Our Verdict: RATING UNKNOWN

Tetrahydro-pseudo-ionone

CAS4433-36-7

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

Tetrahydro-pseudo-ionone — food additive

Tetrahydro-pseudo-ionone is a synthetic flavoring compound used to create fruity and floral taste profiles in food products. It is not approved as Generally Recognized As Safe (GRAS) by the FDA but 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
UnknownUK FSA
Canada
UnknownHealth Canada
Australia
UnknownFSANZ
Japan
UnknownMHLW
South Korea
UnknownMFDS
Brazil
UnknownANVISA
China
UnknownNHC / GB 2760
India
UnknownFSSAI
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 Tetrahydro-pseudo-ionone?

Tetrahydro-pseudo-ionone (CAS Number: 4433-36-7) is a synthetic organic compound belonging to the ionone family of flavoring agents. Ionones are a group of aroma chemicals characterized by their sweet, woody, and fruity sensory properties. The tetrahydro- prefix indicates that the compound has been partially saturated through hydrogenation, which can modify its flavor profile and stability compared to its unsaturated counterpart, pseudo-ionone.

This compound exists as a colorless to pale yellow liquid and is primarily utilized in the flavor and fragrance industry. Its molecular structure allows it to contribute specific taste and aroma notes that food manufacturers seek to replicate in various products.

Common Uses

Tetrahydro-pseudo-ionone functions as a flavoring agent in processed food and beverage applications. It is typically used in very small concentrations—often measured in parts per million—to achieve desired sensory characteristics. Common applications include:

- Confectionery and candy products

- Beverage formulations

- Dairy products

- Baked goods and desserts

- Flavored yogurts and frozen desserts

The compound contributes fruity, slightly floral, and woody notes that can enhance or modify the overall flavor profile of finished food products. Because it is used in minimal quantities, it functions primarily as a flavoring adjuvant rather than a primary ingredient.

Safety Assessment

According to FDA records, tetrahydro-pseudo-pseudo-ionone has generated zero reported adverse events and zero recalls. This absence of safety incidents suggests that the compound, when used in food applications, has not resulted in documented consumer health problems or product safety concerns.

However, the lack of FDA GRAS status indicates that the additive has not undergone the formal FDA GRAS notification process. This distinction is important: the absence of GRAS status does not necessarily indicate danger, but rather that either the manufacturer has not pursued GRAS approval or that the FDA has not made a final determination on safety. Some food manufacturers may use this ingredient under different regulatory frameworks or as part of established flavoring blends.

Toxicological data on tetrahydro-pseudo-ionone is limited in publicly available scientific literature. The compound's safety profile would typically be assessed based on:

- Animal toxicity studies

- Metabolic fate in humans

- Estimated dietary exposure levels

- Comparison to structurally similar approved flavor compounds

Regulatory Status

In the United States, tetrahydro-pseudo-ionone is not on the FDA's GRAS list, meaning it has not received formal approval through the GRAS notification program. However, it may be used in food products under Section 409 of the Food, Drug, and Cosmetic Act if it complies with applicable regulations or if manufacturers have submitted safety data for FDA review.

International regulatory status varies by region. The European Food Safety Authority (EFSA) and other international bodies may have different approval statuses for this compound. Manufacturers using tetrahydro-pseudo-ionone must verify compliance with regulations in each country where their products are sold.

Key Studies

Publicly available independent studies specifically examining tetrahydro-pseudo-ionone are limited. Most safety evaluations for flavor compounds in this category are conducted by manufacturers and submitted to regulatory agencies. The lack of published adverse event data and recalls suggests that any safety monitoring conducted to date has not raised significant concerns.

Future research or safety reviews may provide additional characterization of this compound's toxicological profile, particularly regarding long-term exposure at dietary levels. Consumers or healthcare providers with specific concerns about this additive should consult with regulatory agencies or the product manufacturer for detailed safety documentation.

Frequently Asked Questions

What is Tetrahydro-pseudo-ionone?

Tetrahydro-pseudo-ionone is a synthetic flavoring compound used to create fruity and floral taste profiles in food products. It is not approved as Generally Recognized As Safe (GRAS) by the FDA but has no reported adverse events or recalls associated with its use.

Is Tetrahydro-pseudo-ionone safe?

Tetrahydro-pseudo-ionone 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 Tetrahydro-pseudo-ionone banned in any country?

Tetrahydro-pseudo-ionone 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.