G/TBT/N/EU/596  
 
31 August 2018  
(18-5439) 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/en/   
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): 
Methoxyfenozide (pesticide active substance)  
5. Title, number of pages and language(s) of the notified document: Draft 
Commission Implementing Regulation renewing the approval of the active substance 
methoxyfenozide, as a candidate for substitution, in acc ordance with Regulation (EC) 
No 1107/2009 of the European Parliament and of the Council concerning the placing of  
plant protection products on the market, and amending the Annex to Commission 
Implementing Regulation (EU) No 540/2011 (and its accompanyin g annexes) (4 pages + 
Annexes 3  pages, in English)   
6. Description of content: This draft Commission Implementing R egulation provides that 
the approval of the active substance methoxyfenozide is renewed in accordance with 
Regulation (EC)  No 1107/2009 under restricted conditions and for a period of 7 years. 
Existing authorised plant protection products containing methox yfenozide will have to be 
re-authorised in accordance with the proposed restrictions. The renewal of 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 substa nce was formerly approved under 
Directive  91/414/ EEC.  
This regulation 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 may be taken on MRLs and if so a 
separate notification will be made in accordance with SPS procedures.  G/TBT/N/EU/596  
 
- 2 - 
 
  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 accordance with Regulation 
(EC) No 1107/2009 (concerning the placing of plant protection products on the market), it 
must be demonstrated t hat 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 
Annex  II) which must be met to enable approval.  
During the evaluation and peer -review of the subst ance, a number of issues that could not 
be finalised and an area of concern were identified. These are detailed in the conclusion of 
the European Food Safety Authority (EFSA).  
In particular, the Authority identified as an area of concern the potential gro undwater 
contamination above the parametric drinking water limit of 0.1 µg/L by methoxyfenozide 
and its toxicologically relevant metabolite. Moreover, several data gaps lead to non - 
finalised risk assessment in the area of consumer and non -target organisms  and to 
uncertainty as to whether thyroid toxicity effects in rats could be endocrine -mediated. It is 
therefore necessary to restrict the uses to fruiting vegetables of solanaceae in greenhouses 
for which sufficient evidence allows for the conclusion that there will be limited consumer 
exposure and limited potential environmental exposure. In addition, considering the 
remaining uncertainties, further data are required to confirm the overall conclusion that 
the substance satisfies the approval criteria of Ar ticle 4 of Regulation No  1107/2009. 
Existing authorisations of plant protection products containing methoxyfenozide will need 
to be re -examined by Member States in accordance with Article 43 of Regulation 
No 1107/2009.  
8. Relevant documents:   
Regulation (EC) No 1107/2009 of the European Parliament and of the Cou ncil 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=1442928512004&uri=CELEX:32011R0540  
EFSA (European Food Safety Authority), 2018. Conclusion on the peer review of the 
pesticide risk assessment of the active substance m ethoxyfenozide EFSA Journal 
2017;15(8):4978  
https://www.efsa.europa.eu/en/efsajournal/pub/4978  
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, 
amending 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). 
https://eur -lex.europa.eu/legal -content/EN/TXT/?uri=OJ:L:2008:353:TOC   
9. Proposed date of adoption:  4th quarter 2018  
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  G/TBT/N/EU/596  
 
- 3 - 
 
  11. Texts available from: National enquiry point [  ] or address, telephone and fax 
numbers and email and website addresses, 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 EU -TBT Website: http://ec.europa.eu/growth/tools -
databases/tbt/en/  
https://members.wto.org/crnattachments/2018/TBT/EEC/18_4677_00_e.pdf  
https://members.wto.org/crnattachments/2018/TBT/EEC/18_4677_01_e.pdf