EN    EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/11034/2017  
[…](2017) XXX  draft  
  
COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
concerning the non -renewal of approval of the active substance propineb, 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 2   EN COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
concerning the non -renewal of approval of the active substance propineb, 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 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 2003/39 /EC2 included propineb  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 propineb , as set out in Part A of the Annex to 
Implementing Regulation (EU) No 540/2011 , expires on 31 January  2018. 
(4) An application for the renewal of the approval of propineb  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 wi th 
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/ 39/EC of 15 May 2003 amending Council Directive 91/414/EEC to 
include propineb and propyzamide as active substances  (OJ L 124, 20.5.2003, p. 30). 
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 an d of the Council concerning the 
placing of plant protection products 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 subm itted it to the European Foo d Safety 
Authority ( ‘the Aut hority’) and the Commission on 1 October  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 th e 
Commission. The Authority also made the supplementary summary dossier  available 
to the public.  
(8) On 1 5 November  2016 the Authority communicated to the Commission its 
conclusion6 on whether propineb  can be expected to meet the approval criteria 
provided for in Article  4 of Regulation (EC) No  1107/2009. The Authority concluded 
that the consumer risk assessment through dietary intake cannot be conducted for the 
products of plant and animal origin. Base d on the data available in the dossier it was not 
possible to complete the assessment of relevant metabolites of propineb .  
(9) In addition, the Authority underlined a critical area of concern for propineb related to 
the endocrine disrupting properties  of the relevant  metabolite 4-methylimidazolidine -
2-thione (PTU) which is classified as toxic for reproduction category  2 and has tyroid 
as a target organ for toxicity . 
(10) Moreover,  the Authority could not finalise  the assessment of  the risk to honeybee 
brood  and con cluded that a high risk to honeybee brood development could not be 
excluded  for propineb . 
(11) The Commission invited the applicant to submit its comments on the conclusion of the 
Authority. Furthermore, in accordance with the third paragraph  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.  
(12) However, despite the arguments put forward by the ap plicant, the concerns related to 
the substance  could  not be eliminated.  
(13) Based on these identified risks , it has not been  established with respect to one or more 
representative uses of at least one plant protection product that the approval criteria 
provid ed 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 propineb  in accordance 
with Article 20(1)(b) of that Regulation . 
(14) Commission Implementing Regulation (EU) No 540 /2011 should therefore be 
amended accordingly.  
(15) Member States should be allowed sufficient  time to withdraw authorisations for plant 
protection products containing propineb .  
(16) For plant protection products containing propineb , 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 
15 months from the date of entry into force] .  
                                                 
6 EFSA (European Food Safety Authority), 2016. Conclusion on the peer review of the pesticide risk 
assessment of the active substance propineb . EFSA Journal 2016;14( 11):4605 , 26 pp. 
doi:10.2903/j.efsa.2016.460 5.  
EN 4   EN (17) Commission  Implementing Regulation (EU) 2016/ 20167 extended the expiry date of 
propineb  to 31  January  2018 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 has 
been taken ahead of that extended expiry date, this Regulation should apply as  soon as 
possible.  
(18) This Regulation does not prejudice the submission of a further application for the 
approval of propineb 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 Plants, Animals, Food and Feed,  
HAS ADOPTED THIS REGULATION:  
Article 1  
Non-renewal of approval of active substance  
The approval of the active substance propineb  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 54, on propineb , 
is deleted.  
Article 3 
Transitional measures  
Member States shall withdraw authorisations for plant protection products conta ining 
propineb  as active substance by [ Office of Publications please insert date 3 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 [Office of Publications  please 
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.  
                                                 
7 Commission Implementing Regulation (EU) 2016/ 2016  of 17 November  2016 amending Implementing 
Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active su bstances 
acetamiprid , benzoic acid,  flazasulfuron, mecoprop -p, mepanipyrim, mesosulfuron, propineb, 
propoxycarbazon, propyzamide, propiconazole, Pseudomonas chlororaphis Strain: MA 342, 
pyraclostrobin, quinoxyfen, thiacloprid, thiram, ziram, zoxamide  (OJ L  312, 18.11.2016, p. 21).   
EN 5   EN Done at Brussels,  
 For the Commission  
 The President  
 Jean -Claude JUNCKER