G/SPS/GEN/2110  
 
28 March 2023 
(23-2191) 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 27 March 2023, is the statement made by the United  States 
of America at the 22-24 March 2023  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 again raises our concerns with the European  Union regarding the 
implementation of Article 118 of EU regulation 2019/6.  
2.  The United States again stresses that animal species, specific pathogen -causing diseases, health 
management practices, antimicrobial access, availability of alternative treatments, and an timicrobial 
susceptibility profiles vary by region, country, and even regions within particular countries. 
The European  Union  should allow flexibility to trading partners to use official controls and techniques 
deemed necessary to achieve the same public h ealth objectives, in a manner that is appropriate for 
farmers and producers within the exporting countries ' own domestic context.  
3.  Further, following the recently notified delegated act, the United States again requests the 
European  Union  to share its scien tific evidence used to determine the human health risk posed by 
veterinary use of antimicrobial drugs not identified as medically important for humans, when such 
drugs are used for animals ' growth promotion or to increase yield.  
4.  We also continue to seek cl arification on the EU 's process for amending and updating its list of 
antimicrobials reserved for human use and on the scientific justification and risk assessments for 
the EU 's restrictions on the use of antimicrobial drugs that are not medically importan t for humans, 
including those used for growth promotion in animals.  
5.  The United States further requests clarification around how the European  Union  will consider 
equivalent regulatory systems that achieve the same public health objectives.  
6.  We thank the EU Commission for recently hosting a virtual meeting for third countries to better 
understand Article 118 and the draft Delegate Regulation and encourage the EU Commission to 
continue offering these meetings to further clarify how compliance with this regulat ion will be verified 
and enforced.  
7.  Finally, the United States reiterates its request that the Commission provide a new timeline for 
the pragmatic implementation of these measures that considers the lifespan of different animal 
species and the shelf and sto rage life of products already in the supply chain. Building on our 
previous experience renegotiating certificates for animals and animal products, we would request 
that entry requirements are limited to what is reasonable and necessary to achieve the 
EU's appropriate level of protection.  
8.  Instead of taking unilateral actions to address global challenges like antimicrobial resistance, 
we request the European  Union to work with its trading partners to develop mutually agreed -upon 
measures that are science -based and based on established international standards, and to be G/SPS/GEN/2110  
 
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  mindful of the impacts of its SPS measures on global animal health, food security, international 
trade, and agricultural sustainability.  
9.  The United States appreciates the EU 's dedication to comb atting antimicrobial resistance and the 
international collaboration on this issue. We look forward to continued collaboration and discussion 
on how to best reduce antimicrobial resistance around the world.  
 
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