EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
PLAN/2023/2650  
[…](2024) XXX  draft  
 
COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
withdrawing the approval of the active substance acibenzolar -S-methyl in accordance 
with Regulation (EC) No 1107/2009 of the European Parliament and of the Council, 
amending Commission Implementing Regulation (EU) No 540/2011 and repealing 
Commission Imple menting Regulation (EU) 2016/389  
(Text with EEA relevance)    
EN 1  EN COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
withdrawing the approval of the active substance acibenzolar -S-methyl in accordance 
with Regulation (EC) No 1107/2009 of the European Parliament and of the Council, 
amending Commission Implementing Regulation (EU) No 540/2011 and repealing 
Commission Implementing Regulation (EU) 2016/389  
(Text with 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) The approval of acibenzolar -S-methyl  was renewed by Commission Implementing 
Regulation (EU) 2016/3892.  
(2) Commission Regulation (EU)  2018/6053 amended Regulation (EC) No 1107/2009 by 
introduc ing new criteria to identify active substances which have endocrine disrupting 
properties , which  became applicable on 10 November 2018.   This required that the 
applicant should submit to the Commis sion, the Member States and the Authority 
confirmatory information as regards  the endocrine -disrupting properties of 
acibenzolar -S-methyl .  
(3) The applicant submitted an updated dossier as well as additional information in 
February 2019 . 
(4) On 8 July 2021,  the European Food Safety Authority (‘the Authority’) published a 
peer review of the pesticide risk assessment for the active substance acibenzolar -S-
methyl4 related to the confirmatory data submitted by the applicant, and reporting that 
the assessment of the en docrine -disrupting properties of acibenzolar -S-methyl could 
not be finalised based on the available data for both humans and non -target organisms, 
and identified further data that were necessary to finalise the assessment.  
                                                 
1 OJ L 309, 24.11.2009, p. 1 , ELI:  http://data.europa.eu/eli/reg/2009/1107/oj . 
2 Commission Implementing  Regulation (EU) 2016/389 of 17 March 2016 renewing the approval of the 
active substance acibenzolar -S-methyl , 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, and amending the Annex to Commission Implementing Regulation (EU) No  540/2011 
(OJ L 157, 27.5.2014, p. 96 , ELI: http://data.europa.eu/eli/reg_impl/2016/389/oj ).  
3 Commission Regulation (EU) 2018/605 of 19 April 2018 amending Annex II to Regulation (EC) 
No 1107/2009 by setting out scientific criteria for the determination of endocrine disrupting properties  
(OJ L 101 , 20.4.2018, p. 33 , ELI: http://data.europa.eu/eli/reg/2018/605/oj ). 
4 Peer review of the pesticide risk assessment of the active substance acibenzolar -S-methyl,  
EFSA Journal 2021;19(7):6687 https://doi.org/10.2903/j.efsa.2021.6687 .  
EN 2  EN (5) The Commission therefore launched a review of the existing approval of the active 
substance in accordance with Article 21 of Regulation (EC) No 1107/2009. The 
applicant was invited to submit, by end of June 2025, additional information necessary 
to evaluat e if acibenzolar -S-methyl  still fulfils the criteria for approval laid down in 
point  3.6.5 of Annex II to that Regulation.  
(6) On 8 September 2023, the applicant informed the Commission o f the cessation of 
further studies concerning the endocrine -disrupting at tributes of acibenzolar -S-methyl  
and of its decision to self-classif y that substance as toxic for reproduction category  1B 
(R1B ) under Regulation  (EC) No 1272/2008  of the European Parliament and of the 
Council5.   
(7) Consequently, it has not been established that the approval criteria provided for in 
Article  4 of Regulation (EC) No  1107/2009 are satisfied. The Commission therefore 
considers that acibenzolar -S-methyl  no longer fulfils the criteria for approval laid 
down  in point 3.6.5  of Annex II to that Regulation .  
(8) It is therefore appropriate to withdraw the approval of acibenzolar -S-methyl . 
(9) Implementing Regulation (EU) No 540/2011 should therefore be amended accordingly  
and Implement ing Regulation (EU) No 2016/389  should be repealed . 
(10) Member States should be provided with  sufficient  time to withdraw authorisations for 
plant protection products containing acibenzolar -S-methyl . 
(11) For plant protection products containing acibenzolar -S-methyl , where Member States 
grant any grace period in accordance with Article  46 of Regulation (EC) 
No 1107/2009, that period should  be as short as possible  and expire no later than  
12 months from the date of entry into force  of this Regulation . 
(12) This Regulation does not prevent the submission of a new application for the approval 
of acibenzolar -S-methyl  pursuant to Article  7 of Regulation (EC) No  1107/2009.  
(13) 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 approval of the active substance acibenzolar -S-methyl  is withdrawn.  
Article 2  
Amendment to Implementing Regulation (EU) No 540/2011  
In Part B  of the Annex to Implementing Regulation (EU) N o 540/2011, row 98 on 
acibenzolar -S-methyl  is deleted.  
                                                 
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, ELI: http://data.europa.eu/eli/reg/2008/1272/oj ).  
EN 3  EN Article 3  
Transitional measures  
Member States shall withdraw authorisations for plant protection products containing 
acibenzolar -S-methyl  as active substance by … [Office of Publications : please insert date 
6 months  after  the date of entry into force  of this Regulation ]. 
Article 4  
Grace period  
Any grace period granted by Member States in accordance with Article 46 of Regulation (EC) 
No 1107/2009 shall expire by … [Office of Publications : please  insert date 12 months  after 
the date of entry into force of this Regulation].  
Article 5  
Repeal  
Implementing Regulation (EU) No 2016/389  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 entirety and directly applicable in all Member States.  
Done at Brussels,  
 For the Commission  
 The President  
Ursula VON DER LEYEN