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FDA/CFSAN/OFAS: Agency Response Letter: GRAS Notice No. GRN 000184
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CFSAN/Office of Food Additive Safety
March 20, 2006
Agency Response Letter
GRAS Notice No. GRN 000184
William A. Olson, Ph.D.
Center for Regulatory Services, Inc.
5200 Wolf Run Shoals Road
Woodbridge, VA 22192-5755
Dear Dr. Olson:
Re: GRAS Notice No. GRN 000184
The Food and Drug Administration (FDA) is responding to the notice, dated October 31,
2005, that you submitted on behalf of S‹DZUCKER AG Mannheim/Ochsenfurt
(S‹DZUCKER) in accordance with the agency's proposed regulation, proposed 21 CFR
170.36 (62 FR 18938; April 17, 1997; Substances Generally Recognized as Safe (GRAS);
the GRAS proposal). FDA received the notice on November 1, 2005, filed it on November
4, 2005, and designated it as GRAS Notice No. GRN 000184.
The subject of the notice is isomaltulose. The notice informs FDA of the view of
S‹DZUCKER that isomaltulose is GRAS, through scientific procedures, for use as a
nutritive sweetener in a variety of foods as described in Table 1.
Table 1
Conditions of use proposed by S‹DZUCKER
Food Category Use levels (percent)]
Baked goods and baking mixes (21 CFR 170.3(n)(1)) 10-25
Beverages (21 CFR 170.3(n)(2), 21 CFR 170.3(n)(3)) 1-10
Cereal-based products (21 CFR 170.3(n)(4))
cereals 20-35;
bars 5-20
Confectionery and frostings (21 CFR 170.3(n)(9)) 15-99
Chewing gum (21 CFR 170.3(n)(6)) 5-35
Frozen dairy desserts and mixes (21 CFR 170.3(n)(20)) 30
Fruit and water ices (21 CFR 170.3(n)(21)) 15
Gelatins, desserts, puddings, etc. (21 CFR 170.3(n)(22)) 15-30
http://www.cfsan.fda.gov/~rdb/opa-g184.html
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19.02.2008