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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.
On December 29, 2022, US President Biden signed into law the Food and Drug Omnibus Reform Act (FDORA Act), which included the Modernization of Cosmetics Regulation Act of 2022 (MOCRA Act). This is the first significant amendment to American cosmetics regulations since 1938. Compared with the current Federal Food, Drug and Cosmetic Act (FDC Act), MOCRA Act forces cosmetic enterprises to register their facilities and maintain records for their products.
FAQs on Cosmetics Registration and Filing in China-Safety Assessment
FAQs from Beijing Cosmetics Review and Inspection Center on Ordinary Cosmetics Filing
CIRS Group has prepared a Brief Guide to Regulatory Requirements of Global Cosmetic Regulations to help enterprises better understand cosmetic regulations around the globe. The Guide is compiled based on CIRS Group’s experience with cosmetic registration/filing. It gives a brief introduction to global cosmetic regulations, which makes it easier for related enterprises to collect regulatory information and know what they need to do during is during export or R&D.
Triethanolamine has been getting a lot of attention recently but there is some confusion over mixtures containing it. In general, the concentration of triethanolamine in cosmetics is less than 0.5%, accounting for a low proportion. According to Article 57 of the Detailed Rules on the Implementation of Administration Regulations of the People’s Republic of China on the Administration of Monitored and Controlled Chemicals (MCCs), when the concentration of MCCs is lower than a certain concentration threshold, data declaration and import and export licensing can be exempted. Recently, there was an inquiry on the official website of the General Administration of Customs about the necessity of applying for an Import/Export License for hand sanitizers containing a trace quantity of triethanolamine (0.051).
In September 2022, the European Commission finally published the long-awaited draft amending Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards synthetic polymer microparticles, to limit the use of intentionally added microplastics in various products. The new proposal also puts a restriction on leave-on cosmetics, involving skincare products, perfume, and lip care products. The transition period is 6-12 years. Once the new regulation is implemented, the EU will completely prohibit the use of microplastics in all cosmetics.
Perfume and makeup products are two of the most widely imported cosmetic products to mainland China from the EU and US. They are considered cosmetic products in China because they meet the definition of cosmetic according to the overarching Cosmetic Supervision & Administration Regulation (CSAR), implemented in 2021 by the National Medical Products Administration (NMPA). According to the regulation, cosmetics are defined as daily chemical industrial products applied to skin, hair, nails, lips, and other human surfaces by scrubbing, spraying, or other similar methods for the purpose of cleansing, protecting, beautifying, and modifying.
National Institutes for Food and Drug Control Issued the Latest FAQs on the Registration of Cosmetics in China
There has been a lot of change in the Chinese cosmetics industry since the new overarching regulation – Cosmetics Supervision Administration Regulation (CSAR) – came into force on January 1, 2021. To help you keep up-to-date and compliant we have prepared this infographic of the upcoming compliance deadlines.