Flash dating 1 01 final honeyb section8
Studies conducted before the application of this Regulation, although not fully compliant with GLP requirements or with current test methods, may be integrated into the assessment, when accepted by the competent authorities as scientifically valid, thereby removing the need for repeating animal tests, especially for carcinogenicity and reprotoxicity studies.
In cases of uncertainty, bridging studies shall be submitted to serve as a basis for a decision as to the possible need for repetition of the studies.Where studies are conducted using an active substance of different purity or which contains different impurities or different levels of impurities to the technical specification or where the active substance is a mixture of components, the significance of the differences shall be addressed either by data or scientific case.In cases of uncertainty, appropriate studies using the active substance as manufactured for commercial production shall be submitted to serve as a basis for a decision.In the case of studies in which dosing extends over a period (for example repeated dose studies), dosing shall be done using a single batch of active substance if stability permits.
Whenever a study implies the use of different doses, the relationship between dose and adverse effect shall be reported.
The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health and neither the European Parliament nor the Council has opposed them, HAS ADOPTED THIS REGULATION: Article 1 Data requirements for active substances The data requirements for the active substance provided for in Article 8(1)(b) of Regulation (EC) No 1107/2009 shall be as set out in the Annex to this Regulation.