G/SPS/GEN/2099  
 
1 March 2023  
(23-1401) Page: 1/4 
Committee on Sanitary and Phytosanitary Measures  Original: English  
 
WORKING  GROUP ON APPROVAL PROCEDURES  
OUTCOMES AND RECOMMENDATIONS  
NOTE BY THE WORKING GROUP  
1  INTRODUCTION  
1.1.  Following the recommendation from the fifth review of the operation and implementation of the 
Agreement on the Application of Sanitary and Phytosanitary Measures ( SPS Agreement ), a Working 
Group on Approval Procedures  (Working Group)  was established with the goal of  exploring:  
• Key challenges of approval procedures that impact international trade and that the Committee 
on Sanitary and Phytosanitary Measures (SPS Committee) should seek to address;  
• 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;  
• Tools available and best practices to enhance the implementation of the  obligations of the 
SPS Agreement  as they apply to approval procedures;  and 
• Other topics raised by Working Group participants over the course of the W orking Group. 
1.2.  As noted in the Summary of Process and  Discussions  for the Working Group  (G/SPS/ GEN/2097), 
there have been a number of outcomes and recommendations stemming from the exploration of the se 
topics. Below is a n overview  of the Working Group discussions and the associated recommendations.   
1.3.  The various Working Group output documents, including this note, the Summary of Process and 
Discussions for the Working Group ( G/SPS/ GEN/2097), and the Collection of Available Tools and 
Resources  (G/SPS/ GEN/2098), do not represent a legal interpretation of the rights and obli gations under 
the SPS Agreement  and do not in any way exemplify a legal definition.  
2  COLLECTION OF AVAILABLE TOOLS  AND RESOURCES  
2.1.  Over the course of the W orking Group, participants identified existing available tools and resources  
to enhance the implementation of the obligations of the SPS Agreement  as they apply to approval 
procedures. A detailed summary o f the discussions of the Working Group regarding this topic can  be 
found in Section 2 of document G/SPS/ GEN/2097. Tools and resources  have been compiled in a 
reference document , the Collection of Available Tools and Resource s (G/SPS/ GEN/2098), organized by 
key themes . These themes include : 
• Timing/Undue Delays  and Communication/Information Exchange ; 
• Transparency ; 
• Justification of Approval Procedures ; 
• Harmonization with International Standards  and Regulatory Cooperation ; and 
• General themes and other topics not classified.  G/SPS/GEN/2099  
 
- 2 - 
 
  3  KEY CHALLENGES ASSOCIATED WITH APPROVAL PROCEDURES  
3.1.  Additionally, Working G roup participants discussed the key challenges of approval procedures that 
impact international trade and how the SPS C ommittee could seek to address them. A detailed summary 
of the discussions of the Working Group regarding this topic can be found in Section 3 of document 
G/SPS/ GEN/2097. Participants explored the key challenges faced by Members that are summarized  
below.  
3.1  Transparency ; and communication or information exchange  
3.2.  Participants identified  challenges with approval procedures that stem from:  
• Unclear processes , including insufficient or unclear information on  how to address data 
deficiencies, how to submit data that has been requested by the importing Member , how to 
provide follow -up information, how to request clarification, and how to request status update s 
and gain approval ; 
• Unclear timelines  (i.e. sequence of events related to an approval procedure) , deadlines 
(i.e. critical dates associated with the submission, evaluation , and completion of an approval 
procedure) , and channels of communication (i.e. responsive points of contact within both the 
exporting and importing Member to address questions and comments from either party) 
associated with an approval procedure ; 
• Lack of adoption /use of international standards , guidelines, and recommendations or  tools, 
including for the electronic exchange of certificates.  
3.2  Justification and discrimination of approval procedures; and harmonization with 
international standards  
3.3.  Participants identified several c hallenges associated with  approval procedures they felt were 
unjustified and/or discriminatory, as well a s with harmonization of approval procedures with 
international standards , includ ing: 
• Approval procedures that do not appear to be  based on scientific principles and risk 
assessments ; 
• Approval procedures that appear to be d iscriminatory, such as when requirements for imported 
products are more stringent or burdensome than for the same products produced under similar 
conditions in other countries or domestically ; or the imposition of unjustifiable fees associated 
with an approval procedure ; 
• The lack of harmonization with international standards, guidelines, and recommendations, since 
approval procedures  differing from these standards , guidelines, and recommendations  can 
create difficulties and uncertainty for trade and decrease predictability ; recognizing that 
Members may introduce or maintain measures resulting in a higher level of SPS protection 
if there is a scientific justification  or as a consequence of the level of protect ion Members  
determine to be appropriate  in accordance with the relevant provisions of Article 5 of the 
SPS Agreement ; 
• Instances where t he implementation of  an approval procedure align s with a particular 
international standard, guideline, or recommendation  in principle , but in  application the approval 
procedure does not conform to , nor seem s to be based upon , the referenced international 
standard, guideline, or recommendation. This creat es uncertainty and negatively impact s trade.  
3.3  Timing and undue delays; and other challenges  
3.4.  Delays in approval procedures , which some participants felt were undue,  were also noted as a 
challenge.  Delays slow down approvals, which restrict s trade and negatively affect s exporters and 
consumers. Delays in risk assessment procedures were highlighted as one of the main challenges with 
approval procedures.  Participants identified the following c hallenges related to timing and undue delays:  G/SPS/GEN/2099  
 
- 3 - 
 
  • The ti ming of approval procedures , such as  pre-market approval procedures , can vary between 
Members, which le ads to asynchronous or misalign ed approvals ; 
• The length of approval procedures can vary based on the Member and products involved, which 
result s in unpredictability of the length of approval procedures ; 
• Limited technical or administrative resources result in delays in completion of approval 
procedures ; 
• Global challenges resulting in administrative constrains, such as the COVID -19 pandemic, can 
adversely affect international trade and approval procedures ; 
• Other challenges that can produce delays include lack of trust between parties and a lack of 
capacity to administer the required approval procedures in the competent authority of the 
importing Memb er. 
3.5.  Based on the discussions surrounding key challenges, the Working Group compiled concepts 
regarding how the SPS C ommittee could seek to address these challenges, which informed  the 
discussion s on principles of approval procedures.  
4  PRINCIPLES OF APPROVAL PROCEDURES THAT FACILITATE INTERNATIONAL TRADE  
4.1.  Finally, Working Group participants discussed the principles of approval procedures that facilitate 
international trade while meeting the importing Me mber's ALOP , and the SPS  Committee's role in 
highlighting these principles.  A detailed summary o f the discussions of the Working G roup regarding this 
topic can be found in Section 4 of document G/SPS/ GEN/2097. The principles of approval procedures 
highligh ted by the contributions of participants include  the need for : 
• Science -based and risk-based SPS measures;  
• Timely approval s; 
• Transparency , communication  (e.g. to provide status updates or request additional information 
or clarification ), and publication  of procedures, requirements, and standard processing period s, 
including procedure stages and deadlines ; 
• Non-discrimination between  Members with the same SPS sta tus; 
• Harmonization with international standards  in accordance with Article 3 of the SPS Agreement ; 
and 
• Equitable fees.  
4.2.  It is important to note that these principles are covered within the SPS Agreement , which is 
indicative of its continued applicability today, and that there is general agreement that there is no need 
to explore new obligations or to reopen  the SPS Agreemen t. 
5  CONCLUSION  AND RECOMMENDATIONS  
5.1.  The work of the W orking Group has facilitated a deeper conversation o n the concepts surrounding 
approval procedures and has resulted in recommendations that will aid the SPS Committee in providing 
consistent guidance for M embers who are developing or refining approval procedures.  
5.2.  As an outcome of these discussions, the Working Group makes the following recommendations:  
a. The Collection of Available Tools and Resources  will be  circulated and be kept up to date by 
the SPS Committee with the assistance of the Secretariat ; 
b. Members should consider the use of SPS Committee mechanisms to facilitate discussions on 
the challenges and principles of approval procedures, and to further explore the need f or 
additional guidance or tools to be developed. These mechanism s include , but are not limited 
to: 
i. Agenda item 4(d)  of the formal SPS Committee meeting on  Operation and implementation 
of the SPS Agreement – Control inspection and approval procedures ; G/SPS/GEN/2099  
 
- 4 - 
 
  ii. The u pcoming sixth review process ; 
iii. The thematic groups  established under the MC12 SPS Declaration work programme ; 
c. Members are encouraged to further the implementation of Annex C of the SPS Agreement  
with respect to approval procedures ; 
d. Members are reminded of the importance of key principles of the SPS Agreement , including 
those reflected  in Annex C of the Agreement. Members are reminded of the importance of the 
following principles of approval procedures  to facilitate international trad e while meeting the 
importing Member's ALOP : 
i. Science -based, risk -based SPS measures in accordance with Articles 2.2 , 3, and 5 ; 
ii. Timely approval  and no undue delay in approval procedures in accordance with 
Annex  C.1(a) , and information requirements limited to what is necessary in accordance 
with Annex C.1(c) ; 
iii. Transparency , communication , and publication with respect to approval procedures in 
accordanc e with Article 7 and Annexes B and C : 
• Members are encouraged to make relevant information on approval procedures 
available on official websites, ideally in multiple languages, and to use e -tools to 
provide clear and timely information on approval procedures ; 
• Members are encouraged to have up -to-date contact details of their SPS National 
Enquiry Points and National Notification Authorities available on the e-Ping SPS&TBT 
Platform ; 
• Members are encouraged to notify all new or changed approval procedures that are 
expected to have a significant effect on trade of other Members ; 
• Members are encouraged to provide relevant information proactively at the start of 
the approval process, including with respect to  the requirements for the approval 
procedure, anticipated  processing period, steps of the approval procedure, and 
relevant deadlines and timeframes, as well as to provide regular status updates ; 
• Members are encouraged to  maintain an open and ongoing communication with 
applicants throughout approval processes ; and 
• Members are encouraged , to the extent possible, to use international  tools for the 
electronic exchange  of certificates ; 
iv. Non-discrimination and consistent treatment of Members with the same SPS status in 
accordance with Article 2.3, Article 5.5, and Annex C.1(a) ; 
v. Harmonization with international standards in accordance with Article 3 and Annex C ; and 
vi. Equitable fees in accordance with Annex C.1(f) ; 
e. Members are encouraged to engage in regulatory cooperation to maximize capacity and 
resources , to facilitate approval procedures, and to address asynchronous approvals ; and 
f. Members  are encouraged to adopt approval procedures that make use of modern techno logies 
and practices, such as remote audits , and to work with relevant international organizations in 
this area . 
__________