SPIFAN Stakeholder Panel (March 14, 2018)

Memorandum Date:

November 16, 2017

To:

Fluoride Working Group

Re: Revisions to Method Performance Table in SMPR 2014.016 The current LOQ requirement of 5 µg / 100g specified in SMPR 2014.016, Determination of Fluoride in Infant and Adult/Pediatric Nutritional Formula (attachment 1) is proving difficult to achieve with current technology. Codex Standard 72 – 1981 specifies a maximum level of fluoride of 100 µg / 100Kcal, which is equivalent to 65 µg / 100g. Methods with LOQs higher than 5 µg / 100g could still be useful for the determination of fluoride. The Fluoride Working Group proposes to: 1) adjust the LOQ from 5 µg / 100g to 30µg / 100g; 2) adjust the lower range band [for recovery, RSDr, and RSDR] from 5 – 25 µg / 100g to 30 - 100 µg / 100g. 3) adjust the upper range band [for recovery, RSDr, and RSDR] from 100 µg / 100g to 200 µg / 100g.

30 – 200*

Analytical Range Limit of Quantitation

30*

Ranges

Parameter

30 - 100* 80 – 120

>100*

Recovery (%)

90 – 110

% RSD r % RSD R

≤ 8

≤ 5

≤ 15

≤ 10

* µg/100g.

Concentrations apply to: a) ‘ready-to-feed” liquids “as is”; b) re- constituted powders (25 g into 200 g of deionized water); and c) liquid concentrates diluted 1:1 by weight with deionized water.

Summary of Next Steps: 1) Review cleaned up table with Fluoride Working Group. Soon. 2) Revise SMPR 2014.016. December 2017.

3) Post on AOAC website for public comment. January 2018. 4) Collect, compile and address public comments. Feb 2018. 5) Present proposed revisions to SMPR 2014.016 to SPIFAN in during the March 2018 mid-year meeting.