Table 1.
Compound | Acceptance criteria (USP [9]) | Current criteria (HC [11])* | Current criteria (US-FDA [39]) | Revised criteria (FCC [73])** | Recall incidents in Canada (7/20 to 1/21 [80]) | Recall incidents in US (7/20 to 1/21 [81]) |
---|---|---|---|---|---|---|
Methanol | ≤200 μL/L | ≤200 μL/L | ≤630 μL/L | ≤200 μL/L | 19 | 165 |
Acetaldehyde and acetal | ≤10 μL/L | ≤400 μL/L | ≤50 μL/L | ≤1000 μL/L | 0 | 0 |
Benzene | ≤2 μL/L | ≤2 μL/L | ≤2 μL/L | ** | 0 | 0 |
All other impurities (summed) | ≤300 μL/L | ≤300 μL/L | ≤300 μL/L | ≤5000 μL/L | 62 (Ethyl acetate, 1-propanol) | 3 (1-propanol) |
The criteria are based off the range of acetaldehyde that is currently found in samples from ethanol producers that were submitted to HC for risk assessment. These criteria have decreased over time as distillation methods improve.
The revised FCC criteria now includes limitations of individual volatile organic impurities at 1000 μL/L and a limit of 5000 μL/L of the sum of all impurities. However, benzene is not specifically mentioned.