Our Verdict: RATING UNKNOWN

L-hydroxyproline

CAS51-35-4

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

L-hydroxyproline — food additive

L-hydroxyproline is an amino acid derivative that occurs naturally in collagen and gelatin. While its specific function in food applications remains unclear, it appears in some food products and nutritional supplements.

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
Not EvaluatedHealth 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 L-hydroxyproline?

L-hydroxyproline (also known as 4-hydroxy-L-proline) is a non-standard amino acid and a derivative of the amino acid proline. It is the most abundant amino acid in collagen, making up approximately 10% of collagen's amino acid composition. In collagen, L-hydroxyproline is created through post-translational modification when proline residues are hydroxylated by the enzyme prolyl hydroxylase. This modification is critical for collagen's structural stability and is dependent on vitamin C as a cofactor.

The compound has a molecular formula of C₅H₉NO₃ and CAS number 51-35-4. L-hydroxyproline appears naturally in many foods derived from animal sources, particularly in bone broths, gelatin products, and meat. It also occurs in trace amounts in some plant sources.

Common Uses

L-hydroxyproline appears in food products primarily as a component of hydrolyzed collagen and gelatin-based ingredients. These collagen derivatives are used in various food applications including:

- Bone broths and collagen-enhanced beverages

- Nutritional supplements and protein powders

- Gelatin-based confections and gummies

- Some functional foods marketed for joint, skin, or gut health

- Meat products that incorporate gelatin or collagen hydrolysates

However, it should be noted that the specific functional role of added L-hydroxyproline in these products is not clearly established. It may be present simply as a natural component of collagen-derived ingredients rather than serving a distinct technological function.

Safety Assessment

L-hydroxyproline has a long history of use in foods through traditional collagen and gelatin products, which have been consumed safely for centuries. The compound is naturally present in substantial quantities in the human diet, particularly in cultures with high collagen consumption.

According to FDA records, there have been zero reported adverse events associated with L-hydroxyproline and zero product recalls attributed to this ingredient. This absence of adverse event reports reflects its general recognition as safe in the context of traditional food ingredients.

The European Food Safety Authority (EFSA) has not issued specific safety concerns regarding L-hydroxyproline. Like other amino acids and amino acid derivatives in food, it is generally recognized as safe when consumed in typical dietary amounts.

Limited toxicological studies exist specifically for L-hydroxyproline because it is a naturally occurring compound with extensive historical use. The lack of dedicated safety studies reflects regulatory confidence in its safety status rather than indicating a gap in knowledge.

Regulatory Status

L-hydroxyproline is not listed on the FDA's GRAS (Generally Recognized as Safe) inventory as a direct additive with an assigned function. This designation does not indicate safety concerns; rather, it reflects that the specific technological function of added L-hydroxyproline in food products has not been formally evaluated and documented through the GRAS petition process.

The compound is permitted in the European Union as a food ingredient and does not appear on restriction lists in major regulatory jurisdictions. Many countries permit collagen and gelatin products containing naturally-occurring L-hydroxyproline without specific restrictions.

As a component of hydrolyzed collagen and gelatin, L-hydroxyproline benefits from the established regulatory acceptance of these parent ingredients in most jurisdictions.

Key Studies

Direct research on L-hydroxyproline as a food additive is limited. Most scientific literature focuses on L-hydroxyproline's role in collagen biochemistry and physiology rather than food safety. Extensive research has documented that dietary collagen and gelatin containing L-hydroxyproline are well-tolerated in human diets.

Studies on collagen hydrolysates (which contain significant L-hydroxyproline) have shown favorable safety profiles in clinical nutrition research. The compound is readily absorbed and metabolized when consumed as part of protein sources, following standard amino acid metabolism pathways.

Frequently Asked Questions

What is L-hydroxyproline?

L-hydroxyproline is an amino acid derivative that occurs naturally in collagen and gelatin. While its specific function in food applications remains unclear, it appears in some food products and nutritional supplements.

Is L-hydroxyproline safe?

L-hydroxyproline 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 L-hydroxyproline banned in any country?

L-hydroxyproline 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.