G/SPS/N/EU/684  
6 October 2023  
(23-6732) Page: 1/2 
Committee on Sanitary and Phytosanitary Measures  Original: English  
 
  NOTIFICATION  
1. Notifying Member:  EUROPEAN UNION  
If applicable, name of local government involved:   
2. Agency responsible:  European Commission, Health and Food Safety Directorate -General  
3. Products covered (provide tariff item number(s) as specified in national 
schedules deposited with the WTO; ICS numbers should be provided in addition, 
where applicable):  Feed 
4. Regions or countries likely to be affected, to the extent relevant or practicable : 
[X] All trading partners   
[ ] Specific regions or countries:   
5. Title of the notified document:  Commission Delegated Regulation supplementing 
Regulation (EU) 2019/4 of the European Parliament and of the Council by establishing 
specific maximum levels of cross -contamination of antimic robial active substances in non -
target feed and methods of analysis for these substances in feed ( text with EEA 
relevance) . Language(s):  English . Number of pages:  6 and 5  
https://members.wto.org/crnattachments/2023/SPS/EEC/23_12867_00_e.pdf  
https://members.wto.org/crnattachments/2023/SPS/EEC/23_12867_01_e.pdf  
6. Description of content:  The purpose of this Delegate d Regulation is to supplement 
Regulation (EU) 2019/4 (Medicated Feed Regulation) by establishing, as regards the 
24 antimicrobial active substances, specific maximum levels of cross -contamination for 
these substances in non -target feed and methods of analy sis for these antimicrobial active 
substances in feed.  
The maximum levels of cross -contamination are based on scientific risk assessments 
carried out by the European Food Safety Authority. The European Union Reference 
Laboratory for feed additives recommen ded methods of analysis for the above -mentioned 
24 antimicrobial active substances in feed.  
A cross -contamination level in non -target feed of 1% of the active substance in the 
medicated feed is proposed, based on experiences gained and representing a good balance 
between:  
- the control of antimicrobial resistance and the levels causing effects on growth 
promotion or increased yield, based on the scientific opinions of the Authority;  
- feasibility for the feed industry;  
- enforceability by competent authorit ies. 
Stricter limits are needed e.g. after the production of medicated feed for fish and to avoid 
residues in certain food. Furthermore, limits should apply in non -target feed in case of 
flushing with feed materials after production of medicated feed.  G/SPS/N/EU/684  
 
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  7. Objective and rationale: [X]  food safety, [  ] animal health, [  ] plant protection, 
[ ] protect humans from animal/plant pest or disease, [  ] protect territory from 
other damage from pests.   
8. Is there a relevant international standard? If so, identify  the standard:  
[ ] Codex Alimentarius Commission (e.g.  title or serial number of Codex 
standard or related text) :  
[ ] World Organization for Animal Health (OIE) (e.g.  Terrestrial or Aquatic 
Animal Health Code, chapter number) :  
[ ] International Plant Protection Convention (e.g.  ISPM number) :  
[X] None  
Does this proposed regulation conform to the relevant international standard?  
[ ] Yes   [  ] No 
If no, describe, whenever possible, how and why it deviates from the 
international stand ard:  
9. Other relevant documents and language(s) in which these are available:  
Regulation (EU) 2019/4 of the European Parliament and of the Council of 
11 December  2018, available in all languages of the European Union at https://eur -
lex.europa.eu/legal -content/EN/TXT/?uri=CELEX%3A32019R0004&qid=1696515846729  
10. Proposed date of adoption (dd/mm/yy) : 4th quarter 2023.  
Proposed date of publication (dd/mm/yy) : 1st quarter 2024.  
11. Proposed date of entry into force: [  ] Six months from date of publication , and/or  
(dd/mm/yy) : On the twentieth day following that of its publication in the Official Journal 
of the European Union.  
[ ] Trade facilitating measure   
12. Final date for comments: [X]  Sixty days from the date of circulation of the 
notification and/or (dd/mm/yy) : 5 December 2023  
Agency or authority designated to handle comments: [X]  National Notification 
Authority, [X]  National Enquiry Point. Address, fax number and e -mail address (if 
available) of other body:   
European Commission  
DG Health and Food Safety, Unit A4 -Multilateral International Relations  
Rue Froissart 101  
B-1049 Brussels  
Tel: +(32 2) 29 54263  
E-mail: sps@ec.europa.eu  
13. Text(s) available from: [X]  National Notification Authority, [X]  National Enquiry 
Point. Address, fax number and e -mail address (if available) of o ther body:   
European Commission  
DG Health and Food Safety, Unit A4 -Multilateral International Relations  
Rue Froissart 101  
B-1049 Brussels  
Tel: +(32 2) 29 54263  
E-mail: sps@ec.europa.eu