Dr Chuzel, could you introduce yourself?
I am Franck Chuzel and have a PhD in human biology and endocrine functions followed by an Executive MBA. I have over 20 years experience as a senior manager in Life Science activities and toxicology. My work has always been linked to the understanding of endocrine regulations, with a focus on the reproductive functions. In this respect, I have been involved in OECD activities to help identifying tools and put in place guidelines to better address endocrine disruption mechanisms. As such, I was also part of transatlantic (EU/US) research programs related to human health in this area.
Is natural safe ? What do you have to consider when evaluating the safety of a substance exposing the consumers ?
Natural and harmless are two different concepts. It is not the origin of a compound, natural or not, that determines its safety but rather its way of interacting with the body and how the body interacts with it.
During a safety assessment, effects induced by the compound (if any) are identified, described and then put into perspective with respect to the use that will be made, particularly in relation to the end user exposure (route of administration, quantity, duration, frequency, etc. ).
How have you evaluated the toxicology of Bakuchiol ?
A complete analysis of the available bibliography and experimental data, including the analysis made by different laboratories and different international bodies has been carried out. This enables to draw up the compound toxicological profile, to identify potential targets, and thus to identify the potential risk, if there is one. Finally, a precise analysis of the product end use was performed to identify the conditions to use the product under the best safety conditions.
In order to be precise, what Bakuchiol are we talking about ? How the purity of Bakuchiol can have an impact on the toxicological profile of the substance ?
The analysis carried out was focused on Sytenol®A (Bakuchiol with a purity> 99% demonstrated by the provided certificate of analysis). The purity of an extract is a key information to consider for the toxicological evaluation. In this example, the structures of certain molecules contained in less pure extracts are known to be potentially responsible for phototoxicity (e.g. Psoralen).
According to your study, what can we say regarding the margin of safety of Bakuchiol topically used at 1% in a finished product ?
For use in cosmetics under the best safety conditions, the safety margin recommended and accepted by all the stakeholders must be at least 100. The margin of safety was assessed in a very conservative way and was 5 times the minimum required in case of a topical application to the face of a product containing 1% Bakuchiol with a purity of 99%. Therefore it can be concluded that Sytenol® A (99% purity of Bakuchiol), provides a very good margin of safety for the consumer, which could not be the case with a raw extract.
Do you think a finished product containing Bakuchiol can be used by pregnant women ?
In the absence of data on reproductive and developmental effects, the use for pregnant women should not be recommended.
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