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 Functi oning 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 Commission, the M ember 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 Foo d 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 endocrine -disrupting properties of acibenzolar -S-methyl could 
not be finalised based on the available data for both humans and non -target organisms, 
and identified f urther 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 Imp lementing 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 Re gulation (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 evaluate 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 cessat ion of 
further studies concerning the endocrine -disrupting attributes 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  pursu ant 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) No 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 Regul ation ]. 
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