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

According to information recently released by the State Administration for Market Regulation (SAMR), the number of foods for special medical purposes (FSMP) products approved in China has reached 94. Companies must register FSMP products with the SAMR. This applies to both imported products as well as those produced domestically and marketed in China. 13 new FSMP products were approved for use in 2022.

On December 29, 2022, the General Rules for the Hazardous Chemicals Warehouse Storage (GB 15603-2022) was officially released and will enter into force in China on July 1, 2023. It will repeal and replace GB 16603-1995. GB 15603-2022 is a mandatory national standard. It is of great significance to the safety and management of hazardous chemicals as it provides a universal and basic standard for the storage of hazardous chemicals.

In order to help enterprises better understand the filing status of health food (dietary supplement) in China, CIRS made statistics on the health food approved in 2022 and made an analysis from multiple perspectives.

On January 17, 2023, ECHA added nine substances to the Candidate List of SVHCs. The Candidate List of substances of very high concern (SVHCs) now contains 233 substances that may have serious effects on people or the environment.

On January 16, 2023, China National Center for Food Safety Risk Assessment (CFSA) issued 3 new food contact additives and resins passing the technical review of the CFSA Expert Review Committee for public comments. The deadline for public comments is February 10, 2023.

When Brexit was enacted and the UK left the EU on January 31, 2020, it took certain regulations that were in force and wrote them directly into GB regulations. From that point forward, Great Britain (England, Scotland, and Wales) began adhering to the GB Classification, Labelling and Packaging of Chemicals Regulation (GB CLP). However, the Northern Ireland agreement means that European Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures (EU CLP) is still required in Northern Ireland. It should be noted that any updates to EU CLP that took place after January 31, 2020, do not apply to GB CLP.

For quantitative detection products, appropriate statistical analysis methods such as regression analysis should be selected according to the detection performance of the products for clinical trial results. Within a reasonable confidence interval, investigate whether there was a significant correlation and whether there is a significant statistical difference in the results of quantitative values. If possible, the recommendation should be taken into account that the possible differences in the performance of reagents in different sample concentration intervals, the overall concentration range is subject to interval stratified statistics, and the results in different concentration intervals were analyzed for correlation to better verify the correlation between the two reagents.

In order to prove the hemostatic mechanism of absorbable hemostatic products in China the applicant must submit technical or supporting data that can effectively prove or explain the principle of hemostatic action of the declared product. It must: clarify the hemostatic mechanism of the declared product in detail, describe how the product affects the hemostatic process, the advantages of the product in the hemostatic process, and confirm whether the application of this hemostatic mechanism combined with the declared product is scientific and reasonable. The applicant must review the domestic and foreign research literature supporting the hemostasis principle, and submit the original text and Chinese translation of the relevant scientific literature specifically supporting the hemostasis principle. The applicant must also clarify whether there are products applying the same hemostasis principle on the domestic and foreign markets, and also study whether the declared product may cause thrombosis, coagulation disorders, and other adverse reactions related to its use.

By the end of December 2022, the National Health Commission of the People's Republic of China (NHC) issued three announcements (No. 1 of 2022, No. 2 of 2022, No. 5 of 2022) in the form of "Three New Foods" with 75 of products approved, including new food raw materials (novel food), new food additives and food-related products (new food contact substances). Among them, 32 kinds of new food additives (including expanded use) were approved.