Hazard and risk based allocation of safety instructions to operators handling pesticides

Abstract

Prior to authorisation of plant protection products (PPP) according to Regulation (EC) No 1107/2009 it must be ensured that products placed on the market will not impair the health of humans and animals if used appropriately and as intended. For safe use of pesticides, it is generally necessary to assign obligatory instructions for operators to comply with risk mitigation measures. These instructions are allocated due to the intrinsic toxicological properties of the products combined with qualitative exposure aspects, e.g. for different formulation types and application scenarios. The toxicological properties of PPP are evaluated on the basis of the uniform principles according to Regulation (EC) No 1107/2009, and are communicated by the classification and labelling of the products. Additionally, quantitative exposure estimations carried out within the risk assessment for the products might result in additional instructions for safe use. Those instructions aim to ensure, that the respective toxicological reference value will not be exceeded. The latter issue will be addressed in another article. The general principles for assigning mandatory instructions for professional and non-professional operators of PPP concerning human health are based on the classification and labelling of PPP according to Regulation (EC) No 1272/2008 (CLP-Regulation). Plant protection products are classified based on toxicological tests (mainly acute toxicity, irritation and sensitisation) and on conventional methods based on the above mentioned Regulation (mainly for subacute and chronic effects). Since the CLP-Regulation is obligatory for classification and labelling of mixtures such as PPP from 1 June 2015 onwards, it will be necessary to replace BBA uniform principles for safeguarding the health of applicators of plant protection products (1993) Part 1, 3–3 and adapt its principles for assigning PPE and instructions for safe use on the basis of the new classification and labelling principles for products. This article will provide the necessary support for risk management decisions concerning human health. It presents principles to implement, adapt and specify the rather imprecise provisions concerning the use of PPE laid down in CLP-Regulation to the particular requirements for handling and applying PPP. It might be a basis for European harmonisation concerning allocation of risk mitigation measures to professional and non-professional operators of pesticides, thus, adjusting the different levels of operator protection in the Member States, as stated in Regulation (EC) No 1107/2009.