MCPD-02 Reviewer Forms (July 19, 2018)

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Reviewer 3

LOQ: 2-MCPD esters, 3-MCPD esters, and glycidyl esters: 10 µg/kg (powder), 2 µg/kg (liquid) free 2-MCPD, 3-MCPD: 5 µg/kg (powder), 1 µg/kg (liquid)

Accuracy/Recovery: 91 – 113%

Precision (RSD r

): 1.2 – 1.3% (data supplied only for free 2-MCPD and free 3-MCPD)

Reproducibility (RSD R

): 2.3 – 12%

• System suitability: addressed.

Were the recommendations/comments completed as requested by the ERP?

While the below points have not been fully completed as requested, none of them are serious enough to prevent the method from being advanced to first action official status. • Comments 3 and 25: linearity has been demonstrated separately across partial analytical ranges and not across the entire range (LOQ to upper limit of quantitation). This is not proof that the response factors are constant across the entire analytical range. However other supporting data demonstrate good method performance by the one-point internal calibration approach. • Comment 12: homogeneous distribution of the internal standards does not guarantee quantitative recovery of analytes (as they must be released from the matrix). However other supporting data demonstrate quantitative recovery of fat and analytes.

Recommendation for First Action Official Methods SM status:

I recommend this method for first action official method status.

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