G/TBT/N/EU/644  
 
26 February 2019  
(19-1105) Page: 1/2 
Committee on Technical Barriers to Trade  Original: English  
 
  
NOTIFICATION  
The following notification is being circulated in accordance with Article 10.6  
 
1. Notifying Member: EUROPEAN UNION   
If applicable, name of local government involved (Article 3.2 and 7.2):   
2. Agency responsible: European Commission  
Name and address (including telephone and fax numbers, email and website 
addresses, if available) of agency or authority designated to handle comments 
regarding the notification shall be indicated if different from above:   
European Commission  
EU-TBT Enquiry Point  
Fax: +(32) 2 299 80 43  
E-mail: grow-eu-tbt@ec.europa.eu  
Website: http://ec.europa.eu/growth/tools -databases/tbt/en/   
3. Notified  under Article 2.9.2 [ X], 2.10.1 [  ], 5.6.2 [  ], 5.7.1 [  ], other:  
4. Products covered (HS or CCCN where applicable, otherwise national tariff 
heading. ICS numbers may be provided in addition, where applicable): 
Desmedipham (pesticide active substance)  
5. Title, number of pages and language(s) of the notified document: Draft 
Commission Implementing Regulation 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 
produc ts on the market, and amending the Annex to Commission Implementing 
Regulation (EU) No 540/2011 (5 pages, in English)   
6. Description of content: This draft Commission Implementing Regulation provides that 
the approval of the active substance desmedipham is not renewed in accordance with 
Regulation (EC)  No 1107/2009. Existing authorised plant protection products containing 
desmedipham will be withdrawn from the market. The non -approval is based on the first 
evaluation of the substance for use as a pesticid e active substance in the EU under 
Regulation (EC) No 1107/2009. The substance was formerly approved under 
Directive  91/414/ EEC.  
This decision only concerns the placing on the market of this substance and does not 
affect the Maximum Residue Levels (MRLs) for residues of the concerned pesticide. 
However, following non -approval, separate action may be taken on MRLs. Any subsequent 
action on MRLs will be subject to notification under the SPS procedure.  
7. Objective and rationale, including the nature of urgent problems where 
applicable: Protection of human health or safety; protection of animal or plant life or 
health; protection of the environment.  
In order for an active substance to be approved in accorda nce with Regulation 
(EC) No 1107/2009 (concerning the placing of plant protection products on the market), 
it must be demonstrated that the substance is not harmful to human health, animal health G/TBT/N/EU/644  
 
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  or the environment. Criteria are listed in Article 4 of the Regulation (and also detailed in 
Annex  II) which must be met to enable approval.  
During the evaluation and peer -review of desmedipham, a number of concerns and areas 
that could not be finalised were identified. These are detailed in the conclusion of the 
European Food Safety Authority (EFSA).  
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 exp osure to residues containing 4 -aminophenol 
(classified as mutagen category 2) via animal commodities.  
A high long -term risk to mammals was identified for all representative uses, except for 
insectivorous mammals when the use pattern includes only one appl ication. 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 .  
Finally, the Authority also concluded that assessment of the endocrine disrupting poten tial 
could not be completed based on the available information.  
These concerns mean that desmedipham does not meet the approval criteria as outlined 
in Regulation (EC) No 1107/2009 and cannot be approved currently.  
Existing authorisations will need to be withdrawn; Member States must withdraw existing 
plant protection products containing desmedipham at the latest by 6 months from the 
date of entry into force. A period of grace in line with Article 46 of Regulation 1107/2009 is 
allowed for and shall expire at the latest 12 months from the entry into force.  
8. Relevant documents:   
• 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 79/117/EEC and 91/414/EEC:   
http://eur -lex.europa.eu/legal -
content/EN/TXT/PDF/?uri=CELEX:32009R1107&qid=1437730988988&from=EN  
• 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 -186) 
http://eur -lex.europa.eu/legal -
content/EN/TXT/?qid=1442928512004&uri=CELEX: 32011R0540  
9. Proposed date of adoption:  2nd quarter 2019  
Proposed date of entry into force:  3 days following publication in the Official Journal 
of the EU  
10. Final date for comments: 60 days from notification  
11. Texts available from: National enquiry  point [  ] or address, telephone and fax 
numbers and email and website addresses, if available, of other body:   
European Commission  
EU-TBT Enquiry Point  
Fax: + (32) 2 299 80 43  
E-mail: grow-eu-tbt@ec.europa.e u 
The text is available on the EU -TBT Website:  
http://ec.europa.eu/growth/tools -databases/tbt/en/  
https://members.wto.org/crnattachments/2019/TBT/EEC/19_1087_00_e.pdf