G/TBT/N/EU/701  
5 March 2020  
(20-1744) 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):  
Fenamiphos (pesticide active su bstance); Pesticides and other agrochemicals 
(ICS 65.100)  
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 fenamiphos, 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, and amending the Annex to Commission Implementing 
Regulation (EU) No 540/2011 (5 page(s), in English)  
6. Description of content:  This draft Commission Implementing Regulation provides that 
the approval of the active substance fenamiphos is not renewed in accordance with 
Regulation (EC)  No 1107/2009. EU Member States shall withdraw authorisations for plant 
protection products containing fenamiphos as active substance. The non -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 substance was formerly 
assesse d and approved under Directive  91/414/ EEC.  
This decision only concerns the placing on the market of this substance and plant 
protection products containing it. Following non -approval and the expiry of all grace 
periods for stocks of products containing th is substance, separate action will likely be 
taken on MRLs and a separate notification will be made in accordance with 
SPS procedures.  G/TBT/N/EU/701  
 
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  7. Objective and rationale, including the nature of urgent problems where 
applicable:  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 o r 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 fenamiphos, a number of concerns and areas that could not be 
finalised were  identified. These are detailed in the conclusion of the European Food Safety 
Authority (EFSA).  
• The risk to consumers. The overall consumer risk assessment is provisional since 
the data package for M01 and M02 on genotoxicity was incomplete and the 
expres sion of the risk assessment residue deﬁnition for primary crops is 
provisional. Moreover, the risk assessment residue deﬁnition in rotational crops 
is provisional. However, even if the consumer risk assessment could not be 
ﬁnalised, an acute consumer risk was identiﬁed for all fruiting vegetables 
representative uses while for the ornamentals and nursery stock, which may be 
grown in rotation with food crops, an acute consumer risk cannot be excluded. 
(Although herbaceous ornamentals and nursery stock are not  foodstuff, they 
could be grown in rotation with foodcrops. Thus, based on rotational metabolism 
studies in fruiting vegetables conducted at 1N application rate, when compared 
with the annual application rate from the representative GAP in ornamentals and 
nursery stock and also in view of the very low toxicological reference values of 
fenamiphos, an acute consumer risk cannot be excluded. Moreover, the 
provisional residue definition for rotational crops includes metabolites M01 and 
M02 for which further dat a to exclude a genotoxic potential is required.) 
Furthermore, for the chronic intake consumer exposure, if the calculated 
Maximum Residue Levels (MRLs) resulting from the available residue dataset 
submitted for the renewal process are used in the exposure assessment, the 
maximum TMDI would account for 172% of the ADI.  
• The risk assessment to unique human metabolites could not be ﬁnalised whilst an 
in vitro comparative metabolism study was not submitted.  
• The potential for groundwater contamination and the consumer risk assessment 
through exposure to metabolites from drinking water. While monitoring data from 
three vulnerable regions in Greece indicate that the potential for groundwater 
exposure above the parametric drinking water limit  of 0.1 µg/L was concluded to 
be low for fenamiphos and metabolites M01, M02, M12, M13 and M14 in the 
geoclimatic conditions that are represented in Greece, modelling data indicates 
that there is potential for exceedance of the limit of 0.1 µg/L by M14 (we ll above 
10 µg/L in all scenarios, even at the lower rate of application). An assessment of 
the consumer intake could not be carried out for this metabolite since an ADI 
could not be established based on the data submitted.  
These concerns mean that fenamip hos 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; EU Member States must withdraw existing plant protection 
products containing picoxystro bin at the latest by 6 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 12 months from the entry into force (allowing for a final season 
of use).; Prot ection of human health or safety; Protection of animal or plant life or health; 
Protection of the environment  
8. Relevant documents:   
• Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 
21 October 2009 concerning the placing of p lant 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 G/TBT/N/EU/701  
 
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  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=CE LEX:32011R0540  
• Conclusion on the peer review of the pesticide risk assessment of the active 
substance fenamiphos. EFSA Journal 2019;17(1):5557 
https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2019.5557  
9. Proposed date of adoption:  3rd quarter 2020  
Proposed date of entry into force:  20 days following publication in the Offi cial 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/2020/TBT/EEC/20_1762_00_e.pdf