WORLD TRADE  
ORGANIZATION  G/SPS/GEN/461 
12 December 2003 
 (03-6566) 
Committee on Sanitary a nd Phytosanitary Measures Original:   English 
  
 
REVIEW OF THE SPS AGREEMENT 
 
Update on adaptation to regional conditions
 
 
Submission by the European Communities  
 
 
 The following submission is being circulated at the request of the Delegation of the European 
Communities.  
_______________ 
 
 
 
ARTICLE 6 - Adaptation to Regional Conditions, Including Pest- or  
Disease-Free Areas and Areas of Low Pest or Disease Prevalence 
 
1. Members shall ensure that their sanitary or phytosanitary measures are adapted to the 
sanitary or phytosanitary characteristics of the area - whether all of a country, part of a country, or 
all or parts of several countries - from which the product originated and to  which the product is 
destined.  In assessing the sanitary or phytosanitary characteristics of a region, Members shall take 
into account, inter alia, the level  of prevalence of specific dise ases or pests, the existence of 
eradication or control programmes, and appropriate  criteria or guidelines which may be developed 
by the relevant international organisations.   
 
2. Members shall, in particular, recognize the c oncepts of pest- or disease-free areas and areas 
of low pest or disease prevalence.  Determination of such areas shall be based on factors such as 
geography, ecosystems, epidemiological surveill ance, and the effectiveness of sanitary or 
phytosanitary controls. 
 
3. Exporting Members claiming that areas within thei r territories are pest- or disease-free areas 
or areas of low pest or disease prevalence shall provide the necessary eviden ce thereof in order to 
objectively demonstrate to the importing Member that  such areas are, and are likely to remain, pest- 
or disease-free areas or areas of low pest or dise ase prevalence, respectively.  For this purpose, 
reasonable access shall be given, upon request, to the importing Member for inspection, testing and 
other relevant procedures. 
 
 
I. INTRODUCTION 
1. On 23 November 1998, the SPS Secretariat issued G/SPS/GEN/101 on "Adaptation to 
regional conditions – Equivalence" as submitted by the European Communities.  This paper outlined 
the overall view of the regionalization policy that th e European Communities had developed.  In view 
of the present discussion on the difficulties in the app lication of the regionalization policy, the EC has G/SPS/GEN/461 
Page 2  
 
 submitted this document to amplify its earlier doc ument and provide updated information on the 
implementation of this concep t by the European Union. 
2. Regionalization/zoning is a risk management option which is applied within the European 
Union in a flexible manner, reflecting the complexi ty of the factors involved in the occurrence and 
spread of disease agents, and in the context of other risk management measures aimed at guaranteeing 
an appropriate level of protection against the spr ead of organisms and diseases potentially harmful for 
humans, animals and plants, with the aim of protec ting both human, animal and plant life or health 
without creating unnecessary trade restrictions.  In the same manner and in ac cordance with the same 
principles, the European Union recognises the applica tion of this concept by third countries wishing to 
export to the European Union.  
3. The completion of the Internal Market in th e European Communities in 1992 implied the 
abolition of controls, including ve terinary and phytosanitary checks,  at the borders between member 
States.  Animals, products of animal origin, plan ts and plant products moving within the Community 
are checked at origin to ensure compliance with h ealth rules, and random checks may be made at their 
destination.  Exports to the European Communities are required to meet health standards at least 
equivalent to those applied at EC level.  This policy will continue to apply also in the enlarged 
European Union, which will include ten new Member States as at 1 May 2004. 
4. As human and animal diseases and plant pest s have never respected national boundaries, the 
concept of regionalization or "zoning", had been pr esent in EC sanitary and phytosanitary legislation 
long before the establishment of the internal market.  With the abolition of border controls, this policy 
was reinforced and extended to cover all the pests and diseases of major concern.  
5. Similarly, when assessing the eligibility of a country to export live animals, products of 
animal origin, plants or their products to the European Communities, account may be taken of the 
sanitary or phytosanitary status of regions within the country as well as of the whole country, or even 
beyond the borders of one single country.  
6. This principle of regionalization has been intern ationally recognized, incorporated in the SPS 
Agreement and adopted by the relevant internati onal standard-setting bodies.  The application of 
regionalization for SPS measures, may contribute to meet the provisions of Article 5.6 of the SPS 
Agreement, i.e.:  to choose the least  trade-restrictive measures possible. 
7. In EC legislation sanitary and the phytosa nitary measures are treated separately.  
II. ANIMAL HEALTH MEASURES 
8. As outlined in G/SPS/GEN/101, definitions in the recognition of regions free of certain 
diseases, infected regions and areas of high or low disease prevalence, as required by Article 6 of the 
SPS Agreement, still remain valid.  All necessary elem ents to assess the animal  health status of a 
country, including the appropriate risk assessment, and hence on which the decision to apply or not 
the concept of regionalization equally remain valid as referred to in the cited document. 
9. In recent years the application of regionalizati on/zoning has had a very substantial impact, in 
particular on the animal health policy of the Europe an Union, leading to positive results both in terms 
of disease control and reducing trade barriers.  Inde ed, the possibility to reduce trade barriers through 
regionalization/zoning is a major stimulus to improve disease control and surveillance both in the 
affected and the free areas.  It also has a positive effect on developi ng countries’ trade. 
10. The success of the implementation of regiona lization/zoning is strictly linked to the 
appropriateness and effectiveness of the disease contro l and surveillance measures applied both in the  G/SPS/GEN/461 
 Page 3 
 
 
 infected and the free zone of the country(ies) con cerned.  These measures must ensure both that the 
risk of spread of the disease from the infected zone to the free zone is minimised and that, if such an 
event occurs, the disease agent is rapidly detected  and adequate control measures are immediately 
applied, so that this situation does not po se unacceptable risks for the importing country(ies). 
11. In the case of animal diseases, the European Uni on applies this concept for highly contagious 
and easily spreading contagious diseases such as Foot-and-Mouth Disease, Classical swine fever and 
Avian Influenza, and for less contagious diseases,  such as Aujeszky’s disease or IBR.  (A more 
detailed examination of the regi onalization applied during the F oot-and-mouth epidemic in the 
European Union in 2001 can be found in Annex II).  According to the characteristics of the disease 
and the local epidemiological situation, the Europ ean Union may identify other zones around, or in 
the vicinity of, infected zones which cannot be c onsidered as free because of the high risk that the 
disease may spread into these zones.  However, from these non-infected/non-free zones certain trade 
may take place under certain conditions.  This trade may only be allowed following the application of 
special control measures and/or only for those comm odities posing a limited risk as regards the spread 
of the disease agent in question (e.g. trade in pr oducts like meat from these zones may be allowed, 
whilst trade in live animals is forbidden).  
12. In a similar manner, within an infected zone  "compartments" may also be identified from 
which a certain trade can take place under certain c onditions (e.g. in case of classical swine fever in 
the wild boar, trade in domestic pig meat may be au thorised from the infected areas if certain specific 
surveillance and control measures are applied bot h on feral and domestic pigs in the zone). 
13. Mitigating factors including specific treatments and time periods can also be introduced for 
added security.  This is done for certain comm odities from some third countries e.g. meat from 
Southern Africa. 
14. Examples of the implementation of this con cept within the European Union and of the 
recognition of the policy applied for third countries ar e given in Annex I.  The European Union deems 
that its approach as regards regionalization/zoning is fully in line with the SPS agreement and the OIE 
and other international standards. 
15. A region should be defined on the basis of  geographical features, vector studies, 
meteorological conditions, epidemiological data an d administrative boundaries.  In the case of the 
European Communities, the area may cover territory  in neighbouring member States.  A restricted 
area must be adequately controlled by the national co mpetent authority.  In addition, in the European 
Communities, the Commission's Veterinary Inspector ate from the Food and Veterinary Office carries 
out inspection missions to check on the implementation of the rules by member States.  Monitoring 
inside and outside the area should be carried out ro utinely by the competent authority.  Surveillance 
must be maintained and, in some cases, serologi cal surveys are necessary to  assess the prevalence of a 
disease. 
III. PLANT HEALTH  
16. In the plant health legislation, the regionali zation principle is introduced through the concept 
of "protected zones", exposed to particular plant health risks, and to which special protection is 
accorded.  Within protected zon es, special arrangements are nece ssary to take account of differing 
pest and disease situations and differing crop a nd growing conditions within the European 
Community. 
17. Two types of protected zones can be identified:  G/SPS/GEN/461 
Page 4  
 
 (a) Zones in which pests and diseases established in one or more parts of the European 
Community are not endemic or established;  e.g.: 
 Bark beetles and woodborers of the genera Scolytus  and Ips affecting wood of conifers with 
bark or isolated bark of conifers.  Protected zone are recognised for: 
 
- Ips aminutus  in Greece, France (Corsica), Ireland and United Kingdom; 
- Ips typographus  in Ireland and United Kingdom; 
- Ips cembrae  in Greece, Ireland, United Kingdom (Isle of Man and Northern, Ireland). 
(b) Zones in which there is a danger that certa in harmful organisms will establish, due to 
ecological conditions, despite the fact that the or ganisms are not endemic or established in the 
European Community. 
18. Both the border of the protected zone and the t ype of special protection must be specified on a 
case-by-case basis, taking into account, inter alia , the specific biological interaction of the host plant 
and harmful organism concerned.  
19. The area of a protected zone in the Europ ean Community may cover an entire country, 
whereby the limits of the zone may coincide with natural borders of the member States, different 
countries, or may be an uninfested part of a countr y situated within a generally infested area of that 
country. 
20. The recognition of a particular protected zone  within the European  Community is based: 
- on a request of a member State(s); 
- on an official confirmation by the respons ible official body of the member State 
introducing the above request, that the relevant pest or disease, in respect of which the 
zone is to be recognized as a protected z one, is not endemic or established there, and 
- on an approval under the EC procedure involving the monitoring and evaluation of 
inspections carried out following the above o fficial confirmation, by the Plant Health 
Inspection Unit of the EC Food and Veterinary Office. 
21. Absence of the pest or low prevalence must be confirmed by appropriate monitoring and 
surveillance.  EC legislation lays down rules for su rveys to be carried out.  EC member States must 
take action in order to prevent the entry into the zone, the spread within the zone, or in order to 
eradicate a pest or disease of unknown origin.  Upon  detection, the presence of the harmful organism 
must be notified and a risk assessment undertaken  by the Commission together with the member 
States in the framework of the relevant Regulatory Committee. 
22. The concept of regionalization is also applied for import of specific plant products from some 
third countries.  For instance, the following areas in certain third countries have been recognised as 
being free of some specific diseases affecting Citrus fruits: 
- as regards Citrus canker: 
• in Australia:  New South Wales, Queensland, South Australia and Victoria; 
• 
all areas of Brazil, with the exception of the States of Rio Grande do Sul, 
Santa Catarina, Paraná, São Paulo, Min as Gerais and Mato Grosso do Sul;   G/SPS/GEN/461 
 Page 5 
 
 
 • in the United States:  Arizona, California, Guam, Hawaii, Louisiana, 
Northern Mariana Islands, Puerto Rico, American Samoa, Texas and the United States Virgin Islands;  
• all areas of Uruguay, with the exception of the Departments Salto, Rivera and 
Paysandu – north of River Chapicuy 
 
- as regards Citrus black spot:   
• in South Africa:  Western Cape;  
• in Australia:   South Australia, Western Australia and Northern Territory;  
• in China:  all areas w ith the exception of Sichuan, Yunnan, Guangdong, 
Fujian and Zhejiang;  
• in Brazil:  all areas with the exception of the States of Rio de Janeiro, São 
Paulo and Rio Grande do Sul. 
 23. Similar criteria as for the recognition or the a bolition of protected zones in the European 
Community are taken into consideration. 
IV. CONCLUSIONS 
24. The European Communities has applied the con cepts of regionalization in recognizing, both 
in its own territory and in the territory of certa in exporting countries, regional disease control policies 
as foreseen by the relevant international st andards and Article 6 of the SPS Agreement.  
Unfortunately, very few other WTO Members apply th is policy to other Members, including the EC.  
It should be recognised that recognition of disease- or pest-free areas within a larger geographical 
territory is both logic and necessary and provides fo r continuity in trade, without the importer’s 
sanitary or phytosanitary status being at stake.   
25. These concepts should also be applied in a tran sparent and consistent manner, taking into 
account existing international standards, guidelin es and recommendations and available scientific 
data.  The experience gained by the European Co mmunities in operating this policy has demonstrated 
that it can meet the objective of maintaining a high health status while minimizing barriers to trade. G/SPS/GEN/461 
Page 6  
 
  
V. EXAMPLES OF CURRENT REGIONALIZATION FOR PRODUCTS FROM THIRD 
COUNTRIES 
ANNEX I 
 
SANITARY MEASURES  
 
Application of regionalization within the European Communities
 
 
 
Country Decision No Disease Product Comment 
Southern 
African Countries 1999/283/EC FMD Fresh meat from 
Bovine, ovine, caprine, General 
regionalization with certification 
Botswana 2003/163 FMD Fresh meat from 
Bovine, ovine , 
caprine, farmed 
and wild ungulates Regionalization 
within Botswana to 
ensure imports are not 
from zones directly affected with FMD, or surrounding zones  
South Africa 2001/164 FMD " Regionalization 
following outbreak 
South Africa 2000/739 FMD " Regionalization 
following outbreak 
South America 93/402/EEC FMD Fresh meat from 
Bovine, ovine, caprine, General 
regionalization with certification 
Brazil 2002/908 FMD Bovine, ovine and 
caprine animals 
and swine, fresh 
meat or meat products  Regionalization of a 
border area following 
an FMD outbreak in 
Paraguay 
Paraguay 2002/908 FMD Bovine, ovine and 
caprine animals and swine, fresh 
meat or meat 
products Regionalization 
following an FMD outbreak 
(Subsequently 
repealed by 2003/137 
which banned the whole country following unfavourable FVO 
Mission )  G/SPS/GEN/461 
 Page 7 
 
 
 Country Decision No Disease Product Comment 
Argentina 2002/338 FMD Bone-in ovine, 
caprine and bovine fresh 
meat 
 Further regions 
approved for export following OIE 
proposal to recognise 
certain provinces as FMD free without vaccination. 
Argentina 2002/198 FMD Bone-in ovine, 
caprine and bovine fresh 
meat 
 Following an outbreak 
of FMD in 2002, approval for certain 
regions to export due 
to improving FMD situation.  
Argentina 2002/338 FMD Bone-in ovine, 
caprine and bovine fresh meat 
 Further regions 
approved for export following OIE proposal to recognise 
certain provinces as 
FMD free without vaccination. 
Bulgaria 1999/538 FMD Bovine, ovine and 
caprine fresh meat Removal of general 
regionalization in Bulgaria, but maintenance of 
regionalization in 
buffer zone next to Turkey 
Bulgaria 1999/541 FMD Live sheep and 
goats Maintenance of 
regionalization in buffer zone next to Turkey 
Bulgaria 2001/600 Bluetongue Live Bovines, 
sheep and goats Following outbreak of 
Bluetongue in July 1999, Bulgaria was 
regionalized to 
prevent imports of live animals from affected areas and surrounding regions 
Slovakia 2002/940 Classical 
Swine Fever 
(CSF) Fresh pig meat Authorised from 
territories not under 
restriction due to CSF 
infection in wild boars.  
Czech Republic 1999/538 CSF Fresh pig meat Regionalization to 
take account of CSF in feral pig populations.  G/SPS/GEN/461 
Page 8  
 
 Country Decision No Disease Product Comment 
Brasil, Costa 
Rica, Columbia, Turkey, 
Venezuela  (also 
see below) 92/160/EEC 
 General health 
conditions Horses 
Saudi Arabia 1999/228 
(92/160/EEC) African Horse 
sickness Horses 
Kyrgyzstan 1999/236 
(92/160/EEC) Dourine Horses 
Mexico 2001/611 
(92/160/EEC) Venezuelan 
equine encephalomyelitis 
 Horses 
Russia 92/161 
(92/160/EEC) General health 
conditions Horses 
Egypt 95/536 
(92/160/EEC) General health 
conditions Horses 
South Africa 97/10/EC 
(92/160/EEC) 
 General health 
conditions Horses 
Peru 2001/619 
(92/160/EEC) General health 
conditions Horses Several countries have 
regionalized areas for the import of horses.  
This is due to 
outbreaks of specific equine disease, or more general health concerns.  
 
There are also specific additional safeguards in relation to regionalization in 
certain countries.   
e.g. in some cases, importation is restricted to registered horses, or limited to re-importation of EC 
horses back into the 
EC. 
Australia 1999/549/EC Newcastle 
Disease Live poultry and 
hatching eggs, live ratites and hatching eggs, fresh meat of 
poultry, ratites, 
farmed and wild feathered game.   
United States 2003/67/EC 
 Newcastle 
Disease Live poultry and 
hatching eggs, live ratites 
and hatching eggs, 
fresh meat of poultry, ratites, farmed and wild feathered game. 
 Regionalization to 
allow imports from unaffected states, and 
prevent imports from 
California, Nevada and Arizona. 
United States 2003/337/EC 
 Newcastle 
Disease Live poultry and 
hatching 
eggs, live ratites and hatching eggs, fresh meat of poultry, ratites, 
farmed and wild 
feathered game.  Following addition 
cases of ND, 
regionalization was restricted to prevent imports from newly affected counties in 
Texas and New 
Mexico.   G/SPS/GEN/461 
 Page 9 
 
 
 Country Decision No Disease Product Comment 
Canada 88/212 
(subsequently 2002/199) Bluetongue Bovine animals  Okanagan Valley- 
British Columbia 
Canada 88/212 
(subsequently 
2002/199) Bluetongue Sheep and goats Okanagan Valley- 
British Columbia 
 G/SPS/GEN/461 
Page 10  
 
 ANNEX II 
 
REGIONALIZATION IN THE EU ROPEAN UNION IN 2001  
IN RESPONSE TO THE FOOT-AND-MOUTH EPIDEMIC 
 
 
Introduction  
1. The European Union adopted a regionalized approach during the outbreaks of FMD in 2001.  
This allowed trade to continue both within the unaff ected areas of the member States, and with third 
countries.  The regionalized approach was taken in parallel with severe safeguard measures to contain 
the disease within the infected areas within each affected country.  This was of fundamental 
importance from a practical disease control aspect, but also to ensure that trading partners could be confident in the disease free status of the unaffected areas.  
Method 
 2. Following the first cases of FMD in the UK in February 2001, the first Commission Decision 
(2001/145/EC) prohibited the exports of live animals,  fresh meat and meat products, milk and milk 
products and other animal products from all part s of the UK to other parts of the Community.  
However the Decision set out the basis on whic h areas of UK territory could be regionalized 
subsequently if this w as considered appropriate. 
3. Following confirmed outbreaks in France, the Ne therlands and Ireland, similar provisions for 
regionalization were set out (in Decisions 2001/20 8/EC, 2001/223/EC and 2001/234/EC respectively).  
This ensured that restriction on the trade in animal  products was limited to those regions that were 
directly affected or considered at high risk .  Because the disease was initially well contained and 
generally restricted to specific areas in these ‘secondary’ outbreaks, the balance of risk ensured that 
regionalization could be introduced for non-affected areas from the outset.  Hence in principle meat 
etc from the majority of areas in France, the Nether lands and Ireland could continue to be placed on 
the market. 
4. The containment of disease in France and Irela nd allowed the policy of regionalization to 
continue throughout the course of the epidemic.  Ho wever, in the Netherlands, infection spread to 
areas outside the initial restricted zones.  Hence re gionalization was suspended and restrictions were 
introduced for the whole of the Netherlands in Ap ril 2002 (Decision 2001/306/EC) for a short time.  
However the Netherlands reintroduced regionalizati on for unaffected areas when the epidemiological 
situation improved. 
5. As the epidemic was brought under control, the a ffected Member States were able to repeal 
restrictions and expand regionalized areas as the epid emiological conditions became more favourable.  
However the Commission, in co-operation with th e Member States was careful to ensure that 
restrictions were only repealed when the disease evolution would allow.  Expanded regionalization 
was therefore introduced followi ng a risk assessment approach, and was supplemented by additional 
measures such as physical checks at border regions , and appropriate marking of products to 
differentiate meat etc that had been produced within  the regionalized areas that were therefore eligible 
to be placed on the market.  
Result of regionalization
 
 
6. Member States recognised, and supported the need  to control disease, and prevent the spread 
of infection, and hence in infected areas, strict controls were put in place.  Regionalization provided a focus for targeted measures in ar eas affected by disease, but allowed disease control and prevention  G/SPS/GEN/461 
 Page 11 
 
 
 strategies to be gradually repealed without impac ting areas that were already free of disease.  Hence 
the regionalization of affected MS coul d be expanded as the epidemic progressed.  
7. Member States also supported the principle of  regionalization as it allowed products to be 
placed on the market.  This ensured that trade coul d continue between unaffected Member States that 
remained disease free, and unaffected regions with in the infected countries.  Subsequently, as the 
epidemic began to subside, Member States supporte d the affected countries in the reopening of areas 
that were directly affected by infection, again on a regionalized basis.  Reopening of previously 
restricted areas was based on a risk assessment approach, and was carried out gradually with appropriate and proportional risk reduction measures in order to ensure that the release of restrictions 
did not cause new outbreaks.  Member States embraced the wider regionalization as the epidemic 
declined, and through the SVC, supported the process of opening previously restricted regions up to 
the internal market.  
8. Although necessary restrictions continued to ap ply in the worst affected areas for several 
months, the majority of areas within the affect ed Member States were able to recommence trade 
within a much shorter time period.  This ensured that both farmers and customers could continue to 
maintain safe trade to the benefit of both parties.   It also provided capacity within the market. 
Future provisions for regionalization in the event of an FMD outbreak 
 
 
9. The new FMD Directive recently proposed by the Commission will strengthen the principles 
of regionalization that were used successfully in the 2001 epidemic.  The Directive gives clear 
obligations for member States to regionalise their te rritory into restricted zones and free zones.  The 
Directive further outlines measures to be applied in  the restriction zones, including the tracing of 
potentially infected animals and products  dispatched to other member States. 
 
__________