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Chinese Mainland
Toothpaste Labels with Formatting Issues Shall Be Updated Before July 1, 2024
On September 25, 2023, the National Medical Products Administration (NMPA) issued a notice to implement toothpaste supervision regulations and simply notification document requirements for toothpaste already available in the market. For toothpaste already available in the market prior to December 1, 2023, any labels with formatting issues shall be updated to comply with the new regulations by July 1, 2024.
The GACC Releases the Prohibited Entry List on Cosmetics in April
On June 3, 2024, the GACC updated the list of rejected food and cosmetics in April 2024. One batch of cosmetics imported from France failed customs inspection due to the lack of required certificates or certification documents.
Shandong and Guangzhou Authorities Publishes Three Batches of FAQs
In June 2024, Guangzhou Administration for Market Regulation (AMR) and Shandong Center for Food and Drug Evaluation&Inspection released three batches of FAQs, regarding safety assessment, quality and safety system, cosmetic ingredients, efficacy claims, etc.
Release Date | Regulatory Authority | Batch |
June 4, 2024 | Guangzhou AMR | |
June 7, 2024 | ||
June 21, 2024 | Shandong Center for Food and Drug Evaluation&Inspection |
China NMPA Approves Nine NCIs
In June, the NMPA updated the notification status of nine NCIs. With these recent notifications, a total of 46 NCIs has been notified year to date. Since the detailed technical requirements for newly notified NCIs have not been made public, the English translations below are merely literal translations based on these NCIs’ Chinese names, which may differ from the INCI names provided by notifiers.
3-Hydroxybutyric Acid Glyceride, notified on June 3, 2024
Dihydroquercetin, notified on June 4, 2024
NAEMATELIA AURANTIALBA FRUITING BODY EXTRACT, notified on June 12, 2024
Bakuchiol, notified on June 14, 2024
Hydroxyectoine, notified on June 18, 2024
Cyclotetrapeptide-24 Aminocyclohexane Carboxylate, notified on June 18, 2024
MECONOPSIS RACEMOSA, notified on June 24, 2024
Vitamin K2, notified on June 25, 2024
Fucosyllactose, notified on June 27, 2024
China Issues 12 Cosmetic-related Standards in June
In June 2024, China issued seven cosmetics-related standards and five draft cosmetics standards for public comments. The essential information is as follows:
Release Date | Initiator | Standard Name | Effective Date |
June 5, 2024 | Shanghai Daily Chemistry Trade Association | T/SHRH 60—2024 Guidelines of Precision Skincare Cosmetic Research and Development | June 30, 2024 |
June 5, 2024 | Shanghai Daily Chemistry Trade Association | T/SHRH 061—2024 Guideline for Long-lasting Efficacy Evaluation of Facial Base Makeup | June 30, 2024 |
June 5, 2024 | Shanghai Daily Chemistry Trade Association | T/SHRH 062—2024 Guidelines for General Requirements for Clean Makeup | June 30, 2024 |
June 6, 2024 | Guangdong Cosmetics Association | T/GDCA XXXX—2024 General Principles of Concentrated Cosmetics Essence | / |
June 7, 2024 | Hangzhou Industrial Design Association | / | |
June 7, 2024 | Testing Inspection and Certification Association in Chengdu | June 21, 2024 | |
June 12, 2024 | China Association for Promoting International Economic & Technical Cooperation | T/CIET 543—2024 General Guideline on Carbon Footprint Assessment for Skincare Products | June 12, 2024 |
June 12, 2024 | China Association for Promoting International Economic & Technical Cooperation | T/CIET 544—2024 Specifications for Evaluation of Green Factory in Cosmetics Industry | June 12, 2024 |
June 13, 2024 | Wuhan Internet Industry Chamber of Commerce | June 28, 2024 | |
June 25, 2024 | Science and Technology Department within Ministry of Industry and Information Technology | / | |
June 25, 2024 | Science and Technology Department within Ministry of Industry and Information Technology | / | |
June 25, 2024 | Science and Technology Department within Ministry of Industry and Information Technology | / |
Market Condition
1. According to the National Bureau of Statistics, the retail sales of cosmetic products from January to May 2024 was CNY 176.3 billion, with a year-on-year increase of 5.4%. In May, the retail sales increased by 18.7% YoY to CNY 40.6 billion.
2. According to the GACC, the total import value of cosmetics and toiletries from January to May 2024 was CNY 50.46 billion, declining 10.5% YoY. In May, the import value decreased by 1.7% YoY to CNY 10.7 billion.
Taiwan, China
Taiwan Introduces Two Testing Methods for Cosmetic Colorants
On June 14, 2024, Taiwan Food and Drug Administration (TFDA) released two recommended testing methods for cosmetics, outlining the procedures for determining 22 colorants in cosmetics. The basic information about these two methods is as follows:
No. | Method Name | Colorants Involved |
1 | 12 colorants including pigment orange 13, beta-carotene, solvent green 3, pigment blue 66, pigment red 49, pigment red 64, acid yellow 3, pigment red 57, pigment red 48, pigment red 63, acid yellow 73, and D&C red No. 30. | |
2 | 10 colorants including acid blue 62, disperse yellow 16, food orange 3, solvent red 3, pigment red 53, acid blue 7, acid red 50, direct orange 39, food blue 5, and food green 4. |
Taiwan Updates Applicable Products for PIF Requirements
On June 26, 2024, TFDA released the finalized Cosmetic Categories Required to Establish the Product Information File and Effective Dates (2024), which took effect on July 1, 2024. Compared to the 2019 version, the new regulation revises the terminology and updates its applicable scope.
On June 26, 2024, TFDA announced to repeal Documents Required for Applying Modification of Registrations and Licenses for Specific Purpose Cosmetics. This abolition, aligned with the cancellation of the specific purpose cosmetics category, became effective on July 1, 2024.
Taiwan Updates the Scope for Pre-market Product Notification Requirement
On June 26, 2024, TFDA approved the establishment of Cosmetic Categories Required to Complete Product Notification, repealing the Cosmetic Categories Required to Complete Product Notification and Effective Dates. Under the new regulation, except for solid handmade soaps manufactured in factories enjoying registration exemption, all other cosmetic categories shall be in line with the notification requirement starting from July 1, 2024.
Taiwan Modifies the Applicable Products for GMP Requirements
On May 10, 2024, TFDA announced the draft of Cosmetic Categories for Which Manufacturing Premises Shall Comply with Cosmetics Good Manufacturing Practice Regulations, intended to replace its predecessor titled Cosmetic Categories That Shall Comply with Cosmetics Good Manufacturing Practice Regulations. The draft was finalized on June 28, 2024, and came into force upon its release.
Japan
PMDA: 40 Batches Cosmetics and Quasi-drugs Recalled in June
In June 2024, Japan Pharmaceuticals and Medical Devices Agency (PMDA) notified and recalled a total of 40 batches of cosmetic and quasi-drug products. According to the statistics, over 80% of the recalled products that were recalled were due to incorrect label information, including issues with listed ingredients, expiration dates, and seller details, etc.
Singapore
HSA Alerts 3 Batches of Non-compliant Cosmetics Containing Potent Ingredients Found Overseas
On June 6, 2024, Singapore's Health Sciences Authority (HSA) released a list of products found and reported by overseas regulators in May 2024 that contain potent ingredients, including 3 batches of cosmetics. The potent ingredients detected in these cosmetics include Betamethasone, Mercury, and Hydroquinone, which are prohibited for general use in cosmetics in accordance with ASEAN Cosmetic Directive (ACD).
HSA Amends Regulatory Fees for Cosmetic Products Notification and GMP Certificate
On June 3, 2024, Singapore’s Health Sciences Authority (HSA) issued Health Products (Fees) (Amendment) Regulations 2024, which includes adjustments to the fees for cosmetic products notification and GMP certificate. As revealed by the amendment, fee increase of 5% in average will be implemented, with the minimum increase of $1 and capped at $200 per fee item. This fee revision is necessary to help the HSA recover a portion of the costs associated with the services provided to businesses.
Malaysia
Malaysia Updates Guidance for Preparation of GMP Inspection
National Pharmaceutical Regulatory Agency (NPRA) released an updated June 2024 version of the Guidance Document for Preparation of GMP Inspections on Traditional Medicines, Health Supplements and Cosmetics Manufacturers, superseding the previous 2021 edition. The revisions include:
1. Revising document submission requirements
2. Updating GMP inspection application process
Malaysia Amends Cosmetic Ingredient Use Requirements: 1 Added and 3 Ingredients Revised
On June 19, 2024, NPRA released Circular No. 2/2024 Information on the Updated Status of Ingredients in the Annex of the Guidelines for Control of Cosmetic Products in Malaysia. The amendments are:
1. Annex III: List of Restricted Ingredients - 1 added and 3 revised
2. Annex II, III, VI and VII: List of Prohibited Ingredients, Restricted Ingredients, Permitted Preservatives and Permitted UV Filters - some administrative changes.
Vietnam
Vietnam to Update the HS Codes for Imported and Exported Cosmetics
On June 11, 2024, Vietnam’s Ministry of Health (MoH) issued Circular 09/2024/TT-BYT, updating the Harmonized System (HS) codes for imported and exported drugs, medicinal ingredients, and cosmetics, aiming to supersede the previous Circular 06/2018/TT-BYT. Major changes in List 14 of the new Circular pertain to cosmetics, encompassing product names, newly added items, and HS codes. The new Circular will come into force on July 26, 2024. Companies shall follow the updated Circular when declaring cosmetics for import/export by then.
Vietnam to Establish Decree for Halal Products and Services
On June 25, 2024, Vietnam’s Ministry of Science and Technology (MOST) issued an official notice to seek public opinion on developing the draft Decree on the Management of Halal Products and Services. This draft is developed to go align with the increasing demand for halal product and service both in Vietnam and the rest of the world. Any opinions can be sent to vuhchq@tcvn.gov.vn prior to July 25, 2024.
Thailand
Thailand Consults on Updated Fee Structure for Cosmetic Applications and Approvals
On June 5, 2024, the Thai Food and Drug Administration (Thai FDA) initiated a 15-day public consultation on a draft proposal to revise fees for the cosmetic review process. The draft primarily aims to modify the fees for inspecting establishments involved in cosmetic production, import, or contract manufacturing. Once approved, it will replace the current fee regulation.
India
India Revises Two Standards Relating to Fragrance and Flavour
On May 17, 2024, the Bureau of Indian Standards (BIS) enacted two revised standards relating to fragrance and flavour. The two standards are IS 3926: 2024 Methyl Cinnamate—Specification (Second Revision) and IS 4272: 2024 Vanillin — Specification (Second Revision).
Australia
Australia TGA Updates the Poisons Standard
On June 3, 2024, the Therapeutic Goods Administration (TGA) published the Therapeutic Goods (Poisons Standard – June 2024) Instrument 2024. The new Instrument removes dioxane from clause 1 “Substances exempt at or below certain concentrations” of Appendix G—Dilute preparations and adds exception conditions for dioxane in Schedule 6—Poisons.
Australia Adopts Updated Good Manufacturing Practice (GMP) Guide for Sunscreens
On June 3, 2024, the TGA updates the GMP Guide for sunscreens, unless exempt under the Therapeutic Goods Act 1989 (the Act). The most significant change in the updated GMP guide is the addition of a new Annex 16. The new annex will come into force from September 3, 2024, allowing a three-month transition period for manufacturers. All other changes (i.e., clarifications in Annex 13) are in force from June 3, 2024.
Australia Launches a New Online Tool for Environment Categorization Volume Calculation
On June 17, 2024, the Australian Government launched a new online tool on the AICIS website, making it easier for chemical importers and manufacturers to calculate the environment categorization volume (ECV). Accurate ECV calculation is vital for determining the appropriate environment exposure band (ranging from 1 to 4) applicable to their chemical introductions.
Australia Updates the List of Rolling Action Plan
On June 28, 2024, the AICIS updated its Rolling Action Plan, including completed evaluations of 13 chemicals related to cosmetic use. Each evaluation statement provides comprehensive information on the evaluation subject, reasons, environmental impacts, health hazards, and other relevant details.
The European Union
EU to Ban 21 CMR Substances in Cosmetics from September 2025
On June 24, 2024, EU notified WTO of a draft, proposing amendments to the prohibited and restricted ingredients lists of Regulation (EC) No 1223/2009, in response to newly classified CMR substances (those classified as carcinogenic, mutagenic or toxic for reproduction) in Commission Delegated Regulation (EU) 2024/197. The proposed amendments include:
1. Revising 1 prohibited ingredient, and adding 21 prohibited ingredients;
2. Deleting 1 restricted ingredient.
The United States
Prop 65 TiO2 Warning Lawsuits Halted by California Court Injunction
On May 26, 2023, the Personal Care Products Council (PCPC), an American trade association, filed a constitutional challenge against the Proposition 65 (Prop 65) warning for titanium dioxide, arguing it violated the First Amendment to the United States Constitution as compelled speech. They filed for a preliminary injunction on October 6, 2023. On June 12, 2024, the U.S. District Court for the Eastern District of California issued a preliminary injunction prohibiting any new lawsuits to enforce the Prop 65 warning requirement for titanium dioxide in cosmetic and personal care products.
Connecticut to Ban PFAS in Cosmetics
On June 5, 2024, the governor of Connecticut state signed the Senate Bill No. 292 into law, which will ban the manufacturing, sale, and distribution of cosmetics (excluding soap) that intentionally contain PFAS from July 1, 2026, unless certain exemption conditions are met. A complete ban on the use of PFAS in cosmetics will take effect on January 1, 2028.
Rhode Island to Ban PFAS in Cosmetics
On June 26, 2024, the governor of Rhode Island signed the Senate Bill No. 2152 into law. The bill prohibits the intentional addition of PFAS in cosmetics (excluding soap) sold or manufactured in the state from January 1, 2027.
Canada
Canada Extends the Comment Period on Amendments to Certain Ingredient Use Requirements
On July 13, 2023, Health Canada released a notice concerning the review of several amendments to the Cosmetic Ingredient Hotlist. In May 2024, Canada adopted changes to the use requirements for 9 cosmetic ingredients. In June 2024, Health Canada announced to extend the comment period for the remaining cosmetic ingredients to July 8, 2024.
Canada Proposes to Streamline Requirements for Cannabis Regulations
On June 8, 2024, Canada proposed amendments to certain regulations concerning cannabis, aiming to streamline current regulatory requirements for cannabis. These amendments cover five core aspects, namely, licensing, personnel and physical security measures, production requirements, packaging and labeling requirements, as well as record-keeping and reporting.
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