AOAC SPIFAN Stakeholder Panel Meeting Book (September 7, 2019)

Response - Specialized Nutrition Europe (SNE)

133 rd Annual Meeting & Exposition | Denver, Colorado | September 6-12, 2019 • Reference to AOAC SMPR 2011.004, the Standard Method Performance Requirements for Vitamin D in Infant Formula. • Predicted estimated non-compliance with published RSD R . • Probability of non-compliance will increase further when other variabilities (i.e. process variability & loss over shelf-life) are taken into consideration. • Management of nutrient levels and of vitamin D in IF were addressed in detail during the revision of the Codex Standard for IF (CODEX STAN 72-1981). A review of actual nutrient levels was conducted by IF manufacturers — and resulted in the setting of a maximum for vitamin D at 3.0 ȝJ/100 kcal. • Vitamin D range of at least 1.0 P g/100 kcal between the minimum and maximum value rather than 0.5 P g/100kcal, will reduce the probability of non-compliance. † Commission Delegated Regulation (EU) 2016/127 establishes a Vitamin D range of 2-3 P g/100kcal for infant formula. — W.C. MacLean Jr. et al. / Journal of Food Composition and Analysis 23 (2010) 44–53 Final Action Method Performance • $W OHYHO RI FRQILGHQFH QRQH RI WKH VDPSOHV WHVWHG GXULQJ WKH 0/7 of AOAC 2016.05 demonstrated method precision necessary to meet the requirements based upon Delegated Regulation (EU) 2019/828. • The average reproducibility obtained for a selected range of product tested as part of the MLT of AOAC 2016.05 was between 6.4- RSD R . A product manufactured with a true vitamin D level at exactly the middle of the regulatory range would fail to meet these regulatory UHTXLUHPHQW DSSUR[LPDWHO\ EHWZHHQ DQG RI WKH WLPH • Given the extremely tight regulatory limits, and based upon experience testing vitamin D, there is unlikely to be any method currently available that would have precision significantly better than AOAC 2016.05. Summary / Looking Forward

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133 rd Annual Meeting & Exposition | Denver, Colorado | September 6-12, 2019