. /.WORLD TRADE
ORGANIZATIONG/SPS/N/USA/415
9 April 2001
(01-1797)
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:  Food and Drug Administration - FDA
3. Products covered (provide tariff item number(s) as specified in national schedules
deposited with the WTO; ICS numbers may be provided in addition, whereapplicable).  Regions or countries likely to be affected, to the extent relevant or
practicable:  Food additives
4. Title and number of pages of the notified document:  Food Additives Permitted for
Direct Addition to Food for Human Consum ption; Food Starch-Modified by Amylolytic
Enzymes (2 pages)
5. Description of content:  The Food and Drug Administrati on (FDA) is amending the food
additive regulations to provide for the safe use of food starch-modified by amylolytic
enzymes.  This action is in response to a petition.  The petition proposed to amend the food
additive regulations in Sec. 172.892(i) Food starch-modified (21 CFR 172.892(i)) toprovide for the safe use of food starch-modified by amylolytic enzymes.  These amylolytic
enzymes include beta-amylase, glucoamylase, isoamylase, and pullulanase.  This petitioner
proposes to use these amylolytic enzymes as a method of starch hydrolysis in addition to
the use of alpha-amylase which is currently approved under Sec.172.892(i).  The petitioner
also requested that the limitation on dextrose equivalent (DE) as a measure of starch
hydrolysis not be applied to starches hydrolyzed with beta-amylase, glucoamylase,
isoamylase, or pullulanase.  The petitioner states that standard practice is to measure starchhydrolysis by viscosity and other physiochemical properties rather than by dextrose
equivalence which measures the ratio of reducing sugars to total sugars.
FDA has evaluated the data in the petition and other relevant material. Based on this
information, the agency concludes that the proposed use of beta-amylase, glucoamylase,
isoamylase, and pullulanase enzymes to modify food starch is safe and that the enzymeswill achieve their intended technical effect.
Additionally, the agency is not imposing the limitation that food starch hydrolyzed by
beta-amylase, glucoamylase, isoamylase, or pullulanase enzymes have a DE of less than 20.
Under current Sec. 172.892(i), food starch can only be modified by treatment with
alpha-amylase (E.C. 3.2.1.1) to produce a nonsweet nutritive saccharide polymer with a DEof less than 20.  However, the agency has concluded that this limitation is not necessary for
food starch-modified by the petitioned enzymes, beta-amylase, glucoamylase, isoamylase,
and pullulanase, that the agency is now adding to Sec. 172.892(i).G/SPS/N/USA/415
Page 2
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:  The specification monograph for modified
starches developed by JECFA at its 49th meeting in 1997 was adopted by the Commission as
a Codex Advisory Specification in 1999.
8. Relevant documents and language(s) in which these are available:  66 FR 17508,
2 April 2001 (Available in English)
9. Proposed date of adoption:  2 April 2001
10. Proposed date of entry into force:  2 April 2001
11. Final date for comments:  Submit written objections and requests for a hearing by
2 May 2001
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: The full text, including
directions for submitting objections, 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
Tel:  (202) 720-2239
Fax:  (202) 690-0677
E-mail:  ofsts@fas.usda.gov