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China Clarifies Specific Practices of Cosmetic Adverse Reaction Monitoring and Reporting
On November 25, 2022, the Center for Drug Reevaluation and the National Center for ADR Monitoring of China jointly released the draft of Cosmetic Adverse Reaction Collection and Reporting Guidelines for Cosmetic Registrants and Notifiers (Trial) for public comments. The draft is to guide registrants and notifiers to carry out the collection and reporting of cosmetic adverse reactions, covering collection, recording, transmission, verification, report confirmation, analysis and evaluation, submission, quality control, and record management.
On November 29, 2022, China National Medical Products Administration (NMPA) launched a public consultation on the draft of Regulations on Supervision and Administration of Enterprises in Implementing Entity Responsibility for Cosmetic Quality and Safety (the Regulations). Consisting of 5 chapters and 33 articles, the draft Regulations specifies the responsibility entities of cosmetic's quality and safety, emphasizes the responsibilities of key positions related to cosmetic quality and safety, as well as clarifies the personnel subject to penalties when certain misconduct happens, and the situations where penalties can be mitigated or exempted.
On December 29, NMPA released the finalized version of the Regulations, which will take effect from March 1, 2023.
China Consults on An Enforcement Guidance on the Use of Absolute Terms in Advertising
On December 7, 2022, China's State Administration for Market Regulation (SAMR) released Enforcement Guidance on Absolute Terms in Advertising (Guidance) for public consultation. According to the Guidance, if the absolute terms do not implicate the commodity, or the absolute terms that implicate the commodity do not have the objective effect of misleading consumers or disparaging other operators, their use in advertising can be allowed. Besides, market supervision authorities shall, after considering political, social, and legal effects, impose punishments equal to the fault, be fair and adhere to the principle of comprehensive discretion (based on the fact, consequence, etc.).
China NMPA Allows Self-updating the Notified Ingredient Safety Information by Cosmetic Notifiers
On December 8, 2022, China Cosmetics Notification System announced that a new function of "Ingredient Safety Information Self-updating" had been added to the general cosmetics notification information system. The new function allows companies that meet specified conditions to update and maintain their notified ingredient's safety information on their own, such as ingredient manufacturers and ingredient submission codes.
China Provincial MPA Penalizes One Notifier for Notifying Cosmetics with False Documents
On December 15, 2022, Zhejiang Medical Products Administration (MPA) released one administrative penalty, in which one cosmetic company was fined for notifying cosmetics with false documents. To facilitate the product's releasing to the market, the company submitted false production formula and production process description for four batches of cosmetics while knowing they were inconsistent with the facts. In accordance with Article 65 of Cosmetic Supervision and Administration Regulation (CSAR), the company is prohibited to notify and market the involved cosmetics for the following three years.
China General Administration of Customs (GACC): Four Batches of Cosmetics Rejected in November
On December 18, 2022, GACC updated the list of rejected food and cosmetics in November. Four batches of cosmetics respectively imported from Thailand and China's Taiwan failed customs inspection. For all the four batches, the reason for rejection was lack of required qualified documentation.
China NMPA Issues Two Cosmetics Supplementary Testing Methods
On December 23, 2022, China NMPA released a new supplementary testing method, BJH 202204 Determination of Five Components Including Tetrahydrozoline in Cosmetics, applying to five imidazoline drugs including Tetrahydrozoline, Naphazoline, Oxymetazoline, Antazoline and Xylometazoline. These ingredients are mainly used in the medical field but not allowed to be used in cosmetics.
On December 26, NMPA released another supplementary testing method, BJH 202205 Determination of Dehydroandrographolide Succinate in Cosmetics, specifying the qualitative and quantitative determination method of Dehydroandrographolide Succinate in cream, lotion, liquid (water), and gel-based cosmetics. With the release of these two methods, China has approved seven cosmetics supplementary testing methods in total.
Four Provincial and Municipal MPAs Cancel the Notification of Non-compliant General Cosmetics
In December, Henan MPA, Shanghai Municipal MPA, Guizhou MPA and Hunan MPA successively announced to cancel the notification of nearly 16,000 batches of general cosmetics. These canceled cosmetics are either notified with non-conforming documents, or lacking the required annual report. According to CSAR, if cosmetics are still on the market after being cancelled by the regulatory authorities, depending on the severity of the violations, the relevant responsible persons will be subject to fines, administrative penalties or even criminal penalties.
China NMPA Approves Three New Cosmetic Ingredients
In December, China NMPA updated the notification information of three new cosmetic ingredients (NCIs). The basic information of these new NCIs are as follows:
1) Donkey milk powder, notified on December 8, 2022
2) Swiftlet nest peptide, notified on December 8, 2022
3) Nicotinoyl Tetrapeptide-30, notified on December 29, 2022
Guangzhou AMR and Beijing Municipal MPA Publish FAQs Regarding Cosmetics Notification
In December 2022, Guangzhou Administration for Market Regulation (AMR) and Beijing Municipal MPA released two batches of FAQs concerning issues revolving around cosmetics notification, such as requirements for notification dossiers, cosmetic labelling, product executive standard, safety assessment report, etc.
| Release Date | Regulatory Authority | Batch |
| December 7, 2022 | Guangzhou AMR | The 29th Batch |
| December 9, 2022 | Beijing Municipal MPA | The 15th Batch |
China Issues 12 Cosmetics-related Standards in December
In December, China issued 12 cosmetics-related standards. The basic information is as follows:
Taiwan, China
Taiwan Releases One Test Method for Cosmetics
On December 30, 2022, Taiwan Food and Drug Administration (FDA) released a new test method, Method of Test for Sunscreen Agents in Cosmetics (3), stipulating the test method for 4 sunscreen agents in cosmetics, including benzophenone-4, benzylidene camphor sulfonic acid, camphor benzalkonium methosulfate and phenylbenzimidazole sulfonic acid.
Japan
PMDA: 143 Batches of Cosmetics and Quasi-drugs Were Recalled in December
In December 2022, Japan Pharmaceuticals and Medical Devices Agency (PMDA) announced that 143 batches of non-compliant cosmetics and quasi-drugs were recalled. Among them, 75% of the unqualified product were recalled due to the use of unapproved cosmetic efficacy. Besides, additional 30 batches were rejected for being added with the prohibited ingredient. The remaining cosmetics were rejected because of the wrong labels.
Japan Revises Positive List of Quasi-drug Additives
On December 23, 2022, Japan issued two announcements to revise positive lists of quasi-drug additives, including "The Positive List of Additives in Hair Dyes" and "The Positive List of Quasi-drug Additives". The changes will come into effect on January 1, 2023. Details are as follows:
Additives in hair dyes:
Deleting additive No. 1583 Methylrosanilinium Chlorid;
Revising the English name of 14 additives;
Quasi-drug additives:
Deleting additive No. 1172 Stearyl Dimethyl Amine, and No. 2323 Methylrosanilinium Chloride;
Revising the English name of two additives;
Amending the information of six additives (including name, ingredient code and name in JSQI 2021);
Currently, there are a total of 1,848 additives that can be used in hair dye products and 2,746 additives that can be used in quasi-drug products.
South Korea
South Korea Issues the Guideline on Reporting Functional Cosmetic
On December 1, 2022, the Ministry of Food and Drug Safety (MFDS) released the official version of the Guideline on Submission of Reporting Functional Cosmetic. It specifies the procedures to submit the report and the instructions for filling in the report in different situations.
Indonesia
Indonesia Releases the Draft Regulation for Supervision on Manufacture and Circulation of Cosmetics
On December 6, 2022, Indonesia released the draft Regulation for Supervision on Manufacture and Circulation of Cosmetics. The regulation clarifies responsibilities of cosmetic notification number owner and distributors, as well as supervision target, items, and methods.
India
Gujarat FDCA Launches Online Licensing System for Cosmetics
On December 12, 2022, the Gujarat Food and Drug Control Administration (FDCA) has launched a cosmetics online licensing system for the first time in India. The unique features of the system include online fresh license application, additional product permission, retention application, license amendment-change in constitution, change in place and change in name, technical person approval, certificates, and legacy data.
Australia
Australia Clarifies the Data Required for Certificate Applications of Nanoscale Chemicals
On December 19, 2022, Australia AICIS issued a guidance clarifying the data requirements for assessed introductions of chemicals at the nanoscale, to help enterprises prepare and submit the online certificate application through AICIS Business Services. The required data includes chemical’s identity, toxicity data, and physicochemical properties such as shape of the particle, volume specific surface area and surface charge.
The European Union
EU SCCS Consults on Opinion as to Salicylic Acid
On December 15, 2022, EU Scientific Committee on Consumer Safety (SCCS) released the preliminary opinion on Salicylic Acid (CAS No. 69-72-7). Compared to the restrictions laid in Regulation (EC) No 1223/2009, SCCS opinion allows the use of Salicylic Acid in oral products, and alerts its use in the combination with oral and dermal products. The opinion is open for comments until February 17, 2023.
The United States
New York Outlaws Animal Tests for Cosmetics Since 2023
On December 15, 2022, the Governor of New York State signed a bill (A5653-B/S4839) prohibiting the manufacture and sale of cosmetics that involve new animal testing in the determination of their safety within the state. The bill will take effect on January 1, 2023. Any violators will be fined up to $5,000, with an additional $1,000 for each day the violation continues.
US Includes Cosmetic Regulatory Overhaul in Omnibus Spending Bill
On December 20, 2022, the Congress published the fiscal year 2023 omnibus government funding bill, H.R. 2617. The bill includes a new cosmetic regulation titled "Modernization of Cosmetics Regulations Act of 2022", which plans to overhaul the existing cosmetics regulatory framework. If passed, there will be many new requirements for cosmetic stakeholders. A detailed analysis article will be published later.
Webinar Recommendation
1. Recap Webinar of the Year 2022
Want to know comprehensive cosmetic regulation updates in the key countries worldwide? On January 11, 2023, ChemLinked will hold a year-end recap webinar, providing an overview of revised and emerging cosmetic regulations worldwide over the year 2022. Through the webinar, we wish to help you catch the key regulatory points. Click here for registration now!
2. 2022 Global Cosmetic Animal Testing Regulation Updates Recap
At present, nearly 40 countries and regions around the world have banned animal testing on cosmetics, including the United Kingdom, India, Israel, Australia and the European Union. China officially joined the ranks in May 2021, exempting general cosmetics from mandatory animal testing.
To help companies better cope with the current animal testing regulations in China and the rest of the world, ChemLinked will host a webinar on January 17, 2023 to review the history of global animal testing regulations, and expound on the latest updates on animal testing regulations around the world.
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