G/TBT/N/EU/319  
 
16 October 2015  
(15-5437)  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, wher e applicable): Tricyclazole (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 tricyclazole, 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 (3 pages, in English) 
6. Description of content: This draft Commission Implementing Regulation provides that 
the active substance tricyclazole 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 Plant Protection Products in the EU (but 
has been/is authorised under emergency measures in some MS); the non-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.  
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 placing of pl ant 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 genotoxic and carcinogenic 
potential of tricyclazole could not be conclu ded based on the data package provided and G/TBT/N/EU/319 
 
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  this prevented final human health reference va lues being established and therefore the risk 
assessment for operators, workers, bystanders, residents and consumers could not be finalised. There were also some additional issues identified including the risk to 
groundwater from metabolites and the potent ial of the substance to be an endocrine 
disruptor. 
These concerns mean that tricyclazole does not meet the approval criteria as outlined in 
Regulation (EC) No 1107/2009 and cannot be approved currently. 
As tricyclazole is a new active substance under Regulation (EC) No 1107/2009 (the 
substance was previously authorised in plant protection products (PPPs) in the EU but was 
non-included under the previous legislation in 2008 for the same reasons), there are no 
existing authorisations to withdraw 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: Early 2016 
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_4113_00_e.pdf