About ProSafe-Pesticides – The BfR’s risk classification and assessment system
ProSafe-Pesticides is a web-based application developed by the BfR to support the cumulative evaluation of pesticides products, i.e. mixtures with regards to their human health hazard. The derived proposals for classification and labelling and the associated hazard and safety phrases provide management options for the apportioning of hazard based safety instructions that ultimately ensure safe use for operators, workers, residents and bystanders.
Concept
The assessment of plant protection products (PPP) is based on Regulation (EC) No 1107/2009. The composition of PPPs is verified by the German Federal Office for Consumer Protection and Food Safety (BVL) and provided via the IT-application Infozupf. Further relevant information about the PPP, such as intended use(s), packaging, formulation type etc. is also imported into the data base and are subsequently accessible via ProSafe-Pesticides.
The assessment of biocidal products (BP) is based on Regulation (EC) No 528/2012. The composition of BPs is verified by the Federal Institute for Occupational Safety and Health (BAuA) and provided as a standardized EXCEL-sheet. The composition and further relevant information for the BP are entered into the data base and are then also accessible via ProSafe-Pesticides.
The cumulative hazard assessment of mixtures is based on the „Global Harmonised System (GHS)“ according to the EU’s CLP-Regulation (EC) No 1272/2008. The calculation method is implemented in ProSafe-Pesticides according to the CLP-Regulation. The calculation method enables the estimation of the acute toxicity of mixtures (oral, dermal and inhalation) as well as the assessment of the skin and eye irritating potential based on the toxicological information available from all ingredients. In addition, ProSafe-Pesticides shows the classification for each ingredient of a pesticide product. The classification of an ingredient is indicated as relevant when its concentration is above the specified concentration limit for classification, as defined in the CLP-Regulation.
All relevant data for the assessment are obtained from the BfR-internal substance data base. The data base contains harmonized and non-harmonized classifications and labelling of substances as well as further relevant information such as reference values, dermal absorption values, vapor pressure, viscosity, lipophilicity etc. Further toxicological information, for example data on the acute toxicity such as oral, dermal, inhalation, eye and skin irritation and skin sensitisation for single compounds and mixtures (e.g. PPPs and BPs) is available. The information for substances and mixtures is obtained from different sources, e.g. the ECHA data base, safety data sheets provided by the applicant, EFSA-reviews, BfR-internal assessments, etc. Thus, the data base is constantly expanded with new or updated information. As a result of its continuous use, the data base contains a large and ever-growing data set for mixtures and substances, which is then used during the assessment of pesticide. Furthermore, the sources of all data can be unequivocally tracked using an integrated referencing system. ProSafe-Pesticides’ implemented algorithm uses these toxicological data from the data base to derive classification and labelling proposals for pesticides and to allocate hazard based safety instructions to ensure safe use for operators, workers, residents and bystanders.
Moreover, ProSafe-Pesticides enables the comparison of formulations using read-across from one formulation to another to identify differences in their composition that are relevant for the assessment. This therefore supports another viable alternative method to animal testing.
ProSafe-Pesticides can present all data relevant for the cumulative evaluation of pesticides concerning the human health in a structured way and is therefore the main operational tool for the assessment of these mixtures. In addition, the web application is designed to allow all authorities involved in the evaluation process to gain access to this information using a secure link. Thus, ProSafe-Pesticides has the potential to become the national operational tool for the evaluation process of pesticide products.