G/TBT/N/EU/565  
 
29 March 2018  
(18-1971) 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 appli cable, otherwise national tariff 
heading. ICS numbers may be provided in addition, where applicable): 
Chlorpropham (pesticide active substance)  
5. Title, number of pages and language(s) of the notified document: Draft 
Commission Implementing Regulation co ncerning the non -renewal of approval of the active 
substance chlorpropham, 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 Impleme nting 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 chlorpropham is not renewed in accordance with 
Regulation (EC) No 1107/2009. Existing authorised plant protection products containing 
chlorpropham will be withdrawn from the market.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 
Regulatio n (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. How ever, 
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 marke t), it 
must be demonstrated that the substance is not harmful to human health, animal health or G/TBT/N/EU/565  
 
- 2 - 
 
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 could not finalise the consumer risk assessment  through dietary intake due 
to several data gaps. Moreover, a critical area of concern was identified regarding the 
results of an indicative consumer risk assessment where severe acute and chronic risks 
have been identified both for chlorpropham and for it s major metabolite 3 -chloroaniline.  
Furthermore, the information available is also insufficient to satisfy the requirements set 
out in Article  4(1) to (3) of Regulation (EC) No 1107/2009, in particular further scientific 
assessment is needed to conclude on  the potential endocrine disrupting properties of 
chlorpropham and it was not possible to finalise the risk assessment to non -target 
arthropods for the field uses.  
These concerns mean that chlorpropham 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; EU Member States must withdraw 
existing plant protection products containing chlorpropham at the latest by 6 months from 
the date of entry into f orce. 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 force (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 pesticide risk assessment of the active 
substance chlorpropham. EFSA Journal 2017;15(7):4903 [32 pp.]. doi: 
10.2903/j.efsa.2017.4903 : 
http://onlinelibrary.wiley.com/doi/10.2903/j.efsa.2017.4903/epdf   
9. Prop osed date of adoption: June 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:   
European Commission  
EU-TBT Enquiry Point  
Fax: + (32) 2 299 80 43  
E-mail: grow-eu-tbt@ec.europa.eu  
 
The text is available on the EU -TBT Website: http://ec.europa.eu/growth/tools -
databases/tbt/en/  
 
https://members.wto.org/crnattachments/2018/TBT/EEC/18_1794_00_e.pdf