Our Verdict: SAFE

Manganese Hypophosphite

CAS10043-84-2

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

Manganese Hypophosphite — food additive

Manganese hypophosphite is an inorganic compound used as a nutritional supplement to provide bioavailable manganese in fortified foods and beverages. It serves as a source of the essential trace mineral manganese, which plays important roles in bone development, metabolism, and antioxidant defense.

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 Manganese Hypophosphite?

Manganese hypophosphite is an inorganic salt compound composed of manganese and hypophosphite ions (H₂PO₂⁻). With CAS number 10043-84-2, this compound exists as a white to off-white crystalline powder. It is classified as a nutrient supplement rather than a food additive with a technological function, as its primary purpose is to provide elemental manganese for nutritional fortification.

Common Uses

Manganese hypophosphite is used in the food and beverage industry as a manganese source for nutrient fortification. It may be added to breakfast cereals, nutritional supplements, fortified plant-based beverages, and other foods intended to increase manganese content. The compound is chosen for applications where solubility and bioavailability of manganese are desired.

Manganese is an essential trace element required for multiple physiological functions, including bone mineralization, carbohydrate metabolism, amino acid metabolism, cholesterol synthesis, and as a cofactor for the antioxidant enzyme manganese superoxide dismutase (MnSOD). The adequate intake (AI) for manganese ranges from 1.2-2.3 mg daily depending on age and sex according to the National Institutes of Health.

Safety Assessment

Manganese hypophosphite has not been formally affirmed as Generally Recognized as Safe (GRAS) by the FDA, though this does not indicate safety concerns. Rather, it reflects that few manufacturers have submitted GRAS determinations for this specific compound to the FDA. The FDA maintains zero reported adverse events associated with manganese hypophosphite and zero product recalls, indicating a clean safety record in the regulatory database.

Safety considerations for manganese supplementation focus on total intake rather than specific formulation concerns. The FDA has established an upper tolerable intake level (UL) of 11 mg daily for adult manganese consumption. Excessive manganese intake, particularly from supplemental sources, has been associated with neurological effects in occupational exposure contexts, though dietary sources rarely approach concerning levels. The safety profile of manganese hypophosphite itself as a chemical compound appears benign at typical fortification levels, where it contributes only a fraction of total dietary manganese intake.

Regulatory Status

Manganese hypophosphite is not listed on the FDA's GRAS list, meaning it has not undergone the formal FDA GRAS notification process. However, its absence from the GRAS list does not prohibit its use. Manufacturers may market foods containing this ingredient under the Food and Drug Administration Modernization Act (FDAMA), provided the ingredient meets the definition of a food additive under 21 CFR Part 170 and is used in accordance with applicable regulations.

In the European Union, manganese compounds including hypophosphites may be approved as nutritional additives under Regulation (EC) No. 1925/2006 concerning the addition of vitamins and minerals to foods, though specific approvals vary by jurisdiction.

Key Studies

Scientific literature on manganese hypophosphite specifically is limited. Most relevant research addresses manganese biochemistry, bioavailability of different manganese compounds, and dietary manganese requirements. Studies in the Journal of Nutrition and American Journal of Clinical Nutrition have established the essential nature of manganese and characterized its metabolic roles. Research on various manganese salt formulations indicates differences in bioavailability, with hypophosphite compounds showing reasonable absorption characteristics.

The absence of adverse event reports and recalls in FDA databases, combined with the established safety profile of manganese as a nutritional element, suggests manganese hypophosphite presents minimal safety concerns when used at appropriate fortification levels consistent with maintaining total dietary manganese intake below the established UL.

Frequently Asked Questions

What is Manganese Hypophosphite?

Manganese hypophosphite is an inorganic compound used as a nutritional supplement to provide bioavailable manganese in fortified foods and beverages. It serves as a source of the essential trace mineral manganese, which plays important roles in bone development, metabolism, and antioxidant defense.

Is Manganese Hypophosphite safe?

Manganese Hypophosphite 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 Manganese Hypophosphite banned in any country?

Manganese Hypophosphite 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.