EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
PLAN/2023/1017  
[…](2023) XXX  draft  
 
COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
concerning the non -renewal of the approval of the active substance benthiavalicarb, in 
accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the 
Council, and amending Commission Implementing Regulation (EU) No  540/2011  
(Text with EEA relevance)    
EN 1  EN COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
concerning the non -renewal of the approval of the active substance benthiavalicarb, in 
accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the 
Council, and amending Commission Implementing Regulation (EU) No  540/2011  
(Text with EEA relevance)  
THE EUROPEAN COMMISSION,  
Having regard to the Treaty on the Functionin g 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  20(1) and Article 78(2) thereof,  
Whereas:  
(1) Commission Directive 2008/44/EC2 included benthiavalicarb as an active substance in 
Annex I to Council Directive 91/414/EEC3. 
(2) Active substances included in Annex I to Directiv e 91/414/EEC are deemed to have 
been approved under Regulation (EC) No 1107/2009 and are listed in Part  A of the 
Annex to Commission Implementing Regulation (EU) No  540/20114. 
(3) The approval of the active substance benthiavalicarb, as set out in Part A of th e Annex 
to Implementing Regulation (EU) No 540/2011, expires on 15 November  2024 .  
(4) An application for the renewal of the approval of the active substance benthiavalicarb 
was submitted to Poland, the rapporteur Member State, and France, the co -rapporteur 
Member State, in accordance with Article 1 of Commission Implementing Regulation 
(EU) No 844/20125 within the time period provided for in that Article.  
                                                 
1 OJ L 309, 24.11.2009, p.  1. 
2 Commission Directive 2008/44/EC of 4 April 2008 amending Council Directive 91/414/EEC to include 
benthiavalicarb, boscalid, carvone, fluoxastrobin, Paecilomyces lilacinus and prothioconazole as active 
substances ( OJ L 94, 5.4.2008, p. 13 ). 
3 Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on 
the market (OJ L 230, 19.8.1991, p.  1). 
4 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). 
5 Commission Implementing Regulation (EU) No 844/2012 of 18 September  2012 setting out the 
provisions necessary for the implementation of the renewal procedure for active substances, as provided 
for in Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the 
placing of plant protection produ cts on the market (OJ L 252, 19.9.2012, p. 26) , which continues to 
apply to the procedure for the renewal of the approval of t his active substance pursuant to Article 17 of 
Commission Implementing Regulation (EU) 2020/1740 of 20 November 2020 setting out t he provisions 
necessary for the implementation of the renewal procedure for active substances, as provided for in 
Regulation (EC) No 1107/2009 of the European Parliament and of the Council, and repealing 
Commission Implementing Regulation (EU) No 844/2012 (OJ L 392, 23.11.2020, p. 20) .  
EN 2  EN (5) The applicant submitted the supplementary dossiers required to the rapporteur 
Member State, the co -rappo rteur Member State, the Commission and the European 
Food Safety Authority (‘the Authority’) in accordance with Article 6 of Implementing 
Regulation (EU) No 844/2012. The application was found to be admissible  by the 
rapporteur Member State.  
(6) The rapporteur Member State prepared a renewal assessment report in consultation 
with the co -rapporteur Member State and submitted it to the Authority and the 
Commission on 31 October 2017 .  
(7) The Authority made the supplementary summary dossier available to the public. Th e 
Authority also circulated the renewal assessment report to the applicant  and to the 
Member States for comments and launched a public consultation on it. The Authority 
forwarded the comments received to the Commission.  
(8) On 23 August 2021 , the Authority com municated to the Commission its conclusion6 
(‘the Authority’s conclusion’) on whether benthiavalicarb can be expected to meet the 
approval criteria provided for in Article  4 of Regulation (EC) No  1107/2009.  
(9) In that conclusion, t he Authority identified cer tain specific concerns. In particular, it 
was concluded  that benthiavalicarb has a  carcinogenic potential, which is consistent 
with the proposal of the European Chemical Agency to classif y it as ca rcinogen 
category  1B7. The authority considered also that b enthiavalicarb shows endocrine 
disrupti ng properties that may have adverse effects in humans , as set out in point 3.6.5 
of Annex II of Regulation (EC) No 1107/2009. According to the Authority, r esidues of 
benthiavalicarb  are expected to be above  the value set in point  3.6.5 of Annex II to 
Regulation (EC) No  1107/2009 , and , therefore, such requirement is not fulfilled . 
(10) In its evaluation of whether benthiavalicarb  is necessary to control a serious danger to 
plant health which cannot be contained by  other available means including non -
chemical methods in accordance with Article 4(7) of Regulation (EC) No  1107/2009, 
the Authority  concluded that , despite the fact that there may be an insufficient number 
of chemical alternatives available for some uses of benthiavalicarb and in some 
Member States, some non -chemical methods are also available, and that a combination 
of chemical and non -chemical methods may be possible to control the pests in some 
crops. In addition, the Commission considers that no seriou s danger to plant health has 
been identified. Therefore, the Commission considers that the conditions for the 
application of the derogation in Article 4(7) of Regulation (EC) No 1107/2009 are not 
fulfilled.  
(11) The Commission presented its draft renewal report regarding benthiavalicarb and a 
draft of this Regulation to the Standing Committee on Plants, Animals, Food and Feed 
on 24  May 2023  and on 11  July 2023 , respectively.  
(12) The Commission invited the applicant to submit its comments on the c onclusion of the 
Authority  and on the draft renewal report. The applicant submitted its comments, 
which have been carefully examined.  
                                                 
6 Peer review of the pesticide risk assessment of the active substance benthiavalicarb (variant assessed 
benthiavalicarb -isopropyl)  (EFSA Journal 2021;19(9):6833 ; https://doi.org/10.2903/j.efsa.2021.6833 ). 
7 European Chemicals Agency, Committee for Risk Assessment RAC, Opinion proposing harmonised classification 
and labelling at EU level of benthiavalicarb -isopropyl (ISO); isopropyl [(S) -1- {[(R) -1-(6-fluoro -1,3-benzothiazol -
2- yl)ethyl]carbamoyl} -2-methylprop yl]carbamate EC  Number: - CAS Number: 177406 -68-7 CLH -O-
0000007106 -79-01/F; adopted on 18 March 2022; https://echa.europa.eu/documents/10162/c334cdfd -3fd8-adff-
04a2 -9f84dd871f6a .  
EN 3  EN (13) Despite the comments put forward by the applicant, the concerns  raised in the risk 
assessment of benthiavalicarb  could not  be eliminated.  
(14) Consequently, it has not been established -with respect to one or more representative 
uses of at least one plant protection product containing benthiavalicarb - that the 
approval criteria provided for in Article  4 of Regulation (EC) No  1107 /2009 are 
satisfied. It is therefore appropriate not to renew the approval of the active substance 
benthiavalicarb.  
(15) Implementing Regulation (EU) No 540/2011 should therefore be amended 
accordingly.  
(16) Member States should be given sufficient time to withdraw authorisations for plant 
protection products containing benthiavalicarb.  
(17) For plant protection products containing benthiavalicarb, where Member States grant 
any grace period in accordance with Article 46 of Regulation (EC) No  1107/2009, that 
period should not exceed 12 months  from the date of entry into force of this 
Regulation.   
(18) Commission Implementing Regulation (EU) 202 3/9188 extend s, until 
15 November  2024, the approval of benthiavalicarb i n order to allow the renewal 
process to be completed before the expiry of the approval period of that substance. 
However, given that a decision on the non -renewal of the approval can be taken ahead 
of the expiry date, this Regulation should apply earlier t han that date.  
(19) This Regulation does not preclude the submission of a further application for the 
approval of benthiavalicarb pursuant to Article  7 of Regulation (EC) No  1107/2009.  
(20) The measures provided for in this Regulation are in accordance with the opini on of the 
Standing Committee on Plants, Animals, Food and Feed,  
HAS ADOPTED THIS REGULATION:  
Article 1  
Non-renewal of approval of active substance  
The approval of the active substance benthiavalicarb is not renewed.  
Article 2  
Amendment to Implementing Regulation (EU) No 540/2011  
In Part A of the Annex to Implementing Regulation (EU) No 540/2011 , row 163, 
benthiavalicarb, is deleted.  
                                                 
8 Commission Implementing Regulation (EU) 2023/918 of 4  May 2023 amending Implementing 
Regulation (EU) No  540/2011 as regards the extension of the approval periods of the active substances 
aclonifen, ametoctradin, beflubutamid, benthiavalica rb, boscalid, captan, clethodim, cycloxydim, 
cyflumetofen, dazomet, diclofop, dimethomorph, ethephon, fenazaquin, fluopicolide, fluoxastrobin, 
flurochloridone, folpet, formetanate, Helicoverpa armigera nucleopolyhedrovirus, hymexazol, 
indolylbutyric acid, mandipropamid, metalaxyl, metaldehyde, metam, metazachlor, metribuzin, 
milbemectin, paclobutrazol, penoxsulam, phenmedipham, pirimiphos -methyl, propamocarb, 
proquinazid, prothioconazole, S -metolachlor, Spodoptera littoralis nucleopolyhedrovirus, Trichoderm a 
asperellum strain T34 and Trichoderma atroviride strain I -1237 ( OJ L 119, 5.5.2023, p. 160 ).  
EN 4  EN Article 3  
Transitional measures  
Member States shall withdraw authorisations for plant protection products containing 
benth iavalicarb as an active substance by … [ Office of Publications : please insert date 
6 months from the date of entry into force of this Implementing Regulation ]. 
Article 4  
Grace period  
Any grace period granted by Member States in accordance with Article 46 o f Regulation (EC) 
No 1107/2009 shall expire by … [Office of Publications : please insert date 12 months from 
the date of entry into force of this Implementing Regulation] .  
Article 5  
Entry into force  
This Regulation shall enter into force on 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