1. China Implements Cosmetic Supervision and Administration Regulation (CSAR) and its Subsidiary Regulations
On Jan. 1, 2021, China’s updated overarching cosmetic regulation Cosmetic Supervision and Administration Regulation (CSAR) came into effect. In the following few months, National Medical Products Administration (NMPA) issued 10 finalized CSAR subsidiary regulations, fully implementing a brand-new cosmetic regulatory framework. The exciting news was that starting from May 1, 2021, China exempted animal testing for imported general cosmetics. The details of the 10 subsidiary regulations can be found in the following table. [Read More]
These three regulations detail the requirements for the administration for cosmetic finished products and new cosmetic ingredient (NCI)’s pre-market approval, such as registration/notification procedures, obligations of register/notifier, the documentation requirements for the new application, modification, renewal, and cancellation of registration/notification.
More importantly, they specify that:
May 1, 2021
The regulation specifies that a coding system will be adopted to classify cosmetics. The system covers five layers: efficacy claim, application area, target user, dosage form, and application method.
May 1, 2021
The regulation stipulates that 20 kinds of efficacy claims, such as anti-hair loss and sunscreen, require efficacy evaluation; and lists requirements for evaluation test methods, report, evaluation institutions, and evaluation abstracts.
May 1, 2021
The regulation clarifies the detailed requirements for conducting safety assessment, qualification of safety assessor, and content necessary in the assessment report.
May 1, 2021
The regulation specifies the application scope, competent authorities, drafting procedures, technical guidelines, and compilation rules of the supplementary testing methods of cosmetics.
Jul. 1, 2021
The regulation optimizes the production license management system, refines and clarifies production and operation management requirements, and strengthens the supervisory responsibilities of the administration department.
Jan. 1, 2022
The regulation clarifies children cosmetics' scope, formula design principles, labeling requirements, registrant/notifier's main responsibilities and post-market supervision requirements.
Jan. 1, 2022
The regulation specifies the requirements for cosmetic labeling and claims.
May 1, 2022
In 2021, China updated the use requirements of cosmetic ingredients. NMPA implemented Inventory of Existing Cosmetic Ingredients in China (2021 Edition), Inventory of Prohibited Ingredients for Cosmetics, and Inventory of Prohibited Plant (Animal) Ingredients for Cosmetics, and disclosed the notification information of six NCIs. In addition, NMPA revealed that a list of cosmetic whitening ingredients is being drafted.
It is a list of ingredients that have already been used in cosmetics manufactured and sold in China. All ingredients excluded from the list are deemed "new ingredients."
The key highlights of IECIC 2021 are:
May 1, 2021
Starting from May 28, 2021, cosmetic registrants and notifiers are not allowed to produce or import products containing prohibited ingredients stipulated in the new inventories.
The key highlights of the new inventories are:
May 28, 2021
Starting from May 1, 2021, China implemented a notification system for low-risk NCI. As long as companies complete the submission of dossiers online, their NCI are considered as“notified” and can be added to cosmetic products. Up to now, six NCI have been publicized, four are from Chinese companies, and two are from overseas companies. They are:
List of Permitted Cosmetic Whitening Ingredients
Relevant departments are preparing to draft a list of cosmetic whitening ingredients, which is expected to influence the definition of whitening cosmetics in China.
Currently during the drafting process
During the 33rd ASEAN Cosmetic Committee Meeting (ACC) and the 34th ASEAN Cosmetic Scientific Body (ACSB) meeting, ASEAN adopted significant changes to cosmetic ingredients in the Annexes of the ASEAN Cosmetic Directive (ACD):
Adding 226 prohibited ingredients;
Adding 10 restricted ingredients;
Adding 1 permitted preservative;
Adding 1 permitted UV filter;
Amending requirements for 3 restricted ingredients, 2 permitted colorants, 1 permitted preservative, and the preamble of Annex VI: List of Preservatives Which Cosmetic Products May Contain. [Read More: ChemLinked News 1; ChemLinked News 2]
4. Japan Implements the New Japanese Standards of Quasi-drug Ingredients (JSQI 2021)
On Mar. 25, 2021, the Japan Ministry of Health, Labour and Welfare (MHLW) issued and implemented four regulatory documents, including the new Japanese Standards of Quasi-drug Ingredients (JSQI 2021), new List of Permitted Additives in Quasi-drugs, new Pre-market Application Rules of Quasi-drugs and a Collection of FAQs. The four documents revised the ingredient standards and adjusted the corresponding pre-market application requirements of quasi-drug products.
Among them, the main amendments in JSQI 2021 are particularly worthy of attention, including:
Combining the original two attached active ingredient lists into a single list, and sorting them according to the Japanese syllabaries;
Modifying the specifications of 1,453 ingredients;
Deleting the ingredient Ethanol (96);
Adding 2 general test methods, which brings the total to 84;
Revising 17 test methods. [Read More]
5. China Taiwan Implements Three New Cosmetic Regulatory Systems and An Updated List of Prohibited Cosmetic Ingredients in July
On July 1, 2021, Taiwan implemented three new cosmetic regulatory systems and an updated list of prohibited ingredients in cosmetics. The highlights are as follows:
General cosmetics are subject to notification;
New labeling requirements for cosmetic packaging, containers, labels, and directions are implemented;
Unmedicated toothpaste and mouthwash are classified as general cosmetics.
41 prohibited ingredients are revised and 254 are added. [Read More]
6. South Korea Introduces the Natural and Organic Cosmetic Raw Material Certification Mechanism
On Jan. 29, 2021, the South Korean Ministry of Food and Drug Safety (MFDS) introduced the raw material certification mechanism for natural and organic cosmetics. This new certification mechanism realized the natural and organic cosmetic accreditation by inspecting the raw materials instead of the final products. It reduces the preparation of the documents, which eases the industry's burden.
The enterprises that manufacture, process, or handle the natural or organic materials, can apply to the designated institutions for the certificates. The institutions will then review the contents of the materials in the product and issue a certificate to the applicant if the products comply with the content standard. [Read More]
7. India Clarifies Regulatory Requirements of the Cosmetics Rules 2020
On Dec. 15, 2020, India released and implemented a new cosmetic regulation, the Cosmetic Rules 2020. To help enterprises cope with the new rules, India Central Drugs Standard Control Organization (CDSCO) published a collection of FAQs and a guidance document on Jan. 19, 2021, detailing the categories, procedures, required dossiers, fees, time, etc., for the application of cosmetic import registration certificate. In addition, CDSCO postponed the commencement date of the new rules for stakeholders whose cosmetic approvals, registrations, and licenses were obtained before Dec. 15, 2020, by 18 months or until the certificates expire, whichever is later. [Read More]
8. Thailand Approves 15 Cannabis and Hemp-derived Ingredients for Cosmetics Use
In 2021, Thailand Food and Drug Administration officially allowed the use of low-THC hemp ingredients in cosmetics, and approved 15 hemp ingredients for cosmetics use. Notably, only Thailand domestic companies can produce and sell cosmetics containing these hemp ingredients, provided the product's maximum THC content is within the specified limits and specific warning is marked on the labels. The approved 15 ingredients are:
Cannabis sativa (Hemp) seed oil
Cannabis sativa (Hemp) seed extract
Cannabis sativa (Hemp) seed water
Hydrogenated hemp seed oil
Hydrolyzed hemp seed extract
Hydrolyzed Cannabis sativa seed extract
Cannabis spp. Leaf
Cannabis spp. Root
Cannabis spp. Stem
Cannabis sativa (Hemp) leaf
Cannabis sativa (Hemp) root
Cannabis sativa (Hemp) seed
Cannabis sativa (Hemp) seedcake
Cannabis sativa (Hemp) stem
9. South Korea Consults on Cosmetic Safety Standards
On Dec. 27, 2021, South Korean MFDS issued a notification to solicit public opinions on the draft of Regulation on Safety Standards, etc. for Cosmetics. The draft proposed new prohibited ingredients and the management of unintentionally added ingredients. The consultation period is set to end on Jan. 17, 2022. The key points are:
Eight perfluorinated compounds, persistent pollutants and 1,2,4-Trihydroxybenzene are proposed to be banned from being used in cosmetics;
Benzalkonium Chloride is proposed to be banned from used in the spray-type cosmetics;
New restricted colorants in hair dye products and their use limits are proposed;
Two exceptions of unintentionally adding prohibited ingredients into cosmetics are clarified. [Read More]
10. Indonesia Releases the Draft of the Criteria and Procedure for Submission of Cosmetics Notification
On Dec. 6, 2021, Indonesia released a revised draft of the Criteria and Procedure for Submission of Cosmetics Notification for public consultation. The draft clarifies the scope of notification applicants, necessary documents, notification procedures, notification template, cosmetics categories, etc. The main amendments include:
1) Slightly modifying the documents required for cosmetic notification in Indonesia;
2) Clarifying the requirements for importers and commissioning manufacturers;
3) Adding a situation that allows the use of previously notified cosmetic product names;
4) Adding notification requirements for the cosmetic product set, and applicants with multiple manufacturing sites;
5) Clarifying that applicants can apply for notification information changes for adding packaging manufacturers or manufacturing sites. [Read More]