WORLD TRADE  
ORGANIZATION   
G/SPS/W/260/Rev.1 
19 July 2011 
 (11-3597) 
Committee on Sanitary and Phytosanitary Measures  
  
 
PROCEDURE TO MONITOR THE PROCESS 
OF INTERNATIONAL HARMONIZATION 
 
Draft Thirteenth Annual Report
1 
 
Revision 
 
  The draft Thirteenth Annual Report on the Proce dure to Monitor the Process of International 
Harmonization was considered by the SPS Committee at  its meeting of 30 June - 1 July 2011.  The 
Committee agreed to adopt the report subject to its revision to include information arising from 
discussions under the relevant agenda item at that mee ting.  This revision includes that information.  
  Members wishing to suggest modifications to this draft report are invited to submit their 
comments to the Secretariat (Gretchen.Stanton@wto.org) no later than 2 September 2011 .  If no 
substantive objection to the report has been submitted  by that date, the report will be considered to 
have been adopted. 
 
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A. INTRODUCTION  
1. At its meeting of 15-16 October 1997, the SPS Committee adopted a provisional procedure to 
monitor the process of international harmonization a nd 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 adopted a revision of the 
procedure in October 2004.2  On 28 June 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  This procedure was reviewed as 
part of the Third Review of the Agreem ent adopted by the Committee in March 2010.4  The next such 
review is to be completed in 2013,  and every four years subsequently. 
2. The Committee has previously adopted twelve annual reports on the monitoring procedure.5  
These reports summarize several standards-related is sues that the Committee has considered and the 
responses received from the relevant  standard-setting organizations. 
                                                      
1 This document has been prepared under the Secret ariat's own responsibility and is without prejudice 
to the position of Members or to their rights or obligations under the WTO. 
2 G/SPS/14, G/SPS/17, G/SP S/25 and G/SPS/11/Rev.1. 
3 G/SPS/40. 
4 G/SPS/53. 
5 These were circulated as G/SPS/13, G/ SPS/16, G/SPS/18, G/SPS/2 1, G/SPS/28, G/SPS/31, 
G/SPS/37, G/SPS/42, G/ SPS/45, G/SPS/49, G/ SPS/51 and G/SPS/54. G/SPS/W/260/Rev.1 
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  B. N
EW ISSUES  
3. Since the adoption of the Twelfth Annual Report in October 2010, no new issue has been 
raised under this procedure.  
C. PREVIOUS ISSUES  
4. Since the adoption of the Twelfth Annual Report, there was further discussion on one issue 
previously raised under this procedure.  This issue is  with regard to the lack of adoption by the Codex 
Alimentarius Commission of standards relating to ractopamine.  
Concerns on the lack of adoption of Codex standards relating to ractopamine 
5. Brazil first raised the issue of the lack of a doption of an MRL for ractopamine by Codex at 
the meeting of the Committee of 28-29 October 2009.  Brazil reported that extensive discussions on 
this matter had occurred during the prev ious two Codex sessions and at the 18th session of the Codex 
Committee on Residues of Veterinary Drugs in Foods.  Adoption of the MRLs had been recommended in 2007 by the Committee on Residues of Veterinary Drugs in Foods.  At the October 
2009 meeting, the European Union, China and Norway  stressed that it had been agreed in Codex that 
JECFA would evaluate the latest data submitte d by China before the Codex Commission session in 
July 2010.  
6. This issue was again raised at the SPS Co mmittee meeting in June 2010, where Canada, 
Brazil, South Africa and the United States expressed strong support that the eight MRLs for ractopamine be adopted at the July 2010 meeting of the Codex Commission.  China and the European 
Union reiterated their previous concerns that it was too early to prejudge the outcome of that 
discussion.  The representative of Chile indicated that this type of situation made clear the need for a 
procedure to voice a concern when a Codex sta ndard was held at Step 8 for several years.  
7. At the meeting of the Committee of 30-31 Ma rch 2011, Brazil noted that the continuing 
failure of Codex to adopt MRLs for ractopamine raised  the issue of the lack of respect of scientific 
principles by Codex.  In 2008, Codex had decided to hold the proposals of MRLs for ractopamine at Step 8, and invited members to send further data to  be analysed.  To overco me the deadlock on the 
approval of ractopamine MRLs at the 33
rd Session of the Commission in 2010, a "Friends of the 
Chair" group was established to discuss possible solutions focussing on JECFA risk management.  
There was no scientific justification for the delays in adoption of the standards.  
8. Australia, Argentina, Canada, Chile, Colombia , Costa Rica, Mexico, New Zealand and the 
United States agreed with Brazil on the need for the immediate adoption of a Codex standard for 
ractopamine in order to ensure the protection of cons umers, the promotion of international trade, food 
safety, and the maintenance of the role of Codex as  an international referenc e organization in the area 
of food safety.  
9. The Codex representative stated that the matter of ractopamine MRLs would be examined 
again at the next Commission, and hopefully members would be able to reach a consensus. 
10. The European Union stated that JECFA had pr ovided Codex with a risk assessment, however, 
discussions in Codex focused on risk-management.   Norway and Switzerland agreed that while 
science was indeed a key element, risk managers al so had to consider other factors that impact 
consumers' health.  The European Union, as part of  the "Friends of the Chair", had worked with ten 
other Members to actively search for a solution accep table to all parties, and looked forward to 
making progress in advance of the July 2011 Codex Commission.  G/SPS/W/260/Rev.1 
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  11. The Codex representative stated that the matter of ractopamine MRLs would be examined 
again at the next Commission, and hopefully members would be able to reach a consensus. 
12. At the June 2011 meeting of the Committee, Co sta Rica again raised concerns about the 
delays in the adoption of the proposed standard for ractopamine by the Codex Commission (G/SPS/GEN/1092).  Maximum residue levels (MRLs) for ractopamine had been proposed, based on 
the safety assessment by the FAO/WHO Joint Expert  Committee on Food Additives (JECFA), the 
advisory scientific body of the Codex.  There we re no scientific or procedural reasons to delay 
adoption of the standard for ractopamine.  Costa Rica considered that this was a matter of major 
systemic importance, as there was a need to ensu re that Codex standards were based on scientific 
analysis in order to guarantee the safety of inte rnational food supplies.  The failure to adopt the 
standards cast doubts on the validity of JECFA,  and discouraged Codex members, especially 
developing country members, from participating in the standard-setting process.  Costa Rica stressed 
that Codex should base its decision on science, as th is was important for protecting consumer health 
internationally, the promotion of consumption, a nd maintaining Codex as an international reference 
body in the area of food safety standards. 
13. The United States recalled that the matter of approving MRLs for ractopamine would be 
considered for the fourth time by the Code x Commission the following week. The unjustified 
opposition by some countries to the adoption of a scien ce-based international standard threatened the 
institutional integrity of Codex.  Ractopamine w as approved by 25 national authorities, including the 
United States, for use in the production of beef and por k.  It has been used for 12 years in the United 
States with no adverse effects.  JECFA, an indepe ndent panel of experts, had evaluated it numerous 
times and recommended MRLs for ractopamine in musc le, fat, kidney and liver tissues of cattle and 
swine.  Science-based decision making allowed Codex to be free from national and political influences.  Blocking this decision for non-scientific reasons created a dangerous precedent for countries to block other standards for reasons unrelated  to food safety and consumer health protection.  
While the United States could understand that some  Members did not want to approve the use of 
ractopamine at the national level, blocking the adopti on of an international standard without scientific 
evidence was disruptive to the integrity of Codex.  If international standards were no longer science-
based, this could have adverse effects on the impl ementation of the WTO SPS Agreement, as it refers 
to Codex standards, and it would likely lead to th e development of expensive private standards.  
Failure to adopt the MRLs at th e next Codex meeting would underm ine the scientific decision-making 
process and have adverse impacts on food security, su stainability and interna tional trade in food. 
14. Canada reiterated its support for the science-b ased standard setting process in Codex, while 
acknowledging that non-science factors may be consid ered in the risk management process where 
appropriate.  In developing international food safet y standards, the Codex process was based on sound 
scientific analysis and evidence provided by leadin g international scientists in the field, national 
experts, and independent scientific expert committ ees such as JECFA, JMPR, and JEMRA.  Codex 
had been unable to reach a consen sus in this case because there is an  attempt to introduce into the 
Codex decision-making process regional consumer prefer ences which is not a legitimate factor in the 
global context and does not satisfy the Codex criteria fo r the consideration of other legitimate factors.  
Canada observed that the recommended MRLs were based on the scientific evaluation by JECFA and 
that all Codex procedures were followed, so there was no reason to further delay their adoption.  The 
failure to adopt the standards could seriously  impact the FAO/WHO scientific process on which 
Codex relies, undermine the integrity of the sta ndard-setting process and lead to questioning the 
relevance of the Codex as a reference body under the SPS Agreement.  
15. 
Brazil recalled that it had expressed similar concer ns in the past.  Given the exhaustive work 
by JEFCA, the non-adoption of MRLs could result in systemic problems that jeopardized Codex' role in food safety and posed a risk to the credibility of JEFCA and Codex.  It was important that scientific 
data underpin decision-making to avoid trade barri ers with no scientific basis, and to assist the G/SPS/W/260/Rev.1 
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  provision of safe food at reasonable cost, especially for developing countries.  Brazil requested that 
these concerns be brought to the a ttention of Codex, FAO and WHO. 
16. Argentina, Australia, Chile, New Zealand, Peru  and the Philippines all shared the concerns 
that had been raised regarding th e need to ensure that  the basic principles and processes of Codex be 
respected.  Chile noted that a great deal of work ha d been done to develop a strategic plan for Codex, 
in order to make the standard-setting process less cumbersome.  However, the insistence on national 
preferences, in this case and in another that had dragged on for ten years, had exhausted the strength 
of the international standard-setting system.  Th e Philippines stated that the establishment of a 
standard for ractopamine would allow countries,  especially those with limited resources, to 
differentiate ractopamine from other substances that  are unsafe or used illegally, therefore ensuring 
safe food supplies for consumers.  Australia and Ne w Zealand shared concerns that the failure to 
adopt the proposed standard could have broad imp lications for the integrity of the Codex standard-
setting process. 
17. The European Union stated that it was strongl y committed to the role of science in the 
development of all international standards, as well as in its own legislation.  However, it was 
imperative to understand the role of science as part of  the risk analysis appro ach.  The risk assessment 
by JECFA was valuable input for the Codex discu ssion, but the full range of factors had to be 
considered by Codex acting as risk managers, as was clearly stipulated in the Codex Procedural 
Manual.  The European Union observed that their concerns on the use of ractopamine were supported 
by a significant number of other members, including China, which together with the European Union, constitute the largest producers and consumers of  pig meat and which would thus be the most 
seriously impacted by the adoption of MRLs for ractopamine.  Insofar as the relevance of Codex 
being put into question by delays in the adoption of  such a standard, it was rather the adoption of a 
Codex standard when there was no consensus that  would undermine the validity of Codex.  The 
European Union was disappointed that some Memb ers put more emphasis on the Codex mandate of 
facilitating trade rather than on the mandate of prot ecting the health of consumers.  The European 
Union would make every effort to ensure that c onsumers remain at the centre of the Codex decision-
making process.  
18. China supported the statement of the European Un ion and highlighted that it was the largest 
consumer and producer of pigs in the world.  It s ban was based on inadequate scientific evidence 
regarding ractopamine, and on the need to consider  ractopamine residuals in lung tissue.  China did 
not support the rush to adopt internationa l standards where there was no consensus. 
19. Switzerland and Norway shared the concerns of  China and the European Union.  Switzerland 
indicated that the work of the SPS Committee was ba sed on existing standards, and as currently there 
was no standard for ractopamine, this issue shoul d more appropriately be considered under Other 
Business.  It was fundamental that Codex standa rds be based on scientific principles, and clear 
scientific conclusions, to ensure health.  Overlooking  divergent scientific conclusions and the lack of 
a consensus on this matter would create systemic con cerns and jeopardize the role of Codex.  Norway 
supported the use of science in the development of international standards, but observed that other 
elements also had to be taken into account in risk management decisions. 
20. Costa Rica and the United States asked Members who had indicated that other factors should 
be considered in the adoption of Codex standards to elaborate on what these other factors were.  The 
European Union replied that the SPS Committee was not the appropriate forum for the discussion of 
these factors but that all interested parties to th e discussion on ractopamine were familiar with what 
these other factors were as extensive consultations had taken place on this matter.  It was important 
that these factors be taken into account when th e discussion took place in the appropriate forum, 
namely the Codex.   G/SPS/W/260/Rev.1 
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  D. RESPONSES RECEIVED FROM THE RELEVANT STANDARD -SETTING ORGANIZATIONS  
21. No further information has been provided by the relevant standard-setting organizations 
regarding other issues previously raised.  
 
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