Abstract

Pesticide active ingredients are extensively studied before being authorised for use. These include, among others, efficacy studies, several toxicity studies in mammals and in ecotoxicological relevant species. From these studies, health based limits for the consumer are derived such as the acceptable daily intake (ADI), the acute reference dose (ARfD) and the exposure limits for pesticide operators (AOEL); also, environmental limits are defined and levels of residues in food commodities determined.

Then the exposure for consumer and operators is estimated by using different mathematical models based on the proposed uses scenario (e.g: application doses, period and interval between application, etc). A further step is to compare the estimated exposure with the reference value to assess the risk and conclude if the proposed use is safe, therefore the active ingredient can be put on the market, or not. It has to be underlined that the use scenario for exposure estimation is always based on a worst-case approach to cover all possible conditions.

In particular, estimation of operators’ exposure is made on mathematical models based on dermal and inhalation exposures measured following different type of application in several field studies.

Finally, if safe uses have been identified, approval of an active ingredient and of a commercial formulation is consequently accompanied by indication of the proper application modalities and PPE to be used by the pesticide applicator to reflect the scenario evaluated.

Moreover, the risk assessment is conducted not only for consumer and operators but also for workers re-entering the treated crops, bystander, and especially resident.

Therefore, it can be concluded that if an active ingredient is used on crops according the Good Agricultural Practice and according all indications on the label (e.g.: use of specific PPE, buffer zone, post harvesting interval), negligible risk for human and environment is expected.