Home/Case studies and news/Changes in the requirements for mutagenicity and subchronic toxicity studies for registration in the Russian Federation

Changes in the requirements for mutagenicity and subchronic toxicity studies for registration in the Russian Federation

16.06.2017
Currently, according to the data provided by the experts of Rospotrebnadzor’s Federal Scientific Centre of Hygiene n.a. F.F. Erisman, mutagenicity and subchronic toxicity studies of an active ingredient are not required for the registration of plant protection products in Russia . However, in this case full report of 5-batch analysis must be submitted to prove the equivalence of technical material (active ingredient) to originator’s. 

To prolong existing registrations, one of the following requirements should be met: 

• An applicant should conduct mutagenicity and subchronic toxicity studies of the active ingredient; 
• Or provide 5-batch analysis report and confirm technical material’s chemical equivalence.

Back to the list


Up