# 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: Circumstances in which required

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

For human risk assessment additional dermal studies shall be considered on a case by case basis, unless the active substance is a severe irritant.
For volatile active substances (vapour pressure >10–2 Pascal) expert judgement (for example based on route-specific kinetic data) shall be required to decide whether the short term studies have to be performed by inhalation exposure.

---
Source: https://www.legislation.gov.uk/eur/2013/283/annex/section/5/division/5.3/division/5.3.3/division/1 (the official version)
Page: https://openlegislation.uk/eu-regulation-2013-283/annex/section-5/division-5.3/division-5.3.3/division-1
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.