SORBITAN MONOSTEARATE

Comments:

The previous JECFA derived a group ADI of 0–25 mg/kg bw for the sum of sorbitan fatty acid esters (INS No. 491–495), based on the NOAEL of 2500 mg/kg bw per day and applying an uncertainty factor of 100. However, the genotoxicity studies available to the current JECFA provided an indication of the clastogenic effects of sorbitan monostearate, requiring further investigation. In the absence of the additional data that were available to EFSA, JECFA was not able to conclude on the potential for genotoxicity and withdrew the group ADI of 0–25 mg/kg bw, establishing a temporary group ADI of 0–25 mg/kg bw.

Intake:

The highest dietary exposure estimate of 24 mg/kg bw per day for the sum of sorbitan esters of fatty acids using reported use levels is below the temporary group ADI of 0–25 mg/kg bw. However, use levels for the sum of the five individual sorbitan esters of fatty acids were not considered for important food categories such as water-based flavoured drinks (carbonated, non-carbonated and concentrates), soybean-based beverages, dry and precooked pasta, or eggs and egg-based desserts because they were not available to JECFA. JECFA therefore concluded that the highest exposure estimates, which are based on data from the EU, could be underestimated relative to exposure based on GSFA permissions.

Meeting:

102

Specs Code:

T

ADI:

0-25 mg/kg bw

Comments:

Considered for specification only. Group ADI. As the sum of the sorbitan esters of lauric, oleic, palmitic and stearic acid.

Meeting:

89

Specs Code:

No specifications were prepared. Information is required to prepare specifications

Report: 

Tox Monograph: 

Specification: 

ADI:

0-25 mg/kg bw

Comments:

Group ADI. As the sum of the sorbitan esters of lauric, oleic, palmitic and stearic acid

Meeting:

17

Specs Code:

R

Report: 

Tox Monograph: 

Specification: 

Previous Years: