. /.WORLD TRADE
ORGANIZATIONG/TBT/N/AUS/13
9 January 2003
(03-0101)
Committee on Technical Barriers to Trade Original:  English
NOTIFICATION
The following notification is being circulated in accordance with Article 10.6.
1. Member to Agreement notifying:   AUSTRALIA
If applicable, name of local government involved (Articles 3.2 and 7.2):           
2. Agency responsible:
Food Standards Australia New Zealand
PO Box 7186Canberra BC
ACT 2610
AUSTRALIA
Fax: (+61) 2 62712278
Email: info@foodstandards.gov.au
Name and address (including telephone and fax numbers, e-mail and web-site
addresses, if available) of  agency or authority designated to handle comments
regarding the notification shall be indicated if different from above:           
3. Notified under Article 2.9.2 [ X], 2.10.1 [    ], 5.6.2 [    ], 5.7.1 [    ], other:           
4. Products covered (HS or CCCN where applicable, otherwise national tariff heading.
ICS numbers may be provided in addition, where applicable):   Foods/Processed Foods -
for special medical purposes only
5. Title, number of pages and language(s) of the notified document:   P242 - Foods For
Special Medical Purposes – Draft Assessment Report (84 pages, English)
6. Description of content:   This Draft Assessment Report for Proposal (P242) proposes to
amend the Australia New Zealand Food Standards Code  (the Code ) to provide a specific
standard for ‘Foods For Special Medical Purposes’ (FSMP).
FSMP are principally formulated food products, used under medical supervision for the
dietary management of individuals (including children) with either ongoing chronic medical
conditions or during acute phases of illness, injury or disease states.  They include
‘complete nutrition’ formulas (i.e. intended for use as the sole source of nutrition), either
consumed orally or through an enteral route (e.g. naso-gastric tube), as well as specialiseddietary supplement formulas or foods, and ve ry low energy diet (VLED) formulas used for
weight loss.
There is minimal local manufacture of FSMP as it is estimated that 99% of products are
imported, mainly from the European Union (including UK) and the United States of
America.  On a world scale, the Australian and New Zealand markets are comparativelysmall.G/TBT/N/AUS/13
Page 2
7. Objective and rationale, including the na ture of urgent problems where applicable:
Currently the regulatory status of FSMP is unclear as the Code  does not contain specific
permissions for these products.  This proposal seeks to clarify the regulatory status of this
class of foods in the Code  and provide certainty to suppliers, users and enforcement areas
by providing positive permissions for these products.
FSMP are products specifically formulated for use under medical supervision by vulnerable
individuals who rely either fully or partially on FSMP to meet their specific nutritional
requirements that cannot be satisfied by a normal diet.  It is therefore essential that FSMP
are both safe and effective in meeting the needs of the target population.  The proposal
examines both compositional and information requirements in the context of the following
objectives:
• protecting public health and safety, particularly by ensuring the safe and appropriate
use of FSMP;
• developing harmonised food regulations ap plying to FSMP in Australia and New
Zealand; and
• providing health professionals and consumers with sufficient information to make
choices about the safe and effective use of FSMP.
8. Relevant documents:   Australia New Zealand Food Standards Code
9. Proposed date of adoption:  Recommendation to Government anticipated to be made by
mid 2003.  Entry into force dependent on Government approval.
Proposed date of entry into force:  Entry into force dependent on Government approval,
possibly late 2003
10. Final date for comments:   15 March 2003
11. Texts available from:  National enquiry point [ X] or address, telephone and fax
numbers, e-mail and web-site addresses, if available of the other body:
also directly available on the Food Standards Australia New Zealand website at
http://www.foodstandards.gov.au/standardsdevelopment/proposals/proposalp242foodsforsp
ecialmedicalpurposes/proposalp242darexecs1842.cfm