Flavor ingredient regulatory record
Trilobatin
Trilobatin is an ester in the fruity family, FEMA GRAS under FEMA number 4674 (CAS 4192-90-9). Its odor is sweet, fruity, floral, tropical, berry.
- FEMA
- 4674
- CAS
- 4192-90-9
- JECFA
- 2171
- EU FL
- 16.112
- Formula
- C21H24O10
GRAS status: FEMA GRAS, publication 25. Recorded by FDA in the Substances Added to Food inventory under CAS 4192-90-9.
Structure
Identity
Also known as: 1-Propanone, 1-[4-(β-D-glucopyranosyloxy)-2,6-dihydroxyphenyl]-3-(4-hydroxyphenyl)-, p-Phlorizin, 1-[4-(β-D-Glucopyranosyloxy)-2,6-dihydroxyphenyl]-3-(4-hydroxyphenyl)-1-propanone, p-Phloridzin, Prunin dihydrochalcone, Phloretin 4′-glucoside, Phloretine-4′-glucoside, Phloretin 4′-β-D-glucoside, Phloretin-4′-O-β-D-glucopyranoside, Phloretin-4-O-glycoside, p-phlorizin, p-phloridzin.
Can Trilobatin be labeled natural?
Since trilobatin is found in nature, US labeling follows how it was obtained: natural flavor from a natural source and a natural process, artificial when trilobatin is synthesized. 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
Trilobatin is FEMA GRAS under FEMA number 4674. 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 16.112, Annex I Part A under Regulation (EC) 1334/2008, evaluation status approved (EFSA). The UK retains the same list.
JECFA (WHO / FAO)
JECFA number 2171, evaluated at the 76th meeting in 2012. No safety concern at current levels of intake when used as a flavouring agent.
Other US flags
Not on the California Proposition 65 list.
Odor and taste
Odor: Sweet, fruity, floral, tropical, berry.
Where it is used
Trilobatin is used in beverage, confection, fruit flavors, desserts and ice cream, typically as a fruity note.
Structurally similar flavor ingredients
Flavor ingredients with a GRAS determination closest to Trilobatin by structure. Whether one can replace it is a sensory and regulatory call; the reformulation tool works that through.
| Material | FEMA | Similarity | Occurrence |
|---|---|---|---|
| Naringin dihydrochalcone | 4495 | 96% | Not determined |
| Neohesperidin dihydrochalcone | 3811 | 94% | In nature |
| Myricitrin | 4491 | 92% | In nature |
| Ethyl vanillin beta-D-glucopyranoside | 3801 | 86% | In nature |
| Rebaudioside A | 4601 | 81% | In nature |
More esters in this index
2,4-Hexadienyl propionate · l-Bornyl acetate · Phenethyl cinnamate · Methylthio 2-(propionyloxy)propionate · 3-Hexenyl 3-methylbutanoate · 3-Hexenyl phenylacetate
Trilobatin FAQ
Is trilobatin FEMA GRAS?
Yes. The FEMA Expert Panel lists trilobatin as GRAS under FEMA number 4674. It is also codified at 21 CFR 172.515.
What are the FEMA and CAS numbers for trilobatin?
Trilobatin is FEMA 4674, CAS 4192-90-9. FEMA files it in the fruity flavor category.
Does trilobatin count as natural in the US and the EU?
Trilobatin occurs in nature, so the label depends on the route: trilobatin won from a natural source by a physical, enzymatic or microbiological process is natural flavor in the United States, and synthesized trilobatin is artificial. The EU and UK follow the same logic without a middle class; Mercosur and Mexico label synthetic trilobatin identical-to-natural.
Is trilobatin on the EU Union List?
Trilobatin is on the EU Union List of flavouring substances as FL 16.112 (Annex I Part A) under Regulation 1334/2008.
Has JECFA evaluated trilobatin?
Yes. JECFA number 2171, evaluated at the 76th meeting in 2012. Conclusion: No safety concern at current levels of intake when used as a flavouring agent.
How is trilobatin described, and where does it show up?
Flavorists describe trilobatin as sweet, fruity, floral, tropical, berry. It is used in beverage, confection, fruit flavors, desserts and ice cream.
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Guides: What Is FEMA GRAS? · Natural vs artificial · Filing a GRAS notification
Check Trilobatin in a formula
Screened against FEMA GRAS, 21 CFR and EU rules as you build. Free to start.
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 TRILOBATIN under CAS 4192-90-9 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.