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In 2024, the global cosmetic industry made significant strides in regulations and enforcement aimed at enhancing the safety, quality, and transparency of cosmetics. Governments around the world introduced new policies and regulations to support these objectives, including the release of the MoCRA rules, updates to safety standards, and revisions to ingredient usage requirements. In this article, ChemLinked highlights the top 10 key updates from major regions worldwide.
1. China Grants One-year Buffer for Safety Assessment Report Submission
On April 22, 2024, the China National Medical Products Administration (NMPA) announced measures to optimize cosmetic safety assessment management. Effective until May 1, 2025, cosmetic registrants and notifiers can submit a simplified safety assessment report if the assessment commenced before May 1, 2024. This initiative acknowledges the time needed for cosmetics research and development, easing the burden on companies and facilitating a smoother transition to full safety assessment compliance.
To guide companies, in 2024, the NMPA released several new regulatory documents concerning safety assessments, including guidelines that categorize submission requirements based on risk management principles and provide self-examination points for assessment reports.
ChemLinked Comments
Although the requirement for a full safety assessment report is not yet enforced, local regulatory authorities in China encourage companies to submit the full version now. Businesses should familiarize themselves with the relevant guidelines to ensure timely compliance once the requirement takes effect.
2. U.S. FDA Sets New Schedules for MoCRA Rulemakings
In July 2024, the Office of Information and Regulatory Affairs (OIRA) released the Spring 2024 Unified Agenda of Regulatory and Deregulatory Actions, announcing delays in rulemaking for fragrance allergens and asbestos testing methods mandated by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA).
On December 13, 2024, OIRA published the Fall 2024 Unified Agenda, further revising and delaying the target dates for four proposed cosmetic rules, including three MoCRA-mandated rules. These revised timelines provide the cosmetics industry with additional time to update production processes, revise product labeling, and implement new safety measures.
Proposed Rule | Fall 2024 Agenda |
MoCRA Rule: Testing Methods for Detecting and Identifying Asbestos in Talc-Containing Cosmetics | December 2024 |
MoCRA Rule: Disclosure of Fragrance Allergens in Cosmetic Labeling | January 2025 |
MoCRA Rule: Good Manufacturing Practice for Cosmetic Product Facilities | October 2025 |
March 2025 |
ChemLinked Comments
The draft of Testing Methods for Detecting and Identifying Asbestos in Talc-Containing Cosmetics was released on December 26, 2024. However, the MoCRA Rule on Disclosure of Fragrance Allergens in Cosmetic Labeling was not published as scheduled in January 2025. The anticipated publication dates for these rules remain tentative and may face further delays.
ChemLinked advises cosmetic stakeholders to closely monitor FDA developments to ensure compliance readiness and avoid potential penalties.
3. ASEAN Amends Cosmetic Ingredient Requirements in the Annexes of ACD
In 2024, ASEAN held the 39th and 40th ASEAN Cosmetic Scientific Body (ACSB) meetings, during which revisions to the ingredient annexes of the ASEAN Cosmetic Directive (ACD) were introduced. These amendments include
addition of 26 prohibited ingredients and 2 restricted ingredients;
revisions to 3 prohibited ingredients, 4 restricted ingredients, 9 permitted preservatives, and 4 permitted UV filters.
ChemLinked Comments
ASEAN conducts biannual ACSB meetings, where the ingredient use requirements in the ACD annexes is revised. These revisions will gradually be adopted by ASEAN countries. Companies intending to export cosmetics to the ASEAN market should promptly verify if their products contain any soon-to-be-banned ingredients and make necessary formula adjustments before the regulatory transition period concludes.
4. EU to Ban 21 CMR Substances in Cosmetics from September 2025
On June 24, 2024, the EU notified the WTO of a draft proposing amendments to the prohibited and restricted ingredients lists under Regulation (EC) No 1223/2009 (Cosmetics Regulation). The draft is set to take effect on September 1, 2025.
The proposed amendments introduce 23 changes to the ingredient lists of the Cosmetics Regulation, including:
1) Revising 1 prohibited ingredient, and adding 21 prohibited ingredients;
2) Deleting 1 restricted ingredient.
ChemLinked Comments
The 21 newly prohibited ingredients are all classified as CMR substances (carcinogenic, mutagenic, or toxic for reproduction). This update aligns with the latest CMR classifications in Commission Delegated Regulation (EU) 2024/197. To maintain a consistent prohibition across the internal market, the EU has developed this draft to integrate these substances into the Cosmetics Regulation, ensuring they take effect on the same date as Commission Delegated Regulation (EU) 2024/197.
5. Australia Adopts Updated Sunscreen Standards with Transition Periods
On April 11, 2024, Australia’s Therapeutic Goods Administration (TGA) announced the adoption of the Australian/New Zealand Standard: Sunscreen Products – Evaluation and Classification (AS/NZS 2604:2021) into its therapeutic goods legislation. This 2021 standard replaces the 2012 version and introduces updated testing and labeling requirements for sunscreens in Australia.
Key updates include the incorporation of the latest ISO testing standards, a new flowchart to guide sponsors in determining the applicable sections for primary and secondary sunscreens, and enhanced labeling instructions for aerosol and spray pump sunscreens to reduce misuse and inhalation risks.
ChemLinked Comments
Along with this adoption, the TGA released transition arrangements that businesses must follow. Starting July 1, 2024, all new sunscreen products in the Australian Register of Therapeutic Goods (ARTG) must comply with the updated Sunscreen Standard. Existing aerosol and spray pump products listed in the ARTG before July 1, 2024, have a one-year transition period for labeling updates, while all other sunscreen products (aerosol and non-aerosol) listed before this date have five years to meet revised testing requirements.
By the end of the transition period, full compliance with the updated standard will be mandatory for all sunscreens in Australia.
6. Thailand Updates Titanium Dioxide Regulations for Cosmetics
On November 18, 2024, the Thai Food and Drug Administration (Thai FDA) officially approved amendments to regulations governing the use of Titanium Dioxide in cosmetics. The updated regulations revise Titanium Dioxide requirements as a restricted ingredient, permitted colorant, and sunscreen, ensuring alignment with ASEAN standards. These updates, which reflect changes introduced in the ASEAN Cosmetic Directive (ACD) during the 36th ASEAN Cosmetic Scientific Body (ACSB) meeting, aim to align Thailand's cosmetics regulations with regional standards.
ChemLinked Comments
The amendments took effect on November 19, 2024. Companies should be aware of the transition period associated with these updates. A 180-day grace period has been provided for cosmetic stakeholders to comply with ingredient-related changes if their products containing the affected Titanium Dioxide ingredients were manufactured, imported, or sold before the announcement. However, there is no grace period for updates to the labeling requirements.
7. Taiwan Restructures Cosmetic Ingredient Lists
On January 4, 2024, Taiwan Food and Drug Administration (TFDA) revealed its plans to adjust the cosmetic ingredient lists. The proposed amendments were finalized on May 30, 2024, and took effect on July 1, 2024.
The amendments adopted by TFDA mainly include:
1) Abolishing the current List of Specific Purpose Ingredients in Cosmetic Products, and the List of Antibacterial Ingredients Allowed in Cosmetic Products;
2) Newly establishing the List of UV Filters in Cosmetic Products;
3) Adding 122 ingredients to, revising 31 ingredients in, and deleting 2 ingredients from the List of Ingredients Restricted in Cosmetic Products.
ChemLinked Comments
The cosmetic ingredient list has undergone significant adjustments. The abolition of the two lists aligns with Taiwan's cosmetic category adjustments and international practices. The newly established UV filter list ensures continued regulation after the abolishment of the original lists. Additionally, the restricted ingredient list has been substantially revised. Enterprises must stay informed and comply with the updated regulations.
8. South Korea Consults on Cosmetic Safety Standard
On August 2, 2024, South Korea’s Ministry of Food and Drug Safety (MFDS) released a public consultation on proposed changes to the Cosmetic Safety Standard. Key updates include the addition of a new UV filter, the removal of an existing one, and revised usage limits for six restricted ingredients. Notably, the use of compounds of Lawsone and Dihydroxyacetone as UV filters will be banned, while Tris-Biphenyl Triazine will be introduced as a new UV filter. Specific usage limits will also be set for ingredients like Benzophenone-3, D4, and D5.
ChemLinked Comments
These amendments reflect MFDS's proactive stance on public health by restricting certain ingredients and tightening regulations. For cosmetics companies, these changes may require adjustments in product formulations.
The amendments will take effect six months after its official publication. A two-year grace period will be provided for products manufactured or imported before the amendments come into force. Additionally, companies with products containing D5 will receive a three-year grace period to find alternative ingredients. These transitional periods will help businesses make the necessary adjustments to comply.
9. New Zealand Releases Updated Cosmetic Products Group Standard
On February 24, 2023, New Zealand’s Environmental Protection Authority (EPA) formally received an application under Section 96B of the Hazardous Substances and New Organisms Act 1996 to amend the Cosmetic Products Group Standard 2020 (Group Standard). Following a nearly year-long review, the amendments were approved in January 2024.
Key amendments include:
Expanding the applicable scope of the Group Standard;
Phasing out PFAS (per- and polyfluoroalkyl substances);
Updating ingredient lists to align with EU cosmetic regulations (excluding zinc pyrithione);
Increasing nanomaterial record-keeping requirements;
Aligning with international best practices for alternative compliance.
ChemLinked Comments
The amendments introduce significant ingredient-related changes, including regulations on hazardous substances, banned or restricted ingredients, colorants, preservatives, UV filters, and nanomaterials. Businesses must comply with the staggered implementation timeline to avoid non-compliance risks:
After December 31, 2025 – Products complying with pre-amendment standards cannot be imported or manufactured;
After December 31, 2026 – Products complying with pre-amendment standards cannot be supplied;
By June 30, 2027 – All non-compliant products must be properly disposed of.
10. UK Amends the Lists of Prohibited and Restricted Ingredients
On December 17, 2024, UK published the Cosmetic Products (Restriction of Chemical Substances) (No. 2) Regulations 2024. The Regulation, effective from January 31, 2025, introduce significant changes to the lists of prohibited and restricted ingredients in UK Regulation (EC) 1223/2009.
A total of 64 new ingredients have been added to the prohibited list, primarily comprising CMR substances (carcinogenic, mutagenic, or toxic for reproduction). Notably, one ingredient was removed from previous drafts, demonstrating a careful consideration in regulation formulation. The document outlines transitional provisions allowing products containing these newly prohibited ingredients to remain on the market until specific deadlines, providing companies with some flexibility to adjust their product lines.
Additionally, Kojic Acid has been added to the restricted ingredients list, permitting its use at a maximum concentration of 1% in face and hand products, following a safety assessment by the Scientific Advisory Group on Chemical Safety in Consumer Products (SAG-CS).
ChemLinked Comments
For businesses, these regulatory changes will necessitate prompt action to reformulate products and ensure compliance. While the transitional periods provide some leeway, companies must begin preparing for the regulatory adjustments.
Other Highly Read Articles of 2024
EU Adopts 11 Changes to the Use Requirements for Cosmetic Ingredients
EU Amends the Use Requirements for 13 Nanomaterials in Cosmetics
UK Revokes Proposed Recycling Labelling Requirements for Packaging Producers
Canada Requires Cosmetics to Be Labeled with Fragrance Allergens
Indonesia Amends Cosmetic Labeling, Promotion and Advertising Requirements
Japan Approves A New Ingredient for Rinse-off Hair Styling Products
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