Food Safety Substance
L-LeucineE641
L-Leucine (E641) is a food additive with PUBLISHED in the EU, FDA has no questions in the US, and data from 8 regulatory sources.
Substance Identity
Resolved identifiers used to render this food-safety record.
Multi-Jurisdiction Comparison
Side-by-side status rows for the same resolved substance across public food regulators.
| Jurisdiction | Authority | Status | Evidence |
|---|---|---|---|
| European Union | EU Commission | PUBLISHED | EU additive listing; Annex II entry |
| United States | FDA | FDA has no questions | GRAS notice |
| Canada | Health Canada | Listed | Lubricant and binder used for the manufacture of tablets |
EU Food Additive Status
EU Commission food-additive listing rows from eu_food_additives.
| Jurisdiction | E-number | Status | Type | Name | Note |
|---|---|---|---|---|---|
| European Union | E641 | PUBLISHED | substanceFAD | L-leucine | - |
EU Annex II Authorised Uses
Authorised additive rows and use conditions from EU Annex II tables.
| Jurisdiction | E-number | Name | INS | Policy item | Note |
|---|---|---|---|---|---|
| European Union | E641 | L-leucine | - | POL-FAD-IMPORT-3346 | - |
Conditions and restrictions
| Jurisdiction | Food category | Restriction | Comment | Source |
|---|---|---|---|---|
| European Union | 11.4.3 table-top sweeteners in tablets | ML 50000 mg/kg | - | EU Annex II Union List |
| European Union | 11.4.3 table-top sweeteners in tablets | ML 50000 mg/kg | - | EU Food Additives Database |
FDA GRAS Status
US FDA GRAS notice evidence from enriched and notice tables.
| Jurisdiction | GRN | Substance | FDA response | Intended use | Basis | Notifier |
|---|---|---|---|---|---|---|
| United States | 308 | L-leucine | FDA has no questions | 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 | Ajinomoto Aminoscience, LLC |
| United States | 523 | l-leucine | FDA has no questions | 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... | Scientific Procedures | INNOBIO Limited |
| United States | 308 | L-leucine | FDA has no questions | 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 | Ajinomoto Aminoscience, LLC |
| United States | 523 | l-leucine | FDA has no questions | 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... | Scientific Procedures | INNOBIO Limited |
Health Canada Status
Health Canada food-additive permissions by functional class and food scope.
| Jurisdiction | Class | Permitted foods | Maximum level | List |
|---|---|---|---|---|
| Canada | Lubricant and binder used for the manufacture of tablets | - | Good Manufacturing Practice | List of Permitted Food Additives with Other Purposes of Use |
JECFA ADI Values
JECFA ADI records and evaluation years.
| Jurisdiction | Chemical name | JECFA no. | CAS | ADI | ADI upper | Function | Evaluation year |
|---|---|---|---|---|---|---|---|
| JECFA | L-LEUCINE | 1423 | - | No safety concern at current levels of intake when used as a flavouring agent | - | FLAVOURING_AGENT | 2004 |
Cross-Reference to Cosmetics / Chemicals / Pharma
Same-CAS public rows from adjacent Roots verticals where available.
Cross-Vertical Regulatory Divergence
This substance has different regulatory treatment across food, cosmetics, and industrial use.
Frequently Asked Questions
Food-use, safety, ADI, and cross-vertical answers mirrored into FAQPage JSON-LD.
What is L-Leucine used for in food?
L-Leucine appears in food-use rows as: flavor_enhancer; Lubricant and binder used for the manufacture of tablets.
Is L-Leucine / E641 safe?
This page does not assign a standalone safety verdict; it renders public regulatory evidence. ADI/reference value: ADI No safety concern at current levels of intake when used as a flavouring agent . EU status evidence: PUBLISHED. US/FDA evidence: FDA has no questions.
What is the ADI for L-Leucine?
L-Leucine has this ADI/reference value in the food-safety tables: ADI No safety concern at current levels of intake when used as a flavouring agent . Source: food_substances.
Is L-Leucine also used in cosmetics?
L-Leucine has a same-CAS cosmetics cross-reference: L-Leucine, EU status permitted.