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The Administrative Measures for the Registration of Infant Formula Products (hereinafter referred to as the Administrative Measures) was revised and issued on July 10, 2023, and came into effect on October 1, 2023. Following the implementation of the new national standards, the new registration regulations have further tightened the requirements for infant formula registration. How should enterprises make adjustments to cope with the new circumstances?
FDA Direct is a U.S. Food and Drug Administration's web-based and free structured product labeling (SPL) authoring tool. Previously CDER Direct, FDA Direct now includes CDER Direct and Cosmetics Direct. Users can create separate accounts, depending on drugs or cosmetics submissions, or a single account that includes both CDER Direct submissions as well as Cosmetics Direct submissions.
On December 18, 2023, China's Ministry of Ecological Environment (MEE) announced the addition of a batch of 25 registered substances that fulfill the requirements of existing substances into the Inventory of Existing Chemical Substances in China (IECSC). CIRS warmly reminds you that related enterprises must make sure whether their substances are existing substances. The Provisions on Environmental Administration of New Chemical Substances (MEE Order 12) require enterprises to complete new substance registration/record before manufacturing or importing, or they may face various punishments.
China’s chemical inventory of existing chemical substances is IECSC, which stands for the Inventory of Existing Chemical Substances Produced or Imported in China (IECSC). There are two parts of IECSC, public part and classified/confidential part. Companies can check out the public part by themselves and shall only enquire Authorities for classified/confidential part. If substances are not listed in the public part, companies have to submit a formal enquiry to SCC to check whether a substance is listed in the confidential part. The enquiry costs 3000 RMB.
Since the implementation of CSAR, according to data from the National Medical Products Administration (NMPA), as shown in Figure 1, in 2021, 6 new cosmetic ingredients obtained NMPA numbers, of which 4 were for domestically produced new cosmetic ingredients and 2 for imported cosmetic ingredients. In 2022, 42 new cosmetic ingredients obtained NMPA numbers, with 25 being domestically produced and 17 being imported. As of December 15, 2023, 60 new cosmetic ingredients have obtained NMPA numbers, with 46 being domestically produced and 14 being imported.
Human Milk Oligosaccharides (HMOs) stands as a unique carbohydrate present exclusively in breast milk, ranking as the third-largest solid component, following lactose and fat. With diverse functions, HMOs plays a crucial role in enhancing the gut microbiota, boosting cognitive function, and alleviating symptoms of irritable bowel syndrome, among other benefits. Currently, there are over 150 known types of HMOs, each with distinct structures, functions, and applications. Several types have initiated compliance efforts globally, with commercialization taking root first in the EU and the United States.
Since the publication of the Cosmetics Supervision and Administration Regulations (CSAR, State Order No. 727) on June 29, 2020, a series of supporting regulations have also been introduced. Included among all the supporting regulations are those relating to the registration and filing of new cosmetic ingredients in China, namely the: Measures for the Administration of Cosmetic Registration and Filing; Provisions on the Administration of New Cosmetic Ingredients Registration (hereafter the Provisions); and Filing Data and Technical Guidelines for Cosmetics Safety Assessment.
Since the release of the new pesticide management regulations in 2017, the number of newly registered TGAIs in China has been consistently declining each year. CIRS group has compiled a year-end review, providing a reference for the newly registered TGAIs in China as of December 10th, 2023. Prior to 2017, the annual new registered pesticide TGAIs in China ranged from 200 to 400. After 2019, following the requirements of the new regulations, the number of approved TGAIs ranged from 10 to 70 annually. The figure below shows the yearly registered number of TGAIs from 2019 to 2023.
En Chine, la sécurité des ingrédients cosmétiques est réglementée par la NMPA (Administration Nationale des Produits Médicaux) conformément au CSAR (Règlement sur la Supervision et l'Administration des Produits Cosmétiques). Un ingrédient est considéré comme "nouveau" s'il ne figure pas dans l'IECIC 2021 (Inventaire des Ingrédients Cosmétiques Existants en Chine). Les ingrédients existants en Chine doivent être répertoriés dans l'IECIC 2021, et leurs données de sécurité doivent être rapportées à la NMPA via la plateforme d'information de sécurité des ingrédients cosmétiques.
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