Flavor ingredient regulatory record

2-(4-Methyl-2-hydroxyphenyl)propionic acid-gamma-lactone

2-(4-Methyl-2-hydroxyphenyl)propionic acid-gamma-lactone is a lactone in the fruity family, FEMA GRAS under FEMA number 3863 (CAS 65817-24-5).

FEMA
3863
CAS
65817-24-5
JECFA
1167
EU FL
10.072
Formula
C10H10O2

GRAS status: FEMA GRAS, publication 18. Recorded by FDA in the Substances Added to Food inventory under CAS 65817-24-5.

Structure

2D structure of 2-(4-Methyl-2-hydroxyphenyl)propionic acid-gamma-lactone
Structure of 2-(4-Methyl-2-hydroxyphenyl)propionic acid-gamma-lactone, C10H10O2. Drawn from the canonical SMILES.

Identity

IUPAC name 3,6-dimethyl-3H-1-benzofuran-2-one
CAS number 65817-24-5
FEMA number 3863
Molecular formula C10H10O2
Molecular weight 162.19 g/mol
SMILES Cc1ccc2c(c1)OC(=O)C2C
InChIKey JSJKAEKKWQOCEZ-UHFFFAOYSA-N
PubChem CID 9793908
FDA UNII 0XUR2L45V9
EPA DTXSID DTXSID30984309
Chemical class Lactone
Boiling point 64 °C
Flash point 15 °C

Also known as: 2(3H)-Benzofuranone, 3,6-dimethyl-, 3,6-Dimethyl-2(3H)-benzofuranone, 3,6-Dimethyl-2,3-dihydro-1-benzofuran-2-one, 3,6-Dimethyl-3H-benzo[b]furan-2-one, 3,6-Dimethyl-3H-benzofuran-2-one, 3,6-dimethyl-2(3h)-benzofuranone, 2(3h)-benzofuranone, 3,6-dimethyl-, dimethyl-3,6-benzo-2(3h)-furanone, 3,6-dimethyl-3h-1-benzofuran-2-one, 2-(4-methyl-2-hydroxyphenyl)propionic acid-gamma-lactone [fhfi], 2-(4-methyl-2-hydroxyphenyl)propionic acid-.gamma.-lactone, 2-(4-methyl-2-hydroxyphenyl)propionic acid-.gamma.-lactone [fhfi].

Can 2-(4-Methyl-2-hydroxyphenyl)propionic acid-gamma-lactone be labeled natural?

The process decides for 2-(4-Methyl-2-hydroxyphenyl)propionic acid-gamma-lactone. It occurs in nature, so a natural-source, natural-process material is natural flavor in the US and synthetic 2-(4-Methyl-2-hydroxyphenyl)propionic acid-gamma-lactone is artificial. The EU and UK follow the same logic without a middle class; Mercosur and Mexico label synthetic 2-(4-Methyl-2-hydroxyphenyl)propionic acid-gamma-lactone identical-to-natural.

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

2-(4-Methyl-2-hydroxyphenyl)propionic acid-gamma-lactone is FEMA GRAS under FEMA number 3863. It is cited in the Code of Federal Regulations at 21 CFR 172.515.

21 CFR 172.515

European Union and United Kingdom

Listed on the Union List of flavouring substances as FL 10.072, Annex I Part A under Regulation (EC) 1334/2008, evaluation status approved (EFSA). The UK retains the same list.

JECFA (WHO / FAO)

JECFA number 1167, evaluated at the 61st meeting in 2003. no safety concern at current levels of intake.

JECFA monograph

Other US flags

Not on the California Proposition 65 list.

Odor and taste

Taste: Sweet, creamy, slightly tart.

Where it is used

2-(4-Methyl-2-hydroxyphenyl)propionic acid-gamma-lactone is used in beverage, confection, dairy and fruit flavors, typically as a fruity note.

Structurally similar flavor ingredients

Flavor ingredients with a GRAS determination closest to 2-(4-Methyl-2-hydroxyphenyl)propionic acid-gamma-lactone by structure. Whether one can replace it is a sensory and regulatory call; the reformulation tool works that through.

MaterialFEMASimilarityOccurrence
Dehydromenthofurolactone375585%In nature
Menthofuran323566%In nature
Dihydromintlactone403262%In nature
Phthalide419560%In nature
Piperonyl acetate291258%In nature

More lactones in this index

Phthalide · 5-Hydroxy-8-undecenoic acid delta-lactone · 2-(2-Hydroxyphenyl)-cyclopropanecarbocyclic acid delta-lactone · 4,4-Dibutyl-gamma-butyrolactone · delta-Decalactone · (+/-)-(2,6,6,-Trimethyl-2-hydroxycyclohexylidene)acetic acid gamma-lactone

2-(4-Methyl-2-hydroxyphenyl)propionic acid-gamma-lactone FAQ

Is 2-(4-Methyl-2-hydroxyphenyl)propionic acid-gamma-lactone on the FEMA GRAS list?

It is. FEMA number 3863 covers 2-(4-Methyl-2-hydroxyphenyl)propionic acid-gamma-lactone. The Code of Federal Regulations lists it at 21 CFR 172.515.

What is the FEMA number for 2-(4-Methyl-2-hydroxyphenyl)propionic acid-gamma-lactone?

The FEMA number for 2-(4-Methyl-2-hydroxyphenyl)propionic acid-gamma-lactone is 3863 and its CAS registry number is 65817-24-5. Its flavor category is fruity.

What did JECFA conclude about 2-(4-Methyl-2-hydroxyphenyl)propionic acid-gamma-lactone?

JECFA evaluated 2-(4-Methyl-2-hydroxyphenyl)propionic acid-gamma-lactone at the 61st meeting in 2003 under JECFA number 1167. The panel concluded: no safety concern at current levels of intake.

Is 2-(4-Methyl-2-hydroxyphenyl)propionic acid-gamma-lactone approved in the EU?

Yes. FL 10.072 is the Union List entry for 2-(4-Methyl-2-hydroxyphenyl)propionic acid-gamma-lactone, annex I Part A, under Regulation 1334/2008, and the UK keeps the same list.

Is 2-(4-Methyl-2-hydroxyphenyl)propionic acid-gamma-lactone natural or artificial?

Nature makes 2-(4-Methyl-2-hydroxyphenyl)propionic acid-gamma-lactone, which is why the US label turns on process. A natural route gives natural flavor; synthesis gives artificial 2-(4-Methyl-2-hydroxyphenyl)propionic acid-gamma-lactone, same molecule. The EU and UK grant the natural claim only to that natural route; Mercosur and Mexico call synthetic material identical-to-natural.

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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 2-(4-METHYL-2-HYDROXYPHENYL)PROPIONIC ACID-GAMMA-LACTONE under CAS 65817-24-5 and carries its FEMA number, its JECFA flavor 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.