G/TBT/N/EU/316  
 
18 September 2015  
(15-4790)  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 telephon e 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 applic able, otherwise national tariff heading. 
ICS numbers may be provided in  addition, where applicable): 3-decen-2-one 
(pesticide active substance) 
5. Title, number of pages and language(s) of the notified document: Draft Commission 
Implementing Regulation concerning the non-approval of the active substance 
3-decen-2-one, in accordance with Regula tion (EC) No 1107/200 9 of the European 
Parliament and of the Council concerning the placing of plant protection products on the market (3 pages, in English) 
6. Description of content: This draft Commission Implementing Regulation provides that 
the active substance 3-decen-2-one is not approved in accordance with Regulation (EC) No 1107/2009 and cannot be placed on the market in plant protection products in the 
EU. The substance is not currently authorised in the EU; the non-approval is based on the 
first evaluation of the substance for use as a pesticide active substance in the EU.  
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 plan t 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 Articl e 4 of the Regulation (and also detailed in 
Annex II) which must be met to enable approval.  
During the evaluation and peer-review of th e substance, 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); importantly, the evaluation of the maximum residue levels (MRL) application with the request to exempt 3?decen-2-one from MRL 
setting could not be finalised, since the available information was insufficient to conclude 
whether 3-decen-2-one will have no immediate or delayed harmful effects on human health, including that of vulnerable groups, through dietary intakes. Additionally, the 
presence of positive genotoxicity result s and a limited toxicological data package G/TBT/N/EU/316 
 
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  prevented final toxicological reference values  being established and therefore the risk 
assessment for operators, workers, bystanders, residents and consumers could not be finalised. 
These concerns mean that 3-decen-2-one does not meet the approval criteria as outlined 
in Regulation (EC) No 1107/2009 and cannot be approved currently. 
As 3-decen-2-one is a new active substance being considered for the first time in the EU, 
there are no existing authorisations to with draw and therefore the draft Regulation does 
not refer to any withdrawal action or periods of grace. 
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  
9. Proposed date of adoption: End of 2015  
Proposed date of entry into force: 20 days from publication in the Official Journal of the 
European Union   
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/tbt/   
https://members. wto.org/crnattachments/2015/TBT/EEC/15_3688_00_e.pdf