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RegisterOrange or citrus flavor [Regulatives / Guidelines]
Hi Dr_Dan,
it is a tricky question. On whom is the burden of proof here?
I would perhaps try and argue that since the excipient is common, used for decades, generally allowed and since PRAC and CHMP and SWP and so forth did not in any way indicate the need for a review of safety/potential toxicity etc., the excipient should be considered ok.
At the end of the day the purpose of the regulatory mechanisms is to capture those things since they have access to much more info then you/we have. Their analysis is potentially much more sensitive than anything you can look into or speculate into.
Absence of evidence vs evidence of absence...
it is a tricky question. On whom is the burden of proof here?
I would perhaps try and argue that since the excipient is common, used for decades, generally allowed and since PRAC and CHMP and SWP and so forth did not in any way indicate the need for a review of safety/potential toxicity etc., the excipient should be considered ok.
At the end of the day the purpose of the regulatory mechanisms is to capture those things since they have access to much more info then you/we have. Their analysis is potentially much more sensitive than anything you can look into or speculate into.
Absence of evidence vs evidence of absence...
—
Pass or fail!
ElMaestro
Pass or fail!
ElMaestro
Complete thread:
- Orange or citrus flavor Dr_Dan 2020-02-20 09:01 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Orange or citrus flavor nobody 2020-02-20 09:18
- Orange or citrus flavorElMaestro 2020-02-20 09:41
- Orange or citrus flavor nobody 2020-02-20 12:24
Ing. Helmut Schütz