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NEWS
Breaking! Japan Implements the New Japanese Standards of Quasi-drug Ingredients (JSQI 2021)
Apr 16, 2021
On March 25, 2021, Japan Ministry of Health, Labour and Welfare (MHLW) issued four documents, including the new Japanese Standards of Quasi-drug Ingredients (hereafter referred to as JSQI 2021), new List of Permitted Additives in Quasi-drugs, new Pre-market Application Rules of Quasi-drugs and a Collection of FAQs. In the above four documents, the ingredient standards are revised, and the corresponding pre-market application requirements of quasi-drug products are adjusted.
Japan
Ingredients
Testing
NEWS
China Finalizes Dossier Requirements for Registration and Notification of Cosmetics and New Cosmetic Ingredients
Mar 04, 2021
Detailed documentation requirements for cosmetic and new cosmetic ingredient (NCI) registration and notification are finalized. Imported general cosmetics can be exempt from animal testing from May 1, 2021 under certain conditions. Animal testing alternative method data for NCI registration/notification can be conditionally accepted.
Chinese Mainland
Pre-market Approval
Animal Testing
Testing
CSAR
New Ingredient Management
Enterprise Obligations
NEWS
China Approves Efficacy Evaluation Methods for Freckle Removing (Whitening) and Anti-Hair Loss Products
Mar 03, 2021
China approved seven cosmetic testing methods, including two efficacy evaluation methods for freckle removing (whitening) and anti-hair loss products. The efficacy evaluation cycle of freckle-removing (whitening) products is at least 37 days, and for anti-hair loss products, at least 12 weeks. This will extend the time for product to enter the market and increase R&D costs.
Chinese Mainland
Efficacy
Testing
NEWS
India Implements the Cosmetics Rules 2020
Mar 02, 2021
On December 15, 2020, the MOHFW officially released the finalized regulation-Cosmetics Rules 2020 under the provisions of the Drugs and Cosmetics Act 1940 with immediate effect. The 2020 Rules, consisting of 72 rules, 13 schedules, and 24 appendixes, lays down the regulatory requirements for the manufacture, testing, labeling, import, registration, distribution, and sale of cosmetics in India...
India
Pre-market Approval
Ingredients
Labeling/Claim/Advertising
Post-market Surveillance
Animal Testing
Safety Assessment
Testing
GMP
Toothpaste
NEWS
China’s Long-Anticipated Cosmetic Supervision and Administration Regulation (CSAR) Officially Takes Effect
Jan 01, 2021
As the new year begins, China's new overarching cosmetic regulation - Cosmetic Supervision and Administration Regulation (CSAR) officially took effect, replacing the outdated Cosmetics Hygiene Supervision Regulations (CHSR), which was first introduced over 30 years ago...
Chinese Mainland
Pre-market Approval
Ingredients
Labeling/Claim/Advertising
Post-market Surveillance
Efficacy
Safety Assessment
Testing
GMP
CSAR
Toothpaste
NEWS
Tmall Global Implements a New Random Inspection Standard for CBEC Cosmetics
Dec 16, 2020
On December 9, 2020, the platform released a new technical standard for CBEC cosmetics, i.e., the Implementation Rules for the Conformity Spot Check on Cosmetics Goods on Tmall Global, which spells out the basic requirements for the platform’s irregular random inspections on cosmetics sold...
Chinese Mainland
Post-market Surveillance
CBEC
Testing
NEWS
NIFDC Consults on Seven Testing Methods for Cosmetics
Nov 13, 2020
China National Institutes for Food and Drug Control is consulting on 7 cosmetic testing methods, which are related to boric acid and borate, tretinoin and its derivatives, 47 kinds of hair dyes, and efficacy evaluation of freckle removing and whitening and anti-hair loss.
Chinese Mainland
Efficacy
Testing
NEWS
CSAR Subsidiary Regulations: China Modifies Requirements for New Cosmetic Ingredients Registration and Notification Dossiers
Nov 06, 2020
The second draft modifies new cosmetic ingredients (NCI) registration and notification dossiers requirements and refines requirements for testing institutions qualification and testing method. Internationally accepted methods and new developed testing methods are newly accepted for NCI physical and chemical test, microbiological test and efficacy evaluation. If the animal testing alternative methods are used for toxicological test, the evidence proving the consistency of results obtained from the animal testing alternatives and the traditional toxicological test methods should be submitted...
Chinese Mainland
Pre-market Approval
Ingredients
Post-market Surveillance
Efficacy
Animal Testing
Safety Assessment
Testing
CSAR
New Ingredient Management
Enterprise Obligations
NEWS
South Korea to Exempt More Functional Cosmetics from Evaluation Dossier Submission
Oct 12, 2020
MFDS unveiled the draft of Regulation on the Examination of Functional Cosmetics to solicit public opinion. In the draft, new functional cosmetics subject to dossiers exemption are proposed. General testing institutions are to be approved for the human testing of alleviating skin itching cosmetics.
South Korea
Safety Assessment
Testing
NEWS
Two Policy Shifts towards Animal Testing in China’s Cosmetic Sector
Sep 11, 2020
Two draft subsidiary regulations of CSAR released on August 28 (Instructions for Cosmetic Registration and Notification Dossiers and Instructions for New Cosmetic Ingredient Registration and Notification Dossiers) introduce 2 policy shifts towards animal testing management in China.
Chinese Mainland
Animal Testing
Testing
CSAR
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Stay Current: China’s Cosmetic Safety Assessment Regulatory Landscape
Under the current regulatory framework, cosmetics registrants and notifiers can continue to submit a simplified version of the safety assessment report during the registration or notification process until May 1, 2025. Following this deadline, a full version of the safety assessment will be mandated. To facilitate a smooth transition, China is planning to release a set of technical guidelines.
China’s Safety and Technical Standards for Cosmetics (STSC) and Its Updates
The current cosmetic technical standard STSC 2015 specifies the cosmetics' general safety standards, prohibited/restricted/permitted ingredients and testing methods. It is revised aperiodically in response to changing trade practices in the industry. China is planning to issue a new version of STSC.
Cannabis Cosmetics Regulatory Updates in the Asia Pacific Region
Cannabis cosmetics are undoubtedly one of the hottest products across the globe in recent years, but with few regulations. To assist cosmetics companies to avoid compliance risks and seize market opportunity, ChemLinked has compiled the regulations.
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