Regulations of Beta Glucan

BETA-GLUCAN

Identifiers

FormulaC18H32O16·CAS9041-22-9·EC801-082-8

Functions

BulkingSKIN Conditioning - Miscellaneous

How does the regulatory treatment of Beta-glucan differ by market or product category?

Regulatory treatment of Beta-glucan varies by market and product category. In the EU, it is listed in the ECHA C&L Inventory with aggregated GHS notifications, indicating hazard communication obligations. In the US, FDA has no questions for its use as a fiber source in specified foods at 0.75–3.0 g per serving, excluding infant/toddler and meat/poultry products. In cosmetics, it is active in the EU with no restrictions or concentration limits. In New Zealand, it lacks individual approval but may be used under a group standard. These differences mean compliance is category- and jurisdiction-specific.

Which United States federal regulations apply to Beta glucan?

1 regulation

FDA GRAS Notices

GRAS notices

NoticeNotifierIntended useBasisFiledClosedFDA responseStatus
309
GGlucan Corporation, Limited
Ingredient in baked goods and baking mixes, beverages and beverage bases, cereal and cereal products, dairy product analogs, milk and milk products, plant protein products, processed fruits and fruit juices, and soft candy, at concentrations ranging from 120 to 150 milligrams per servingScientific procedures17 Dec 200914 Jun 2010FDA has no questionsauthorized
961
SSichuan Synlight Biotech, Ltd.
Intended for use as an ingredient in baked goods and baking mixes; beverages and beverage bases; breakfast cereals; dairy product analogs; frozen dairy desserts; grain products and pastas; gravies and sauces; jams and jellies; milk products; processed fruits and fruit juices; and processed vegetables and vegetable juices at levels ranging from 0.1 to 0.9%Scientific procedures 19 May 2021At the notifier's request, FDA ceased to evaluate this notice (in PDF)authorized
1308
KKluyveromyces Yeast Technology (Hainan) Co., Ltd.
Intended for use as an ingredient at a maximum level of 667 mg/100 g in cookies and graham crackers, nutritional drinks and powders; cereal, breakfast and nutritional bars, soy milk and yogurt, kefir, kombucha, yogurt and yogurt beverages, fruit juices, drinks, nectars and smoothies, chocolate confections, and soups and soup mixes, excluding use in infant formula, and in products under the jurisdiction of the United States Department of Agriculture.Scientific procedures  Pendingauthorized
413
SSuper Beta Glucan, Inc.
As an ingredient in baked goods and baking mixes, beverages and beverage bases, cereal and cereal products, dairy product analogs, milk and milk products, plant protein products, processed fruits and fruit juices, and soft candy at a level of 150 milligrams β-glucans derived from G. lucidum mycelium per servingScientific procedures11 Jan 201210 Aug 2012FDA has no questionsauthorized
995
SSuper Beta Glucan
Intended for use as an ingredient in various foods at specified maximum use levels (excluding use in infant formula, or in any products under the jurisdiction of the United States Department of Agriculture).Scientific procedures 14 Jun 2022FDA has no questions (in PDF)authorized
1124
SSuper Beta Glucan, Inc.
Intended for use as an ingredient at levels up to 150 mg/serving in cookies; non-milk and milk-based meal replacement beverages; cereal bars (breakfast, granola, and protein); soy protein bars; soy milk; yogurt, yogurt beverages, and milk-based beverages containing live microorganisms; fruit juices, drinks, and smoothies); and chocolate confections.Scientific procedures 28 Sept 2023At the notifier's request, FDA ceased to evaluate this notice (in PDF)authorized

What regulations apply to Beta glucan in China?

1 regulation

IECIC Listed Ingredients (List I)

Published
24 Jun 2025
Effective
24 Jun 2025

Regulatory records

EntryRegulationTypeStatus
1010Inventory of Existing Cosmetic Ingredients in China (IECIC) IList Iauthorized

Record details

Inventory of Existing Cosmetic Ingredients in China (IECIC) I

professional use only
No

What regulations apply to Beta glucan in New Zealand?

1 regulation

New Zealand EPA Inventory of Chemical Status

.beta.-D-Glucan: Does not have an individual approval but may be used under an appropriate group standard

Which conditions, limits, and use contexts most affect a compliance assessment for Beta-glucan?

The most decision-relevant conditions are the FDA food-use parameters: Beta-glucans as a fiber source at 0.75–3.0 g per serving in specific food categories, with explicit exclusions for infant/toddler foods and meat/poultry products. In the EU, GHS classification notifications imply labeling and safety data sheet requirements, but no concentration limits are specified. For cosmetics, no restrictions or maximum concentrations are listed. These conditions directly affect formulation and labeling, and the absence of limits in some categories does not imply unrestricted use.

What should be in place before a product containing Beta-glucan is assessed for launch?

Before launch, a compliance assessment should confirm the product category and jurisdiction, then verify applicable conditions. For US foods, ensure Beta-glucan is used within the FDA-accepted serving range and food categories, and that exclusions are respected. For EU cosmetics, confirm the ingredient is listed as active with no restrictions, but still prepare for GHS labeling if applicable. For New Zealand, verify eligibility under a group standard. Documentation should include the specific Beta-glucan source and its CAS/EC numbers, as multiple identifiers exist.

Where does the available regulatory position stop short of supporting a decision on Beta-glucan?

The available regulatory position is insufficient to support a full launch decision because it lacks detail on several fronts. The FDA food additive entry is a 'no questions' response to a specific petitioner, not a general approval, and its applicability to other suppliers or formulations is uncertain. The EU GHS notification does not specify hazard categories or concentration limits. The New Zealand group standard is not detailed. For cosmetics, the absence of restrictions does not confirm safety for all uses. These gaps mean a decision requires additional regulatory or legal review.

Which recent regulatory changes or effective dates are material for Beta-glucan?

No recent regulatory changes or effective dates are provided in the evidence. The only dated item is the FDA 'no questions' response from July 31, 2012, which is not a recent change. The EU cosmetic listing is marked as active and in the official journal, but no revision date is given. Without evidence of amendments or upcoming deadlines, no material regulatory change can be identified. This absence should be treated as a gap, not as confirmation of stability.