G/SPS/N/EU/313  
 
20 March 2019  
(19-1741) 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): HS Code(s): 1001, 1002, 1003, 1004, 1005, 1006, 1007, 1008, 
0201, 0202, 0203, 0204, 0205, 0206, 0207, 0208, 0209, 0210  
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 (EU) amending Annexes 
II, III and V to Regulation (EC) No 396/2005 of the European Parliament and of the 
Council as regards maximum residue levels for amitrole, fipronil, flufenoxuron, 
flupyrsulfuron -methyl, imazosulfuron, isopr oturon, orthosulfamuron and triasulfuron in or 
on certain products (Text with EEA relevance) . Language(s): English.  Number of 
pages: 10 
https://members.wto.org /crnattachments/2019/SPS/EEC/19_1614_00_e.pdf  
https://members.wto.org/crnattachments/2019/SPS/EEC/19_1614_01_e.pdf  
6. Description of content: The proposed draft Regulation concerns the review of the 
existing maximum residue levels (MRLs) for the substances amitrole, fipronil, 
flufenoxuron, flupyrsulfuron -methyl, imazosulfuron, isoproturon, orthosulfamuron and 
triasulfuron. MRLs for these substances in certai n 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 pest or disease, [  ] protect territory from 
other damage from pests.  
8. Is there a relevant international standard? If so, identif y the standard:  
[X] Codex Alimentarius Commission (e.g.  title or serial number of Codex 
standard or related text) :  
Codex Maximum Residue Limits 79 – Amitrole - http://www.fao.org/fao -who-
codexalimentarius/codex -texts/dbs/pestres/pesticide -detail/en/?p_id=79  
Codex Maximum Residue Limits 202 – Fipronil  - http://www.fao.org/fao -who-
codexalimentarius/codex -texts/dbs/pestres/pesticide -detail/en/?p_id=202  
Codex Maximum Residue Limits 275 – Flufeno xuron  - http://www.fao.org/fao -
who-codexalimentarius/codex -texts/dbs/pestres/pesticide -detail/en/?p_id=275  G/SPS/N/EU/313  
 
- 2 - 
 
  [ ] 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  
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 conclusions on 
the peer review of the pesticide risk assessment for the active substances amitrole, 
fipronil and flefe noxuron. Based on these opinions, 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; Conclusion on the peer review of the pesticide risk 
assessment for the active substance amitrole. EFSA Journal 2014;12(7):3742  
− European Food Safety Authority; R easoned opinion on the modification of maximum 
residue levels (MRLs) for fipronil following the withdrawal of the authorised uses on 
kale and head cabbage. EFSA Journal 2014;12(1):3543  
− European Food Safety Authority; Conclusion on the peer review of the pesticide risk 
assessment for the active substance flefenoxuron. EFSA Journal 2011;9(3):2088  
(available in English)  
10. Proposed date of adoption (dd/mm/yy) : October 2019  
Proposed date o f publication (dd/mm/yy) : November 2019  
11. Proposed date of entry into force: [  ] Six months from date of publication , 
and/or  (dd/mm/yy) : 20 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) : 19 May 2019  
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  
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 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