# Dl-valine

> Source URL: https://additivefacts.com/additives/dl-valine
> Markdown URL: https://additivefacts.com/additives/dl-valine.md

**Safety rating:** SAFE
**CAS number:** 516-06-3
**Category:** flavoring
**FDA GRAS:** no
**Adverse events (FDA AERS):** 0
**FDA recalls:** 0
**Last updated:** 2026-04-02

## Summary

DL-valine is a synthetic amino acid used as a flavoring agent and nutrient supplement in food products. It is the racemic mixture of both D and L forms of the amino acid valine, an essential amino acid important for protein synthesis and muscle metabolism.

## Regulatory status

| Country | Status |
| --- | --- |
| United States | approved |
| European Union | not_evaluated |
| United Kingdom | not_evaluated |
| Canada | approved |
| Australia | not_evaluated |
| Japan | not_evaluated |
| South Korea | not_evaluated |
| Brazil | not_evaluated |
| China | not_evaluated |
| India | not_evaluated |

## Detailed analysis

## What is DL-valine?

DL-valine (CAS Number: 516-06-3) is a synthetic amino acid comprising equal parts of D-valine and L-valine. Valine is one of three branched-chain amino acids (BCAAs) essential for human nutrition. In its natural form, L-valine is incorporated into proteins and plays critical roles in muscle protein synthesis, energy metabolism, and immune function. The DL- designation indicates this is a racemic mixture—containing both the left-handed (L) and right-handed (D) configurations of the molecule.

## Common Uses

DL-valine is utilized in the food industry primarily as a nutrient supplement and flavoring agent. It is commonly added to:

- Protein supplements and sports nutrition products
- Amino acid formulations and medical foods
- Fortified beverages and nutritional drinks
- Infant formula and specialized dietary products
- Flavor enhancement in certain food applications

The compound contributes to the amino acid profile of foods intended for muscle maintenance, athletic performance, and general nutritional supplementation. Its use as a flavoring agent relates to its role in amino acid-based flavor systems.

## Safety Assessment

DL-valine has not received FDA GRAS (Generally Recognized as Safe) status, which means it has not undergone the formal GRAS notification process. However, this designation does not indicate safety concerns. Rather, it reflects that manufacturers may not have pursued formal GRAS affirmation for this particular ingredient in the United States.

According to FDA records, there have been zero reported adverse events and zero recalls associated with DL-valine, indicating no documented safety incidents in commercial food use. L-valine itself is recognized as safe when consumed through normal dietary sources and is an established component of amino acid medical foods and supplements.

The distinction between D-valine and L-valine is biochemically important. L-valine is the bioactive form utilized by the human body for protein synthesis and metabolic processes. D-valine, the mirror-image form, is not incorporated into human proteins and is metabolized differently. The presence of D-valine in a racemic mixture means only approximately 50% of the DL-valine consumed would contribute to the body's valine requirements.

Toxicological data on valine compounds supports a favorable safety profile at levels used in food fortification. Amino acids are fundamental nutrients with extensive human consumption history through dietary proteins.

## Regulatory Status

In the United States, DL-valine is permitted for use in foods under FDA regulations, though it lacks specific GRAS status. It may be used in dietary supplements, medical foods, and fortified food products within applicable regulations for amino acid supplements.

The European Food Safety Authority (EFSA) has evaluated amino acids used in food fortification. L-valine is recognized as a safe nutrient in the European Union. Regulatory status for DL-valine specifically varies by jurisdiction, and manufacturers should verify compliance with local regulations where products will be marketed.

## Key Studies

Research on branched-chain amino acids, including valine, demonstrates their importance in muscle protein synthesis and exercise metabolism. Studies have established the safety of amino acid supplementation at typical dietary levels. Published research on amino acid safety in food fortification supports the use of individual amino acids in nutritional products.

The lack of adverse event reports in FDA databases, combined with valine's fundamental role as a dietary nutrient, indicates DL-valine has demonstrated a practical safety record in food applications. Further formal safety assessments may be warranted for new or expanded uses.

## Sources

- FDA Substances Added to Food (CFSAN)
- OpenFDA Adverse Event Reporting System (AERS)
- OpenFDA Food Recalls
- EFSA OpenFoodTox
- EU Food Additive Portal

## Citation

Additive Facts. "Dl-valine — Safety, regulation, and evidence." https://additivefacts.com/additives/dl-valine. Accessed 2026-05-19.