February 17, 2023, ECHA has released two substances that are proposed to be identified as substances of very high concern (SVHC) for public consultation. Related enterprises may make comments on the two substances before April 3, 2023.

We’ve translated a selection of some of the latest FAQs on cosmetics registration and filing in China with a focus on execution standard to help you understand the current requirements.

On January 12, 2023, the Taiwan’s Environmental Protection Administration supplemented a total of 15 chemical substances to the concerned chemical list in the following 3 categories: 5 substances with concerns about food safety risks; 2 new psychoactive substances (NPS); and 8 explosive precursors.

On February 9, the Environment, Public Health and Food Safety (ENVI) Committee tweeted that it has endorsed the Carbon Border Adjustment Mechanism (CBAM), a measure aimed at responding to climate change and preventing carbon leakage, with 63 votes in favor, 7 votes against and 7 votes in abstention.

What you need to know about the South Korean MSDS submission process and CBI protection

On January 13, 2023, five countries – Denmark, Germany, the Netherlands, Norway, and Sweden – submitted a restriction proposal to ECHA on Perfluoroalkyl and Polyfluoroalkyl Substances (PFAS) under REACH. On February 7, ECHA published the detailed restriction proposal of roughly 10,000 PFASs, which is the broadest restriction proposal in history. Next, ECHA will start a six-month public consultation on PFASs on March 22.

We are pleased to announce the launch of an upgraded Chinese Cosmetic Ingredient Regulatory Database – China CosIng 2.0 – to better help global cosmetic companies and ingredient suppliers comply with cosmetic regulatory requirements in China. The powerful new China CosIng 2.0 introduces several new features and is available in English, Japanese, and Korean.

The most important step in hazardous chemical compliance in China is to determine whether chemicals are hazardous or whether they are listed in the Catalog of Hazardous Chemicals (hereinafter referred to as the Catalog). Enterprises must obtain an operation permit or license of hazardous chemicals (in short as HC Operation Permit) if their chemicals are listed in the Catalog. Related enterprises may leave a message on the website of the Ministry of Emergency Management (MEM) if there are any questions about hazardous chemicals management to get public replies from the Ministry (as shown below).

On January 19, 2023, China National Center for Food Safety Risk Assessment (CFSA) released National Food Safety Standard - Standard for the Use of Food Nutrition Enhancers (Draft) for public comment. Significant changes have been made and we have summarized them as follows:

Policy Interpretation – How to Enter the "Fast Track" of Priority Approval? ——This policy was implemented on January 1, 2017 1. Scope of priority approval Projects those are applicable to the priority approval of "fast track" a. Applications for registration of domestic Class III medical devices. b. Applications for registration of imported Class II and Class III medical devices. Projects those are not applicable to the "fast track" of Priority Approval a. Filing of Class I medical devices; b. Applications for registration renewal and registration change; c. Applications that have been included in the approval process in accordance with the emergency approval procedures for medical devices or the special approval procedures for innovative medical devices. 2. The conditions for applying for priority approval (1) Diagnose or treat rare diseases, with obvious clinical advantages. (2) Diagnose or treat malignant tumors, with obvious clinical advantages. (3) Diagnose or treat specific and multiple diseases to the elderly, and there are currently no effective diagnoses or treatments. (4) Dedicated to children, with obvious clinical advantages. (5) Clinically urgently needed, and for which there are no registered medical devices of the same species in China. (6) Medical devices listed in major national science and technology projects or national key research and development programs. (7) Other medical devices that should be prioritized for approval, shall be determined by NMPA after extensively soliciting of opinions and organizing experts to demonstrate. 3. When is the priority approval application submitted? Those who meet the above priority approval conditions shall submit the application for priority approval together with the registration application for medical devices.