Our Verdict: RATING UNKNOWN

Dl-cystine

CAS923-32-0

Insufficient data to assign a rating

We do not have enough regulatory data to assign a safety rating to this additive at this time.

Adverse Events

0

FDA CFSAN

FDA Recalls

0

OpenFDA

United States

Approved

FDA

European Union

Not_evaluated

EFSA

Dl-cystine — food additive

DL-cystine is a non-essential amino acid used in food manufacturing as a dough strengthener, flavor enhancer, and nutrient supplement. It functions to improve dough elasticity and protein quality in baked goods and other food products.

US Status

Approved

FDA

EU Status

Not_evaluated

EFSA

Adverse Events

0

FDA CFSAN

FDA Recalls

0

OpenFDA

Global Regulatory Status

United States
ApprovedFDA
European Union
Not EvaluatedEFSA
United Kingdom
Not EvaluatedUK FSA
Canada
ApprovedHealth Canada
Australia
Not EvaluatedFSANZ
Japan
Not EvaluatedMHLW
South Korea
Not EvaluatedMFDS
Brazil
Not EvaluatedANVISA
China
Not EvaluatedNHC / GB 2760
India
Not EvaluatedFSSAI
Country data is sourced from official regulatory databases and enriched via AI analysis. Always verify with the relevant national authority before making dietary decisions.

What is DL-cystine?

DL-cystine (CAS Number: 923-32-0) is a non-essential amino acid composed of two cysteine molecules linked by a disulfide bond. It exists as a racemic mixture containing both D- and L-enantiomers, which is indicated by the "DL" prefix. In its natural form, L-cystine is found in proteins throughout the body and in various food sources. The synthetic DL-cystine used as a food additive provides both forms and serves multiple functional roles in food manufacturing.

Common Uses

DL-cystine is primarily employed in the baking industry where it functions as a dough strengthener. It works by promoting the formation and stabilization of disulfide bonds within gluten networks, resulting in improved dough elasticity, extensibility, and overall handling properties. This makes it particularly valuable in commercial bread production where consistent dough performance is critical.

Beyond its structural applications, DL-cystine serves as a flavor enhancer and flavoring agent adjuvant, contributing to umami taste development and overall sensory profile enhancement. It is also utilized as a nutrient supplement to increase the amino acid content and protein quality of food products, particularly in fortified grain and meat-based foods.

Safety Assessment

DL-cystine has not been designated as Generally Recognized as Safe (GRAS) by the FDA, which means it has not undergone the streamlined GRAS notification process. However, this status does not indicate safety concerns; rather, it reflects that manufacturers have not submitted GRAS documentation to the FDA or that the agency has not made a final determination on such submissions.

The safety profile of DL-cystine appears favorable based on available data. The FDA Adverse Events system contains zero reported adverse events associated with this additive, and there are no documented recalls linked to DL-cystine. This absence of reported safety issues suggests that food products containing this ingredient have not generated consumer health complaints that reached regulatory attention.

L-cystine is recognized as a naturally occurring amino acid in foods and is considered an acceptable dietary component. The L-form is used in nutritional supplements and medical applications without significant documented safety concerns at typical food additive levels. The D-form in the DL-cystine mixture has minimal biological activity in comparison to the L-form.

As with most amino acids used in food manufacturing, DL-cystine is used at levels substantially below those that would present nutritional or toxicological concerns. The amounts added to foods are typically measured in parts per million or very small percentages by weight.

Regulatory Status

DL-cystine's regulatory status varies internationally. In the United States, while not GRAS-designated, it is not banned and can be used in foods subject to FDA compliance. In the European Union, similar amino acids are evaluated through their food additive approval processes. The lack of GRAS status in the U.S. does not prohibit its use; manufacturers simply must ensure compliance with applicable food regulations for food additives or processing aids.

The ingredient is sometimes classified as a processing aid rather than a food additive in certain jurisdictions, which can affect labeling and regulatory requirements. Manufacturers should verify current regulatory status in their specific markets before use.

Key Studies

Limited peer-reviewed literature specifically addresses DL-cystine as a food additive. Most research on cystine and cysteine focuses on their nutritional roles, amino acid metabolism, and use in clinical nutrition rather than as food processing aids. Studies on dough strengtheners generally demonstrate that disulfide-bond-forming amino acids improve bread quality parameters including volume, crumb structure, and handling properties.

The safety of L-cystine in food and supplements has been reviewed in multiple contexts, with established acceptable daily intakes when used appropriately. Further specific safety studies on DL-cystine as a food additive at current usage levels would strengthen the evidence base, though current use appears consistent with established safety practices for amino acid food additives.

Frequently Asked Questions

What is Dl-cystine?

DL-cystine is a non-essential amino acid used in food manufacturing as a dough strengthener, flavor enhancer, and nutrient supplement. It functions to improve dough elasticity and protein quality in baked goods and other food products.

Is Dl-cystine safe?

Dl-cystine is currently rated "unknown" based on FDA and EFSA data. It is approved in the US and not_evaluated in the EU. There are 0 FDA adverse event reports associated with this additive.

Is Dl-cystine banned in any country?

Dl-cystine is approved in the United States and not_evaluated in the European Union. Review the regulatory status cards above for the most current information.

Data Sources

Data is sourced exclusively from official government databases and updated periodically. This page does not constitute medical advice. Consult a healthcare professional for dietary guidance.