Summary of a Consultation to amend the Food and Drug Regulations to Permit the Use of Cross-Linked Carboxymethyl Cellulose as a Food Additive in Table-Top Sweetener

Health Canada's Food Directorate conducted a detailed and rigorous evaluation of the submission for use of cross-linked carboxymethyl cellulose (CMC) in table-top sweetener tablets, through which it was concluded cross-linked CMC meets the conditions of an acceptable food additive on the basis of toxicological, nutritional, and chemical safety grounds, and that the submission meets the requirements of section B.16.002 of the Regulations.

In addition, the Food Directorate agrees with the Joint WHO/FAO Expert Committee on Food Additives' (JECFA) evaluation of the toxicity of cross-linked CMC and its established acceptable daily intake (ADI) of not specified. ADI's of "not specified" are only assigned to those food additives that are of very low toxicity and for which dietary exposure from its food additive uses (at levels consistent with good manufacturing practices), and any normal background levels, would not present a hazard to human health.

Health Canada's Food Directorate recently completed a consultation on its proposal to amend the Food and Drug Regulations (Regulations) to permit the use of cross-linked carboxymethyl cellulose (CMC) as a food additive in table-top sweetener tablets. This consultation was open to both domestic and international stakeholders for a 75 day period between July 28, 2011 and October 11, 2011.

There were no comments received on this proposal throughout the 75 day consultation period. Since table-top sweeteners do not have a standard of identity in the Regulations, it was considered unnecessary to conduct an external consultation during the safety evaluation of cross-linked CMC.Furthermore, this proposal would not impose a new regulatory requirement on the food industry; rather, the proposal involves the introduction of enabling regulations.

As a result of both its evaluation and subsequent consultation processes, it is the intention of Health Canada's Food Directorate to amend table VIII, Division 16 of the Food and Drug Regulations to permit the use of cross-linked CMC, at levels consistent with good manufacturing processes (GMP), in "table-top sweetener tablets containing sweeteners approved in Table IX for use in table-top sweeteners", in accordance with the Canada Gazette, Part II publication process.

Once this additive is available for use, a notification will be sent out through Health Canada's Food Additives E-Notice to verify this progress.

For more information on this initiative, please contact the Bureau of Chemical Safety's Chemical Health Hazard Assessment Division at bcs-bipc@hc-sc.gc.ca.

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