Table 2

Excipients and cut-off values for safe exposure per age group, derived from EMA publications

Excipient	Age	Limit	Explanation
Ethanol21	<2 years	Avoid
	2–5 years	6 mg/kg	Suggested limit in medicines based on a BAC rise of 0.01 g/L.
	≥6 years	75 mg/kg	Suggested limit in medicines based on a BAC rise of 0.125 g/L.
Propylene glycol26	Neonates	1 mg/kg/day	Considered to be safe and with no noticeable effects whatever the duration and the route of administration.*
	1 month–4 years	50 mg/kg/day
	≥5 years	500 mg/kg/day
Benzyl alcohol29	Preterms and neonates	Not recommended
Propyl paraben30	Any	2 mg/kg/day	Permitted daily exposure according to the method outlined in ICH Q3C.