Table 16.
Nutritional analysis of the NF
| Parameter (unit) | Batch number | Method of analysis | ||||
|---|---|---|---|---|---|---|
|
#1 |
#2 |
#3 |
#4 |
#5 |
||
| Calories (kcal/100 g) |
364.4 |
364.8 |
363.5 |
366.0 |
358.3 | Calculation |
| Monounsaturated fat (g/100 g) | < 0.10 |
< 0.10 |
< 0.10 |
< 0.10 |
< 0.10 |
AOAC 996.06 |
| Polyunsaturated fat (g/100 g) |
2.11 |
1.98 |
2.02 | 2.03 | 2.06 | |
| Saturated fat | 0.62 | 0.58 | 0.58 | 0.59 | 0.58 | |
| Trans fat (g/100 g) | < 0.10 | < 0.10 | < 0.10 | < 0.10 | < 0.10 | |
| Cholesterol (mg/100 g) | < 0.8 | < 1.0 | < 1.0 | < 1.0 | < 1.0 | Direct saponification‐GC/FID method (AOAC 994.10) |
| Glucose (g/100 g) | 1.30 | 1.40 | 0.94 | 1.90 | 1.60 | LC/RI (AOAC 980.13) |
| Sodium (mg/100 g) | 97.1 | 108 | 103 | 99.5 | 104 |
ICP‐AES (AOAC 984.27) |
| Potassium (mg/100 g) | 4,310 | 4,170 | 3,890 | 3,910 | 3,990 | |
| Calcium (mg/100 g) | 76.9 | 72.4 | 69.1 | 69.2 | 73.3 | |
| Iron (mg/100 g) | 2.7 | 5.6 | 2.9 | 4.9 | 3.3 | |
| Moisture (g/100 g) | 3.15 | 2.73 | 3.35 | 2.71 | 4.41 | Gravimetry, (AOAC 926.08) |
| Ash (g/100 g) | 9.45 | 9.47 | 9.32 | 9.28 | 9.59 | Gravimetry (AOAC 945.46) |
| Vitamin D2 (μg/g) 1 | 250 | 268.05 | 160.16 | 128.39 | 342.22 |
UHPLC‐MS/MS (AOAC 2011.11 Mod) |
| Vitamin D3 (μg/g) | N.A | < 0.0055 | < 0.0055 | < 0.0055 | < 0.0055 | |
AOAC: Association of Official Analytical Chemists; GC/FID: Gas Chromatography/Flame Ionisation Detection; LC/RID: Liquid Chromatography/Refractive Index Detection; ICP‐AES: Inductively Coupled Plasma – Atomic Emission Spectroscopy; UHPLC‐MS/MS: Ultra high performance liquid chromatography‐mass spectrometry tandem mass spectrometry; N.A: not analysed.
The applicant provided 2 sets of batch‐to‐batch analyses on the vitamin D2 content in the NF performed by different laboratories using different methods of analysis (HPLC‐DAD and UHPLC‐MS/MS (AOAC 2011.11 Mod)). Considering that all 10 batches are produced with the same production process and vitamin D2 content is within the specifications range, all 10 batches are representative of the final ingredient. Therefore, the applicant indicates that all 10 analyses should be considered for the risk assessment.