EN    EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/11019/2017 rev. 5  
[…](2018) XXX  draft  
  
COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
concerning the non -renewal of approval of the active substance thiram, and prohibiting 
the use and sale of seeds treated with plant protection products containing 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 1   EN COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
concerning  the non -renewal of approval of the active substance thiram, and prohibiting 
the use and sale of seeds treated with plant protection products containing thiram, in 
accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the 
Council c oncerning the placing 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), Article 49(2)  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 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 thiram , as set out in Part A of the Annex to 
Implementing Regulatio n (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 substances  (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 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 products on the market  (OJ L 252, 19.9.2012, p. 26 ).  
EN 2   EN (6) The rapporteur Member State prepared a renewal as sessment report in consultation 
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 application of thiram by foliar  spray ing. Furthermore, 
it identified a high risk to birds and mammals  from all representative 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 substance 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 cou ld 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 con cerns 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) On 18 May 2018 the applicant wrote to the Commission to withdraw from the renewal 
application the representative uses concerning application by  foliar spraying.  
(13) Implementing Regulation (EU) No 540/2011 should therefore be amended 
accordingly.  
(14) 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 . 
                                                 
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 (15) The prohibition of placing on the market and use of treated seeds should apply as of 
[publications office insert date 15 months + 1 day from the date of entry into force] in 
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.  
(16) Member States should be allowed sufficient  time to withdraw authorisations for plant 
protection products containing thiram .  
(17) 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 6 months from the date 
of entry into force]  for plant protection  products used for foliar application and on  
[publications office insert date 15  months from the date of entry into force]  for other 
plant protection products , including those used for seed treatment .  
(18) Commission  Implementing Regulation (EU) 201 8/5247 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 enter into force  as soon as 
possible . 
(19) 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.  
(20) The measures provided for in this Regulation are in accordance with the opinion of the  
Standing Committee on Plant s, Animals, F ood 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.  
                                                 
7 Commission Implementing Regulation (EU) 2018/524 of 28 March 2018 amending Implementing 
Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active 
substances Bacillus subtilis (Cohn 1872) Strain QST 713, identical with strai n AQ 713, clodinafop, 
clopyralid, cyprodinil, dichlorprop -P, fosetyl, mepanipyrim, metconazole, metrafenone, pirimicarb, 
Pseudomonas chlororaphis strain: MA 342, pyrimethanil, quinoxyfen, rimsulfuron, spinosad, 
thiacloprid, thiamethoxam, thiram , tolclofos -methyl, triclopyr, trinexapac, triticonazole and ziram. 
(OJ L 88, 4.4.2018, p. 4).   
  
EN 4   EN Article 4 
Transitional measures  
Member States shall withdraw authorisations for plant protection products containing thiram  
as active substance by [ Office of Publications please insert date 3 months  from the date of 
entry into force ] at the latest.   
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  [publications office insert date 
6 months from the date of entry into force]  for plant protection products used for foliar 
application  and on [publications office insert date 15 months from the date of entry into force] 
for other plant protection products, including those used for seed treatment , at the latest.  
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 . 
Article 3 shall apply as of [publications office insert date 15 months + 1 day from th e 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