ROSEMARY EXTRACT

Comments:

A BMDL20 of 97 mg/kg bw per day expressed as carnosic acid plus carnosol was calculated for a new study on thyroid hormone levels in rat pups from dams treated with rosemary extract in the diet during pregnancy and lactation. This BMDL20 is higher than the NOAEL of 64 mg/kg bw per day, expressed as carnosic acid plus carnosol, on which the current temporary ADI for rosemary extract is based. In the derivation of the temporary ADI of 0–0.3 mg/kg bw per day, an additional uncertainty factor of 2 was incorporated into the overall uncertainty factor of 200 to account for the absence of studies to elucidate the potential developmental and reproductive toxicity of rosemary extract. This factor is no longer necessary. The temporary ADI of 0–0.3 mg/kg bw per day (expressed as carnosic acid and carnosol) was therefore withdrawn and an ADI of 0–0.6 mg/kg bw per day (expressed as carnosic acid and carnosol) was established.

Intake:

Estimated high dietary exposures to rosemary extract (expressed as carnosic acid plus carnosol) based on naturally occurring sources combined with dietary exposures from added sources at typical use levels were up to 0.84 mg/kg bw per day for children and up to 0.32 mg/kg bw per day for adults. The MOE between the BMDL20 for reduction in T4 levels in pups and the estimated high dietary exposure for children is greater than 100, and is considered sufficient. JECFA therefore did not consider the slight exceedance of the ADI, which was only by children, as a safety concern.

Meeting:

100

Report: 

Tox Monograph: 

Specification: 

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 The temporary ADI will be withdrawn if the requested studies are not submitted by the end of 2021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: 

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: