. /.WORLD TRADE
ORGANIZATIONG/SPS/N/USA/309
20 July 2000
(00-3006)
Committee on Sanitary and Phytosanitary Measures Original:  English
NOTIFICATION
1. Member to Agreement notifying:  UNITED STATES
If applicable, name of local government involved:           
2. Agency responsible:  US Food and Drug Administration
3. Products covered (provide tariff item number(s) as specified in national schedules
deposited with the WTO; ICS numbers may be provided in addition, where applicable).
Regions or countries likely to be affected, to the extent relevant or practicable:  Food
contact substances
4. Title and number of pages of the notified document:  Food Additives: Food Contact
Substance Notification System (16 pages); Addendum - Draft Guidance for Industry: Food-
Contact Substance Notification System; Availability (1 page plus guidance document)
5. Description of content:  The Food and Drug Administra tion (FDA) is proposing to
implement the premarket notification process for food contact substances (FCS's) established
by the Food and Drug Administration Mo dernization Act (FDAMA) of 1997.  Once
implemented, the notification process will be the primary method for authorizing new uses of
food additives that are FCS's.  FDA is proposing regulations that identify the circumstances
under which a food additive petition (FAP) will be  required to authorize the use of an FCS;
specify the information required in a notification for an FCS;  describe the administration of
the notification process; and establish the procedure by which the agency may deem a
notification to no longer be effective.
Additionally, FDA is announcing the availability of a draft guidance document entitled
"Preparation of Premarket Notifications for Food Contact Substances".  This guidance
document is intended to provide guidance for industry regarding the preparation of premarket
notifications for food-contact substances (FCS).  FDA is providing this draft guidance as part
of its implementation of the premarket notification process for FCS established by the Food
and Drug Administration Modernization Act of 1997 (FDAMA).
6. 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           
7. An international standard, guideline or recommendation does not exist [  X ].
If an international standard, guideline or recommendation exists, give the appropriate
reference and briefly identify deviations:
8. Relevant documents and language(s) in which these are available: 65 FR 43269,
13 July 2000 (Available in English)G/SPS/N/USA/309
Page 2
9. Proposed date of adoption:  To be determined.
10. Proposed date of entry into force:  To be determined.
11. Final date for comments:  26 September 2000
Agency or authority designated to handle comments: Food and Drug Administration
[    ] National notification authority, [     ] National enquiry point, or address, fax number
and E-mail address (if available) of other body:  Detailed instruction on where and how to
send comments is in the body of the full text - which will be sent upon request to the address in
paragraph 12.
12. Texts available from: [  X ] National notification authority, [  X ] National enquiry point or
address, fax number and E-mail address (if available) of other body:
United States SPS Enquiry Point/Notification Authority
USDA/FAS/FSTSD
Attn: Carolyn F. Wilson
Room 5545 South Agriculture Building
Stop 1027
1400 Independence Avenue, S.W.Washington, D.C. 20250
Phone (202) 720-2239
Fax (202) 690-0677
E-mail Address: ofsts@fas.usda.gov