G/TBT/W/515  
 
23 April 2018  
(18-2486) Page: 1/2 
Committee on Technical Barriers to Trade  Original: English  
 
EUROPEAN UNION — REGULATION (EC) NO 1 107/2009 - NON-RENEWAL OF APPROVAL 
OF THE ACTIVE SUBSTA NCE PICOXYSTROBIN   
STATEMENT BY THE EUR OPEAN UNION TO THE C OMMITTEE ON TECHNICA L BARRIERS TO TRADE  
21 AND 22 MARCH 2018  
The following communication, dated 16 April 2018, is being circulated at the request of the 
delegation of the European Union . 
 
_______________  
 
 
1.  The European Union thanks Brazil for raising this issue and recalls that detailed written 
information was provided, upon request, on this issue on 1 9 July 2017.  
2.  The European Union notes that, under Regulation (EC) No 1107/2009 on the placing of plant 
protection products on the market, only substances for which risk assessment is successful and for 
which the safe use is confirmed, can be approved. The  risk assessment involves both the European 
Food Safety Authority (EFSA) and all Member States. Regulation (EC) No 1107/2009 makes it clear 
that it is the responsibility of industry to demonstrate that substances placed on the market do not 
have any harmfu l effects on human or animal health or any unacceptable effects on the 
environment. According to the Regulation, active substances can only be approved for use in plant 
protection products when certain criteria are fulfilled.  
3.  Picoxystrobin was part of the third stage of the EU renewal programme for active substances 
used in plant protection products and has been subject to a comprehensive assessment and peer 
review under EU rules.  
4.  The large number of issues identified during  the risk assessment and peer rev iew of  
picoxystrobin are presented in the EFSA Conclusion pu blished in June 2016, which includes a 
number of critical areas of concern  and other  areas that could not be finalised relat ing to human 
health and the environment . The Conclusion also includes da ta gaps .  
5.  Based on this EFSA Conclusion, the Commission proposed not to renew the approval of 
picoxystrobin taking into consideration the approval criteria outlined in the legislation. It was not 
established with respect to one or more representa tive uses of at least one plant protection 
product that the approval criteria provided fo r in Article 4 of Regulation (EC) No 1107/2009 are 
satisfied. Therefore, it was not possible to renew the approval of the active substance.  
6.  On 18 May 2017, Member States voted o n the proposal for non -renewal of approval of 
picoxystrobin at the Standing Committee on Plants, Animals, Food and Feed. The proposal was not 
supported by a qualified majority of Member States and a "no opinion" was delivered by the 
Committee.  
7.  Subsequently, on 12 July 2017, an Appeal Committee was held where a vote was taken on the 
proposal to non -renew the approval. Member States failed to deliver an opinion and subsequently 
the Commission adopted the measure, which was published on 10 August 2 017 ( Commission 
Implementing Regulation (EU) 2017/1455). Authorisations for plant protection products containing 
picoxystrobin in the EU were required to be withdrawn by 30 November 2017. Member States 
were permitted to allow for a grace period until 30 No vember 2018 at the latest.  G/TBT/W/515  
 
- 2 - 
 
  8.  However, it should be  highlighted that the non -renewal decision does not prejudice the 
submission of a further application for the approval of picoxystrobin in accordance with Article 7 of 
Regula tion (EC) No 1107/2009, provided that the necessary data can be submitted to address the 
concerns and issues identified.  
9.  The EU n otes that the applicant for renewal  did not agree with the outcome of the peer-review 
as detailed in the EFSA Conclusion. However, this outcome is the result of an extensive and 
rigorous scientific evaluat ion involving experts from EFSA and Member S tates. According to EU 
legislation, EFSA conclusions shall be taken into acc ount in the decision making for an active 
substance.  
10.  In relation to the  assessment of genoto xicity, the Commission decision not to  renew  
picoxystrobin  does not , in any way , state th at picoxystrobin is a genotoxic substance, but rather  
that, on the basis of the information available in the dossier, it was not possible to conclude on the 
genoto xic potential of picoxystrobin. However, it is also important to highlight th at the incomplete 
assessment of genotoxicity was one of several concerns identified, and that the other issues 
identified preclude themselves the renewal of approval.  
11.  The EU discussed  the EFSA Conclusion with the applicant  on several occasions and has also 
carefully considered all comments rece ived during the decision making process. However, given 
that EU  legislation lays down strict rules for approval which have not been satisfied, a  proposal for 
the non -renewal of the approv al of picoxystrobin was considered  the appropriate course of action.  
12.  The EU notified third countries of the proposed action via the TBT procedure. The measure did  
not lead to immediate disruptions in trade , as the measure itself does not amend th e maximum 
residue levels (MRLs) and  provides  for a grace period  for use of products containing picoxystrobin . 
13.  Given the issues identified by EFSA , the existing MRLs will likely be reviewed in a separate 
measure in vi ew of their safety to consumers. Any such action on MRLs will take into account the 
period of grace allowed for and will be subject to a notification under the WTO/ SPS procedure.  
Import tolerance requests would  however  remain possible and will be assessed case by case by 
EFSA.  
 
 
__________