G/TBT/N/EU/525  
 
16 November 2017  
(17-6226) 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/  
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): Propineb 
(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 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 t he 
market, and amending the Annex to Implementing Regulation (EU) No 540/2011 
(5 page(s), in English)    
6. Description of content: This draft Commission Implementing Regulation provides that 
the approval of the active substance propineb is not renewed in accordance with 
Regulation (EC)  No 1107/2009. Existing authorised plant protection products containing 
propineb will be withdrawn from the market. The non -approval is based on the first 
evaluation of the substance for use as a pesticide 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 co ncerned pesticide. However, 
following non -approval, separate action may be taken on MRLs and if so a separate 
notification will be made in accordance with SPS procedures.  
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 accordance 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 or G/TBT/N/EU/525  
 
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  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 the substance, 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).  
The Authority identified some issues of  concern which could not be finalised in particular 
the consumer risk assessment cannot be conducted considering the outstanding data to 
address the toxicity of relevant metabolites, the magnitude of different compounds 
included in plant residue definition  and to perform a comprehensive livestock exposure 
assessment. In addition, the Authority could not conclude on the risk assessment for 
honeybee brood and underlined a critical area of concern for propineb due to the endocrine 
disrupting properties of its major metabolite PTU.  
These concerns mean that propineb 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 existi ng 
plant protection products containing propineb at the latest by 3 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 15 months from the entry into forc e (allowing for a final 
season of use).  
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  
 Conclusion on the peer review of the pe sticide risk assessment  
of the active substance propineb EFSA Journal 2016;14(11):4605, 26 pp. 
doi:10.2903/j.efsa.2016.4609. 
http://onlinelibrary.wiley.com/doi/10.2903/j.efsa .2016.4605/epdf  
 Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 
December 2008 on classification, labelling and packaging of substances and 
mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and 
amending Regulation (EC) No 1907/2006 ( OJ L 353, 31.12.2008, p.  1). http://eu r-
lex.europa.eu/legal -content/en/TXT/?uri=CELEX:32015R1221&qid=1484416483641   
9. Proposed date of adoption: 25 January 2018  
Proposed date of entry into force: 20 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:   
https://members.wto.org/crnattachments/2017/TBT/EEC/17_5107_00_e.pdf