ROSEMARY EXTRACT
Overview
Chemical Names
Rosemary extract
Synonyms
Carnosic acid
INS
392
Functional Class
Food Additives
ANTIOXIDANT
Food Additives
ANTIOXIDANT
Food Additives
INS matches
392
Evaluations
Evaluation year: 2019
ADI:Temporary ADI of 0–0.3 mg/kg bw (expressed as carnosic acid and carnosol)
ADI:
Temporary ADI of 0–0.3 mg/kg bw (expressed as carnosic acid and carnosol)
Comments:
The Committee concluded that the new studies provided evidence for the
absence of reproductive toxicity, but not for the absence of developmental
toxicity. The Committee retained the temporary ADI of 0–0.3 mg/kg bw,
pending the submission of studies on the developmental toxicity of
rosemary extract and studies to elucidate whether the effects noted on
rodent pup thyroid hormone levels can be replicated. The temporary ADI
will be withdrawn if the requested studies are not submitted by the end of
2021
Meeting:
87
Specs Code:
R
Report:
Tox Monograph:
Specification:
Evaluation year: 2016
ADI:
Temporary ADI of 0–0.3 mg/kg bw (expressed as carnosic acid and carnosol)
Comments:
The Committee established a temporary ADI of 0–0.3 mg/kg bw for rosemary extract, expressed as carnosic acid and carnosol, on the basis of a NOAEL of 64 mg carnosic acid + carnosol/kg bw per day, the highest dose
tested in a short-term toxicity study in rats, with application of a 200-fold uncertainty factor. This uncertainty factor
incorporates a factor of 2 to account for the temporary designation of the ADI. The Committee made the ADI
temporary pending the submission of studies to elucidate the potential developmental and reproductive toxicity of
the rosemary extract under consideration. An additionaluncertainty factor to account for the lack of a chronic
toxicity study was not considered necessary based on the absence of adverse effects in the short-term toxicity
studies at doses up to and including the highest dose tested.
The temporary ADI applies to rosemary extract that meets the specifications prepared at the present
meeting. It will be withdrawn if the required data are not provided by the end of 2018.
The Committee noted that the dietary exposure estimates for rosemary extract for high consumers, 0.09–0.81 mg/kg
bw per day (as carnosic acid plus carnosol), may exceed the upper bound of the temporary ADI by up to 2.7-fold
(for young children at the top end of the range of estimated dietary exposures). Based on the conservative
nature of the dietary exposure assessments, in which it was assumed that all foods contained rosemary extracts
at the maximum use level, the Committee concluded that this exceedance of the temporary ADI does not
necessarily represent a safety concern.
Meeting:
82
Specs Code:
T
Report:
Tox Monograph:
Specification: