EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX  
SANTE/11253/2018 rev. 0  
[…](2018) XXX  draft  
 
COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
concerning the non -renewal of approval of the active substance thiophanate -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  
(Text with EEA relevance)   EN 1  EN COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
concerning the non -renewal of approval of the active substance thiophanate -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  
(Text with EEA relevance)  
THE E UROPEAN 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  79/11 7/EEC and 91/414/EEC1, and in particular 
Article  20(1)  and Article 78(2) thereof,  
Whereas:  
(1) Commission Directive 2005/53/EC2 included thiophanate -methyl as an active 
substance in Annex I to Council Directive 91/414/EEC3. 
(2) Active substances included in Annex I to Directive 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 thiophanate -methyl , as set out in Part A of the 
Annex to Implementing Regulation (EU) No 540/2011 , expires on 31  October  2019 . 
(4) An application for the renewal of the approval of thiophanate -methyl was submitted in 
accordance with Articl e 1 of Commission Implementing Regulation (EU) 
No 844/20125 within the time period provided for in that Article.  
(5) The applicant submitted the supplementary dossiers required in accordance with 
Article  6 of Implementing Regulation (EU) No  844/2012 . The appli cation was found 
to be complete by the rapporteur Member State.  
                                                 
1 OJ L 309, 24.11.2009, p.  1. 
2 Commission Directive 2005/53/EC of 16 September 2005 amending Council Directive 91/414/EEC to 
include chlorothalonil , chlorotoluron, cypermethrin, daminozide and thiophanate -methyl as active 
substances ( OJ L 241, 17.9.2005, p.  51). 
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 Imp lementing 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 Cou ncil concerning the 
placing of plant protection products on the market  (OJ L 252, 19.9.2012, p.  26). EN 2  EN (6) The rapporteur Member State prepared a renewal assessment report in consultation 
with the co -rapporteur Member State and submitted it to the European Food Safety 
Authority (‘the Authority’) and the Commission on 1 November  2016 . 
(7) The Authority communicated the renewal assessment report to the applicant and to the 
Member States for comments and forwarded the comments received to the 
Commission. The Authority also made the supplementary summary dossier available 
to the public.  
(8) On 1 7 January  2018 the Authority communicated to the Commission its conclusion6 
on whether thiophanate -methyl can be expected to meet the approval criteria provided 
for in Article  4 of Regulation (EC) No  1107/2009.  The Commission presented the 
draft renewal report for thiophanate -methyl t o the Standing Committee on Plants, 
Animal, Food and Feed on 24  October  2018.  
(9) Specific concerns  were identified . In particular, it was not possible to exclude exposure 
risk to consumers, operators, workers, bystanders and residents due to their exposure to  
residues of thiophanate -methyl (for which the genotoxic potential could not be excluded) 
and its main metabolite carbendazim (for which harmonised classification is mutagen 
category  1B and toxic for reproduction category  1B). The Authority also concluded that 
a high long -term risk was identified to birds and mammals for all representative uses. 
Finally, the Authority highlighted lack of toxicological data for the metabolites 2 -AB, 
FH-432, DX -105 to which consumers might be exposed and for metabolite CM-0237 
which might occur in surface and groundwater .  
(10) Furthermore, Authority concluded that there is enough evidence to conclude that the 
substance is an endocrine disruptor and that the mechanism is relevant to humans.  
(11) The Commission invited the applican t to submit its comments on the conclusion of the 
Authority  and, in accordance with the third paragraph of Article  14(1) of 
Implementing Regulation (E U) No  844/2012, to submit comments on the draft 
renewal report. The applicant submitted its comments, whic h have been carefully 
examined.  
(12) However, despite the arguments put forward by the applicant, the concerns referred to 
in recital 9  could not be eliminated.  
(13) Consequently, it has not been  established with respect to one or more representative 
uses of at leas t one plant protection product that the approval criteria provided for in 
Article  4 of Regulation (EC) No  1107/2009 are satisfied. The approval of the active 
substance thiophanate -methyl should therefore not be renewed.  
(14) Implementing Regulation (EU) No 540/ 2011 should therefore be amended 
accordingly.  
(15) Member States should be given  sufficient time to withdraw authorisations for plant 
protection products containing thiophanate -methyl . 
(16) For plant protection products containing  thiophanate -methyl , where Member States 
grant any grace period in accordance with Article  46 of Regulation (EC) 
No 1107/2009, that period should at the latest, expire on [ Office of Publications please 
insert date 12 months from the date of entry into force ]. 
                                                 
6 EFSA (European Food Safety Authority), 2018. Conclusion on the peer review of the pesticide risk 
assessment of the active substance thiophanate -methyl  EFSA Journal 2018;16(1):51 33. 
https://www.efsa.europa.eu/en/efsajournal/pub/51 33.  EN 3  EN (17) Commission Implementing Regula tion (EU) 2018/ 12627 extended the approval period  
of thiophanate -methyl to 31  October  2019  in order to allow the renewal process to be 
completed before the expiry of the approval period of that substance. Given that a 
decision on the non -renewal of the app roval has been taken ahead of that extended 
expiry date, this Regulation should apply as soon as possible.  
(18) This Regulation does not p revent  the submission of a further application for the 
approval of thiophanate -methyl pursuant to Article 7 of Regulation ( EC) 
No 1107/2009.  
(19) The measures provided for in this Regulation are in accordance with the opinion of the  
Standing Committee on Plant s, Animals, Food and Feed , 
HAS ADOPTED THIS REGULATION:  
Article 1  
Non-renewal of approval of active substance  
The approval of the active substance thiophanate -methyl 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 105, on 
thiophanate -methyl , is deleted.  
Article 3 
Transitional measures  
Member States shall withdraw authorisations for plant protection products containing 
thiophanate -methyl as active substance by [ Office of Publications please insert date 6 months 
from the date of entry into force ] at the latest.  
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 1 2 months from the 
date of entry into force]  at the latest.  
Article 5  
Entry into force  
This Regulation shall enter into force on the third  day following that of its publication in the 
Official Journal of the European Union . 
                                                 
7 Commission Implementing Regulation (EU) 2018/1262 of 20 September 2018 amending Implementing 
Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances 
1-methylcyclopropene, beta -cyfluthrin, chlorothalonil, chlorotoluron, clomazone, cypermethrin, 
daminozide, deltamethrin, dimethenamid -p, diuron, fludioxonil, flufena cet, flurtamone, fosthiazate, 
indoxacarb, MCPA, MCPB, prosulfocarb, thiophanate -methyl and tribenuron  (OJ L 238, 21.9.2018, 
p. 62). EN 4  EN This Regulation shall be binding in its entirety and directly applicable in all Member States.  
Done at Brussels,  
 For the Commission  
 The President  
 Jean -Claude JUNCKER