EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/10308/2021 Rev 0  
[…](2020) XXX  draft  
 
COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
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 market,  amending 
Commission Implementing R egulation (EU) No 540/2011 and repealing Implementing 
Regulation (EU) No 1037/2012  
(Text with EEA relevance)    
EN 1  EN COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
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 market,  amending 
Commission Implementing Regulation (EU) No 540/2011 and repealing Implementing 
Regulation (EU) No 1037/2012  
(Text w ith EEA relevance)  
THE EUROPEAN COMMISSION,  
Having regard to the Treaty on the Functioning of the European Union , 
Having regard to 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/EEC1, and in particular Article 
21(3) and Article 78(2)  thereof,  
Whereas:  
(1) Commission Implementing Regulation  (EU) No 1037/20122 approved  isopyrazam  as 
an active substance in accordance with Regulation (EC) No  1107/2009  and listed it in 
Part B of the Annex to Commission Implement ing Regulation (EU) No 540/20113. 
(2) On 10 December 2020, the Committee  for Risk Assessment  of the European 
Chemicals Agency ad opted an opinion4 in accordance with Article 37(4) of Regulation 
(EC) No 1272/2008  of the European Parliament and of the Council5 in which it 
concluded that isopyrazam meets the criteria to be classified as toxic for reproduction 
category 1B and carcinogen ic category 2.  
(3) Commission Delegated Regulation (EU) …/…  [Office of Publications : Please insert 
in the text the number of the Delegated Regulation and insert the number, date, title 
                                                 
1 OJ L 309, 24.11.2009 , p. 1. 
2 Commission Implementing Regulation (EU) No  1037/2012 of 7  November 2012 approving 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 prod ucts on the market, and amending the 
Annex to Commission Implementing Regulation (EU) No  540/2011 (OJ L 308, 8.11.2012, p. 15).  
3 Commission Implementing Regulation (EU) No  540/2011 of 25  May 2011 implementing Regulation 
(EC) No  1107/2009 of the European P arliament and of the Council as regards the list of approved active 
substances (OJ L 153 , 11.6.2011, p. 1) . 
4 Committee for Risk Assessment , Opinion proposing harmonised classification and labelling at EU  level 
of Reaction mass of 3 -(difluoromethyl) -1-meth yl-N-[(1RS,4SR,9RS) -1,2,3,4 -tetrahydro -9-isopropyl -
1,4-methanonaphthalen -5-yl]pyrazole -4-carboxamide and 3 -(difluoromethyl) -1-methyl -N-
[(1RS,4SR,9SR) -1,2,3,4 -tetrahydro -9-isopropyl -1,4-methanonaphthalen -5-yl]pyrazole -4-carboxamide  
[>78% syn isomers <15% anti isomers relative content]; isopyrazam. EC Number: - CAS Number: 
881685 -58-1 CLH -O-0000006915 -65-01/F, adopted on 10 December 2020 . 
5 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  (OJ L 353, 31.12.2008, 
p. 1).  
EN 2  EN and OJ reference of that Regulation in the footnote ]6 consequently amended Annex VI 
to Regulation (EC) No 1272/2008 and classified isopyrazam as toxic for reproduction 
category 1B.  
(4) Under p oint 3.6.4 of Annex II to Regulation (EC) No 1107/2009  an active substance is 
only to be approved  if it is not or has not to be classified in accordance with the 
provisions of  Regulation (EC) No 1272/2008  as toxic for reproduction category 1B , 
unless the exposure of humans to that substance  in a plant protection product under 
realistic proposed conditions of use  is negligible.   
(5) For the represent ative uses of isopyrazam, residues of isopyrazam  on food and feed  
exceed t he default value within the meaning of  Article 18(1) , point (b), of Regulation 
(EC) No 396/2005, therefore  the condition of negligible exposure with respect to 
dietary exposure is not met.  
(6) Consequ ently, isopyrazam no longer fulfils the criterion for approval laid down in 
point 3.6.4 of  Annex II to Regulation (EC) No  1107/2009.  
(7) In accordance with Article 21(1) of Regulation (EC) No 1107/2009 , the Commission 
informed the Member States , the European Food Safety Authority and the applicant 
that it considered the approval criterion laid down in point 3.6.4 of  Annex II to 
Regulation (EC) No  1107/2009  may no longer be met  given that isopyrazam meets the 
criteria to be classified as toxic fo r reproduction category 1B and invited the applicant 
to submit its comments . 
(8) The applicant  neither provide d any information  to demonstrate negligible exposure  nor 
any evidence that the conditions of Article 4(7)  of Regulation  (EC) No 1107/2009 , 
concerning substances which are needed to control a serious danger to plant health that 
cannot be contained by other available means,  are fulfilled .  
(9) Consequently, it is appropriate to withdraw the approval of isopyrazam .  
(10) The Annex to  Implementing Regulation (EU) No  540/2011 should therefore be 
amended accordingly  and Implementing Regulation (EU) No 1037/2012 should be 
repealed . 
(11) Member States should be provided with  sufficient  time to withdraw authorisations for 
plant protection products containing  isopyrazam . 
(12) For pl ant protection products containing  isopyrazam , where Member States grant any 
grace period in accordance with Article  46 of Regulation (EC) No  1107/2009, th at 
period should  be as short as possible  and expire no later than  6 months from the date 
of entry int o force  of this Regulation . 
(13) This Regulation does not prevent the submission of a further application for the 
approval of isopyrazam pursuant to Article  7 of Regulation (EC) No  1107/2009.  
(14) The measures provided for in this Regulation are in accordance with the opinion of the 
Standing Committee on Plants, Animals, Food and Feed , 
HAS ADOPTED THIS REGULATION:  
Article 1  
Withdrawal of approval  
The a pproval of the active substance  isopyrazam  is withdrawn.  
                                                 
6 Commission Delegated Regulation (EU) …/… ( OJ …, p. …) .  
EN 3  EN Article 2 
Amendment to Implementing Regulation (EU) No 540/2011  
In Part B  of the Annex to Implementing Regulation (EU) No 540/2011, row 27 on isopyrazam  
is deleted.  
Article 3 
Transitional measures   
Member States shall withdraw authorisations for plant protection products containing 
isopyrazam  as active substance by … [Office of Publications : please insert date 3 months 
after entry into force  of this Regulation ]. 
Article 4  
Grace period  
Any grace period granted by Member States in accordance with Article 46 of Regulatio n (EC) 
No 1107/2009 shall expire by … [Office of Publications : please  insert date 6 months from the 
date of entry into force  of this Regulation ].  
Article 5 
Repeal  
Implementing Regulation (EU) No 1037/2012 is repealed.  
Article 6  
Entry into force  
This Regulation shall enter into force on the twentieth  day following that of its publication in 
the Official Journal of the European Union . 
This Regulation shall be binding in its entire ty and directly applicable in all Member 
States.  
Done at Brussels,  
 For the Commission  
 The President  
Ursula VON DER LEYEN