EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX  
SANTE/10324/2020  
[…](2020) XXX  draft  
 
COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
concerning the non -renewal of the approval of the active substance mancozeb, 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 A nnex 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 the approval of the active substance mancozeb, 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 EUROPE AN 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 m arket 
and repealing Council Directives  79/117/EEC and 91/414/EEC1, and in particular 
Article  20(1) and Article 78(2) thereof,  
Whereas:  
(1) Commission Directive 2005/72/EC2 included mancozeb 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 mancozeb , as set out in Part A of the Annex to 
Implementing Regulation (EU) No 540/2011, expires on 31  January  2021.  
(4) Applications  for the renewal of the approval of mancozeb were 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 s submitted the supplementary dossiers required in accordance with 
Article  6 of Implementing Regulation (EU) No  844/2012. The applicat ions were found 
to be complete by the rapporteur Member State.  
                                                 
1 OJ L 309, 24.11.2009, p.  1. 
2 Commission Directive 2005/72/EC of 21 October 2005 amending Council Directive 91/414/EEC to 
include chlorpyrifos, chlorpyrifos -methyl, mancozeb, maneb, and metiram as active substances  (OJ L 
279, 22.10.2005, p. 63 .  
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 act ive 
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 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 27 September  2017 . 
(7) The Authority made the supplementary summary dossier available to the public. The 
Authority also circulated the renewal assessment report to the applicants and to the 
Member States for comments and launched a public co nsultation on it. The Authority 
forwarded the comments received to the Commission.  
(8) On 20 June 2019 , the Authority communicated to the Commission its conclusion6 on 
whether mancozeb 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 mancozeb to the Standing Committee on Plants, Animal, Food and 
Feed on  23 and 24 March 2020 . 
(9) The Authority  indentified  certain specific concerns .  In particular, i t conclud ed that 
mancozeb has been  classified a s toxic for reproduction category 1B and that the new 
criteria to identify endocrine disrupting properties are met for humans and most likely for 
non-target organisms. In addition , it concluded that the non -dietary exposure estimates 
exceed the reference values for  the representative uses in  tomatoes, p otatoes, cereals and 
grapevines . Therefore for the representative uses considered, non -dietary exposure to 
mancozeb also cannot be considered as negligible  for the pur poses of  point s 3.6.4 and 
3.6.5  of Annex II to Regulation (EC) No 1107/2009.    
(10) The Commission invited the applicant s to submit their comments on the conclusion of 
the Authority  and, in accordance with the third paragraph of Article  14(1) of 
Implementing Re gulation (E U) No  844/2012, on the draft renewal report. The 
applicant s submitted their comments which have been carefully examined.  
(11) However, despite the arguments put forward by the applicant s the concerns  regarding  
the active substance  could not be eliminated.  
(12) 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 the  approval of the active substance mancozeb . 
(13) Implementing Regulation (EU) No 540/2011 should therefore be amended 
accordingly.  
(14) Member States should be given  sufficient time to withdraw authorisations for plant 
protection products containing mancozeb . 
(15) For plant protection products containing mancozeb , 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 Pub lications please insert date 
6 months from the date of entry into force ]. 
(16) Commission Implementing Regulation (EU) 2019/20947 extended until 
31 January  2021  the period of approval of mancozeb in order to allow the renewal 
                                                 
6 EFSA (European Food Safety Authority), 2019. Conclusion on the peer review of the pesticide risk 
assessment of the active substance mancozeb. EFSA Journal 2019;17(7):5755 
DOI:  10.2903/j.efsa .2019.5755   
7 Commission implementing Regulation (EU) 2019/2094 of 29 November 2019 amending Implementing 
Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances EN 3  EN process to be completed before the ex piry of the approval period of that substance. 
Given that a decision on the non -renewal of the approval has been taken ahead of that 
extended expiry date, this Regulation should apply as soon as possible.  
(17) This Regulation does not prevent the submission of a further application for the 
approval of mancozeb pursuant to Article  7 of Regulation (EC) No  1107/2009.  
(18) 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 mancozeb 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 114, on 
mancozeb , is deleted.  
Article 3  
Transitional measures  
Member States shall withdraw authorisations for plant protection products containing 
mancozeb as an active substance by [ Office of Publications please insert date 3 months from 
the date of entry into force ]. 
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 6 months from the 
date of entry into force] . 
Article 5  
Entry into force   
This Regulation shall enter into force on twentieth  day following that of its publication in the 
Official Journal of the European Union . 
This Regulation shall be bi nding in its entirety and directly applicable in all Member States.  
                                                                                                                                                         
benfluralin, dimoxystrobin, fluazi nam, flutolanil, mancozeb , mecoprop -P, mepiquat, metiram, oxamyl 
and pyraclostrobin ( OJ L 317, 9.12.2019, p. 102).  EN 4  EN Done at Brussels,  
 For the Commission  
 The President  
 Ursula VON DER LEYEN