COMMI SSION IMPLEMENTING REGUL ATION (EU) 2019/1100 
of 27 June 2019 
concer ning the non-renewal of appro val of the activ e subst ance desmedipham, in accordance with 
Regulation (EC) No 1107/2009 of the European Parliament and of the Council concer ning 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 EUR OPEAN COMMISSION, 
Having regar d to the Treaty on the Functioning of the European Union, 
Having regar d to Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 
concer ning the placing of plant prote ction products on the mark et and repealing Council Directives 79/117/EEC and 
91/414/EEC (1), and in particular Article 20(1) and Article 78(2) thereof, 
Whereas: 
(1)  Commission Directive 2004/58/EC (2) included desmedipham as an active substance in Annex I to Council 
Directive 91/414/EEC (3). 
(2)  Active substances included in Annex I to Directive 91/414/EEC are deemed to have been appro ved under 
Regulation (EC) No 1107/2009 and are liste d in Part A of the Annex to Commission Implementing Regulation 
(EU) No 540/2011 (4). 
(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 2020. 
(4)  An application for the renewal of the appro val of desmedipham was submitted in accordance with Article 1 of 
Commission Implementing Regulation (EU) No 844/2012 (5) within the time period provided for in that Article. 
(5)  The applicant submitted the supplementar y dossiers required in accordance with Article 6 of Imple menting 
Regulation (EU) No 844/2012. The application was found to be complet e by the rappor teur Member State. 
(6)  The rappor teur Member State prepared a renewal assessment repor t in consultation with the co-rappor teur 
Member State and submitt ed it to the European Food Safet y Author ity (‘the Author ity’) and the Commission on 
21 December 2016. 
(7)  The Author ity communicate d the renewal assessment repor t to the applicant and to the Member States for 
comments and forwarded the comments received to the Commission. The Authority also made the supple ­
mentar y summar y dossier available to the public. 
(8)  On 10 Januar y 2018, the Author ity communicate d to the Commission its conclusion (6) on whether 
desmedipham can be expect ed to meet the appro val criteria provid ed for in Article 4 of Regulation (EC) 
No 1107/2009. 28.6.2019 L 175/17 Official Jour nal of the European Union EN     
(1)OJ L 309, 24.11.2009, p. 1. 
(2)Commission Directive 2004/58/EC of 23 Apr il 2004 amending Council Directive 91/414/EEC to include alpha-cyper methr in, 
benalaxyl, bromo xynil, desmedipham, ioxynil and phenmedipham as active substances (OJ L 120, 24.4.2004, p. 26). 
(3)Council Directive 91/414/EEC of 15 July 1991 concer ning 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 regar ds the list of approved active substances (OJ L 153, 11.6.2011, p. 1). 
(5)Commission Implementing Regulation (EU) No 844/2012 of 18 Sept ember 2012 setting out the provisions necessar y for the implemen ­
tation of the renewal procedure for active substances, as provided for in Regulation (EC) No 1107/2009 of the European Parliament and 
of the Council concer ning the placing of plant prot ection products on the market (OJ L 252, 19.9.2012, p. 26). 
(6)EFSA (European Food Safet y 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/efsajou rnal/pub/5150 (9)  The Author ity identified specifi c concer ns. In particular , it was not possible to exclude exposure of consumers 
and/or livestoc k to residues containing free and/or conjugat ed aniline (classified as mutagen catego ry 2 and 
carcinog en catego ry 2) and consumer exposure to residues containing 4-aminophenol (classified as mutagen 
catego ry 2) via animal commodities. In addition, the Author ity concluded that a high long-t erm risk to mammals 
was identif ied for all representative uses, exce pt for insectivoro us mammals when the use patter n includes only 
one application. A high long-ter m risk for birds was identif ied for the representative uses in sugar beet/f odder 
beet, when the use patt ern includes two or three applications. 
(10)  Further more, the Auth ority also concluded that the assessment of endocr ine disrupting proper ties could not be 
compl eted based on the available information. 
(11)  The Commission invit ed the applicant to submit its comments on the conclusion of the Author ity and, in 
accordance with the third subparagraph of Article 14(1) of Implementing Regulation (EU) No 844/2012, on the 
draf t renewal repor t. The applicant submitted its comments, which have been carefully examined. 
(12)  Howe ver, despit e the arguments put forward by the applicant, the concer ns 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 
prot ection product that the approval criteria provi ded for in Article 4 of Regulation (EC) No 1107/2009 are 
satisfied. It is theref ore appropr iate 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 theref ore be amended according ly. 
(15)  Member States should be given suffic ient time to withdraw author isations for plant prote ction products 
containing desmedipham. 
(16)  For plant prot ection products containing desmedipham, 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 1 July 
2020. 
(17)  Commission Implementing Regulation (EU) 2019/707 (7) extended the appro val period of desmedipham to 
31 July 2020 in order to allow the renewal process to be compl eted before the expir y of the appro val of that 
substance. However , given that a decision on the non-renewal of the approval has been taken ahead of that 
exte nded expir y date, this Regulation should apply as soon as possible. 
(18)  This Regulation does not prevent the submission of a further application for the approval of desmedipham 
pursuant to Article 7 of Regulation (EC) No 1107/2009. 
(19)  The measures provi ded for in this Regulation are in accordance with the opinion of the Standing Committee on 
Plants, Animals, Food and Feed, 
HAS ADOPTED THIS REGUL ATION: 
Article 1 
Non-renewal of the appro val of activ e subst ance 
The approval of the active substance desmedipham is not renewed. 28.6.2019 L 175/18 Official Jour nal of the European Union EN     
(7)Commission Implementin g Regulation (EU) 2019/707 of 7 May 2019 amending Implementing Regulation (EU) No 540/2011 as 
regar ds the exten sion of the approval periods of the active substances alpha-cyper methr in, beflubutamid, benalaxyl, benthia valicarb, 
bifenazate, boscalid, bromo xynil, captan, cyazofam id, desmedipham, dimethoate, dimethomor ph, diuron, ethephon, etoxazole, 
famo xadone, fenamiphos, flumio xazine, fluoxastrobin, folpet, foramsulfuron, formetanate, metalaxyl-m, methiocarb, metr ibuzin, 
milbemectin, Paecilomy ces lilacinus strain 251, phenmedipham, phosmet, pirimiphos-methyl, propamocarb, prothioconazole, 
s-meto lachlor and tebuconazole (OJ L 120, 8.5.2019, p. 16). 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 delet ed. 
Article 3 
Transitional measures 
Member States shall withdraw author isations for plant protect ion products containing desmedipham as active substance 
by 1 Januar y 2020 at the lates t. 
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 1 July 2020 at the latest . 
Article 5 
Entr y into force 
This Regulation shall enter into force on the third day followi ng 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 State s. 
Done at Brussels, 27 June 2019. 
For the Commission 
The President 
Jean-Claude JUNCK ER  28.6.2019 L 175/19 Official Jour nal of the European Union EN