EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX  
SANTE/10555/2018 rev. 0  
[…](2018) XXX  draft  
 
COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
concerning the non -renewal of approval of the active substance desmedipham, 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 An nex 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 approval of the active substance desmedipham, 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  79/11 7/EEC and 91/414/EEC1, and in particular 
Article  20(1)  and Article 78(2) thereof,  
Whereas:  
(1) Commission Directive 2004/58/EC2 included desmedipham  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 desmedipham , as set out in Part A of the Annex 
to Implementing Regulation (EU) No 540/2011 , expires on 31  July 2019 . 
(4) An application for the renewal of the approval of desmedipham 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 2004/58/EC of 23 April 2004 amending Council Directive 91/414/EEC to 
include alpha -cypermethrin, benalaxyl, bromoxynil, desmedipham, ioxynil and  phenmedipham as 
active substances (OJ L 120, 24.04.2004, p. 26. ) 
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 Septembe r 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 prod ucts 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 21 December  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 10 January  2018, the Authority communicated to the Commission its conclusion6 
on whether desmedipham  can be  expected to meet the approval criteria provided for in 
Article  4 of Regulation (EC) No  1107/2009.  
(9) The Autority identified specific  concerns. In particular, it  was not possible to exclude  
exposure of consumers and/or livestock to residues containing free and/or conjugated 
aniline (classified as mutagen category  2 and carcinogen category  2) and consumer 
exposure to residues containing 4-aminophenol (classified as mutagen category  2) via 
animal commodities. In addition, the Authority concluded that a high long -term risk to 
mammals was identified for all representative uses, except for insectivorous mammals 
when the use pattern includes only one application . A high long -term risk for birds 
was identified for the representative uses in sugar beet/fodder beet, when the use 
pattern includes two or three applications .  
(10) Furthermore, the Authority also concluded that the assessment of endocrine disrupting 
properties could not be completed based on the available information .  
(11) The Commission invited the applicant to submit its comments on the conclusion of the 
Authority  and, in accordance with the third subparagraph of A rticle  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.  
(12) However, despite the arguments put forward by the applicant, the concerns regarding 
the active substance could not be eliminated.  
(13) 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 desmedipham  in accordance with 
Article  20(1)(b) of that Regulation . 
(14) Implementing Regulation (EU) No 540/2011 should therefore be amended 
accordingly.  
(15) Member States shou ld be given sufficient time to withdraw authorisations for plant 
protection products containing desmedipham . 
(16) For plant protection products containing  desmedipham , 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 please insert date 
12 months from the date of entry into force] .  
                                                 
6 EFSA (European Food Safety Authority), 2018. Conclusion on the peer review of the pesticide risk 
assessment of the active substance desmedipham EFSA Journal 2018;16(1):5150  
https://www.efsa.europa.eu/en/efsajournal/pub/5150  . 
 EN 3  EN (17) Commission Implementing Regulation (EU) 2018/ 9177 extended the approval period 
of desmed ipham  to 31  July 2019  in order to allow the renewal process to be completed 
before the expiry of the approval of that substance. However, given that a decision on 
the non -renewal of the approval has been taken ahead of that extended expiry date, this 
Regul ation should apply as soon as possible.  
(18) This Regulation does not p revent  the submission of a further application for the 
approval of desmedipham  pursuant to Article 7 of Regulation (EC) No 1107/2009.  
(19) The measures provided for in this Regulation are in acco rdance with the opinion of the  
Standing Committee on Plant s, Animals, Food and Feed , 
HAS ADOPTED THIS REGULATION:  
Article 1  
Non-renewal of the approval of active substance  
The approval of the active substance desmedipham  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 86, on 
desmedipham , is deleted.  
Article 3 
Transitional measures  
Member States shall withdraw authorisations for plant protection products containing 
desmedipham  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 expire by [insert date 1 2 months from the date of entry into force]  at the 
latest.  
Article 5  
Entry into force  
This Regulation shall enter into fo rce on the third day following that of its publication in the 
Official Journal of the European Union . 
                                                 
7 Commission Implementing Regulation (EU) 2018/917 of 27 June 2018 amending Implementing 
Regulation (EU) No 540/2011 as regards the exten sion of the approval periods of the active substances 
alpha -cypermethrin, beflubutamid, benalaxyl, benthiavalicarb, bifenazate, boscalid, bromoxynil, captan, 
carvone, chlorpropham, cyazofamid, desmedipham, dimethoate, dimethomorph, diquat, ethephon, 
ethopr ophos, etoxazole, famoxadone, fenamidone, fenamiphos, flumioxazine, fluoxastrobin, folpet, 
foramsulfuron, formetanate, Gliocladium catenulatum strain: J1446, isoxaflutole, metalaxyl -m, 
methiocarb, methoxyfenozide, metribuzin, milbemectin, oxasulfuron, Paec ilomyces lilacinus strain 251, 
phenmedipham, phosmet, pirimiphos -methyl, propamocarb, pro thioconazole, pymetrozine and 
s-metolachlor – (OJ L 163, 28.6.2018, p. 13 ). EN 4  EN 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