STARCH SODIUM OCTENYLSUCCINATE

Comments:

Considered for specification only.

Meeting:

86

Specs Code:

R, T

Report: 

Specification: 

ADI:

NOT SPECIFIED

Meeting:

82

Specs Code:

R, T

Report: 

Specification: 

ADI:

Not specified

Comments:

The Committee evaluated the safety of OSA-modified starch for use as an emulsifier in infant formula and in formula for special medical purposes intended for infants. At the twenty-sixth meeting, the Committee assigned an ADI “not specified” to OSA-modified starch. Since the time of that meeting, new data have become available, including a 90-day oral toxicity study, genotoxicity studies and a longterm toxicity and carcinogenicity study. All of the new data confirm the very low toxicity of OSA-modified starch, and the Committee confirmed the ADI “not specified”. The Committee took into account the overall low toxicity of OSA modified starch, the conservatism in the NOAEL, which was the highest dose tested in a study in neonatal animals, and in the exposure assessments, as well as the supporting evidence from clinical trials and post-marketing surveillance and concluded that the consumption of OSA-modified starch in infant formula or formula for special medical purposes intended for infants is not of concern at use levels up to 20 g/L.

Meeting:

79

Specs Code:

R

Report: 

Tox Monograph: 

Specification: 

ADI:

NOT SPECIFIED

Meeting:

26

Specs Code:

R (1989)

Report: 

Tox Monograph: 

Specification: 

Previous Years: