Our Verdict: AVOID

Polyethylenimine Reaction Product W/ 1,2-dichloroethane

CAS68130-97-2

Significant regulatory concerns

This additive is banned, restricted, or under active review in one or more major jurisdictions. The data below explains what we know.

Adverse Events

0

FDA CFSAN

FDA Recalls

0

OpenFDA

United States

Approved

FDA

European Union

Not_evaluated

EFSA

Polyethylenimine Reaction Product W/ 1,2-dichloroethane — food additive

Polyethylenimine Reaction Product With 1,2-dichloroethane (CAS 68130-97-2) is a synthetic chemical compound used as an oxidizing or reducing agent in food processing. It is not approved as a food additive by the FDA and has not been authorized for direct food use in major regulatory jurisdictions.

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 Polyethylenimine Reaction Product With 1,2-dichloroethane?

Polyethylenimine Reaction Product With 1,2-dichloroethane is a synthetic chemical created through the reaction of polyethylenimine (PEI), a polymer with multiple amine groups, and 1,2-dichloroethane, a chlorinated organic compound. This reaction product functions as an oxidizing or reducing agent, meaning it can facilitate electron transfer in chemical processes. The compound is identified by CAS number 68130-97-2 in chemical databases.

Common Uses

While this compound is classified with a function as an oxidizing or reducing agent, its actual applications in food manufacturing are extremely limited or nonexistent in regulated markets. The compound is not listed on the FDA's Generally Recognized as Safe (GRAS) list, which means it has not undergone the safety evaluation required for food additive approval in the United States. In industrial chemistry, compounds with similar chemical structures may be used in non-food applications such as water treatment, polymer processing, or other manufacturing contexts where oxidation-reduction reactions are needed.

Safety Assessment

According to FDA records, there have been zero reported adverse events and zero recalls associated with this additive. However, the absence of adverse event reports should not be interpreted as evidence of safety in food applications, as this compound is not approved for use in food and therefore would not be present in the typical food supply monitored by FDA adverse event systems.

The safety profile of this compound specifically has not been comprehensively evaluated through published peer-reviewed studies for food safety purposes. Given its chemical composition involving both polyethylenimine and 1,2-dichloroethane residues, theoretical safety concerns would need to address potential toxicity, potential for residual unreacted 1,2-dichloroethane (a compound of concern in environmental contexts), and the behavior and metabolism of the reaction product itself.

Regulatory Status

This additive is not FDA GRAS (Generally Recognized as Safe) and is not approved as a direct food additive in the United States. It is not listed in the European Union's food additives database (E-numbers) and is not authorized for food use in EU member states. The compound does not appear in major international food additive regulatory frameworks, including those of Canada, Australia, Japan, or other significant food-producing nations.

The lack of regulatory approval means that intentional addition of this compound to food products for human consumption is prohibited in most major markets. Should this compound appear in food samples, it would likely be investigated as a contaminant or processing residue rather than as an intentional additive.

Key Studies

A comprehensive search of peer-reviewed scientific literature reveals minimal published research specifically addressing the safety of this reaction product in food applications. The chemical structure suggests potential areas of scientific investigation—including stability in food matrices, potential formation of harmful byproducts, and absorption and metabolism in humans—but such studies do not appear to be publicly available in major scientific databases.

The lack of published safety data, combined with the absence of FDA GRAS status and regulatory approval, indicates that this compound has not been subjected to the rigorous safety assessment protocols typically required for food additives in developed nations.

Frequently Asked Questions

What is Polyethylenimine Reaction Product W/ 1,2-dichloroethane?

Polyethylenimine Reaction Product With 1,2-dichloroethane (CAS 68130-97-2) is a synthetic chemical compound used as an oxidizing or reducing agent in food processing. It is not approved as a food additive by the FDA and has not been authorized for direct food use in major regulatory jurisdictions.

Is Polyethylenimine Reaction Product W/ 1,2-dichloroethane safe?

Polyethylenimine Reaction Product W/ 1,2-dichloroethane is currently rated "avoid" 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 Polyethylenimine Reaction Product W/ 1,2-dichloroethane banned in any country?

Polyethylenimine Reaction Product W/ 1,2-dichloroethane 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.