WORLD TRADE  
ORGANIZATION   
G/SPS/GEN/1092 
20 June 2011 
 (11-3039) 
Committee on Sanitary and Phytosanitary Measures Original:   English/ 
 Spanish 
 
 
 
DEFENSE OF THE SCIENTIFIC PRINCIPLES OF CODEX - RACTOPAMINE1 
 
Communication of Costa Rica 
 
 
 The following communication, received on 16 June 2011, is being circulated at the request of 
the Delegation of Costa Rica. 
 
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 1. According to the Codex Procedural Manual,  all food standards, guidelines and other 
recommendations of Codex Alimentari us shall be based on an analysis and solid scientific data, which 
implies an exhaustive assessment of all the pertinen t information, to ensure that the standards 
guarantee the quality and safety of food supplies. 
2. Although the members of Codex have diver se social, economic, political and cultural 
situations, these differences should not block the appr oval of new standards nor lead to the rejection 
of internationally accepted scientific research. 
3. Nevertheless, there is an exam ple of a Codex Alimentarius decision where the principle of 
scientific research and the analysis of the evid ence seem not to have been respected:  the case of 
ractopamine . 
4. Currently, ractopamine has been approved by 26 countries, and it has been assessed on 
various occasions by JECFA
2, namely during the 40th meeting (1993) and the 62nd meeting (2005).  
JECFA has concluded that this product is safe to us e in pigs, and for the s ubsequent consumption of 
pork products by humans, under the "good veterinary practice" standards.  In addition, both an 
acceptable daily intake (ADI) and a maximum residue limit (MRL) have been suggested.  In 2008, the 
Codex Commission decided to hold back the propo sal of a maximum residue limit for ractopamine3 at 
step 8, and determined that members of Codex should send more data to the Codex Committee on 
Residues of Veterinary Drugs in Foods (May 2009)  for its analysis, in order to determine if 
ractopamine should be reassessed by JECFA. 
                                                      
1 The statement delivered by Brazil at the WTO SPS Committee meeting in March 2011 was used as a 
basis for this section of this document. 
2 JECFA is the Joint FAO/WHO Committee on Food Additives, formed by a group of international 
experts who, over many years, have developed data a nd reference information recognized worldwide and widely 
used by governments, industry and research centers.  Its contribution to the work of the Codex Alimentarius 
Commission (CAC) is essential for decisionmaking. 
3 Ractopamine is a product for veterinary use that promotes growth in pigs.  Several studies from 
JECFA have determined that this product may be  applied to pigs without risk to consumers. G/SPS/GEN/1092 
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  5. In light of the new data provided by member  countries, in May 2010 JECFA again concluded 
that the recommended maximum residue limit is compa tible with the acceptable daily intake, and that 
no problems for consumers' health were identified.  
6. During the 33
rd meeting of the Codex Alimentarius  Commission in 2010, there was an 
extensive debate around the approval of the MRL for ractopamine, but no conclusion was reached.  
With the objective of overcoming this "dead end", a group of "Friends of the Chair" was established 
to discuss possible solutions, with a focus on risk  management, but avoiding the reassessment of 
scientific aspects already done by JECFA. 
7. Costa Rica shares the view of other countries that  the delay in approving a standard that has 
followed each step of the Codex process and has receiv ed approval from the scientific advisory body 
of Codex, sets a precedent that: 
 jeopardizes the role of the FAO/WHO group of experts that supports Codex decisions; 
 discourages the participation of Codex members,  particularly of developing countries, in 
Codex activities, as well as the development of  studies and data provided by the patent 
holders of veterinary drugs;  and  
 represents a risk for the future role of Co dex as an international standard-setting body. 
 In short, both from the scientific point of view a nd in regard to the Codex decision-making process, 
there is no reason to delay the adoption of the MR L for ractopamine by the Codex Alimentarius.  
From a scientific perspective, JECFA has extensivel y analyzed and reviewed the relevant studies and 
properly followed the established procedures.  
Implications of refusing to recognize Codex experts, and its effects on  developing countries
4 
 8. Some members of the Codex have tried to have  issues other than science reflected in Codex 
texts, which goes against the nature of the Codex Alimentarius, and against its mandate of ensuring 
fair practices in food trade, since these factors are ambiguous and imprecise. 
9. Furthermore, more worrying is the attempt to  disregard the Codex expert committees, (such 
as, in this case, the JECFA) and the use of science, in favor of non-scientific factors.  This could have 
the effect of discouraging Codex members' partic ipation in the process of developing standards and 
related documents, and might unf ortunately harm the credibility of the Codex decision-making 
process. 
10. Another risk is that given the inability of the Codex to agree on a standard, private standards 
could come to fill the gap, at the expense of th e transparent process that the Codex Alimentarius 
follows to adopt its standards. 
11. In addition, the Codex plays a key role for developing countries, which may not have the 
infrastructure, financial resources and knowledge to generate their own technical analyses to support 
technical regulations. 
                                                      
4 Based on a paper prepared by Costa Rica and Mexi co for future circulation to Codex members.  G/SPS/GEN/1092 
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  12. It is for all the above that the fundamental pr emise of Codex to base its standards and related 
texts on science must prevail.  Doing otherwise would undermine the principles concerning the role of science in the Codex decision-making process.  It would also discourage members from participating 
in the standard setting process, would create an  international bias in decision-making that 
compromises the genuine objectives of the WTO and would put developing countries at a 
disadvantage.  For these reasons, the immediate adop tion of the MRL for ractopamine is of paramount 
importance for the worldwide protection of consumers'  health, the promotion of international trade, 
the assurance of food security and the maintena nce of the role of Codex Alimentarius as an 
international reference organization in the area of food safety.  Costa Rica considers that Codex 
members must fight together for this cause and ther efore, it is essential to attend or be represented at 
the Commission meeting of 2011. 
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