SPIFAN Stakeholder Panel (March 15, 2017)

GB Analytical Methods (1)

• Most current GB analytical methods for infant formulas are: Either modified from or replacing existing methods Reviewed and updated every 5 years

• The methods are assigned (after evaluating applications) with government budget, developed and have to be submitted by Chinese government labs through a special government channel for guaranteed objectiveness and fairness. • Submitted methods will be evaluated by a group of experts (same as ERP), and finally approved by an administrative authority body.

March 14, 2017

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• Submitted methods should be scientifically sound with literature sources; not conflict, cross and overlap with other current regulations and GBs. • Submitted methods should be compared to national and international related standard methods; similarity and differences should be detailed. If differences exist, a scientific explanation is needed. • If the method is innovative, 3 qualified labs (other than submitter) are needed for the validation; • If the method is the same level as the international standard, 1 lab is needed for the validation; • If the method is a modification from an international standard, at least 1 more lab (other than the submitter) is needed for the validation. GB Analytical Methods (2)

March 14, 2017

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