Scientific Opinion on the Science behind the Revision of the Guidance Document on Dermal Absorption


Panel on Plant Protection Products and their Residues
EFSA Journal
EFSA Journal 2011;9(7):2294 [73 pp.].
Panel Members
Jos Boesten, Claudia Bolognesi, Theo Brock, Ettore Capri, Anthony Hardy, Andrew Hart, Karen Hirsch-Ernst, Susanne Hougaard Bennekou, Michael Klein, Robert Luttik, Bernadette Ossendorp, Annette Petersen, YolandaPico, Andreas Schäffer, Paulo Sousa, Walter Steurbaut, Anita Strömberg, Maria Tasheva, Ton van der Linden, Christiane Vleminckx

EFSA wishes to thank the members of the Working Group on Toxicology of Pesticides Claudia Bolognesi, Susanne Hougaard Bennekou, Karen Hirsch-Ernst, Yolanda Pico, Maria Tasheva and Christiane Vleminckx,the hearing experts Ingrid Becks-Vermeer and Ian Dewhurst and the EFSA staff Manuela Tiramani, Juan Parra Morte,István Sebestyén, Judith Ricketts and Hans Steinkellner for the support provided to this scientific output

Opinion of the Scientific Committee/Scientific Panel
On request from
Question Number
29 June 2011
Published in the EFSA Journal
12 July 2011
European Food Safety Authority (EFSA), Parma, Italy

This opinion provides the relevant data, evaluations and references that support the criteria proposed in the new draft guidance needed to facilitate assessment of dermal absorption of plant protection products (PPPs) under Directive 91/414/EEC[1] and Regulation (EC) No 1107/2009[2]. The new guidance will be finalised and published only after adoption and publication of this opinion. This opinion has been developed after a public consultation of EFSA on the current guidance document and an outsourced project carried out by the UK Chemicals Regulation Directorate (CRD, 2010). It is not intended to be an exhaustive review but builds on existing documents to which the reader is referred to, and addresses in more detail elements that are specifically relevant for the assessment of dermal absorption of plant protection products. It contains an overview on skin and substance properties and other determinants that have an impact on absorption, a description of important elements in the design of experimental studies and an analysis of available data on dermal absorption of PPPs. The PPR Panel concludes that assessment of dermal absorption in the absence of specific studies can be performed based on default values that the Panel derived from the analysis of the available databases. Elements for a tiered approach are described and commented on. The PPR Panel also concludes that in vitro human studies can be used as a stand alone test for assessment of dermal absorption. The Panel indicates some additional requirements to adapt existing OECD test guidelines to the special requirements of PPPs and their formulations. A harmonised reporting of the studies is also considered important. Some areas where further research could usefully be conducted have been identified.

Dermal Absorption, Pesticides, Guidance
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