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The Paramount Importance of Technical Equivalence Assessment for Active Substances in Crop Protection and Biocidal Products

Hanna Skarpos

DOI https://doi.org/10.21552/icrl/2019/1/5



This article outlines the importance of assessing the technical equivalence regarding the chemical composition and hazard profile for different new sources of an active substance compared to the reference source of the same active substance used for the initial risk assessement. The legal provisions of past directives and two current regulations as last amended, Regulation (EC) No 1107/2009 concerning the placing of plant protection products on the market and Regulation (EU) No 528/2012 concerning the placing on the market and use of biocidal products, are addressed in detail. Moreover, the harmonised procedures for assessing technical equivalence of different sources, based on the information presented in different supporting guidelines, are portrayed and discussed. Following the presentation of all legal provisions, a two-tiered approach as proposed for assessing the equivalence of different sources of active substances is presented in detail.

Dr. Hanna Skarpos is a scientific expert / regulatory chemist at knoell Germany. She has many years experience in preparation of different technical equivalences. She would like to express her appreciation to her colleagues Dr. Daniela Fruth, Dr. José João Dias Carvalho and Dr. Michael Cleuvers for their support. For correspondence: <mailto:hskarpos@knoell.de>

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