OMB Meeting Book - Jan. 11, 2018

2016.03 (Nov. 2017) - Chlor-02/04 Final Action Review FOR ERP USE ONLY DO NOT DISTRIBUTE

Statistical evaluation: After data collection, outliers were detected using Cochran and Grubbs tests. Average concentrations, standard deviations and relative standard deviations of repeatability (S r and RSD r ) were estimated from the blind duplicates. Standard deviations of reproducibility (S R ), relative standard deviations of reproducibility (RSD R ) and HorRat (Horwitz ratio) values (RSD R /predicted RSD R ) were also estimated. Details on statistical analysis can be found in the “Appendix D: Guidelines for Collaborative Study Procedures To Validate Characteristics of a Method of Analysis” of the Official Methods of Analysis of AOAC [4]. Results and Discussion Twenty six laboratories initially agreed to participate to the collaborative study. One laboratory dropped out during Part 1 due to time availability. Nine laboratories were un- able to receive samples due to customs. The remaining 16 laboratories set up the method as described in the protocol for both Part 1 and 2. Four laboratories used the additional protein precipitation steps (F. d-f) based on regional requirements. After data compilation, average and standard deviation of repeatability and reproducibility were calculated. Conclusions The precision figures obtained during this collaborative study show that method 2016.03 complies with the requirements set in the corresponding SMPR, and thus, it is fit for purpose for the analysis of chloride in milk, milk products, infant formula and adult/pediatric nutritionals. These data were submitted to the SPIFAN ERP (Expert Review

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