Chemical Substance - Ethanol
NHPID name:
Ethanol
Reference:
Proper name(s):
Common name(s):
Category:
Approved Chemical Name
Structure:
Monograph(s):
Schedule 1:
CAS registry number:
Additional details:
Detail:
If the ethanol is denatured, the denaturant(s) must be represented separately as non-medicinal ingredient(s). The EMA reference document (EMA/HMPC/85114/2008) provides sample calculations to determine theoretical blood ethanol concentrations, and the reference weights used in the calculations should be consistent with the Dietary Reference Intakes. Reference: Otten JJ, Pitzi Hellwig J, Meyers LD, editors. 2006. Institute of Medicine. Dietary Reference Intakes: The Essential Guide to Nutrient Requirements. Washington (DC): National Academies Press.
Roles
Medicinal
Rationale:
Classified as an NHP under Schedule 1, item 2 (an isolate) of the Natural Health Products Regulations
Reference: NNHPDNon-medicinal
Purposes:
Antifoaming Agent
,
Astringent
,
Flavour Enhancer
,
Fragrance Ingredient
,
Preservative Antimicrobial
,
Solubilizing Agent
,
Solvent
,
Viscosity Decreasing Agent
Restrictions:
General:
Route Of administration:
Detail:
For use by children under 12 years of age, the quantity of ethanol provided by the product, according to the recommended dose, should not yield a blood ethanol concentration in excess of 0.125 g/l, for any single dose. The restrictions on the use of ethanol in children presented in EMA/HMPC/85114/2008 should be used, unless sufficient evidence is provided that supports the product's safe use, according to the recommended conditions of use.
Reference: