Table 1b.
Batch to batch analysis of the NF (40% standard)
| Parameter (unit) | Batch number | |||||
|---|---|---|---|---|---|---|
| PB15232.3 | PB16940715 | NS‐8107.2 | PB19284.L | NS‐9127 | NS‐9126 | |
| Fatty acids (%FA) | ||||||
| Myristic – 14:0 | 0.5 | 0.5 | 0.7 | 0.7 | 0.7 | 0.7 |
| Pentadecanoic – 15:0 | 0.1 | 0.1 | 0.1 | 0.3 | 0.1 | 0.1 |
| Palmitic – 16:0 | 26.9 | 21.9 | 33.2 | 22.7 | 23.2 | 22.3 |
| Palmitoleic – 16:1 (hexadecenoic 16:1 total) | 0.2 | 0.3 | 0.2 | 0.3 | 0.3 | 0.3 |
| Margaric – 17:0 | 0.1 | 0.1 | 0.1 | 0.2 | 0.2 | 0.1 |
| Heptadecenoic – 17:1 | 0.2 | 0.3 | 0.2 | – | 0.1 | 0.3 |
| Stearic – 18:0 | 1.8 | 1.5 | 1.5 | 1.5 | 1.4 | 1.3 |
| Oleic – 18:1(n‐9) | 15.9 | 12.3 | 4.3 | 16.5 | 13.4 | 13 |
| Cis‐vaccenic – 18:1(n‐7) | 0.3 | 0.3 | 0.2 | 0.4 | 0.4 | 0.4 |
| Linoleic – 18:2(n‐6) | 2.5 | 2.3 | 0.5 | 0.7 | 1.9 | 1.8 |
| γ‐Linolenic – 18:3(n‐6) | 0.1 | 0.1 | 0.1 | 0.1 | 0.1 | 0.1 |
| α‐Linolenic – 18:3(n‐3) | 0.1 | 0.2 | 0.1 | 0.1 | 0.1 | 0.2 |
| Stearidonic –18:4(n‐3) | 0.1 | 0.2 | 0.2 | 0.2 | 0.2 | 0.2 |
| Arachidic – 20:0 | 0.2 | 0.2 | 0.2 | 0.2 | 0.2 | 0.2 |
| Icosenoic – 20:1 TOTAL | 0.1 | – | – | 0.1 | 0.1 | – |
| Eicosatrienoic 20:3(n‐3) | – | – | – | – | – | – |
| Homo‐γ‐linolenic – 20:3(n‐6) | 0.1 | 0.1 | 0.2 | 0.1 | 0.1 | 0.2 |
| Arachidonic – 20:4(n‐6) | – | 0.6 | – | – | – | – |
| Icosatetraenoic – 20:4(n‐3) | 0.4 | 0.6 | 0.6 | 0.6 | 0.6 | 0.6 |
| Eicosapentaenoic (EPA) – 20:5(n‐3) | 0.5 | 0.5 | 0.6 | 0.6 | 0.6 | 0.6 |
| Behenic – 22:0 | 0.3 | 0.2 | 0.2 | 0.3 | 0.3 | 0.2 |
| Docosatetraenoic – 22:4(n‐6) | – | – | – | – | – | – |
| Docosapentaenoic (DPA) – 22:5(n‐6) | 7.5 | 9.4 | 10.4 | 8.3 | 9.0 | 10.0 |
| Docosapentaenoic – 22:5(n‐3) | 0.1 | 0.1 | 0.1 | 0.1 | 0.1 | 0.1 |
| Docosahexaenoic (DHA) – 22:6(n‐3) | 40.5 | 46.3 | 44.7 | 43.5 | 44.9 | 45.3 |
| Tetracosanoic – 24:0 | – | 0.1 | – | – | – | – |
| Minors (others in very low levels) | 1.5 | 1.8 | 1.6 | 2.5 | 2.0 | 2.0 |
| Free fatty acids | 0.04 | 0.06 | 0.06 | 0.04 | 0.11 | 0.07 |
| Trans fatty acids | < 0.4 | < 0.4 | < 0.4 | < 0.4 | < 0.4 | < 0.4 |
| Sterols | ||||||
| Total sterol content (mg/kg) | 4,037.5 | 5,097.0 | 3,470.3 | 4,510.7 | 3,659.1 | 4,473.2 |
| Cholesterol (%) | 66.0 | 70.8 | 63.9 | 62.2 | 65.8 | 69.1 |
| Brassicasterol (%) | 2.0 | 2.4 | 3.6 | 3.8 | 3.1 | 2.6 |
| Stigmasterol (%) | 6.5 | 5.2 | 17.7 | 11 | 8.4 | 6.9 |
| Beta‐sitosterol (%) | 12.8 | 7.4 | 6.6 | 12.1 | 8.7 | 7.6 |
| Delta‐5‐avenasterol (%) | 1.6 | 1.4 | 0.9 | 1.1 | 1.9 | 1.5 |
| Delta‐5‐campesterol (%) | 1.8 | 1.7 | 2.0 | 3.1 | 2.0 | 2.1 |
| Delta‐7‐stigmasterol (%) | 7.0 | 9.6 | 4.6 | 6.0 | 9.3 | 8.3 |
| Delta‐7‐avenasterol (%) | 2.3 | 1.5 | 0.7 | 0.7 | 0.8 | 1.9 |
| Metals (mg/kg) | ||||||
| Mercury | < 0.005 | < 0.005 | < 0.005 | < 0.005 | < 0.005 | < 0.005 |
| Cadmium | < 0.005 | < 0.005 | < 0.005 | < 0.005 | < 0.005 | < 0.005 |
| Arsenic | < 0.01 | < 0.01 | < 0.01 | < 0.01 | < 0.01 | < 0.01 |
| Lead | < 0.01 | < 0.01 | < 0.01 | < 0.01 | < 0.01 | < 0.01 |
| Copper | < 0.01 | < 0.01 | < 0.01 | < 0.01 | < 0.01 | < 0.01 |
| Iron | < 0.1 | < 0.1 | < 0.1 | < 0.1 | < 0.1 | < 0.1 |
| Tin | < 0.01 | < 0.01 | < 0.01 | < 0.01 | < 0.01 | < 0.01 |
| Aluminium | 0.02 | 0.03 | < 0.02 | < 0.02 | < 0.02 | < 0.02 |
| Phosphorous | < 1 | ‐ | < 1 | < 1 | < 1 | < 1 |
| Nickel | < 0.01 | < 0.01 | < 0.01 | < 0.01 | < 0.01 | < 0.01 |
| Microbiological analysis (CFU/g) | ||||||
| Total plate count 30°C (ISO 4833‐1) | < 10 | < 40a | < 40a | < 10 | < 10 | < 10 |
| Moulds | < 10 | < 10 | < 10 | < 10 | < 10 | < 10 |
| Yeasts | < 10 | < 10 | < 10 | < 10 | < 10 | < 10 |
| Coliforms 30°C (ISO 4832) | < 10 | < 10 | < 10 | < 10 | < 10 | < 10 |
| E. coli detection (ISO 16649‐3) | Absence/1 g | Absence/1 g | Absence/1 g | Absence/1 g | Absence/1 g | Absence/1 g |
| Staphylococcus aureus detection (ISO 6888‐3) | Absence/1 g | Absence/1 g | Absence/1 g | Absence/1 g | Absence/1 g | Absence/1 g |
| Sulfite reducing anaerobic bacteria (ISO 15213) | < 10 | < 10 | < 10 | < 10 | < 10 | < 10 |
| Bacillus cereus (ISO 7932) | < 50 | < 50 | < 50 | < 50 | < 50 | < 50 |
| Salmonella detection (real‐time PCR eq. ISO 6579) | Absence/25 g | Absence/25 g | Absence/25 g | Absence/25 g | Absence/25 g | Absence/25 g |
| Listeria monocytogenes detection (ISO 11290‐1) | Absence/25 g | Absence/25 g | Absence/25 g | Absence/25 g | Absence/25 g | Absence/25 g |
| Cronobacter spp detection (q PCR eq. ISO 22964) | Absent/10 g | Absent/10 g | Absent/10 g | Absent/10 g | Absent/10 g | Absent/10 g |
| Enterobacteria detection (ISO 21528‐1) | Absent/10 g | Absent/10 g | Absent/10 g | Absent/10 g | Absent/10 g | Absent/10 g |
| Mycotoxins (μg/kg) | ||||||
| Aflatoxin M1b | < 0.05 | < 0.05 | < 0.05 | < 0.05 | < 0.05 | < 0.05 |
| Aflatoxin B1 | < 0.07 | < 0.07 | < 0.07 | < 0.07 | < 0.07 | < 0.07 |
| Aflatoxin B2 | < 0.5 | < 0.5 | < 0.5 | < 0.5 | < 0.5 | < 0.5 |
| Aflatoxin G1 | < 0.5 | < 0.5 | < 0.5 | < 0.5 | < 0.5 | < 0.5 |
| Aflatoxin G2 | < 0.5 | < 0.5 | < 0.5 | < 0.5 | < 0.5 | < 0.5 |
| Fumonisin B1 | < 1 | < 1 | < 1 | < 1 | < 1 | < 1 |
| Fumonisin B2 | < 2 | < 2 | < 2 | < 2 | < 2 | < 2 |
| Fumonisin (sum of B1+B2) | < 3 | < 3 | < 3 | < 3 | < 3 | < 3 |
| T‐2 Toxin | < 20 | < 20 | < 20 | < 20 | < 20 | < 20 |
| HT‐2 Toxin | < 20 | < 20 | < 20 | < 20 | < 20 | < 20 |
| Nivalenol | < 200 | < 200 | < 200 | < 200 | < 200 | < 200 |
| Ochratoxin A | < 0.05 | < 0.05 | < 0.05 | < 0.05 | < 0.05 | < 0.05 |
| Patulin | < 100 | < 100 | < 10 | < 10 | < 10 | < 10 |
| Deoxynivalenol | < 5 | < 5 | < 5 | < 5 | < 5 | < 5 |
| Zearalenone | < 1 | < 1 | < 1 | < 1 | < 1 | < 1 |
| PCB and dioxins (upper bound results) | ||||||
| Sum of dioxins and furans (PCDD/F TEQ) (pg/g) | 0.021 | 0.021 | 0.023 | 0.021 | 0.021 | 0.021 |
| Sum of dioxins, furans and dl‐PCBs (total TEQ) (pg/g) | 0.024 | 0.024 | 0.026 | 0.024 | 0.024 | 0.024 |
| PCB (sum 6 ndl‐PCBs) (ng/g) | < 0.150 | < 0.150 | < 0.150 | < 0.150 | < 0.150 | < 0.150 |
| Polycyclic aromatic hydrocarbons (μg/kg) | ||||||
| Benzoapyrene | < 0.1 | < 0.1 | < 0.1 | < 0.1 | < 0.1 | < 0.1 |
| Benzoaanthracene | < 0.1 | < 0.1 | 0.2 | < 0.1 | < 0.1 | < 0.1 |
| Chrysene | < 0.1 | < 0.1 | 0.1 | < 0.1 | < 0.1 | < 0.1 |
| Benzob‐fluoranthene | < 0.1 | < 0.1 | < 0.1 | < 0.1 | < 0.1 | < 0.1 |
| Sum | < 0.4 | < 0.4 | < 0.5 | < 0.4 | < 0.4 | < 0.4 |
| Pesticides | ||||||
| Multiresidues GC 150 | ND | ND | ND | ND | ND | ND |
| Multiresidues LC 150 | ND | ND | ND | ND | ND | ND |
| Process formed contaminants | ||||||
| Glycidyl fatty acid esters expressed as glycidiol (μg/kg)c | 70 | 81 | < 50 | < 50 | < 50 | < 50 |
| Sum of 3‐MCPD and 3‐MCPD fatty acid esters, expressed as 3‐MCPD(μg/kg)d | 214 | 380 | < 50 | < 50 | < 50 | < 50 |
| Marine biotoxins | ||||||
| Domoic acid (mg/kg) | NA | < 5 | < 5 | < 5 | < 5 | < 5 |
| Okadaic acid (μg/kg) | NA | < 40 | < 40 | < 40 | < 40 | < 40 |
| Dinophysistoxin‐1 (μg/kg) | NA | < 40 | < 40 | < 40 | < 40 | < 40 |
| Dinophysistoxin‐2 (μg/kg) | NA | < 40 | < 40 | < 40 | < 40 | < 40 |
| Pectenotoxin‐2 (μg/kg) | NA | < 40 | < 40 | < 40 | < 40 | < 40 |
| Yessotoxin (μg/kg) | NA | < 125 | < 125 | < 125 | < 125 | < 125 |
| Homo yessotoxin (μg/kg) | NA | < 125 | < 125 | < 125 | < 125 | < 125 |
| Azaspiracid‐1 (μg/kg) | NA | < 40 | < 40 | < 40 | < 40 | < 40 |
| Azaspiracid‐2 (μg/kg) | NA | < 40 | < 40 | < 40 | < 40 | < 40 |
| Azaspiracid‐3 (μg/kg) | NA | < 40 | < 40 | < 40 | < 40 | < 40 |
| 13‐desmethyl spirolide C (μg/kg) | NA | < 100 | < 100 | < 100 | < 100 | < 100 |
| Gymnodimine (μg/kg) | NA | < 50 | < 50 | < 50 | < 50 | < 50 |
| Pinnatoxin G (μg/kg) | NA | < 25 | < 25 | < 25 | < 25 | < 25 |
NA: not analysed; ND: Not detected; 3‐MCPD: 3‐monochloro‐propanol‐1,2‐diol.
a
Total plate count at 30°C was detected but at levels lower than 40 CFU/g.
b
It is noted that aflatoxin M1 in infant formulae (IF) should not exceed 0.025 μg/kg while an LOQ of 0.05 μg/kg was used to perform the analysis. Nevertheless, considering the incorporation rate of the NF in IF (max 87.5 mg NF/100 mL), the limit of 0.025 μg/kg in IF is expected to be respected.
c
It is noted that glycidyl fatty acid esters in infant formulae (IF) should not exceed the maximum level (ML) of 6 μg/kg for liquid IF and FOF while a max concentration of 81 μg/kg was found in batch PB16940715. However, considering the incorporation rate of the NF in IF (max 87.5 mg NF/100 mL), the ML of 6 μg/kg in IF is expected to be respected.
d
It is noted that the sum of 3‐MCPD and 3‐MCPD esters, expressed as free 3‐MCPD in IF should not exceed the maximum level (ML) of 15 μg/kg for liquid IF and FOF while a max concentration of 380 μg/kg (sum expressed as 3‐MCPD) was found in batch PB16940715. However, considering the incorporation rate of the NF in IF (max 87.5 mg NF/100 mL), the ML of 15 μg/kg in IF is expected to be respected.