EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX  
SANTE/11931/2017 Rev 1  
[…](2018) XXX  draft  
 
COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
concerning the non -renewal of approval of the active substance propiconazole, 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 Comm ission Implementing Regulation (EU) No 540/2011  
(Text with EEA relevance)   EN 2  EN COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
concerning the non -renewal of approval of the active substance propiconazole, 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)  
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 rep ealing 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 2003/70/EC2 included propiconazole as 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 (E U) No 540/20114. 
(3) The approval  of the active subs tance propiconazole , as set out in Part A of the Annex 
to Implementing Regulation (EU) No 540/2011, expires on 31  January  2019. 
(4) An application for the renewal of the approval  of propiconazole  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 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 2003/70/EC of 17 July 2003  amending Council Directive 91/414/EEC to include 
mecoprop, mecoprop -P and propiconazole  as active substances (OJ L 184, 23.7.2003, p. 9).  
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 540/2 011 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 produc ts on the market  (OJ L 252, 19.9.2012, p. 26 ). EN 3  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 Foo d Safety 
Authority ( ‘the Aut hority’) and the Commission on 15 April  2015. 
(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 14 June 2017 , the Authority communicated to the Commission its conclusion6 on 
whether propiconazole can be expected to meet the approval criteria provided for in 
Article  4 of Regulation (EC) No  1107/2009 . 
(9) The Authority referred to the opinion7 of the Risk  Assessment Committee of the 
European Chemicals Agency, adopted on 9 December 2016 pursuant to Article 36(4) of 
Regulation (EC) No 1272/2008 of the European Parliament and of the Council8, which 
proposed  that propiconazole be classified as toxic for reprod uction category  1B in 
accordance with that Regulation.  Commission Regulation (EU) 2018/XXX9 
consequently amended  Annex VI to Regulation (EC) No 1272/2008 and classified  
propiconazole as toxic for reproduction category 1B.   
(10) Based on the data available in the dossier the Authority concluded that  Maximum 
Residue Levels ( ‘MRLs ’) in accordance with Regulation (EC) No 396/2005 of the 
European Parliament and of the Council10 could not be confirmed for plant and animal 
products since  data on the magnitude and toxicity of metabolites that are included in 
the residue definition for risk assessment  was not available . The current MRLs for the 
proposed uses of propiconazole are above the default value  in the meaning of Article 
18(1)(b) of Regulation (EC) No 396/2005 . For th ose reasons, it cannot be considered 
that exposure of humans to the active substance is negligible.   Therefore , the 
requirements  set out in Point 3.6.4 of Annex  II to Regulation (EC) No  1107/2009 are  
not fulfilled.   
(11) A critical  concern w as identified by the Authority in relation to the contamination of 
groundwater by metabolites of propiconazole. In  particular, metabolite NOA436613 is 
predicted to occur above the parametric value of 0.1  μg/L in all pertinent scenarios fo r 
all proposed uses of propiconazole, even when the substance is used biennally. Two 
other metabolites are predicted to occur in groundwater above 0.1  μg/L in the majority 
of pertinent scenarios. These metabolites are considered a priori  of concern since i t 
can not be excluded that they do not share the same potential for reproductive toxicity 
as parent propiconazole. Therefore, it cannot currently be established that the presence 
                                                 
6 EFSA (European Food Safety Authority), 2016. Conclusion on the peer review of the pesticide risk 
assessment of the active substance propiconazole. EFSA Journal 2017;15(7):4887, 28 pp. 
10.2903/j.efsa.2017.488 7.  
7  European Chemicals Agency (ECHA) (2016). Opinion of the Committee for Risk Assessment on a 
dossier proposing harmonised classification and labelling of propiconazole 
(ISO);  (2RS,4RS;2RS,4SR) -1-{[2-(2,4-dichlorophenyl) -4-propyl -1,3-dioxolan -2-yl]met hyl}-1H-1,2,4 -
triazole.  
8  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, an d amending Regulation (EC) No 1907/2006 ( OJ L 353, 
31.12.2008, p.  1). 
9  
10 Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23  February 2005 on 
maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending 
Council Directive 91/414/EEC ( OJ L 70, 16.3.2005, p.  1). EN 4  EN of metabolites  of propiconazole in groundwater will not result in unacceptabl e effects 
on groundwater and in harmful effects on human health  in the meaning of  
Article  4(3)(b)  and (e)  of Regulation (EC) No  1107/2009.  
(12) Additionally , the Authority concluded that propiconazole  caused toxic  effects on 
endocrine organs . However, the scientific assessment to determine the endocrine 
disrupting potential of propiconazole  could not be finalised by the Authority based on 
the information available in the dossier . Furthermore, the assessment of several aspects  
necessary to conclude on the risk to consumers through dietary intake could not be 
finalised based on the information available  in the dossier.  
(13) Given these  concerns, it is not possible  to provide for a n approval in accordance with 
Article  4(7) to Regulation (EC) No  1107/2009 . 
(14) The Commission invited the applicant to submit its comments on the conclusion of the 
Authority and, in accordance with the third subparagraph of Article  14(1) of 
Implementing Regulation (E U) No  844/2012, on the draft renewal report . The 
applicant submitted  its comments, which have been carefully examined.  
(15) However, despite the arguments put forward by the applicant, the concerns related to 
the substance  could  not be eliminated.  
(16) Consequently , it has not been established with respect to one or more representa tive 
uses of at least one plant protection product containing propiconazole 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 propiconazole  
in accordance with Article  20(1)(b) of that Regulation . 
(17) Implementing Regulation (EU) No 540/2011 should therefore be amended 
accordingly.  
(18) Member States should be given  sufficient  time to  withdraw authorisations for plant 
protection products c ontaining propiconazole.   
(19) For plant protection products containing  propiconazole , where Member States grant 
any grace period in accordance with Article  46 of Regulation (EC) No  1107/2009, th at 
period should , at the latest,  expire  on [Office of Publications  insert date 15 months  
from the date of entry into force] .  
(20) Commission Implementing Regulation (EU ) 2018/ 8411 extended the expiry date of 
propiconazole to 31 January  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 is taken ahead of this extended expiry date, this Regulation sh ould apply  as 
soon as possible . 
(21) This Regulation does not prevent  the submi ssion of a further application  for the 
approval of propiconazole  in accordance with  Article 7 of Regulation (EC) 
No 1107/2009 . 
(22) The measures provided for in this Regulation are in accordance with the opinion of the  
Standing Committee on Plant s, Animals, Foo d and Feed , 
                                                 
11 Commission Implementing Regulation (EU) 2018/84 of 19 January 2018 amending Implementing 
Regulation (EU) No 540/2011 as regards the extension of the approval periods of the acti ve substances 
chlorpyrifos, chlorpyrifos -methyl, clothianidin, copper compounds, dimoxystrobin, mancozeb, 
mecoprop -p, metiram, oxamyl, pethoxamid, propiconazole, propineb, propyzamide, pyraclostrobin and 
zoxamide . (OJ L 16, 20.1.2018, p.  8).  EN 5  EN HAS ADOPTED THIS REGULATION:  
Article 1  
Non-renewal of approval of active substance  
The approval of the active substance propiconazole  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 51, on 
propiconazole , is deleted.  
Article 3 
Transitional measures  
Member States shall withdraw authorisations for plant protection products containing 
propiconazole 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 be as short as possible and shall expire by [insert date 15 months  from the 
date of entry into force]  at the latest.   
 
Article 5  
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  
 Jean -Claude JUNCKER