G/TBT/N/EU/735  
8 September 2020  
(20-6059) 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 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/e n/  
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):  
Fenpyrazamine (pesticide active substance)  
5. Title, number of pages and language(s) of the notified document:  Draft 
Commission Implementing Regulation amending Implementing Regulation (EU) 
No 540/2011 as regards the conditions of approval of the active substance fenpyrazamine 
(4 page(s), in English; 2 page(s), in English)  
6. Description of content:  This draft Commission Implementing Regulation provides that 
the approval of the active substance fenpyrazamine is amended in accordance with 
Regulation (EC)  No 1107/2009. EU Member States shall review authorisations for plant 
protection products containing fenpyrazamine as an active substance, where relevant. 
The amendment of the conditions of approval is based on the evaluation to clarify the 
technical specif ication proposed in the approval of fenpyrazamine for use as a pesticide 
active substance in the EU under Regulation (EC) No 1107/2009.  
This decision only concerns the placing on the market of this substance and plant 
protection products containing it and  does not affect the Maximum Residue Levels (MRLs) 
for residues of the concerned pesticide; the impurity was considered not to be new in the 
commercial produced batches.  
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 thereto) which must be met to enable approval. The reference 
specification as established at the time of first approval of fenpyrazamine was upd ated 
based on batch data from the technical material as commercially manufactured. The G/TBT/N/EU/735  
 
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  review has established that for the active substance notified by the applicant, the 
minimum purity is higher and there is one toxicologically relevant impurity, hydrazin e. 
The content of hydrazine in the active substance as manufactured shall be a maximum 
concentration of 0.0001% (1 mg/kg). These are detailed in the conclusion of the European 
Food Safety Authority (EFSA). Existing authorisations will need to be adapted ac cordingly; 
EU Member States must ensure that the placing on the market of fenpyrazamine and the 
plant protection products containing it are in compliance with Part B of the Annex to 
Implementing Regulation (EU) No  540/2011 as replaced by this draft Commiss ion 
Implementing Regulation; 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:  
https://eur -lex.europa.eu/legal -
content/AUTO/?uri=CELEX:32009R1107&qid=1590756186915&rid=1  
•  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)  
https://eur -lex.europa.eu/legal -
content/AUTO/?uri=CELEX:32011R0540&qid=1590756246146&rid=1  
• Outcome of the consultation on the pesticide risk assessment  of confirmatory data 
for the active substance fenpyrazamine. EFSA Journal (2012) 10(1):2496. 
doi:10.2903/j.efsa.2012.2496.  
http://www.efsa.europa.eu/en/supporting/pub/en -630 
9. Proposed date of adoption:  Fourth quarter 2020  
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/tools -
databases/tbt/en/  
https:/ /members.wto.org/crnattachments/2020/TBT/EEC/20_5315_00_e.pdf  
https://members.wto.org/crnattachments/2020/TBT/EEC/20_5315_01_e.pdf