WORLD TRADE  
ORGANIZATION  G/SPS/W/144 
11 March 2004 
 (04-1085) 
Committee on Sanitary a nd Phytosanitary Measures Original:   English/ 
 French/  Spanish 
 
  
DRAFT DECISION ON THE IMPLEMENTATION OF ARTICLE 6 OF THE AGREEMENT 
ON THE APPLICATION OF SANITARY AND PHYTOSANITARY MEASURES 
 
Comments by the European Commun ities on the proposal of Chile
 
(G/SPS/W/140/Rev.1)  
   The following communication, dated 8 March 2004, is being circulated at the request of the 
Delegation of the European Communities. 
 
_______________ 
 
  The Committee on Sanitary and Phytosanitary Measures, 
 Having regard to paragraph 1 of Article 12 of the Ag reement on the Application of Sanitary 
and Phytosanitary Measures (SPS Agreement);   
 Reaffirming  the right of Members to establish sanitary and phytosanitary measures necessary 
to ensure the protection of human, animal and plant life or health and the protection of their territory 
from other damage caused by the entry, establishmen t or spread of pests,  in accordance with the 
SPS Agreement; 
 Desiring  to make operational the provisions of Article 6 of the SPS Agreement; 
 Noting  that the sanitary or phytosanitary status of countries is an important factor in 
permitting, preventing, or improving the conditions for the entry of any potential pest- or disease-carrying products; 
 Recognizing  that regionalization can be applied betw een all Members, irrespective of their 
level of development; 
 Considering  that Members are facing difficulties in appl ying the provisions of Article 6 of the 
SPS Agreement; 
 Taking into account  the specific concerns raised by  exporting Members regarding the 
difficulties involved in obtaining recognition by importing Members of their sanitary and 
phytosanitary status; 
 Recognizing that the application of the "princip le of regionalization" set forth in Article 6 
makes it possible to limit the possible negative effects involved in applying sanitary or phytosanitary 
measures in trade and to improve market access opportun ities, particularly for products of interest to 
developing country Members; G/SPS/W/144 
Page 2  
 
  Recognizing  that transparency, exchange of inform ation and the promotion of confidence and 
credibility among importing and exporting Members ar e essential to the recognition of sanitary and 
phytosanitary status between Member countries; 
 Recognizing  that the application of the "principle of regionalization" provides an effective 
technical and administrative way to ensure that trade opportunities are not wasted because of the 
presence in, or entry into a country of a disease or pest; 
 
 Decides as follows: 
 
1. Regionalization shall be acceptable for smaller isolated ecosystems able to provide with 
enough guaranties of protection from the entry, es tablishment and spread of pests (e.g. farms, 
greenhouses, fisheries, or one or more enterprises of similar epidemiological status), a part of a country, all of a country, or several countries, in respect of sanitary or phytosanitary status relating to a given animal disease or plant pest.  Members shall, when so requested in view of the pest or disease 
involved, consider the technical feasibility of applying on a scientific basis the concept of 
regionalization.  An evaluation by the importing Member of the organizational structure of the 
regulatory bodies of the exporting Member and the implementation of prevention, control or eradication programmes  may  be required in pa rticular in the  case of a first decision on 
regionalization .  A recognition of the Sanitary or ph ytosanitary situation shall not require the drafting 
of a formal agreement.  
2. In order to initiate the process of recognition of regionalization, the importing Member shall 
take account of the exporting Member's pest- or disease-free areas and areas of low pest or disease 
prevalence as established by a national official orga nism  in accordance with the regulations of the 
competent international organizations, in particular  the International Office of Epizootics (OIE) and 
the International Plant Protection Convention (IPPC). 
3. To facilitate the implementation of Article 6 of  the SPS Agreement on regionalization, at the 
request of the exporting Member the importing Member shall explain the requirements and stages 
involved in obtaining recognition of sanitary or phyto sanitary status with respect to a given pest or 
disease.  The exporting Member shall send the tec hnical file establishing compliance with the 
requirements laid down by the importing Member, accompanied by an official declaration from the national regulatory body attesting that the ecosystem is a pest- or disease-free area or an area of low pest or disease prevalence, or shall provide supportin g information showing that the procedures used 
to obtain recognition are based on an internationa l standard, guideline or recommendation established 
by competent bodies under the SPS Agreement.  The exporting Member shall also supply any further 
information that could help the importing Member to reach its decision on recognition.   
4. Importing Members shall respond as quickly as possible to the request of an exporting 
Member for recognition of regionalization, and shall normally begin the examination of an application 
for recognition, for a given pest or disease, of the status of pest- or disease-free area or area of low 
pest or disease prevalence within a period not ex ceeding two months.  That period may be longer 
depending on the time of marketing of the goods  concerned, in accordance with the corresponding 
seasonal trade flows. 
5. The exporting Member shall provide science-base d and technical information to support its 
objective demonstration of its sanitary or phyto sanitary status.  This information may include, 
inter alia,  reference to relevant international standards, or to the relevant risk assessment guaranteeing 
or largely supporting the sanitary or phytosanitary status of the zone in question.  In addition, the exporting Member shall provide reasonable acces s, upon request, to the importing Member for 
inspecting, testing and other relevant procedures fo r recognition of regionalization. Without prejudice  G/SPS/W/144 
 Page 3 
 
 
 to the provisions laid down in paragra ph 9, the expenses related to these inspections and tests should 
not be borne by the exporting Member. 
6. The consideration by an importing Member of a request submitted by an exporting Member 
for the recognition of the status of pest- or di sease-free area or area of low pest or disease prevalence 
with respect to a given pest or disease in its territory  shall not in itself be a sufficient reason to change 
the existing  import conditions with respect  to related products from that Member. 
7. The importing Member, when considering a request  for sanitary or phytosanitary recognition, 
shall not impose demands in excess of those relating to the pest or disease in question, and shall analyse the science-based and tec hnical information provided by the exporting Member on its sanitary 
and phytosanitary measures with a view to determ ining whether those measures achieve the adequate 
level of protection against the risk under consideration. 
8. Should its final analysis and possible on-the-spot  verification lead to a satisfactory outcome 
for the exporting Member concerned, the importing Member shall launch its internal administrative 
and/or legal procedures with a view to ensuring th at its decision to recognize the regionalization can 
be put into effect as rapidly as possible a nd no later than a deadline to be established
, taking account 
of the complexity of particular cases, with the agreement of both the importing and exporting 
Member.  If it rejects the request for sanitary or  phytosanitary recognition, the  importing Member 
shall provide technical grounds for its decision so that the exporting Member can modify and adapt its system with a view to seeking recognition once again. 
9. In accordance with Article 9 of the Agreement (Technical Assistance), a Member shall give 
full consideration to requests by another Member , especially a developing country Member, for 
appropriate technical assistance to facilitate the implementation of Article 6 (Adaptation to Regional 
Conditions). 
10. The Committee on Sanitary and Phytosanitary Measures recognizes the need to continue 
developing guidelines for the determination of pest or disease-free areas and areas of low pest or disease prevalence, and shall urge the OIE and the Interim Commission on Phytosanitary Measures to 
continue, as appropriate, to draw up guidelines on animal and plant health respectively.  These 
organizations, together with the Codex Alimentari us Commission, shall be invited to keep the 
Committee on Sanitary and Phytosanity Measures regularly informed regarding their activities 
relating to the concept of adaptati on to regional conditions or zoning. 
11. Members shall periodically provide the Comm ittee on Sanitary and Phytosanitary Measures 
with information on their experience regarding the im plementation of Article 6 of the SPS Agreement.  
In particular, Members are urged to notify the Co mmittee on Sanitary and Phytosanitary Measures of 
ongoing 
negotiations  for the recognition of regionalization  and of any agreement concerning pest or 
disease free areas and areas of low pest or disease prevalence. 
 
__________