Australian Approved Name (AAN): Orange oil bitter
Common names and synonyms: Oil of orange bigarde; orange peel bitter oil
Warnings and Restrictions: Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance.
If used in a flavour, the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance, the total fragrance concentration in a medicine must be no more 1%.
SENS – Application to skin may increase sensitivity to sunlight (or words to that effect), must be include on the medicine label UNLESS the medicine is:
a) for internal use;
b) in preparations containing 1.4% or less of orange oil bitter;
c) for use in soaps or bath or shower gels that are washed off.
Allowable purpose of the ingredient: Excipient
TGA reference: Fenaroli’s Handbook of Flavour Ingredients