Orange or citrus flavor [Regulatives / Guidelines]

posted by Dr_Dan  – 2020-02-20 09:01  – Posting: # 21181
Views: 681

Dear all
It´s not a question with direct reference to bioequivalence but maybe you have some experience that you can share.
Oral formulations that are a suspension or a solution at time of administration often contain a flavoring agent. In case this is a orange or citrus flavor the German regulatory authority asks whether this flavor contains perilla aldehyd. According to EFSA (European Food Safety Authority) perilla aldehyd contains an α,β-unsaturated carbonyl group, which is a structural alert for toxicity. However, citrus fruits naturally contain perilla aldehyd and if the flavoring agent in your formulation contains natural citrus oil you can not exclude contamination with perilla aldehyd. How can one argue against the authority? Eventually drinking of orange juice is still considered harmless....
Looking forward to your reply.

Kind regards and have a nice day
Dr_Dan

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