On the other hand, there are studies designed to be used to evaluate intrinsic properties of the chemical and to assess under which conditions it may be used safely.
For any chemical to be put on the market, these studies are mandatory for the industry to conduct.
Their goal is to provide calibrated data to the authorities in order to determine if this substance can, or cannot, be safely put on the market.
These are called REGULATORY STUDIES.
They represent large investments, since:
- Their design must be compliant with strict, robust, controlled, official* protocols of research.
For example, this means gathering a sufficient amount of data (on multiple models, on numerous individuals and samples) in order to minimize the possibility of errors. - They must be conducted in laboratories respecting official guidelines called Good Laboratory Practices.
For example, this implies a highly controlled environment (hygiene, physical constraints, duration …), explicit statistical analysis of the data and documentation requirements, in order to be able to reproduce the experiment.
Based on their review, a substance can be deemed safe, or authorities can require more tests to be performed.
*: calibrated according to international independent scientific bodies (ex : OECD).
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