With the full application of Regulation 1107/2009, a number of new elements have been introduced which will need detailed consideration to assist the process of implementation.
One element of major uncertainty is the application of the comparative assessment and substitution provision as set out in Article 50 of the Regulation.
ECPA organised a workshop on 22nd November in order to discuss this issue, as well as other provisions in the Regulation related to approval criteria and the development of EU guidance documents for evaluations implementation.
The presentations of the workshop are available below.
ECPA position on comparative assessment_JP Busnardo.pdf
Industry guidance on comparative assessment_C Thomas.pdf
ECPA position on defining negligible exposure_M Griffiths.pdf
ECPA position on article 4(7) implementation_JP Busnardo.pdf
Development of EU Risk Assessment guidance documents_E Jones.pdf
ECPA position on PBT_P Dohmen.pdf
MS view on implementing Comparative Assessment_P Bergkvist.pdf