Negligible exposure

Date: 24 April 2020

According to Regulation (EC) No 1107/2009 an active substance can only be approved if it is not or has not to be classified as hazardous according to the cut-off criteria (for further information please refer to Academy Article “Cut-off criteria”), unless the exposure of humans to that active substance in a plant protection product, can be considered as negligible, under realistic proposed conditions of use, meaning under conditions in agricultural practice.

The term “negligible” reflects that a plant protection product is used in conditions excluding exposure of humans to this specific active substance and that any possible residues of the active substance on food and feed items do not exceed the default value of 0.01 mg/kg set in accordance with Regulation (EC) No 396/2005.

According to the draft technical guidance SANCO/2014/12096, the negligible exposure has to be shown for a) dietary exposure and b) non-dietary exposure.

Even if negligible exposure can be shown for an active substance, it can nevertheless only be approved as candidate for substitution and the approval will only be granted for a period not exceeding seven years.

Currently the draft technical guidance SANCO/2014/12096 does not give any guidance for consideration of negligible exposure for non–target organisms (other than humans). Accordingly, there is no need of assessments of potential negligible exposure for such non-target organisms.

Joachim Kranz