G/SPS/GEN/1909  
25 May 2021  
(21-4332) Page: 1/5 
Committee on Sanitary and Phytosanitary Measures    
 
  
ANNUAL REPORT ON THE PROCEDURE TO MONITOR THE PROCESS  
OF INTERNATIONAL HARMONIZATION  
NOTE BY THE SECRETARIAT1 
1  INTRODUCTION  
1.1.  At its meeting of 15 -16 October 1997, the SPS Committee adopted a provisional procedure to 
monitor the process of international harmonization and the use of international standards, guidelines 
or recommendations, as provided for in Articles 3.5 and 12.4 of the SPS Agreement. The Committee 
extended the provisional monitoring procedure in 1999, 2001, and 2003 , and revised the procedure 
in October 2004.2 In 2006, the Committee agreed to extend the provisional procedure indefinitely, 
and to review its operation as an integral part of the periodic review of the operation and 
implementation of the Agreement under  Article 12.7.3 The procedure was reviewed as part of the 
Third Review of the Agreement4, and again in the context of the Fourth5 and Fifth Review.6  
1.2.  In November 2020, New Zealand submitted a proposal on the procedure to monitor the process 
of internat ional harmonization (G/SPS/GEN/1851 ), followed by a subsequent proposal  
(G/SPS/GEN/1877 ) in February 2021 . The Committee discussions on these proposals are detailed in 
Section 4.1 of this document.  
1.3.  The Committee has previously considered twenty -two annual reports on the monitoring 
procedure.7 These reports summarize several standards -related issues that the Committee  has 
considered and the responses received from the relevant standard -setting organizations.  
This current report includes the issues that were considered in the June and November 2 020, and 
March 2021  Committee meetings.  
2  NEW ISSUES  
2.1.  Since the 20 20 Annual Report, four new issues have been raised under this procedure : 
(i) Codex Maximum Residue Limits and Risk Management Recommendations for Residues of 
Veterinary Drugs in Foods (CX/MRL 2 -2018) ; (ii) Codex Alimentarius Guidelines for the Conduct of 
Food Safety Assessment of Foods Derived from Recombinant -DNA Plants (CAC/GL 45 -2003); 
(iii) Newcastle disease restrictions not consistent with the OIE international standard; and 
(iv) restrictions on exports of chocolate and cocoa products due to the lack of an international 
standard . 
 
1 This document has been prepared under the Secretariat's own responsibility and is without prejudice 
to the position of Members  or to their rights and  obligations under the WTO.  
2 G/SPS/14 , G/SPS/17 , G/SPS/25  and G/SPS/11/Rev.1 . 
3 G/SPS/40 . 
4 G/SPS/53 . 
5 G/SPS/62 . 
6 G/SPS/64 /Add.1 . 
7 These were circulated as G/SPS/13 , G/SPS/16 , G/SPS/18 , G/SPS/21 , G/SPS/28 , G/SPS/31 , G/SPS/37 , 
G/SPS/42 , G/SPS/45 , G/SPS/49 , G/SPS/51 , G/SPS/54 , G/SPS/56 , G/SPS/59 , G/SPS/60 , G/SPS/GEN/1332 , 
G/SPS/GEN/1411 , G/SPS/GEN/1490 , G/SPS/GEN/1550 , G/SPS/GEN/1617 , G/SPS/GEN/1710  and 
G/SPS/GEN/1776 . G/SPS/GEN/1909  
 
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  2.1  Codex Maximum Residue Limits and Risk Management  Recommendations for 
Residues of Veterinary Drugs in Foods (CX/MRL 2 -2018)  
2.2.  At the June 2020  Committee meeting, the United States submitted its statement in document 
G/SPS/GEN/1801/Rev.1 . 
2.3.  Canada provided the following statement: Canada would like to thank the United States for 
raising the issue of the Codex Maximum Residue Limits and Risk Management Recommendations for 
Residues of Veterinary Drugs in Foods. Canada recalls the substantial effort to establish an 
international standard for ractopamine at Codex. The FAO/W HO Expert Committee on Food Additives 
(JECFA) conducted comprehensive risk assessments considering its toxicology, residues in and 
intake from food animals in 1993, 2004, 2006 and in 2010, and concluded that the recommended 
MRLs were safe for the consumpti on of muscle, liver, kidney and fat. The Codex Alimentarius 
Commission adopted MRLs for ractopamine in 2012 after discussing the issue for the previous four 
sessions. Non -adoption by Members of the ractopamine MRL, as well as other standards, 
recommendatio ns and guidance established by Codex may unnecessarily increase costs for 
producers, processors and exporters, which results in higher prices for consumers around the world.  
2.4.  Paraguay provided the following statement: My delegation would like to thank the d elegation 
of the United States for placing this item on the agenda. Paraguay has always supported and will 
continue to support the Codex work in this area. We urge all Members to follow the Codex 
recommendations to avoid the proliferation of non -tariff bar riers to trade in agricultural products 
and of standards with which compliance may be impossible for developing countries that depend on 
exports of these products to sustain their economy and the subsistence of hundreds of thousands of 
people.  
2.2  Codex Alimen tarius Guidelines for the Conduct of Food Safety Assessm ent of Foods 
Derived from Recombinant -DNA Plants (CAC/GL 45 -2003)  
2.5.  At the November 2020 Committee meeting, the United States submitted its statement in 
document G/SPS/GEN/1864 , which highlighted the gaps between the regulatory pr ocedures 
maintained by some Members for approval of genetically engineered (GE) food products and the 
Codex Guideline CAC/GL 45 -2003. The  United  States regretted that some Members' requirements 
to conduct animal studies delayed the approval of, use of, and  trade in useful and demonstrably safe 
products. The United States encouraged Members to eliminate those requirements, focus data 
requirements on the information necessary for conducting safety assessments, and consider Codex 
guidelines.  
2.6.  Argentina consider ed that Members should eliminate their requirements to routinely perform 
animal studies, which affected innovation and normal trade flows. Argentina reaffirmed the 
importance of following international, science -based guidelines.  
2.7.  Canada thanked the United S tates and reiterated the importance to base measures on 
international standards. Highlighting some of the conclusions of CAC/GL 45 -2003, Canada underlined 
the importance of Members taking timely science - and risk -based regulatory decisions, taking into 
account the Codex food safety advice.  
2.8.  Paraguay expressed interest in sponsoring this item, highlighting the unnecessary costs and 
requirements resulting from differences between Codex and approval procedures established by 
some Members. Paraguay urged Members  to contribute to international harmonization in order to 
facilitate trade.  
2.3  Newcastle disease restrictions not consistent with the OIE international standard  
2.9.  At the November 2020 Committee meeting,  Turkey expressed its concern regarding the import 
restrict ions imposed by some countries for heat -treated poultry meat from Turkey with regard to 
Newcastle disease. Turkey stated that paragraph 2 of Article 10.9.15 of the OIE Terrestrial Code 
indicated that heat -treated poultry meat was not an import risk. Accord ing to Turkey, some Members 
still imposed trade barriers for the heat -treated poultry meat products. Turkey referred to Article 3 
of the SPS Agreement on harmonization and requested Members to follow the recommendations in 
Article 10.9.20 of the OIE  Terres trial Code.  G/SPS/GEN/1909  
 
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  2.4  Restrictions on exports of chocolate and cocoa products due to the lack of an 
international standard  
2.10.   At the November 2020 Committee meeting, Peru referred to the development and discussion 
of maximum levels of cadmium in chocolate and cocoa pro ducts within the Codex Committee on 
Contaminants in Foods (CCCF), as well as the importance of having an international standard for a 
sector that is of great social and economic significance to Peru . The lack of a Codex standard had 
led countries to adopt standards that were more trade restrictive than necessary . 
2.11.   Peru invited Members to coordinate with their respective health authorities, in order to achieve 
consensus by honouring the agreement to apply a criterion of proportionality when establishing, at 
the next CCCF meeting, maximum levels of cadmium for the following categories: (i)  cocoa powder 
ready for consumption containing or declaring 100% total cocoa solids; and (ii)  chocolate containing 
between 30% and 50% of total dry cocoa solids.  Peru requeste d the secretariat of the Codex 
Alimentarius Commission (CAC)  to ensure the development of science - and data -based standards. 
Peru also asked Members having already established maximum levels of cadmium for chocolate and 
cocoa products to review their stand ards on the basis of the findings presented within the CCCF and 
to inform their trade operators that these standards do not apply to cocoa beans . 
2.12.   Colombia indicated that this topic was of high interest for Colombia, given the implications in 
trade of choco late and cocoa products. Colombia invited Members to take into account the 
considerations raised by Peru.  
3  PREVIOUS ISSUES  
3.1.  Since the 2020 Annual Report, there was further discussion on two issues previously raised 
under this procedure  regarding : (i) ASF restrictions not consistent with the OIE international 
standard; and (ii) HPAI restrictions not consistent with the OIE international standard.  
3.1  ASF restrictions not consistent with the OIE internat ional standard  
3.2.  At the June 2020  Committee meeting , the European Union  submitted the following statement: 
Once again, the European Union must draw the attention of WTO Members to inconsistencies in the 
application of OIE international standards related to A frican swine fever. The OIE Terrestrial Code 
contains clear guidance for the identification, treatment and certification of tradable products. Yet, 
several WTO Members chose to ignore these recommendations that were developed, consolidated 
and adopted in t he OIE with the support of these same Members.  
3.3.  Through the European Union's strict regionalisation policy, the European Union demonstrates 
every day in its single market that African swine fever can be managed effectively to make sure that 
legitimate and safe trade is not the cause of any outbreak. The European Union is highly transparent 
on its disease control measures and provides information through the websites of the 
EU Commission, of the member States, of the OIE and through bilateral contacts with trade partners. 
For example, weekly synthesis reports are published by the EU Commission.  
3.4.  The European Union would like to insist that WTO Members apply import measures that are 
consistent with the SPS Agreement and with international standar ds. The European Union continues 
to give high priority to this issue and stands ready to work with WTO Members to remove 
country -wide and scientifically unjustified bans. Given the large number of WTO Members affected 
by the disease, from EU member States to China, from Belarus to Malaysia, the European Union has 
suggested to organise a thematic session on the subject of African swine fever ( G/SPS/W/322 ). 
3.5.  At the November 2020 Committee meeting, the European Union drew Members' attention t o 
inconsistencies in the application of OIE  international standards related to ASF. The European Union 
noted that several Members did not follow the OIE Terrestrial Code recommendations that had been 
developed and adopted with their support. The European U nion had demonstrated in its single 
market that the disease could be managed effectively to ensure that legitimate trade was not the 
cause of any outbreak . The European Union was transparent on its disease control measures and 
provided information through many channels. ASF was a disease affecting many EU and 
non-EU countries.  G/SPS/GEN/1909  
 
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  3.6.  The European Union welcomed the decision to organize a thematic session on ASF in 
March  2021. The objective would be to build confidence among Members to apply trade conditions 
consistent with the SPS Agreement and international standards. The European Union invited 
Members to work together to prepare the th ematic session and work on the removal of country -wide 
and scientifically unjustified trade bans.  
3.7.  At the March 2021 Committee meeting, the European Union drew the Committee's attention 
to inconsistencies in the application of OIE international standards re lated to ASF. The European 
Union considered that many Members did not follow the OIE Terrestrial Code guidance for the 
identification, treatment and certification of tradable products. The European Union highlighted that 
it had, as well as other Members, d emonstrated that ASF could be managed effectively to ensure 
that legitimate trade was not the cause of any outbreak. The European Union added that ASF was a 
disease affecting many EU and non -EU countries. The European Union invited Members to work on 
the removal of country -wide and scientifically unjustified trade bans.  
3.2  HPAI restrictions not consistent with the OIE international standard  
3.8.  At the June 2020 Committee meeting, the European Union submitted the following statement: 
The European Union appreciates the cooperation with those WTO Members that recognise the 
principle of zoning and accept the regionalisation measures put in place in the European Union. Many 
Members trust the European Union's effective and transparent system of control and eradication of  
animal diseases like avian influenza for many years now (and vice versa) and we do not experience 
any incident that would put this trust in question. On the other hand, there is still a significant 
number of WTO Members that disregard their obligations un der Article 6 and Annex C of the SPS 
Agreement, in particular China, Korea and South Africa.  
3.9.  Country -wide bans after a disease outbreak are not scientifically justified. There is also no 
justification for WTO and OIE Members to wait one year or more to res tore the disease -free 
status  - instead of the three months defined by the OIE Code.  The European Union successfully 
manages regionalisation measures in its entire territory, namely the single market of its member 
States. The veterinary services of all EU m ember States work in full transparency. Trade partners of 
the European Union can be reassured that it is at all times fully aware of the animal health situation 
in all member States.  
3.10.   The European Union reiterates its call to all WTO Members to respect thei r obligations on 
regionalisation under the WTO SPS Agreement; allow trade of all safe products from non -affected 
zones; lift all bans after regaining freedom 3 months after the application of stamping -out, cleaning 
and disinfection of all affected premises ; refrain from imposing trade restriction s in case of HPAI in 
wild or captive birds; refrain from imposing trade restriction s in case of detected LPAI. The European 
Union has repeatedly explained the disease control and regionalisation measures taken in th e event 
of an outbreak and offered bilateral structured dialogues to come to a solution with WTO Members. 
Unfortunately, these offers have not yielded concrete results so far.  
3.11.   The European Union appeals to WTO Members to respect the recommendations of 
international standard -setting bodies. These recommendations were developed and adopted with 
their support.  
3.12.   At the November 2020 Committee meeting, the European Union praised those Members that 
trusted the EU effective and transparent system of control and era dication of animal diseases such 
as AI. The European Union regretted that some Members disregarded their obligations under Article 
6 and Annex C of the SPS Agreement. Country -wide bans after a disease outbreak were not 
scientifically justified, and there w as no justification to wait one year or more to restore the disease -
free status, instead of the three months defined by the OIE Terrestrial Code. The European Union 
reiterated its call to all Members to respect their regionalization obligations; allow trad e of all safe 
products from non -affected zones; lift all bans after regaining freedom three months after 
eradication and re -instate trade conditions applicable to disease -free countries without delay ; refrain 
from imposing trade restrictions in case of HPA I in wild birds; and refrain from imposing trade 
restrictions in case of detected LPAI. The European Union appealed to Members to respect the 
recommendations of ISSBs that had been developed and adopted with their support.  G/SPS/GEN/1909  
 
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  3.13.   At the March 2021 Committee meeti ng, the European Union praised those Members trusting 
the effective and transparent EU system of surveillance, regionalization and eradication of animal 
diseases such as avian influenza. The European Union regretted, however, that some Members 
disregarded their obligations under Article 6 and Annex C of the SPS Agreement. Country -wide bans 
after a disease outbreak were not scientifically justified where effective movement controls were in 
place, and there was no justification to wait one year or more to res tore the disease -free status, 
instead of the three months in the OIE Terrestrial Code. The European Union reiterated its call to 
Members to respect their regionalization obligations; allow trade from non -affected zones; lift bans 
three months after eradica tion and reinstate trade conditions applicable to disease -free countries 
without delay; refrain from imposing trade restrictions in case of HPAI in wild birds; and refrain from 
imposing trade restrictions in case of detected low pathogenicity avian influen za (LPAI). The 
European Union called on Members to respect the recommendations of ISSBs, which had been 
developed and adopted with their support.  
3.14.   The OIE provided an update regarding the relevant chapter of the OIE Terrestrial Code 
(Chapter 10.4), which ha d undergone extensive revisions to be proposed for adoption at its May 
2021 General Session. The OIE highlighted some of the revisions, including a change to the title of 
the chapter (to refer to infection with HPAI viruses), a modification to the list of disease names in 
Chapter 1.3, and impacts on notification and surveillance requirements notably for LPAI, a new 
article on safe commodities, and a revision of the definition of poultry. The OIE pointed to the 
Terrestrial Code Commission Report of February 2021 (Part A) on its website, detailing the 
amendments.  
4  OTHER ISSUES  
4.1  Procedure to monitor the process of international harmonization  
4.1.  At the November 2020 Committee meeting, New Zealand presented its proposal submitted in 
G/SPS/GEN/1851 . New Zealand' s proposal was in response to renewed discussion by the ISSBs on  
the use and impact of their standards. The  IPPC had reported on the activities of the Implementation 
Review and Support System (IRSS), including a general survey on the IPPC and use of its st andards. 
The OIE had initiated an Observatory project with the aim of assessing the implementation of 
standards, and what the impediments were to their implementation.  Codex was exploring the issue 
in relation to its parent bodies (FAO/WHO), as significant  funds were used to develop standards. 
New Zealand believed there was merit in promoting some discussion on what further role the 
Committee could play in assisting the ISSBs in monitoring the use of their international standards, 
as laid out in Articles 3. 5 and 12.4 of the SPS  Agreement. New Zealand suggested that the 
Secretariat invite Members and the ISSBs to propose ideas and suggestions on how the Committee 
could proactively explore this topic.  
4.2.  At the March 2021 Committee meeting, the Chairperson remind ed the Committee that 
Members had had an opportunity to discuss New Zealand's submissions in G/SPS/GEN/1851  and 
G/SPS/GEN/1877  regarding the procedure to monitor the process of international harmonization at 
the informal meeting of the Committee of 24  March 2021. The Chairperson drew the Committee's 
attention t o the summary of these discussions in his draft report on the informal meeting, which had 
been shared with Members to provide comments  by the deadline of 23 April .8 
5  RESPONSES RECEIVED FROM THE RELEVANT STANDARD -SETTING ORGANIZATIONS  
5.1.  There have been no further responses received from the relevant standard -setting 
organizations  since the last annual report . 
__________  
 
8 The Chairperson's summary of the discussion s on New Zealand's proposal held in the March 2021 
informal Committee meeting is contained in Annex A of the summary report , G/SPS/R/101 .