   
  
G/SPS/GEN/2097  
 
1 March 2023  
(23-1403) Page: 1/29 
Committee on Sanitary and Phytosanitary Measures  Original: English  
 
WORKING  GROUP  ON APPROVAL PROCEDURES  
SUMMARY OF PROCESS  AND DISCUSSIONS  
NOTE BY THE WORKING GROUP  
The Report of the Fifth Review of the Operation and Implementation of the SPS Agreement  
(Fifth  Review Report)1, adopted by the Committee on Sanitary and Phytosanitary Measures 
(SPS Committee) on 31 July 2020, contained  several recommendations . This includ ed a 
recommendation that "[f]ollowing the fruitful exchange of experiences and ideas at the November 
2019 SPS Committee  Thematic Session on Approval Procedures, the Committee should create a 
working  group open to the participation of all Members and Observ ers to continue to examine the 
topic of approval procedures."2 
The SPS Committee  Working  Group  on Approval Procedure s (Working  Group ) started its work in 
November  2020, along the lines of Canada's proposed  guidance set out in document 
G/SPS/W/328/Rev.1 , as updated  by Canada and Paraguay  in document G/SPS/W/328/Rev.1/Add.1 . 
While it was initially foreseen that the Working  Group  would  conclude its work in November 2021 , 
the Working  Group  was extended until November 20223, and subsequently until March 2023.4 
Twenty -five Members  participated in the Working  Group : Argentina, Belize, Brazil, Canada, Chile, 
Colombia, Costa Rica, Ecuador, the European Union, Japan, Mexico, New  Zealand, Norway, 
Paraguay, Peru, the  Philippines,  the Russian  Federation, Singapore, South  Africa, Switzerland, 
Chinese  Taipei, Ukraine, the United  Kingdom, the United  States, and Uruguay.5 The OECD  was also  
a participant.  
Canada and Paraguay acted as co -stewards to the Working  Group . The Working  Group  worked 
electronically and met virtually (u sing WebEx) on the margins of the SPS Committee  meetings as 
well as intersessionally, as required . Work was primarily conducted in English.  
 
1 G/SPS/64  and G/SPS/64/Add.1 . 
2 See paragraph 3.12 of the Fifth Review Report ( G/SPS/64 ). 
3 Canada's proposal f or the Working  Group  contained in document G/SPS/W/328/Rev.1  indicated that 
the Working  Group would conclude at the November 2021 SPS Committee  meeting, unless the Working  Group  
and SPS Committee  agreed to extend the timeframe.  At its meeting of 1 November 2021, the Working  Group 
agreed that it would like to continue its work and extend its timeline for another year to allow the 
Working  Group  to continue its in -depth discussions on key challenges and address principles of approval 
procedures. At its November 2021 meeting, the SP S Committee agreed to extend the Working  Group until 
November  2022.  
4 At its meeting of 7 November 2022, the Working  Group agreed that it would like to continue its work 
and extend its timeline until March 2023 to allow the Working  Group to finalise work o n its output documents 
to be circulated to the SPS  Committee. At its November 2022 meeting, the SPS  Committee agreed to extend 
the Working  Group until March 2023.  
5 The first meeting of the Working  Group was open to all Members and observer organizations o f the 
SPS Committee . Interested Members or observers wishing to join the Working  Group  were invited to sign up 
via the Secretariat . The Working Group was thereafter restricted to registered participants.  G/SPS/GEN/2097  
 
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  The Working  Group  conducted seven  rounds  of work , which  mirrored  the schedule of SPS Committee  
meetings.6 Following each round of work, t he co -stewards reported on the work at the informal 
meeting of the SPS Committee  to keep Members appraised  of the Working  Group 's progress.7 
At the outset , the Working  Group  considered  the process for its work as well as  the topics that it 
would discuss .8 The Working  Group  then focused on : 
a. developing a common understanding of approval procedures for the purposes of 
the Working  Group ; 
b. discussing tools available and best practices to enh ance the implementation of 
the obligations of the SPS Agreement  as they apply to approval procedures and compiling 
a collection of readily available tools and resources ; 
c. identifying key challenges of approval procedures that impact international trade and that 
the SPS Committee  should seek to address;  
d. identifying  principles of approval procedures that facilitate international trade while 
meeting the importing Member's appropriate level of sanitary or phytosanitary protection  
(ALOP)  and the SPS Committee 's role in highlighting these principles;  and 
e. discussing possible  Working  Group  outcomes .9 
This document  is a factual account of  the Working  Group 's work in these five areas . It complements 
the Working Group 's note on O utcomes and Recommendations (G/SPS/ GEN/2099). 
 
6 Following the SPS  Committee schedule, these seven rounds of work took place in: (i) November 2020 
– March 2021; (ii) March 2021 – July 2021; (iii) July 2021 – November 2021; (iv) November 2021 –
March  2022; (v) March 2022 – June 2022; (vi) June 2022 – November 2022 ; and (vii) November 2022 – 
March  2023. 
7 The Chairperson of the SPS  Committee reported on the discussions held at the informal 
SPS Committee meetings on this topic to the formal SPS  Committee meetings. See Annex A of G/SPS/R/101 , 
Annex  A of G/SPS/R/102 , Annex A of G/SPS/R/103 , Annex A of G/SPS/R/104 , Annex A of G/SPS/R/105 , 
Annex  A of G/SPS/R/106 , Annex  A of G/SPS/R/107 , and Annex B of G/SPS/R/108 . See also Section 4.4.2 and 
Annex B of G/SPS/R/100 . 
8 Annex A provides an overview of the main topics for the Working  Group's consideration, as  they 
emerged from these initial discussions. Annex B describ es the various phases for the Working  Group as they 
were envisaged by the co -stewards following identific ation of the se main topics.  
9 In addition, the Working  Group liaised with the OECD on its related work on approval procedures, with 
the OECD providing regular updates and participants providing input on this OECD work project. The  OECD 
work project on appr oval procedures conducted within its Joint Working Party on Agriculture was in the form of 
a three -part study: (i) part 1 to provide an overview of issues and current developments in the administration 
of approval procedures based on consultations with exp erts and literature review, which led to the 
identification of seven key issues faced by countries related to approval procedures ; (ii) part 2 to evaluate the 
relative importance of these issues and possible trade implications based on an analysis of STCs and a 
questionnaire focusing on Members' positive developments and experiences; (iii) part  3 to highlight key 
findings of the study. Some Working  Group  participants provided input on and responded to the questionnaire 
to explore Members' positive developme nts and experiences with approval procedures.  The OECD report, 
Sanitary and phytosanitary  approval procedures , Key issues, their impact on trad e and ways to address them , 
was published in February  2023. G/SPS/GEN/2097  
 
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  Table of contents  
Page 
1   COMMON UNDERSTANDING OF APPROVAL PROCEDURES FOR THE PURPOSES  
OF THE WORKING  GROUP  ................................ ................................ ................................  4 
1.1   Summary of discussions and proposals ................................ ................................ ...........  4 
1.2   Agreed common understanding of approval procedures for the purposes of  
the Working Group  ................................ ................................ ................................ ..............  9 
2   TOOLS AVAILABLE AND BEST PRACTICES TO ENHANCE THE IMPLEMENTATION  
OF THE OBLIGATIONS OF THE SPS  AGREEMENT AS THEY APPLY TO APPROVAL 
PROCEDURES  ................................ ................................ ................................ .................  10 
2.1   Summary of initial discussions  ................................ ................................ ..................... 10 
2.2   Collection of Available Tools and Resources (G/SPS/GEN/2098)  ................................ ........ 12 
3   KEY CHALLENGES OF APPROVAL PROCEDURES THAT IMPACT INTERNATIONAL  
TRADE AND THAT THE SPS  COMMITTEE SHOULD SEEK TO ADDRESS  .............................  13 
3.1   "Transparency" and " Communication or information exchange"  ................................ ........ 13 
3.2   "Justification and discrimination of approval procedures" and "Harmonization with 
international standards"  ................................ ................................ ................................ ......15 
3.3   "Timing and undue delays" and "Other challenges"  ................................ ......................... 17 
4   PRINCIPLES OF APPROVAL PROCEDURES TH AT FACILITATE INTERNATIONAL  
TRADE WHILE MEETING THE IMPORTING MEMBER'S ALOP AND  
THE SPS  COMMITTEE'S ROLE IN HIGHLIGHTING THESE PRINCIPLES  ............................  21 
5   ADDITIONAL DISCUSSIONS ON POSSIBLE WORKING  GROUP OUTCOMES  ................  24 
ANNEX A: OVERVIEW OF SUGGESTED TOPICS FOR THE WORKING  GROUP 
CONSIDERATION  ................................ ................................ ................................ ...........  26 
ANNEX B: OVERARCHING PROCESS FOR THE WORKING  GROUP  ................................ .... 29 G/SPS/GEN/2097  
 
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  1  COMMON UNDERSTANDING OF APPROVAL PROCEDURES FOR THE PURPOSE S OF THE 
WORKING  GROUP  
1.1.  At the outset of the Working Group's work,  a number of participants raised the topic s of defining  
approva l procedures , identifying the types of approval procedure  that would fall within the scope of 
the Working  Group, or developing a glossary. These early proposals led to discussions about the 
possibility and benefit of developing a common understanding of ap proval procedure s prior to 
engaging on other topics (Section  1.1  ), with the Working Group agreeing on such a common 
understanding for the purpose s of its work (Section  1.2  ). 
1.1  Summary of  discussions and proposals  
1.2.  Several proposals were put forward regarding defining  approval procedures , developing a 
glossary, or identifying types of approval procedure . One such proposal was that the Working  Group  
clarify the definitio n of the term "approval procedures". The term "approval procedures" meant the 
procedures to check and ensure the fulfilment of SPS measures , as reflected in Annex C of the 
SPS Agreement . Some Members , however,  considered  that approval procedures also included  
procedures for risk assessment s under Article 5 of the SPS Agreement . 
1.3.  To support national and regional efforts to increase access to biotechnology products, one 
participant suggested  that the Working  Group  develop a glossa ry of mutually agreed upon terms 
and definitions that would establish a baseline or common language for the SPS Committee  on topics 
of mutual interest such as data portability, common application dossiers, unilateral and mutual 
recognition, history of safe  use, and emergency use authorization. Commonly agreed language could 
serve as a starting point for future conversations to streamline and improve regulatory approaches 
to pre -market approvals. This proposal found some support in the Working  Group  to facil itate 
discussions on data portability, common application dossiers, the recognition of authorizations, and 
the management of low -level presence  situations . 
1.4.  In addition, one participant  proposed  that the Working  Group  develop a common understanding 
of approval procedures, including the types of approval procedures and associated definitions. 
In some areas, Annex C was precise in its language as appropriate, while  also providing a reasonable 
amount of flexibility so tha t its provisions applied to a wide range of regulatory approaches. However, 
this created the possibility of challenges and uncertainty in the implementation of the obligations of 
the SPS Agreement  as they appl ied to approval procedures. Therefore, the Working Group  could 
consider the types of approval procedures taken by Members, and how to enhance the 
implementation of the various types of approval procedures meeting the  importing Member's ALOP 
while facilitating international trade.  In agreeing with the  proposal to consider the different types of 
approval procedures taken by Members and how to enhance their implementation, 
another  participant highlighted the importance of this analysis for biotechnology products.  
1.5.  A related proposal was for the Working  Group to work on definitions, classification of 
approval  procedures , and basic criteria consolidation. Defining and grouping main approval 
procedures was seen as helpful to identify  basic criteria to facilitate  completion of the  procedures. 
Criteria consolidation could also reduce the work involved for exporting Members in making 
submissions to each importing Member . 
1.6.  To provide parameters for future work , the co -stewards suggested  that participants focus on 
identifying the scope o f approval procedures . This  could include, as appropriate, determining 
types/categories of approval procedures and their general characteristics. This work would be 
without prejudice to the rights and obligations of Members under the SPS Agreement , would n ot be 
used to develop an exhaustive list of approval procedures, and would  not constitute legal definitions. 
The co-stewards suggested the scoping exercise in the hope that it would  facilitate the work of the 
Working  Group  by establishing a collective knowledge and shared understanding of approval 
procedures that facilitate international trade while meeting the importing Member's ALOP. 
The co-stewards further suggested that the proposal to develop a glossary of terms and definitions 
in the fi eld of biotechnology be revisited once the scope of approval procedures was clarified.10 
 
10 Some participants considered that the Working Group should avoid entering into detailed discussions 
on the specificities of individual approval procedures and definitions related to them. This w as more within the 
realm of the role of the International Standard Setting Bodies ( ISSBs ). If the Working Group decided to work 
on a glossary, this glossary should have a broader scope, not only focus on biotechnology.  G/SPS/GEN/2097  
 
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  1.7.  Several p articipants welcomed the  co-stewards' proposed way forward . It was essential to 
establish a shared understanding of approval procedure  before discussing key c hallenges and 
principles of approval procedures. A common understanding of approval procedures would have  
various benefits, including: (i) provid e a reference framework and facilitating the discussions; 
(ii) help focus the discussions on the most important  approval procedures given that Annex C was 
broad in scope; (iii) help identify whether to address all types of approval procedures or classify 
them in order to find common points for each group of approval procedures; (iv)  increas e Members' 
collective kno wledge of approval procedures; (v) identif y similarities between types of approval 
procedures taken by Members and their general characteristics; and (vi)  enhanc e implementation 
of the obligations of the  SPS Agreement as they apply to approval procedures.  The co-stewards'  
clarification that exploring the scope of approval procedures would be without prejudice to the rights 
and obligations of Members under the SPS Agreement  and would not constitute legal definitions  was 
also welcomed  by many. The  common unde rstanding would be developed solely for the purposes of 
facilitating the work of the Working  Group  and would be within the framework of Article 8 and 
Annex  C of the SPS Agreement .11 
1.8.  Different types of approval procedures  were proposed for the purpose of de veloping a common 
understanding. One participant  referred  to: (i) pre-market product approvals; (ii) certification; 
(iii) audits; and (iv)  import checks.  The different characteristics and impacts on food, animal, and 
plant trade of these approval procedures merited deeper examination. They were being proposed  
without prejudice to the rights and obligations of Members under the SPS Agreement  and they did 
not constitute an exhaustive list of approval procedures . The participant  noted initial characteristics 
of these types of approval procedures : 
a. Pre-market product approval  referred  to approval procedures that require d individual 
products to be assessed before t hey were permitted to be placed on the market as opposed 
to entire categories of products being approved such as when a pest risk assessment was 
conducted.  Pre-market product approvals often applied to tools used in agriculture or food 
manufacturing and th e applicant was usually the developer or manufacturer of the product, 
not normally the grower or exporter that needed to meet an importing Member's 
requirements and very rarely the exporting Member.12 Pre-market approval procedures 
might vary between Membe rs, leading to asynchronous or misalignment of approvals13; 
b. Certification referred  to the issuing of end -use assurance documents that formally 
recognize d that the importing Member was aware of, and ha d no immediate objections to, 
the proposed import ation of specific goods by the stated importer, for the stated end -use 
and end -user. Certification might negatively impact trade when certification requirements 
were not limited to the extent necessary to meet the importing Members' ALOP or did not 
reflect the ci rcumstances of risks to human, animal, or plant life or health, or where it was 
not recognized that assurances could be provided through means other than certificates ; 
c. Audits refer red to official examinations of another Member's  SPS measures . These  were 
conducted to ensure a measure or group of measures'  ability to provide required 
assurances and meet the ALOP of the importing Member . Audits generally focus ed on the 
control programme of the exporting Member and could  include the review of their 
inspectio n and audit programmes, and on -site inspections of facilities. Audit provisions 
could  be related to, but have obligations separate from, equivalency provisions.  
Audits  could impact trade when there was lack of clarity, transparency, and predictability 
in the purpose and outcome of audits and in the audit processes ; 
d. Import checks were conducted to determine that imported products compl ied with the 
prescribed SPS requirements of the importing Member . This implied  an inspection, 
examination, sampling, review o f documentation, test, or procedure, including laboratory, 
organoleptic, or identity, conducted at the border or otherwise during the entry process 
 
11 One participant recalled that during the process of the fifth review of the SPS  Agreement, many 
Members had emphasized that the result of the fifth review should not go beyond the obligations of the 
SPS Agreement. The discussions in the Working  Group shoul d focus on the implementation of the obligations of 
the SPS  Agreement rather than create new obligations. This principle should be reflected in the Working 
Group's output documents.  
12 Canada's  presentation  at the 2019 Thematic Session on Approval Procedures  was referenced. 
Examples of pre -market product approval procedures included: plant protection products and veterinary drug 
MRLs, which were established as part of an approval procedures for the product itself, and products of 
biotechnology.  
13 See para. 3.40.   below.  G/SPS/GEN/2097  
 
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  by an importing Member or its representative to determine if a consignment complie d with 
the SPS requirement s of the importing Member . Import checks could impact trade when 
there was lack of clarity, transparency, and predictability in these processes, impact the 
integrity of the good more than necessary, and when import checks were more frequent 
than necessary based on risk.  
1.9.  Other participants referred to: (i) procedures for the recognition of pest/disease -free areas; 
(ii)  procedures for the approval of genetically modified organisms (GMOs), with issues deriving from 
asynchronous approvals, resulting from the l ack of operational capacity or undue delay (there were 
also cases in which the applicants were not always interested in submitting their requests in different 
markets at the same time, which  could affect the regular international trade of grains)14; 
(iii) registration of certain food, such as formula for infants and young children; (iv) approval 
procedures of pesticide or veterinary drugs and additives or auxiliary substances; or (v) differential 
procedures for the approval of new food (novel foods) in acco rdance with the criteria established by 
some Members. Audit and inspection procedures  were also mentioned , as well as laying down 
requirements for the certification and registration of products. Such a product registration procedure 
had the purpose of: ens uring that products placed on the domestic  market (whether of domestic or 
foreign production) met the requirements regarding maximum residue limits (MRLs), additives, 
auxiliary substances, contaminants, general and nutrition labelling, etc.; being able to identify the 
manufacturer, importer, fractionator; and allowing for the product to be identified, tracked, and 
recalled by the public authority, if applicable.  
1.10.   Another participant suggested that the Working Group limit its  work to approval procedures 
aimed at obtaining SPS market access, such as: (i)  pest risk analyses for plant products; (ii) import 
risk analyses for animal products; (iii) animal health, plant health, and food safety control system 
audits; and (iv) adminis trative procedures related to the authorization of processing establishments 
for food and feed. The Working  Group could identify and characterize the approval procedures most 
commonly applied by Members or those that were most important to trade, as well a s their respective 
normal processing periods. This could be done by designing a survey to  be circulate d among 
Members, consulting the  International Standard Setting Bodies ( ISSBs ) for a characterization of 
procedures for the SPS  Committee's consideration, and having information collected directly from 
Members through, for example, some form of notification or trade policy review. Once this 
information obtained, especially on normal or expected processing periods, a definition of the term 
"undue delays" coul d be elaborated.  
1.11.   One participant put forward the following types of approval procedures: (i) a pproval of the 
import of plants, animals, and their products, i.e. the procedure carried out by the competent 
authorities in the SPS area to establish the SPS  measures that will be applied to the import of plants, 
animals, and their products, as appropriate; (ii) approval of food and feed, approval of plant 
protection products (pesticides) and veterinary drugs, approval of food additives, and approval of 
GMOs, i.e.  registration procedure prior to commercialization in the local market carried out by the 
competent sanitary authority according to the request presented by the manufacturer, importer, 
developer, or whoever corresponded; and (iii) approval of establishment s, i.e. registration of 
establishments that manufacture food and feed that sold in the local market as well as the 
establishments authorized by the competent authority of the exporting Member , as they complied 
with the requirements of the importing Member . 
1.12.   Another proposal was  that the Working  Group  be guided by what was contained in the 
WTO Analytical Index, specifically where reference was made to jurisprudence under Annex C of the 
SPS Agreement . Examples of approval procedures included : (i) the conduct of a risk assessment for 
a product; (ii) pest or disease -free area recognition process es; and (iii)  procedures for the approval 
of the use of additives or for the establishment of tolerances for contaminants in food, beverages,  
and feedstuff s. Another participant echoed  the idea that WTO jurisprudence related to Annex C could 
provide guidance , and in this context referred to  processes involved in equivalence determination s, 
import risk analys es, and pre -market approval s. 
1.13.   The Working  Group  further  addressed  whether its scope of work should include elements such 
as sampling and analytical capacity and the possibilities of finding common ground regarding 
methodologies for laboratories . Several  participants understood approval procedures to include 
measu res, such as sampling , testing, certification,  and laboratory analysis , as they follow ed 
 
14 Another participant also referred to m easures adopted by Members  to manage approval asynchronies 
between Members  that export and import GMOs , recognizing that some Member s were  not party t o the 
Cartagena Protocol . G/SPS/GEN/2097  
 
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  SPS approvals and consist ed in control measures at the border when a commodity enter ed the 
importing Member's territory.15 One participant referred to the review, through available 
documentary information, of recommended conformity assessment procedures (inspection 
protocols, laboratory tests , and/or analytical methodologies) applicable to the imported goods in 
port, in compliance with the SPS measures . Anot her participant further referred to  national systems 
and procedures for approving the use of additives or for establishing tolerances for contaminants in 
foods, beverages , or feedstuffs. In this connection, one participant took the view that the 
Working  Group needed  to provide  clear guidelines regarding laboratory work , while another stated 
that relevant  methodologies needed to  adhere to international recommendations.  
1.14.   Other views were shared, with one participant requesting  that the inclusion of additional 
elements such as inspection, sampling, laboratory, or analytical capacity be decided at a later stage.  
Another participant noted that conformity assessment procedures, including inspection protocols, 
laboratory tests, and/ or analytical methodologies  were usually covered by the TBT Agreement rather 
than the SPS Agreement , and thus queried whether the Working  Group  would not ex tend its work 
beyond the scope of the SPS Agreement . Another  participant underscored the importance of 
science -based measures, and noted that laboratory sampling and analysis procedures were within 
the scope of the SPS Agreement , considering that : (i) Annex C on control, inspection and approval 
procedures  stated that such procedures included sampling, te sting, and certification procedures; 
and (ii) Article  5 on risk assessment and determination of the ALOP  required  Members to ensure that 
their SPS measures  were based on an assessment, as appropriate to the circumstances, of the risks 
to the life and health of individuals and animals and that in the risk assessment process, Members 
were required to  take into account existing scientific evidence, relevant production processes and 
methods, as well as relevant methods of inspection , sampling , and testing.  
1.15.   Other participants expressed concerns regarding  a possible common understanding of 
approval procedures. One participant cautioned that, while the Working  Group may not intend to 
venture into l egal definitions, developing a common understanding of approval procedures could 
nonetheless be construed as providing legal interpretations  of the SPS  Agreement or as listing or 
defining something that the SPS  Agreement may have intentionally not listed o r defined. 
Another  participant cautioned against defining approval procedures in a way that would limit 
Members to predetermined procedures, disregarding their autonomy, and possibly generating major 
commercial problems considering the need for greater or lesser complexity of procedures in each 
Member. This issue could lead to even longer delays. Furthermore, standardization directly violated 
the principle of equivalence provided for the SPS  Agreement, which was focused on obtaining 
expected results.  While agreeing that the idea of classifying different types of approval  procedures 
could help advance the work of the Working  Group , some participants also worried that reaching an 
agreement regarding the classification of different types of approval procedures would involve 
lengthy discussions. The  Working  Group  should not diverge its focus away from the key topics that 
it had been  set to discuss.  The Working  Group should focus on implementation challenges and the 
tools and best practices that could be shared wi th Members to address these challenges , without 
creating additional obligations or definitions . 
1.16.   In light of these discussions , the co -stewards presented the following  proposal regarding a 
possible common understanding of approval procedures : 
1. The majority of WG participants value a common understanding to advance the objectives 
of the WG and to facilitate discussions among participants. Other participants also cautioned 
that any identification of a common understanding of approval procedures may po ssibly be 
interpreted as the identification of a legal definition.  
2. Participants' submissions reveal general alignment in the parameters for the WG's 
understanding of approval procedures.  
 
15 Referring to the authorization process  in its own country, one participant clarified that the process  
would begin with a request made by the competent authority of the country of origin concerned, which was 
subject to evaluation by an internal evaluation commission, and which result ed in the approval or not of the 
interested establishment. The approval of establishments was given through a process of consultation, 
evaluation, review of questionnaires and, wh en appropriate, audits to the competent authority and 
establishments in the country of origin. The authorization process was continuous  and depend ed on the 
fulfilment of the sanitary requirements (which was verified through the control measures taken at th e border 
inspection posts , such as documentary and physical inspection, sampling, and subsequent laboratory analysis) 
and on the renewal of the approval where applicable . G/SPS/GEN/2097  
 
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  3. The descriptor of a common understanding of approval procedures below  is generated solely 
for the practical purpose of advancing the objectives of the WG on approval procedures. 
It does not represent a legal interpretation of the rights and obligations of the Agreement on 
the Application of Sanitary and Phytosanitary Measur es (SPS Agreement ) and does not in any 
way constitute a legal definition.  
4. Many participants recalled that as per the SPS Agreement , "approval procedures" are any 
procedure to check and ensure the fulfilment of sanitary or phytosanitary measures. 
Approval  procedures may include the following:  
• Approval of food and feed, and approval of the import of plants, animals, plant and 
animal products;  
• Pre-market product approvals, approval of the use of additives or for the 
establishment of tolerances for contaminants  in food, beverages and feedstuff, 
approval of plant protection products (pesticides) and veterinary drugs, and approval 
of genetically modified organisms;  
• Conduct of risk assessment for a product, Pest Risk Analysis, and Import Risk Analysis;  
• Certification, authorization/approval of establishments, and animal or plant life and 
health and food safety control system audits;  
• Pest- or disease -free area recognition and equivalence determination; and  
• Import checks, sampling, laboratory analysis, and control measure.  
This is not an exhaustive list of approval procedures.  
5. This recommended approach strikes the appropriate balance to prevent protracted 
discussions that may unnecessarily delay the advancement of the WG's objectives and clarify 
the meaning of approval procedures for the purpose of the WG objectives.  
6. With acknowledgement of a common understanding of approval procedures for the purpose 
of fulfilling the WG objectives, the participants can now identify key challenges of approval 
procedures that  impact international trade that the Committee should seek to address. 
In undertaking this work, a number of participants suggest focusing on the types of approval 
procedures that pose the greatest challenges to international trade. Next, the principles of  
approval procedures that facilitate international trade while meeting the importing Member's 
appropriate level of sanitary and phytosanitary measures will be discussed.  
1.17.   Participants  welcomed the co -steward s' proposal. They supported the idea that the descriptor 
of a common understanding of approval procedures did not represent a legal interpretation of the 
rights and obligations under  the SPS Agreement  and did not in any way constitute a legal definition . 
One participant  suggest ed to indicate  this principl e clearly in the output  documents  of th e 
Working  Group . In addition, t he Working  Group  engaged specifically on point 4 of the  co-steward s' 
proposal, i.e. the illustrative list of approval procedures . One suggestion was to clarify that the list 
was for the purposes of the Working  Group  and had been  developed to facilitate its work.  
1.18.   Taking into account comments received,  the co -stewards presented a revised proposal for a 
common understanding of approval procedure s, keeping  the illustrative list of approval procedures, 
but clarify ing that the illustrative  list of approval procedures in their proposal was "[f]or the purposes 
of this WG" and " ha[d] been developed to facilitate the work of this WG ". The co -stewards observed  
that h aving a common understanding would help guide the conversation, but that there was not an 
expectation that each of the items listed would be covered comprehensively by the Working  Group . 
1.19.   Many participants  welcomed the revised  proposal . Other  participants raised or reiterated 
concerns with the co-stewards' proposed illustrative list  of approval procedures . One concern was 
that the illustrative list might broaden the scope of work too much. In this connection, one participant 
expressed doubts about including equivalence as well as sampling and laboratory analysis within the 
list and wondered if the approval of plant protection products would not rather fall under the G/SPS/GEN/2097  
 
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  TBT Agreement. Another participant considered that the approval  procedures listed were of different 
kinds, and include d approval procedures that should be discussed in the context of provisions of the 
SPS Agreement  other  than Article 8 and Annex C.  Procedures for risk assessment and pest -free area 
recognition conducted in order to establish SPS measures  might sometimes be considered as a part 
of approval procedures, but  the se were provided for in other provisions of the SPS Agreement , 
such as Article s 5-6, and possibly entailed a large number of controversial aspects. If the 
Working  Group  were to lay all the elements on the table for consideration at one time, 
Working  Group discussion s would be  scattere d and would  not efficiently lead to future work o f the 
SPS Committee  on this topic.  The co-stewards should select the most appropriate elements of 
approval procedures among those listed in their proposal as a subject for discussion by the 
Working  Group . The Working  Group  could give priority to discussing  the implementation of import 
procedures under already established SPS measures . 
1.20.   Another query was whether the Working  Group  would be proposing this common 
understanding to the SPS Committee  or proposing tools, best practices, or recommendations in the 
SPS Committee . One suggestion was that the Working  Group  could develop tools dealing with the 
most common concerns  identified. Members  could be consulted  through a  questionnaire , for example 
on the proper timing for different approval procedures . Based on this consultation,  
the Working  Group  could then move to discussing concrete proposals on how to address the main 
concerns with approval procedures.  
1.21.   Finally,  one participant cautioned  the Working  Group  against going  too far in th e exercise of 
identifying ap proval procedures. Approval procedures often consisted of internal processes and 
requirements for potential exporters, e.g. in the form of requests for various types of information 
used in importing Member's internal evaluation processes. If the goal was t o publish a list of tools, 
the tools could be restructured around undue delay, information sharing, and related international 
standards. The Working  Group  needed to  reflect on taking a step back and discuss general 
requirements spanning all types of approv al procedures without trying to enumerate them. 
The Working  Group  could  then further the conversation around some practical ways to address key 
issues, such as undue delays and issues pertaining to communication.  
1.2  Agreed common understanding of approval pro cedures  for the purpose s of the 
Working Group  
1.22.   The co -stewards developed a revised common understanding of approval procedures, taking 
into account the various  comments  from participants on their proposed approach . The revised 
common understanding was developed for the purposes of the Working  Group  and to facilitate the 
discussions in the Working  Group  as follows : 
1. The majority of WG participants value a common understanding to advance the objectives 
of the WG and to facilitate discussions among participants. Other participants also cautioned 
that any identification of a common understanding of approval procedures may possibly be 
interpreted as the identification  of a legal definition.  
2. Participants ' submissions reveal general alignment in the parameters for the WG 's 
understanding of approval procedures.  
3. The descriptor of a common understanding of approval procedures below is generated solely 
for the practical purp ose of advancing the objectives of the WG on approval procedures. 
It does not represent a legal interpretation of the rights and obligations of the Agreement on 
the Application of Sanitary and Phytosanitary Measures  (SPS Agreement ) and does not in any 
way constitute a legal definition.  
4. Many participants recalled that as per the SPS Agreement , "approval procedures" are any 
procedure to check and ensure the fulfilment of sanitary or phytosanitary measures. 
The 2019 Thematic Session on Approval Procedures  highlighted a number of types of approval 
procedures, which WG participants may want to take into consideration in the work of this 
WG. The report of the Thematic Session is cont ained in document  G/SPS/R/97/Rev.1 . This is 
not an exhaustive list of approval procedures; it can facilitate the work of this WG and is 
without prejudice to the positions of Members or to their rights and obligations under the  WTO.  G/SPS/GEN/2097  
 
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  5. The common understanding of approval procedur es outlined above, provides participants 
with a basis for discussions as the WG moves forward to advance the WG 's objectives. 
This common understanding does not require all participants to have the same position on the 
scope of approval procedures.  
6. This re commended approach strikes the appropriate balance to prevent protracted 
discussions on the scope of the common understanding of approval procedures that may 
unnecessarily delay the advancement of the WG 's objectives and clarifies the meaning of 
approval p rocedures for the purpose of the WG objectives.  
7. If required, the WG can return to reflect on the common understanding of approval 
procedures for the purpose of fulfilling the WG 's objectives. The common understanding of 
approval procedures outlined in this document may be revised, as needed.  
1.23.   The co-stewards noted that this revised proposal outline d a broader approach to the 
Working  Group 's common understanding of approval procedures. It aimed to address the concerns 
that had been raised by participants by providing a more flexible common understanding.  In the 
absence of further comments, the Working  Group  was deemed to  have reached consensus on th is 
proposed common understanding of approval procedures  for the purpose s of its work . 
2  TOOLS AVAILABLE AND BES T PRACTICES TO ENHANCE THE IMPLEMENTATION OF THE 
OBLIGATIONS OF THE SPS AGREEMENT  AS THEY APPLY TO APPROVAL PROCEDURES  
2.1.  In the first two rounds of work, participants put forward tools and best practices to enhance 
the implementation of the obligations of the SPS  Agreement as they applied to approval procedures 
(Section  2.1  ). The Working  Group's work on this topic  subsequently focused on developing a 
compilation of readily available tools and resources  (Section  2.2  ). 
2.1  Summary o f initial discussions  
2.2.  Participants identified various best practices  and approaches  to enhance the  implementation of 
the obligations of the SPS Agreement . Many participants referred to transparency  in this context. 
As a transparency -related best practice, participants  referred to compliance with the notification 
obligations of Article  7 and Annex  B of the SPS Agreement . One participant proposed to encourag e 
Members when submitting notifications to include the specifi c international standard that they are 
referencing . The participant also referred to : (i) having functional SPS National Enquiry Points 
(Article 7 and Annex B of the SPS Agreement ) and encouraging  Members to have up-to-date contact 
details for their SPS National Enquiry Points and National Notification Authorities available on the 
ePing  SPS&TBT Platform  to assist in knowing where to channel queries and to result in timely 
responses ; and (ii)  easily accessible established procedures, either posted on a website or available 
from the SPS National Enquiry Point . Most competent authorities of Members have off icial websites  
and Members should be encourage d to make their approval procedures available on  websites. 
2.3.  The WTO notification system was seen as  the cornerstone of the transparency provisions of the 
SPS Agreement , providing a user -friendly platform through  which Members  could notify other 
Members of new or significantly  modified SPS measures . Presentations made during the 
2019 Thematic SPS Workshop on Transparency and Coordination  could serve as a reference for 
Members looking to strengthen their internal capacities to align with the SPS Agreeme nt's 
transparency provisions, paying particular attention to the importance of timely notifications and of 
providing Members an opportunity for meaningful engagement so that comments could be 
considered.  
2.4.  In connection with timing/ undue delays  and communica tion/ information exchange , 
one participant referred to  document G/SPS/W/317 , a submission fro m Brazil, Kenya, Paraguay, and 
the United States on enabling access to tools and technologies: towards safer and more sustainable 
agriculture through regulatory collaboration . Although set within the context of fall armyworm, this 
document provide d a compilation of concepts that could  be employed, on a voluntary basis, to 
improve and streamline regulatory processes, while safeguarding human, plant,  and animal heal th. 
This compilation serve d as a resource  for authorities with capacity constraints to help identify 
regulatory efficiencies that could  lead to greater and faster market access. It referred to tools and 
technologies, although the general concepts were applicable to a variety of market access requests.  
These concepts include d common application requirements, joint risk assessments, data portability, 
adaptation to regional conditions, unilateral recognition, mutual recognition, familiarity, history of G/SPS/GEN/2097  
 
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  safe us e, equivalence, and harmonization. Familiarity and history of safe use could  be particularly 
relevant within the context of approval procedures , as they might  allow Members to leverage 
previous experience (both  direct and indirect) to inform and streamline  internal evaluation 
processes. In this context, several tools from  the Global Low -Level Presence Initiative were 
identified . The participant  also referred  to the APEC brochure , "A Trade Facilitative Approach to 
Pesticide MRL Compliance " and the  Crop Life' s Regulatory Harmonization webpage , as reflected in 
the compilation of readily available tools and resources . To the extent practicable, the voluntary 
adoption of these concepts to national regulatory frameworks could increase the relative speed and 
ease w ith which approvals could  be considered, thereby reducing undue delays.  
2.5.  Other best practices put forward included national coordination . In many Members , approval 
procedures could entail more than one government agency or entity. National Coordination could 
help remove excess steps in the approval procedures and facilitate the harmonization of procedures 
among diverse agencies, in turn minimizing undue delays and unnecessary or burdensome steps or 
procedures.  
2.6.  Another area for best practices suggested by many  participants related to  the use of 
international standards . To the extent possible,  Members should base approval procedures on 
international standards, guidelines,  or recommendations. Additionally, where the lack of a measure 
and the capacity to speci fy one was causing a trade concern, importing Members should consider 
basing a n SPS measure on international standards, guidelines , or recommendations until approval 
was established domestically.  Harmonization of SPS measures  with international standards, 
guidelines , or recommendations could facilitate  approval procedures by ensuring that SPS measures 
were scientifically justified and by decreasing the likelihood of discrimination between and among 
trading partners.  
2.7.  Setting of import tolerances/thresholds  was also addressed. Members could consider 
either establishing import -specific tolerance to assure food safety while facilitating trade when a 
product was not used domestically or establishing an appropriate threshold that provide d for food 
safety or animal  health or plant health protection.  One participant also referred to import tolerances 
in the case of substances not regulated at national level but regulated by international standards.  
2.8.  The Working  Group  further  discussed regulatory cooperation and consideration of other 
Members' approvals . On the topic of regulatory cooperation, Members could  facilitat e approval 
procedures by working jointly with other Members to maximize capacity and resources. 
This approach would be  facilitated by Members following international standards, guidelines , or 
recommendations and risk assessment techniques developed by the relevant international 
organizations. In relation to the c onsideration of other Members' approvals , one participant stated 
that Members could  consider taking into account the results or information from another Member's 
approval procedure as part of domestic approval procedure s and to determine how to respond to a 
non-compliance.  
2.9.  In echoing these latter two suggestions, one pa rticipant considered  the recognition of risk 
assessments to be a fundamental tool, especially in the approval process for biotechnology products. 
In that regard, the mechanism for the recognition of risk assessments carried out or authorizations 
given by o ther Members  should ensure the exchange of complete information related to risk analy ses 
to guarantee transparency and access to information and improve the  implementation of approval 
procedures so that the ALOP is achieved, while facilitating trade. The participant further observed 
that many developing  country  Members did not have the conditions to properly implement the 
approval processes for commodities related to biotechnology products. Considering intellectu al 
property rights and patents  and that authorizations (including assessments) of biotechnology 
products were carried out on a case -by-case basis, as well as  recognizing that the producer or 
importer / exporter was not in a position to easily obtain risk i nformation, recognition mechanisms 
were required to include the consent of the biotechnology industry to proactively provide information 
to competent authorities, or to allow the exchange of information between competent authorities of 
trading partner Memb ers adopting  recognition strategies (i.e. common application dossiers).  
2.10.   Another suggestion  was to develop best practices to address asynchronous approvals . 
The participant putting forward this suggestion recalled that a n asynchronous authorization was a 
situation where there was a regulatory authorization for a product, such as an rDNA plant intended 
for food and feed use, in the country of origin and no corresponding authorization in a country of 
import. Asynchronous authorizations could  delay commercializ ation of new products as well as create 
the potential for trade disruptions, for example, those arising from the low -level presence of 
unauthorized rDNA plants in food and feed shipments. The proposal was for the Working  Group  to G/SPS/GEN/2097  
 
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  develop a consensus docume nt of best practices to help reduce occurrences of asynchronous 
authorizations, recognizing that individual Members  needed to devise measures consistent with their 
domestic legal requirements, and acknowledging that regulatory approaches should provide 
transparent and predictable timeframes for decision making, be science -based, be no more trade 
restrictive than necessary, and be consistent with relevant international obligations.  
2.11.   This proposal was echoed by others in the Working  Group . One participant considered this to 
be of special interest for living modified organisms (LMOs) . The participant suggested that the 
Working  Group  develop a section on best practices for the unilateral  or mutual recognition of risk 
assessments.  Another participant suggested that the Working  Group  lay down actions to improve 
asynchronous approval o f GMOs, particularly regarding unnecessary requirements in the approval 
procedures which delayed commercial approvals. Regarding good practices, it would be  helpful if the 
developers ma de joint and simultaneous presentations both in the exporting and importing 
Members , since the synchronization of approvals would facilitate  the free circulation of products . 
2.12.   Other participants generally agreed that it would be helpful to identify a set of best practices 
to provide guidance for Members throughout the process of developing and establishing approval 
procedures. These discussions could focus on: use of and harmonizati on with international 
standards; regulatory cooperation, including recognition of joint risk assessments or third -country 
risk assessments to facilitate decision making and inform appropriate responses to non -compliance; 
and use of import tolerances and/or  thresholds. Discussions in these areas could  advanc e the 
understanding o f ways in which Members could strengthen and streamline their approval procedures 
to facilitate safe trade. It would also  help generat e a general reference framework for the appropria te 
implementation of the different approval procedures, according to the principles included in  Annex 
C, as well as address situations of non -compliance.   
2.2  Collection of Available Tools and Resources  (G/SPS/ GEN/ 2098 ) 
2.13.   Over the course of the Working  Group , many participants submitted ideas of readily available 
resources . The Working  Group  developed  a collection of readily available  tools and resources  to 
enhance the implementation of the obligations of the SPS Agreement  as they app lied to approval 
procedures . In the process,  the Working  Group  consulted with the ISSBs, with WOAH (founded as 
OIE) provid ing input on the collection . 
2.14.   The Working  Group developed this collection with the understanding  that it did not involve a 
substantive analysis and did not constitute an exhaustive list of tools and resources  related to 
approval procedures. It was an evergreen document to be updated by the Working  Group  
as it progressed with its work. The discussions relating to this collection of tools and resources 
focused on the types and individual resources to be added to the collection, how they should be 
grouped, the purpose of the collection, and how it could be complemented or improved.  
2.15.   Regardi ng the themes used for grouping the resources in this collection, o ne participant noted 
that some of the m were topics ( e.g. transparency  and undue delay) while other  resources were 
identified by sources. Another  participant suggested to separate tools and resources  from 
multilateral intergovernmental organizations from those  of other organizations. Another  question 
was whether some tools would benefit from appearing twice in the document when they were 
relevant to more than one theme. Eventually, tools  were included in the compilation to feature only 
once in the document for simplicity and classified  where they were deemed to be  most useful.  
2.16.   In addition, one participant  proposed that, when contributing to the list of available tools, 
participants should also identify  the type of approval procedures or aspects of approval procedures 
that these tools relate d to or were relevant for. This was however not done consistently and was 
therefore not reflected in the collection.  
2.17.   One additional related proposal was to include guidelines of individual WTO Members on their 
own approval procedures and to create a repository of Member's approval procedures. 
Other  participants acknowledged the usefulness of the suggestion but worried about the workload 
that would result from  updating and maintaining a document containing Members' approval 
procedures. It was also queried whether including such information might change the purpose of the 
collection of available tools and resources . As an alternative, Members could provide concr ete 
examples of the application of the tools and resources  contained in the collection of available tools. 
The Working  Group  did not move ahead  to implement  these suggestions.  G/SPS/GEN/2097  
 
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  3  KEY CHALLENGES OF APPROVAL PROCEDURES THAT IMPACT INTERNATIONAL TRADE 
AND THAT T HE SPS COMMITTEE  SHOULD SEEK TO ADDRESS  
3.1.  The focus of the  Working  Group  throughout  several rounds of its work was on key challenges 
of approval procedures that impact ed international trade and that the SPS Committee  should seek 
to address . Discussions focus ed on challenges associated with : 
a. timing and undue delays;  
b. transparency;  
c. communication or information exchange;  
d. justification and discrimination of approval procedures;  
e. harmonization with international standards; and  
f. other challenges such as COVID -19. 
3.2.  To facilitate the discussions , the Working  Group  addressed  a few key challenges at a time , 
staggering the discussions to address : challenges associated with "t ransparency " and 
"communication or information exchange " (Sect ion 3.1  ); challenges associated with "justification 
and discrimination of approval procedures" and "harmonization of international standards"  
(Section  3.2  ); and  "timing and undue delays" as well as  "other challenges such as COVID -19" 
(Section  3.3  ). 
3.1  "Transparency " and "Communication or information exchange " 
3.3.  Improving  the communication and exchange of information among Members and increas ing 
the transparency of the different stages of approval procedures were some of the main  and most 
important  challenges of approval proce dures  mentioned . One participant proposed that transparency 
of approval procedures be discussed in import risk analys es, while another considered that  issues of 
transparency of procedures for sampling, testing and certification were the key challenges that  the 
SPS Committee  should seek to address.  
3.4.  On the issue of transparency , uncertainty of the steps of approval procedures and the lack of 
clarity as to the type of information required and the process to submit information , as well as 
undefined deadlines,  were highlighted by various participants . The Working  Group  also discussed 
effects on trade of such challenges.  For example, a participant noted that audits could impact trade 
when there was lack of clarity, transparency, and predictability in t he purpose and outcome of audits 
and the audit processes.  Building on this comment, another  participant added that trade could  be 
impacted when there was lack of clarity, transparency, and predictability in the times of realization 
and dictum of audits.  
3.5.  While acknowledging transparency -related challenges, one participant underlined that capacity 
constraints of developing countr y Members  had to be taken into consideration . Transparency  
discussions should take into account technical and human capacities at domestic  level.  
3.6.  Many  participants  also linked the discussion on transparency to that of timing and undue delays 
in approval procedures.  In this context, one participant remarked that some Members fail ed to have 
a clear process for their approval procedures  related to the importation of animal s or animal products 
into their territory . The participant had  for example been  asked to complete a questionnaire and 
thereafter an audit of the farm's facilities had been  conducted by the potential importing country. 
In addition, the competent authority of that country had evaluated its veterinary services. No report 
had been  produced , despite  repeated requests. This had created a great deal of uncertainty as to 
any additional steps or what might have been  hindering the completion of the report.  
3.7.  One participant  distinguished between exporting and importing point s of view . The participant 
noted that from the exporting side, the main challenges were the lack of transparency , including the 
availability of the rules, unclear procedures, and vague time frame. The interpretation of the 
expression of "undue delay" could be considered as well in this context. In  contrast, from the 
importing side, the main challenges were unclear and not sufficiently justified reques ts, as well as 
the lack of necessary data and guarantees.  
3.8.  In view of dealing with associated challenges, a participant suggested that the Working  Group  
discuss minimum requirements for information necessary to complete the approval procedures. 
Another  proposal was that the criteria for examining the completeness of the documentation should 
be clarified and that the applicant  should be informed  in a precise and complete manner of all G/SPS/GEN/2097  
 
- 14 - 
 
  deficiencies in the context of paragraph 1(b) of Annex C of the SPS Agreeme nt. Specifically, 
necessary documents and their contents should be announced to all applicants in advance as 
repeated requests for additional documents without advance announcement could lead to delays in 
the approval procedure.  The same participant sugges ted that there be specific procedures to ensure 
that the competent body transmit ted as soon as possible the results of the procedure in a precise 
and complete manner to the applicant so that corrective action could be taken if necessary as 
mentioned in par agraph 1(b) of Annex C of the SPS Agreement . The presentation of reasons and 
detailed explanations for the result of the procedure were important for an approval procedure to be 
implemented without undue delay.  These proposals were echoed by another partic ipant, who 
highlighted the importance of: (i) clarifying  criteria for examining completeness of documentation; 
and ( ii) announcing necessary documents to applicants in advance. These two recommendations 
were also linked to the WTO Trade  Facilitation Agreement, which required  Members to simplify their 
import processes and notify their standards of inspection.  
3.9.  Regarding communication and information exchange , the function of Members ' National 
Enquiry Points  was highlighted , as the entities  responsible for the provision of answers to all 
reasonable questions from interested Members, as well as for the provision of relevant documents.  
3.10.   To facilitate further exchanges  in the Working Group , the co-steward s provided a summary  
of the Working  Group discussions and the 2019 Thematic Session on Approval Procedures  relating 
to key challenges . On transparency and communication or information exchange , the co -stewards 
highlight ed inter alia the following points  from this summary : 
a. A lack of transparency in approval procedures had been underlined as a challenge 
impacting trade, in particular when information on the rules and approval procedure 
processes wa s unavailable, the approval procedures were unclear, and the deadlines or 
timeframes were vague or undefined ; 
b. Challenges were experienced when the information required by the importing Member to 
complete their approval procedures was not readily available.  Additionally, a lack of clarity, 
transparency, and predictability in audits and import checks could negatively impact trade ; 
c. The technical and human capacities at the country level had been highlighted as 
considerations that needed to be taken into accoun t; 
d. Difficulties with communication and information exchange had been noted as a challenge 
impacting trade, leading to situations where it was unclear what type of information or 
data was required, the process to submit the required information or data, the  duration of 
different steps in the approval procedures, and the process to provide additional or follow -
up information ; 
e. The lack of timely and objective responses also created uncertainty for trade. There  may 
be challenges in receiving confirmation as to whether additional steps or information was 
required to complete the approval procedure, resulting in uncertainty on the overall status 
of the approval. Delays in communicating the result of the approval procedure in a timely 
manner negatively impacted tra de; 
f. Another challenge that had been identified was when the importing Member did not 
communicate in advance to applicants details on all the necessary documents and the 
information required for these documents. Repeated requests for additional documents 
and information could lead to delays in the approval procedure ; 
g. The need for information exchange and communication between regulators and industry 
had also been highlighted.  
3.11.   Participants welcomed  the co -steward s' summary  and generally agreed with the description 
of key challenges. Some participants , however, queried whether the summary covered all the 
relevant issues. In this context, one participant highlighted the importance and role of SPS National 
Enquiry Points for the purposes of  communication and information exchange , as specified in the 
SPS Agreement . SPS National Enquiry Points should be included in the description of this item.  
3.12.   Another participant referred to its practice of making relevant information available online , 
which could be a practical recommendation for Members, including having a functioning website with G/SPS/GEN/2097  
 
- 15 - 
 
  available information for example on SPS National Enquiry Points  as well as a functional mailbox to 
facilitate the information exchange on  different topics, and using different languages. These could 
possibly form part of Working  Group  recommendations. The co -stewards acknowledged  that 
providing comprehensive information online in various languages would be useful to a global 
audience and could be a co st-saving activity as it could lead to a reduction in the number of 
ad hoc requests for information. Participants however also recognized that there could  be possible 
legitimate limitations as to what was reasonable to expect given resource constraints . Members d id 
not necessarily have the resources to maintain functioning websites. One suggestion made in this 
respect was that Members could identify priorities and that there could be regional initiatives to 
develop similar requirements for approval procedures.  
3.13.   Specific c hallenges that had been  observed with approval procedures in terms of transparency 
and communication or information exchange  were further discussed . One participant  referred to 
unclear information requirements and difficulties in obta ining information pertaining to the 
requirements for the approval procedures. It was also sometimes unclear whether an approval 
procedure was in fact required and there could be a lack of clari ty and accessible guidance for 
information requirements in the processes for pre -market approval procedures. There could also be 
a lack of transparency on the implementation of approval procedures as well as the maintenance of 
approvals, for example transparency on listing requirements for products and establishments,  
how these lists were prepared and maintained, and who was responsible for maintaining the lists. 
The participant  added that this could lead to miscommunication and lack of understanding on whom 
to notify and when. The same participant further referred to a lack of transparency with respect to  
maint aining approval procedures.  
3.14.   Addressing challenges relating to communication and information exchanges in relation to 
listing products and establishments, one participant highlighted that there was  significant 
uncertainty for exporters when there was a lack of timely responses to requests, incomplete 
responses,  or imprecise description of deficiencies in applications. This could cause challenges in 
communication regarding the required information and lead to multip le requests back -and-forth, 
burdensome information requirements, and delays in providing the results of approval procedures. 
Possible solutions to these challenges  should be explored . 
3.15.   One participant took the view that the type of approval procedures posin g the greatest 
challenges to international trade were risk assessment procedures, with undue delays being the  main 
issue. Concerns  raised in the SPS Committee  often related to undue delays of risk assessment 
procedures and guidance on this issue was availa ble in WTO panel and Appellate Body reports. 
The participant, however, considered that the type of approval procedures posing the greatest 
challenges to international trade needed to be distinguished from the type of approval procedures 
that the SPS Commit tee should seek to address. Taking time and resource constraints into account, 
the Working  Group  should avoid conducting a n analysis more detailed than that of WTO  panels and 
avoid protracted discussions on the legal definition of the term approval procedu res. Issues related 
to transparency of procedures for sampling, testing and certification should be identified as the key 
challenges that the SPS Committee  should seek to address.  
3.16.   Finally, one  participant requested that the issue of obtaining complete information at the 
beginning of the process be reflected in the work of the Working  Group  and suggested to work on a 
recommendation for Members to make their best efforts to give complete informat ion at the 
beginning of the process. While recognizing Members' autonomy in defining and conducting approval 
procedures , greater predictability in approval procedures  was key . Members  needed  to provide 
transparency in the negotiation processes and to have a temporal forecast of the duration of 
processes . This would allow for  greater predictability regarding when processes  would end as well 
as provide  a better understanding of what would qualify as undue delay.  
3.2  "Justification and discrimination of approval p rocedures " and "Harmonization with 
international standards " 
3.17.   On the topic of harmonization with international standards , several participants recalled 
that Members were encouraged to use international standards, guidelines, and recommendations 
where these exist ed in accordance with Article  3.1 of the SPS Agreement . Howev er, 
several  participants reported challenges related to the lack of harmonization of approval procedur es 
with international standards . One participant noted that, in the trade in animals or animal products, 
while Members at times m ight reference a  standard or guideline  developed by WOAH  (founded as 
OIE), in applying a sanitary measure for  the trade in anim als or animal product s, the measure did 
not always  conform to nor seem ed to be based on th at standard  or guideline . G/SPS/GEN/2097  
 
- 16 - 
 
  3.18.   In addition, many participants highlighted challenges relating to unjustified approval 
procedures or measures applied in an unjustified or d iscriminatory manner . In this context,  
the importance of science -based  SPS measures  was highlighted, and the Working  Group  was called 
to discuss the review of the application of unjustified SPS measures  in trade, related to export 
restrictions by Member s that were not backed by scientific evidence and affected food exports.  
One participant noted that it had faced situations where a disease was present in the potential 
importing country, but the sanitary measure applied to the imported product  require d that the 
exporting country  be free of the  same  disease . Another participant referred to situations with 
certification requireme nts where information required or import checks seemed to go beyond what 
was necessary to meet the importing Member's ALOP.  In earlier discussions, this participant had 
noted that import checks could impact trade when there was lack of clarity, transparenc y, and 
predictability in these processes ; the integrity of the good was affected more than necessary ; and 
when import checks were more frequent than necessary , based on risk. Building on this comment, 
another participant highlighted the need to check  that there was equal treatment.16 
3.19.   To foster  Working Group discussions, the co -steward s updated their  summary on key 
challenges .17 Based on this revised summary, t he co -steward s highlighted the following  key points 
that had emerged  as they relate to "justification and discrimination" as well as "harmonization with 
international standards ": 
a. There were challenges when approval procedures were not justified or based on scientific 
principles and risk assessments ; these approval procedure s negatively impacted trade. 
This could lead to approval procedures that were overly burdensome, more trade 
restrictive than necessary, did not take into account bilateral circumstances or past 
performance, and could lead to duplicative requirements ; 
b. Discriminatory approval procedures were a challenge impacting trade, for example when 
disease freedom was required for exporting countries even though the disease in question 
was present in the importing country. As well, there could be discriminatory fees ; 
c. The lack of harmonization with international standards, guidelines, and recommendations 
was a challenge, since differing approval procedures created difficulties and uncertainty 
for trade and decreased predictability ; 
d. Another challenge was that Members might indicate that an approval procedure aligned 
with a particular international standard, guideline, or recommendation, but in  application 
the approval procedure did not conform to nor seemed to be based upon the referenced 
international standard, guideline, or recommendation. This created uncertainty and 
negatively impacted trade.  
3.20.   Participants considered the co -steward s' summary to be helpful to advance the discussions. 
One participant expressed reservation, however, as to whether the summary cover ed all the issues, 
discrimination being one of the most difficult issues to identify. Another  participant  cautioned  not to 
discuss specific SPS measures  that might be taken by particular Members, but to approach these 
issues from an eyes wide -open perspect ive. There were instances where Members imposed 
measures without a  sound justification or without basing these measures on international standards  
because of domestic or political considerations. The Working  Group  was not a forum to discuss  those 
instances  where Members might be adopting SPS measures  while being fully aware that these were 
inconsistent with the SPS Agreement . Rather, it would be  more productive to focus on how technical 
capacities and regulatory cooperation could be strengthened, so that Me mbers c ould have the 
required resources to comply with the SPS Agreement . 
3.21.   On the topic of  harmonization with international standards, the following challenge was  further 
discussed: standards were not developed quickly enough in light of international devel opments. 
The process of agreeing  on new standards  was a difficult one , and since standards were sometimes 
outdated, WTO Members needed to adopt other SPS measures . In that context,  one possible 
recommendation  that the Working  Group  could develop would be t o encourage the use of e -tools to 
provide clear and timely information. Encouraging the sharing of information online could help 
address many of the challenges discussed in the Working  Group . 
 
16 See para. 1.8.   et seq. above.  
17 See para. 3.10.   above.  G/SPS/GEN/2097  
 
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  3.22.   On discriminatory treatment , one participant  noted that,  in certain instances, 
different  exporting Members receive d different information from the same importing Member 
regarding its approval procedures : one exporting Member might  not have all relevant information, 
while other s might. One participan t specifically referred to: (i)  receiving basic information on 
approval procedures, which  fitted under the umbrella of transparency obligations in  the 
SPS Agreement  but was not always provided; and (ii) receiving complete information on 
requirements. Regar ding the latter , an importing Member might present a list of approval steps and, 
after a long period, inform the exporting Member of the need for additional information that had not 
been required in the initial list. Two proposals were submitted to deal wi th this issue: 
(i) recommending that all Members should make their best efforts to give complete information in a 
non-discriminatory manner, which could be easily achieved through accessible information on 
websites or by providing documents with informatio n on exporting to a certain Member ; and 
(ii) recommending that organizations dealing with cooperation and technical assistance help 
Members make complete information available to all Members.  
3.23.   Building on these comments, another participant observed that the themes of transparency, 
information sharing, and communication, were intertwined with other key challenges  and could be 
possible areas for further reflection and possibly  a complementary Working  Group  outcome. 
The importance of having information availab le online and having complete information available to 
all Members from the outset  was acknowledged . In addition, a number of specific trade concerns 
(STCs) raised in the SPS Committee  had highlighted these key challenges of justification, 
discrimination, and harmonization with international standards. One particular challenging area was 
approval and listing of establishments, where there could be burdensome information requirements 
beyond what was necessary, not based on international standards or supporte d by scientific 
evidence. This could cause lengthy approval listing processes, including with costly and burdensome 
audits, questionnaires, and exchange of information processes. There were also  challenges with 
certification processes, where requirements w ent beyond what was necessary or deviated from 
international standards, increasing costs and administrative burdens and creating obstacles for 
trade. As seen in the SPS Committee, these challenges related to different types of approval 
procedures, such as pre -market approvals.  
3.24.   With respect to pre -market product approvals,  one participant observed that Members needed 
to adhere to what was established in the international standards; so that these allowed the 
commercialization without the r equirements being excessive, especially for products for which there 
was already market access. Sometimes, excessively detailed questionnaires were requested and did 
not take into account justifiable international standards. It would be important that already 
completed control, inspection , and approval processes be taken into account and recognized for 
other similar products.  
3.25.   Finally, the Working  Group  discussed  outreach and capacity building, as well as stakeholder 
engagement as possible areas where ideas  could be shared , including on how Members  might 
overcome human resource limitations. In this connection, t he co-stewards reminded  that, 
following  the discussions on  what the key challenges were that participants faced , the next step 
would be to discuss pos sible principles  of approval procedures . 
3.3  "Timing and undue delays " and "Other challenges " 
3.26.   Issues related to timing, undue delay, or synchronization  were raised as cross -cutting 
issues  by many participants. The issue of undue delay was said to be critical and of particular 
concern.  To illustrate this, one participant  observed that most STCs in the SPS Committee  reflected 
undue delays.  
3.27.   One participant observed that when a Member unduly delayed, without due justification, 
the acceptance into its mark et of a product from an exporting Member , which was exported to 
multiple destinations in compliance with the SPS requirements for the product, this created 
unnecessary and unjustified barriers to trade affecting negatively both exporters and consumers. 
Recalling that international trade must be facilitated , another participant called on the 
Working  Group  to analy ze the issue of undue delays in approval procedures to avoid 
establishing/generating technical barriers to trade , as well as to analy ze unjustified  delays in the 
inspection and phytosanitary qualification processes for entry by importing Members . 
3.28.   In addition, p articipants shared experiences about delays , for example  situations where 
reports on the progress or outcome of an approval procedure were still awaited, despite several 
requests.  Unjustified delays in SPS admissibility processes by Members  that import agricultural and G/SPS/GEN/2097  
 
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  agro-industrial products were highlighted,  with the effect of slowing down formalities, thereby 
restricting trade flows and access for goods. The lack of timely and objective responses in terms of 
inspections conducted by health authorities of importing Members  to approve producing and 
exporting e stablishments in other Members  was also raised as a topic for discussion by the 
Working  Group . 
3.29.   One participant identified the following approval procedures, where undue delays had major 
impact for international trade of livestock and agriculture products: (i) approval of import for food 
and feed, plants, animals, plant and animal products; (ii) risk assessment for a particular product, 
such as pest risk analysis , and import risk analysis; (iii) authorization/approval of processing 
establishments; and (iv) a nimal or plant health and food safety control system audits. 
These  approval procedures  were usually initiated with a request for market access from the 
exporting party. Generally, the continuation of the process was conditioned to the finalization or 
prioritization of other requirements or depended on the administrative burden of the importing party. 
This, in  addition to the fact that approval procedures also implied exchanges of information between 
competent authorities and could imply physical audits, cou ld take several years. In the participant's 
experience,  the entire process could take between two and ten years, with a great variability among 
Members and products, making it very difficult to estimate the time that a particular process would 
take. Furthe rmore, m ain difficulties and possible causes of undue delays were  identified , e.g. the 
excessive administrative burden, the lack of transparency of the importing party, the difficulties of 
communication in the process, and non -science -based/unjustified requirements.  
3.30.   In the early Working  Group  discussions, some participants had also zoom ed-in on pre -market 
approval procedures, and the issue of these varying between Members and leading to asynchronous 
or misaligned  approvals.18 One participant had added that r egarding the approval of individual 
products instead of complete product categori es, approval/inspection processes were presented 
focused on each individual establishment, instead of carrying out comprehensive evaluations focused 
on the exporting Member 's systems . These processes  needed to be repeated  after a few years, 
which  cause d duplication of control, inspection , and approval procedures, in addition to increasing 
costs and hindering access to markets.  
3.31.   Some participants suggested that the Working  Group  draft guidelines, for example with 
definitive timeframes . One such proposal was for the Working  Group  to draft recommendations on 
the proper implementation of paragraphs 1(a) and 1(b) of Annex C to the SPS Agreement . In order 
to provide useful information that could serve as a basis for future SPS Committee recommendations 
in this area, the following was suggested: (i) identification and characterization of approval 
procedures most commonly applied or of greater importance in trade, as well as their respective 
standard processing periods; and (ii) review and ana lysis of the predictability of, and Members' 
compliance with, that period, as set forth in paragraph 1(b) of Annex C of the SPS Agreement . 
Another  suggestion was that each Member outline its approval procedures in detail in the first stage 
of negotiations with the other party and that the maximum deadline for completing all stages of the 
approval procedures not exceed 24 months, subject to specific adjustments or the possibility to use 
alternative procedures in adverse cases (regional or global, such as the  COVID -19 pandemic).19 
Finally, the Working  Group  could discuss approaches to the definition of "reasonable time" required 
for the approval procedures.  Other participants highlighted that in  the development of guidelines 
and specifically relating  to timeframes, the Working Group should  ensure that no additional burden 
was placed on Members  with limited resources . 
3.32.   With respect to other challenges , the impact of the COVID -19 pandemic on 
approval  procedures and SPS requirements in general for market access of imported products was 
put forward as a possible topic for the Working  Group . One participant cautioned that any alternative 
procedures , if agreed to in order to meet deadlines in adverse cases  such as the COVID -19 pandemic , 
needed to be used to avoid barriers to trade and unnecessary delays in face of situations of regional 
and/or global adversities . Another  proposal was to discuss c ollaborative strategies to ensure the 
implementation of approval procedures by Member s, overcoming administrative constraints or even 
situations like COVID -19, in order to prevent trade from being adversely affected . 
3.33.   Another frequent challenge when seeking approval for market access  was highli ghted by a 
participant  who imported a significant proportion of the raw materials used for processing due to its 
limited agricultural activity. Yet, t his production model was not recognized/permitted in certain 
 
18 See para. 1.8.   above.  
19 This proposal and subsequent discussions in the Working  Group are detailed in paragraph 4.7.   et 
seq. below.  G/SPS/GEN/2097  
 
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  Members' approval procedures. Given the conne ctedness of global supply chains, the participant  
noted that similar production models could be adopted by more Members . Allowing Members  to 
leverage the increasingly connected global supply chain created more opportunities for an effective 
use of resource s. 
3.34.   To foster further discussion s, the co -steward s highlighted the following key points on "timing 
and undue delay" as well as "other challenges, such as COVID -19" from their  revised  summary of 
key challenges , which they had based on  Working  Group  discussions  thus far  and the 2019 Thematic 
Session on Approval Procedures : 
a. Undue delays in approval procedures were noted as a challenge by participants. 
Undue  delays slowed down approvals, which restricted trade and negatively affected 
exporters and consumers. Undue delays in risk assessment procedures had been 
highlighted as one of the main challenges with approval procedures ; 
b. The timing of approval procedures was also noted as a challenge. For instance, pre -market 
approval procedures could vary between Members, which led to asynchronous or 
misalignment of approvals. Although typically considered a temporary issue, these delays 
could result in decreased profit a nd delayed innovation due to the potential loss of product 
and product quality ; 
c. The impact of undue delays in approval procedures initiated by market access requests on 
trade of livestock and agriculture products was highlighted as a common and critical is sue. 
These approval procedures included the exchange of information between competent 
authorities and in some cases audits, and their conclusion could depend on the finalization 
or prioritization of other requirements, or the administrative resources of th e importing 
party; 
d. The length of approval procedures could vary based on the Member and products involved, 
which resulted in unpredictability of the length of approval procedures ; 
e. Greater predictability and transparency in approval procedures had been emph asized, with 
a view to predict the duration of approval procedures and establish an understanding of 
what could be classified as undue delay ; 
f. Global challenges resulting in administrative constrains, such as the COVID -19 pandemic, 
could adversely affect in ternational trade and approval procedures ; 
g. Other challenges included the lack of trust between parties, and a lack of capacity to 
administer the required approval procedures in the competent authority of the importing 
Member.  
3.35.   In the discussions that follow ed, one participant provided an illustrative list of challenges of 
approval procedures associated with timing and undue delays . Citing the case of citrus fruit exports, 
the participant  noted that there had been cases of undue delays of up to five years bet ween the 
initiation of a request and the reception of the proposal for phytosanitary import requirements. 
Additional  examples of undue delays in approval procedures related to the export of sheep meat, 
beef, poultry, and honey; noting that there had been r equests for information, which had been 
previously submitted, lack of response from counterparts, delays in on -site inspections, and 
instances where the counterpart had requested to advance simultaneously with the market 
authorization of its export products as a condition to advance the process. Referring to the impact 
of these challenges on international trade, one participant  highlighted that unjustified and undue 
delays had restricted market access of agricultural products, which had created dispa rities with 
Members where similar sanitary and phytosanitary conditions prevailed and could be considered a 
disguised barrier to trade. Additional challenges related to the complexity and lack of harmonization 
of questionnaires requested by importing Membe rs, as well as the request for nonessential 
information in certain occasions.  
3.36.   Other examples of issues associated with timing and undue delays were identified in relation 
to pest risk analysis processes and pre -audit evaluations for live animals. One parti cipant identified 
instances  where additional information had been requested by the importing party in the revision of 
pest risk analysis questionnaires or pre -audit evaluations, which was technically unjustified or 
unnecessary for the approval procedure. It would be  useful to simplify the questionnaire and the G/SPS/GEN/2097  
 
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  exchange of pest risk analysis and pre -audit information to reduce documentary stages. 
Delays resulted from  unjustified steps in pest risk analysis processes and from the lack of information 
at the st art of the pest risk analysis process regarding possible  additional steps . A reduction or 
anticipation of such delays would provide more predictability to these processes or evaluations.  
3.37.   Undue delays  were also observed in the context of  on-site audits for the renovation of or 
first-time authorizations for processing plant facilities . Remote audit contingency plans could help 
address this issue. Alternative approval inspection processes, such as remote or documentary audits, 
could be implemented in emergency  cases such as the COVID -19 pandemic, where on -site 
evaluations were not possible. Related i ssues included  uncertainty related to timing and undue 
delays and the problems these created for the private sector, particularly in the context of 
seasonality in a gricultural production.  
3.38.   One participant distinguished between delays caused by  the potential exporter  and those 
caused by the potential importer. The participant  highlighted situations in which a workplan had 
been carried out by the importing and exporting  party and technical consultations and work had 
been completed, but the process had come to a halt. Recalling  an earlier suggestion to work on a 
recommendation for Members to make their best efforts to give complete information at the 
beginning of the proc ess, this referred to approval procedures where there was a broadly predictable 
timetable, but once the timetable had been completed the process had nonetheless stopped.  
3.39.   Understanding that there was no easy definition, one participant considered it would b e useful 
to characterize what was considered an undue delay. At the beginning of the approval process, 
clear steps and an average time for conclusion  of the process  should be indicated . This would create 
predictability to the exporting party and provide a better understanding of what could be considered 
to be an undue delay.  
3.40.   Another participant  noted that while approval procedures could be resource intensive and 
require d time, they could be com pleted without undue delays. Delays or asynchrony in the timing 
of approval procedures between Members could negatively impact trade , creating uncertainty 
between exporters. The participant  referred to delays in the approval of listing of establishments, 
in providing the results of approvals and publishing the list of approved products and establishments, 
and in the implementation of import conditions, in particular for restoring and/or providing new 
market access. Other delays related to the negotiation of  export certification, scheduling of audits 
or issuance of reports. In addition, issues with timing and undue delays  were again highlighted  for 
pre-market product approval, such as approval of biotechnology products, which could vary between 
Members and be  misaligned with best practices. While a temporary issue, it was one that frequently 
impacted trade and could result in delays in the commercialization of new products, or increased 
costs, prompting Members to implement controls to ensure that products wer e not exported to 
Members where they were not approved.  
3.41.   Finally, another participant  highlighted the importance of acknowledging the significance of 
the market access process. The effects of delays  as well as resource constraints faced by Members  
were ackn owledged . The participant  considered that there was a perspective component in 
determining undue delays as Members asking for market access could consider any delay as undue. 
In relation to previous exchanges in the Working  Group  regarding efforts to strea mline processes, 
the participant  considered it useful to look at approval processes through the lens of resource 
constraints, and to identify alternatives to streamline the approval process whilst considering the 
level of protection needed in the domestic market and ensuring the safety of products.  
3.42.   Concluding the discussions on key challenges, t he co -stewards thanked participants for their 
interventions around the topics of resource constraints, definition of undue delay, and need for 
alternatives, as well as the reinforcement of issues such as transparency, advance awareness of 
the process and communication. The co -stewards noted that emphasizing these issues reinforced 
the importance of the linkages of timing and undue delays and tran sparency or having a clear 
understanding of the processes and technical justification for requirements at the outset. 
The co-stewards highlighted the issue of linking import and export requests, which was not a 
legitimate consideration when making technica l assessments. In addition, the issue of resource 
constraints and the need to prioritize were highlighted. The co -stewards noted that the discussions 
led to conversations about possible solutions and recalled the  then upcoming Thematic Session on 
the Use of Remote (Virtual) Audit s and Verification in Regulatory Frameworks . G/SPS/GEN/2097  
 
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  4  PRINCIPLES OF APPROVAL PROCEDURES THAT FACILITATE INTERNATIONAL TRADE 
WHILE MEETING THE IMPORTING  MEMBER'S ALOP AND THE SPS COMMITTEE 'S ROLE IN 
HIGHLIGHTING THESE PRINCIPLES  
4.1.  The Working  Group  also discussed  the principles of approval procedures that facilitate d 
international trade while meeting the importing Member's ALOP, and the SPS Committee 's role in 
highlighting these principles. The discussions were informed by the Working  Group 's work on tools 
and best practices  (Section  2  ) and key ch allenges  of approval procedures (Section  3  ). 
4.2.  Participants proposed several principles of approval procedures , largely mirroring the key 
challenges of approval procedures discussed in the Working Group . One participant referred to 
ensuring that SPS measures  were science -based in line with Articles 3 and 5 of the SPS Agreement ; 
the principle of transparency , where Members make information available via a website or upon 
request through the SPS National Enquiry Points , in line with Annex B of the SPS Agreement ; 
the principle of non -discrimination whereby Members shall ensure that their SPS measures  do not 
arbitrarily or unjustifi ably discriminate between Members, in particular where the SPS situation was 
similar in the importing and exporting Member , in line with Article 2.3 of the SPS Agreement ; and 
the principle of consistency , where by an importing Member's treatment of like pro ducts should be 
the same when these products were imported from different Members  with the same SPS status.  
4.3.  Another participant also drew attention to the principles of risk -based  approval procedures , 
timely approval, communication , and transparency . Some of these principles and characteristics 
could be considered by Members to build into their domestic systems to support approval procedures 
that met the ALOP while facilitating trade. The participant highlighted the need for approval 
procedures to be based on scientific principles and an assessment of risk, to be conducted and 
completed in a timely manner  and for the outcomes of the approval procedure to be communicated 
upon the conclusion of the assessment. The need for approval procedures to include mechan isms 
for communication, allowing for opportunities for clarification of requirements, was highlighted as a 
tool to facilitate the provision of the necessary information by the proponent. Open and ongoing 
communication was a key element for approval procedu res to be undertaken in a timely manner. 
Approval procedures should be transparent, with information on status and requirements, such as 
guidance documents, made available or provided to the proponent proactively or upon request.  
4.4.  One participant  also propo sed the operationality and timely flow of information within  stages 
of approval procedures, including : publication of the processing period; examination of the 
completeness of the documentation and the communication of deficiencies; transmission of the 
results of the procedure; processing of applications, even when these had deficiencies; and reporting 
on the stage of the procedure, with an explanation for any delays.  
4.5.  Another participant suggested  that the Working  Group  discuss  the following  as draft  principles 
of approval procedures:  simplified procedures, expedited and completed without undue delays; 
procedures not applied in a manner that would constitute an arbitrary or unjustifiable discrimination 
against other Members; publication of the standard processing period or communication of the 
anticipated processing periods of procedures upon request; inform ation requirements limited to the 
extent necessary for appropriate control, inspection and approval procedures, including for the 
approval of the use of additives or establishment of tolerances for contaminants in food, beverages , 
or feedstuffs; and fees i mposed for the procedures equitable in relation to fees charges on like 
domestic products and no higher than the actual cost of the service.  
4.6.  Further d rawing attention to the topics of transparency, necessity, communication,  
and harmonization with internati onal standards, one participant noted that, as a general rule, 
the fundamental principles of the SPS Agreement  should be implemented and precisely described in 
document s related to approval procedure s. The participant highlighted the need for transparency on 
the applicable regulation of each approval procedure and who must comply with it. 
Explanatory  documents and the  publication of procedures and requirements, including stages and 
deadlines applicable to both parties , were necessary to avoid undue delays. The participant referred 
to instances where deadlines were set but often vague. Noting that in some instances the information 
requested, for example through questionnaires, was difficult to gather, the participant remarked the 
need to explain the reasons f or the importing Member to demand compliance with approval 
procedures and to justify the documentation required. Lastly, the participant highlighted the need 
to promote opportunities to consult on the approval procedure, the documentation to be submitted, 
and the procedure's  progress and results. Promoting harmonization of approval procedures with 
international standards, guidelines, and recommendations  to facilitate trade was also highlighted.  G/SPS/GEN/2097  
 
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  4.7.  Putting forward  a proposal for the review of approval procedure s, one participant indicated that 
its position  was directly linked to the issue of undue delays, an issue that was also reflected in  most 
of the STCs presented in recent  meetings of the SPS Committee . The participant proposed that 
Members detail their approval procedures in the first stage of negotiations with the relevant party, 
including information on the stages of the approval procedures and deadlines for completion, as well 
as responses or inform ation input from both parties. Regarding the maximum deadline for 
completion of all stages of the approval procedure, the participant suggested it should not exceed 
24 months, with the possibility for adjustments if bilaterally agreed. The participant high lighted that 
parties should be encouraged to adopt simplification or facilitation procedures, taking into account 
the recognitions of equivalence between systems. Deadline  extensions for each stage of the approval 
procedure were to be duly justified in ord er not to exceed the maximum final deadline bilaterally 
agreed upon to complete the process. The  participant also suggested that Members should have 
pre-stipulated or bilaterally agreed alternative procedures, such as video conference inspections 
and/or th e adoption of simplified and electronic procedures, to meet the deadlines in adverse cases 
such as those related to the COVID -19 pandemic.  
4.8.  On this specific proposal, another participant remarked that the Working  Group  would need to 
define  stages of approva l procedures with clear time  limitations to  finalize the overall process within 
24 months  as proposed. The participant  queried  whether the Working  Group  would have enough 
time to proceed with the suggestion given the timelines set forth in document G/SPS/W/328/Rev.1 . 
The partic ipant further noted that the suggestions contained details aimed to build up and 
standardize approval procedures, and that it would be challenging for the Working  Group  and the 
SPS Committee  to reach consensus. The proponent replied that the proposal consi sted in 
establishing a text to guide Members to commit themselves to establish a timetable that listed the 
approval procedures and their deadlines for conclusion, thereby making undue delay in approval 
procedures easier to identify and characterize. To avo id becoming a limitation to Members , possible 
extensions for the conclusion could be agreed between the parties. Referring to the maximum limit 
of 24 mo nths for the entire approval procedure, the participant noted that they were  open to other 
suggestions. According to the participant, the proposal respected the regulatory differences among 
Members and allowed for flexible approval procedures on a bilateral basis. The suggested approach 
intended to prevent the use of unclear and undefined approval procedure steps to justify undue 
delays, which  unnecessarily prolonged the process and created trade barriers.  
4.9.  One participant considered that a transparency approach should be part of each Members' 
approval procedure, with Members clearly determining their approval  procedures at the beginning 
of the negotiation process including steps and deadlines, as well as providing information and 
justifications for possible postponements. The participant deemed useful to include a maximum time 
for completion of all approval pr ocedures, including necessary postponements.  In relation to another  
participant's suggestion to base approval procedures on international standards, guidelines , or 
recommendations "as far as possible ", using the standards provisionally until regulatory coo peration 
between the relevant parties was achieved, one participant took the  view that the term "as far as 
possible" weakened the SPS Agreement  and international standards . The parties involved should be 
encouraged to seek measures in compliance  to what was  provided  in the SPS Agreement  and with 
basis on ISSB guidelines in order to simplify the process and make it more agile.  
4.10.   Another participant proposed to develop an approval  procedure to be agreed by the 
Working  Group  and indicated that it was essential to have standardized approval methods to have 
certainty and transparency in the results, therefore reducing uncertainty to a minimum acceptable 
to the parties. The participant  further noted that approval procedures should be based on scientific 
principles and risk assessments to increase reliability, and to define the scope of the approval 
procedure and its cross -border trade implications to facilitate compliance.  
4.11.   One participa nt suggested that the Working Group  define and clarify key principles that should 
guide the development and improvement of approval  procedures, which would align with proposals 
to address specific challenges associated with approval  procedures. The partici pant referred to 
Annex C of the SPS Agreement  and indicated that its flexibilities, while necessary to account for the 
range of regulatory approaches used by Members, could  lead to challenges and uncertainty.  
4.12.   The co-stewards presented a summary of exchange s on principles of approval procedures, 
based on participants' contributions throughout the discussions in the Working  Group  and the  
presentations and discussions during the  2019 Thematic Session on Approval Procedures . 
The co-steward s highlighted the following points:  G/SPS/GEN/2097  
 
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  a. Basing approval procedures on risk and  applying approval procedures only to the extent 
necessary and in the least trade restrictive manner were items highlighted by participants 
in the discussions ; 
b. Conducting approval procedures in a timely manner and without undue delay; 
the importance of ens uring timely and predictable approvals, completed without undue 
delays; outlining timeliness of approval procedures; accepting applications at any time of 
the year; initiating approval procedures once applications were received; and 
communicating the concl usions of the procedure in a timely manner had been emphasized 
by participants ; 
c. The importance of transparency and communication was also highlighted. This included 
communicating with the proponent through online systems or websites prior to 
commencing and  during the approval procedures, as well as providing updates on the 
status of the approval procedure to the proponent and communicating the anticipated 
duration and timelines in advance of commencing an approval procedure ; 
d. The importance of ensuring that SPS measures  did not unjustifiably discriminate between 
Members had also been raised in the discussions. Participants had emphasized that 
approval procedures should equally not be applied in a manner that would constitute an 
arbitrary discrimination agains t other Members ; 
e. The need for increased acceptance of international standards, guidelines and 
recommendations for approval procedures, as well as the importance of promoting the 
application of international standards, guidelines and recommendations had als o been 
highlighted ; 
f. Participants had also highlighted that the fees imposed for an approval procedure on 
imported products should be equitable in relation to fees charged on like domestic 
products, and no higher than the actual cost of the service.  
4.13.   Partici pants welcomed the co -steward s' summary. One participant recalled that it had 
suggested a pragmatic approach focusing on concrete issues identified by participants  and that many 
of the key challenges related to principles already contained in the SPS Agree ment. The participant 
highlighted the need to avoid discussions on the legal interpretation of the SPS Agreement  and to 
be mindful of the scope of the SPS Agreement  and the role of the Working  Group . Regarding the 
structure of the co-steward s' summary , another participant suggested using a template to identify 
the challenges from an exporting and importing Member's perspective.  
4.14.   Inviting additional comments from participants, t he co-stewards noted that the following main 
principles of approval procedures had emerged from the exchanges : 
a. need for science -based, risk -based SPS measures ; 
b. timely approval and no undue delay;  
c. transparency, communication, and publication;  
d. non-discriminatory and consistent treatm ent of Members with the same SPS status;  
e. harmonization with international standards; and  
f. equitable fees . 
4.15.   Participants made some additional remarks regarding these principles. Participants 
highlighted the need for  science -based, risk -based approval procedures to enable the 
predictability and reliability of approval procedures.  
4.16.   Regarding the principles of timely approval and no undue delay , conducting  approval 
procedures in a timely manner, ensuring the timeliness in approval procedures, and the need to 
conduct and complete approval procedures without undue delays were highlighted by several 
participants. The need to communicate the outcome of the appr oval procedure in a timely manner 
upon the conclusion of the assessment  was also noted . 
4.17.   Turning to the topics of transparency, communication, and publication , the role of 
transparency in improving the predictability of the approval procedure process and ad dressing undue 
delays was remarked by participants. Some participants highlighted the need for information on the 
approval procedure and its requirements, including guidance documents and questionnaires, to be G/SPS/GEN/2097  
 
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  made available from the outset ; the need to sh are information on the standard processing period in 
advance; the need to proactively or upon request provide status updates on the approval procedures 
to the proponent; and the need to have standardized approval methods.  For approval procedures to 
be cond ucted and completed in a timely manner, some participants highlighted the need to reinforce 
and maintain an open and ongoing communication, with one participant stressing the need to include 
mechanisms for communication in approval procedures to allow for opportunities for clarification of 
the requirements and help the proponent to provide the necessary information.  Certain  participants 
also highlighted th e need for information requirements to be limited to what was necessary for 
appropriate control, inspec tion and approval procedures. Some  participants noted that the 
requirements and standard processing period s of approval procedures, including procedure sta ges 
and deadlines applicable to both parties, should  be published to avoid undue delays.  
4.18.   Regarding the principle of non-discriminatory and consistent treatment of Members 
with the same SPS status , certain participants again highlighted the need for Members to ensure 
that their SPS measures  did not arbitrarily or unjustifiably discriminate betw een Members, 
especially  where similar SPS conditions prevailed between the importing and exporting Member, and 
for approval procedures not to be applied in a manner which would constitute an arbitrary or 
unjustifiable discrimination.  
4.19.   The principle s of harm onization with international standards  and equitable fees  were 
also again underlined by participant s. 
5  ADDITIONAL DISCUSSIONS ON POSSIBLE WORKING  GROUP  OUTCOMES  
5.1.  The Working  Group  discussed possible outcomes of its work  and output documents throughout 
its various rounds of w ork, as reflected in Sections 2-4 above . For example, in the initial  rounds of 
work, in addition to its collection of available tools and resources , one partici pant proposed that 
Members provide their own approval procedures to be collected in the form of a repository.20 
Other  suggestions included  recommendations on the use of e -tools to provide clear and timely 
information  and SPS Committee  guidelines on transparency, information sharing, and 
communication.  
5.2.  The Working Group's sixth round of work focused on discussing  possible outcomes  of the 
Working  Group . One participant considered that the development of a survey open to 
SPS Committee Mem bers would have a positive impact on the development of guidance as an 
outcome of the Working  Group. The survey could replicate the exchanges of the experiences and 
concerns on approval procedures in the Working  Group, with a view to collect and classify M embers' 
concerns or possible solutions. Based on the co -stewards' summary of key challenges of approval 
procedures, another  participant suggested to include columns reflecting the views of the importing 
and exporting Members, and possible solutions to stre amline the process in relation to the challenges 
that had been broadly identified in the Working  Group. Another participant questioned the efficacy 
of conducting a survey.  
5.3.  The Working Group further  discussed the possibility of developing guidelines or 
recommendations. One participant noted that the SPS Committee  could develop guidelines on the 
implementation of Annex C of the SPS Agreement , to allow for concrete examples and 
recommendations on what would be expected from Members concerning the principles co ntained in 
Annex C . The Working  Group  could draft recommendations focused on the principles of approval 
procedures that addressed the challenges which had been discussed in the Working  Group . 
5.4.  Another participant reiterated its proposal to develop  guideline s on certain principles including 
those of transparency, information sharing, and communication . The participant took the view that 
it could be a useful outcome of the Working  Group , as these guidelines could enhance the 
implementation of approval procedur es in accordance with the provisions of Annex  C of the 
SPS Agreement  and could complement existing SPS Committee  guidelines and the standards, 
guidelines , and recommendations developed by the ISSBs . These  guidelines could also help address 
the challenge of  undue delays. If the Working  Group  were to agree to develop  guidelines, 
another  participant suggested that an initial draft be prepared for discussion,  noting the lengthiness 
of the process of developing SPS Committee  guidelines. Preparing a compilation o f best practices or 
recommendations based on the Working Group's discussions could be an alternative  outcome to the 
development of SPS Committee  guidelines.  
 
20 See para. 2.17.   above.  G/SPS/GEN/2097  
 
- 25 - 
 
  5.5.  The co -stewards  suggested a report to the SPS Committee  with a factual account of  the 
Working Group's discussion s and recommendations /observations. One such observation could be  
that the challenges and principles that had emerged from the discussions were within the bounds of 
and addressed by the SPS Agreement . One participant emphasized th e importance of predictability, 
the idea that Members must make their approval procedures public and the importance of notifying 
approval procedures . This was an area that should be reflected in the report to the SPS Committee . 
Another participant suggeste d that the recommendations or observations of the Working  Group  
could be channelled through the sixth review of the operation and implementation of the 
SPS Agreement. A nother participant supported the idea , provided that it worked timing -wise. 
One particip ant proposed to refer to the document as a compilation of the Working  Group 's process , 
not a "report" . There could also be a shorter easier -to-digest summary  of the Working Group's work . 
5.6.  The co -steward s noted that the output documents of the Working  Group  could consist of: 
a short document with a high -level account of the work of the W orking Group, setting -out the 
outcomes of the W orking Group ; a factual process -based summary of the discussions, building on 
the compilations of participants' contributions that had been circulated by the Secretariat to the 
Working Group in each round of work; and the collection of available tools and resources . 
These documents were further discussed in the Working Group's seventh and final round of work 
and eventually circulated as documents G/SPS/ GEN/2099, G/SPS/ GEN/2097, G/SPS/ GEN/2098. 
 
_______________ 
  G/SPS/GEN/2097  
 
- 26 - ANNEX A: OVERVIEW  OF SUGGESTED TOPICS  FOR THE WORKING  GROUP  CONSIDERATION  
This table provides an overview of the main topics  to be explored by the Working  Group , as they emerged from initial Working  Group  discussions . This table does 
not reflect topics that were subsequently put forward or clarifications subsequently provided . 
Main theme  Suggested topic  Individual participant's suggestions  
Common 
understanding 
of approval 
procedures  Types of 
approval 
procedures and 
associated 
definitions  Consider types of 
approval procedures 
and how to enhance 
implementation of 
these various types. 
Initial consideration: 
audits, import 
checks, certification, 
and pre -market 
product approvals.  Determine a definition 
of "approval 
procedures": "approval 
procedures" are 
procedures to check 
and ensure the 
fulfilment of 
SPS measures , but 
some Members regard 
them as including 
procedures for risk 
assessment.  Glossary of terms / 
definitions: data 
portab ility, common 
application dossiers, 
unilateral and mutual 
recognition, history of 
safe use, emergency 
use authorization.     
Key challenges 
of approval 
procedures that 
impact 
international 
trade and that 
the Committee 
should seek to 
address  International 
Standards  Members may refer 
to an OIE standard  
(now WOAH) , but the 
measure does not 
conform/is not based 
on this standard.  Review of 
recommended 
conformity assessment 
procedures applicable 
to the imported goods 
in port.      
 Justification 
and 
discrimination 
of approval 
procedures  Disease -free status 
required from 
exporting Member 
even when the 
disease is present in 
importing Member . Review of the 
application of 
unjustified 
SPS measures , 
restrictions not backed 
by science.  Importing side: 
unjustified requests.    
  
  G/SPS/GEN/2097  
 
- 27 - Main theme  Suggested topic  Individual participant's suggestions  
 Transparency  Lack of clear process 
(animal and animal 
products).  Operationality and 
timely flow of 
information in relation 
to stages of approval 
procedures: publication 
of the processing 
period.  Transparency 
regarding the 
availability of the 
rules, unclear 
procedures, vague 
timeframes. 
Importing side: 
unclear.  Clarification of 
criteria for 
examining 
completeness of 
documentation. 
Necessary 
documents to be 
announced to 
applicants in 
advance.  Transparency of 
approval procedures 
in import risk 
analysis, including 
regarding 
regionalization 
recognition 
processes.  
Minimum 
requirements for 
information necessary 
to complete approval 
procedures.   
 Communication 
and information 
exchange  Lack of 
communication. After 
repeated requests, 
reports have not 
been shared, creating 
uncertainty. Unclear 
what may be 
hindering the 
completion of the 
report.  Approval procedures 
should contain 
mechanisms for 
communication, to 
allow for opportunities 
to clarify r equirements 
of the approval 
procedure s. Timely flow of 
information in 
relation to stages of 
approval procedures: 
completeness of the 
documentation and 
the communication of 
deficiencies; 
transmission of the 
results of the 
procedure; reporting 
the stage of t he 
procedure, explaining 
any delays.  Importing side: 
unclear, lack of 
data, guarantee.  Informing applicant in 
a precise and 
complete manner of 
deficiencies .  
 Timing/undue 
delays  Undue delays: a few 
participants  
suggested guidelines 
with timeframes. 
No additional burdens 
should be placed on 
Members with limited 
resources.  To serve as a basis for 
Committee 
recommendation: 
consideration  of 
approval procedures 
commonly applied or of 
great importance, and 
their stan dard 
processing periods; 
analysis of the 
predictability of, and 
Members' compliance 
with these periods.  Unjustified delays 
slowing down 
formalities.  
Lack of timely and 
objective responses 
in inspections to 
approve producing / 
exporting 
establishments.  
Operationality and 
timely flow of 
information.  Interpretation of 
"undue delay" 
could be 
considered.  Procedures to ensure 
that results are 
transmitted "as soon 
as possible ... in a 
precise and complete 
manner". Importance 
of reasons / 
explanations for 
impleme ntation 
without undue delay.  Approaches to 
the definition 
of "reasonable 
time" required 
for the 
approval 
procedures.  
 Other 
challenges  Impact of COVID -19 
on approval 
procedures/SPS 
requirements.        
  G/SPS/GEN/2097  
 
- 28 - Main theme  Suggested topic  Individual participant's suggestions  
Principles of 
approval 
procedures that 
facilitate 
international 
trade while 
meeting the 
importing 
Member's ALOP  
and the 
Committee's 
role in 
highlighting 
these principles   Key principles: 
(i) ensuring 
SPS measures  are 
science -based; 
(ii) transparency; 
(iii) non-
discrimination; 
(iv) consistency of 
treatment for 
Members with same 
SPS status.  Principles for initial 
consideration: 
(i) risk-based; 
(ii) timely; 
(iii) communication; 
(iv) transparency.  Elements: 
(i) simplified 
procedures, without 
undue delay; (ii) non -
discrimination; 
(iii) publication/ 
communication of 
standard/ anticipated 
processing period; 
(iv) information 
requirements limited 
to what is necessary; 
(v) equitable fees.     
Tools available 
and best 
practices to 
enhance the 
implementation 
of the 
obligations of 
the 
SPS Agreement  
as they apply to 
approval 
procedures   Best Practices on: 
(i) transparency 
(compliance with 
notification 
obligations with 
reference to 
international 
standards); 
(ii) functional SPS 
National Enquiry 
Points ; (iii) accessible 
established 
procedures; 
(iv) national 
coordination.  Best practices on : 
(i) international 
standards; 
(ii) regulatory 
cooperation; 
(iii) setting of import 
tolerances /  
thresholds; 
(iv) consideration of 
other Members ' 
approvals as part of 
domestic approval 
procedure / to respond 
to a non -compliance.  Measures to manage 
approval 
asynchronies 
between Members 
that export and 
import GMOs.  
Collaborative 
strategies to ensure 
implementation of 
procedures, 
overcoming 
administrative 
constraints or even 
situations like 
COVID -19. After identifying 
challenges, 
Working  Group  
can deal with 
tools and best 
practices 
available to 
address them.  Tools include: 
(i) decision by WTO 
Ministerial 
Conference; 
(ii) SPS Committee  
guidelines.  Best practices 
to address 
asynchronous 
approvals  
  
  G/SPS/GEN/2097  
 
- 29 - ANNEX  B: OVERARCHING PROCESS  FOR THE WORKING  GROUP  
The following reflects a document shared with the participants on 9 December 2021,  highlighting  the various phases for the Working  Group  as they were envisaged 
by the co -stewards following initial identification  of the various topics for the Working  Group 's consideration.  
 
NB: Ph ases are not related to the "rounds" occurring between the SPS Committee  meetings. There may be multiple rounds in each phase depending on the process achieved by 
the WG. The WG will enter a new phase once the objectives have been achieved.  
 
__________  Round 1
Theme: Common 
understanding
Theme: Key challenges
Theme: Principles
Theme: Tools and best 
practicesRound 2
Develop a common 
understanding
Develop a collection of tools 
and best practicesNext Phase
Based on the common 
understanding
Based on the collection of 
tools and best practices
Further identify key challengesFollowing Phase
Based on the common 
understanding
Based on the collection of 
tools and best practices
Based on the identified key 
challenges
Further identify principlesSubsequent Phase
Based on the common 
understanding
Based on the collection of 
tools and best practices
Based on the identified key 
challenges
Based on the identified 
principles
Consider need for additional 
tools and best practicesWG Outcome