ZMUni Compliance Centre

    On November 1, China’s State Administration for Market Regulation (SAMR) released key review guidelines for implementing the replacement of health foods that lack "expiration dates and product technical standards" (referred to as “dual-no” products). This initiative aims to standardize legacy registrations, improve documentation, and unify regulatory standards. Through re-certification, SAMR will assign expiration dates, regulate health claims, and align registrations with production licenses and oversight, reinforcing compliance responsibilities for manufacturers and regulators.   Products requiring certificate replacement include all "卫食健字" labeled items and certain "国食健字" items approved during the 2003-2005 regulatory transition, as specified by the Health Function Catalogue Allowed for

    On October 30, 2024, China National Medical Products Administration (NMPA) announced amendments to the Safety and Technical Standards for Cosmetics (2015 Edition) (STSC), introducing 3 new testing methods and revising 2 existing testing methods. These updated methods, effective from July 1, 2025, will apply to cosmetic registration, notification, and sampling tests. Detailed information as follows:   No. Testing Method Newly Added/Revised 1 Determination of Azelaic Acid and its Salts in Cosmetics Newly Added 2 Determination of Phenacetin in Cosmetics 3 Determination of Hydroxycapric Acid in Cosmetics 4 Determination of Asbestos in Cosmetics Revised 5 Determination of Glucuronic Acid and Other 14

  On October 24, 2024, China National Center for Food Safety Risk Assessment(CFSA) issued two notices soliciting public comments for two new food ingredients and six new food additives respectively. On October 25, 2024, CFSA issued notice, consulting on three new varieties of food-related products.   Two New Food Ingredients Name(CN&EN) Source Deadline for Comments 樱花多酚 (Sakura polyphenol) Cerasus serrulata var. lannesiana (Carr.) Makino November 23, 2024 鸡冠透明质酸钠 (Rooster comb sodiu) Comb of Gallus gallus domesticus    Six New Varieties of Food Additives Category Name(CN&EN) Deadline for Comments Enzyme 过氧化物酶 (Peroxidase) November 24, 2024 木聚糖酶 (Xylanase) Nutritional fortification substances 3’-唾液酸乳糖钠盐 (3’-Sialyllactose sodium salt) 乳糖-N-新四糖 (Lacto-N-neotetraose，LNnT) Food

      On October 22, 2024, China's State Administration for Market Regulation (SAMR) released the Working Procedures for Priority Review and Approval of Registration for Food for Special Medical Purposes(FSMP) (hereinafter referred to as "Working Procedures"), effective immediately. This document is formulated based on the Administrative Measures for Registration of Foods for Special Medical Purposes(hereinafter referred to as "Measures") and related regulations, aiming to encourage research and innovation, meet urgent clinical nutritional needs, and standardize the prioritized review and approval process for FSMP registration.   On the same day, China SAMR provided a policy interpretation of this document, detailing the following key points:  

  Previously, the Beijing Municipal MPA launched an entry-level guide on conducting full-version safety assessment reports for cosmetics, providing fundamental insights into the process.   On October 16, 2024, the Beijing Municipal MPA released the "FAQs on Notification of General Cosmetics (Vol. 37)," which offers a more advanced guide for completing full-version safety assessment reports. This practical resource addresses common issues related to the using of nano materials, plant extracts, and new cosmetic ingredients still under safety monitoring in general cosmetics.     Q1: Is the Ingredient Usage Information of Marketed Products equivalent to the Inventory of Existing Cosmetic Ingredients in China 2021?   A:

    On October 10, 2024, China National Health Commission (NHC) issued a notice on 12 Three New Food. These include two new food ingredients; four new food additives; and six new food contact materials (FCM) substances.   The details are as follows:   Category Name in EN Status Remark New Food Ingredients Nannochloropsis qaditana oil Approved / Procyanidins New Food Additives D-psicose 3-epimerase Approved enzyme preparation 2’-fucosyllactose，2’-FL nutritional fortification substances Lacto-N-neotetraose，LNnT Sodium ferrous citrate Expanded Usage Scope nutritional fortification substance New FCM Substances C.I.Pigmentblack7;Carbonblack Expanded Usage Scope FCM additives Sodiumhydroxide Dibutylsebacate 2,4,8,10-Tetraoxa-3,9-diphosphaspiro [5.5]undecane,3,9-bis[2,4- bis(1-methyl-1-phenylethyl)phenoxy]- Copolymerof trimethoxyphenylsilane, methyltrimethoxysilane, andsilica Approved FCM resins Benzene, ethenyl-, polymer with 1,3-butadiene, hydrogenated Expanded Usage Scope   ZMUni

     On October 11, 2024, the State Administration for Market Regulation (SAMR) of China issued a public notice seeking comments on two draft documents: the 2024 Edition of the Dosage Forms and Technical Requirements for Health Food Filing (Draft) and the 2024 Edition of the List of Auxiliary Materials for Health Food Filing and Terms of Use (Draft). Comments can be submitted via the official website (http://www.samr.gov.cn), email (bjspba@cfe-samr.org.cn), or mail, with a deadline of November 11, 2024.   The 2024 Edition Drafts supplements new dosage forms for nutrient supplement health food filings, expanding options to include candy, beverages, chocolate, jelly, and powders—formats that are

      On October 8, 2024, the National Health Commission (NHC) launched a public consultation for 19 national food safety standards. The draft standards cover six related to food additives, one for contaminants, one product standard, and eleven testing standards. Comments can be submitted through the online system until October 18, 2024.   The 19 standards are as follows:   No. Standard Revision/Formulation 6 Standards for Food Additives 1.  General Rules for Flavorings Revision 2.  Food Additive Erythritol Revision 3.  Food Additive Sodium Alga Acid (Also known as Sodium Alginate) Revision 4.  Amendment Sheet Standards for Six Colorants, including Brilliant