Flavor ingredient regulatory record
Ferrous lactate
Ferrous lactate is a lactate in the earthy family, FEMA GRAS under FEMA number 4699 (CAS 85993-25-5). Its odor is earthy, metallic, slightly sour, mineral.
- FEMA
- 4699
- CAS
- 85993-25-5
- EU FL
- 16.096
- Formula
- C6H10FeO6
GRAS status: FEMA GRAS, publication 25. Recorded by FDA in the Substances Added to Food inventory under CAS 85993-25-5.
Structure
Identity
Also known as: Iron, bis[(2S)-2-(hydroxy-κO)propanoato-κO]-, (T-4)-, Iron, bis(2-hydroxypropanoato-O1,O2)-, [T-4-(S),(S)]-, Propanoic acid, 2-hydroxy-, iron complex, (S)-, (T-4)-Bis[(2S)-2-(hydroxy-κO)propanoato-κO]iron, iron(ii) lactate, iron dilactate, iron(2+) lactate, propanoic acid, 2-hydroxy-, iron(2+) salt (2:1), ins no.585, ins-585, e 585, e-585.
Can Ferrous lactate be labeled natural?
The process decides for ferrous lactate. It occurs in nature, so a natural-source, natural-process material is natural flavor in the US and synthetic ferrous lactate is artificial. In the EU and UK the natural claim likewise needs the natural route, while Mercosur and Mexico keep a third class, identical-to-natural, for the synthetic material.
- United States
- Natural or artificial, by process
- European Union and UK
- Natural only from natural material
- Mercosur and Mexico
- Natural or identical-to-natural
How each market defines the classes: natural vs artificial flavor under 21 CFR 101.22.
Regulatory status, with citations
United States
Ferrous lactate is FEMA GRAS under FEMA number 4699. It is cited in the Code of Federal Regulations at 21 CFR 172.515.
European Union and United Kingdom
Listed on the Union List of flavouring substances as FL 16.096, Annex I Part A under Regulation (EC) 1334/2008, evaluation status approved (EFSA). The UK retains the same list.
JECFA (WHO / FAO)
Ferrous lactate has not been evaluated by JECFA as a flavouring agent, or no evaluation is on file.
Other US flags
Not on the California Proposition 65 list.
TSCA Inventory status
A flavor ingredient is also an industrial chemical. Ferrous lactate appears on the EPA Toxic Substances Control Act Chemical Substance Inventory under CAS 85993-25-5, where EPA names it Iron, bis[(2S)-2-(hydroxy-.kappa.O)propanoato-.kappa.O]-, (T-4)-.
Active in US commerce
EPA designates this substance active, so no Notice of Activity Form B is required before manufacturing. What active and inactive mean.
EPA regulatory flags
| Flag | EPA definition | What it obliges |
|---|---|---|
| PMN | Indicates a commenced PMN substance. | Nothing new. The substance already went through premanufacture review and someone filed a notice of commencement, which is why it is on the Inventory. It is an existing chemical and needs no new premanufacture notice. Read more |
PMN does not establish: The flag records how the substance arrived, not what may be done with it. Check the flags beside it.
From the EPA non-confidential TSCA Inventory, July 2026 release. EPA also maintains a confidential portion it does not publish. Search the Inventory by CAS number.
Odor and taste
Odor: Earthy, metallic, slightly sour, mineral.
Taste: Sour, metallic, slightly bitter.
Where it is used
Ferrous lactate is used in beverage, fortification and nutritional supplements, typically as a earthy note.
Ferrous lactate FAQ
Does ferrous lactate have FEMA GRAS status?
Ferrous lactate holds FEMA GRAS status under FEMA number 4699. The Code of Federal Regulations lists it at 21 CFR 172.515.
How do I cite ferrous lactate by FEMA or CAS number?
Cite ferrous lactate as FEMA 4699 or CAS 85993-25-5; both point to the same entry. Its flavor category is earthy.
What does ferrous lactate smell and taste like, and where is it used?
The odor of ferrous lactate is earthy, metallic, slightly sour, mineral. On the palate it is sour, metallic, slightly bitter. Typical uses are beverage, fortification and nutritional supplements.
Can ferrous lactate be used in the EU and UK?
Yes. FL 16.096 is the Union List entry for ferrous lactate, annex I Part A, under Regulation 1334/2008, and the UK keeps the same list.
Can ferrous lactate be labeled a natural flavor?
Nature makes ferrous lactate, which is why the US label turns on process. A natural route gives natural flavor; synthesis gives artificial ferrous lactate, same molecule. The EU and UK follow the same logic without a middle class; Mercosur and Mexico label synthetic ferrous lactate identical-to-natural.
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Guides: What Is FEMA GRAS? · Natural vs artificial · Filing a GRAS notification
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Sources and attribution. The identity and regulatory facts on this page are taken from the FDA Substances Added to Food inventory, a US government record, which lists this substance as FERROUS L-LACTATE under CAS 85993-25-5 and carries its FEMA number. The inventory is searchable at FDA. FDA records its technical effect as flavoring agent or adjuvant.
A FEMA GRAS conclusion is reached by the Expert Panel of the Flavor and Extract Manufacturers Association of the United States, and the FEMA number names that conclusion. FEMA publishes its own entry for this substance in the FEMA Flavor Library, which is the authoritative record of what the Panel decided and is worth reading alongside this page.
Ambrose Compliance is not affiliated with, endorsed by, or sponsored by FEMA. FEMA and FEMA GRAS are used here as identifiers for a published regulatory determination, not as marks of any relationship between FEMA and Ambrose.
About this page. Facts come from the FDA Substances Added to Food inventory, the Code of Federal Regulations, the EPA TSCA Inventory, the EU Union List, JECFA and the Ambrose database, with FEMA's published determination cited where it applies; parts of the text are written by Ambrose AI, which can make mistakes. Check the cited source before relying on anything here. This is not regulatory or legal advice.