Our Verdict: RATING UNKNOWN

10-hydroxymethylene-2-pinene

CAS128-50-7

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

10-hydroxymethylene-2-pinene โ€” food additive

10-hydroxymethylene-2-pinene (CAS 128-50-7) is a naturally-derived organic compound used as a flavoring agent in food products. It is not approved as a Generally Recognized as Safe (GRAS) substance by the FDA, though it has no reported adverse events or recalls associated with its use.

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 10-hydroxymethylene-2-pinene?

10-hydroxymethylene-2-pinene is an organic chemical compound derived from pinene, a natural monoterpene found in pine trees and other plants. This specific derivative contains a hydroxymethylene functional group attached to the pinene molecule structure. The compound is classified as a flavoring agent or flavoring adjuvant, meaning it is used to enhance, modify, or contribute to the flavor profile of food and beverage products.

The compound's molecular structure allows it to interact with taste and aroma sensory receptors, making it useful in formulating food flavors. Like many flavoring compounds, it exists at very low concentrations in finished food productsโ€”typically measured in parts per million (ppm).

Common Uses

10-hydroxymethylene-2-pinene is used in the flavor industry to create or enhance fruity, woody, and herbal notes in various food and beverage applications. These may include:

- Flavored beverages (soft drinks, juices, flavored waters)

- Confectionery products (candies, chewing gum)

- Baked goods and grain products

- Dairy products (yogurts, flavored milk)

- Savory food products

As a flavoring adjuvant, this compound typically functions at very low use levels, often in combination with other flavoring substances to achieve desired sensory characteristics. The compound contributes subtle aromatic and taste components rather than serving as a primary flavor ingredient.

Safety Assessment

According to FDA records, there have been zero reported adverse events associated with 10-hydroxymethylene-2-pinene and zero product recalls linked to its use. This suggests a favorable safety profile based on historical use data.

However, the compound is not listed as a GRAS (Generally Recognized as Safe) substance by the FDA. GRAS status indicates that a substance is widely recognized among qualified experts as safe for its intended use based on scientific evidence and history of use. The absence of GRAS status does not indicate that a substance is unsafe; rather, it means the compound has not undergone or completed the formal GRAS determination process with the FDA.

For substances used as flavoring agents in the United States, FDA regulations (21 CFR Part 182) establish guidelines for acceptable use levels and applications. Manufacturers using non-GRAS flavoring compounds must ensure compliance with applicable regulations, including submitting safety data or obtaining appropriate regulatory clearance.

Regulatory Status

In the United States, 10-hydroxymethylene-2-pinene does not hold FDA GRAS status, meaning it operates under different regulatory requirements than GRAS-affirmed flavoring substances. Manufacturers incorporating this compound into food products may be subject to specific labeling, documentation, and notification requirements.

The European Food Safety Authority (EFSA) maintains separate evaluations of flavoring compounds used in EU member states. Regulatory status may vary by jurisdiction, as different countries maintain their own food additive approval systems.

Manufacturers considering use of this compound should verify current regulatory requirements in their target markets and maintain documentation of safe use levels and applications.

Key Studies

Limited published scientific literature is available specifically examining 10-hydroxymethylene-2-pinene in isolation. Most safety data derives from:

- Historical use records in flavoring applications

- General toxicology data on similar pinene derivatives

- Structural similarity assessments to related compounds with established safety profiles

- Manufacturer safety data submissions to regulatory agencies

The absence of reported adverse events or recalls suggests that historical use patterns have not identified safety concerns. However, comprehensive toxicological studies specific to this compound may be limited in the public domain. For manufacturers or regulators requiring additional safety information, such data would typically be obtained through direct communication with suppliers or through formal safety assessment submissions.

Frequently Asked Questions

What is 10-hydroxymethylene-2-pinene?

10-hydroxymethylene-2-pinene (CAS 128-50-7) is a naturally-derived organic compound used as a flavoring agent in food products. It is not approved as a Generally Recognized as Safe (GRAS) substance by the FDA, though it has no reported adverse events or recalls associated with its use.

Is 10-hydroxymethylene-2-pinene safe?

10-hydroxymethylene-2-pinene 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 10-hydroxymethylene-2-pinene banned in any country?

10-hydroxymethylene-2-pinene 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.