   
  
G/SPS/N/EU/578  
 
12 July 2022  
(22-5326) Page: 1/3 
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 Annex II to 
Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards 
maximum residue levels for abamectin in or on certain products (Text with EEA relevance) . 
Language(s):  English . Number of pages:  262 
https://members.wto.org/crnattachments/2022/SPS/EEC/22_4610_00_e.pdf  
https://members.wto.org/crnattachments/2022/SPS/EEC/22_4610_01_e.pdf  
https://members.wto.org/crnattachments/2022/SPS/EEC/22_4610_02_e.pdf  
https://members.wto.org/crnattachments/2022/SPS/EEC/22_4610_03_e.pdf  
6. Description of content:  The proposed draft Regulation concerns the review of existing 
MRLs for abamectin. MRLs for these substances in certain commodities are changed: either 
increased or lowered. Lower MRLs are set after updating the limits of determination and/or 
deleting old uses which are not authorised any more in the European Union or for which a 
human health concern may not be excluded.  
7. Objective and rationale: [X]  food safety, [  ] animal health, [  ] plant protection, 
[ ] protect humans from animal/plant pes t 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 abamectin (177)  
https://www.fao.org/fao -who-codexalimentarius/codex -
texts/dbs/pestres/pesticide -detail/en/?p_id=177  
[ ] 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/578  
 
- 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 current EU policy is to align EU MRLs with CXLs if three 
conditions are fulfilled: (i) that the E uropean Union sets MRLs for the commodity under 
consideration; (ii) that the current EU MRL is lower than the CXL; and (iii) that the CXL is 
acceptable to the E uropean Union with respect to aspects such as consumer protection, 
supporting data, and extrapolations.  
Where the E uropean Union considers that a proposed CXL is not acceptable, it makes a 
reservation to the Codex Committee on Pesticide Residues (CCPR). Reservations made by 
the European Union, are listed in the relevant CCPR reports:  
http://www.fao.org/fao -who-codexalimentarius/committees/committee/related -
meetings/en/?committee=CCPR  
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 Directiv e 91/414/EEC  
− http://eur -lex.europa.eu/legal -content/EN/ALL/?uri=CELEX%3A32005R0396  
− European Food Safety Authority; Reasoned opinion on focused assessment of certain 
existing maximum residues levels of concern for abamectin. EFSA Journal 
2021;19(10):6842  
− https://efsa.onlinelibrary.wiley.com/doi/pdf/10.2903/j.efsa.2021.6842  
− European Food Safety Authority; Reasoned opinion on setting of import tolerances for 
abamectin in various crops. EFSA Journal 2020;18(7):6173  
− https://efsa.onlinelibrary. wiley.com/doi/epdf/10.2903/j.efsa.2020.6173  
− European Food Safety Authority; Reasoned opinion on evaluation of confirmatory data 
following the Article 12MRL review and modification of the existing maximum residue 
levels for abamectin in various commodities. EFSA Journal 2020;18(1):5989  
− https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2020.5989  
(available in English)  
10. Proposed date of adoption (dd/mm/yy) : January 2023  
Proposed date of publication (dd/ mm/yy) : February 2023  
11. Proposed date of entry into force: [  ] Six months from date of publication , and/or  
(dd/mm/yy) : Twenty days after 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) : 10 September 2022  
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 D2 -Multilateral International Relations  
Rue Froissart 101  
B-1049 Brussels  
Tel: +(32 2) 29 54263  
Fax: +(32 2) 29 98090  
E-mail: sps@ec.europa.eu  G/SPS/N/EU/578  
 
- 3 - 
 
  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 Foo d Safety, Unit D2 -Multilateral International Relations  
Rue Froissart 101  
B-1049 Brussels  
Tel: +(32 2) 29 54263  
Fax: +(32 2) 29 98090  
E-mail: sps@ec.europa.eu  
 