EFSA has published new guidance on dermal absorption of plant protection products (PPPs). The guidance proposes default values to be used in the absence of experimental data for the risk assessment of active substances used in PPPs.
The document, which updates the guidance published by EFSA in 2012, was drafted in the light of newly available human in vitro studies.
Analysis of the new information – provided by the German Federal Institute for Risk Assessment (BfR) and the European Crop Protection Association (ECPA) – indicated that levels of dermal absorption are significantly affected by the concentration of the active ingredient in the formulation and by the type of formulation. The proposed new default values are therefore based on these two factors.
EFSA also recommends that the OECD’s dermal absorption guidance and test guideline documents be revised. This would support a more harmonised approach to the evaluation of dermal absorption of chemicals, better reflect the extensive experience gained in the use of in vitro methods, and increase global acceptance of this method as an alternative to animal testing.
A technical meeting with stakeholders will be held on 27-28 September to explain how the document differs from the guidance issued in 2012, answer questions and collect feedback on the new document. The meeting will be held in Parma, Italy.