SPIFAN Stakeholder Panel (September 23, 2017)

4. Method Performance Requirements:

84 85 86

3-MCPD

3-MCPD * in dry infant formula samples (powder)

3-MCPD* in liquid infant formula samples

Analytical range

25 – ≥ 1000 µg/kg

3 – ≥ 120 µg/kg

LOD LOQ

N/A

N/A

≤ 25 µg/kg 70-125 %

≤ 3 µg/kg 70-125 %

Accuracy

% RSD r

≤ 22 %

≤ 22 % ≤ 44 %

25-100 µg/kg

> 100 µg/kg

%RSD R

≤ 44% ≤ 25% * overall analyte content resulting either from separate or from combined determination of free 3-MCPD and bound 3-MCPD.

87 88 89 90

2-MCPD

2-MCPD ** in dry infant formula samples (powder)

2-MCPD** in liquid infant formula samples 3 – ≥ 60 µg/kg

25 – ≥ 500 µg/kg

Analytical range

LOD

N/A

N/A

≤ 25 µg/kg

≤ 3 µg/kg

LOQ

Accuracy

70-125 %

70-125 %

% RSD r

≤ 22 %

≤ 22 %

25-100 µg/kg

> 100 µg/kg

%RSD R

≤ 44 %

≤ 44 %

≤ 25 %

** overall analyte content resulting either from separate or from combined determination of free 2-MCPD and bound 2-MCPD.

91

3