Food

Select Committee on GRAS Substances (SCOGS) Opinion: Carboxymethyl cellulose (packaging) and Sodium carboxymethyl cellulose

The GRAS Substances (SCOGS) Database allows access to opinions and conclusions from 115 SCOGS reports published between 1972-1980 on the safety of over 370 Generally Recognized As Safe (GRAS) food substances. The GRAS ingredient reviews were conducted by the Select Committee in response to a 1969 White House directive by President Richard M. Nixon.

Carboxymethyl cellulose (packaging) and Sodium carboxymethyl cellulose

SCOGS Report Number: 25
NTIS Accession Number: PB274667*
Year of Report: 1973, and Addendum
GRAS SubstanceID Code21 CFR Section
Carboxymethyl cellulose (packaging)9000-11-7 
Sodium carboxymethyl cellulose9004-32-4182.1745

SCOGS Opinion:

Cellulose is a major constituent of many foods of plant origin. As such it is a significant portion of the diet, but is neither degraded nor absorbed. Cellulose derivatives considered in this report are virtually unabsorbed and little or no degradation of absorbable products occurs in the human digestive tract. In man, consumption of large amounts appears to have no effect other than providing dietary bulk, reducing the nutritive value of such foodstuffs and possibly exerting a laxative effect. However, the existence of certain data and the different categorization of cellulose and the several cellulose derivatives on the GRAS list suggest that the Select Committee should render a separate opinion on each substance considered in this report.

C. CARBOXYMETHYL CELLULOSE

Carboxymethyl cellulose is converted spontaneously to a salt in alkaline solution, and it is probable that the distinction between carboxymethyl cellulose and its salts is artificial. However, carboxymethyl cellulose is listed as GRAS as a substance migrating to food from cotton or cotton fabrics used in dry food packaging, while its sodium salt is listed as GRAS as a miscellaneous or general purpose food additive.

In view of the separate listing of carboxymethyl cellulose, the Select Committee concludes that:

There is no evidence in the available information on carboxymethyl cellulose that demonstrates, or suggests reasonable grounds to suspect, a hazard to the public when it is used in dry food packaging materials originating from cotton or cotton fabrics as now practiced or as it might reasonably be expected to be used for such purposes in future.

D. SODIUM CARBOXYMETHYL CELLULOSE

Despite the probable lack of distinction between sodium carboxy methyl cellulose and its parent compound, carboxymethyl cellulose, only the sodium carboxymethyl cellulose is GRAS as a miscellaneous and general purpose food additive. As such, there are no data that suggest it reacts differently than pure and regenerated cellulose or carboxymethyl cellulose.

In view of the foregoing the Select Committee concludes that:

There is no evidence in the available information on sodium carboxymethyl cellulose that demonstrates, or suggests reasonable grounds to suspect, a hazard to the public when it is used at levels that are now current or that might reasonably be expected in future.


ADDENDUM

Since the Select Committee on GRAS Substances submitted its report. "Evaluation of the Health Aspects of Cellulose and Certain Cellulose Derivatives as Food Ingredients" to FDA in December. 1973 it has come to our attention that one of the substances discussed. carboxymethyl cellulose is presumed by FDA to be GRAS but unpublished as well as GRAS under 21 CFR 121.101(i). Therefore. the Select Committee on GRAS Substances now submits this addendum to be included in its December 1973 report to clarify the conclusions concerning both direct and indirect food uses of carboxymethyl cellulose and sodium carboxymethyl cellulose.

The Select Committee has reevaluated the available information on carboxymethyl cellulose and its sodium salt. Because carboxymethyl cellulose becomes the sodium salt in the presence of sodium ion, no distinction between the two substances as used in food need be made. There are no data to suggest acute or chronic toxicity of either substance beyond those which are already included in the December, 1973 report on cellulose and cellulose derivatives.

Based upon this reevaluation the Select Committee finds that subsections C and D, pages 18 and 19, of its report, Evaluation of the Health Aspects of Cellulose and Certain Cellulose Derivatives as Food Ingredients. December, 1973. should be clarified to read as follows:

C. CARBOXYMETHYL CELLULOSE

Because carboxymethyl cellulose becomes the sodium salt in the presence of sodium ion, no distinction between the two substances as used in food need be made. Carboxymethyl cellulose is designated GRAS as a substance migrating to food from cotton or cotton fibers used in dry food packaging and is also presumed by FDA to be GRAS but unpublished.

In view of all of the foregoing, the Select Committee concludes that:

There is no evidence in the available information on carboxymethyl cellulose that demonstrates or suggests reasonable grounds to suspect a hazard to the public when it is used as a direct or indirect food ingredient at levels that are now current or that might reasonably be expected in future.

D. SODIUM CARBOXYMETHYL CELLULOSE

Sodium carboxymethyl cellulose is designated GRAS as a miscellaneous and/or general purpose food additive. There are no data to suggest that its physiological action differs from that of carboxymethyl cellulose.

In view of the foregoing the Select Committee concludes that:

There is no evidence in the available information on sodium carboxymethyl cellulose that demonstrates or suggests reasonable grounds to suspect a hazard to the public when it is used at levels that are now current or that might reasonably be expected in future.


*Complete reports containing details of the safety studies that formed the basis of the opinions and conclusions and are available from the National Technical Information Service (NTIS), 5285 Port Royal Road, Springfield, VA 22161 (703) 605-6000.

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