EFSA toxicology reference values

2-Ethyl-4-hydroxy-5-methyl-3(2H)-furanone

SOURCE efsa openfoodtox 3 0 export repository

2-Ethyl-4-hydroxy-5-methyl-3(2H)-furanone (CAS 27538-09-6). Cannabis testing data across 0 states. Action levels when present, testing requirements, compliance status.

2-Ethyl-4-hydroxy-5-methyl-3(2H)-furanone is a cannabis analyte contaminant represented in the cannabis public dataset.

CAS 27538-09-6 Cannabis Analyte

Substance Identity

Analyte identity and classification used for this cannabis substance page.

SOURCE efsa substances
Analyte name
2-Ethyl-4-hydroxy-5-methyl-3(2H)-furanone
CAS number
27538-09-6
Contaminant class
Cannabis Analyte

Contaminant Class Badge

Color-coded cannabis class signal for scanning pesticide, metal, solvent, mycotoxin, and potency pages.

SOURCE State Cannabis Regulations
Cannabis Analyte Cannabis contaminant class used to group state testing rows.

Dataset Snapshot

Compact public-data summary for page quality, state coverage, lab rows, and potency sample groups.

SOURCE cannabis page data
Quality score
2
thin
Jurisdictions
0
No state rows
Lab/analyte rows
0
0 failed (-)
Potency samples
0
27538-09-6

EFSA Substance Identity

EFSA substance identity rows matched by chemical name or CAS.

SOURCE efsa openfoodtox 3 0 export repository
2-Ethyl-4-hydroxy-5-methyl-3(2H)-furanone
CAS 27538-09-6 / mono-constituent substance
C7H10O3 / 7 dossier(s)

EFSA Reference Values

Reference values from efsa_reference_values_v2 for toxicology and food-safety context.

SOURCE efsa openfoodtox 3 0 export repository
DescriptorValuePopulationEndpointBody
TTC Cramer Class III 1.5 µg/kg bw/day consumers - -
TTC Cramer Class III 1.5 µg/kg bw/day consumers - other:
TTC Cramer Class III 1.5 µg/kg bw/day consumers - -
TTC Cramer Class II 9 µg/kg bw/day consumers - other:
TTC Cramer Class II 9 µg/kg bw/day consumers - -
TTC Cramer Class II 9 µg/kg bw/day consumers - other:
MSI/FC 88 mg/kg cat fdf932af-9106-4261-ab2d-7c33a20cbaea -
MSI/FC 106 mg/kg dog fdf932af-9106-4261-ab2d-7c33a20cbaea -
margin of safety 59,000 other: consumers 513d9e62-a387-4c0e-8da7-2111d6389561 -
Incomplete dataset - workers - -

EFSA Study Results

Endpoint-level study rows from efsa_study_results matched to this substance.

SOURCE efsa openfoodtox 3 0 export repository
EndpointSpeciesRouteEffectAssessment
chronic toxicity: other route rat - 200 mg/kg bw/day -
chronic toxicity: other route rat - 200 mg/kg bw/day -
appearance / physical state / colour - - - experimental study
partition coefficient - - - experimental study
Carcinogenicity_EU_PPP - - - The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (the Panel) was asked to provide scientific advise for the Commission on the implications for human health of chemically defined flavouring substances used in or on foodstuffs in the Member States. In particular, the Panel was asked to evaluate flavouring substances using the Procedure as referred to in the Commission Regulation (EC) No 1565/2000. The present Flavouring Group Evaluation 220 (FGE.220) concerns 10 substances, corresponding to subgroup 4.4 of FGE.19. The 10 substances are alpha,beta-unsaturated 3(2H)-furanones. The substances in this FGE.220 were further subdivided into two subgroups as five of the 10 substances can only exist as alpha, beta-unsaturated ketones (subgroub 4.4a) while in the other five substances, the alpha,beta double bond can be involved in keto-enol tautomerism (subgroup 4.4b).
Carcinogenicity_EU_PPP - - - The European Food Safety Authority (EFSA) asked the Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (the Panel) to provide scientific advice to the Commission on the implications for human health of chemically defined flavouring substances used in or on foodstuffs in the Member States. In particular, the Panel was requested to consider the Joint FAO/WHO Expert Committee on Food Additives (the JECFA) evaluations of flavouring substances assessed since 2000, and to decide whether no further evaluation is necessary, as laid down in Commission Regulation (EC) No 1565/2000. These flavouring substances are listed in the Register, which was adopted by Commission Decision 1999/217/EC and its consecutive amendments. This consideration deals with five furanone derivatives, 4-hydroxy-2,5-dimethylfuran-3(2H)-one [FLno: 13.010], 2-ethyl-4-hydroxy-5-methyl-3(2H)-furanone [FL-no: 13.084], 4-hydroxy-5-methylfuran-3(2H)-one [FL-no: 13.085], 4-acetoxy-2,5-dimethylfuran-3(2H)-one [FL-no: 13.099] and furaneyl butyrate [FL-no: 13.176], which are in the Register and which were evaluated by the JECFA at its 63rd, 65th and 69th meetings. The Panel concluded that no supporting Flavouring Group Evaluation (FGE) was available for the substances in the present FGE.
Carcinogenicity_EU_PPP - - - Following a request from the European Commission the Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF Panel) was asked to deliver a scientific opinion on the implications for human health of chemically defined flavouring substances used in or on foodstuffs in the Member States. In particular, the Panel was asked to evaluate 10 flavouring substances in Flavouring Group Evaluation 220 (FGE.220) using the Procedure as referred to in the Commission Regulation (EC) No 1565/2000. Flavouring Group Evaluation 220 (FGE.220) concerned 10 substances, corresponding to subgroup 4.4 of FGE.19. The 10 substances are alpha,beta-unsaturated 3(2H)-furanones [FL-no: 13.010, 13.084, 13.085, 13.089, 13.099, 13.117, 13.119, 13.157, 13.175 and 13.176]. The substances were further subdivided into two subgroups as five [FL-no: 13.089, 13.117, 13.119, 13.157 and 13.175] of the 10 substances can only exist as alpha,beta-unsaturated ketones (subgroup 4.4a) while in the other five substances [13.010, 13.084 and 13.085, 13.099 and 13.176], the alpha,beta double bond can be involved in keto-enol tautomerism (subgroup 4.4b).
Carcinogenicity_EU_PPP - - - The European Food Safety Authority (EFSA) asked the Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (the Panel) to provide scientific advice to the Commission on the implications for human health of chemically defined flavouring substances used in or on foodstuffs in the Member States. In particular, the Panel was asked to evaluate flavouring substances using the Procedure as referred to in the Commission Regulation (EC) No 1565/2000. The present revision of FGE.220, FGE.220Rev1, concerns the evaluation of additional data submitted by Industry in response to the requested genotoxicity data in FGE.220 on the representative substance for subgroup 4.4b, 4-hydroxy-2,5-dimethylfuran-3(2H)-one [FL-no: 13.010]. Flavouring Group Evaluation 220 (FGE.220) concerns 10 substances, corresponding to subgroup 4.4 of FGE.19. The 10 substances are alpha,beta-unsaturated 3(2H)-furanones [FL-no: 13.010, 13.084, 13.085, 13.089, 13.099, 13.117, 13.119, 13.157, 13.175 and 13.176]. The substances were further subdivided into two subgroups as five of the 10 substances can only exist as alpha,beta-unsaturated ketones (subgroup 4.4a) while in the other five substances the alpha,beta double bond can be involved in keto-enol tautomerism (subgroup 4.4b).
Carcinogenicity_EU_PPP - - - Following a request from the European Commission, the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) was asked to deliver a scientific opinion on the implications for human health of chemically defined flavouring substances used in or on foodstuffs in the Member States. In particular, the Panel was asked to evaluate 10 flavouring substances in Flavouring Group Evaluation 220 (FGE.220) using the Procedure as referred to in the Commission Regulation (EC) No 1565/2000. The Industry has tested again 4-acetyl-2,5-dimethylfuran-3(2H)-one [FL-no: 13.175] in an in vitro micronucleus assay in the presence of S9-mix (3+21 hours). These data are evaluated in the present Revision 3 of FGE.220 (FGE.220 Rev3). The available data suggest that 4-acetyl-2,5-dimethylfuran-3(2H)-one [FL-no: 13.175] did not induce reproducible statistically significant increase in micronucleated binucleate cells across replicate cultures indicating that the test substance can be considered negative for clastogenicity and aneugenicity. The Panel therefore concluded that [FL-no: 13.175] does not give rise to concern with respect to genotoxicity and accordingly can be evaluated using the Procedure. This is also applicable to 2,5-dimethyl-4-methoxyfuran-3(2H)-one [FL- no:13.089] and 2,5-dimethyl4-ethoxyfuran-3(2H)-one [FL-no:13.117] which are covered by the representative substance 4-acetyl2,5-dimethylfuran-3(2H)-one [FL-no:13.175]. Based on the available data all 9 substances of this FGE are no longer of concern with respect to genotoxicity and can be evaluated through the Procedure.
Carcinogenicity_EU_PPP - - - Following a request from the European Commission, the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF Panel) was asked to deliver a scientific opinion on the implications for human health of chemically defined flavouring substances used in or on foodstuffs in the Member States. In particular, the Panel was requested to consider the Joint FAO/WHO Expert Committee on Food Additives (the JECFA) evaluations of flavouring substances assessed since 2000, and to decide whether no further evaluation is necessary, as laid down in Commission Regulation (EC) No 1565/2000. These flavouring substances are listed in the Register, which was adopted by Commission Decision 1999/217/EC and its consecutive amendments. The present revision of FGE.99, FGE.99Rev1, includes the assessment of one additional candidate substance, the 2,5-dimethyl-4-methoxyfuran-3(2H)-one [FL-no: 13.089], which was evaluated by the JECFA at its 63rd meeting. This substance, containing an alpha,beta-unsaturated carbonyl, raised concern for genotoxicity. In the recently published FGE.220Rev3, new genotoxicity data on the structurally related 4-acetyl-2,5-dimethylfuran-3(2H)-one [FL-no: 13.175] have become available. The Panel concluded that the data available rules out the concern for genotoxicity for [FL-no: 13.089] and accordingly this substance can be evaluated through the Procedure in this revision.
Carcinogenicity_EU_PPP - - - Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of 23 compounds belonging to different chemical groups. This opinion concerns eight out of the 23 compounds, which are currently authorised for use as flavours in food.
Genetic Toxicity - - - Following a request from the European Commission, the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF Panel) was asked to deliver a scientific opinion on the implications for human health of chemically defined flavouring substances used in or on foodstuffs in the Member States. In particular, the Panel was requested to consider the Joint FAO/WHO Expert Committee on Food Additives (the JECFA) evaluations of flavouring substances assessed since 2000, and to decide whether no further evaluation is necessary, as laid down in Commission Regulation (EC) No 1565/2000. These flavouring substances are listed in the Register, which was adopted by Commission Decision 1999/217/EC and its consecutive amendments. The present revision of FGE.99, FGE.99Rev1, includes the assessment of one additional candidate substance, the 2,5-dimethyl-4-methoxyfuran-3(2H)-one [FL-no: 13.089], which was evaluated by the JECFA at its 63rd meeting. This substance, containing an alpha,beta-unsaturated carbonyl, raised concern for genotoxicity. In the recently published FGE.220Rev3, new genotoxicity data on the structurally related 4-acetyl-2,5-dimethylfuran-3(2H)-one [FL-no: 13.175] have become available. The Panel concluded that the data available rules out the concern for genotoxicity for [FL-no: 13.089] and accordingly this substance can be evaluated through the Procedure in this revision.

Frequently Asked Questions

FAQ answers are generated from the same fetched cannabis, EFSA, cosmetics, and chemical rows rendered above.

SOURCE page FAQ dataset

What is the regulatory limit for 2-Ethyl-4-hydroxy-5-methyl-3(2H)-furanone in cannabis?

2-Ethyl-4-hydroxy-5-methyl-3(2H)-furanone does not have a numeric cannabis_contaminant_tests range in the fetched page data. The current page query does not expose a separate action-limit column.

Which states test for 2-Ethyl-4-hydroxy-5-methyl-3(2H)-furanone?

2-Ethyl-4-hydroxy-5-methyl-3(2H)-furanone does not have state-level cannabis testing rows in the fetched page data.

What are the EFSA reference values for 2-Ethyl-4-hydroxy-5-methyl-3(2H)-furanone?

2-Ethyl-4-hydroxy-5-methyl-3(2H)-furanone has 10 EFSA OpenFoodTox reference value rows in the cannabis database, including TTC Cramer Class III, TTC Cramer Class II, MSI/FC, margin of safety.

Is 2-Ethyl-4-hydroxy-5-methyl-3(2H)-furanone also regulated in cosmetics or food?

2-Ethyl-4-hydroxy-5-methyl-3(2H)-furanone has a cosmetics ingredient cross-reference with EU status permitted. EFSA food/toxicology context is available on this page.