# Commission Regulation (EU) No 283/2013 of 1 March 2013 setting out the data requirements for active substances, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market (Text with EEA relevance), Division 5.1.2: Absorption, distribution, metabolism and excretion after exposure by other routes

Extent: E+W+S+N.I.

Data on absorption, distribution, metabolism and excretion (ADME) following exposure by the dermal route shall be provided where toxicity following dermal exposure is of concern compared to that following oral exposure. Before investigating ADME in vivo following dermal exposure, an in vitro dermal penetration study shall be conducted to assess the likely magnitude and rate of dermal bioavailability.
Absorption, distribution, metabolism and excretion after exposure by the dermal route shall be considered on the basis of the above information, unless the active substance causes skin irritation that would compromise the outcome of the study.
Dermal absorption estimation from data generated in these studies on the active substance shall be critically assessed for relevance to humans. Dermal absorption measurement of the plant protection product is specifically considered under point 7.3 of Part A of the Annex to Regulation (EU) No 284/2013.
For volatile active substances (vapour pressure > 10–2 Pascal) absorption, distribution, metabolism and excretion after exposure by inhalation may be useful in human risk assessments.

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Source: https://www.legislation.gov.uk/eur/2013/283/annex/section/5/division/5.1/division/5.1.2 (the official version)
Page: https://openlegislation.uk/eu-regulation-2013-283/annex/section-5/division-5.1/division-5.1.2
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.