EUROPE – COM : Update of guidance documents on new active substance data post approval, on rules for revision of assessment reports and on data matching
20 October 2021
FRANCE – ANSES : Update of the memo on advices to applicants in the framework of Regulation (EC) n° 1107/2009 for the evaluation of plant protection (rev. 2)
20 October 2021
The Commission published an update of guidance documents SANCO/10473/2003 ‘for generation and evaluation of data on the physical, chemical and technical properties of plant protection products under regulation (EC) N° 1107/2009’. The intention of this guidance document is to describe the physical, chemical and technical data required to support the registration and/or authorisation of a formulation as set out in Regulation (EU) No. 284/2013.
This latest version 5 describes the relevant physical, chemical and technical properties to plant protection products and the appropriate analytical methods for their measurements. It also details the requirements for the technical characteristics and the means of generating data by type of formulation. The currently used liquid, solid, seed treatment and miscellaneous preparations are mentioned.
This 5th version applies to submissions made from 01.11.2021.
To download: SANCO/10473/2003 –rev.5
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