The medicated oral-care products are re-classified from two to three classes, and the new regulations regarding the types, specifications and dosages of active ingredients in the new class are stipulated. The specifications of active ingredients in hair coloring agents and permanent wave agents are modified.
On Dec. 8, 2020, Japan MHLW released three amendments for public consultation, which proposes the modification of the standards for marketing approval of three kinds of quasi-drugs, namely medicated oral-care products, hair coloring agents and permanent wave agents. Any comments shall be submitted before Jan. 6, 2021.
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Under the current regulatory framework, cosmetics registrants and notifiers can continue to submit a simplified version of the safety assessment report during the registration or notification process until May 1, 2025. Following this deadline, a full version of the safety assessment will be mandated. To facilitate a smooth transition, China is planning to release a set of technical guidelines.
The current cosmetic technical standard STSC 2015 specifies the cosmetics' general safety standards, prohibited/restricted/permitted ingredients and testing methods. It is revised aperiodically in response to changing trade practices in the industry. China is planning to issue a new version of STSC.
