. /.WORLD TRADE
ORGANIZATIONG/SPS/N/CAN/159
6 February 2003
(03-0793)
Committee on Sanitary and Phytosanitary Measures Original:  English/
French
NOTIFICATION
1. Member to Agreement notifying:   CANADA
If applicable, name of local government involved:
2. Agency responsible:  Health Canada
3.Products covered (provide tariff item num ber(s) as specified in national schedules
deposited with the WTO; ICS numbers should be provided in addition, where
applicable):  Pre-term Infant Formulas (ICS:  67.230)
4. Regions or countries likely to be affected, to the extent relevant or practicable:  Not
stated
5. Title, language and number of pages of the notified document:   Interim Marketing
Authorization to Increase the Maximum Levels of Vitamins A and D in Pre-term Infant
Formulas (English and French;  pages 200-201)
6. Description of content:  Health Canada has received a submission to increase the
maximum levels of vitamins A and D in pre-term infant formula from the current permitted
levels of 500 International Units (IU) for vitamin A and 80 IU for vitamin D per100 kilocalories (kcal) to 1 420 IU and 300 IU for vitamins A and D, respectively, per
100 kcal.  These maximum levels include any overages that may be required to assure that
the amounts of the vitamins indicated on the label are present in the food throughout its
shelf life.
Health Canada has completed a safety assessment of the proposal to increase the maximum
levels of vitamins A and D in pre-term infant formula to the levels stated above.Evaluation of the available data supports the safety of these maximum levels of vitamins A
and D in pre-term infant formula.
Therefore, Health Canada intends to recommend that section B.25.054 of the Food and
Drug Regulations  be amended to provide that a human milk substitute represented solely
for use by pre-term infants may contai n a maximum amount, including overage, of
1,420 IU of vitamin A and a maximum amount, in cluding overage, of 300 IU of vitamin D
per 100 available kilocalories.
As a means to improve the responsiveness of the regulatory system, an Interim Marketing
Authorization (IMA) is being issued to permit the immediate sale of pre-term infantformula with maximum levels of vitamins A and D as indicated above, while the regulatory
process is undertaken to formally amend the Regulations.  A revision to this notification
will be published at the start of the amendment process and Members will be given the
opportunity at that time to submit comments on this proposed measure.G/SPS/N/CAN/159
Page 2
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. International standard, gu ideline or recommendation:
[   ] Codex Alimentarius Commission, [   ] Office International des Epizooties,
[   ] International Plant Prot ection Convention, [ X ] None
If an international standard , guideline or recommendation exists, give the appropriate
reference and briefly identify deviations:
9. Relevant documents and language(s) in which these are available:  Canada Gazette,
Part I, 1 February 2003 (English and French)
10. Proposed date of adoption:  Immediate for this IMA. For the final regulation, will be stated
in subsequent Revision or A ddendum to this notification.
11. Proposed date of entry into force:  Immediate for this IMA. For the final regulation, will be
stated in subsequent Revision or  Addendum to this notification.
12. Final date for comments:  This document is not for comment at this time.  A comment
period will be provided in a Revision of this notification.
Agency or authority designated to handle comments:  [   ] National notification
authority, [ X ] National enquiry point, or address, fax number and E-mail address (if
available) of other body:
13. Texts available from:  [   ] National notification authority,  [ X ]  National enquiry point,
or address, fax number and E-mail address (if available) of other body:
The electronic version of the regulatory text can be downloaded at:
http://canadagazette.gc.ca/partI/2003/20030201/pdf/g1-13705.pdf