WORLD TRADE G/SPS/N/USA/415 9 April 2001 ORGANIZATION (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, where applicable). 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 Consumption; Food Starch-Modified by Amylolytic Enzymes (2 pages)

5. Description of content: The Food and Drug Administration (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)) to provide 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 starch hydrolysis 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 enzymes will 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 DE of 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).

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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: [email protected]