G/TBT/N/EU/857  
26 November 2021  
(21-8932) 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/tb t/en/  
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):  
Isopyrazam (pesticide active substance); Pesticides and other agrochemicals (ICS 
65.100)  
5. Title, number of pages and language(s) of the notified document:  Draft 
Commission Implementing Regulation withdrawing the approval of the active substance 
isopyra zam 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, 
amending Commission Implementing Regulation (EU) No 540/2011 and repealing 
Implementing Reg ulation (EU) No 1037/2012 (4 page(s), in English)  
6. Description of content:  This draft Commission Implementing Regulation provides that 
the approval of the active substance isopyrazam is withdrawn in accordance with 
Regulation (EC)  No 1107/2009.  
EU Memb er States shall withdraw authorisations for plant protection products containing 
isopyrazam as an active substance.  
This decision only concerns the placing on the market of this substance and plant 
protection products containing it. Following withdrawal of approval and the expiry of all 
grace periods for stocks of products containing this substance, separate action may be 
taken on MR Ls and a separate notification will be made in accordance with SPS 
procedures.  
7. Objective and rationale, inclu ding 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 subst ance 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. Active G/TBT/N/EU/857  
 
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  substances may be reviewed at any time where in t he light of new scientific and technical 
knowledge there are indications that the substance no longer satisfies the approval 
criteria laid down in Article 4 of Regulation (EC) No 1107/2009. Substances that are or 
have to be classified as toxic for reproduc tion category 1B (R1B) according to Regulation 
(EC) No 1272/2008 cannot be approved unless exposure to humans is demonstrated to 
be negligible under realistic conditions of use. In December 2020, the ECHA Committee 
for Risk Assessment concluded that isopyr azam meets the criteria to be classified as R1B. 
Negligible exposure is not demonstrated since residues are expected in crops (therefore 
there is no negligible exposure demonstrated for consumers). This means that isopyrazam 
no longer fulfils the approval criteria as outlined in Regulation (EC) No 1107/2009 and 
the approval should therefore be withdrawn. Existing authorisations will need to be 
withdrawn; EU Member States must withdraw existing plant protection products 
containing isopyrazam at the latest by  3 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 6 months from the entry into force. Protection of human health or safety; 
Protection of animal or p lant 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 Counci l 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  
Opinion of the Committee for Risk Assessment, adopted on 10 December 2 020 
https://echa.europa.eu/documents/10162/095e630c -18d9-994c-4d8f-82c4c28e3238   
Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 
December 2008 on classification, labelling and packaging of substances and mixtures, 
amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending 
Regulation (EC) No 1907/2006  
https://eur -lex.europa.eu/legal -content/EN/TXT/?uri=celex%3A32008R1272   
Notification G/TBT/N/EU/826  
http://tbtims.wto.org/en/RegularNotific ations/View/173586?FromAllNotifications=True   
9. Proposed date of adoption:  1st quarter 2022  
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/2021/TBT/EU/21_7369_00_e.pdf