G/SPS/GEN/1979  
 
11 November  2021 
(21-8554) Page: 1/2 
Committee on Sanitary and Phytosanitary Measures  Original: English  
 
THE EUROPEAN UNION' S VETERINARY LEGISLATION THAT WOULD  
RESTRICT THE USE OF ANTIMICROBIALS BY PRODUCERS  
IN THIRD COUNTRIES – SPECIFIC TRADE CONCERN 446  
SUBMISSION BY THE UNITED STATES  OF AMERICA  
The following submission, received on 8 November  2021, is the statement made by the United States 
of America at the 3-5 November  2021 WTO SPS Committee, and is being  circulated at the request 
of the Delegation of the United States  of America . 
 
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1.  The United States would like to once again call attention  to previous statements made at the 
SPS Committee, most recently during our July 2021 meetings and documented in the summary 
reports that lay out our concerns regarding the implementation of Article 118 of EU Regulation 
2019/6.  
2.  First, we would like to ackn owledge the outcome of the 15 September 2021 session of the 
European Parliament, which allowed for the science -based criteria to move forward and be used to 
determine the EU list of antimicrobials reserved for human use. This is a positive step, particular ly 
given recent opposition to the criteria.  
3.  As the European Union  starts to apply its criteria to develop its list of antimicrobials reserved for 
human use, we would like to request that the European Union  provide details on how the list will be 
maintained  to ensure a fair, transparent, and science -based risk assessment. Regardless of when 
the measures are implemented, we would like to reiterate our concerns that, as currently envisioned, 
the legislation may unjustifiably limit access to the medicines neede d to address common livestock 
diseases associated with modern husbandry, particularly in developing countries where alternative 
treatments are not available.  
4.  Animal species, pathogens causing diseases, health management practices, antimicrobial access, 
availability of alternative treatments, and antimicrobial susceptibility profiles vary by country and 
regions within particular countries.  
5.  The restricted use of antimicrobial drugs without scientific justification may result in unintended 
negative animal health consequences through disease spread and damage the livelihoods of livestock 
producers in the European Union  and beyond, ultimately af fecting countries ' abilities to achieve goals 
related to food security and sustainable development.  
6.  We understand that the EU legislation includes restrictions around specific uses of antimicrobial 
drugs that are not medically important for humans. These p rovisions may divert countries ' resources 
away from more meaningful interventions around antimicrobial resistance, or AMR, with direct 
human health impacts. Therefore, we again ask the European Union  to provide scientific justification 
for the restrictions  on the use of antimicrobial drugs for growth promotion that are not medically 
important for humans.  
7.  Finally, as we have noted in our previous interventions, we reiterate the importance of 
appropriate transition periods for justified SPS measures, which sh ould be based on the lifespan of 
livestock under production and should also consider the shelf and storage life of products already in 
the supply chain.  G/SPS/GEN/1979  
 
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  8.  Moving forward, we urge the European Union  review and revise its proposed timeline for 
implementation o f these measures in order to avoid trade disruptions, to base its regulations on 
science and risk, and to consider the impact of its SPS measures on global animal health, food 
security, and agriculture sustainability. The United States also requests that t he European Union  
both recognize and respect the level of protection provided by national regulatory systems and afford 
national competent authorities the flexibility they need to implement their own effective 
SPS systems.  
 
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