The State Administration for Market Regulation ("SAMR") has recently drafted and issued the Administrative Measures for Registration of Formulas of Infant Formula Powder Products (Draft for Comment) (the "Draft for Comment") for public comment by July 25, 2019.
According to the Draft for Comment, the revised measures highlight revisions in five respects as below. The first is further tightening registration of formulas. The second is further ramping up punishment against violations. The third is further implementing requirements for "the reform of delegating powers, strengthening administration and improving services". The fourth is providing further clarity on duties, procedures and time limits. And the fifth is adjusting the names of relevant functional departments and the wording. The Draft for Comment requires that applicants shall have in place complete production techniques, enumerates seven circumstances under which registration applications will be disapproved, details prohibitive requirements for labels and user instructions, and clearly specifies what materials need to be provided for applications for changes. Meanwhile, the situation in which applicants are placed on the list of enterprises with serious violations and discreditable acts will be one of the circumstances under which registration applications will be rejected or disapproved; and those who commit acts of "falsifying, reselling, leasing out, lending out, or transferring" registration certificates for infant formula powder products will face more severe punitive measures.