Top 10 Global Cosmetic Regulation Highlights in 2023

In 2023, the global cosmetic industry experienced notable progresses in regulations and enforcement, which focus on improving safety, quality, and transparency of cosmetics. Governments worldwide introduced new policies and regulations to achieve these goals. Developments encompass the introduction of cosmetic overarching regulation, updates to pre-market and post-market supervision, and revisions to ingredient use requirements. In this article, ChemLinked highlights the top 10 significant updates in major regions worldwide.

1. Advancements in US MoCRA Implementation and Progress in 2023

On December 29, 2022, Modernization of Cosmetics Regulation Act (MoCRA) was signed into law by US President Joe Biden as part of the Consolidated Appropriations Act, 2023. MoCRA establishes federal standards for cosmetic business registration, product listing, recordkeeping, adverse event reporting, safety substantiation, GMP, and recalls. Throughout 2023, US focused its efforts on implementing and enforcing MoCRA, particularly regarding facility registration and product listing.

On December 18, 2023, the US FDA released the final Guidance on Registration and Listing of Cosmetic Product Facilities and Products. This document provides detailed instructions for submitting cosmetic facility registrations and product listings to the FDA, covering aspects such as term explanations, responsible entities for application submission, necessary dossiers, submission methods, and deadlines.

On December 29, 2023, MoCRA officially took effect. This means that requirements such as facility registration, product listing, safety substantiation, adverse event recordkeeping and reporting, professional-use cosmetics labeling, and FDA's mandatory recall authority are now in force.

ChemLinked Comments

The passage of MoCRA will have a profound and wide impact on the cosmetics industry. Given the intricacies of this new legislation, it may take the FDA several years to achieve the fully implementation of its provisions. Stakeholders intending to enter the US market should thoroughly study the regulatory changes and remain attentive to the corresponding compliance deadlines.

2. ASEAN Amends Cosmetic Ingredient Requirements in the Annexes of ACD

In 2023, ASEAN held the 37th and 38th ASEAN Cosmetic Scientific Body (ACSB) meetings, during which revisions to the ingredient annexes of the ASEAN Cosmetic Directive (ACD) were introduced. So far, only the amendments from the 37th ACSB meeting have been disclosed. These amendments include

• addition of 19 prohibited ingredients and 2 restricted ingredients;

• revisions to the use conditions of 1 permitted preservative and 2 permitted UV filters.

These amendments will officially come into effect on May 8, 2025.

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.

3. EU Adds 56 Newly Identified Fragrance Allergens

In September 2022, the EU notified the WTO of a draft regulation to extend the individual labelling requirements for 56 newly identified fragrance allergens. On July 27, 2023, the finalized Regulation 2023/1545 was released, with these substances added to the allergens list, whose individual labelling on cosmetic product packaging is required when their concentration exceeds 0.001% in leave-on products or 0.01% in rinse-off products.

Furthermore, for clarity and simplicity, this amendment aligns the names of existing allergens with the latest Common Ingredients Glossary, updates CAS and EC numbers to prevent errors, and groups similar substances under one entry.

ChemLinked Comments

Cosmetics manufacturers should promptly adjust product formulas and packagings to comply with the new requirements within the provided transition period. After July 31, 2026, only compliant products can be newly placed on the EU market, and after July 31, 2028, only compliant products can be circulated, which requires the recall of non-compliant products. 

4. South Korea Amends Cosmetic Safety Standard

In 2023, South Korea made revisions to the Regulation on Safety Standards, etc., for Cosmetics, including changes to cosmetic ingredient names and use requirements. The specific revisions are as follows:

1) Addition of five prohibited hair dyes;

2) Addition of seven prohibited ingredients;

3) Lowering of upper concentration limits for two restricted hair dye ingredients;

4) Addition of one restricted UV filter;

5) Inclusion of relevant CAS numbers and chemical names of all prohibited and restricted ingredients.

The above revisions took effect on November 30, 2023, with the exception of amendments related to hair dyes. The ban on the five hair dyes was implemented on August 22, 2023. The revised usage limits for the two hair dyes will be implemented from May 30, 2024.

ChemLinked Comments

South Korea adopts a negative list approach to regulate cosmetic ingredients. Companies are prohibited from using ingredients listed in the Prohibited Ingredient List for manufacturing cosmetics. Restricted ingredients must be used in accordance with the specified requirements listed in the Restricted Ingredient List. When exporting cosmetics to South Korea, companies must ensure compliance with the updated ingredient usage requirements.

5. China Releases Several CSAR Subsidiary Regulations and Technical Guidelines

In 2023, China issued six subsidiary regulations and seven technical guidelines related to the Cosmetic Supervision and Administration Regulation (CSAR). Please refer to the table below for further details.

6. China Revises the Safety and Technical Standards for Cosmetics 2015

On August 28, 2023, China NMPA announced significant amendments to the 2015 Edition of the Safety and Technical Standards for Cosmetics (STSC), focusing on prohibited ingredients and testing methods. The key updates include:

1. Addition of "Benvimod" as a newly banned ingredient. A new note emphasizes that if benzene is an unavoidable impurity in cosmetics, its limit should not exceed 2mg/kg.

2. Release of five updated testing methods to replace the original ones outlined in STSC. These revised testing methods will apply to cosmetics registration, notification, and sampling inspection starting from March 1, 2024.

3. Introduction of 14 new test methods, including physical and chemical testing methods for pH value, colorants, hair dyes, etc., as well as new alternatives to animal testing and new toxicological test methods.

Except for the revised methods set to take effect on March 1, 2024, all other updates became effective immediately upon release.

ChemLinked Comments

ChemLinked recommends that businesses familiarize themselves with these new methods to ensure compliance with the test report requirements for new products. Additionally, businesses should check existing products containing relevant ingredients to ensure their actual concentration and residual amount of risk substances meet the limitations outlined in the new methods, and determine if further testing is necessary.

7. Japan Designates Tetrahydrocannabihexol (THCH) as a Controlled Substance

On July 25, 2023, the Ministry of Health, Labour and Welfare (MHLW) of Japan announced that Δ8-THCH and Δ9-THCH would be classified as designated drugs. Consequently, the manufacturing, import, sale, possession, and non-medical use of these drugs would be strictly prohibited. This announcement took effect on August 4, 2023.

ChemLinked Comments

THCH (Tetrahydrocannabihexol) has similar structure to THC (Tetrahydrocannabinol) and close effects to psychoactive effects. It has been used as a substitute for THC due to its lack of legal restrictions.

Δ8-THCH and Δ9-THCH have already entered Japan through importation. Since March 2023, at least nine safety incidents related to these substances have been reported across the country. To prevent the importation and misuse of dangerous drugs from abroad, MHLW intends to strengthen border control measures. This includes stricter approval and authorization processes for pharmaceutical products and enhanced supervision of their sales, including online sales.

8. Thailand Cosmetic Ingredient Updates: New Prohibited Ingredient List and Revised Permitted Preservatives

On June 22, 2023, the Ministry of Public Health of Thailand (MOPH) issued three notices through the 140^th Government Gazette of 2023, announcing regulatory revisions regarding prohibited ingredients and permitted preservatives in cosmetics. These notices came into effect on June 23, with a transition period for certain rules. The key amendments are:

1) Introduction of a new list of 1,610 prohibited ingredients, replacing the previous version published in 2016. The new list incorporates updates made by the Thai FDA from 2016 to 2022 and adds 220 additional prohibited ingredients;

2) Revision of the CAS No., maximum authorized concentration, and use conditions for the permitted preservative polyaminopropyl biguanide;

3) Addition of a new permitted preservative, Hydroxyethoxyphenyl Butanone.

ChemLinked Comments

Thailand's addition of 220 prohibited ingredients aligns with the updates made to the prohibited ingredients list of the ASEAN Cosmetics Directive (ACD), adopted during the 34th ASEAN Cosmetic Scientific Body (ACSB) meeting. Similarly, the revisions to the use requirements for the two permitted preservatives are consistent with the updates made to the preservatives list in the ACD, adopted at the 35th ACSB meeting.

It is important to note that Thailand has implemented additional restrictions regarding the prohibited ingredient silver nitrate, distinguishing its requirements from those of the broader ASEAN region. While silver nitrate is permitted for use in hair dye cosmetics exclusively for export purposes, Thailand prohibits the sale of export-oriented cosmetics containing silver nitrate within the country.

9. India Proposes Amendments to Cosmetics Rules 2020

On May 17, 2023, the Ministry of Health and Family Welfare of India initiated a 45-day public consultation on proposed amendments to the Cosmetics Rules 2020. The objective is to enhance the regulation and quality control of cosmetics in India. The proposed changes encompass the following:

1) Modification of terminologies to improve clarity and consistency;

2) Addition of new specifications;

3) Relaxation of certain regulatory requirements.

ChemLinked Comments

The proposed revisions to the Cosmetics Rules 2020 are aimed at bolstering safety measures, improving labeling standards, and ensuring regulatory compliance in the Indian cosmetics sector. These revisions specifically address concerns regarding label clarity, streamline regulatory authorities, enhance testing and analytical procedures, and establish stringent requirements for record-keeping.

10. Indonesia Amends Required Documents for Product Information File (PIF)

On August 2, 2023, BPOM (Indonesian Food and Drug Control Agency) released and implemented the finalized Guidelines for Product Information File (PIF). The Guidelines consists of six chapters, sixteen articles, and one appendix, covering requirements for documents, language, retention, storage format, PIF review methods, and more. The key amendments include:

1) Clarification of the standards for document included in PIF;

2) Amendments to the required documents in the PIF;

3) Other revisions, such as changes to the retention time of the PIF and clearer clarification on the PIF review method.

ChemLinked Comments

Before applying for cosmetics notification in Indonesia, manufacturers and importers must prepare the PIF in advance and store it as electronic and/or written documents. During inspections conducted by BPOM, relevant PIF documents must be provided. For imported cosmetics, the Guidelines has introduced new documents required by the PIF, including ingredient quality specification certificates, information on the source and/or manufacturing process of certain ingredients, and product contamination control, etc.

Enterprises are recommended to closely adhere to the Guidelines' requirements for PIF documents through promptly update of the PIF. This will ensure the accuracy, completeness, and timeliness of the PIF.

Further Reading

• Recap of 2023: A Recap of New Cosmetic Ingredients Notified in China in 2023

• Recap of 2023: A Collection of China Cosmetic National/Industry/Group Standards in 2023

• Recap of 2023: EU Safety Gate Alerts 1,089 Batches of Non-compliant Cosmetics in 2023, with 95.5% Containing Prohibited Ingredients

• Webinar | Cosmetic Regulatory Updates in China

• Webinar | Cosmetic Regulatory Updates in Asia Pacific

• Webinar | Cosmetic Regulatory Updates in Europe and North America