G/SPS/N/EU/258  
 
16 May 2018  
(18-2922) 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 practic able: 
[X] All trading partners  
[ ] Specific regions or countries:  
5. Title of the notified document: Draft Commission Regulation 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 bromadiolone, etofenprox, paclobutrazol and 
penconazole in or on certain products (Text with EEA relevance) . Language(s): English.  
Number of pages: 16 
https://members.wto.org/crnattachments/2018/SPS/EEC/18_2474_00_e.pdf  
https://members.wto.org/crnattachments/2018/SPS/EEC/18_2474_01_e.pdf  
https://members.wto.org/crnattachments/2018/SPS/EEC/18_2474_02_e.pdf  
6. Description of content: The proposed draft Regulation concerns the review of existing 
MRLs for bromadiolone, etofenprox, paclobutrazol and penconazole 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 etofenprox and 
penconazole. The list of Codex MRLs is available at: http://www.fao.org/fao -who-
codexalimentarius/code x-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  G/SPS/N/EU/258  
 
- 2 - 
 
  Does this proposed regula tion 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 reasoned 
opinions on the review of the existing  maximum residue levels for etofenprox and 
penconazole. Based on these opinions, 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 Food Safety Authority on the setting of MRLs 
for bromadiolone  
https://www.efsa.europa.eu/en/efsajournal/pub/4835  
Reasoned opinion published by the European Food Safety Authority on the setting of MRLs 
for etofenprox  
https://www.efsa.europa.eu/en/efsajournal/pub/4964  
Reasoned opinion published by the European Food Safety Authority on the setting of MRLs 
for paclobutrazol  
https://www.efsa.europa.eu/en/efsajournal/pub/4974  
Reasoned opinion published by the European Food Safety Authority on the setting of MRLs 
for penconazole  
https://www.efsa.europa.eu/en/efsajournal/pub/4853  (available in English)  
10. Proposed date of adoption (dd/mm/yy) : February 2019  
Proposed date of publication (dd/mm/yy) : February 2019  
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) : 15 July 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) 295 4263  
Fax: +(32 2) 299 8090  
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) 295 4263  
Fax: +(32 2) 299 8090  
E-mail: sps@ec.europa.eu