AGREEMENT ON THE APPLICATION OF
SANITARY AND PHYTOSANITARY MEASURES

Members,

      Reaffirming that no Member should be prevented from adopting or 
      enforcing measures necessary to protect human, animal or plant life or 
      health, subject to the requirement that they are not applied in a 
      manner which would constitute a means of arbitrary or unjustifiable 
      discrimination between Members where the same conditions prevail or a 
      disguised restriction on international trade;  

      Desiring to improve the human health, animal health and phytosanitary 
      situation in all Members;

      Noting that sanitary and phytosanitary measures are often applied on 
      the basis of bilateral agreements or protocols;  

      Desiring the establishment of a multilateral framework of rules and 
      disciplines to guide the adoption, development and the enforcement of 
      sanitary and phytosanitary measures in order to minimize their  
      negative effects on trade;

      Recognizing the important contribution that international standards, 
      guidelines and recommendations can make in this regard;  

      Desiring to further the use of harmonized sanitary and phytosanitary 
      measures between Members, on the basis of international standards, 
      guidelines and recommendations developed by the relevant international 
      organizations, including the Codex Alimentarius Commission, the 
      International Office of Epizootics, and the relevant international and 
      regional organizations operating within the framework of the 
      International Plant Protection Convention, without requiring Members 
      to change their appropriate level of protection of human, animal or 
      plant life or health;

      Recognizing that developing country Members may encounter special 
      difficulties in complying with the sanitary or phytosanitary measures 
      of importing Members, and as a consequence, in access to markets, and 
      also in the formulation and application of sanitary or phytosanitary 
      measures in their own territories, and desiring to assist them in 
      their endeavours in this regard;  
      Desiring therefore to elaborate rules for the application of the 
      provisions of the GATT 1994 which relate to the use of sanitary or 
      phytosanitary measures, in particular the provisions of Article 
      XX(b)[1];  

Agree as follows:  

1.    This Agreement applies to all sanitary and phytosanitary measures 
which may, directly or indirectly, affect international trade.  Such 
measures shall be developed and applied in accordance with the provisions of 
this Agreement.

2.    For the purposes of this Agreement, the definitions provided in Annex 
A shall apply.  

3.    The annexes are an integral part of this Agreement.

4.    Nothing in this Agreement shall affect the rights of Members under the 
Agreement on Technical Barriers to Trade with respect to measures not within 
the scope of this Agreement.  

Basic Rights and Obligations

5.    Members have the right to take sanitary and phytosanitary measures 
necessary for the protection of human, animal or plant life or health, 
provided that such measures are not inconsistent with the provisions of this 
Agreement.  

6.    Members shall ensure that any sanitary or phytosanitary measure is 
applied only to the extent necessary to protect human, animal or plant life 
or health, is based on scientific principles and is not maintained without 
sufficient scientific evidence, except as provided for in paragraph 22.

7.    Members shall ensure that their sanitary and phytosanitary measures do 
not arbitrarily or unjustifiably discriminate between Members where 
identical or similar conditions prevail, including between their own 
territory and other Members.  Sanitary and phytosanitary measures shall not 
be applied in a manner which would constitute a disguised restriction on 
international trade.

8.    Sanitary or phytosanitary measures which conform to the relevant 
provisions of this Agreement shall be presumed to be in accordance with the 
obligations of the Members under the provisions of the GATT 1994 which 
relate to the use of sanitary or phytosanitary measures, in particular the 
provisions of Article XX(b).

Harmonization

9.    To harmonize sanitary and phytosanitary measures on as wide a basis as 
possible, Members shall base their sanitary or phytosanitary measures on 
international standards, guidelines or recommendations, where they exist, 
except as otherwise provided for in this Agreement, and in particular in 
paragraph 11.

10.   Sanitary or phytosanitary measures which conform to international 
standards, guidelines or recommendations shall be deemed to be necessary to 
protect human, animal or plant life or health, and presumed to be consistent 
with the relevant provisions of this Agreement and of the GATT 1994.

11.   Members may introduce or maintain sanitary or phytosanitary measures 
which result in a higher level of sanitary or phytosanitary protection than 
would be achieved by measures based on the relevant international standards, 
guidelines or recommendations, if there is a scientific justification, or as 
a consequence of the level of protection a Member determines to be 
appropriate in accordance with the relevant provisions of paragraphs 16 
through 23.[2]  Notwithstanding the above, all measures which result in a 
level of sanitary or phytosanitary protection different from that which 
would be achieved by measures based on international standards, guidelines 
or recommendations shall not be inconsistent with any other provision of 
this Agreement.  

12.   Members shall play a full part within the limits of their resources in 
the relevant international organizations and their subsidiary bodies, in 
particular the Codex Alimentarius Commission, the International Office of 
Epizootics, and in the international and regional organizations operating 
within the framework of the International Plant Protection Convention, to 
promote within these organizations the development and periodic review of 
standards, guidelines and recommendations with respect to all aspects of 
sanitary and phytosanitary measures.
                       
13.   The Committee on Sanitary and Phytosanitary Measures, as provided for 
in paragraphs 38 and 41, shall develop a procedure to monitor the process of 
international harmonization and coordinate efforts in this regard with the 
relevant international organizations.

Equivalence

14.   Members shall accept the sanitary or phytosanitary measures of other 
Members as equivalent, even if these measures differ from their own or from 
those used by other Members trading in the same product, if the exporting 
Member objectively demonstrates to the importing Member that its measures 
achieve the importing Member's appropriate level of sanitary or 
phytosanitary protection.  For this purpose, reasonable access shall be 
given, upon request, to the importing  Member for inspection, testing and 
other relevant procedures.

15.   Members shall, upon request, enter into consultations with the aim of 
achieving bilateral and multilateral agreements on recognition of the 
equivalence of specified sanitary or phytosanitary measures.  
Assessment of Risk and Determination of the Appropriate Level of Sanitary or 
Phytosanitary Protection

16.   Members shall ensure that their sanitary or phytosanitary measures are 
based on an assessment, as appropriate to the circumstances, of the risks to 
human, animal or plant life or health, taking into account risk assessment 
techniques developed by the relevant international organizations.

17.   In the assessment of risks, Members shall take into account available 
scientific evidence;  relevant processes and production methods;  relevant 
inspection, sampling and testing methods;  prevalence of specific diseases 
or pests; existence of pest-or disease-free areas; relevant ecological and 
environmental conditions; and quarantine or other treatment.

18.   In assessing the risk to animal or plant life or health and 
determining the measure to be applied for achieving the appropriate level of 
sanitary or phytosanitary protection from such risk, Members shall take into 
account as relevant economic factors:  the potential damage in terms of loss 
of production or sales in the event of the entry, establishment or spread of 
a pest or disease;  the costs of control or eradication in the territory of 
the importing Member;  and the relative cost effectiveness of alternative 
approaches to limiting risks.

19.   Members should, when determining the appropriate level of sanitary or 
phytosanitary protection, take into account the objective of minimizing 
negative trade effects.

20.   With the objective of achieving consistency in the application of the 
concept of appropriate level of sanitary and phytosanitary protection 
against risks to human life or health, or to animal and plant life or 
health, each Member shall avoid arbitrary or unjustifiable distinctions in 
the levels it considers to be appropriate in different situations, if such 
distinctions result in discrimination or a disguised restriction on 
international trade.  Members shall co-operate in the Committee on Sanitary 
and Phytosanitary Measures in accordance with paragraphs 38, 39 and 40 of 
this Agreement to develop guidelines to further the practical implementation 
of this provision.  In developing the guidelines the Committee shall take 
into account all relevant factors, including the exceptional character of 
human health risks to which people voluntarily expose themselves.

21.   Without prejudice to paragraph 10, when establishing or maintaining 
sanitary or phytosanitary measures to achieve the appropriate level of 
sanitary or phytosanitary protection, Members shall ensure that such 
measures are not more trade restrictive than required to achieve their 
appropriate level of protection, taking into account technical and economic 
feasibility.[3]
  
22.   In cases where relevant scientific evidence is insufficient, a  Member 
may provisionally adopt sanitary or phytosanitary measures on the basis of 
available pertinent information, including that from the relevant 
international organizations as well as from sanitary or phytosanitary 
measures applied by other Members.  In such circumstances, Members shall 
seek to obtain the additional information necessary for a more objective 
assessment of risk and review the sanitary or phytosanitary measure 
accordingly within a reasonable period of time. 

23.   When a Member has reason to believe that a specific sanitary or 
phytosanitary measure introduced or maintained by another Member is 
constraining, or has the potential to constrain, its exports and the measure 
is not based on the relevant international standards, guidelines or 
recommendations, or such standards, guidelines or recommendations do not 
exist, an explanation of the reasons for such sanitary or phytosanitary 
measure may be requested and shall be provided by the Member maintaining the 
measure.

Adaptation to Regional Conditions, including Pest- or Disease-Free Areas and 
Areas of Low Pest or Disease Prevalence

24.   Members shall ensure that their sanitary or phytosanitary measures are 
adapted to the sanitary or phytosanitary characteristics of the area - 
whether a country, part of a country, or areas 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 
diseases or pests, the existence of eradication or control programmes, and 
appropriate criteria or guidelines which may be developed by the relevant 
international organizations.  
25.   Members shall, in particular, recognize the concepts 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 surveillance, and the effectiveness of sanitary 
or phytosanitary controls.

26.   Exporting Members claiming that areas within their territories are 
pest- or disease-free or areas of low pest or disease prevalence shall 
provide the necessary evidence thereof in order to objectively demonstrate 
to the importing Member that such areas are, and are likely to remain, pest- 
or disease-free or areas of low pest or disease prevalence, respectively.  
For this purpose, reasonable access shall be given, upon request, to the 
importing Member for inspection, testing and other relevant procedures.

Transparency

27.   Members shall notify changes in their sanitary or phytosanitary 
measures and shall provide information on their sanitary or phytosanitary 
measures in accordance with the provisions of Annex B.

Control, Inspection and Approval Procedures

28.   Members shall observe the provisions of Annex C in the operation of 
control, inspection and approval procedures, including national systems for 
approving the use of additives or for establishing tolerances for 
contaminants in foods, beverages or feedstuffs, and otherwise ensure that 
their procedures are not inconsistent with the provisions of this Agreement.

Technical Assistance

29.    Members agree to facilitate the provision of technical assistance to 
other Members, especially developing country Members, either bilaterally or 
through the appropriate international organizations.  Such assistance may 
be, inter alia, in the areas of processing technologies, research and 
infrastructure, including in the establishment of national regulatory 
bodies, and may take the form of advice, credits, donations and grants, 
including for the purpose of seeking technical expertise, training and 
equipment to allow such countries to adjust to, and comply with, sanitary or 
phytosanitary measures necessary to achieve the appropriate level of 
sanitary or phytosanitary protection in their export markets. 

30.   Where substantial investments are required in order for an exporting 
developing country Member to fulfil the sanitary or phytosanitary 
requirements of an importing Member, the latter shall consider providing 
such technical assistance as will permit the developing country Member to 
maintain and expand its market access opportunities for the product 
involved.

Special and Differential Treatment

31.   In the preparation and application of sanitary or phytosanitary  
measures, Members shall take account of the special needs of developing 
country Members, and in particular of the least-developed ones.  

32.   Where the appropriate level of sanitary or phytosanitary protection 
allows scope for the phased introduction of new sanitary or phytosanitary 
measures, longer time-frames for compliance should be accorded on products 
of interest to developing country Members so as to maintain opportunities 
for their exports.

33.   With a view to ensuring that developing country Members are able to 
comply with the provisions of this Agreement, the Committee on Sanitary and 
Phytosanitary Measures, provided for below, is enabled to grant to such 
countries, upon request, specified, time-limited exceptions in whole or in 
part from obligations under this Agreement, taking into account their 
financial, trade and development needs.

34.    Members should encourage and facilitate the active participation of 
developing country Members in the relevant international organizations.  

Consultations and Dispute Settlement

35.   The provisions of Articles XXII and XXIII of the GATT 1994 as 
elaborated and applied by the MTO Understanding on Rules and Procedures 
Governing the Settlement of Disputes shall apply to consultations and the 
settlement of disputes under this Agreement, except as otherwise 
specifically provided herein.

36.   In a dispute under this Agreement involving scientific or technical 
issues, a panel should seek advice from experts chosen by the panel in 
consultation with the parties to the dispute.  To this end, the panel may, 
when it deems it appropriate, establish an advisory technical experts group, 
or consult the relevant international organizations, at the request of 
either party to the dispute or on its own initiative.

37.   Nothing in this Agreement shall impair the rights of Members under 
other international agreements, including the rights to resort to the good 
offices or dispute settlement mechanisms of other international 
organizations or established under any international agreement.

Administration

38.   A Committee on Sanitary and Phytosanitary Measures shall be  
established to provide a regular forum for consultations.  It shall carry 
out the functions necessary to implement the provisions of this Agreement 
and the furtherance of its objectives, in particular with respect to 
harmonization.  The Committee shall reach its decisions by consensus. 

39.   The Committee shall encourage and facilitate ad hoc consultations or 
negotiations among its Members on specific sanitary or phytosanitary issues.  
The Committee shall encourage the use of international standards, guidelines 
or recommendations by all Members and, in this regard, shall sponsor 
technical consultation and study with the objective of increasing 
coordination and integration between international and national systems and 
approaches for approving the use of food additives or for establishing 
tolerances for contaminants in foods, beverages and feedstuffs.

40.   The Committee shall maintain close contact with the relevant 
international organizations in the field of sanitary and phytosanitary 
protection, especially with the Codex Alimentarius Commission, the 
International Office of Epizootics, and the Secretariat of the International 
Plant Protection Convention, with the objective of securing the best 
available scientific and technical advice for the administration of this 
Agreement and in order to ensure that unnecessary duplication of effort is 
avoided.  

41.   The Committee shall develop a procedure to monitor the process of 
international harmonization and the use of international standards, 
guidelines or recommendations.  For this purpose, the Committee should, in 
conjunction with the relevant international organizations, establish a list 
of international standards, guidelines or recommendations relating to 
sanitary or phytosanitary measures which the Committee determines to have a 
major trade impact.  The list should include an indication by Members of 
those international standards, guidelines or recommendations which they 
apply as conditions for import or on the basis of which imported products 
conforming to these standards can enjoy access to their markets.  For those 
cases in which a Member does not apply an international standard, guideline 
or recommendation as a condition for import, the Member should provide an 
indication of the reason thereof, and, in particular, if it considers that 
the standard is not stringent enough to provide the appropriate level of 
sanitary or phytosanitary protection.  If a Member revises its position, 
following its indication of the use of a standard, guideline or 
recommendation as a condition for import, it should provide an explanation 
for its change and so inform the MTO Secretariat as well as the relevant 
international organizations, unless such notification and explanation is 
given according to the procedures of Annex B.  

42.   In order to avoid unnecessary duplication, the Committee may decide, 
as appropriate, to use the information generated by the procedures, 
particularly for notification, which are in operation in the relevant 
international organizations.

43.   The Committee may, on the basis of an initiative from one of the  
Members, through appropriate channels invite the relevant international 
organizations or their subsidiary bodies to examine specific matters with 
respect to a particular standard, guideline or recommendation, including the 
basis of explanations for non-use given according to paragraph 41 above.  

44.   The Committee shall review the operation and implementation of this  
Agreement three years after entry into force of the Agreement Establishing 
the MTO, and thereafter as the need arises. Where appropriate, the Committee 
may submit to the Council for Trade in Goods proposals to amend the text of 
this Agreement having regard, inter alia, to the experience gained in its 
implementation.  

Implementation

45.    Members are fully responsible under this Agreement for the observance 
of all obligations set forth herein.  Members shall formulate and implement 
positive measures and mechanisms in support of the observance of the 
provisions of this Agreement by other than central government bodies.  
Members shall take such reasonable measures as may be available to them to 
ensure that non-governmental entities within their territories, as well as 
regional bodies in which relevant entities within their territories are 
Members, comply with the relevant provisions of this Agreement.  In 
addition, Members shall not take measures which have the effect of, directly 
or indirectly, requiring or encouraging such regional or non-governmental 
entities, or local governmental bodies, to act in a manner inconsistent with 
the provisions of this Agreement.  Members shall ensure that they rely on 
the services of non-governmental entities for implementing sanitary or 
phytosanitary measures only if these entities comply with the provisions of 
this Agreement.  

Final Provisions

46.   The least developed country Members may delay application of the 
provisions of this Agreement for a period of 5 years following the date of 
entry into force of the MTO  with respect to their sanitary or phytosanitary 
measures affecting importation or imported products. Other developing 
country Members may delay application of the provisions of this Agreement, 
other than paragraphs 23 and 27, for 2 years following the date of entry 
into force of the Agreement establishing the MTO with respect to their 
existing sanitary or phytosanitary measures affecting importation or 
imported products where such application is prevented by a lack of technical 
expertise, technical infrastructure or resources.

                                 ANNEX A

                             DEFINITIONS[4]


      For the purposes of this Agreement, the following definitions shall 
apply:  

1.    Sanitary or phytosanitary measure - Any measure applied:

      -    to protect animal or plant life or health within the territory of 
           the Member from risks arising from the entry, establishment or 
           spread of pests, diseases, disease-carrying organisms or 
           disease-causing organisms;  

      -    to protect human or animal life or health within the territory of 
           the Member from risks arising from additives, contaminants, 
           toxins or disease-causing organisms in foods, beverages or 
           feedstuffs;  

      -    to protect human life or health within the territory of the  
           Member from risks arising from diseases carried by animals, 
           plants or products thereof, or from the entry, establishment or 
           spread of pests;  or

      -    to prevent or limit other damage within the territory of the  
           Member from the entry, establishment or spread of pests.  

Sanitary or phytosanitary measures include all relevant laws, decrees, 
regulations, requirements and procedures including, inter alia, end product 
criteria;  processes and production methods;  testing, inspection, 
certification and approval procedures;  quarantine treatments including 
relevant requirements associated with the transport of animals or plants, or 
with the materials necessary for their survival during transport; provisions 
on relevant statistical methods, sampling procedures and methods of risk 
assessment; and packaging and labelling requirements directly related to 
food safety.  

2.    Harmonization - The establishment, recognition and application of 
common sanitary and phytosanitary measures by different Members.  

3.    International standards, guidelines and recommendations

      -    for food safety, the standards, guidelines and recommendations 
           established by the Codex Alimentarius Commission relating to food 
           additives, veterinary drug and pesticide residues, contaminants, 
           methods of analysis and sampling, and codes and guidelines of 
           hygienic practice; 

      -    for animal health and zoonoses, the standards, guidelines and 
           recommendations developed under the auspices of the International 
           Office of Epizootics; 

      -    for plant health, the international standards, guidelines and 
           recommendations developed under the auspices of the Secretariat 
           of the International Plant Protection Convention in co-operation 
           with regional organizations operating within the framework of the 
           International Plant Protection Convention;  and


      -    for matters not covered by the above organizations, appropriate 
           standards, guidelines and recommendations promulgated by other  
           relevant international organizations open for Membership to all 
           Members, as identified by the Committee on Sanitary and 
           Phytosanitary Measures.

4.    Risk assessment - The evaluation of the likelihood of entry,  
establishment or spread of a pest or disease within the territory of an 
importing Member according to the sanitary or phytosanitary measures which 
might be applied, and of the associated potential biological and economic 
consequences; or the evaluation of the potential for adverse effects on 
human or animal health arising from the presence of additives, contaminants, 
toxins or disease-causing organisms in food, feedstuffs and beverages.

5.    Appropriate Level of Sanitary or Phytosanitary Protection - The level 
of protection deemed appropriate by the Member establishing a sanitary or 
phytosanitary measure to protect human, animal or plant life or health 
within its territory.  

NOTE:  Many Members otherwise refer to this concept as the "acceptable level 
of risk".

6.    Pest- or Disease-Free Area - An area, whether all of a country, part 
of a country, or all or parts of several countries, as identified by the 
competent authorities, in which a specific pest or disease does not occur. 

NOTE:  A pest- or disease-free area may surround, be surrounded by, or be 
adjacent to an area - whether within part of a country or in a geographic 
region which includes parts of or all of several countries -in which a 
specific pest or disease is known to occur but is subject to regional 
control measures such as the establishment of protection, surveillance and 
buffer zones which will confine or eradicate the pest or disease in 
question.

7.    Area of low pest or disease prevalence - An area, whether all of a 
country, part of a country, or all or parts of several countries, as 
identified by the competent authorities, in which a specific pest or disease 
occurs at low levels and which are subject to effective surveillance, 
control or eradication measures.  


                                ANNEX  B

         TRANSPARENCY OF SANITARY AND PHYTOSANITARY REGULATIONS


1.    Publication of regulations

1.1    Members shall ensure that all sanitary and phytosanitary 
regulations[5] which have been adopted are published promptly in such a 
manner as to enable interested Members to become acquainted with them.

1.2   Except in urgent circumstances, Members shall allow a reasonable 
interval between the publication of a sanitary or phytosanitary regulation 
and its entry into force in order to allow time for producers in exporting 
Members, and particularly in developing country Members, to adapt their 
products and methods of production to the requirements of the importing 
Member.

2.    Enquiry points

2.1   Each Member shall ensure that one enquiry point exists which is 
responsible for the provision of answers to all reasonable questions from 
interested Members as well as for the provision of relevant documents 
regarding:  

      (a)  any sanitary or phytosanitary regulations adopted or proposed 
           within its territory;  

      (b)  any control and inspection procedures, production and quarantine 
           treatment, pesticide tolerance and food additive approval 
           procedures, which are operated within its territory; 
           
      (c)  risk assessment procedures, factors taken into consideration, as 
           well as the determination of the appropriate level of sanitary  
           and phytosanitary protection;  

      (d)  the Membership and participation of the Member, or of relevant 
           bodies within its territory, in international and regional 
           sanitary and phytosanitary organizations and systems, as well as 
           in bilateral and multilateral agreements and arrangements within 
           the scope of this Agreement, and the texts of such agreements and 
           arrangements.  

2.2   Members shall ensure that where copies of documents are requested by 
interested Members, they are supplied at the same price (if any), apart from 
the cost of delivery, as to the nationals[6] of the Member concerned.

3.    Notification procedures

3.1   Whenever an international standard, guideline or recommendation does  
not exist or the content of a proposed sanitary or phytosanitary regulation 
is not substantially the same as the content of an international standard, 
guideline or recommendation, and if the regulation may have a significant 
effect on trade of other Members, Members shall:

      (a)  publish a notice at an early stage in such a manner as to enable 
           interested Members to become acquainted with the proposal to 
           introduce a particular regulation;

      (b)  notify other Members, through the MTO Secretariat, of the 
           products to be covered by the regulation together with a brief 
           indication of the objective and rationale of the proposed 
           regulation.  Such notifications shall take place at an early 
           stage, when amendments can still be introduced and comments taken 
           into account;

      (c)  provide upon request to other Members copies of the proposed 
           regulation and, whenever possible, identify the parts which in 
           substance deviate from international standards, guidelines or 
           recommendations;  

      (d)  without discrimination, allow reasonable time for other Members 
           to make comments in writing, discuss these comments upon request, 
           and take the comments and the results of the discussions into 
           account.
         
3.2   However, where urgent problems of health protection arise or threaten 
to arise for a Member, that Member may omit such of the steps enumerated in 
paragraph 3.1 of this Annex as it finds necessary, provided that the Member:

      (a)  immediately notifies other Members, through the MTO Secretariat, 
           of the particular regulation and the products covered, with a 
           brief indication of the objective and the rationale of the 
           regulation, including the nature of the urgent problem(s);

      (b)  provides upon request to other Members copies of the regulation;

      (c)  allows other Members to make comments in writing, discusses these 
           comments upon request, and takes the comments and the results of 
           the discussions into account.

3.3   Notifications to the MTO Secretariat shall be in English, French or 
Spanish.

3.4   Developed country Members shall, if requested by other Members, 
provide copies of the documents or, in case of voluminous documents, 
summaries of the documents covered by a specific notification in English, 
French or Spanish.  

3.5   The MTO Secretariat shall promptly circulate copies of the 
notification to all Members and interested international organizations and 
draw the attention of developing  country Members to any notifications 
relating to products of particular interest to them.

3.6    Members shall designate one single central government authority as 
responsible for the implementation, on the national level, of the provisions 
concerning notification procedures according to paragraphs 3.1, 3.2, 3.3 and 
3.4 of this Annex.

4.    General reservations

4.1   Nothing in this Agreement shall be construed as requiring:

      (a)  the provision of particulars or copies of drafts or the 
           publication of texts other than in the language of the  Member 
           except as stated in paragraph 3.4 of this Annex;  or

      (b)  Members to disclose confidential information which would impede 
           enforcement of sanitary or phytosanitary legislation or which 
           would prejudice the legitimate commercial interests of particular 
           enterprises.  
                                 ANNEX C

             CONTROL, INSPECTION AND APPROVAL PROCEDURES[7]


1.    Members shall ensure, with respect to any procedure to check and 
ensure the fulfilment of sanitary or phytosanitary measures, that:  

      (a)  such procedures are undertaken and completed without undue delay 
           and in no less favourable manner for imported products than for  
           like domestic products;  

      (b)  the standard processing period of each procedure is published or 
           that the anticipated processing period is communicated to the 
           applicant upon request;  when receiving an application, the 
           competent body promptly examines the completeness of the 
           documentation and informs the applicant in a precise and complete 
           manner of all deficiencies;  the competent body transmits as soon 
           as possible the results of the procedure in a precise and 
           complete manner to the applicant so that corrective action may be 
           taken if necessary;  even when the application has deficiencies, 
           the competent body proceeds as far as practicable with the 
           procedure if the applicant so requests;  and that upon request, 
           the applicant is informed of the stage of the procedure, with any 
           delay being explained;

      (c)  information requirements are limited to what is necessary for 
           appropriate control, inspection and approval procedures,  
           including for approval of the use of additives or for the 
           establishment of tolerances;  

      (d)  the confidentiality of information about imported products 
           arising from or supplied in connection with control, inspection 
           and approval is respected in a way no less favourable than for 
           domestic products and in such a manner that legitimate commercial 
           interests are protected;

      (e)  any requirements for control, inspection and approval of 
           individual specimens of a product are limited to what is 
           reasonable and necessary;  

      (f)  any fees imposed for the procedures on imported products are 
           equitable in relation to any fees charged on like domestic 
           products or products originating in any other Member and should 
           be no higher than the actual cost of the service;  

      (g)  the same criteria should be used in the siting of facilities used 
           in the procedures and the selection of samples of imported 
           products as for domestic products so as to minimize the 
           inconvenience to applicants, importers, exporters or their 
           agents;  

      (h)  whenever specifications of a product are changed subsequent to 
           its control and inspection in light of the applicable 
           regulations, the procedure for the modified product is limited to 
           what is necessary to determine whether adequate confidence exists 
           that the product still meets the regulations concerned;  and

      (i)  a procedure exists to review complaints concerning the operation 
           of such procedures and to take corrective action when a complaint 
           is justified.  


Where an importing Member operates a system for the approval of the use of 
food additives or for the establishment of tolerances for contaminants in 
food, feedstuffs or beverages which prohibits or restricts access to its 
domestic markets for products based on the absence of an approval, the 
importing Member shall consider the use of a relevant international standard 
as the basis for access until a final determination is made.

2.    Where a sanitary or phytosanitary measure specifies control at the 
level of production, the Member in whose territory the production takes 
place shall provide the necessary assistance to facilitate such control and 
the work of the controlling authorities.

3.    Nothing in this Agreement shall prevent Members from carrying out 
reasonable inspection within their own territories.                     

1. In this Agreement, reference to Article XX(b) includes also the chapeau 
of that Article.

2. For the purposes of paragraph 11, there is a scientific justification if, 
on the basis of an examination and evaluation of available scientific 
information in conformity with the relevant provisions of this Agreement, a 
Member determines that the relevant international standards, guidelines or 
recommendations are not sufficient to achieve its appropriate level of 
protection.


3. For purposes of paragraph 21, a measure is not more trade restrictive 
than required unless there is another measure, reasonably available taking 
into account technical and economic feasibility, that achieves the 
appropriate level of protection and is significantly less restrictive to 
trade.

4. For the purpose of these definitions "animal" includes fish and wild 
fauna;  "plant" includes forests and wild flora;  "pests" include weeds;  
and "contaminants" include pesticide and veterinary drug residues and 
extraneous matter.

5. Sanitary and phytosanitary measures such as laws, decrees or ordinances 
which are applicable generally.

6. When "nationals" are referred to in this Agreement, they shall be deemed, 
in the case of a separate customs territory Member of the MTO, to mean 
persons, natural or legal, who are domiciled or who have a real and 
effective commercial establishment in that customs territory.

7. Control, inspection and approval procedures include, inter alia, 
procedures for sampling, testing and certification.



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