SAMR Releases Q&A Guidance for Infant Formula

China’s SAMR (State Administration of Market Regulation) released Q&A guidance for infant formula recipe registration during the grace period prior to the implementation of new regulations. It is expected that many infant product manufacturers will need to apply for registration alteration. For formulations that will add or remove certain optional ingredients, the existing recipe registration must first be cancelled and followed by registration of the new recipe. For infant products that adjust the recipe to comply with new standards but do not add or remove ingredients, it is necessary to provide product stability research so that a determination can be made in terms of whether to apply for recipe alteration or submit a new recipe registration. The new guidance from SAMR is part of an objective to provide more robust legislation around infant products.

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Posted on 14 July 2021