G/SPS/N/EU/171  
 
31 October 2016  
(16-5966) 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 Consumers 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 count ries:   
5. Title of the notified document: Annexes to "Draft Commission Regulation amending 
Annexes II and III and V to Regulation (EC) No 396/2005 of the European Parliament 
and of the Council as regards maximum residue levels for fluopyram, 
hexachloroci clohexane (HCH), alpha -isomer, hexachlorociclohexane (HCH), beta -isomer, 
hexachlorociclohexane (HCH), sum of isomers, except the gamma isomer, lindane 
(hexachlorociclohexane (HCH), gamma -isomer), nicotine and profenofos in or on certain 
products (Text with  EEA relevance)" . Language(s): English . Number of pages: 19 
http://members.wto.org/crnattachments/2016/SPS/EEC/16_4547_00_e.pdf  
http://members.wto.org/crnattachments/2016/SPS/EEC/16_4547_01_e.pdf  
6. Description of content: These notified annexes to the draft Regulation set proposed 
maximum residue levels for fluopyram, hexachlorociclohexan e (HCH), alpha -isomer, 
hexachlorociclohexane (HCH), beta -isomer, hexachlorociclohexane (HCH), sum of 
isomers, except the gamma isomer, lindane (hexachlorociclohexane (HCH), gamma -
isomer), nicotine and profenofos in or on certain products in Annex II and V to 
Regulation (EC) No 396/2005. MRLs for these substances in certain commodities are 
changed: either increased, lowered, or deleted.  Higher MRLs are set to accommodate 
new uses in the European Union and in third countries which export those commodities 
to the European Union. Lower MRLs are set after updating the limit of determination 
and/or deleting old uses which are not authorized any more in the European Union or for 
which there is not enough data for an MRL to be set. Deleted MRLs for 
hexachlorocicloh exane (HCH), sum of isomers, except the gamma isomer are replaced 
by specific MRLs for hexachlorociclohexane (HCH), alpha -isomer and 
hexachlorociclohexane (HCH) beta -isomer.  
7. Objective and rationale: [X]  food safety, [ ]  animal health, [ ]  plant protect ion, 
[ ] protect humans from animal/plant pest or disease, [ ]  protect territory from 
other damage from pests.   G/SPS/N/EU/171  
 
- 2 - 
 
  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 pesticides 
fluopyram, lindane and profenofos. The list of Codex MRLs is available at: 
http://ww w.fao.org/fao -who-codexalimentarius/standards/pestres/pesticides/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 reasoned 
opinio ns on the review of the existing maximum residue levels for fluopyram. Based on 
this opinion the Regulation (EC) No 396/2005 should therefore be amended following a 
risk analysis approach.  
9. Other relevant documents and language(s) in which these are ava ilable:  
 "Regulation (EC) No 396/2005 of the European Parl iament 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/LexUriServ/LexUriServ.do?uri  
=CONSLEG:2005R0396:20120101:EN:PDF  
 Reasoned opinion published by the European Food Safety Authority on the setting o f 
MRLs for fluopyram  
http://www.efsa.europa.eu/en/efsajournal/pub/4520  
(available in English)  
10. Proposed date of adoption (dd/mm/yy) : April 2017  
Proposed date of publication (dd/mm/yy) : April 2017  
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) : 30 December 2016  
Agency or authority designated to handle comments: [X]  National Notification 
Authority, [X]  National Enquiry Point. Address, fax number and e -mail address 
(if av ailable) of other body:  
European Commission  
DG Health and Consumers, 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 Consumers, 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