G/TBT/N/EU/625  
 
4 December 2018  
(18-7666) Page: 1/3 
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): 
Chlorothalonil (pesticide active substance)  
5. Title, number of pages and language(s) of the notified document: Draft 
Commission Implementing Regulation concerning the non -renewal of the approval of the 
active substance chlorothalonil, in accordance with Regulation (EC) No 1107/2009 of the 
European Parliament and of the Council concerning the placing of plant protect ion 
products on the market, and amending Commission 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 chlorothaloni l is not renewed in accordance with 
Regulation (EC)  No 1107/2009. Existing authorised plant protection products containing 
chlorothalonil will be withdrawn from the market. The non -approval is based on the first 
evaluation of the substance for use as a pes ticide 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 (M RLs) 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/625  
 
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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 chlorothalonil, a number of concerns and areas 
that could not be finalised were identified. These are detailed in the conclusion of t he 
European Food Safety Authority (EFSA).  
In particular, a genotoxicity concern could not be excluded for residues to which consumers 
will be exposed. Several toxicologically relevent metabolites have been identified which  are 
predicted to occur above the  parametric value of 0.1 μg/L in groundwater for all scenarios 
evaluated. A high risk to amphibians and fish was identified.  
Furthermore, the Authority concluded that the analytical methods used in the toxicological 
studies were not identified and therefor e not validated, this question the validity of the 
studies, in particular repeated -dose dietary studies. Also several other areas of the risk 
assessment could not be finalised due to insufficient data in the dossier. In particular, the 
assessment of consum er risk from dietary exposure could not be completed because of a 
lack of data to confirm the definition of the residue in plants and the livestock exposure 
assessment, including the toxicological assessment of a metabolite.  
Additionally, chlorothalonil is  classified as carcinogen category 2 in accordance with 
Regulation (EC) No 1272/2008 of the European Parliament and of the Council while in the 
conclusion of the Authority it is indicated that chlorothalonil should be classified as 
carcinogen category 1B. For the representative uses considered, residue levels as referred 
to in point (b) of Article 18(1) of Regulation (EC) No 396/2005 could not be confirmed for 
plant and animal products due to lack of missing data on the magnitude and toxicity of 
metabolites  that are included in the residue definition for risk assessment. Consequently, 
the requirement set out in Points 3.6.3 of Annex II to Regulation (EC) No 1107/2009 is 
not fulfilled.  
These concerns mean that chlorothalonil does not meet the approval criteri a 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 chlorothalonil 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  
• Conclusion on the peer review of the peer review of the pesticide risk 
assessment of the active substance chlorothalonil. EFSA Journal 
2018;16(1):5126, 40 pp.  https://doi.org/10.2903/j.efsa.2018.5126   
9. Proposed date of adoption:  1st quarter 2019  
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  G/TBT/N/EU/625  
 
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  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_6220_00_e.pdf