G/SPS/GEN/2007  
 
4 April 2022 
(22-2681) 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 28 March 2022, is the statement made by the United  States 
of America at the 23-25 March 2022 WTO SPS Committee, and is being  circulated at the request of 
the Delegation of the United States  of America . 
 
_______________  
 
 
1.  The United States would like to once again call attention to previous statements made at the 
SPS Committee, most recently during the November 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.  We appreciate that the EU Commission  met with third countries to provide information about the 
developments of the legislation in 2019 and 2020, and note that in July 2021 DG SANTE offered to 
meet and provide updates to third countries. However, that meeting has not taken place. 
We encourage  the European Union  to prioritize this meeting as soon as possible in 2022 to share 
the outstanding details of the legislation, including how the proposed measures will consider the 
competence of third country 's regulatory systems.  
3.  The United States notes that the European Medicine Agency, or EMA, published the recommended 
list of antimicrobials that will be reserved for human use. We ask that the EU Commission follow the 
scientific recommendations of the EMA in the delegated acts that will formalize the im plementation 
of Article 118.  
4.  The United States will also note that the delays in implementation of the veterinary medicine 
legislation are causing significant uncertainty for producers in third countries, including the 
United  States.  
5.  Further, animal specie s, specific pathogens 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 United S tates requests 
that any EU measure allows flexibility to trading partners to meet the EU level of protection by 
imposing requirements in their own jurisdictions that are appropriate for the circumstances in the 
Member.  
6.  The restricted use of antimicrobial drugs may result in unintended negative animal health 
consequences through the spread of disease and negatively impact livelihoods of livestock producers 
in the European Union  and beyond, ultimately preventing countries from achieving food security and 
sustainable development goals.  
7.  The United States requests that the EU Commission provide a new timeline, taking into 
consideration the lifespan of different animal species, for a pragmatic implementation process that 
consid ers the shelf and storage life of products already in the supply chain. For example, US cattle 
would need at least five years to implement any potential changes to animal health requirements.  G/SPS/GEN/2007  
 
- 2 - 
 
  8.  Regardless of when the measures are implemented, our concerns re main that the legislation may 
unjustifiably limit access to the medicines needed in modern animal husbandry, particularly in 
developing countries where alternative treatments are not available.  
9.  The United States requests for clarification on the European U nion's  scientific justification for the 
restrictions on the use of antimicrobial drugs that are not medically important for humans. Such a 
provision may divert countries ' resources away from more meaningful interventions around 
antimicrobial resistance wit h direct human health impacts.  
10.  Therefore, we reiterate our request to the EU Commission to provide details on how the list of 
antimicrobials will be maintained to ensure a fair, transparent, and science - and risk -based 
approach.  
11.  The United States again urg es the European Union  to base its regulations on science and risk, 
and to consider the impact of its SPS measures on global animal health, food security, trade, and 
agricultural sustainability.  
__________