EPA TSCA Regulatory Flag
jurisdiction: US; framework: TSCA (Toxic Substances Control Act); listing_status: not listed on TSCA Inventory; requires PMN process for listing; annex_or_entry: TSCA Inventory; entry type: not listed (new chemical)
Identifiers
The only regulatory treatment identified for Brazzein is under the U.S. Toxic Substances Control Act (TSCA), where it is not listed on the TSCA Inventory and is therefore treated as a new chemical substance. No food additive approvals, limits, or category-specific regulations were found in the supplied evidence. This means that for food or beverage use, there is no confirmed regulatory status in any market. The TSCA listing status is relevant only to non-food industrial applications, not to food product categories. Businesses should not assume any food-use approval exists based on this evidence.
2 regulations
jurisdiction: US; framework: TSCA (Toxic Substances Control Act); listing_status: not listed on TSCA Inventory; requires PMN process for listing; annex_or_entry: TSCA Inventory; entry type: not listed (new chemical)
GRAS notices
| Notice | Notifier | Intended use | Basis | Closed | FDA response | Status |
|---|---|---|---|---|---|---|
| 1167 | PPerfect Day, Inc. | Intended for use as a sweetener in foods generally at levels consistent with good manufacturing practices. | Scientific procedures | 08 Oct 2024 | FDA has no questions (in PDF) | authorized |
| 1142 | OOobli, Inc. | Intended for use as a sweetener at maximum levels ranging from 2 to 99 mg/100 g in packaged alcoholic cocktail drinks; packaged water-based beverages; non-milk-based meal replacement beverages and protein drinks; chewing gum; ready-to-drink coffee and tea beverages; milk substitutes; non-dairy yogurts; ice cream; frozen yogurt; frozen milk desserts and bars; edible ices; sherbet; sorbet; cereal, granola, energy, protein, and meal replacement bars; granola; packaged milk-based beverages; yogurt and yogurt drinks; packaged fruit drinks, nectars, and fruit-based smoothies; fruit-based bars; truffles; and gummy bears. | Scientific procedures | 11 Mar 2024 | FDA has no questions (in PDF) | authorized |
The only condition identified is the U.S. TSCA requirement: because Brazzein is not listed on the TSCA Inventory, a Premanufacture Notice (PMN) process is required before it can be added to the inventory for non-food uses. No use limits, maximum levels, or permitted conditions for food or beverage applications were provided. For compliance assessment, the key boundary is that TSCA applies to chemical substances generally, not to food additives. Therefore, the PMN requirement does not address food safety or food-use conditions, and no food-specific limits can be inferred.
Before launch, the only documented requirement is to address the U.S. TSCA status: since Brazzein is not on the TSCA Inventory, a PMN submission would be needed for any non-food chemical use. For food products, no evidence of a food additive petition, GRAS determination, or other approval was provided, so a compliance assessment cannot rely on any existing regulatory clearance. The absence of food additive listings means the product would need to establish its own regulatory pathway, but the evidence does not specify what that pathway is. Documentation of TSCA status is the only concrete item to prepare.
The available regulatory position stops at the U.S. TSCA inventory status and does not extend to food or beverage use. There is no evidence of approvals, denials, or pending petitions from any food regulatory authority, nor any safety assessments or acceptable daily intake values. This gap is material because TSCA is not a food safety framework, and the absence of a TSCA listing does not imply anything about food legality. A decision on food use cannot be supported by the supplied evidence, and any inference of food approval would be unsupported.
No recent regulatory changes or effective dates were identified in the supplied evidence. The only regulatory data point is the current TSCA inventory status, which indicates Brazzein is not listed, but no timeline for any change or review was provided. This absence means there is no basis to anticipate near-term regulatory shifts. For planning, the lack of change data should be treated as a neutral factor, not as evidence of stability. Any decision should be based on the current TSCA status and the need for a PMN, without assuming future regulatory developments.