G/TBT/W/625  
 
8 April 2019 
(19-2231) Page: 1/2 
Committee on Technical Barriers to Trade  Original: English  
 
EUROPEAN UNION - CHLOROTHALONIL (PESTICI DE ACTIVE SUBSTANCE)  
STATEMENT BY THE EUROPEAN UNION TO THE COMMITTEE ON TECHNICAL BARRIERS T O TRADE  
6 AND 7  MARCH  2019 
The following communication, dated 5 April  2019, is being circulated at the request of the delegation 
of the European Union . 
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1.  The European Union thanks various members for raising this issue.  
2.  The European Union proposed not to renew the approval of chlorothalonil and notified third 
countries of the draft Regulation via the TBT procedure. The measure did not lead to immediate 
disruptions in trade, as the measure itself does not amend the maximum residue levels (MRLs) and 
provides for a grace period for use of products containing chlorotha lonil. 
3.  The EU confirms that the possibility for granting transitional measures will be considered when 
proposing any changes to existing MRLs. The timeframe for a possible amendment of the current EU 
MRLs will not be before expiry of the grace periods for use of products containing chlorothalonil in 
the notified draft Regulation. Furthermore, any action to reduce MRLs in the future will be subject 
to a separate notification under the WTO/SPS procedure.  
4.  Chlorothalonil is part of the third stage of the EU re newal programme for active substances used 
in plant protection products and has been evaluated in accordance with Regulation 
(EC) No. 1107/2009 on the placing of plant protection products on the market. A comprehensive 
and transparent assessment of the inf ormation submitted by the applicant was carried out by the 
designated rapporteur Member State and peer -reviewed by all other Member States and the 
European Food Safety Authority (EFSA). EFSA's Conclusion on chlorothalonil following this extensive 
peer revi ew process was published in January 2018.  
5.  During this assessment, it has not been established with respect to one or more representative 
uses of at least one plant protection product that the approval criteria provided for in Article 4 of 
Regulation (EC) No. 1107/2009 are satisfied.  
6.  A critical concern was identified by the Authority in relation to the contamination of groundwater 
by certain metabolites of chlorothalonil. Therefore, it cannot currently be established that the 
presence of metabolites of chl orothalonil in groundwater will not result in unacceptable effects on 
groundwater and in harmful effects on human health as required by Article 4(3)(b) of Regulation 
(EC) No . 1107/2009. Furthermore, the Authority could not exclude a genotoxicity concern fo r 
residues to which consumers will be exposed and identified a high risk to amphibians and fish for all 
the uses evaluated.  
7.  Furthermore, several areas of the risk assessment could not be finalised due to insufficient data 
in the dossier. In particular, the  assessment of consumer risk from dietary exposure could not be 
completed because of lack of data to confirm the definition of the residue in plants and the livestock 
exposure assessment, including the toxicological assessment of a metabolite.  G/TBT/W/625  
 
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  8.  Additionall y, 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 car cinogen category 1B.  
9.  The European Union therefore proposed not to renew the approval of the active substance 
chlorothalonil in accordance with Article 20(1)(b) of that Regulation.  
10.  Import tolerance requests however remain possible and will be assessed on a case-by-case 
basis by the rapporteur Member State and EFSA. Such requests would have to be supported by 
substantial new data addressing the concerns.  
 
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