Review Team (February 2016)

Bio-03 (February 2016) FOR ERP USE ONLY DO NOT DISTRIBUTE

Table 4

Precision - repeatability.

Nr. replicates (n) (Duplicates on 3 or 6 days)

Conc. Level (mcg/100g liquid)

Product

Conc. Level

SPIFAN Code

Analyte

REQUIREMENTS SMPR

RSDr b

RSD iR

RSDr

RSD iR

Child Formula Powder, placebo Infant Elemental Powder, Placebo

00847RF00 00796RF00 00821RF00 00820RF00

Biotin Biotin Biotin Biotin Biotin Biotin Biotin Biotin Biotin Biotin Biotin Biotin Biotin Biotin Biotin Biotin Biotin Biotin Biotin

6 6 6 6 6

Not detected Not detected Not detected Not detected Not detected

NA NA NA NA NA 1.5 0.5 0.5 1.9 2.5 0.7 1.2 1.9 2.6 1.2 3.0 1.7 1.0 0.6

NA NA NA NA NA 2.6 1.6 1.3 4.5 3.3 2.8 1.8 4.5 4.1 3.0 4.0 4.1 3.4 3.1

(mcg/100g liquid)

≤ Z % ≤ W %

Biotin Biotin

0.1-1

≤ 8 ≤ 6

Adult Nutritional RTF High Protein, placebo Adult Nutritional RTF High Fat, placebo Infant Formula RTF Milk Based, Placebo

>1

EV4H2Q CLC10-b

22.4 a 4.07 4.43 10.7 2.90 31.9 21.6 10.7 1.66 5.11 5.15 3.86 56.8 76.2

SRM 1849a

12 12 12 12 12 12 12 12 12 12 12 12 12 12

Infant Formula Powder Partially Hydrolyzed Milk Based Infant Formula Powder Partially Hydrolyzed Soy Based

410057652Z 410457651Z 4052755861 4044755861 00859RF00 00866RF00 00795RF00 50350017W1

Toddler Formula Powder Milk-Based Infant Formula Powder Milk Based Adult Nutritional Powder Low Fat

Child Formula Powder Infant Elemental Powder

Infant Formula Powder FOS/GOS Based Infant Formula Powder Milk Based Infant Formula Powder Soy Based Infant Formula RTF Milk Based Adult Nutritional RTF High Protein Adult Nutritional RTF High Fat

K16NTAV E10NWZC

EV4H2R

00730RF00 00729RF00

Global Mean %

1.5

3.2

a. Results reported as mg/kg powder to be consistant with COA. b. The largest RSDr among the 6 days.

SPIFAN ERP X Checklist v 1.0