On 6 May 2011, the Australia and New Zealand Food Regulation Ministerial Council (the Ministerial Council) approved a new policy guideline on the Regulation of Infant Formula Products. This guideline requires a pre-market assessment by Food Standards Australia New Zealand of all substances proposed for use in infant formula that do not have a history of safe use in these products. A pre-market assessment includes the requirement to substantiate the role of the substance in normal infant growth and development. The revised guideline was developed following a public consultation process. The Food Regulation Standing Committee prepared a decision making RIS that was provided to the Ministerial Council when considering the policy guideline. The RIS was assessed as adequate by the Office of Best Practice Regulation.
