Normativa otros paísesAgo. 19, 2011
Canadá: proponen permitir el uso de reticulado caboximetilcelulosa en tabletas edulcorantes
3 August 2011
|Committee on Sanitary and Phytosanitary Measures||Original: English/
|1.||Notifying Member: Canada
If applicable, name of local government involved:
|2.||Agency responsible: Health Canada|
|3.||Products covered (provide tariff item number(s) as specified in national schedules deposited with the WTO; ICS numbers should be provided in addition, where applicable): Cross-linked Carboxymethyl cellulose (ICS Code: 67.220)|
|4.||Regions or countries likely to be affected, to the extent relevant or practicable:
[X] All trading partners
[ ] Specific regions or countries:
|5.||Title of the notified document: Information Document on Health Canada’s Proposal to amend the Food and Drug Regulations to allow the use of cross-linked Carboxymethyl cellulose in table-top sweetener tablets Language(s): English and French Number of pages: 8 and 9|
|6.||Description of content: This document provides information on Health Canada’s proposal to amend the Food and Drug Regulations (“Regulations”) to permit the use of cross-linked Carboxymethyl cellulose in table-top 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-top 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-top 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-top sweetener tablets at levels consistent with good manufacturing practice was enabled under an IMA that was published in the Government of Canada’s 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 Canada’s 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-top 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-top sweeteners containing any of the sweeteners approved for such use in table-top 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-top sweetener tablets.
|7.||Objective and rationale: [X] food safety, [ ] animal health, [ ] plant protection, [ ] protect humans from animal/plant pest or disease, [ ] protect territory from other damage from pests.|
|8.||Is there a relevant international standard? If so, identify the standard:
[X] Codex Alimentarius Commission (e.g. title or serial number of Codex standard or related text)
Cross-linked CMC (INS 468) was adopted in 2005 by the Codex Alimentarius Commission as an additive permitted for use in food in general, unless otherwise specified, in accordance with GMP (Table Three of the General Standard for Food Additives).
Available in English and French:
[ ] World Organization for Animal Health (OIE) (e.g. Terrestrial or Aquatic Animal Health Code, chapter number)
[ ] International Plant Protection Convention (e.g. ISPM number)
[ ] None
Does this proposed regulation conform to the relevant international standard?
[X] Yes [ ] No
If no, describe, whenever possible, how and why it deviates from the international standard:
|9.||Other relevant documents and language(s) in which these are available:
Health Canada’s Food and Nutrition – “Public Involvement and Partnerships” Website, posted 28 July 2011 (available in English and French):
|10.||Proposed date of adoption (dd/mm/yy): Normally within four to five months from the posting of the Information Document on the Health Canada website.
Proposed date of publication (dd/mm/yy):
|11.||Proposed date of entry into force: [ ] Six months from date of publication, and/or (dd/mm/yy): On the date the measure is adopted.
[ ] Trade facilitating measure
|12.||Final date for comments: [ ] Sixty days from the date of circulation of the notification and/or (dd/mm/yy): 11 October 2011
Agency or authority designated to handle comments: [ ] National Notification Authority, [X] National Enquiry Point. Address, fax number and e‑mail address (if available) of other body:
|13.||Texts available from: [ ] National Notification Authority, [X] National Enquiry Point. Address, fax number and e‑mail address (if available) of other body:
The electronic version of “Information Document on Health Canada’s Proposal to amend the Food and Drug Regulations to allow the use of cross-linked Carboxymethyl cellulose in table-top sweetener tablets” can be downloaded at: