May 2023: Global Cosmetic Regulatory Updates

This is a collection of global cosmetic regulatory updates, including cosmetic regulations in China, the EU etc. 🇨🇳China China Issues the First License for Cosmetic Personalized Service On April 26, 2023, the SkinCeuticals store located in Shanghai Pudong New Area was granted a cosmetic production license for on-site personalized service by the Shanghai Municipal Medical Products Administration (MPA). This license allows the enterprise to provide consumers with personalized services that involve direct contact with cosmetic contents at the store. As the first license of its kind in China, it marks a milestone in the development of China\’s personalized cosmetic industry. (Read more) China NIFDC Consults on One Technical Guideline for Cosmetics Testing On May 4, 2023, China National Institutes for Food and Drug Control (NIFDC) started a public feedback process for the draft Technical Guidelines for Skin Sensitization Test. Consisting of five parts, the draft introduces the basic test principles and contents, and gives instructions…

Jun. 06th, 2023

ASEAN Updates Cosmetic Ingredient Annexes for ACD: 42 New Ingredients Added and 10 Revised

The main amendments include: 1) adding 42 prohibited ingredients, and revising the requirements for 1 prohibited ingredient; 2) revising the requirements for 4 restricted ingredients; 3) revising the requirements for 1 permitted colorant; 4) revising the requirements for 3 permitted preservatives; 5) revising the requirements for 1 permitted UV-filter. In January 2023, ASEAN introduced the latest amendments to the ingredient annexes to ASEAN Cosmetic Directive (ACD). These amendments were approved in the 36th ASEAN Cosmetic Scientific Body (ACSB) meeting, and will officially take effect on November 21, 2024. Detailed amendments to each annex are as follows (the text in red indicates changes to the previous lists): 1. Annex II – List of Prohibited Ingredients: 42 added and 1 revised The meeting agreed to newly include 42 prohibited ingredients, based on the amendments adopted by EU in Commission Regulation (EU) 2019/831, Commission Regulation (EU) 2019/1966, Commission Regulation (EU) 2021/850, and Commission Regulation (EU) 2021/1902 as part of the reference. Besides, Myanmar updated other member…

May. 31st, 2023

China Implements Strict Cosmetic Sampling and Testing Regulations Under CSAR Subsidiary

In September 2020 and June 2022, China NMPA issued two drafts of Measures for the Management of Cosmetic Sampling Testing (Measures). Finally, on January 12, 2023, NMPA released the finalized Measures. On Mar. 1, 2023, China National Medical Products Administration (NMPA) implemented Measures for the Management of Cosmetic Sampling Testing. The Measures is divided into 8 chapters and 61 articles, providing detailed requirements on the formulation of sampling testing work plan, sampling, testing and result submission, objection and re-testing, verification and disposal of unqualified products, as well as information disclosure. The key points are summarized and analyzed as follows. Sampling Methods To strengthen the supervision of cosmetic manufacture and operation in China, local medical products administration departments (MPAs) will organize the sampling testing according to their annual sampling testing plans. Special personnel will be assigned to carry out the sampling through on-site sampling or online product sampling. Recognized testing institutions will be responsible for the…

May. 31st, 2023

China Permits Low-Risk General Cosmetic Stakeholders to Submit Self-Testing Reports for Notification Applications

Under certain conditions, notifiers or entrusted manufacturers of Chinese domestic low-risk cosmetics are allowed to conduct self-testing and submit the product self-testing reports as part of notification dossiers. On January 18, 2023, China’s National Medical Products Administration (NMPA) issued a notice, further optimizing the management measures for the notification testing of general cosmetics. Specifics are as follows: 1. The notice allows domestic low-risk general cosmetics to conduct self-testing and issue reports for notification. Cosmetics notifiers who meet the following prerequisites can conduct self-testing per relevant requirements for cosmetics technical specifications, and submit the self-testing reports issued by themselves or the entrusted manufacturers when applying for notification. For general cosmetics, the company adopts testing methods as the quality control measures, rather than non-testing methods; The general cosmetics’ production process has been included in the scope of daily supervision of provincial medical products administration authorities; The product safety risk assessment results can…

May. 31st, 2023

March 2022: Global Cosmetic Regulatory Updates

This is a collection of global cosmetic regulatory updates, including cosmetic regulations in China, the EU etc. 🇨🇳China China to Implement the First Regulation on the Supervision for Cosmetic Online Operation On April 4, China National Medical Products Administration (NMPA) issued the finalized Supervision and Administration Measures on Online Operation of Cosmetics (Measures) and would implement it on September 1, 2023. The Measures clarifies the regulatory objectives and authorities of cosmetics online operation, the management responsibilities of cosmetics e-commerce platforms, and the obligations of cosmetic operators on the e-commerce platforms. (Read more) China Releases Guidelines for the Registration Review of Radio Frequency Beauty Devices On April 12, China NMPA issued Guidelines for Review of Registration of Radio Frequency Beauty Devices to assist relevant enterprises in preparing registration application documents, and the technical review department under the supervision authority in reviewing documents. (Read more) China NIFDC Consults on Seven Technical Guidelines for the Testing of Cosmetic Products and…

May. 15th, 2023

March 2022: Global Cosmetic Regulatory Updates

This is a collection of global cosmetic regulatory updates, including cosmetic regulations in China, the EU etc. 🇨🇳China China NMPA Provides Relief for Cosmetic Industry with Eased Ingredient Safety Information Submission Policies On March 27, 2023, China NMPA issued the adjusted management policies on the submission of cosmetic ingredient safety information. The new rule highlights that for ingredients without an ingredient submission code, cosmetics registrants and notifiers can now fill in and submit the ingredient safety information documents by themselves. The transition period of the cosmetic ingredient safety information submission policies has been extended to January 1, 2024. For all cosmetics registered and notified before 2024, only registrants and notifiers of specific categories of ingredients are required to supplement the safety information. (Read more)  China SAMR to Implement the Administrative Measures on Toothpaste On March 23, 2023, China SAMR issued the finalized Administrative Measures on Toothpaste, which clarifies the responsibilities of all parties, the…

Apr. 14th, 2023

February 2022: Global Cosmetic Regulatory Updates

This is a collection of global cosmetic regulatory updates, including cosmetic regulations in China, the EU etc. 🇨🇳China China NMPA Approves Three New Cosmetic Ingredients In February, China NMPA updated the notification status of three new cosmetic ingredients (NCIs), two of which are Hydrolyzed Alpha-Glucan Polysaccharide, and β-Nicotinamide Mononucleotide. Details of the NCI notified most recently have not been published so far. ChemLinked will provide an update once this information is released. China Issues Eight Cosmetics-related Standards in February In Jan. 2023, China issued 7 cosmetics-related standards. The basic information is as follows: In February, China issued eight cosmetics-related standards. The essential information is as follows: Release   Date Initiator Standard Name  Effective Date February 1, 2023 Beijing Daily Chemical Association Guidelines for the Design and Development of Personalized Cosmetic Requirements (Draft) / February 3, 2023 Guangdong Chamber of Daily Used Chemicals Soothing Efficacy Test of Cosmetics: In Vitro Test Method for the…

Mar. 06th, 2023

January 2022: Global Cosmetic Regulatory Updates

This is a collection of global cosmetic regulatory updates, including cosmetic regulations in China, the EU etc. 🇨🇳China China NMPA Approves Three New Cosmetic Ingredients In Jan. 2023, NMPA updated the notification information of three new cosmetic ingredients (NCIs). The basic information about these new NCIs is as follows: 1) Donkey oil, notified on Jan. 4, 2023 2) Azelamidopropyl Dimethyl Amine, notified on Jan. 4, 2023 3) Potassium Dihydroavenous Alkaloid D, notified on Jan. 6, 2023 China Issues 7 Cosmetics-related Standards in January In Jan. 2023, China issued 7 cosmetics-related standards. The basic information is as follows: Type Initiator Standard Name Release Date Effective Date Provincial Standard Hebei MPA Simultaneous Determination of Methylmercury, Ethylmercury and Inorganic Mercury in Cosmetics (Draft) Jan. 17, 2023 / Group Standard Fujian Botanical Society T/FJBS 1-2023 FuDing Gardenia Cell Liquid Jan. 1, 2023 Jan. 2, 2023 T/FJBS 2—2023 FuDing Gardenia Hydrosol Jan. 1, 2023 Jan. 2, 2023 Guangdong Beauty,…

Feb. 10th, 2023

China Issues a New Cosmetics Supplementary Testing Method: Five Imidazoline Drugs Involved

The new cosmetic supplementary testing method applies to five imidazoline drugs such as Tetrahydrozoline and Naphazoline in cream, lotion, liquid (water), gel, and wax-based cosmetics.Up to now, China has approved six cosmetic supplementary testing methods. On December 23, 2022, China NMPA released a new cosmetics supplementary testing method, BJH 202204 Determination of Five Components Including Tetrahydrozoline in Cosmetics, which specifies the qualitative and quantitative determination method of the following five prohibited ingredients. No. Ingredient Name (CAS No.) Detection Limit (μg/L) Lower Quantitative Limit (μg/L) Detection Concentration (mg/kg) Minimum Quantitative Concentration (mg/kg) 1 Tetrahydrozoline (84-22-0) 0.0016 0.005 0.08 0.25 2 Naphazoline (835-31-4) 0.0016 0.005 0.08 0.25 3 Oxymetazoline (1491-59-4) 0.0016 0.005 0.08 0.25 4 Antazoline (91-75-8) 0.0016 0.005 0.08 0.25 5 Xylometazoline (526-36-3) 0.0016 0.005 0.08 0.25 (Table 1 Five Imidazoline Drugs) The five imidazoline drugs are mainly used in the medical field but are not allowed to be used in cosmetics….

Jan. 19th, 2023

China NMPA Allows Self-Updating the Notified Ingredient Safety Information

NMPA’s general cosmetic notification information system has added a new function, which allows companies that meet specified conditions to update and maintain their notified ingredient safety information on their own, such as ingredient manufacturers and ingredient submission codes. Background The Provisions for Management of Cosmetic Registration and Notification Dossiers (the Provisions), one of the significant subsidiary regulations of the Cosmetic Supervision and Administration Regulation (CSAR), puts forward provisions on changing the ingredient safety information, which requires that: For a registered or notified product, if the ingredient manufacturer or ingredient quality specifications have been added or changed, and the ingredients’ content in the formula as well as the types and proportions of specific components in the ingredients have not been changed, the information of ingredient manufacturer and ingredient safety shall be updated and maintained through the registration and notification information platform. In case of any change in product safety assessment documents, the product safety assessment documents shall…

Jan. 13th, 2023
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