Normativa otros paísesAbr. 27, 2012
Canadá: solicitan permitir el uso de dos aditivos alimentarios L-leucine
17 April 2012
|Committee on Sanitary and Phytosanitary Measures||Original: English/
The following communication, received on 5 April 2012, is being circulated at the request of the Delegation ofCanada.
|Regulations Amending the Food and Drug Regulations (1571 – Food Additives)|
| Health Canada has received a submission from industry requesting that the Food and Drug Regulations be amended to permit the use of two food additives: (1) L-leucine to be used as a lubricant and/or binder in the production of table-top sweetener tablets containing sucralose, at a maximum level of use of 10 per cent of tablet weight; and (2) carboxymethyl cellulose, cross-linked, also called sodium carboxymethyl cellulose, cross-linked, to be used for tablet disintegration in table-top sweetener tablets containing sucralose, at a maximum level of use of 2 per cent of tablet weight.
An Interim Marketing Authorization (“IMA”) was issued to permit the immediate use of L-leucine as proposed in the submission while the regulatory process was undertaken to amend the Regulations. The IMA for L-leucine was published in the government notices section of the Canada Gazette, Part I, on 10 May 2008 (G/SPS/N/CAN/329).
As a new food additive, carboxymethyl cellulose, cross-linked (sodium carboxymethyl cellulose, cross-linked), did not meet the IMA eligibility requirements. Consequently, a public consultation on the proposal to amend the Regulations to permit the use of carboxymethyl cellulose, cross-linked (sodium carboxymethyl cellulose, cross-linked) in table-top sweetener tablets was conducted through postings on Health Canada’s Website on 28 July 2011 (G/SPS/N/CAN/554).
Evaluation of available data supports the safety and effectiveness of these food additives in the above specified uses. Therefore, the Food and Drug Regulations have been amended to permit the use of the food additives mentioned above in the specified applications.
These Regulations entered into force on 15 March 2012.
|This addendum concerns a:|
|[ ] Modification of final date for comments|
|[X] Notification of adoption, publication or entry into force of regulation|
|[ ] Modification of content and/or scope of previously notified draft regulation|
|[ ] Withdrawal of proposed regulation|
|[ ] Change in proposed date of adoption, publication or date of entry into force|
|[ ] Other:|
|Comment period: (If the addendum extends the scope of the previously notified measure in terms of products and/or potentially affected Members, a new deadline for receipt of comments should be provided, normally of at least 60 calendar days. Under other circumstances, such as extension of originally announced final date for comments, the comment period provided in the addendum may vary.)|
|[ ] Sixty days from the date of circulation of the addendum to the notification and/or (dd/mm/yy): Not applicable|
|Agency or authority designated to handle comments: [ ] National Notification Authority, [ ] National Enquiry Point. Address, fax number and e-mail address (if available) of other body:|
|Text available from: [ ] National Notification Authority, [X] National Enquiry Point. Address, fax number and e-mail address (if available) of other body:|
|The full text of the adopted measure can be downloaded from the Internet addresses indicated below:
or requested from:
Canadian Enquiry Point
Standards Council of Canada
200-270 Albert Street
Tel: +(613) 238-3222
Fax: +(613) 569-7808