Chemical Substance - L-Malic acid

NHPID name:
L-Malic acid

Reference:
KIBBE

Proper name(s):

Common name(s):
L-Malic acid

Category:
Approved Chemical Name
Structure:
Image of molecular structure representing L-Malic acid


Schedule 1:
Isolate

CAS registry number:
97-67-6



Additional details

Detail:
The presence of this ingredient as restricted on the List of Prohibited and Restricted Cosmetic Ingredients (the Cosmetic Ingredient Hotlist) indicates that there are potential safety issues. This ingredient must be used in accordance with the restrictions set out on the Hotlist when included in natural health products, unless additional evidence for safety is submitted.


Roles

Medicinal

Rationale:

Classified as an NHP under Schedule 1, item 2 (an isolate) of the Natural Health Products Regulations.

Reference:  PDL

Non-medicinal

Purposes:
Buffering Agent , Flavour Enhancer , PH Adjuster
Restrictions:

General

Detail:
For skin products, the concentration of alpha-hydroxy acids alone or in combination, when used as non-medicinal ingredients, should be lower than 3% and not contribute to the product's pharmacological effects.

Reference:
CIH

Non-NHP

Rationale:

A non-NHP when the product is captured by the Prescription Drug List: When sold in topical formulations containing alpha hydroxy acids alone or in combination at concentrations greater than 30% and/or with a pH lower than 3.0, except when sold to be applied to warts, corns or calluses.

Reference:  NNHPD