EN    EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/11019/2017 rev. 3  
[…](2018) XXX  draft  
  
COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
concerning the non -renewal of approval of the active substance thiram, 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 
Commission Implementing Regulation (EU) No 540/2011  
(Text with EEA relevance)    
EN 0   EN  
EN 1   EN COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
concerning the non -renewal of approval of the active substance thiram, in accordance 
with Regulation (EC) No 1107/2009 of the European Parliament and of the Council 
concerning the p lacing of plant protection products on the market, and amending 
Commission Implementing Regulation (EU) No 540/2011  
(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  79/11 7/EEC and 91/414/EEC1, and in particular 
Article  20(1)  and Article 78(2) thereof,  
Whereas:  
(1) Commission Directive 2003/8 1/EC2 included thiram  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 Re gulation (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 thiram , as set out in Part A of the Annex to 
Implementing Regulation (EU) No 540/2011 , expires on  30 April  2019. 
(4) An application for the renewal of the approval of thiram  was submitted in accordance 
with Article 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 application was found 
to be complete by the rapporteur Member State.  
                                                 
1 OJ L 309, 24.11.2009, p. 1.  
2 Commission Directive 2003/8 1/EC of 5 September 2003 amending Council Directive 91/414/EEC to 
include molinate, thiram and ziram  as active substa nces (OJ L 224 , 6.9.2003, p. 29 ). 
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 th e 
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 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 consultat ion 
with the co -rapporteur Member State and submitted it to the European Food Safety 
Authority (‘the Authority’) and the Commission on 20 January  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 27 January 2017 the Authority communicated to the Commission its conclusion6 
on whether thiram can be expected to meet the approval c riteria provided for in 
Article  4 of Regulation (EC) No  1107/2009. The Authority identified  a high acute risk 
to consumers and to workers from the foliar uses assessed  and a high risk to birds and 
mammals  from all uses assessed , including as a seed treatment,  even taking into account  
the application of higher tier refinements  in the risk assessment . Residue definitions for 
risk assessment purposes could not be derived  from the incomplete information 
available on metabolite  M1, consequently the assessment of consumer risk through 
dietary intake could not be completed and maximum residue levels could not be 
established . Furthermore, t he formation of N -N-dimethylnitrous amide (NDMA), a 
substa nce of concern  given its intrinsic hazard , in drinking water when surface water 
and groundwater containing thiram and its metabolite DMCS is subject to water 
treatment processes could not be excluded  by the Authority based on the available 
information and in addition a high risk to aquatic organisms from exposure to DMCS 
was concluded by the Authority  based on the limited information available . Also, 
based on the information available the Authority could not conclude on the endocrine 
disrupting potential of thiram .  
(9) The Commission invited the applicant to submit its comments on the conclusion of the 
Authority. Furthermore, in accordance with the third subparagraph  of Article  14(1) of 
Implementing Regulation (E U) No 844/2012, the Commission invited the applicant to 
submit comments on the draft renewal report . The applicant submitted its comments, 
which have been carefully examined.  
(10) However, despite the arguments put forward by the applicant, the concerns related to 
the substance  could  not be eliminated.  
(11) Consequently, it has not been  established with respect to one or more representative 
uses of at least one plant protection product that the approval criteria provided for in 
Article  4 of Regulation (EC) No 1107/2009 are satisfied. It is therefore appropriate not 
to renew t he approval of the active substance thiram  in accordance with Article 
20(1)(b) of that Regulation . 
(12) Implementing Regulation (EU) No 540/2011 should therefore be amended 
accordingly.  
(13) Taking into account the risk  identified for birds and wild mammals from treated seeds  
the placing on the market and the use of seeds treated with plant protection products 
containing thiram should be prohibited . 
(14) The prohibition of placing on the market and use of treated seed s should apply as of 
[publications office insert date 15 months + 1 day from the date of entry into force] in 
                                                 
6 EFSA (European Food Safety Authority), 2016. Conclusion on the peer review of the pesticide risk 
assessment of the active substance thiram. EFSA Journal 201 7;15(7):4700 [29 pp.].  
doi:10.2903/j.efsa.2017.4700 .  
EN 3   EN order to allow for a sufficient period of transition for the seed supply chain taking into 
account the limited availability of seeds that are not treated with  products containing 
thiram.  
(15) Member States should be allowed sufficient  time to withdraw authorisations for plant 
protection products containing thiram .  
(16) For plant protection products containing thiram , 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 [publications office insert date 15  months  from the date 
of entry into force] .  
(17) Commission  Implementing  Regulation (EU) 201 7/XXX7 extended the expiry date of 
thiram  to 30 April  2019 in order to allow the renewal process to be completed before 
the expiry of the approval of that substance. However, g iven that a decision is taken 
ahead of th at extended expiry date, this Regulation sh ould apply  as soon as possible . 
(18) This Regulation does not prevent  the submission of a further application for the 
approval of thiram  in accordance with Article  7 of Regulation (EC) No  1107/2009.  
(19) The measures provided for in this Regu lation 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 thiram  is not renewed.   
Article 2  
Amendments to Implementing Regulation (EU) No 540/2011  
In Part A of the Annex to Implementing Regulation (EU) No 540/2011, row 73, on thiram , is 
deleted.  
Article 3 
Prohibition of placing on the market of treated seeds  
Seeds which have been treated with plant protection products containing thiram shall not be 
used or placed on the market.  
Article 4 
Transitional measures  
Member States shall withdraw authorisations for plant protection products containing thiram  
as active substance by [ Office of Publication s please insert date 6 months  from the date of 
entry into force ] at the latest.   
                                                 
7 Commission Implementing Regulation (EU) 2017/XXX (…) (OJ L  XXX ).   
EN 4   EN Article 5 
Grace period  
Any grace period granted by Member States  in accordance with Article 46 of Regulation (EC) 
No 1107/2009 shall be as short as possible and shall expire by [insert date 15 months  from the 
date of entry into force]  at the latest.  
Article 6 
Entry into force   
This Regulation shall enter into force on the twentieth day following that of its publication i n 
the Official Journal of the European Union . 
Article 3 shall apply as of [publications office insert date 15 months + 1 day  from the date of 
entry into force] . 
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