– INSIGHT BIOSOLUTIONS –
New regulatory guidances for using improved and defined approaches in cosmetic safety assessment
11th revision of the SCCS’ Notes of Guidance and OECD guideline 497
11th revision of the SCCS’ Notes of Guidance (NoG) for the testing of cosmetic ingredients and their safety evaluation
In comparison with the previous version, this 11th revision of the SCCS’ notes of Guidance, published on April 2021 , focus on the application of alternative methods, specifically on non-animal methods/new approach methodology (NAM).
This NoG has been revised with a particular emphasis on six main and important changes which including general updating of NAMs and also in silico methodology for genotoxcity/carcinogenicity. The two key benefits of this NoG is to improve harmonized compliance with the current cosmetic EU legislation and to accept finally the alternative methods to animal testing.
OECD guideline 497: Defined approaches for skin sensitization with in silico, in chemico, in vitro data sources
OECD published on the June 14th 2021 a new guideline on Defined Approaches for Skin Sensitization. This new OECD guideline which uses combined different information sources to generate product safety data and thus replace the use of animal test data.
In the defined approaches, the different selected data sources are combined and the resulting data generated is interpretated by a fixed Data Interpretation Procedure (DIP).
Two main benefits of these new defined approaches:
1. these approaches are able to provide equivalent or even more informative information than that generated by the LLNA method (OECD TG429) for the skin sensitization hazard identification,
2. these approaches are able to overcome the limits of the individual methods.
Insight Biosolutions provides a combined in vitro and in silico services: in vitro regulatory tests and in silico prediction applications with software tools including in these guidelines.
The services provided by Insight Biosolutions are in line with the 11th revision of the SCCS’NoG and the new OECD TG497 guideline.