Defined Organism Substance - Spartan Oregano Essential Oil

NHPID name:
Spartan Oregano Essential Oil

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Proper name(s):

Common name(s):

Category:
Approved Herbal Substance Name

Schedule 1:

Source material(s):

Preparations:


Roles

Medicinal

Rationale:

Considered NHP under Schedule 1 item 2, (an extract), of the NHP Regulations.

Reference:  NNHPD
Restrictions:

General:

Detail:
The quantity or concentration of carvacrol in all applicable essential oils or extracts must be declared. Based on safety concerns, oregano oil intake of up to 0.27 micrograms/kg body weight per day is allowed. Applicants must provide evidence to support the safe use of the carvacrol content of oil of oregano, if they would like to use a higher quantity as a NMI in their product. If the daily exposure of carvacrol exceeds 0.23 micrograms/kg bw per day from the NHP in the absence of adequate safety evidence, the oil of oregano cannot be considered to be a NMI.

Reference:


Non-medicinal

Purposes:
Restrictions:

General:

Detail:
The quantity or concentration of carvacrol in all applicable essential oils or extracts must be declared. Based on safety concerns, oregano oil intake of up to 0.27 micrograms/kg body weight per day is allowed. Applicants must provide evidence to support the safe use of the carvacrol content of oil of oregano, if they would like to use a higher quantity as a NMI in their product. If the daily exposure of carvacrol exceeds 0.23 micrograms/kg bw per day from the NHP in the absence of adequate safety evidence, the oil of oregano cannot be considered to be a NMI.

Reference:

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