EFSA has made available for public consultation its draft Guidance on dermal absorption of chemical plant protection products (PPPs). The Guidance, which updates the document published by EFSA in 2012, was drafted in the light of newly available human in vitro studies.
The revised Guidance proposes new default values to be used in the absence of experimental data for the risk assessment of PPPs.
EFSA’s 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.