply for movement  restrictions on poultry, captive birds, day-old 
chicks, hatching eggs, table eggs, carcasses as well as  for other possible means for virus spread such 
as vehicles, manure, litter, equipment and the moveme nt of people.  The establishment of these zones 
takes into account the geographical situation includ ing natural boundaries, the location and proximity 
and the estimated number of poultry in the holdings located in the zone, as well as facilities to best 
control the movements.  If required by the disease situa tion, the CA can establish a "further restricted 
zone" of a more than 10 km radius around the infe cted holding where some or certain control and 
restriction measures laid down for the protection and surveillance zones apply.  Where necessary a 
"standstill" can be applied to the whole territory of  a member State for movements of poultry, poultry 
products and vehicles used by the poultry sector. 
IV. ADDITIONAL MEASURES IN CASE OF HPAI H5N1 IN POULTRY  
14. Member States are required to define, for their territory, "higher risk areas" for HPAI H5N1 
virus introduction based on identified risk factor s in relation to the poultry species and production 
cycle, husbandry systems (e.g. free range), proximity to staging and mixing points for wild migratory 
waterfowl, in particular those coming from areas and countries with disease presence in poultry or 
wild birds.  At farm level, poultry keepers are ob liged to promptly report even slight changes in 
production such as reduced water and feed intake, eg g drop and increased morbidity/mortality above 
defined thresholds. 
15. When HPAI H5N1 infection is suspected or detected in poultry the control measures of 
Directive 2005/94/EC apply.  Taking into account the specificities of the HPAI H5N1 spread by wild 
birds, additional measures laid do wn in Commission Decision 2006/415/EC3 must be implemented.  
The 3 km protection and 10 km surveillance zones based on the Directive, constitute the high risk 
"Area A".   A larger surrounding low risk "Area B"  serves as a buffer zone between the high risk 
area and the unaffected territory.  Further restric tions on movements of live poultry and its products, 
such as certain by-products and meat of wild feathe red game must be applied.   Stringent biosecurity 
must be observed on poultry farms. 
V. CONTROL MEASURES FOR HPAI H5N1 FINDINGS IN WILD BIRDS 
16. Decision 2006/563/EC4 details protection measures in the event that HPAI H5N1 is detected 
in wild birds.  A control area of at least one km radius around the positive wild bird finding must be established where movement restrictions on live poul try and poultry products must be applied until 
investigations have ruled out a possible virus intr oduction into poultry holdings.  Around the control 
area a monitoring area of at least ten km radius must  be established.  Intensified surveillance in wild 
birds and enhanced biosecurity measures on poultry fa rms must be implemented.  Gatherings of birds, 
game bird release and hunting are prohibited in tho se areas.  The size and the shape of the areas under 
restriction can be adapted e.g. to follow rivers, s ea and lake shores thereby considering geographical, 
ecological, wild bird species and habitat specific aspects. 
                                                      
 3 http://eur-lex.europa.eu/LexUriServ/LexUri Serv.do?uri=OJ:L:2006:164:0051:0060:EN:PDF . 
 4 http://eur-lex.europa.eu/LexUriServ/LexUri Serv.do?uri=OJ:L:2006:222:0011:0019:EN:PDF . G/SPS/GEN/1159 
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  VI. CONCLUSIONS WITH RESPECT TO ZONING FOR INTRA-EU AND 
INTERNATIONAL TRADE  
17. By means of the new legal framework, the Eur opean Union has successfully prevented major 
outbreaks of LPAI and HPAI (including HPAI H5N1) in the European Union.  The outbreaks of avian influenza which have occurred in poultry in the Euro pean Union in the last six years originated from 
wild birds and they have been successfully controlle d and eradicated in the identified affected areas, 
with only very limited exceptions that have not led to any serious disturbance to the EU Single Market. 
18. While wild birds will continue to pose a risk as regards the spread of avian influenza in 
poultry in Europe as well as in any other area of th e world, the European Un ion considers that the 
introduction of new legislation has been very successful in reducing the risks posed by LPAI, HPAI 
and HPAI H5N1 and it has led to the achievement of the four objectives indicated in paragraph 1. 
19. EU disease control and zoning measures are largely predictable, as legislation considers very 
detailed disease scenarios that are further develope d in the member States' contingency plans.  
Immediate implementation of trade restrictions in th e event of an outbreak is followed by a repealing 
of the measures once there is evidence that the outbreak has been successful ly eradicated.  Both 
aspects are essential to minimize the impact of the outbreak on trade. 
20. The synergistic way in which disease surveillan ce, control and zoning measures are applied 
and the fact that those measures are firstly ai med at preventing unnecessary disruption of the EU 
Single Market are the best guarantees that the Eu ropean Union can provide to third countries as 
regards the safety of the poultry commodities origin ating from the non-affected areas of the European 
Union. 
21. The Commission is available to provide further information on this issue to third countries' 
trade partners, if requested. 
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