G/SPS/GEN/1895  
 
1 April  2021 
(21-2744) Page: 1/2 
Committee on Sanitary and Phytosanitary Measures  Original: English  
 
 
THE EUROPEAN UNION' S (EU) VETERINARY LEGISLATION THAT WOULD  
RESTRICT THE USE OF ANTIMICROBIALS BY PRODUCERS IN  
THIRD COUNTRIES – SPECIFIC TRADE CONCERN 446  
SUBMISSION BY THE UNITED STATES  
The following submission , received on 30 March 2021, is being circulated at the request of the 
Delegation of the United S tates. 
 
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1.1.  The United States would like to call attention to our previous statements made at the July  2018, 
November 2018, March 2019, and June 2020 Committee meetings that lay out our concerns 
regarding the implementation by the EU of Artic le 118 of EU 2019/6.   
1.2.  We will not reiterate the details of our previous interventions, as they are documented in the 
Committee 's summary reports.   
1.3.  We appreciate our bilateral engagement with the EU, as well as the EU 's willingness to meet 
with concerned third countries, most recently in December 2020.  
1.4.  However, we are concerned that the European Commission has not yet published the delegated 
act of the criteria to designate antimicrobials to be reserved for human treatment for comment and 
review, which we understand will be adopted no later than 27 September 2021. The EU has also not 
yet published the implementing acts on the list and rules for imports that, again, we understand 
must be adopted no later than 27 January 2022. Recognizing these still remainin g steps in the EC 
legislative process, we urge the EC to issue relevant documents in a timely manner allowing sufficient 
time for careful review and comments by stakeholders.  
1.5.  Further, the EU has yet to provide details regarding the scientific justification  and risk 
assessments that will inform its list of antimicrobials reserved for human use. The EU has also not 
clarified how risk assessment will be used to inform its import policies, including whether data from 
third countries will be considered in assess ments, nor has the EU explained how producers will be 
able to meet the requirements when the legislation is expected to go into force in less than one year.  
1.6.  Third countries cannot begin to make changes to their production practices until they know 
which an timicrobials may be reserved for human use or what type of control systems the European 
Commission may require for imports.  
1.7.  In addition to concerns around the extraterritorial implications of the EU 's proposed measures, 
we are concerned that the EU will no t allow a sufficient transition period between the finalization of 
its list of antimicrobials reserved for human use and the application of SPS measures to imported 
products. From our perspective, an appropriate transition period for justified SPS measures  would 
be based on the lifespan of livestock under production and would also consider the shelf and storage 
life of products already in the supply chain. Cattle producers, for example, may need at least five 
years to adopt changes in the use of antimicrobi al treatments.   
1.8.  Through its actions, we fear that the EU may end up limiting access by veterinarians to the 
medicines they need to address common livestock diseases associated with modern husbandry, G/SPS/GEN/1895  
 
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  while at the same time undermining the competence of national veterinary authorities, and we 
remind the EU that equivalence is a key provision of the SPS Agreement.  
1.9.  While we support innovation and the search for alternative approaches, data and information 
on safe and effective alternative approaches simply do not currently ex ist in some cases. 
Unnecessarily limiting access to safe veterinary medical products and practices will likely result in 
unintended negative animal health consequences and damage the livelihoods of livestock producers 
in the EU and beyond its borders. This , in turn, will affect Members' ability to achieve goals related 
to food security and sustainable development.  
1.10.   Therefore, we ask the EU to limit phasing out the use of antimicrobials for growth promotion 
to those products that are medically important, rat her than all antimicrobials. This would allow 
countries to focus efforts and resources on areas of public health concern while supporting safe and 
effective animal husbandry practices.     
1.11.   The United States has avoided trade restrictions while successfully  implementing national 
programs to address the development and spread of antimicrobial resistance. Beyond simply 
considering possible human health outcomes, we urge the EU to consider the needs of agricultural 
producers and both recognize and respect the l evel of protection provided by national regulatory 
systems as it works to implement its own system.  
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