G/TBT/N/EU/437  
 
6 January 2017  
(17-0059) 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 ad dress (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) : Picoxystrobin  (pesticide 
active substance)  
5. Title, number of p ages  and language(s)  of the notified document : Draft Commission 
Implementing Regulation concerning the non -renewal of approval of the active substance 
picoxystrobin, in accordance with Regulation (EC) No 1107/2009 of the European 
Parliament and of the Coun cil concerning the placing of plant protection products on the 
market, and amending the Annex to Implementing Regulation (EU) No 540/ 2011 (5 pages, 
in English)  
6. Description of content : This draft Commission Implementing Regulation provides that 
the approval of the active substance picoxystrobin is not renewed  in acc ordance with 
Regulation (EC)  No 1107/2009 . Existing authorised plant protection products containing 
picoxystrobin will be withdrawn from the market.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 does not affect 
the Maximum Residue Levels (MRLs) for residues of the concerned pesticide.  However, 
following non -approval, separate action will be taken to lower MRLs to the limit of 
quantification (LOQ).  A separate notification will be made in accordance with  SPS procedures 
in relation to action taken on MRLs.  
7. Objective and 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 acc ordance with Regulation 
(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 G/TBT/N/EU/437  
 
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  the environment. Criteria are listed in Article 4 of the Regulation (and also detailed in 
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 finalised we re identified. These are detailed in the conclusion of the 
Europe an Food Safety Authority (EFSA).   
The following concerns were identified: health -based reference values for use in risk 
assessment could not be established as it was not possible to conclude on the genotoxic 
potential of picoxystrobin based on the available data.  Consequently, the consumer and non -
dietary risk asessements could not be conducted. Furthermore, a clastogenic and aneugenic 
potential of metabolite IN -H8612 formed as a residue cann ot be excluded . In addition, a  
high risk to aquatic organisms and earthworms from exposure to picoxystrobin and a high 
risk to earthworm -eating mammals from exposure to metabolize IN -QDY63 was identified.  
Moreover, a number of areas of the assessment coul d not be finalised. T he compliance of the 
toxicity studies compared to the technical specification and the relevance of impurities 
could not be finalised given that the genotoxic potential of picoxystrobin remains 
inconclusive. An in vitro  comparative meta bolism study was not submitted and therefore 
the possible formation of unique human metabolites is unknown and the need for further 
tests and risk assessment cannot be concluded. The absence of endocrine -mediated effects 
caused by picoxystrobin could also not be concluded.  
The dietary risk assessment from exposure to metabolites could not be finalised as further 
data are needed to define the toxicological profile of several metabolites; consequently, a 
residue definition for risk assessment purposes could not be derived.  
Furthermore, the genotoxic potential of several metabolites predicted to occur in 
groundwater could not be concluded based on the data available. Finally, the assessment 
of the risk from secondary poisoning via the aquatic food chain for b irds and mammals 
could not be finalised.  
These concerns mean that picoxystrobin  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 withdraw n; Member Stat es must withdraw existing 
plant protection products containing picoxystrobin  at the latest by 3 months from the date 
of entry into force.  A period of grace in line with Article 46 of Regulation 1107/2009 is 
allowed for and shall expire at the latest 15 mon ths 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=14377309889 88&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=1442928512004&uri=CELEX:32011R0540  
Conclusion on the peer review of the pesticide risk assessment of the activ e substance 
picoxystrobin. EFSA Journal 2016;14(6):4515, 26 pp. doi:10.2903/j.efsa.2016.4515  
http://www.efsa.europa.eu/en/efsajournal/pub/4515   
9. Proposed date of adoption : 2nd quarter  2017. 
Proposed date of entry into force : 20 days f ollowing publication in the Official Journal of 
the EU   
10. Final date for comments : 60 days from notification  G/TBT/N/EU/437  
 
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  11. Texts available from : National enquiry point  [ ] or address, telephone and fax 
number s and e mail and website address es, if available , 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_0028_00_e.pdf