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U.S. Department of Health and Human Services

GRAS Notices
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GRN No. 1238

2'-fucosyllactose

Intended Use: Intended for use as an ingredient in non-exempt infant formula for term infants at a maximum use level of 2.4 g/L as consumed, and in other food categories at the maximum levels shown in Table 1 of FDA's response letter.
Basis: Scientific procedures
Notifier: Cataya Bio (Shanghai) Co., Ltd.
Notifier Address: 88 Daerwen Road, 4F/Building 2
Pudong New District, Shanghai, 201203
CHINA
GRAS Notice (releasable information): GRN 1238 with amendments (in PDF) (6.7 MB)
Date of closure: Jun 17, 2025
FDA's Letter: FDA has no questions (113 kB)
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