Safety evaluation of certain food additives - ipcs inchem

CALCIUM LIGNOSULFONATE (40–65)
First draft prepared by
Dr I.C. Munro 1 and Ms J. Baines 2
1 Cantox Health Sciences International, Mississauga,
Ontario, Canada
2 Food Standards Australia New Zealand, Canberra, ACT,
Australia
Explanation ................................................................................
Chemical and technical considerations ...............................
Biological data ...........................................................................
Biochemical aspects ...........................................................
Absorption, distribution and excretion ...........................
Biotransformation ..........................................................
Toxicological studies ...........................................................
Short-term studies of toxicity ........................................
Genotoxicity ..................................................................
Reproductive toxicity .....................................................
Special study on immune responses ............................
Special study on skin sensitization ...............................
Studies on other lignosulfonate salts ............................
Dietary exposure .......................................................................
Comments .................................................................................
Toxicological data ...............................................................
Assessment of dietary exposure .........................................
Evaluation ..................................................................................
References ................................................................................
1. EXPLANATION
This substance, under the name “ligninsulfonate”, was placed on the agenda
of the present meeting at the request of the Codex Committee on Food Additives
at its Thirty-ninth Session (Codex Alimentarius Commission, 2007) for assessment
of safety, specification and dietary exposure. The Committee received information
only on calcium lignosulfonate and decided to refer to the specified material as
“calcium lignosulfonate (40–65)” to distinguish it from other calcium lignosulfonates
on the market. The number included in the name of the additive reflects the weightaverage
molecular weight range (40 000–65 000) specified in the specifications
monograph developed by the Committee at its present meeting. Calcium
lignosulfonate (40–65) is intended for use as a carrier of encapsulated food
ingredients. It has not been evaluated previously by the Committee.
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