  
  
G/TBT/N/EU/1040  
18 December 2023  
(23-8642) 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 Comm ission,  
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 [  ], 3.2 [  ], 7.2 [  ], 
other :  
4. Products covered (HS or CCCN where applicable, otherwise national tariff 
heading. ICS numbers may be provided in addit ion, where applicable):  
Mepanipyrim (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 mepanipyrim, i n accordance with Regulation (EC) No 1107/2009 of the 
European Parliament and of the Council, 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 mepanipyrim is not renewed in accordance with 
Regulation (EC) No 1107/2009. EU Member States shall withdraw authorisations for plant 
protection products contai ning mepanipyrim as an 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 
assessed and approved un der 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 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:  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, G/TBT/N/EU/1040  
 
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  animal health or the environment. Criteria are listed in Article 4 of the Regulation (and 
also detaile d in Annex II thereto) which must be met to enable approval.  
During the evaluation and peer -review of mepanipyrim, 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, based on the available information submitted in the dossier, mepanipyrim 
is considered to meet the criteria for endocrine disruptors for humans and wild mammals 
as non -target organisms for the EAS -modalities according to po ints 3.6.5 and 3.8.2 of 
Annex II of Regulation No 1107/2009, as amended by Commission Regulation (EU) 
2018/605. Negligible exposure cannot be demonstrated for mepanipyrim since residues 
above the default value of 0.01 mg/kg are expected to occur. Therefore , the requirements 
set out in point 3.6.5 and 3.8.2 of Annex II to Regulation (EC) No 1107/2009 are not 
fulfilled.  
Furthermore, a high long -term risk was identified for wild mammals exposed to 
mepanipyrim via dietary exposure, for all representative uses. There was also a need for 
further tests and risk assessment to unique human metabolites while an in vitro 
comparative metabolism study is not submitted. Mepanipyrim was considered phototoxic 
in the in -vitro study. The assessment of phototoxic and photomuta genic potential of 
mepanipyrim could not be finalised and neither could the consumer risk assessment.  
A derogation in accordance with Article 4(7) to Regulation (EC) No 1107/2009 does not 
apply for the reasons set out in the draft Regulation.  
These concern s mean that mepanipyrim 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 c ontaining mepanipyrim 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; Protection of human heal th 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=CELEX:32011R0540  
Commission Regulation (EU) 2018/605 of 19 April 2018 amending Annex II to Regulation 
(EC) No 1107/ 2009 by setting out scientific criteria for the determination of endocrine 
disrupting properties ( OJ L 101, 20.4.2018, p. 33).  
https://eur -lex.europa.eu/legal -content/EN/ TXT/?uri=CELEX%3A32018R0605   
Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 
February 2005 on maximum residue levels of pesticides in or on food and feed of plant 
and animal origin and amending Council Directive 91/414/EEC (OJ L 70, 16.3.2005, p. 
1). 
https://eur -lex.europa.eu/legal -content/EN/ALL/?uri=celex%3A32005R0396  
EFSA (European Food Safety Authority), Alvarez, F., Arena, M., Auteri, D., Batista Leite, 
S., Binaglia, M., Castoldi, A., Chiusolo, A., Cioca, A., Colagiorgi, A., Colas, M., Crivellente, 
F., De Lentdecker, C., De Magistris, I., Egsmose, M., Fait, G., Fer illi, F., Gouliarmou, V., 
Halling, K., ... Villamar -Bouza L. (2023). Updated peer review of the pesticide risk G/TBT/N/EU/1040  
 
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  assessment of the active substance mepanipyrim. EFSA Journal, 21(8), 1 –26. 
https://doi.org /10.2903/j.efsa.2023.8196  
9. Proposed date of adoption:  2nd quarter 2024  
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/to ols-
databases/tbt/en/  
https://members.wto.org/crnattachments/2023/TBT/EEC/23_14689_00_e.pdf  
 