NHPD revises maximum daily limit of carvacrol for natural health products containing Oil of Oregano as a medicinal ingredient.
Oil of oregano, derived from the species of Origanum spp., is a popular natural health product that is acclaimed for its ability to reduce upper respiratory tract infections. Using of oil of oregano in natural health products is not a new idea, however, there have been several updates from the NHPD, particularly regarding the limit for carvacrol, an alcohol that is naturally present in oil of oregano and the claims that you can make.
Originally, the Maximum Survey-Derived Dietary Intake (MSDRI) for the European Union (EU) had determined that 0.23 µg/kg body weight/day or 0.016 mg for a 70 kg human was the upper limit for carvacrol. This was based on a report from The Joint Food and Agriculture Organization/World Health Organization Expert Committee on Food Additives (JECFA). Adopting this, the NHPD sent out Section 16 notices to request evidence from industry and stakeholders to support the safe use of carvacrol in higher amounts.
Increase in acceptable amount of carvacrol in Oil of Oregano:
Recently, the NHPD has revised the acceptable safe limit of carvacrol as a medicinal ingredient to 189 mg (2.7 mg / kg body weight / day) in an average 70 kg healthy adult. However, it is important to note that this limit is applicable to all species of oregano, regardless of the source, and the total carvacrol content must be less that 189mg for an adult. It is also of note that the carvacrol has been deemed safe for children as well, provided you apply the same limit of 2.7 mg / kg body weight / day taking into account their body weight.
However, it is important for the industry to be aware that the increased amount of carvacrol is limited to medicinal ingredients – non medicinal ingredients are still required to abide by previously defined limits. Therefore, to include oil of oregano as a non medicinal ingredient the amount of carvacrol must be no more than 0.016 mg (0.23 ug/kg body weight/day) in an average 70 kg healthy adult.
Moreover, we are noticing a trend in natural health products receiving licences with antioxidant claims on the Licensed Natural Health Products Database. Although, it is important to be aware that these types of claims are only possible provided that you submit sufficient evidence to support this claim to the NHPD.
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