Table A.1.
Summary of evaluation of exposure and evaluation status of rum ether components which have been evaluated as flavouring substances
| FL‐no FGE | EU Register name | Structural formula | Cramer class | α,β subgroup | EFSA Evaluation status | JECFA no CoE no CAS no | SCF statusa JECFA statusb CoE statusc | Comments |
|---|---|---|---|---|---|---|---|---|
| 02.004– | Butan‐1‐ol |
|
Class I | – | No safety concern at the estimated level of intake based on the MSDI approach |
85 52 71‐36‐3 |
Category 1 (SCF, 1995) No safety concern (JECFA, 1999) Category A (CoE, 1992) |
Evaluated by JECFA before 2000 – No EFSA consideration required |
|
02.078 – |
Ethanol |
|
Class I | – | No safety concern at the estimated level of intake based on the MSDI approach |
41 1189164‐17‐5 |
Category 1 (SCF, 1995) No safety concern (JECFA, 1997) |
At the forty‐sixth JECFA meeting (JECFA, 1997), the Committee concluded that ethanol posed no safety concern at its current level of intake when ethyl esters are used as flavouring agents |
|
05.001 – |
Acetaldehyde |
|
Class I | – | No safety concern at the estimated level of intake based on the MSDI approach |
80 89 75‐07‐0 |
Category 1 (SCF, 1995) No safety concern (JECFA, 1999) Category A (CoE, 1992) |
Evaluated by JECFA before 2000 – No EFSA consideration required |
|
06.001 61 |
1,1‐Diethoxyethane |
|
Class I | – | No safety concern at the estimated level of intake based on the MSDI approach |
941 35 105‐57‐7 |
– No safety concern (JECFA, 2002a) Category A (CoE, 1992) |
|
|
06.015 61 |
1,1‐Dimethoxyethane |
|
Class I | – | No safety concern at the estimated level of intake based on the MSDI approach |
940 510 534‐15‐6 |
– No safety concern (JECFA, 2002a) Category A (CoE, 1992) |
|
|
06.023 – |
1,1‐Diethoxyhexane |
|
– | No safety concern at the estimated level of intake based on the MSDI approach |
– 557 3658‐93‐3 |
– – Category A (CoE, 1992) |
||
|
06.057 03 |
1,1‐Diethoxy‐2‐methylbutane |
|
Class I | – | No safety concern at the estimated level of intake based on the MSDI approach |
– 10013 3658‐94‐4 |
||
|
06.058 03 |
1,1‐Diethoxy‐2‐methylpropane |
|
Class I | – | No safety concern at the estimated level of intake based on the MSDI approach |
– 10015 1741‐41‐9 |
||
|
06.059 03 |
1,1‐Diethoxy‐3‐methylbutane |
|
Class I | – | No safety concern at the estimated level of intake based on the MSDI approach |
1730 10014 3842‐03‐3 |
||
|
06.061 03 |
1,1‐Diethoxybutane |
|
Class I | – | No safety concern at the estimated level of intake based on the MSDI approach |
– 10009 3658‐95‐5 |
||
|
06.064 03 |
Diethoxymethane |
|
Class I | – | No safety concern at the estimated level of intake based on the MSDI approach |
– 10012 462‐95‐3 |
||
|
06.069 03 |
1,1‐Diethoxypropane |
|
Class I | – | No safety concern at the estimated level of intake based on the MSDI approach |
– 10018 4744‐08‐5 |
||
|
06.084 03 |
1‐Ethoxy‐1‐methoxyethane |
|
Class I | – | No safety concern at the estimated level of intake based on the MSDI approach |
– 10039 10471‐14‐4 |
||
|
07.044 204 |
3‐Penten‐2‐one |
|
Class I | 1.2.1 | Evaluated in FGE.204, additional genotoxicity data required | |||
|
07.050 – |
Acetone |
|
Class I | – | No safety concern at the estimated level of intake based on the MSDI approach |
139 737 67‐64‐1 |
Category 1 (SCF, 1995) No safety concern (JECFA, 2000a) Category A (CoE, 1992) |
Evaluated by JECFA before 2000 – No EFSA consideration required |
|
07.052 – |
Diacetyl |
|
Class II | – | No safety concern at the estimated level of intake based on the MSDI approach |
408 752 431‐03‐8 |
– No safety concern (JECFA, 2000a) Category A (CoE, 1992) |
Evaluated by JECFA before 2000 – No EFSA consideration required |
|
07.053 – |
Butan‐2‐one |
|
Class I | – | No safety concern at the estimated level of intake based on the MSDI approach |
278 753 78‐93‐3 |
Category 1 (SCF, 1995) No safety concern (JECFA, 2000a) Category A (CoE, 1992) |
Evaluated by JECFA before 2000 – No EFSA consideration required |
|
07.054 – |
Pentan‐2‐one |
|
Class I | – | No safety concern at the estimated level of intake based on the MSDI approach |
279 754 107‐87‐9 |
Category 1 (SCF, 1995) No safety concern (JECFA, 2000a) Category A (CoE, 1992) |
Evaluated by JECFA before 2000 – No EFSA consideration required |
|
07.060 – |
Pentan‐2,3‐dione |
|
Class II | – | No safety concern at the estimated level of intake based on the MSDI approach |
410 2039 600‐14‐6 |
– No safety concern (JECFA, 2000a) Category A (CoE, 1992) |
Evaluated by JECFA before 2000 – No EFSA consideration required |
|
07.090 92 |
1‐Hydroxybutan‐2‐one |
|
Class I | – | No safety concern at the estimated level of intake based on the MSDI approach |
1717 11102 5077‐67‐8 |
||
|
07.149 51 |
Cyclopentanone |
|
Class II | – | No safety concern at the estimated level of intake based on the MSDI approach |
1101 11050 120‐92‐3 |
– No safety concern (JECFA, 2002b) – |
|
|
07.169 10 |
1‐Hydroxypropan‐2‐one |
|
Class I | – | No safety concern at the estimated level of intake based on the MSDI approach |
– 11101 116‐09‐6 |
||
|
08.001 – |
Formic acid |
|
Class I | – | No safety concern at the estimated level of intake based on the MSDI approach |
79 1 64‐18‐6 |
Category 1 (SCF, 1995)No safety concern (JECFA, 1999) Category A (CoE, 1992) |
Evaluated by JECFA before 2000 – No EFSA consideration required |
|
08.002 – |
Acetic acid |
|
Class I | – | No safety concern at the estimated level of intake based on the MSDI approach |
81 2 64‐19‐7 |
Category 1 (SCF, 1995) No safety concern (JECFA, 1999) Category A (CoE, 1992) |
Evaluated by JECFA before 2000 – No EFSA consideration required |
|
08.003 – |
Propionic acid |
|
Class I | – | No safety concern at the estimated level of intake based on the MSDI approach |
84 3 79‐09‐4 |
Category 1 (SCF, 1995) No safety concern (JECFA, 1999) Category A (CoE, 1992) |
ADI not limited (JECFA, 1974) Evaluated by JECFA before 2000 – No EFSA consideration required |
|
08.005 – |
Butyric acid |
|
Class I | – | No safety concern at the estimated level of intake based on the MSDI approach |
87 5 107‐92‐6 |
Category 1 (SCF, 1995) No safety concern (JECFA, 1999) Category A (CoE, 1992) |
Evaluated by JECFA before 2000 – No EFSA consideration required |
|
09.001 – |
Ethyl acetate |
|
Class I | – | No safety concern at the estimated level of intake based on the MSDI approach |
27 191 141‐78‐6 |
– No safety concern (JECFA, 1997) Category A (CoE, 1992) |
ADI: 0–25 (JECFA, 1968) Evaluated by JECFA before 2000 – No EFSA consideration required |
|
09.002 – |
Propyl acetate |
|
Class I | – | No safety concern at the estimated level of intake based on the MSDI approach |
126 192 109‐60‐4 |
– No safety concern (JECFA, 1999) Category A (CoE, 1992) |
Evaluated by JECFA before 2000 – No EFSA consideration required |
|
09.004 – |
Butyl acetate |
|
Class I | – | No safety concern at the estimated level of intake based on the MSDI approach |
127 194 123‐86‐4 |
– No safety concern (JECFA, 1999) Category A (CoE, 1992) |
Evaluated by JECFA before 2000 – No EFSA consideration required |
|
09.005 – |
Isobutyl acetate |
|
Class I | – | No safety concern at the estimated level of intake based on the MSDI approach |
137 195 110‐19‐0 |
– No safety concern (JECFA, 1999) Category A (CoE, 1992) |
Evaluated by JECFA before 2000 – No EFSA consideration required |
|
09.023 – |
Methyl acetate |
|
Class I | – | No safety concern at the estimated level of intake based on the MSDI approach |
125 213 79‐20‐9 |
– No safety concern (JECFA, 1999) Category A (CoE, 1992) |
Evaluated by JECFA before 2000 – No EFSA consideration required |
|
09.037 71 |
Ethyl acrylate |
|
Class III | – | No safety concern at the estimated level of intake based on the MSDI approach |
1351 245 140‐88‐5 |
– No safety concern (JECFA, 2005) Category A (CoE, 1992) |
|
|
09.039 – |
Ethyl butyrate |
|
Class I | – | No safety concern at the estimated level of intake based on the MSDI approach |
Category 1 (SCF, 1995) No safety concern (JECFA, 1997) Category A (CoE, 1992) |
ADI: 0–15 (JECFA, 1968). Evaluated by JECFA before 2000 – No EFSA consideration required |
|
|
09.060 – |
Ethyl hexanoate |
|
Class I | – | No safety concern at the estimated level of intake based on the MSDI approach |
31 310 123‐66‐0 |
– No safety concern (JECFA, 1997) Category A (CoE, 1992) |
Evaluated by JECFA before 2000 – No EFSA consideration required |
|
09.072 – |
Ethyl formate |
|
Class I | – | No safety concern at the estimated level of intake based on the MSDI approach |
26 339 109‐94‐4 |
– No safety concern (JECFA, 1997) Category A (CoE, 1992) |
GrADI: 0–3 (JECFA, 1980). Evaluated by JECFA before 2000 – No EFSA consideration required |
|
09.107 – |
Ethyl nonanoate |
|
Class I | – | No safety concern at the estimated level of intake based on the MSDI approach |
34 388 123‐29‐5 |
Category 1 (SCF, 1995) No safety concern (JECFA, 1997) Category A (CoE, 1992) |
ADI: 0–2.5 (JECFA, 1980). Evaluated by JECFA before 2000 – No EFSA consideration required |
|
09.121 – |
Ethyl propionate |
|
Class I | – | No safety concern at the estimated level of intake based on the MSDI approach |
28 402 105‐37‐3 |
– No safety concern (JECFA, 1997) Category A (CoE, 1992) |
Evaluated by JECFA before 2000 – No EFSA consideration required |
|
09.124 – |
Butyl propionate |
|
Class I | – | No safety concern at the estimated level of intake based on the MSDI approach |
143 405 590‐01‐2 |
– No safety concern (JECFA, 1999) Category A (CoE, 1992) |
Evaluated by JECFA before 2000 ‐ No EFSA consideration required |
|
09.134 – |
Methyl propionate |
|
Class I | – | No safety concern at the estimated level of intake based on the MSDI approach |
141 415 554‐12‐1 |
– No safety concern (JECFA, 1999) Category A (CoE, 1992) |
Evaluated by JECFA before 2000 – No EFSA consideration require |
|
09.147 – |
Ethyl valerate |
|
Class I | – | No safety concern at the estimated level of intake based on the MSDI approach |
30 465 539‐82‐2 |
Category 1 (SCF, 1995) No safety concern (JECFA, 1997) Category A (CoE, 1992) |
Evaluated by JECFA before 2000 – No EFSA consideration required |
|
09.248 05 |
Ethyl trans‐2‐butenoate |
|
Class I | – | No safety concern at the estimated level of intake based on the MSDI approach |
– 2244 623‐70‐1 |
– – Category B (CoE, 1992) |
|
|
09.375 05 |
Ethyl methacrylate |
|
Class III | – | No safety concern at the estimated level of intake based on the MSDI approach |
– – 97‐63‐2 |
||
|
09.379 05 |
Ethyl pent‐2‐enoate |
|
Class I | – | No safety concern at the estimated level of intake based on the MSDI approach |
– 10623 2445‐93‐4 |
||
|
09.409 – |
Ethyl 2‐methylbutyrate |
|
Class I | – | No safety concern at the estimated level of intake based on the MSDI approach |
206 265 7452‐79‐1 |
– No safety concern (JECFA, 1999) Category B (CoE, 1992) |
(R) or (S) enantiomer not specified by CASrn in Register Evaluated by JECFA before 2000 – No EFSA consideration required |
|
09.413 – |
Ethyl isobutyrate |
|
Class I | – | No safety concern at the estimated level of intake based on the MSDI approach |
186 288 97‐62‐1 |
– No safety concern (JECFA, 1999) Category A (CoE, 1992) |
Evaluated by JECFA before 2000 – No EFSA consideration required |
|
09.433 64 |
Ethyl lactate |
|
Class I | – | No safety concern at the estimated level of intake based on the MSDI approach |
931 371 97‐64‐3 |
– No safety concern (JECFA, 1999) Category A (CoE, 1992) |
|
|
09.435 – |
Ethyl 4‐oxovalerate |
|
Class I | – | No safety concern at the estimated level of intake based on the MSDI approach |
607 373 539‐88‐8 |
– No safety concern (JECFA, 2000b) Category B (CoE, 1992) |
Evaluated by JECFA before 2000 – No EFSA consideration required |
|
09.442 64 |
Ethyl pyruvate |
|
Class I | – | No safety concern at the estimated level of intake based on the MSDI approach |
938 430 617‐35‐6 |
– No safety concern (JECFA, 2002a) Category B (CoE, 1992) |
|
|
09.444 – |
Diethyl succinate |
|
Class I | – | No safety concern at the estimated level of intake based on the MSDI approach |
617 438 123‐25‐1 |
– No safety concern (JECFA, 2000b) Category B (CoE, 1992) |
Evaluated by JECFA before 2000 – No EFSA consideration required |
|
09.447 – |
Ethyl isovalerate |
|
Class I | – | No safety concern at the estimated level of intake based on the MSDI approach | 196442108‐64‐5 |
– No safety concern (JECFA, 1999) Category B (CoE, 1992) |
Evaluated by JECFA before 2000 – No EFSA consideration required |
|
09.541 – |
Ethyl 3‐methylvalerate |
|
Class I | – | No safety concern at the estimated level of intake based on the MSDI approach |
215 – 5870‐68‐8 |
– No safety concern (JECFA, 1999) – |
(R) or (S) enantiomer not specified by CASrn in Register Evaluated by JECFA before 2000 – No EFSA consideration required |
|
09.642 02 |
Methyl formate |
|
Class I | – | No safety concern at the estimated level of intake based on the MSDI approach |
– 10795 107‐31‐3 |
||
|
13.001 218/66 |
5‐Methylfurfural |
|
Class III | 4.2 | No safety concern at the estimated level of intake based on the MSDI approach. Genotoxicity concern could be ruled out (FGE.218Rev1). |
745 119 620‐02‐0 |
– No safety concern (JECFA, 2001) Category B (CoE, 1992) |
|
|
13.018 218/66 |
Furfural |
|
Class III | 4.2 | No safety concern at the estimated level of intake based on the MSDI approach |
450 2014 98‐01‐1 |
Category 4 (SCF, 1995) No safety concern (JECFA, 2001) Category B (CoE, 1992) |
GrADI: 0–0.5 (JECFA, 2001), (EFSA, 2004) |
|
13.030 – |
2‐Methylfuran |
|
Class III | – | No longer supported by Industry (DG SANCO, 2013b) |
1487 2209 534‐22‐5 |
– No evaluation (JECFA, 2009) Category B (CoE, 1992) |
|
|
13.054 221/67 |
2‐Acetylfuran |
|
Class III | 4.5 | Evaluated in FGE.67Rev1, additional genotoxicity data are required |
1503 11653 1192‐62‐7 |
– No evaluation (JECFA, 2009) – |
|
|
13.122 13 |
Ethyl 2‐furoate |
|
Class III | – | No safety concern at the estimated level of intake based on the MSDI approach |
– 10588 614‐99‐3 |
||
|
13.126 – |
Furfural diethyl acetal |
|
Class III | – | Not in the Union List. EFSA Opinion ‐ Group ADI with furfural |
– – 13529‐27‐6 |
ADI: 0.5 mg/kg bw for furfural and the furfural component of furfural diethylacetal (EFSA, 2004) |
FL‐no: FLAVIS number; FGE: Flavouring Group Evaluation; MSDI: maximised Survey‐derived Daily Intake; ADI: acceptable daily intake.
Category 1: Considered safe in use, Category 2: Temporarily considered safe in use, Category 3: Insufficient data to provide assurance of safety in use, Category 4: Not acceptable due to evidence of toxicity.
No safety concern at estimated levels of intake.
Category A: Flavouring substance, which may be used in foodstuffs, Category B: Flavouring substance which can be used provisionally in foodstuffs.