G/TBT/N/EU/495  
 
25 July 2017  
(17-4091) Page: 1/3 
Committee on Technical Barriers to Trade  Original:  English  
 
  NOTIFICATION  
The following notification is being circulated in accordance with Article 10.6  
 
1. Notifying Member : EUROPEAN UNION   
If applicable, name of local government involved  (Article 3.2 and 7.2) :  
2. Agency responsible:  European Commission  
Name and address (including telephone and fax numbers , email and website 
addresses, if available) of agency or authority designated to handle comments 
regarding the notification  shall be indicated if different from above :  
European Commission  
EU-TBT Enquiry Point  
Fax: +(32) 2 299 80 43  
E-mail: grow-eu-tbt@ec.europa.eu  
Website: http://ec.europa.eu/growth/tools -databases/tbt/  
3. Notified under  Article 2.9.2 [ X], 2.10.1 [  ], 5.6.2 [  ], 5.7.1 [  ], other:  
4. Products covered (HS or CCCN where applicable, otherwise national tariff heading. 
ICS numbers may be provided in addition, where applicable):  Iprodione (pesticide 
active substance)  
5. Title, n umber of pages  and language(s)  of the notified document:  Draft Commission 
Implementing Regulation concerning the non -renewal of approval of the active substance 
iprodione, in accordance with Regulation (EC) No 1107/2009 of the European Parliament 
and of th e Council concerning the placing of plant protection products on the market, and 
amending the Annex to Implementing Regulation (EU) No 540/2011 (5 page(s), in English)    
6. Description of content:  This draft Commission Implementing Regulation provides tha t 
the approval of the active substance iprodione is not renewed in accordance with 
Regulation (EC)  No 1107/2009. Existing authorised plant protection products containing 
iprodione will be withdrawn from the market. The non -approval is based on the first 
evaluation of the substance for use as a pesticide active substance in the EU under 
Regulation (EC) No 1107/2009. The substance was formerly approved under 
Directive  91/414/ EEC.  
This decision only concerns the placing on the market of this substance and doe s not affect 
the Maximum Residue Levels (MRLs) for residues of the concerned pesticide. However, 
following non -approval, separate action may be taken on MRLs and if so a separate 
notification will be made in accordance with SPS procedures.  
7. Objective an d rationale , including the nature of urgent problems where applicable: 
Protection of human health or safety; Protection of animal or plant life or health; 
Protection of the environment;  
In order for an active substance to be approved in accordance with Re gulation 
(EC) No 1107/2009 (concerning the placing of plant protection products on the market), it 
must be demonstrated that the substance is not harmful to human health, animal health or 
the environment. Criteria are listed in Article 4 of the Regulation (and also detailed in G/TBT/N/EU/495  
 
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  Annex  II) which must be met to enable approval.  
During the evaluation and peer -review of the substance, a number of concerns and areas 
that could not be finalized were identified. These are detailed in the conclusion of the 
European Food Safety Authority (EFSA).  
The Authority concluded that there is a high potential for the representative uses assessed 
to result in groundwater exposure above the parametric drinking water limit of 0,1 μg/l by 
the relevant metabolites of iprodione in s ituations represented by all pertinent 
groundwater scenarios; one relevant metabolite is even predicted to exceed 0.75 μg/L in 
all pertinent groundwater scenarios. In addition, the Authority also concluded that there is 
a high long -term risk to aquatic org anisms.  
Furthermore, the Authority concluded for one metabolite, found as a residue in plants and 
as an impurity in the technical material, that the genotoxic potential cannot be excluded 
and therefore the setting of reference values for that metabolite ca nnot be confirmed 
based on the information available. Moreover, based on the available information, the 
dietary risk assessment could not be ﬁnalized  as it is not possible to establish residue 
definitions for risk assessment, nevertheless, an acute consumer risk could not be excluded. 
Finally, the long -term risk assessment for wild mammals for all the releva nt routes of 
exposure could not be ﬁnalised.  
Additionally, iprodione is classified as carcinogenic category 2 in accordance with 
Regulation (EC) No 1272/2008 of the European Parliament and of the Council   and in the 
conclusion of the Authority it is indica ted that during the peer review it was proposed that 
iprodione should be classified as carcinogen category 1B and as toxic for reproduction 
category 2.  
These concerns mean that iprodione does not meet the approval criteria as outlined in 
Regulation (EC) No  1107/2009 and cannot be approved currently.  
Existing authorisations will need to be withdrawn; Member States must withdraw existing 
plant protection products containing iprodione at the latest by 3 months from the date of 
entry into force. A period of gra ce in line with Article 46 of Regulation 1107/2009 is allowed 
for and shall expire at the latest 15 months from the entry into force (allowing for a final 
season of use).  
8. Relevant documents:   
 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  
 Commission Implementing Regulation (EU) No  540/2011 of 25  May 2011 
implementing Regulation (EC) No  1107/2009 of the European Parliament and  of 
the Council as regards the list of approved active substances ( OJ L 153, 11.6.2011, 
p. 1–186) 
http://eur -lex.europa.eu/legal -
content/EN/TXT/?qid=144292 8512004&uri=CELEX:32011R0540  
 Conclusion on the peer review of the pesticide risk assessment of the active 
substance iprodione. EFSA Journal 2016;14(11):4609, 31 pp. 
doi:10.2903/j.efsa.2016.4609. 
http://onlinelibrary.wiley.com/doi/10.2903/j.efsa.2016.4609/epdf  
 Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 
December 2008 on classification, labelling and packaging of substances and 
mixtures, amen ding and repealing Directives 67/548/EEC and 1999/45/EC, and 
amending Regulation (EC) No 1907/2006 ( OJ L 353, 31.12.2008, p.  1). http://eur -
lex.europa.eu/legal -content/en/TXT/?uri=CELEX:32015R1221&qid=1484416483641  G/TBT/N/EU/495  
 
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  9. Proposed date of adoption: 4th quarter 2017  
Proposed date of entry into force: 20 days following publication in the Official Journal of 
the EU  
10. Final date for comments:  60 days from notification  
11. Texts available from : National enquiry point  [ ] or address, telephone and fax 
number s and e mail and website address es, if availab le, of other body:   
European Commission  
EU-TBT Enquiry Point  
Fax: + (32) 2 299 80 43  
E-mail: grow-eu-tbt@ec.europa.eu  
The text is available on the Website: http://ec.europa.eu/growth/tools -databases/tbt/  
https://members.wto.org/crnattachments/2017/TBT/EEC/17_3387_00_e.pdf