G/TBT/N/EU/561  
 
20 March 2018  
(18-1690) Page: 1/2 
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): Fenamidone 
(pesticide active substance)  
5. Title, number of pages and language(s) of the notified document: Draft 
Commission Implementing Regulation concerning the non -renewal of approval of the active 
substance fenamidone, in accordance with Regulation (EC) No 1107/2009 of the European 
Parliament and of the Council concerning the placing of plant protection products  on the 
market (5 page(s), in English)    
6. Description of content: This draft Commission Implementing Regulation provides that 
the approval of the active substance fenamidone is not renewed in accordance with 
Regulation (EC)  No 1107/2009. Existing authorised plant protection products containing 
fenamidone will be withdraw n 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 may be taken on MRLs. Any subsequent action on 
MRLs will b e subject to notification under the SPS procedure.  
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 that the substance is not harmful to 
human health, animal health or th e environment. Criteria are listed in Article 4 of the 
Regulation (and also detailed in Annex  II) which must be met to enable approval.  G/TBT/N/EU/561  
 
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  During the evaluation and peer -review of fenamidone, a number of concerns and areas 
that could not be finalised were id entified. These are detailed in the conclusion of the 
European Food Safety Authority (EFSA).  
In particular it was not possible to conclude on the genotoxic potential of fenamidone and no 
health -based reference values could be set. Consequently, the consum er and non -dietary risk 
asessements could not be conducted.   Furthermore, a high potential for groundwater 
contamination above the parametric drinking water limit of 0.1 μg/L by a toxicologically 
relevant metabolite (RPA 412708) was indicated in all pertin ent scenarios for crops grown 
in soils of predominantly pH 7 or above.  
In addition, the consumer risk assessment for exposure to another groundwater metabolite 
(RPA 412636) which is also found in food of plant and animal origin could not be finalised. 
Furtermore, the residue definitions for risk assessment in plant and livestock commodities 
are not finalised in terms of the inclusion of potentially relevant metabolites.  
Finally, the risk assessment for wild mammals could not be concluded and a high risk t o 
aquatic organisms from exposure to the metabolite acetophone could not be excluded 
based on the available information.  
These concerns mean that fenamidone does not meet the approval criteria as outlined in 
Regulation (EC) No 1107/2009 and cannot be appr oved currently.  
Existing authorisations will need to be withdrawn; Member States must withdraw existing 
plant protection products containing fenamidone at the latest by 6 months from the date of 
entry into force. A period of grace in line with Article 46 o f Regulation 1107/2009 is allowed 
for and shall expire at the latest 15 months from the entry into force.  
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 reg ards 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 active 
substance fenamidone. EFSA Journal 2016;14(2)4406:, 102 pp. 
doi:10.2903/j.efsa.2016.4406.  
https://www.efsa.europa.eu/en/efsajournal/pub/4406   
9. Proposed date of adoption: 3rd 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  
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_1506_00_e.pdf