Table B.1.
Summary of safety evaluation applying the Procedure (based on intakes calculated by the MSDI approach)
| FL‐no | EU register name | Structural formula | MSDIa (μg/capita per day) | Classb Evaluation procedure pathc | Outcome on the named compoundd , e | Outcome on the material of commercef , g , h | Evaluation remarks |
|---|---|---|---|---|---|---|---|
| 02.077 | Pentan‐3‐ol |
|
0.19 |
Class I A3: intake below threshold |
d | f | |
| 02.124 | 6‐Methylhept‐5‐en‐2‐ol |
|
0.0061 |
Class I A3: intake below threshold |
d | f | |
| 02.142 | 3,3‐Dimethylbutan‐2‐ol |
|
0.24 |
Class I A3: intake below threshold |
d | f | |
| 02.148 | Dodecan‐2‐ol |
|
0.35 |
Class I A3: Intake below threshold |
d | f | |
| 02.177 | 2‐Methylhexan‐3‐ol |
|
0.12 |
Class I A3: Intake below threshold |
d | f | |
| 02.182 | 3‐Methylpentan‐2‐ol |
|
0.12 |
Class I A3: Intake below threshold |
d | f | |
| 02.183 | 4‐Methylpentan‐2‐ol |
|
0.0012 |
Class I A3: Intake below threshold |
d | f | |
| 02.190 | Nonan‐3‐ol |
|
0.011 |
Class I A3: Intake below threshold |
d | f | |
| 02.255 | (Z)‐4‐Hepten‐2‐ol |
|
0.03 |
Class I A3: Intake below threshold |
d | f | |
| 07.084 | Pentan‐3‐one |
|
0.24 |
Class I A3: Intake below threshold |
d | f | |
| 07.178 | 3‐Methylbutan‐2‐one |
|
0.073 |
Class I A3: Intake below threshold |
d | f | |
| 07.239 | [R‐(E)]‐5‐Isopropyl‐8‐methylnona‐6,8‐dien‐2‐one |
|
0.24 |
Class I A3: Intake below threshold |
d | f | |
| 09.304 | sec‐Heptyl isovalerate |
|
0.0012 |
Class I A3: Intake below threshold |
d | f | |
| 09.323 | sec‐Butyl acetate |
|
0.0012 |
Class I A3: Intake below threshold |
d | f | |
| 09.325 | sec‐Butyl butyrate |
|
1.3 |
Class I A3: Intake below threshold |
d | f | |
| 09.328 | sec‐Butyl formate |
|
0.12 |
Class I A3: Intake below threshold |
d | f | |
| 09.332 | sec‐Butyl hexanoate |
|
0.024 |
Class I A3: Intake below threshold |
d | f | |
| 09.386 | sec‐Hept‐4(cis)‐enyl acetate |
|
0.024 |
Class I A3: Intake below threshold |
d | f | |
| 09.388 | sec‐Heptyl acetate |
|
0.12 |
Class I A3: Intake below threshold |
d | f | |
| 09.391 | sec‐Heptyl hexanoate |
|
0.12 |
Class I A3: Intake below threshold |
d | f | |
| 09.604 | Isopropyl decanoate |
|
0.12 |
Class I A3: Intake below threshold |
d | f | |
| 09.605 | Isopropyl dodecanoate |
|
0.12 |
Class I A3: Intake below threshold |
d | f | |
| 09.606 | Isopropyl hexadecanoate |
|
0.012 |
Class I A3: Intake below threshold |
d | f | |
| 09.608 | Isopropyl octanoate |
|
1.3 |
Class I A3: Intake below threshold |
d | f | |
| 09.609 | Isopropyl valerate |
|
0.012 |
Class I A3: Intake below threshold |
d | f | |
| 09.676 | sec‐Octyl acetate |
|
0.011 |
Class I A3: Intake below threshold |
d | f | |
| 09.880 | (Z)‐Hept‐4‐enyl‐2 |
|
0.79 |
Class I A3: Intake below threshold |
d | f | |
| 09.926 | Octan‐3‐yl formate |
|
0.24 |
Class I A3: Intake below threshold |
d | f | |
| 02.131 | But‐3‐en‐2‐ol |
|
0.0012 |
Class II A3: Intake below threshold |
d | f | |
| 02.145 | 2,6‐Dimethylocta‐1,5,7‐trien‐3‐ol |
|
0.0085 |
Class II A3: Intake below threshold |
d | f | |
| 02.187 | Non‐1‐en‐3‐ol |
|
0.58 |
Class II A3: Intake below threshold |
d | f | |
| 02.194 | Octa‐1,5‐dien‐3‐ol |
|
0.061 |
Class II A3: Intake below threshold |
d | f | |
| 02.211 | Undeca‐1,5‐dien‐3‐ol |
|
0.061 |
Class II A3: Intake below threshold |
d | f | |
| 07.072 | 6‐Methylheptan‐3‐one |
|
0.19 |
Class II A3: Intake below threshold |
d | f | |
| 07.150 | Decan‐2‐one |
|
0.52 |
Class II A3: Intake below threshold |
d | f | |
| 07.156 | 2,6‐Dimethyloct‐6‐en‐3‐one (mixture of E and Z) |
|
0.0012 |
Class II A3: Intake below threshold |
d | f | |
| 07.157 | 6,10‐Dimethylundecan‐2‐one |
|
0.085 |
Class II A3: Intake below threshold |
d | f | |
| 07.158 | Dodecan‐2‐one |
|
0.73 |
Class II A3: Intake below threshold |
d | f | |
| 07.160 | Heptadecan‐2‐one |
|
0.12 |
Class II A3: Intake below threshold |
d | f | |
| 07.161 | Hex‐1‐en‐3‐one |
|
0.012 |
Class II A3: Intake below threshold |
d | f | |
| 07.162 | Hex‐5‐en‐2‐one |
|
0.049 |
Class II A3: Intake below threshold |
d | f | |
| 07.181 | 6‐Methylheptan‐2‐one |
|
0.0012 |
Class II A3: Intake below threshold |
d | f | |
| 07.185 | 3‐Methylpentan‐2‐one |
|
1.2 |
Class II A3: Intake below threshold |
d | f | |
| 07.189 | Nonan‐4‐one |
|
0.52 |
Class II A3: Intake below threshold |
d | f | |
| 07.198 | Pseudo‐ionone |
|
0.12 |
Class II A3: Intake below threshold |
d | f | |
| 07.199 | Tetradecan‐2‐one |
|
0.073 |
Class II A3: Intake below threshold |
d | f | |
| 07.201 | Tridec‐12‐en‐2‐one |
|
0.024 |
Class II A3: Intake below threshold |
d | f | |
| 07.204 | 3,3,6‐Trimethylhepta‐1,5‐dien‐4‐one |
|
0.012 |
Class II A3: Intake below threshold |
d | f | |
| 07.205 | 6,10,14‐Trimethylpentadecan‐2‐one |
|
0.0073 |
Class II A3: Intake below threshold |
d | f | |
| 07.210 | 1‐Nonene‐3‐one |
|
0.0012 |
Class II A3: Intake below threshold |
d | f | |
| 07.236 | (Z)‐5‐Octen‐2‐one |
|
0.0097 |
Class II A3: Intake below threshold |
d | f | |
| 07.262 | 9‐Decen‐2‐one |
|
73 |
Class II A3: Intake below threshold |
d | f | |
| 07.182 | 5‐Methylheptan‐3‐one |
|
0.32 |
Class II B3: Intake below threshold B4: Adequate NOAEL exists |
d | f | NOAEL for neurotoxicity: 82 mg/kg bw per day |
MSDI: Maximised Survey‐derived Daily Intake; NOAEL: no observed adverse effect level; bw: body weight.
EU MSDI: Amount added to food as flavour in (kg/year) × 10E9/(0.1 × population in Europe (= 375 × 10E6) × 0.6 × 365) = μg/capita per day.
Thresholds of concern: Class I = 1,800 μg/person per day, Class II = 540 μg/person per day, Class III = 90 μg/person per day.
Procedure path A substances can be predicted to be metabolised to innocuous products. Procedure path B substances cannot.
No safety concern based on intake calculated by the MSDI approach of the named compound.
Data must be available on the substance or closely related substances to perform a safety evaluation.
No safety concern at the estimated level of intake of the material of commerce meeting the specification requirement (based on intake calculated by the MSDI approach).
Tentatively regarded as presenting no safety concern (based on intake calculated by the MSDI approach) pending further information on the purity of the material of commerce and/or information on stereoisomerism.
No conclusion can be drawn due to lack of information on the purity of the material of commerce.