information document on health canadas proposal to amend the food and drug regulations to allow the use of cross-linked carboxymethyl cellulose in table-to sweetener tablets this document provides information on health canadas proposal to amend the food and drug regulations regulations to permit the use of cross-linked carboxymethyl cellulose in table-to sweetener tablets. cross-linked carboxymethyl cellulose cross-linked cmc would be used as a disintegrant to decrease the time required for tablets to dissolve in beverages. health canada received a submission requesting that the regulations be amended to permit the addition of l-leucine and cross-linked cmc at a level of 10 per cent and 2 per cent w w respectively in tablet formulations of sucralose-containing table-to sweeteners. l-leucine is an amino acid permitted to be added to infant formulas and formulated liquid diets. a provision also currently exists in table viii division 16 of the food and drug regulations for the use of l-leucine at 3 per cent of tablet weight as a lubricant in the manufacture of table-to sweetener tablets containing aspartame. as l-leucine is already an approved food additive under division 16 the requested extension of use to a new food was eligible for an interim marketing authorization ima once the evaluation of the submission confirmed that there would be no human health concerns with the proposed use. as a result the requested use of l-leucine as a lubricant and or binder in table-to sweetener tablets at levels consistent with good manufacturing practice was enabled under an ima that was published in the government of canadas official newspaper the canada gazette on 10 may 2008 notified under g sps n can 329 . cross-linked cmc is the product resulting from the treatment of carboxymethyl cellulose with acid and heat and is not a permitted food additive in canada. although a related additive carboxymethyl cellulose is currently permitted at different levels in a variety of foods as listed in table iv division 16 of the regulations cross-linked cmc is considered a new food additive in canada and was therefore not eligible for an ima. as a result cross-linked cmc is the focus of the current notification. health canadas food directorate has completed a safety assessment of cross-linked cmc when used as described in the submission. as no safety concerns have been raised with the proposed use in sucralose-containing table-to sweetener tablets the department is proposing amendments to the regulations to allow the proposed use of cross-linked cmc. further based on the safety data it is proposed that the use of this additive may be permitted in table-to sweeteners containing any of the sweeteners approved for such use in table-to sweeteners under table ix division 16 of the regulations. such provisions would allow for the use of cross-linked cmc when there is a technological justification that is when the sweeteners are sold in tablet form. this approach is consistent with that taken for l-leucine the use of which has previously been enabled in table-to sweetener tablets