G/SPS/N/EU/166  
 
20 June 2016  
(16-3338)  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; IC S numbers should be provided in 
addition, where applicable): Pesticide active substances 
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 setting out scientific 
criteria for the determination of endocrine disrupting properties and amending Annex II to Regulation (EC) 1107/2009 (Text with EEA relevance)  Language(s): English
  
Number of pages: 4 pages + Annex 6 pages 
http://members.wto.org/crnattachments/2016/SPS/EEC/16_2410_00_e.pdf  
6. Description of content: This notification is for transparency purposes and does not 
prejudge the position of the European Unio n on the applicability of the SPS Agreement 
to the notified measures, or on the nature and effects of the measure itself. 
This draft Commission Regulation sets the specific scientific criteria in relation to the 
endocrine disrupting properties for the approval of the active substances for use in plant 
protection products in accordance with Regulation (EC) No 1107/2009. 
The criteria are based on the definition of endocrine disruptors published in 2002 by the 
World Health Organisation (WHO) through its International Programme for Chemical 
Safety (WHO/IPCS). 
The draft regulation was preceded by an impact assessment and a public consultation. 
In accordance with Regulation (EC) No 1107/2009 if a substance is found to be an 
endocrine disruptor according to the criteria se t in this draft regulation, it will not be 
approved for use in plant protection products unless it is demonstrated that the 
conditions set in Point 3.6.5.2 of Annex II of Regulation (EC) No 1107/2009 are met. 
7. Objective and rationale: [X] food safety, [ ] animal health, [X] plant protection, 
[ ] protect humans from animal/plant pest or disease, [ ] protect territory from 
other damage from pests.   
8. Is there a relevant international st andard? If so, identify the standard:  
[ ] Codex Alimentarius Commission (e.g. title or serial  n u m b e r  o f  C o d e x  
standard or related text)   
[ ] World Organization for Animal Health (OIE) (e.g. Terrestrial or Aquatic 
Animal Health Code, chapter number)    G/SPS/N/EU/166 
 
- 2 - 
 
  [ ] International Plant Protection Convention (e.g. ISPM number)    
[X] None Does this proposed regulation conform to the relevant international standard?   
[ ] Yes   [ ] No 
If no, describe, whenever possible, how and why it deviates from the 
international standard:   
9. Other relevant documents and language (s) in which these are available:  
 Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 
21 October 2009 concerning the placing of plant protection products on the market 
and repealing Council Directives 79/117/EEC and 91/414/EEC: http://eur-
lex.europa.eu/legal-
content/EN/TXT/PDF/?uri=CELEX:32009R1107&qid=1437730988988&from=EN  
(available in 23 EU languages) 
 Commission Communication: 
http://ec.europa.eu/health/endocrine_disruptors/docs/com_2016_350_en.pdf  
(available in 23 EU languages) 
 Public consultation Report: http://ec.europa.eu/dgs/health_food-
safety/dgs_consultations/food/consult ation_20150116_endocrine-disruptors_en.htm  
(available in English) 
 Impact assessment: 
http://ec.europa.eu/health/endocrine_disruptors/policy/index_en.htm  (available in 
English)   
10. Proposed date of adoption (dd/mm/yy) : Fourth quarter of 2016. 
Proposed date of publication (dd/mm/yy) : After adoption. 
11. Proposed date of entry into force: [ ] Six months from date of publication , 
and/or  (dd/mm/yy) : 1 January 2017 
[ ] 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 August 2016 
Agency or authority designated to hand le 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 Notifi cation 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