G/TBT/N/EU/617  
 
1 November  2018 
(18-6872) 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): 
Ethoprophos (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 ethoprophos, in accordance with Regulation (EC) No 1107/2009 of the 
European Parliament and of the Council concerning the placing of plant protection 
produc ts on the market, and amending 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 ethoprophos is not renewed in accordance with 
Regulation (EC)  No 1107/2009. Existing authorised plant protection products containing 
ethoprophos will be withdrawn from the market. The non -approval is based on the first 
evaluation of the substance for use as a pesticide activ e 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 res idues of the concerned pesticide. 
However, following non -approval, separate action may be taken on MRLs. Any subsequent 
action on MRLs will be subject to notification under the SPS procedure.  
7. Objective and rationale, including the nature of urgent prob lems 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 placin g of plant 
protection products on the market), it must be demonstrated that the substance is not G/TBT/N/EU/617  
 
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  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 ethoprophos, 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).  
In particular, it wa s not possible to conclude on the genotoxic potential of ethoprophos and 
no final health -based reference values could be established. Consequently, the consumer 
and non -dietary risk asessements could not be conducted.  
A high acute risk to birds and a high  risk to soil dwelling non -target arthropods and to soil 
organisms was identified.   In addition, the Authority concluded that several areas of the 
risk assessment could not be finalised including the consumer assessment with respect 
to residues in food of plant and animal origin, the assessment of developmental 
neurotoxicity, the groundwater exposure assessment, the long -term risk to birds, the 
assessment of secondary poisoning for birds and mammals, the risk to soil organisms 
from exposure to metabolites o f ethoprophos and the risk to earthworms.  
Finally, the Authority concluded that assessment of the endocrine disrupting potential 
could not be concluded.  
These concerns mean that ethoprophos does not meet the approval criteria as outlined in 
Regulation (E C) 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 ethoprophos 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.  
8. Relevant documents:   
• Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 
21 Oct ober 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 regard s 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  
9. Proposed date of adoption: 1st quarter 2019  
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_5699_00_e.pdf