Monthly Recap: Global Cosmetic Regulatory Updates | March 2024

Shanghai Government Clarifies Requirements for Cosmetics Advertising

On March 6, 2024, Shanghai Municipal Administration for Market Regulation (AMR) and Shanghai Municipal Medical Products Administration (MPA) jointly released the finalized version of the Shanghai Cosmetics Industry Advertising Compliance Guidelines. Effective immediately, the Guidelines outlines the responsibilities of cosmetic manufacturers and operators, along with the required documentation for cosmetic advertising. It also specifies permissible efficacy claims, content specifications, and prohibited advertising contents.

Shanghai Reports 19 Batches of Over-Packaged Cosmetics

On March 8, 2024, Shanghai Municipal AMR unveiled the results of its supervision and random inspections conducted on cosmetic packaging in the latter half of 2023. Following standards such as GB 23350-2021, which imposes restrictions on excessive packaging for food and cosmetics, these inspections primarily targeted the interspace ratio and package layers of cosmetic packaging. Out of the 157 batches inspected, 19 were non-compliant, involving multiple well-known brands.

China May Provide Six-month Transition Period for Submission of Cosmetic Safety Assessment Report (Full Version)

On March 15, 2024, China Pharmaceutical News, the official industry newspaper of the National Medical Products Administration (NMPA), reported via their WeChat public account that NMPA had been in the process of developing optimization measures and technical guidance documents related to cosmetic safety assessment. Additionally, NMPA is considering the implementation of a six-month transition period for the submission of the full version of safety assessment reports. Registrants and notifiers of cosmetic products who initiated or will initiate safety assessments prior to May 1, 2024, will be allowed to submit a simplified version of the report within a designated timeframe.

China Unveils Guidelines for Threshold of Toxicological Concern (TTC) Method and Read Across in Cosmetic Safety Assessment

On March 20, 2024, China National Institutes for Food and Drug Control (NIFDC) published the Technical Guidelines for the Application of Threshold of Toxicological Concern (TTC) Methods and the Technical Guidelines for the Application of Read Across for public comments until April 7, 2024. These guidelines offer detailed instructions on applying the TTC method and Read Across in cosmetic safety assessments, providing valuable guidance for industry stakeholders.

China Amends the Safety and Technical Standards for Cosmetics 2015: 5 Prohibited Ingredients and 29 Testing Methods Involved

On March 21, 2024, China NMPA released two announcements detailing significant amendments to the Safety and Technical Standards for Cosmetics (2015 Edition) (STSC). The updates encompass the addition of 5 newly prohibited ingredients, the revision of 3 cosmetic testing methods, and the introduction of 11 new cosmetic testing methods along with 15 new toothpaste testing methods. Notably, the ingredient list was updated with immediate effect, while the revised testing methods are set to take effect on December 1, 2024.

China General Administration of Customs (GACC): 13 Batches of Cosmetics Rejected in the First Two Months of 2024

On March 27, 2024, GACC updated the list of rejected food and cosmetics in January and February 2024. In January, four batches of cosmetics imported from Germany failed customs inspection due to the lack of required qualified documentation and non-compliant labeling. In February, nine batches of cosmetics imported from South Korea, Thailand, Malaysia, Italy, and Spain were rejected for similar reasons, including inadequate documentation, non-compliant labeling, and expired shelf life.

China Exempts Two Types of Cosmetics from Safety Assessment Report Submission Requirements

On March 29, 2024, China NIFDC released two significant documents for public consultation: the Guidelines for Submission of Cosmetics Safety Assessment Dossiers (Draft for Comments) and the Technical Guidelines for Identification and Assessment of Cosmetic Risk Substances (Draft for Comments) until April 8, 2024.

• The former categorizes cosmetics into three tiers depending on their risk levels. Category 1 cosmetics require the submission of complete safety assessment reports, whereas Category 2 and Category 3 cosmetics are only subject to safety assessment conclusions. The safety assessment reports for Category 2 and Category 3 cosmetics can be retained by enterprises for future reference.

• The latter standardizes the identification and evaluation of hazardous substances in cosmetics, offering practical guidance to industry players.

The 2024 Annual Report Submission Period of General Cosmetics Closed on March 31

On March 31, 2024, the three-month submission period of the annual report of general cosmetics for the current year ended, which targeted general cosmetics notified before January 1, 2023, including Chinese domestic and imported products. The required reporting information includes the general situation of the production and import of the products, the suspension of production during the reporting period (if any), as well as self-inspection on the conformity of products with laws and regulations, mandatory national standards, and technical specifications.

China NMPA Approves Seven New Cosmetic Ingredients (NCIs)

In March 2024, NMPA updated the notification status of seven NCIs, while the technical requirements for these ingredients have not been made public. With these recent notifications, a total of 23 NCIs has been notified year to date.

Beijing and Guangzhou Authorities Publish FAQs Regarding Cosmetics Notification

In March 2024, Beijing Municipal MPA and Guangzhou AMR published three batches of FAQs. These FAQs address various aspects of general cosmetics notification, with a focus on requirements related to NCI, product formula, annual report, children's cosmetics, and more. 

China Issues Six Cosmetics-related Standards in March

In March 2024, China issued six cosmetics-related standards. The essential information is as follows:

Market Condition

1. According to the National Bureau of Statistics, the retail sales of cosmetic products from January to February 2024 was CNY 67.8 billion, with a year-on-year increase of 4%. Compared to the same period in previous years, the total retail sales of cosmetics products from January to February 2024 hit a new high.

2. According to the GACC, the total import value of cosmetics and toiletries from January to February 2024 totaled CNY 16.79 billion, declining 16.7% YoY. In January, the import value was CNY 9.77 billion, with a 18.1% YoY increase. In February, the import value decreased by 40.9% YoY to CNY 7.02 billion.

Taiwan Amends the List of Prohibited Ingredients in Cosmetics

On December 13, 2023, Taiwan Food and Drug Administration (TFDA) introduced the draft amendments to the List of Prohibited Ingredients in Cosmetics. These amendments were finalized on March 21, 2024, with the majority of them set to take effect on January 1, 2025. Compared to the current list, the updated list newly includes nine ingredients, and revises the use conditions of two existing ingredients.

PMDA: 82 Batches Cosmetics Recalled in March

In March 2024, Japan Pharmaceuticals and Medical Devices Agency (PMDA) issued notifications regarding 82 batches of non-compliant cosmetics that were recalled due to labeling violations. The notification highlighted several issues found on the labels, including:

1. Lack of Japanese labels on the immediate containers of the products.

2. Inappropriate labeling of product efficacy in English on the outer packaging.

3. Incorrect manufacturer and distributor information displayed on the labels.

4. Inclusion of ingredients on the labels that were not actually present in the products.

Japan Plans to Approve a New Ingredient for Rinse-off Hair Styling Products

On March 8, 2024, the Ministry of Health, Labour and Welfare of Japan opened the consultation of a proposal for the Standards for Cosmetics, requesting the inclusion of "Cysteamine Hydrochloride". Any comments can be submitted before April 8, 2024.

Japan JCIA Updates Voluntary Standards for Tar Colors
On March 19, 2024, Japan Cosmetics Industry Association (JCIA) released an amendment for Voluntary Standards for Tar Colors in Cosmetics. The amendment stated that the JCIA established voluntary management limits to regulate the presence of specific aromatic amines and potential impurities in nine types of tar colors, and set maximum limits for five specific aromatic amines.

South Korea to Modify Two Guidelines of Alternative Animal Testing Methods for Cosmetics

On March 14, 2024, The Korean Cosmetic Association (KCIA) published a notice for public opinion on the modifications of two guidelines of alternative animal testing methods for cosmetics. The proposed modifications lie in two aspects:

Firstly, the authority intends to amend the provisions related to material information and excipients in the Guidelines of Alternative Animal Testing Methods for Cosmetics: Phototoxicity Test Using Reconstructed Human Epidermis.

Additionally, the test method’s name and the referenced materials are proposed to be modified in the Guideline of Alternative Animal Testing Methods for Cosmetics (In Vitro Skin Sensitization: ARE-Nrf2 Luciferase LuSens Test).

South Korea Publishes the Cosmetic Policy Plan for 2024

On March 21, 2024, the Ministry of Food and Drug Safety (MFDS) publishes three main initiatives for the cosmetics industry in 2024, with plans to establish the cosmetics safety assessment system and implement the cosmetics e-label pilot project. The main initiatives include implementation of a proactive safety network based on science, improvement of safety and welfare, and innovation of regulation.

Indonesia Proposes to Amend Cosmetic Ingredient Use Requirements

On March 1, 2024, the Indonesian Agency for Food and Drug Control (BPOM) released the amended draft of the Technical Requirements for Cosmetic Ingredients for public consultation until March 19, 2024. The proposed amendments include:

1. Deleting requirements specifically related to cosmetics containing alpha arbutin or beta arbutin;

2. Appendix I: List of Restricted Ingredients – 1 revised;

3. Appendix III: List of Permitted Preservatives – 2 deleted;

4. Appendix IV: List of Permitted Sunscreens – 1 revised;

5. Appendix V: List of Prohibited Ingredients – 75 added.

Indonesia BPOM Unveils the 2024 Legislative Plan

On March 1, 2024, BPOM released the 2024 legislative plan, including the finalized/draft version of amendments and new regulations. Among them, 11 are related to cosmetics.

Indonesia BPJPH Emphasizes Mandatory Non-halal Information Labeling for Non-halal Products

According to Indonesian Halal Product Assurance Organizing Agency (BPJPH)’s article published on March 24, 2024 on its website, products originating from non-halal sources or containing non-halal materials are not subject to the halal certification requirement. Because these products are exempt from halal certification, they can still be traded as long as their non-halal nature are clearly labeled.

Malaysia Publishes Three Information Sharing Papers on Cosmetic Refilling, Cosmetics in Vials and Ampoules, and Personalized Cosmetics

On March 27, 2024, Malaysia National Pharmaceutical Regulatory Agency (NPRA) released an announcement regarding three information sharing papers adopted during the 37th ASEAN Cosmetic Committee Meeting held on May 8-9, 2023. These papers cover topics including cosmetics refilling, cosmetics in vials and ampoules, as well as personalized cosmetics. They serve as guidance for the industry and are not legally binding as they are not part of the Guideline for Control of Cosmetic Products in Malaysia.

Vietnam Bans 15 Substances as Cosmetic Ingredients

On March 4, 2024, the Drug Administration of Vietnam (DAV) issued amendments to the annexes of the ASEAN Cosmetic Directive (ACD). The amendments include the prohibition of 15 substances as cosmetic ingredients, the establishment of the maximum concentration limits for three cosmetic ingredients, and some other requirements.

India Updates the Standard for para-Phenylenediamine in Cosmetics

On March 19, 2024, the Bureau of Indian Standards (BIS) issued the IS 10377: 2024 Specification for para-Phenylenediamine (First Revision), superseding the previous edition published in 1982 and reaffirmed in 2019. This updated standard brings several notable changes, including a refined material description and the inclusion of requirements for heavy metals and impurities, along with their corresponding test methods.

Australia Adds Two Cosmetic Ingredients to the Australian Inventory of Industrial Chemicals (AIIC)

On March 5, 2024, the Australian Industrial Chemicals Introduction Scheme (AICIS) made additions to the AIIC under Section 83 of the Industrial Chemicals Act 2019. The newly added substances are as follows:

1. Cyclopentanol, 2-methyl-5-(1-methylethyl)-, 1-propanoate (CAS No. 1245725-35-2)

2. 2(3H)-Furanone, 5-(6-hepten-1-yl)dihydro-, (5S)- (CAS No. 3017933-60-4)

These ingredients have undergone assessment and are permitted for importation in fragrance formulations for local reformulation into cosmetics and household products. The maximum annual import volume allowed for each ingredient is one ton.

Australia No Longer Permits Cosmetic Injectables to Be Advertised with Terms Promoting Prescription Medicines

On March 7, 2024, the Therapeutic Goods Administration (TGA) announced the update to its guidance regarding the advertising of cosmetic injectables. Previously, the TGA allowed the use of terms like “wrinkle reducing injections” to distinguish cosmetic clinics offering these services from those that did not. However, the TGA has now prohibited the use of such terms in advertising for cosmetic injectables.

The reason is that the TGA considers these terms are presented to promote prescription medicines. This update is in line with the approach taken by other regulators in Australia, which emphasize the involvement of healthcare professionals in performing non-surgical cosmetic procedures. It also acknowledges the growing vulnerability of Australians who may be influenced by advertisements in the cosmetic industry.

Australia Releases Assessment Statements of 15 Cosmetic Ingredients

On March 12, the AICIS published the assessment statements of 20 new chemicals under the section 37 of the Industrial Chemicals Act 2019. Among them, 15 are components for cosmetic and household products, including:

• 2H-Pyran-4-ol, 2-(1-ethylpropyl)tetrahydro-4-methyl-

• 2H-Pyran, tetrahydro-3-(phenylmethyl)-

• 7-Nonenal, 6,8-dimethyl-

• 9-Decen-2-one

• 2-Pentanol, 1-[[(2S,5R)-4,4,8-trimethyltricyclo[6.3.1.02,5]dodec-1-yl]oxy]-, (2R)-

• 2-Pentanol, 1-[[(2S,5R)-4,4,8-trimethyltricyclo[6.3.1.02,5]dodec-1-yl]oxy]-, (2S)-

• 2-Pentanol, 1-[[(2S,5R)-1,4,4-trimethyltricyclo[6.3.1.02,5]dodec-8-yl]oxy]-, (2R)-

• 2-Pentanol, 1-[[(2S,5R)-1,4,4-trimethyltricyclo[6.3.1.02,5]dodec-8-yl]oxy]-, (2S)-

• 1,3-Dioxane, 2-(3,3-dimethyl-1-cyclohexen-1-yl)-2,5,5-trimethyl-

• Hexanal, 6-cyclopentylidene-2H-Pyran-2-one, tetrahydro-5-propyl-

• 2H-Pyran, 3,6-dihydro-4-methyl-2-[(2,2,3-trimethyl-3-cyclopenten-1-yl)methyl]-

• 2H-Pyran, 5,6-dihydro-4-methyl-2-[(2,2,3-trimethyl-3-cyclopenten-1-yl)methyl]-

• 2H-Pyran, tetrahydro-4-methylene-2-[(2,2,3-trimethyl-3-cyclopenten-1-yl)methyl]-

• 2H-Pyran, 3-heptyltetrahydro-

Australia Amends Categorization, Reporting, and Record-keeping Requirements for Industrial Chemicals

On March 21, 2024, the AICIS announced the amendment to the Industrial Chemical (General) Rules 2019. The amendment, scheduled to take effect on April 24, 2024, mainly involves the following content:

1. Records replace some written undertakings, making compliance easier for introducers (manufacturers or importers) who find it difficult to obtain undertakings from chemical identity holders.

2. International Nomenclature of Cosmetic Ingredients (INCI) names are accepted for three types of exempted/reported introductions, if the introducer does not know the CAS or IUPAC (International Union of Pure and Applied Chemistry) name.

3. Categorization criteria are expanded for:

   a) Domestic soap makers

   b) Introducers of chemicals in flavor and fragrance blends

   c) Introducers of hazardous chemicals where introduction and use are controlled.

4. Criteria and/or reporting requirements are enhanced for health and environmental protection, as an effort to prevent persistent organic pollutants (POPs) from being categorized as exempted or reported introductions.

Australia Amends the Industrial Chemicals Categorization Guidelines

On March 27, 2024, the AICIS declared that Version 2 of the Industrial Chemicals Categorization Guidelines would be published and come into force on April 24, 2024, coinciding with the entry-into-force time of the amendment to the General Rules will take effect.

Key changes to the Guidelines include:

1. Requirements are more detailed for checking for hazardous esters and salts of chemicals on the “List of Chemicals with High Hazards for Categorization” (hereafter referred to as the List)

2. Highly hazardous chemicals are added to the List based on an AICIS assessment or evaluation

3. Options are expanded for introducers to demonstrate the absence of skin irritation and skin sensitization.

4. More models are provided for in silico predictions and an added test guideline for ready biodegradability.

Another update of the Guidelines is scheduled to be published in September this year.

Washington State to Ban Animal Testing for Cosmetics

On March 15, 2024, the Governor of Washington State signed HB 1097 into law, prohibiting the sale of cosmetics developed or manufactured using animal testing within the state. The legislation is set to take effect on January 1, 2025.

Health Canada Extends Comment Period for Updates to the Use Requirements for Five Cosmetic Ingredients

On July 13, 2023, Health Canada issued a notice regarding the review of proposed amendments to the Cosmetic Ingredient Hotlist. Recently, Health Canada extended the comment period for updates to the use requirements for five cosmetic ingredients for 60 days starting from March 13, 2024. The ingredients for which comments are invited are as follows:

1. Thioglycolic acid esters

2. Retinoic acid precursors (Retinal and Retinol and its esters)

3. Mixed cresols and derivatives (p-, m-, and o-Cresol)

4. Aluminum chlorohydrate and its associated complexes

5. Peroxide and peroxide-generating compounds and Benzoyl Peroxide.

For updates to use requirements for other ingredients, Health Canada will review the comments received during the 2023 consultation period. Minor changes may be made to entries for clarity. The final updates to these ingredients in the Hotlist are expected to be released in Spring 2024.

EU SCCS Consults on the Opinion About Acetylated Vetiver Oil

On March 5, 2024, EU Scientific Committee on Consumer Safety (SCCS) released the preliminary opinion on the inhalation toxicity of Acetylated Vetiver Oil (CAS No. 84082-84-8) in sprayable cosmetics. It is open for comments until May 3, 2024.

EU Amends the Use Requirements for 13 Nanomaterials in Cosmetics

On May 23, 2023, EU notified WTO of a draft Commission Regulation, proposing to ban the use of 12 nanomaterials, and restrict the use of Hydroxyapatite (nano) in cosmetics. On March 15, 2024, EU published the finalized regulation in its Official Journal, set to come into effect on April 4, 2024.

EU SCCS Finalizes Opinions on Two Cosmetic Ingredients

In March, SCCS issued the final opinions respectively on Hexyl Salicylate, as well as Hydroxypropyl p-Phenylenediamine and its dihydrochloride salt. These opinions uphold the same conclusions as their preliminary versions.