Reasoned opinion on the setting of an import tolerance for didecyldimethylammonium chloride (DDAC) in citrus

didecyldimethylammonium chloride (DDAC), citrus, MRL application, Regulation (EC) No 396/2005, consumer risk assessment, alkyl-quaternary ammonium
First published in the EFSA Journal
29 May 2013
27 May 2013
Reasoned Opinion


In accordance with Article 6 of Regulation (EC) No 396/2005, The Netherlands, hereafter referred to as the evaluating Member State (EMS), received an application from Exponent International Ltd (on behalf of ICA International Chemicals (PTY) Ltd) to set an import tolerance in citrus from South Africa for the active substance didecyldimethylammonium chloride (DDAC) at the level of 6 mg/kg. The Netherlands drafted an evaluation report in accordance with Article 8 of Regulation (EC) No 396/2005, which was submitted to the European Commission and forwarded to EFSA. According to EFSA, the data require the setting of an import tolerance of 6 mg/kg for citrus. However, additional information on the typical South African post-harvest treatment practice should be provided to decide whether the submitted trials are representative of the authorised GAP. A sufficiently validated analytical method to enforce the proposed MRL of DDAC on citrus is available. EFSA concludes that the consumer risk assessment did not identify a consumer health risk resulting from the post harvest uses of DDAC on citrus fruits. However it should be noted that the risk assessment is affected by a high degree of uncertainties which result from data gaps identified in the dossier. Finally, EFSA concludes that risk managers have to decide whether the setting of an import tolerance of 6 mg/kg is acceptable since the MRL currently into force for citrus in South Africa is 2 mg/kg only.

European Food Safety Authority
pesticides.mrl [at]
EFSA Journal 2013;11(5):3246
Question Number
On request from
European Commission

Background documents