On March 31, 2022, China National Institutes for Food and Drug Control (NIFDC) released the draft of Safety and Technical Standard for Cosmetics 2022(the draft STSC 2022) for public comments, which is devised to supersede the existing overarching technical standard STSC 2015.
The draft STSC 2022 inherits the basic framework of STSC 2015. Still, it overhauls the original content, including revising the content that is unsuitable for the current supervision practice, retaining the content that is still applicable, incorporating the previous revisions for STSC 2015, as well as standardizing and improving some terms and expressions.
2. South Korea’s Amendments to Cosmetic Ingredient Use Requirements
On April 1, 2022, the Ministry of Food and Drug Safety (MFDS) unveiled the updated Regulation on Safety Standards, etc., for Cosmetics. Seven kinds of perfluorinated compounds and persistent pollutants are newly specified as prohibited ingredients. New restricted colorants in hair dye products and their use limits are added. The regulation also clarifies the exemption situations that allow the use of radioactive substances, THC and CBD, as well as a fluorescent whitening agent in cosmetic products.
Then on September 5, 2022, MFDS published a notice to solicit public opinions on the modifications of Regulation on Safety Standards, etc., for Cosmetics. Five hair dye ingredients are proposed as prohibited for they are possibly genotoxic according to the authority's regular inspection results.
3. 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 came 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;
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.
On July 1, 2022, Taiwan Food and Drug Administration (TFDA) officially implemented the latest version of the List of Prohibited Ingredients in Cosmetics. The list deletes Bithionol and Beryllium and Its Compounds due to entry duplication, and adds four ingredients, namely Alanroot Oil (Inula Helenium L.), Rauwolfia Serpentina L., Alkaloids and Their Salts, Yohimbine and Its Salts, and Tripterygium Wilfordii Hook.f.
From the effective date, the manufacture, import, sale, supply, and display of cosmetics containing the ingredients in the list are strictly prohibited.
On November 21, 2022, South Korea unveiled a notice to solicit public opinion on the new Guideline on Submission of Reporting Functional Cosmetic. The Guideline drafts the procedures to submit the report and the instructions for filling in the report in different situations. On December 1, the authority released the official version of the Guideline.
During the 35th ASEAN Cosmetic Scientific Body (ACSB) meeting, ASEAN adopted several new changes to cosmetic ingredients in the Annexes of the ASEAN Cosmetic Directive (ACD):
1) Annex II: List of prohibited ingredients – 1 added and 1 revised
2) Annex III: List of restricted ingredients – 1 added and 10 revised
3) Annex VI: List of permitted preservatives – 1 added and 2 revised
7. China Releases Several CSAR Subsidiary Regulations
On January 1, 2021, China’s updated overarching cosmetic regulation Cosmetic Supervision and Administration Regulation (CSAR) came into effect. In 2022, China released seven CSAR subsidiary regulations. Details are shown in the following table.
The Practices are divided into nine chapters with two annexes, covering all aspects of cosmetic production and quality control such as ingredients, personnel, equipment, sanitation, inspection, packaging, storage, transportation, sales and recall. The implementation of the Practices indicates that cosmetics production in China will enter a more standardized era.
July 1, 2022
The Measures is China’s first regulation specifically for the management of cosmetic adverse reaction monitoring. It consists of 7 Chapters and 47 Articles, making systematic requirements for cosmetic adverse reaction monitoring from the aspects of responsibilities and obligations, adverse reaction reporting, analysis and evaluation, as well as adverse reaction investigation, supervision and management, etc.
October 1, 2022
The Points consists of 105 inspection points, and sets separate inspection items for manufacturing and entrusting enterprises. Besides, it introduces the judgment principles of cosmetics regulatory departments, offering enterprises guidance on complying with the Good Manufacturing Practices for Cosmetics.
December 1, 2022
|China Finalizes Inspection Pointsand Judgment Principles of Cosmetic Good Manufacturing Practices|
The Guidelines is formulated to provide technical guidance for the registrant, notifier, and Chinese domestic responsible person when applying for the registration and notification of children cosmetics. It also aims to provide the basis for competent authorities' technical review of special children cosmetics and post-notification review of general children cosmetics.
The Measures spells out the requirements for and procedures of sampling testing, and corresponding obligations of all stakeholders.
The Guidelines integrates the regulatory requirements for “freckle-removing and whitening cosmetics” in CSAR and its subsidiary regulations, including product definition, scope, requirements for using freckle-removing and whitening agents, prohibited claims, safety assessment, and efficacy evaluation. It provides the basis for registrants to prepare registration documents, and for the technical review department to review registration documents.
The Measures comprehensively and systematically stipulates the management requirements on cosmetics e-commerce platforms, cosmetics operators on the platforms, and supervision and administration departments.
On January 7, 2022, Indonesia released and implemented the finalized Technical Requirements for Cosmetics Claims, replacing the previous 2015 version. The regulation clarifies requirements for cosmetic claims and attaches two lists of examples of prohibited and permitted claim. Claims that have been labeled or published prior to January 7, 2022, must comply with the finalized regulation before January 8, 2023.
9. Philippines to Modify the Requirements for Licensing and Inspection of Health Products, Cosmetics Included
On October 3, 2022, Philippine FDA launched the second round of consultation on the draft amendment to Administrative Order No. 2020-0017. Compared with the first draft, supplements are added to further clarify the requirements for the Qualified Person (QP) and the License to Operate (LTO) application. To ensure a smooth transition, Philippine FDA also sets transitional provisions for concerned establishments.
On June 9, 2022, Thai FDA released the revised criteria and requirements for the registration of cannabis and hemp-based cosmetics as well as a checklist of required registration documents. On June 22, 2022, it issued the cannabis cosmetic certificate templates and a Q&A collection. According to above documents, only four types of Thai domestic cannabis and hemp ingredients are allowed for use in cosmetics in Thailand. The four ingredients are:
Hemp seed oil or hemp seed extract with a THC content no more than 0.2% w/w;
The bark, stem, fiber, branch, root, and leaf (without flowers and inflorescence) of cannabis and hemp, as well as the hemp seed;
Cannabidiol (CBD) extracts with a THC content no more than 0.2% w/w;
Terpenes derived from cannabis or hemp.
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 the picture below for registration now!