G/TBT/N/EU/651  
 
23 April 2019  
(19-2692) 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):  Methiocarb  
(pesticide active substance)  
5. Title, number of pages and language(s) of the notified document:  Draft 
Commission Implementing Regulation concerning the non -renewal of the approval of the 
active substance methiocarb, 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 ac tive substance methiocarb is not renewed in accordance with 
Regulation (EC)  No 1107/2009. Existing authorised plant protection products containing 
methiocarb will be withdrawn from the market. The non -approval is based on the first 
evaluation of the substa nce 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. Following 
non-approval and t he expiry of all grace periods for stocks of products containing this 
substance, separate action may be taken on MRLs and a separate notification will be made 
in accordance with SPS procedures.  
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 pl acing 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/651  
 
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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 methiocarb, 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).  
Critical area of concerns were identified, in particular, exposure for workers loading and 
sowing the treated seed was above the AOEL (628 % of the AOEL) and AAOEL (826 % of 
the AAOEL) even with the use of personal protective equipment. Furthermore, high risks to 
birds, ma mmals and earthworms have been identified. Moreover, the Authority could not 
conduct the consumer risk assessment because the residue definition for risk assessment 
in plant commodities could not been finalised since the genotoxic potential of metabolite 
M01 could not be ruled out based on the available data.  
These concerns mean that methiocarb 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 methiocarb 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 la test 6 months from the entry into force.; 
Protection 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 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=CEL EX:32011R0540  
Conclusion on the peer review of the pesticide risk assessment of the active substance 
methiocarb.  
The EFSA Conclusions regarding the peer review of the pesticide risk assessment of 
methiocarb (EFSA Journal 2018;16(10):5429) https://www.efsa.europa.eu/en/  
efsajournal/pub/rn -79 
9. Proposed date of adoption:  3rd quarter 2019  
Proposed date of entry into force:  3 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.euro pa.eu/growth/tools -
databases/tbt/en/  
https://members.wto.org/crnattachments/2019/TBT/EEC/19_2330_00_e.pdf