G/SPS/N/EU/247  
 
28 March 2018  
(18-1913) 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 practica ble: 
[X] All trading partners  
[ ] Specific regions or countries:  
5. Title of the notified document: Draft Commission Regulation amending Annexes III and 
V to Regulation (EC) No 396/2005 of the European Parliament and of the Council as 
regards maximum residue levels for diphenylamine and oxadixyl in or on certain products 
(Text with EEA relevance) . Langua ge(s): English.  Number of pages: 4+4 
6. Description of content: The proposed draft Regulation concerns the review of existing 
MRLs for diphenylamine and oxadixyl in certain food commodities to reflect recent 
monitoring data submitted by the European Food Safety Authority and food business 
operators, which show that residues of those substances no longer occur at levels above 
the relevant limits of determination in the European Union.  
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:  
[X] Codex Alimentarius Commission (e.g.  title or serial number of Codex 
standard or related text) : Codex Maximum Residue Limits for diphenylamine. 
The list of Codex MRLs is available at: http://www.fao.org/ fao-who-
codexalimentarius/codex -texts/dbs/pestres/pesticide -detail/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  
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 G/SPS/N/EU/247  
 
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  opinion on the review of the existing maximum residue levels for diphenylamine 
recommending lowering the MRLs for apples and pears. Based on the opinion, Regulation 
(EC) No 396/2005 should be amended accordingly.  
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  
 Reasoned opinion published by the European Foo d Safety Authority on the setting of 
MRLs for diphenylamine  
https://www.efsa.europa.eu/en/efsajournal/pub/2336  
 Reasoned opinion published by the European Food Safety Authority o n the setting of 
MRLs for oxadixyl  
https://www.efsa.europa.eu/en/efsajournal/pub/2565  
(available in English)  
10. Proposed date of adoption (dd/mm/yy) : October 2018  
Proposed date of publication (dd/mm/yy) : October 2018  
11. Proposed date of entry into force: [X]  Six months from date of publication , 
and/or  (dd/mm/yy) : Twenty days after publication in the Official Journal.  
[ ] Trade facilitating measure  
12. Final date  for comments: [X]  Sixty days from the date of circulation of the 
notification and/or (dd/mm/yy) : 27 May 2018  
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