OpinionOnUseOfCrossLinkedSodium

CarboxymethylCelluloseInStrongDietary
Supplements
Terms of reference
To suggest the Payment in regard to the demand to extend making use of cross-linked salt
carboxymethyl cellulose as a disintegrant in strong nutritional supplements taking account of
the additional toxicological and exposure data details sent by the petitioner.
Background
Cross-linked sodium carboxymethyl cellulose is also called croscarmellose salt or customized
cellulose gum. The Committee has actually formerly suggested that using cross-linked salt
carboxymethyl cellulose served as a disintegrant for sweetener tablets.

1 This viewpoint was based on toxicity data on the non-cross-linked father and mother
fabric (sodium carboxymethyl cellulose), restricted toxicity data on cross-linked sodium
carboxymethyl cellulose itself, the assumption that cross-linking would result in a
reduction in any type of potential toxicity, info on the nature of the cross links, the
identity and magnitude of deposits of catalysts as well as solvents, and the spec of the
last completed item.

2 Back then the Board used an estimate of severe intake of 2.7 mg/kg bodyweight/day if
it were utilized in sweetener tablet computers at the optimum asked for level of 60g/kg.
Although the toxicological information was not sufficient to set an Acceptable Daily
Intake, the Board taken into consideration, for the factors set out above, that making
use of cross-linked salt carboxymethyl cellulose as a disintegrant in table-top sugar
tablets was acceptable.

Cross-linked sodium carboxymethyl cellulose was initially created as a tablet computer

disintegrant for medical foods and dietary food supplements, enabling dissolution at reduced
usage levels (0.25-3.0 %). It has an offical essay in the European Pharmacopoeia. In the U.S.A,

it is made use of as a disintegrant in prescribed medications and also has usually recognised as
safe (GRAS) condition for usage in dietary supplements.
A demand for using cross-linked salt carboxymethyl cellulose as a disintegrant in strong
nutritional supplements has currently been sent to the European Payment. In considering this
demand, the Board was offered with details on technological validation, consumption quotes,
and also a new 90-day rat dental eating research on cross-linked sodium carboxymethyl
cellulose.
Forecasted intakes.
While the original entry on sweetener tablets asked for consume to an optimum level of
60g/kg, the Board has actually been informed that, considering that 1991, it has been made
use of in sweetener tablet computers at an optimum degree of 30g/kg. The very same level of
30g/kg has actually been requested for use in dietary supplement tablets.

Presuming a "worst case" intake of 30 sweetener tablets a day, each considering 90 mg, as
well as 12 nutritional supplement tablet computers a day, each weighing 1200 mg, as well as a
cross-linked sodium carboxymethyl cellulose msds material of 30g/kg, the price quote of
extreme intake of cross-linked sodium carboxymethyl cellulose from both usages is 8.5 mg/kg
bodyweight/day.
This stands for simply over a 3-fold boost in severe consumption from the two usages, if both
uses are at a level of 30g/kg, compared to the previous price quote of severe intake of 2.7
mg/kg bodyweight/day from usage just in sugar tablets at a level of 60g/kg.
Additional poisoning information.
A new 90-day oral feeding study4 was performed where teams of rats were fed diet regimens
containing 0, 10,000 or 50,000 ppm cross-linked sodium carboxymethyl cellulose or 50,000
ppm of a comparable changed cellulose gum.
There were no treatment-related results, besides decreased bodyweight in men and raised food
intake and mineralisation of the kidney in women in the team provided 50,000 ppm crosslinked salt carboxymethyl cellulose.
Comparable results were seen in the team offered 50,000 ppm changed cellulose gum.
Nephrocalcinosis is not unusually observed in researches feeding high levels of non-nutrients in
the diet regimen.
Lowered bodyweight and also boosted food consumption were additionally seen in all therapy
groups in a previous 13-week dental feeding study,2 which contrasted 10,000 and also 50,000
ppm cross-linked salt carboxymethyl cellulose with the parent substance, salt carboxymethyl
cellulose.
Taking into account the adverse results noted at 50,000 ppm, the no-observed-effect level
(NOEL) for cross-linked salt carboxymethyl cellulose is 10,000 ppm, equivalent to 757mg/kg
bodyweight/day as well as 893 mg/kg bodyweight/day for men and also women respectively.
This provides a margin of security of around 100 in between the NOEL and the anticipated
extreme consumption of 8.5 mg/kg bodyweight/day for man.

Conclusion.
The Board has actually appraised the previous and freshly offered technological and also
toxicological details on cross-linked sodium carboxymethyl cellulose. It keeps in mind the lack
of poisoning as well as long record of secure usage of the parent substance, sodium
carboxymethyl cellulose. The parent compound is understood to be poorly taken in, if in any
way, in animals and man, as well as it is likely that cross-linking reduces absorption even
further. The Board as a result advises that the expansion of usage of cross-linked sodium
carboxymethyl cellulose as a disintegrant in nutritional supplements at a degree not exceeding
30g/kg is acceptable.