G/SPS/GEN/1942  
 
23 July 2021 
(21-5804) 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  OF AMERICA  
The following submission, received on 20 July 2021, is the statement made by the United States of 
America at the 14-16 July 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 again call attention to our previous statements made at the July 
2018, November 2018, March 2019, June 2020, and March 2021 meetings of this Committee and 
documented in the summary reports that lay out our concerns regarding the implementation of 
Article 118 of EU Regulation 2019/6.  
2.  Since the March 2021 Committee meeting, the  European Commission notified two proposals 
associated with the prohibition of certain uses of antimicrobials. However, we continue to have 
concerns that the European Commission has not yet published the implementing acts on the list and 
rules for imports that we understand must be adopted no later than 28 January 2022.  
3.  The European Commission notified G/SPS/N/EU/464  that adds to Article 118 of EU Regulation 
2019/6 and amends Regulation 2017/625 regarding official controls on animals and products of 
animal origin exported from third c ountries into the European Union. The legislation, however, does 
not explain how the European Union plans to verify compliance of imported products with Article  118. 
As such, the implications of this legislation on trade to the European Union remain unclea r. 
In particular, there has been no clarification on how risk assessments will be used to inform import 
policies, nor has the European Union appeared to consider the challenges foreign producers will face 
to comply with the legislation when it enters into force in a few months.  
4.  The European Commission also notified G/SPS/N/EU/478  of the delegated regulation to establish 
the criteria for the designation of antimicrobials to be reserved for the treatment of certain infections 
in humans and adopted the criteria on 26 May 2021. However, w e remain concerned that the 
European Union has not provided details on how the criteria will be used to inform its list of 
antimicrobials reserved for human use and how or whether the list will be updated. We note that 
this information is necessary to ensu re a fair, transparent, and science -based risk assessment.  
5.  We understand that, through the criteria it developed, the European Commission is attempting 
to enhance its One Health approach to addressing AMR. As Members of this Committee are aware, 
a One Health approach recognizes the interconnectedness of people, animals, plants, and their 
shared environment.  
6.  Animal species, pathogens causing diseases, health management practices, antimicrobial access, 
availability of alternative treatments, and antimicro bial susceptibility profiles vary by country, and 
the United States is concerned that the European Union is not adequately or appropriately 
considering the health of animals within this new policy, especially in cases where alternative 
treatments are not a vailable in an exporting country.  G/SPS/GEN/19 42 
 
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  7.  Specifically, through its actions, we fear that the European Union may unnecessarily limit access 
to the medicines needed to address common livestock diseases associated with modern husbandry. 
Risk management actions such as restricting use of antimicrobial drugs without scientific justification 
may result in unintended negative animal health consequences through disease spread and 
ultimately damage the livelihoods of livestock producers in the European Union and beyond its  
borders. This, in turn, may affect countries' abilities to achieve goals related to food security and 
sustainable development.  
8.  We are also concerned that the European Union will not 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. We would note that, to limit unnecessary disruptions in 
production and trade, an appropriate transition period for justified SPS measures should 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, poultry, and pigs, for example, have different life cycles 
and the transition periods for use of antimicrobial t reatments would likely need to reflect those 
differences.  
9.  Further, we understand that the EU legislation includes restrictions around specific uses of 
antimicrobial drugs that are not medically important for humans, and we are concerned that these 
provisio ns will divert countries' attention and resources away from more meaningful interventions 
with direct human health impacts. Therefore, we ask the European Union to maintain the use of 
antimicrobials for growth promotion that are not medically important for  humans. This would allow 
countries to focus efforts and resources on areas of public health concern while promoting safe and 
effective animal husbandry practices that support agriculture sustainability and food security.  
10.  AMR is a health issue, and should not be used as an unjustified barrier to trade. For instance, 
the United States has avoided trade restrictions while successfully implementing national programs 
to address the development and spread of AMR. We urge the European Union to avoid trade 
disrupt ion, 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.  
11.  Through this intervention, we reiterate our request that the European Commission issue 
relevant implementing regulations in a timely manner and allow sufficient time for careful review 
and comments by Members and foreign stakeholders such that the input may be considered. Further, 
as the European  Union moves forward with this process, we reques t that the 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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