Our Verdict: SAFE

Petroleum Wax, Synthetic

E-numberE905CAS977045-73-0

This additive is considered safe

Based on current FDA and EFSA assessments. Approved in both the United States and the European Union.

Adverse Events

0

FDA CFSAN

FDA Recalls

0

OpenFDA

United States

Approved

FDA

European Union

Not_evaluated

EFSA

Petroleum Wax, Synthetic — food additive

Petroleum Wax, Synthetic (CAS 977045-73-4) is a man-made wax derived from petroleum hydrocarbons, used in food as a masticatory substance and surface-active agent. It functions primarily in chewing gum and similar products to provide texture and coating properties.

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 Petroleum Wax, Synthetic?

Petroleum Wax, Synthetic is a hydrocarbon-based wax produced through chemical synthesis from petroleum derivatives. Unlike natural waxes derived from plants or animals, synthetic petroleum wax is engineered to achieve consistent physical and chemical properties. It exists as a solid at room temperature with a melting point typically between 70-100°C, depending on the specific formulation. The synthetic nature allows manufacturers to control molecular weight, crystalline structure, and purity more precisely than with naturally occurring waxes.

Common Uses

In food applications, Petroleum Wax, Synthetic functions as a masticatory substance, primarily found in chewing gum formulations. It contributes to the gum's texture, elasticity, and chewing characteristics. The additive also serves as a surface-active agent, helping to coat food surfaces or stabilize emulsions in certain food products. In some confectionery items, it may be used to provide a glossy coating or prevent sticking. The additive is not intended to be nutritious or provide functional benefits beyond texture and appearance.

Safety Assessment

As a food additive, Petroleum Wax, Synthetic is intended for limited ingestion, primarily through chewing gum where it is not typically swallowed in significant quantities. The FDA has not granted this substance GRAS (Generally Recognized As Safe) status, which reflects the limited data available or specific regulatory classification rather than a safety concern. According to FDA records, there have been zero adverse events reported associated with this additive and zero product recalls linked to its use. This absence of reported harm provides some reassurance regarding its historical safety profile in food applications.

The toxicological profile of synthetic petroleum waxes is generally considered low-concern due to their high molecular weight hydrocarbons, which are poorly absorbed by the gastrointestinal tract. Most ingested material would transit through the digestive system with minimal absorption. However, the lack of extensive modern safety studies means long-term effects cannot be definitively characterized. The European Food Safety Authority (EFSA) has evaluated various petroleum-derived waxes, though specific determinations vary by formulation and intended use.

Regulatory Status

Petroleum Wax, Synthetic is regulated in the United States as a food additive but operates without GRAS status, meaning it falls under the FDA's food additive petition and approval framework for specific uses. It is approved for use in certain food categories, particularly chewing gum and similar masticatory products, where intentional ingestion is not the primary endpoint. Different countries maintain varying approval statuses; it is permitted in some jurisdictions for food use while others may have restrictions or require specific purity standards.

Manufacturers using this additive must comply with specifications regarding purity, mineral oil content, and contaminant levels. The additive must meet established identity and function criteria defined in food chemical codices such as the Food Chemicals Codex (FCC).

Key Studies

Limited peer-reviewed studies specifically examine Petroleum Wax, Synthetic in food applications. Available toxicological data on related petroleum-derived hydrocarbons suggest minimal systemic absorption when consumed in typical food use amounts. Regulatory agencies have determined acceptable use levels based on animal studies and chemical properties rather than extensive human clinical trials, which is standard practice for non-nutritive food additives with low bioavailability.

Frequently Asked Questions

What is Petroleum Wax, Synthetic?

Petroleum Wax, Synthetic (CAS 977045-73-4) is a man-made wax derived from petroleum hydrocarbons, used in food as a masticatory substance and surface-active agent. It functions primarily in chewing gum and similar products to provide texture and coating properties.

Is Petroleum Wax, Synthetic safe?

Petroleum Wax, Synthetic is currently rated "safe" 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 Petroleum Wax, Synthetic banned in any country?

Petroleum Wax, Synthetic 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.