G/SPS/GEN/1864  
 
18 November  2020 
(20-8297) Page: 1/2 
Committee on Sanitary and Phytosanitary Measures  Original: English  
 
 
MONITORING  OF THE USE OF INTERNATIONAL STANDARDS –  
CODEX ALIMENTARIUS GUIDELINES FOR THE CONDUCT OF FOOD SAFETY ASSESSMENT 
OF FOODS DERIVED FROM RECOMBINANT -DNA PLANTS (CAC/GL 45 -2003)  
SUBMISSION  BY THE UNITED STATES  OF AMERICA  
The following document , received on 13 November  2020, is being circulated at the request of the 
Delegation of the United Sta tes of America . 
 
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1.1.  The United States would like to recall the lively exchange of ideas during the November 2019 
Thematic Session on Approval Procedures, where we heard how overly burdensome data 
requirements are leading to unpredictable delays in approval timelines. These de lays and burdens 
have significant adverse effects on agricultural sustainability, trade and innovation.  
1.2.  During the November discussion, one Member acknowledged that its requirements were indeed 
very strict but asserted that they were based on Codex standar ds. 
1.3.  Today, we would like to highlight the persistent gaps between the regulatory procedures 
maintained by some Members for approval of genetically engineered (GE) food products and the 
Codex Alimentarius Guideline for the Conduct of Food Safety Assessment of Foods Derived from 
Recombinant -DNA Plants (CAC/GL 45 -2003).  
1.4.  In 2003, the Codex Alimentarius stated in CAC/GL 45 -2003 that, "animal studies cannot readily 
be applied to testing the risks associated with whole foods", and that, "detecting any potential 
adverse effects and relating these conclusively to an individual characteristic of the food can 
therefore be extremely difficult".  
1.5.  Despite these limitations, certain Members continue to require these studies to search for 
unintended effects related to human health or to instill consumer confidence. This is not consistent 
with Codex Guideline CAC/GL 45 -2003, which explicitly states, "Another consideration in deciding 
the need for animal studies is whether it is appropriate to subject experimental animals to su ch a 
study if it is unlikely to give rise to meaningful information".  
1.6.  We note that some Members have statutory requirements that include whole food animal 
feeding studies as part of their safety assessment of GE products. One Member recently revised its 
guidelines for these studies and all applicants were forced to resubmit their studies for pending 
applications. Finally, another Member requires that studies performed outside its territory be 
replicated by its own scientists, claiming that its people 's dietary habits are different enough to 
warrant a new study.  
1.7.  These unnecessary requirements and costly procedures, such as 90 -day animal feeding 
studies, delay the approval of, use of, and trade in useful and demonstrably safe products. The 
Codex Guidelines h ighlight the importance of molecular analysis of the plant, compositional analysis 
of the food, and toxicity and allergenicity analyses of any new proteins in the food as sufficient to 
determine safety.  
1.8.  Competent authorities worldwide have successfully eva luated many genetically engineered 
plant varieties without requiring animal feeding studies.  G/SPS/GEN/1864  
 
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  1.9.  We are aware of three separate projects funded by European governments to look at the value 
of these studies. All three projects concluded that these expensive stu dies did not meaningfully 
improve the safety assessment in these cases.  
1.10.   We strongly encourage Members to eliminate their requirements that rat feeding studies be 
routinely performed. If the characterization of the food indicates that the available data are  sufficient 
for a thorough safety assessment, requiring feeding studies is not consistent with the international 
guidelines established by the Codex Alimentarius in 2003.  
1.11.   Further, we encourage Members to focus data requirements on the information necessary  for 
conducting the safety assessment, and to consider the assessments of other Members that have 
been conducted according to the Codex guidelines. The FAO GM Foods Platform  contains a useful 
repository of food safety assessments performed around the world. Countries may wish to consider 
the context provided by these assessments when performing their own assessments.  
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