G/TBT/N/EU/597  
 
3 September 2018  
(18-5487) 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/   
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): 
Mepanipyrim (pesticide active substance)  
5. Title, number of pages and language(s) of the notified document: Draft 
Commission Implementing Regulation renewing the approval of the active substance 
mepanipyrim 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 (and its accompanying annexes) (4 pages + annexes 3 pages, in English)   
6. Description of content: This draft Commission Implementing Regulation provides that 
the approval of th e active substance mepanipyrim  is renewed in accordance with 
Regulation (EC)  No 1107/2009.  It is, however, necessary to include certain conditions and 
restrictions. In particular, only the use in greenhouses can be approved. Existing 
authorised plant prote ction products containing mepanipyrim  will be amended or 
withdrawn from the market. The restriction 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 subs tance was formerly approved under Directive  91/414/ EEC.  
This regulation 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.  
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 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.  G/TBT/N/EU/597  
 
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  During the evaluation and peer -review of mepanipyrim, a number of concerns and areas 
that could not be finalised were identified. These are detailed inthe conclusion of the 
European Food Safety Authority (EFSA).  
In particular, the consumer risk assessment could not be finalised considerin g the outstanding 
data to finalise the residue definitions for risk assessment in primary crops and in processed 
commodities, except for tomatoes in greenhouses.  
Furthermore, the endocrine disrupting potential of mepanipyrim could not be ruled out and 
further clarification is needed.  
Finally, A high long -term risk was identified for wild mammals exposed to mepanipyrim via 
dietary exposure.  
In order to avoid exposure of wild mammals to mepanipyrim, it is necessary to restrict the 
approval to uses in greenhou ses only.  
These concerns mean that mepanipyrim  can only meet the approval criteria as outlined in 
Regulation (EC) No 1107/2009 if the approval is restricted to use in greenhouse only.  
Existing authorisations will need to be amended or withdrawn; EU Member States must 
amend or withdraw existing plant protection products containing 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 la test 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:32 011R0540  
EFSA (European Food Safety Authority), 2017. Conclusion on the peer review of the 
pesticide risk assessment of the active substance mepanipyrim . EFSA Journal 
2017;15(6):4852, 22 pp. doi: 10.2903/j.efsa.2017.4852  
https://www.efsa.europa.eu/en/efsajournal/pub/4852   
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 Website: http://ec.europa.eu/growth/tools -databases/t bt/ 
https://members.wto.org/crnattachments/2018/TBT/EEC/18_4706_00_e.pdf  
https://members.wto.org/crnattachments/2018/TBT/EEC/18_4706_01_e.pdf