G/SPS/N/EU/516  
 
30 November 2021  
(21-8993) Page: 1/3 
Committee on Sanitary and Phytosanitary Measures  Original: English  
 
  NOTIFICATION  
1. Notifying Member:  EUROPEAN UNION  
If applicable, name of local government involved:   
2. Agency responsible:  European Commission, Health and Food Safety Directorate -General  
3. Products covered (provide tariff item number(s) as specified in national 
schedules deposited with the WTO; ICS numbers should be provided in addition, 
where applicable):  Isopyrazam (pesti cide active substance)  
4. Regions or countries likely to be affected, to the extent relevant or practicable : 
[X] All trading partners   
[ ] Specific regions or countries:   
5. Title of the notified document:  Draft Commission Implementing Regulation withdrawing 
the approval of the active substance isopyrazam 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 m arket, amending Commission Implementing Regulation 
(EU) No 540/2011 and repealing Implementing Regulation (EU) No 1037/2012 . 
Language(s):  English . Number of pages:  4 
https://members.wto.org/crnattachments/2021/SPS/EEC/21_7410_00_e.pdf  
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the approval of the active substance isopyrazam is withdrawn in accordance with 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.  
Member States shall withdraw authorisations for plant protection products containing 
isopyrazam as an active substance.  
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 harmfu l 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 substances may be reviewed at any time where in the light of new sc ientific 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 reproduction 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 isopyrazam 
meets the cri teria 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 outlin ed in Regulation 
(EC) No 1107/2009 and the approval should therefore be withdrawn.  G/SPS/N/EU/516  
 
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  Existing authorisations will need to be withdrawn; Member States must withdraw existing 
plant protection products containing isopyrazam at the latest by three  months from th e 
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 six months from the entry into force.  
This decision only concerns the placing on the market of this substance and pl ant 
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 MRLs and a separate notification will be made in accordance with 
SPS procedures.  
This draft Commission Implementing Regulation was also notified under the 
TBT Agreement in notice G/TBT/N/EU/857.  
7. Objective and rationale: [X]  food safety, [  ] animal health, [X]  plant protection, 
[X] protect humans from animal/plant pest or disease, [X]  protect territory from 
other damage from pests.   
8. Is there a relevant international standard? If so, identify the standard:  
[ ] Codex Alimentarius Commission (e.g.  title or serial number of Codex 
standard or related tex t):  
[ ] World Organization for Animal Health (OIE) (e.g.  Terrestrial or Aquatic 
Animal Health Code, chapter number) :  
[ ] International Plant Protection Convention (e.g.  ISPM number) :  
[X] None  
Does this proposed regulation conform to the relevant international standard?  
[ ] Yes   [  ] No 
If no, describe, whenever possible, how and why it deviates from the 
international standard:   
9. Other relevant documents and language(s) in which these are available:   
− 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 regards the list of approved active substances ( OJ L 153, 11  June 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 2020  
https://echa.e uropa.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 Direc tives 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/RegularNotifications/View/173586?FromAllNotifications=True  
10. Proposed date of adoption (dd/mm/yy) : 1st quarter 2022  
Proposed date of publication (dd/mm/yy) : 1st quarter 2022  G/SPS/N/EU/516  
 
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  11. Proposed date of entry into force: [  ] Six months from date of publication , and/or  
(dd/mm/yy) : 20 days following publication in the Official Journal of the European Union.  
[ ] Trade facilitating measure   
12. Final date for comments: [  ] Sixty days from the date of circulation of the 
notification and/or (dd/mm/yy) : Not applicable. Comments are only welcomed on 
TBT related issues and to be addressed to the TBT Enquiry Point on notice 
G/TBT/N/EU/857.  
Agency or authority designated to handle comments: [X]  National Notification 
Authority, [X]  National Enquiry Point. Address, fax number and e -mail address (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  
13. Text(s) available from: [X]  National Notification Authority, [X]  National Enquiry 
Point. Address, fax number and e -mail address (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