G/SPS/N/EU/347  
 
17 September 2019  
(19-5970) 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 Annexes II and 
III to Regulation (EC) No 396/2005 of the European Parliament and of the Council as 
regards maximum residue levels for myclobutanil, napropamide and sintofen in or on 
certain products (Text with EEA rele vance) . Language(s):  English . Number of pages:  5 
+ Annexes  
https://members.wto.org/crnattachments/2019/SPS/EEC/19_5094_00_e.pdf  
https://members.wto.org/crnattachments/2019/SPS/EEC/19_5094_01_e.pdf  
https://members.wto.org/crnattachments/2019/SPS/EEC/19_5094_02_e.pdf  
https://member s.wto.org/crnattachments/2019/SPS/EEC/19_5094_03_e.pdf  
https://members.wto.org/crnattachments/2019/SPS/EEC/19_5094_04_e.pdf  
6. Description of content:  The pro posed draft Regulation concerns the review of existing 
MRLs for myclobutanil, napropamide and sintofen in certain food commodities. 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. The residue definition for some substances has also been updated.  
7. Objective and ratio nale: [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:  
[X] Codex Alimentarius Commission (e.g.  title or serial number of Codex 
standard or related text) : Codex Maximum Residue Limits for myclobutanil. The 
list of Codex MRLs is available at: http://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) :  G/SPS/N/EU/347  
 
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  [ ] International Plant Protect ion Convention (e.g.  ISPM number) :  
[ ] None  
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 the existing maximum residue levels for myclobutanil. Based on 
this opinion, Regulation (EC) No 396/2005 should be amended accordingly.  
9. Other relevant documents and language(s) in which the se 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  
− "Reasoned opinion on the review of the existing maximum residue levels for 
myclobutanil according to Article 12 of Regulation (EC) No 396/2005." EFSA Journal 
2018;16(8):5392.  
https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2018.5392  
− "Reasoned opinion on the review of the existing maximum residue levels for 
napropamide according to Article 12 of Regulation (EC) No 396/2005". EFSA Journal 
2018;16(8):5399.  
https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2018.5394  
− "Reasoned opinion on the review of the existing maximum residue levels for sintofen 
according to Article 12 o f Regulation (EC) No 396/2005". EFSA Journal 
2018;16(9):5409.  
https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2018.5406  
(available in English)  
10. Proposed date of adoption (dd/mm/yy) : 25 April 2020  
Proposed date of publication (dd/mm/yy) : 25 July 2020  
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) : 16 November 2019  
Agency or author ity 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/347  
 
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  13. Text(s) available from: [X]  National Notification Authority, [X]  National Enquiry 
Point. Address, fax number and e -mail addr ess (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