Identifiers
Functions
6 regulations
L-Leucine is listed on the EPA's Chemical Data Reporting (CDR) system. Manufacturers and importers of L-Leucine are required to report information about their production and use of this chemical to the EPA under the Toxic Substances Control Act (TSCA). (40 eCFR Part 711)
L-Leucine is a food additive permitted for direct addition to food for human consumption, as long as 1) the quantity of the substance added to food does not exceed the amount reasonably required to accomplish its intended physical, nutritive, or other technical effect in food, and 2) any substance intended for use in or on food is of appropriate food grade and is prepared and handled as a food ingredient.
Sources
GRAS notices
| Notice | Notifier | Intended use | Basis | Filed | Closed | FDA response | Status |
|---|---|---|---|---|---|---|---|
| 308 | AAjinomoto Aminoscience, LLC | Ingredient in non-milk and milk based meal replacements, sports and isotonic beverages, vitamin enhanced waters, and meal replacement bars, at levels of 0.5 to 3 grams per serving | Scientific procedures | 02 Nov 2009 | 30 Apr 2010 | FDA has no questions | authorized |
| 523 | IINNOBIO Limited | For use as an ingredient in milk and non-milk meal replacement beverages, sports beverages, and vitamin enhanced waters, and meal replacement bars at levels of use intended to provide between 1.5 and 3 g of added L-leucine per serving. | Scientific Procedures | 12 Jun 2014 | 11 Dec 2014 | FDA has no questions | authorized |
Regulatory records
| Regulation | Status |
|---|---|
| FDA Technical Effect: FLAVOR ENHANCER | authorized |
| FDA Technical Effect: FLAVORING AGENT OR ADJUVANT | authorized |
| FDA Technical Effect: NUTRIENT SUPPLEMENT | authorized |
SRP: Expired or waste pharmaceuticals shall carefully take into consideration applicable DEA, EPA, and FDA regulations. It is not appropriate to dispose by flushing the pharmaceutical down the toilet or discarding to trash. If possible return the pharmaceutical to the manufacturer for proper disposal being careful to properly label and securely package the material. Alternatively, the waste pharmaceutical shall be labeled, securely packaged and transported by a state licensed medical waste contractor to dispose by burial in a licensed hazardous or toxic waste landfill or incinerator.
3 regulations
Status: Active Update: 07-04-2022 https://echa.europa.eu/registration-dossier/-/registered-dossier/11897
Regulation (EC) No 1831/2003 (amended)
Regulation (EC) No 1831/2003 (amended)
1 regulation
Regulatory records
| Entry | Regulation | Type | Status |
|---|---|---|---|
| 61-90-5 | SOR/94-311 | DSL | authorized |
Conditions
This substance is on the Domestic Substances List (DSL). This substance was added to the DSL as an “Existing Substance” given that it meets the criteria set out in CEPA for substances that were in commerce in Canada between 1984 and 1986.
Record details
1 regulation
Regulatory records
| Entry | Regulation | Type | Status |
|---|---|---|---|
| 4317 | Inventory of Existing Cosmetic Ingredients in China (IECIC) I | List I | authorized |
Record details
1 regulation
Chemical: L-Leucine
1 regulation
Leucine: Does not have an individual approval but may be used as a component in a product covered by a group standard. It is not approved for use as a chemical in its own right.