WORLD TRADE  
ORGANIZATION  G/SPS/GEN/588 
8 July 2005 
 (05-3028) 
Committee on Sanitary a nd Phytosanitary Measures Original:   English 
  
 
  
CLARIFICATION OF ARTICLE 6 OF THE SPS AGREEMENT 
 
Communication from the European Communities
 
 
  The following communication, submitted on 28 J une 2005, is circulated at the request of the 
Delegation of the European Communities.  
_______________ 
 
 A. B
ACKGROUND  
1. Several Members have submitted substantial proposals on the regionalization principle1 
(Article 6 in the SPS Agreement) in an attempt to further the discussion on how to best implement it.  
The European Communities has submitted two documents over the years to the SPS Committee 
(G/SPS/GEN/101 and G/SPS/GEN/461).  These documen ts provided practical examples of how the 
principle had been successfully applied in  both the animal and plant health areas. 
2. However, most other documents submitted so far to the WTO Secretariat deal with the more 
general question of exactly what type of info rmation Members need in order to successfully 
implement Article 6, and to what extent the Intern ational Standard setting Bodies (ISB) play a role.  
On this basis, pre-determined guidelines should then be set by the Committee. No Members have 
replied to the Chairman's request in October 2004 to submit practical examples as the best means to 
understand how regionalization is a pplied, and hence the foreseen workshop on the topic has been 
postponed. 
3. At the last SPS Committee meetings (Octobe r 2004 and March 2005), the possibility of 
putting together a list of questions to be submitted to OIE and IPPC was discussed.  The Chairman of 
the SPS Committee had circulated questions to Memb ers in advance of the October 2004 meeting to 
facilitate discussion.  Although the intention had be en to reach a decision quickly so the questions 
could be discussed at the April and May genera l meetings of IPPC and OIE respectively, no 
consensus was reached at the March 2005 meeting of the Committee on the type of questions to be 
submitted to the ISB.  
4. Several Members shared the view that it is pref erable to await further developments in the 
ISB before continuing to discuss development of guidelines in the Committee.  This would allow 
determining gaps and overlaps in the work of the ISB and the SPS Committee and thus identifying 
needs and avoiding duplication.  The European Co mmunities fully subscribes to such arguments, but 
is convinced that guidance by the SPS Committee should remain as general as possible. 
                                                      
1 The term "regionalization" in the context of this discussion covers all other terms discussed in this 
framework (i.e. zoning, co mpartmentalisation etc.) G/SPS/GEN/588 
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__________ 5. At the March 2005 Committee meeting, a propo sal for a work programme was discussed but 
not adopted.  The major concerns reflected in th e document were the need for guidance on how to 
implement the regionalization principle as well as the need for clear-cut timeframes.  The European Communities felt that if the intention was to ensu re rapid implementation of the regionalization 
principle, this proposal would substantially slow down the whole process.   
B. T
HE EC POSITION ON REGIONALIZATION … 
6. Notwithstanding the ongoing efforts and discu ssions at SPS Committee meetings to make 
progress on the effective operation and implementati on of Article 6 of the SPS Agreement, the result 
so far has been a delay thereof.  The Article has already been applied for several years, although only 
by a few Members, e.g. the European Communities.   Sufficient experience exists upon which can be 
built; of course this should not hinder inclusion of any new developments. 
A flexible and adaptable practice,  
 
7. The European Communities has systematically applied the principles of regionalization for 
many years now, both in the animal health and in the plant health areas, a nd both in the internal 
market and with third country part ners.  Substantial experience has b een gained from this practice and 
overall the balance is very positive.  It has been de monstrated that by implementing regionalization, a 
high standard of animal and plant health can be maintained, whilst not interrupting trade more than 
necessary.  In this way the Eur opean Communities deems that it has properly implemented Article 6 
of the SPS Agreement and recognizes that, in the first instance, it is an excellent tool to contain and 
manage animal and/or plant diseases. 
8. Over the years this experience has led to the application of the principles of regionalization in 
as flexible a manner as appropriate and as frequently as possible.  This entails that guidelines are well-
known and the European Communities is happy to sh are its experience in the matter. In addition, 
some examples and further guidance can possibly be provided during a workshop at the WTO, later on this year. 
... based on mutual trust and confidence,  
 
9. The European Communities considers that mutual  trust and confidence building are important 
elements of this process.  The competent authority with the responsibility for implementing the zoning policy (the exporting party) is in the best position to  define and maintain the zone.  Provided the zone 
is defined and maintained according to the require ments of the importing party in agreement with 
criteria such as those laid down in the annex, the decision of the exporting party's competent authority 
shall be the basis for trade. 
10. In order to maintain confidence in the competent authority of the exporting party, the 
exporting party shall inform the importing party on an ongoing basis and without delay of any 
evolution in the disease situation and any measure taken. 
11. In determining whether trade in animals and animal products can occur, the importing party 
may decide to carry out an inspection in the territory of the exporting party concerning the implementation and enforcement of the zoning provis ions.  Such an inspection shall be carried out 
without delay and shall be carried out on the basi s of an audit, including an assessment of the 
performance of the competent author ity.  The past history of the results of previous checks and 
controls on importation should also be taken into account. 
12. The final decision whether trade in animals and animal products on the basis of zoning can 
occur lays with the importing party.  In consulta tion with the exporting party, the importing party may  G/SPS/GEN/588 
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 decide on additional guarantees or risk mitigating factors, such as deboning/maturation, treatment, 
quarantine, time delays and tests.  Decisions on zoning and risk mitigation/management requirements 
will be made in a manner that ensures the righ ts and obligations of both importing and exporting 
parties under the WTO SPS Agreement.  
13. Moreover, the basis for successful regionalization is  the animal and/or plant health status and 
its maintenance through adequate surveillance.  These conditions must  be managed reliably in order 
not to jeopardise the animal and/or plant health stat us in the importing country/z one.  There is more to 
it than a mere trade facilitating measure that can si mply be negotiated.  A nother essential prerequisite 
to achieve a successful regionalization exercise is the genuine commitment of both parties to obtain 
such a goal.  When the importing coun try/zone has no intentions to a pply it properly and solely uses it 
as a disguise to disrupt trade, and when the expo rting country/zone does not take the requests for 
information seriously, then of course the whole process cannot succeed.  Much of this commitment 
also plays an important role in determining th e timeframes in which success can be obtained.   
... to be applied without undue delay 
 
14. In this context the European Communities sees no absolute need to set timeframes.  If both 
parties work together effectively, the regionali zation process will automatically follow the “without 
undue delay” route.  In view of the very different  circumstances that can occur, this process will, 
however, not always have the same timeframes.  In some instances it might be envisaged to set a maximum deadline, which could be decided betwee n both parties (although this may not be very 
constructive for the reasons menti oned above) in order to finalize the process within a “reasonable” 
delay. 
15. An additional argument for the redundancy of setti ng timeframes is that it is in the exporting 
country’s own interest to regionalise in its own territory as quickly as feasible in the first place to contain a disease (outbreak) but also from a trade pe rspective, in order to have all documentation at 
hand upon an importer’s request. 
16. In an attempt to further the practical implemen tation of the Article 6 principle, the European 
Communities of course relies on the latest developmen ts in the ISB, and in particular the OIE and 
IPPC.  In view of this, the SPS Committee shoul d encourage the ISB to start/continue working 
thoroughly on the issue in order to make possible an d facilitate an efficient implementation of Article 
6.  An important aspect thereof is to ask the IS B to take into account the geographical basis for 
recognition of regionalization, beyond all newer concep ts.  On the basis of the ISB's work and their 
work programmes, the SPS Committee can th en define its own work programme. 
17. It is clear to the European Communities that SPS guidelines should be limited to 
administrative rather than technical guidance.  Such an SPS guidance document should limit itself to general issues on the process and procedures to follo w rather than on the technicalities, as these will 
differ from one case to another.  In this logic, the European Communities se es no absolute need to 
await the responses from IPPC and OIE to the SPS Committee’s questions, nor the answers to the 
Chairman’s questions to Members, before proceedi ng to develop this genera l guidance. In addition, 
there is no absolute need to await the new deve lopments by the ISB, as the SPS guidelines should be 
drafted in such a way that they automatically cove r these or that reference is made to the ISB.   
C. W
ORK OF THE INTERNATIONAL STANDARD - SETTING BODIES  
1. OIE 
18. Article 1.3.5.1 of the Office International d es Epizooties (OIE) Terrestrial Animal Health 
Code (2004) describes zoning or regionalization (fo r the purposes of the Code these have the same G/SPS/GEN/588 
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__________ meaning) as a procedure implemented by a country to  define geographical areas of subpopulations of 
different animal health status within its territory  for the purpose of interna tional trade in accordance 
with the relevant chapters of the Code. 
19. Therefore the implementation of Art. 6 of the SPS Agreement should take into account all 
new developments in OIE. 
2. IPPC 
20. The term “regionalization” has not been exp licitly referred to in the International Plant 
Protection Convention (IPPC) text, but some articles thereof are nevertheless of direct relevance (see document G/SPS/GEN/529). In this respect the te rms “pest free area” a nd “area of low pest 
prevalence” are used.  Also many International St andards for Phytosanitary Measures (ISPMs) have 
relevance to regionalization (see also document G/SPS/GEN/529) although the concept is not 
explicitly mentioned. The most important ones ar e ISPM 4 (Requirements for the establishment of 
pest free areas) and the recently (April 2005) adopted ISPM on “Requirements for the establishment of areas of low pest prevalence”. In ISPM 1, wh ich is currently under revision, a new principle 
concerning “administrative delays” is proposed. 
21. During the seventh meeting of the Interim Commission on Phytosanitary Measures (ICPM), 
an open-ended working group on regionaliza tion was convened. The ICPM  decided inter alia  that a 
feasibility study be undertaken on the international recognition of pest free areas, which would take 
into account legal, technical and economic factor s and assess feasibility and sustainability of such a 
system. It was further decided that a concept ISPM  “Guidelines for the recognition of pest free areas 
and areas of low pest prevalence” would be develo ped urgently.  The ISPM would provide general 
guidance for the recognition process but would not in clude specified timelines.  Notwithstanding this, 
the European Communities has alread y applied the principle both in the own internal market as for 
some third countries (see G/SPS/GEN/101 and G/SPS/GEN/461). 
22. In addition, the implementation of Article 6 of  the SPS Agreement should take into account 
all new developments in IPPC. 
D. C
ONCLUSION  
23. The European Communities hopes that guidelines su ch as those provided in the annex to this 
document can assist WTO Members to successfully implement the principles of Article 6 of the SPS Agreement.  G/SPS/GEN/588 
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 ANNEX 
 
RELEVANT PRINCIPLES AND GUIDELINES TO EFFECTIVELY IMPLEMENT 
THE PROVISIONS OF ARTIC LE 6 OF THE SPS AGREEMENT 
 
Regionalization on animal health issues  
  
1. In an attempt to further the ongoing discussi on on regionalization in the SPS Committee, the 
European Communities makes use of the following guida nce to implement the principle of Article 6.  
The overall intention hereof is to convince Member s that in principle, bilateral arrangements on 
regionalization can easily be transposed to a mu ltilateral one when using these general guidelines and 
hence facilitate trade considerably. 
2. The following clarifies in the simplest way what steps need to be taken to apply the principles 
of Article 6 of the SPS Agreement in the animal health area. 
3. Certain principles should be used as crite ria for applying and assessing zoning and 
regionalization (for simplicity the term zone is used henceforth). A very important element to keep in 
mind is that in terms of their level of relevance,  these principles are interdependent and variable, and 
depend on the epidemiology of the disease in the area in which zoning is applied.  
4. Their application and assessment depend on factors such as:  
• OIE notifiable diseases; 
• basic scientific knowledge of the epidemiology of the disease, in particular as regards 
animals and commodities causing spread of disease; 
• the specificity of the zones: - Geographical factors, 
  - (Micro) climatological factors,       - Infrastructural factors,       - Environmental factors.  
A. Z
ONES OF DIFFERENT HEALTH STATUS  
(a) Zones may be established in the course of eradication measures to control an outbreak 
of a disease including zoonoses or, 
  Zones refer to the presence or absence of  the disease / pathogen in a zone, different 
prevalence of the disease in zones or the control measures (including vaccination) in place in the zones. 
 
(b) Zones of different health status are separate and distinct. The following zones can be 
distinguished: infected zone, free zone, bu ffer zone, control programme/surveillance 
zone, zones with a certain prevalence and vaccinated zones. 
B. B
ORDERS OF THE ZONE  
- The function of the borders is to protect and/or define the free/buffer/control zone; 
- The borders of the zones may be legal, natura l or artificial (geographical/physical) barriers; 
- Legal borders are legally determined for the competence of an administration such as 
countries, states, provinces, communes, other ad ministrative entities such as shires, divisions, 
etc; G/SPS/GEN/588 
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__________ - Natural borders include mountains, rivers, seas, lakes, etc; 
- Artificial borders include physical features su ch as roads, canals, railways, and intangible 
lines such as geographic information system coordinates; 
- Regardless of the type of border used, the zone status of each animal and each farm or 
management unit should be clear. The choice of the type of borders should always take into 
account the best available option or combination of options. 
C. L
EGISLATION  
- Effective legislation must be in force and av ailable to enable the est ablishment, maintenance 
and control of the zones and their borders; 
- Effective legislation must be available fo r movement controls and temporary movement 
restrictions under conditions to be determined by the competent authority for all susceptible 
animals and animal products and ri sk material (where relevant); 
- Effective legislation must be available for imposing actions to control the disease in the zone 
and to manage the zones (surveillance, sampling etc); 
- The criteria for this legislation are that: 
 - it must allow establishment or lifting of zones without delay, 
 - it must not be hindered by procedural/competence/budget problems,  - it must be risk based and flexible, reflecting the different levels of risk. 
 
D. P
OWERS AND PERFORMANCE OF THE COMPETENT AUTHORITY  
- In most cases the competent authority is the o fficial veterinary service but may be any service 
that has been given this responsibility. The comp etent authority must be able to count on an 
effective co-operation with the police, ar my and any other services necessary for the 
enforcement of the measures;  
- The competent authority should be a central service with central power and, in case of 
decentralised power, (such as federal states and territories or autonomous regions) structured 
provisions and legislation should be available to ensure an appropriate interregional co-
operation. 
E. DISEASE REPORTING  
5. The disease for which zoning is carried out must  be notifiable or reportable. Quality of 
disease reporting/notification depends on:  
 - disease surveillance, early investigation and reporting; 
 - legal provisions for the disease being notifia ble/reportable to the competent authority; 
 - public awareness;  - history of disease occurrence;  - compensation provisions in case of obligatory eradication measures;  - legal penalties in case of non-compliance. 
  G/SPS/GEN/588 
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 F. EPIDEMIOLOGICAL INVESTIGATIONS  
6. Investigations should take into account the ep idemiology of the disease under consideration. 
For diseases that can be transmitted by contagious means, investigations should focus on tracing 
forwards and backwards from positive disease finding s. For non-contagious diseases the investigation 
should take into account inter alia  relevant information related to possible vectors. 
7. The effectiveness of these investigations depends on: 
 - Epidemiological knowledge of a given disease in the zone under consideration; 
 - Experience, performance and power of the competent authority;  - Performance of the laboratories;  - Knowledge of trade structures and patterns; 
 - Knowledge of degree of risk po sed by feral animal reservoirs; 
 - Quality of record keeping systems;  - Stability of pathogen or vector systems;  - Traceability of animals and animal pr oducts (where appropr iate) depends on good 
identification and/or registration systems. 
G. R
ELIABILITY OF LABORATORY PROCEDURES  
- Reliability of laboratory procedures is crucial for confirmation of diagnosis, epidemiological 
investigations, surveillance, and movement controls. 
- Reliability must be judged in qualitative a nd quantitative terms. Laboratory capacity and 
speed of reporting may be crucial in certain circumstances.  
H. MOVEMENT CONTROL AND TRADE RESTRICTIONS  
- Movement control concerns move ments within and between zones. 
- For diseases that can be spread by contagious mean s, the stability of a certain disease status in 
a zone depends on an effective movement control, which in turn depends on:  
 - Performance and power of the competent aut hority and its co-operation with other services; 
 - Traceability of animals and animal products via identification and/or registration systems; 
 - Quality of record keeping systems. 
- For diseases that cannot be transmitted by contagio us means, the value of movement controls 
on animals or animal products depends on the epidemiology of the disease under consideration. 
I. L
EVEL OF SURVEILLANCE  
- To effectively manage the zones, surveillan ce must be carried out inside and outside the 
different zones. 
- Surveillance programs should consider the ep idemiology of the disease, and may include 
active and passive surveillance, as appropr iate according to scientific standards. 
- Confirmed and suspected cases should be follo wed by epidemiological investigations and 
surveillance. G/SPS/GEN/588 
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__________ - Surveillance programs should be designed according to 
• the disease agent as regards: 
  - surveys for evid ence of the agent, 
  - routine sampling on farms, markets and abattoirs,   - sentinel animal and vector trapping programs, 
  - banking of samples for retrospective surveys, 
  - analysis of laboratory records;  
• the host population as regards: 
  - demographics, 
  - movement and trade patterns,   - interaction between domesticated and wild animals, 
  - animal identification and registration systems, 
  - management factors;  
• environmental factors as regards:  
  - air and quality, 
  - vector distribution and competence, 
  - topography, 
  - meteorology,   - degree of uniformity of the above; 
• infrastructure as regards: 
  - feed distribution, 
  - marketing, distribution and slaughter of animals, 
  - pharmaceutical and other relevant industries, 
  - veterinary and practice; 
• measures taken in the zone – see below. 
J. M
EASURES IN THE ZONES  
8. If disease is detected in a free/buffer/control zone, the status of that zone must be reassessed. 
Scientifically supportable measures may be taken to protect or re-establish the status of the zone, 
including: 
 - stamping out, 
 - movement control,  - stand still,  - vaccination (including safety of vaccines used).  K. C
ONTROL OF ENTRY  
9. Zones of higher health status should be protect ed from disease incursions by measures that 
consider the epidemiology of the disease and are consistent with international guidelines. These 
measures may include controls on the importation of  animals, genetic material, animal products, 
fomites, animal feeds including swill, biologics and border audit (as appropriate). These controls are 
intended to apply (where appropria te) to the boundary of a free zone, which may or may not be a 
national border.   G/SPS/GEN/588 
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 L. NOTIFICATION TO THE OIE 
10. Where applicable, the party involved notifies the occurrence of the disease to the OIE in 
accordance with OIE rules. 
__________