Reasoned opinion on the modification of the existing MRL for guazatine in citrus fruits


European Food Safety Authority
EFSA Journal
EFSA Journal 2014;12(8):3818 [29 pp.].
Reasoned Opinion
On request from
European Commission
Question Number
25 August 2014
Published in the EFSA Journal
28 August 2014
European Food Safety Authority (EFSA), Parma, Italy

In accordance with Article 6 of Regulation (EC) No 396/2005, the United Kingdom, 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 for the active substance guazatine in citrus fruits. In order to accommodate for the reported post-harvest use of guazatine acetates in South Africa, the United Kingdom proposed the MRL of 4 mg/kg. The United Kingdom 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 metabolism of guazatine acetates in citrus fruits is not fully elucidated. A tentative MRL proposal of 5 mg/kg for guazatine acetates (corresponding to 4 mg/kg for residues expressed as guazatine) was derived. This MRL proposal should be considered as tentative. The MRL set in the country of origin is 5 mg/kg for guazatine. Although the indicative consumer risk assessment did not identify a consumer health risk for the reported post-harvest use of guazatine acetates on citrus fruits imported from South Africa, EFSA does not propose to set a MRL in citrus since the risk assessment is affected by a high level of scientific uncertainties resulting from the validity of the toxicological reference values, the lack of elucidation of the metabolic pathway in plants and livestock and the validity of the supervised residue trials analysed with an analytical method which is based on the analysis of one constituent of the technical material (marker substance GG-diacetate) only. Thus, EFSA is of the opinion that the available data are not sufficient to demonstrate that the residues of guazatine acetates on citrus fruits resulting from the South African GAP are safe for European consumers.

guazatine, citrus fruits, MRL application, Regulation (EC) No 396/2005, consumer risk assessment, guanidine fungicide, GG-diacetate
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