G/SPS/N/EU/653  
7 July 2023  
(23-4631) 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):  Cereals (HS codes: 1001, 1002, 1003, 1004, 1005, 1006, 1007, 
1008), foodstuffs of animal origin (HS codes: 0201, 0202, 0203,  0204, 0205, 0206, 0207, 
0208, 0209, 0210) and certain products of plant origin, including fruit and vegetables  
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:  Draft Commission Regulation amending Annexes II and 
V to Regulation (EC) No 396/2005 of the European Parliament and of the Council as 
regards maximum residue levels for indoxacarb in or on certain products (T ext with EEA 
relevance) . Language(s):  English . Number of pages:  4 + Annexes  
https://members.wto.org/crnattachments/2023/SPS/EEC/23_10837_00_e.pdf  
https://members.wto.org/crnattachments/2023/SPS/EEC/23_10837_01_e.pdf  
https://members.wto.org/crnattachments/2023/SPS/EEC/23_10837_02_e.pdf  
https://members.wto.org/crnattachments/2023/SPS/EEC/23_10837_03_e.pdf  
6. Descri ption of content:  The proposed draft Regulation concerns the review of existing 
MRLs for indoxacarb in certain food commodities following the non -approval of indoxacarb 
in the European Union. Lower MRLs are set after deleting old uses which are not 
authori sed any more in the European Union. MRLs in certain commodities for which a 
human health concern may not be excluded are also lowered.  
7. Objective and rationale: [X]  food safety, [  ] animal health, [  ] plant protection, 
[ ] protect humans from animal/pla nt pest or disease, [  ] protect territory from 
other damage from pests.   
8. Is there a relevant international standard? If so, identify the standard:  
[X] Codex Alimentarius Commission (e.g.  title or serial number of Codex 
standard or related text) : Codex Maximum Residue Limits for indoxacarb in 
some commodities. CODEX MRLs List is available at https://www.fao.org/fao -who-
codexalimentarius/ codex -texts/dbs/pestres/pesticides/en/ . 
[ ] World Organization for Animal Health (OIE) (e.g.  Terrestrial or Aquatic 
Animal Health Code, chapter number) :  
[ ] International Plant Protection Convention (e.g.  ISPM number) :  
[ ] None  G/SPS/N/EU/653  
 
- 2 - 
 
  Does this proposed regulation conform to the relevant international standard?  
[ ] Yes   [X] No  
If no, describe, whenever possible, how and why it deviates from the 
international standard:  The European Food Safety Authority published a reasoned 
opinion on the review of MRLs for indoxacarb. Based on this opinion, Regulation (EC) 
No 396/2005 should be amended following a risk analysis approach.  
9. Other relevant documents and language(s) in which these are available:   
− Regulation (EC) No 396/2005 of the European Parliament and of the Council of 
23 February 2005 on maximum residue levels of pesticides in or on food and feed of 
plant and animal origin and amending Council Directive 91/414/EEC  
http://eur -lex.europa.eu/legal -content/EN/ALL/?uri=CELEX%3A32005R0396  
− European Food Safety Authority; Targeted review of maximum residues levels (MRLs) 
for indoxacarb. EFSA Journal 2022;20(8):7527  
https://www.efsa.europa.eu/en/efsajournal/pub/7527  
− European Food Safety Authority; Conclusion on the peer review of the pesticide risk 
assessment of the active substance indoxacarb. EFSA Journal 2018;16(1):5140  
https://www.efsa.europa.eu/en/efsajournal/pub/5140  
(available in English)  
10. Proposed date of adoption (dd/mm/yy) : January 2024  
Proposed date of publication (dd/mm/yy) : February 2024  
11. Proposed date of entry into force: [  ] Six months from date of publication , and/or  
(dd/mm/yy) : This Regulation shall enter into force on the twentieth day following its 
publication in the Official Journal of the European Union and apply six months thereafter.  
[ ] Trade fac ilitating measure   
12. Final date for comments: [X]  Sixty days from the date of circulation of the 
notification and/or (dd/mm/yy) : 5 September 2023  
Agency or authority designated to handle comments: [X]  National Notification 
Authority, [X]  National Enquir y 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 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