Temporary acceptable daily intake (ADI) of 0-0.8 mg/kg bodyweight, based on the previous ADI of 0-1.5 mg/kg bodyweight and applying an additional safety factor of 2.
It will be considered as NMI if below 1%. At or above that level, considered a drug (non-NHP) for diaper rash products (1-30% dimethicone).
When it is not associated with a health claim and has a valid non-medicinal purpose, Dimethicone is an acceptable non medicinal ingredient in a natural health product in the minimum concentration necessary to achieve the excipient effect.
At any concentration where Dimethicone is associated with a health claim (e.g. as a barrier in diaper rash products), Dimethicone is classified as a drug medicinal ingredient subject to the Food and Drug Regulations, not an NHP.