Registration Dossier

Toxicological information

Additional toxicological data

Currently viewing:

Administrative data

Endpoint:
additional toxicological information
Type of information:
other: GRAS notification
Adequacy of study:
supporting study
Reliability:
other:
Rationale for reliability incl. deficiencies:
other: GRAS notification

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
2002
Report Date:
2002

Materials and methods

Results and discussion

Any other information on results incl. tables

Listing of Specific Substances Affirmed as GRAS

 

Sec. 184.1505 Mono- and diglycerides.

 

Mono- and diglycerides consist of a mixture of glyceryl mono-and diesters, and minor amounts of triesters, that are prepared from

fats or oils or fat-forming acids that are derived from edible sources. The most prevalent fatty acids include lauric, linoleic, myristic, oleic, palmitic, and stearic. Mono- and diglycerides are manufactured by the reaction of glycerin with fatty acids or the reaction of glycerin with triglycerides in the presence of an alkaline catalyst. The products are further purified to obtain a mixture of glycerides, free fatty acids, and free glycerin that contains at least 90 percent-by-weight glycerides. In accordance with Sec. 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe (GRAS) as a direct human food ingredient is based on current good manufacturing practice conditions of use.

 

Applicant's summary and conclusion