G/SPS/GEN/2082  
 
16 November  2022 
(22-8510) Page: 1/2 
Committee on Sanitary and Phytosanitary Measures  Original: English  
 
EUROPEAN UNION  REVIEW OF LEGISLATION ON VETERINARY MEDIC INAL PRODUCTS  
– SPECIFIC TRADE CONCERN 446  
SUBMISSION BY THE UNITED STATES  OF AMERICA  
The following submission, received on 11 November 2022, is the statement made by the Uni ted 
States of America at the 9-11 November 2022 WTO SPS Committee, and is being  circulated at the 
request of the Delegation of the United States  of America . 
 
_______________  
 
 
1.  The United States again must raise our concerns with the European  Union regarding the 
implementation of Article 118 of EU regulation 2019/6. We draw the Committee's attention to our 
intervention from the June 2022 SPS Committee meeting, which can be found in G/SPS/GEN/2046 . 
2.  We would like to emphasize again that animal species, specific pathogen -causing diseases, health 
management practices, antimicrobial access, availability of alternative treatments, and antimicrobial 
susceptibility profiles vary by region, country, and even regions within particular countries. 
The European  Union  should allow flexibility to trading partners to use least restrictive tools and 
techniques to meet the EU level of protection, in a manner that is appropriate for farmers and 
producers within the exporting co untries' own domestic context.  
3.  Further, the United States again requests clarification on the process for amending and updating 
the list of antimicrobials reserved for human use and the scientific justification for the EU  restrictions 
on the use of antimic robial drugs that are not medically important for humans, including those used 
for growth promotion in animals.  
4.  As we have previously noted, such provisions may negatively impact livelihoods of livestock 
producers in the European  Union and beyond, and ulti mately prevent countries from achieving food 
security and sustainable development goals.  
5.  We would like to again remind the Commission that in July 2021, DG SANTE offered to meet with 
and provide updates to third countries. Such a meeting would be an opport unity for the 
European  Union to share the outstanding details of the legislation, including its scientific justification, 
the intrinsic relationship between the proposed measures and their risk assessments, and how the 
proposed measures will consider the r elationship between antimicrobial resistance and consumption 
of animal products, as well as the competence of third country regulatory systems. However, no  such 
meeting has taken place. We await further information on when a meeting could be scheduled.  
6.  Finally, the United States reiterates its request that the Commission provide a new timeline for 
the pragmatic implementation of these measures in order to properly consider the lifespan of 
different animal species and the shelf and storage life of product s already in the supply chain. As  the 
implementing acts for these measures are developed, we would also request that the 
European  Union be mindful of our recent experience renegotiating certificates for animals and animal 
products to ensure that our hard w ork in this area was not done in vain, and we would request that 
entry requirements are limited to what is reasonable and necessary to achieve the appropriate level 
of protection.  
7.  Instead of taking unilateral actions to address global challenges like antim icrobial resistance, 
we request the European  Union to work with its trading partners to develop measures that are G/SPS/GEN/2082  
 
- 2 - 
 
  science -based and consistent with relevant international standards, and to be mindful of the impacts 
of its SPS  measures on global animal heal th, food security, international trade, and agricultural 
sustainability.  
__________