China: Toothpaste Notification Dossiers
On Nov. 22, 2023, China’s National Medical Products Administration (NMPA) released the finalized "Provisions for Management of Toothpaste Notification Dossiers,"1 which came into effect on Dec. 1, 2023.2 This document consists of three chapters and 32 articles and outlines specific requirements for toothpaste notification, covering aspects such as product formula, labeling, efficacy claims and sales packaging. The aim is to provide clear guidance for toothpaste notifiers in preparing and submitting notification dossiers.
Key highlights include:
- Clarified dossier documentation: The documentation required for toothpaste notification largely mirrors that outlined in general cosmetics regulations. This includes the notifier’s name, address and contact details; the production enterprise’s name, address and contact details; and product name specifics, formula details, product executive standards, label sample, testing reports and safety assessment documents. However, due to the unique nature of toothpaste, certain requirements are tailored specifically for this category, particularly concerning test reports and efficacy evaluations.
- Comprehensive product testing reports: Notifiers are required to submit a comprehensive product testing report during toothpaste notification that encompasses microbiological and physicochemical testing, toxicological testing, efficacy evaluation and other relevant aspects. The testing criteria for toothpaste slightly differs from those for general cosmetics, with safety assessment requirements being somewhat relaxed for toothpaste. For example, in cases where the safety of formula ingredients cannot be confirmed through public data, toothpaste notifiers are allowed to provide objective proof of safe use history for more than three years for the ingredients.
- Supervisory focus: Special attention is given to categories such as children's toothpaste, toothpaste containing new ingredients and toothpastes with specific efficacy claims (e.g., preventing caries, inhibiting dental plaque, resisting dentin hypersensitivity and alleviating gum-related problems). These categories are subject to heightened supervision and scrutiny.
China: New Cosmetic Ingredients Identification
On Dec. 1, 2023, China's National Institutes for Food and Drug Control (NIFDC) unveiled the second draft of the "Technical Guidelines for Determination and Research of New Cosmetic Ingredients (NCIs)."3 This follows the initial release of the first draft on Jan. 19, 2023. The purpose of these guidelines is to establish standardized principles for the identification and research of NCIs. The second draft provides comprehensive insights into NCI categorization, research content and naming requirements.
Key aspects of the second draft include:4
1. Introducing two dimensions for NCI categorization.
- Management attributes categorization: NCIs are classified into three distinct groups based on their impact — those affecting cosmetic products, those affecting the surface of the human body and those influencing both products and the body's surface.
- Management categories categorization: NCIs are further delineated into three categories based on their introduction status — those introduced for the first time both domestically and internationally, those introduced solely within China and those representing enhancements or innovations to existing ingredients.
2. Introducing criteria for identifying ingredients not considered NCIs, including:
- Ingredients exceeding cosmetic definition boundaries in terms of usage method, application site or purpose.
- Ingredients explicitly prohibited by cosmetic technical regulations; ingredients sharing similarities with prohibited ingredients in structure, properties or functions; and ingredients posing potential harm to human health under normal usage conditions.
- Ingredients listed in the “Inventory of Existing Cosmetic Ingredients in China (IECIC),”5 including specific group categories and those sharing material foundations with listed ingredients.
China: Toothpaste Ingredients List
In a significant development for the oral care industry, the China Oral Care Products Industry Association (COCIA) unveiled the initial edition of the “Inventory of Existing Toothpaste Ingredients in China”6 on Jan. 12, 2024.7 This comprehensive inventory encompasses 1,026 ingredients, providing essential information such as the Chinese name, INCI/English name, highest historical use concentration and relevant notes.
All ingredients listed in the inventory have a usage history of three years or more. Companies involved in toothpaste manufacturing can refer to the highest historical use concentration provided in the inventory as evidence of ingredient safety during safety assessments for toothpaste formulations. However, for ingredients not included in the inventory, companies must follow specific guidelines:
- If a marketed toothpaste product contains ingredients not listed in the inventory and has undergone simplified notification, the company is obligated to monitor the product's adverse reactions.
- In cases where such ingredients have not been used in toothpaste products before, companies must register or notify these ingredients per the "Provisions for Management of Toothpaste Notification Dossiers.”
China: Eased Triethanolamine Restriction
In a notable regulatory adjustment, China's Ministry of Industry and Information Technology (MIIT), Ministry of Commerce (MOFCOM) and the General Administration of Customs (GACC) jointly announced on Jan. 25, 2024, the removal of import license requirements for certain products containing low-concentration triethanolamine (TEA), including cosmetics. This policy change, effective since Feb. 1, 2024, signals a significant shift in import regulations concerning TEA.8
Triethanolamine (CAS No. 102-71-6) is a common organic compound utilized in cosmetics as well as in the production of chemical weapons. Previously categorized under the “Catalogue of Dual-use Items and Technologies Subject to Import and Export License Administration,”9 TEA was subject to stringent import regulations. Regardless of concentration, exporters of cosmetics containing TEA were required to obtain an "import license for dual-use items and technologies" to export their products to China. The removal of import license requirements for certain low-concentration TEA products, including cosmetics, streamlines import procedures and reduces regulatory barriers for businesses.
Taiwan: Prohibited Ingredients
On Dec. 13, 2023, the Taiwan Food and Drug Administration (TFDA) introduced a draft amendment to the “List of Prohibited Ingredients in Cosmetics,”10 which was open for public consultation until Feb. 15, 2024.11 The key modifications include:
1. The addition of nine ingredients: The draft suggests the inclusion of the nine ingredients (see Table 1) to the list of prohibited ingredients in cosmetics. This move aims to align Taiwan's regulations with international practices observed in regions such as ASEAN and the EU.
2. Revised use conditions: The use conditions for two existing ingredients are proposed to be revised. The ingredients: "cells, tissues or products of human origin" are set to be amended to "cells, tissues or products of human origin, except for specific exosomes-related cases* that have been reviewed and approved by the competent authority." Additionally, the ingredient "zirconium and its compounds" is proposed to be altered to "cells, tissues or products of human origin, except for specific exosomes-related cases that have been reviewed and approved by the competent authority."
The effective date for these proposed revisions is scheduled for July 1, 2024, except for changes related to the substance "cells, tissues or products of human origin," which may be subject to a separate timeline.
Taiwan: Cosmetic Ingredients Lists
On Jan. 4, 2024, the TFDA announced plans to revise the current cosmetic ingredient lists, aiming to enhance regulatory clarity and align with evolving industry standards. The proposed amendments encompass the following details:
1. Abolition of specific purpose and antibacterial ingredient lists: The existing "List of Specific Purpose Ingredients in Cosmetic Products"12 and the "List of Antibacterial Ingredients Allowed in Cosmetic Products"13 are slated for elimination. Ingredients featured in these lists will be reassigned to other relevant lists.
2. Establishment of UV filters list: A new "List of UV Filters in Cosmetic Products"14 is set to be introduced, comprising 27 UV filters. Among these, 26 UV filters are sourced from the current specific purpose ingredients list, primarily used for sunscreen purposes. Titanium dioxide is sourced from the restricted ingredients list.
3. Inclusion, revision and deletion of ingredients: The TFDA proposes to add 122 ingredients to, revise 31 existing ingredients in, and remove two ingredients from the "List of Ingredients Restricted in Cosmetic Products."15
These proposed amendments were subject to public feedback until Mar. 4, 2024. Following the consultation period, the amendments are scheduled to become effective on July 1, 2024.
South Korea: Cosmetic Safety Standard
On Nov. 30, 2023, the Ministry of Food and Drug Safety (MDFS) of South Korea announced significant revisions to the “Regulation on Safety Standards, etc., for Cosmetics,” effective immediately, with certain changes related to hair dye ingredients taking effect six months later, on May 30, 2024.16
Key amendments include:
- Prohibited ingredients: Seven restricted ingredients have been designated as prohibited ingredients for hair dyes. These include 2-nitro-p-phenylenediamine and its salts; 2-amino-4-nitrophenol; 2-amino-5-nitrophenol; 2-amino-5-nitrophenol sulfate; o-aminophenol sulfate; o-chloro-p-phenylenediamine sulfate; and m-phenylenediamine sulfate.
- Revised requirements: Specific requirements for three restricted ingredients have been updated. The concentration upper limit for the restricted hair dye ingredient 2,4-diaminophenol sulfate has been reduced from 0.5% to 0.02% in oxidative hair dye products. Similarly, the limit for restricted hair dye ingredient sodium perborate has been lowered from 12% to 7% in hydrogen peroxide in hair dye (including desalting agents and decoloring agents). Additionally, a new UV-filter ingredient, methoxypropylamino cyclohexenylidene ethoxyethylcyanoacetate, has been added to the restricted ingredient list for cosmetics.
- Enhanced identification: Relevant CAS numbers and general chemical names have been inserted for both prohibited and restricted ingredients, aiding in accurate identification.
South Korea: Proposed THB Ban
On Dec. 7, 2023, the MFDS proposed amendments to the “Regulation on Safety Standards, etc. for Cosmetics” to designate 1,2,4-trihydroxy benzene (THB) as a prohibited ingredient in cosmetics.17 This proposal follows safety verification results conducted by the Cosmetic Ingredient Safety Evaluation Committee, which indicated that THB poses potential genotoxicity risks.
Upon the enactment of the proposed amendment, the use of THB in cosmetics will be strictly prohibited. However, products containing THB that have already been manufactured before the implementation of the amendment can continue to be sold until Oct. 1, 2024.
South Korea: Cosmetic Labeling
On Jan. 31, 2024, the MFDS released a legislative proposal for amendments to the “Enforcement Rule of the Cosmetics Act” and opened it for public consultation until Mar. 12, 2024.18 This initiative aims to enhance labeling requirements for special cosmetics to ensure consumer safety.
Key proposed amendments to the act include:
- Mandating the labeling of ingredients list and precautions for "external genital cleansers" and "eyelash perm wave products," irrespective of product volume.
- Allowing the use of certification results from private institutions, in addition to those from institutions delegated by the MFDS, for cosmetic advertising.
- Optimizing administrative measures concerning responsible sales manager resignation and business information changes.
Simultaneously, the draft “Regulation of Labeling Cosmetics Precautions for Use and Fragrance Allergens” was also published for consultation until Feb. 21, 2024, with key proposed amendments, including:19
- Incorporating modifications for "external genital cleansers" and "eyelash perm wave products" following updates to the “Enforcement Rule of the Cosmetics Act.” "Eyelash perm wave products" are newly added to "1. Types of Cosmetics" in Appendix 1 of the regulation, with precautionary information included in the "2. Precautions when using" section.
Additionally, the proposed revisions pertaining to eyelash perm products align with the authority's plan to classify "eyelash perm products" as cosmetics starting in 2023.20
Malaysia: Ingredient Updates
On Jan. 19, 2024, Malaysia National Pharmaceutical Regulatory Agency (NPRA) issued “Circular No. 1/2024 Information on the Updated Status of Ingredients in the Annex of the Guidelines for Control of Cosmetic Products in Malaysia.”21 The key amendments highlighted in the circular include:
- Annex II — List of prohibited ingredients: Fifteen prohibited ingredients have been added, and the names of four prohibited ingredients have been amended to ensure clarity.
- Annex III — List of restricted ingredients: The use requirements of five restricted ingredients (Methyl-N-methylanthranilate, Tagetes erecta flower extract and flower oil, Tagetes patula flower extract and flower oil, Tagetes minuta flower extract and flower oil, and Hydrogen peroxide, and other compounds or mixtures that release hydrogen peroxide, including carbamide peroxide and zinc peroxide) have been amended. Notified cosmetic products failing to comply with the updated conditions are permitted to be sold on the market until Jan. 19, 2024.
- Annex IV — List of permitted colorant: The use requirements of one permitted colorant (CI 45430) have been amended.
- Annex VI — List of permitted preservatives: One permitted preservative (methenamine 3-chloroallylochloride) has been deleted, and the preamble to Annex VI has been amended for clarity.
- Annex VII — List of permitted UV filters: Two permitted UV filters have been added, and the use requirements of one permitted UV filter (benzophenone-3) have been modified.
Indonesia: Ingredient Updates
On Aug. 24, 2023, Indonesia introduced draft amendments to the appendices in the "Technical Requirements for Cosmetic Ingredients." These amendments were finalized and implemented on Dec. 7, 2023. Key updates include:22
- Amending the use requirements of six restricted ingredients (salicylic acid, tagetes minuta flower extract and flower oil, Tagetes patula flower extract and flower oil, Tagetes erecta flower extract and flower oil, HEMA, Di-HEMA Trimethylhexyl Dicarbamate) and adding a new restricted ingredient, methyl-N-methylanthranilate;
- Revising the use requirements of one permitted colorant (CI. 77891), two permitted preservatives (salicylic acid and sodium hydroxymethylglycinate) and two permitted sunscreens (octocrylene and titanium dioxide).
Notably, cosmetics notification holders who obtained notification numbers before Dec. 7, 2023, are required to ensure compliance with the new requirements by Dec. 7, 2025
Vietnam: Proposed Cosmetic Regulation Overhaul
In a move to address existing limitations and align with contemporary requirements, the Vietnam Ministry of Health (MoH) has unveiled plans for a reform of the country's cosmetic regulations. The proposed overhaul, announced on Dec. 13, 2023, introduces a new decree on cosmetics management, comprising 15 chapters and 63 articles.23
The key focus areas for the proposed overhaul include:
- Cosmetic notification: The proposed decree seeks to refine the process of cosmetic notification by providing more detailed instructions on classifying and declaring cosmetic features. Additionally, it aims to enhance the regulations governing cosmetic notification documents, ensuring clarity and compliance for enterprises.
- Post-market surveillance: The new decree is expected to establish a national cosmetics database through the implementation of a comprehensive information system for cosmetics management and traceability, streamline the regulations on cosmetic advertising, strengthen oversight of online cosmetic businesses, etc.
- Quality enhancement for domestic cosmetics: The new decree proposes specific production requirements, specifies clear criteria that businesses must adhere to for their quality management systems and outlines procedures for granting certification of production compliance in cases where facilities undergo rearrangement or factory redesign, etc.
The proposed timeline for the new decree involves a two-stage process. The initial stage focuses on preparing decree development documents, with submission to the national assembly for consideration. The second stage outlines the draft decree development timeline, with key milestones such as submission to the government and national assembly for feedback and approval.
New Zealand: PFAS Ban
On Jan. 30, 2024, the Environmental Protection Authority (EPA) of New Zealand announced a ban on the use of per- and polyfluoroalkyl substances (PFAS) in cosmetic products.24 This decision, reflected in the amendment to the “Cosmetic Products Group Standard,” aligns with New Zealand's precautionary approach to managing potential risks associated with these chemicals.
The ban on PFAS in cosmetics comes with transitional provisions to facilitate compliance:
1. Manufacture ban: Effective Dec. 31, 2026, the manufacture of cosmetic products containing PFAS ingredients will be prohibited.
2. Sale ban: From Dec. 31, 2027, the sale of cosmetic products containing PFAS ingredients will be banned. Retailers and distributors are required to remove these products from their shelves.
3. Product disposal: Any remaining cosmetic products containing PFAS ingredients must be disposed of by June 30, 2028. This ensures the complete removal of these products from the market and minimizes potential exposure to PFAS.
Conclusion
In conclusion, recent regulatory updates across the Asia-Pacific region demonstrate ongoing efforts to enhance and refine the cosmetics regulatory framework. China in particular is making strides in areas such as toothpaste products and the regulation of new cosmetic ingredients, with the aim of ensuring product safety and compliance.
Meanwhile, ingredient updates, particularly regarding prohibited substances, are a significant focus across various countries in the Asia-Pacific region. Stakeholders are advised to pay close attention to these updates, adapt their strategies to navigate regulatory requirements effectively and ensure the quality and safety of cosmetic products in the market.
* Effective from March 21, 2023, for case review, the applicant should submit relevant documents or information, including the qualifications of the exosome donor, preparation processes and inspection reports, stability tests, safety tests, as well as absorption, distribution, metabolism, and excretion tests.
** The full list of 15 newly included prohibited ingredients is available here: https://resource.chemlinked.com.cn/cosmetic/newly-included-prohibited-ingredients.pdf
References
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Table 1.
