During the period from January to March 2024, several noteworthy regulatory developments have taken place globally. Notably, the Chinese mainland plans to introduce a transition period for safety assessment and makes amendments to Safety and Technical Standards for Cosmetics. Moreover, countries/regions including South Korea, Japan, Malaysia, Vietnam, the EU, the US, and New Zealand have also implemented some regulatory changes. Here are brief updates on these developments.

1. EU

EU Amends the Use Requirements for 13 Nanomaterials in Cosmetics

On May 23, 2023, the European Union (EU) notified WTO of a draft Commission Regulation proposing revisions to the ingredient lists in Regulation (EC) No 1223/2009 concerning the use of nanomaterials in cosmetics. On March 15, 2024, the EU published the finalized regulation in the Official Journal, and it came into effect on April 4, 2024. The regulation includes the following amendments:

1. Ban on 12 nanomaterials: Due to insufficient safety data and concerns regarding potential health risks to consumers, the EU has prohibited the use of 12 specific nanomaterials in cosmetics;
2. Restriction on Hydroxyapatite (nano): The Scientific Committee on Consumer Safety (SCCS) assessed Hydroxyapatite (nano) and determined that it can be safely used in cosmetics under certain restrictions. Consequently, it is added to the list of restricted ingredients.

Starting from February 1, 2025, cosmetic products containing the 12 banned nanomaterials, or containing Hydroxyapatite (nano) that do not comply with the restrictions may not be placed on the EU market. From November 1, 2025, these products may not be made available on the EU market.

New Update to Candidate List of SVHCs

On January 23, 2024, the ECHA (European Chemicals Agency) released the new Candidate List of SVHCs, expanding the list by five substances and bringing the total number of SVHCs to 240. The newly added substances are:

• 2,4,6-tri-tert-butylphenol (2,4,6-TTBP)
• 2-(2H-benzotriazol-2-yl)-4-(1,1,3,3-tetramethylbutyl)phenol (UV-329)
• 2-(dimethylamino)-2-[(4-methylphenyl)methyl]-1-[4-(morpholin-4-yl)phenyl]butan-1-one
• Bumetrizole (UV-326)
• Oligomerization and alkylation reaction products of 2-phenylpropene and phenol (OAPP)

Additionally, the entry for DBP was updated to include its endocrine disrupting properties for the environment.

In March 2024, ECHA initiated a consultation to identify two substances proposed by Norway and France as SVHCs. The public can provide comments on these proposals until April 15, 2024. Once identified as SVHCs, both substances will be added to the Candidate List. The two substances under consideration are:

• Bis(α,α-dimethylbenzyl) peroxide
• Triphenyl phosphate

ECHA Consults on Recommending Five Substances for Authorization List

On February 7, 2024, European Chemicals Agency (ECHA) released a draft 12th recommendation to the European Commission, which recommends the inclusion of 5 substances to the REACH Authorisation List.

1. Melamine
2. Bis(2-ethylhexyl) tetrabromophthalate covering any of the individual isomers and/or combinations thereof
3. S-(tricyclo[5.2.1.0 2,6]deca-3- en-8(or 9)-yl) O-(isopropyl or isobutyl or 2-ethylhexyl) O- (isopropyl or isobutyl or 2- ethylhexyl) phosphorodithioate
4. Diphenyl(2,4,6- trimethylbenzoyl)phosphine oxide
5. Barium diboron tetraoxide

ECHA is looking for further information on the uses of these substances in scope of authorization, their possible exemptions from the authorisation requirement and on the structure and complexity of the supply chains. The consultations are open until May 7, 2024.

ECHA Announces Next Steps for PFAS Restriction Proposal

In March 2024, the European Chemicals Agency (ECHA) delineated a schedule for evaluating the PFAS restriction proposal, with attention given to various sectors, including cosmetics. This evaluation will have implications for manufacturers globally, who will need to make adjustments to align with the new standards.

2. US

MoCRA Updates: FDA Unveils Additional Submission Tools for Cosmetic Facility Registration and Product Listing

On January 8, 2024, the U.S. Food and Drug Administration (FDA) introduced new submission tools to supplement the existing electronic submission portal, Cosmetic Direct. These tools include Structured Product Labeling (SPL) Xforms, as well as Form FDA 5066 and Form FDA 5067. These additions offer stakeholders increased flexibility in meeting their specific needs in cosmetic facility registration and product listing.

1. Structured Product Labeling (SPL) Xforms: This tool serves as an SPL authoring tool, facilitating the creation of SPL file containing information on cosmetic product facility registration and product listing;
2. Form FDA 5066 and Form FDA 5067: These forms are designated for paper submissions. Form FDA 5066 is used for cosmetic facility registration, while Form FDA 5067 directs at cosmetic product listing.

3. China

NMPA Plans to Set a Transition Period for Submission of the Full Version of Safety Assessment Report

Until May 1, 2024, China National Medical Products Administration (NMPA) allows a simplified version of cosmetic safety assessment report for registration or notification. However, starting from May 1, 2024, the full version of the report is required. This transition poses challenges for the industry due to difficulties such as lack of ingredient toxicological data and shortage of safety assessment personnel.

To optimize safety assessment management, NMPA is formulating measures in four aspects:

1. Setting a six-month transition period. Registrants and notifiers who have already started safety assessments before May 1, 2024, will be permitted to submit a simplified report within a specified timeframe;
2. Strengthening technical guidance by introducing draft guidelines for Threshold of Toxicological Concern (TTC) Method and Read Across, and formulating guidelines for physical and chemical stability, preservative challenges, and packaging material compatibility testing;
3. Integrating ingredient data resources by establishing a cosmetic ingredient safety database;
4. Innovating assessment report management mechanisms by categorizing cosmetics into three tiers based on risk levels. Category 1 cosmetics require complete safety assessment reports, while Category 2 and Category 3 cosmetics only need safety assessment conclusions.

ChemLinked Comments

The above measures are still in draft form and yet to be implemented. Companies are advised to proactively prepare for the full version of the report. This includes assembling qualified personnel, reviewing ingredients and addressing data gaps, and seeking expert consultants, etc.

NMPA Amends the Safety and Technical Standards for Cosmetics 2015

On March 21, 2024, NMPA announced significant amendments to the Safety and Technical Standards for Cosmetics (2015 Edition) (STSC). The updates include:

1. Addition of 5 newly prohibited ingredients: Bimatoprost, Tafluprost, Taflupamide, Travoprost, and Latanoprost;
2. Revision of 3 existing testing methods, including those for dioxane and other prohibited and restricted ingredients;
3. Introduction of 11 new testing methods, covering areas such as acute inhalation toxicity, skin sensitization, and reproductive toxicity.

The updated ingredient list is in effect immediately, while the revised testing methods will take effect on December 1, 2024.

4. Taiwan

TFDA Amends Cosmetic Ingredient Use Requirements

Taiwan Food and Drug Administration (TFDA) issued several announcements on December 13, 2023, and January 4, 2024, regarding the revision of prohibited and restricted ingredients for cosmetics. Please refer to the table below for the specific amendments.

5. South Korea

South Korea Bans THB in Cosmetics

On December 7, 2023, the Ministry of Food and Drug Safety (MFDS) proposed an amendment to the Regulation on Safety Standards for Cosmetics. The purpose was to prohibit the use of 1,2,4-trihydroxy benzene (THB) as an ingredient in cosmetics. The decision was based on safety verification results from the Cosmetic Ingredient Safety Evaluation Committee, which indicated that the genotoxicity potential of THB cannot be ruled out.

The amendment was finalized on February 7, 2024, and MFDS officially implemented the ban on THB in cosmetics.

6. Japan

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

The Ministry of Health, Labour and Welfare (MHLW) of Japan introduced a proposal for the Standards for Cosmetics on March 8, 2024. The proposal seeks to include “Cysteamine Hydrochloride” as an ingredient in hair styling products exclusively intended for hair application and rinsing off.

ChemLinked Comments

The revised standards are anticipated to be implemented in late June 2024. Cosmetic manufacturers and distributors will be required to adhere to the updated guidelines, which may involve modifying product formulations, manufacturing processes, labeling, and quality control measures.

7. Malaysia

Malaysia Amends Cosmetic Ingredient Use Requirements

On January 19, 2024, Malaysia National Pharmaceutical Regulatory Agency (NPRA) released Circular No. 1/2024 Information on the Updated Status of Ingredients in the Annex of the Guidelines for Control of Cosmetic Products in Malaysia. According to the Circular, the amendments are:

1. Adding 15 ingredients to, and revising 4 ingredients in the List of Prohibited Ingredients;
2. Revising 5 ingredients in the List of Restricted Ingredients;
3. Revising 1 ingredient, CI 45430 (2), in the List of Permitted Colorants;
4. Deleting 1 ingredient, Methenamine 3-chloroallylochloride, from the List of Permitted Preservatives;
5. Adding 2 ingredients to, and revising 1 ingredient in the List of Permitted UV Filters.

ChemLinked Comments

Most of the aforementioned revisions align with the updates made to the ingredient annexes of the ASEAN Cosmetic Directive (ACD) during the 38^th ASEAN Cosmetic Scientific Body (ACSB) meeting. It is crucial for enterprises to stay informed about the updated ingredient usage requirements and refrain from incorporating newly prohibited ingredients into their cosmetic production processes. In cases where newly added or revised restricted ingredients are used, enterprises are recommended to ensure compliance with their updated usage conditions.

8. Vietnam

Vietnam Amends Cosmetic Ingredient Use Requirements

Drug Administration of Vietnam (DAV) released Official Letter No. 589/QLD-MP on March 4, 2024, to announce the updated use requirements for cosmetic ingredients. The amendments are:

1. Adding 15 ingredients to, and revising 4 ingredients in Annex II List of Substances Which Must Not Form Part of the Composition of Cosmetic;
2. Revising 5 ingredients in the Annex III List of Substances Which Cosmetic Products Must not Contain Except Subject to Restrictions and Conditions Laid Down;
3. Revising 1 ingredient, CI 45430 (2), in the Annex IV List of Colouring Agents Allowed for Use in Cosmetic Products;
4. Deleting 1 ingredient, Methenamine 3-chloroallylochloride, from the Annex VI List of Preservatives Which Cosmetic Products May Contain;
5. Adding 2 ingredients to, and revising 1 ingredient in the Annex VII List of Permitted UV Filters Which Cosmetic Products May Contain.

ChemLinked Comments

The above changes align with the updates to ACD passed by the 38^th ACSB meeting. Cosmetic companies are advised to proactively review cosmetic ingredients during production, import, and trade, in order to mitigate the risk of product recalls.

9. New Zealand

New Zealand EPA Bans PFAS in Cosmetics

On January 30, 2024, the New Zealand Environmental Protection Authority (EPA) announced a ban on PFAS in cosmetics. The ban, outlined in the updated “Cosmetic Products Group Standard,” reflects New Zealand’s precautionary approach to managing the potential risks associated with these chemicals.

To ensure compliance, the ban on PFAS in cosmetics includes the following transitional provisions:

1. Manufacture Ban: Starting from December 31, 2026, the manufacture and import of cosmetic products containing PFAS will be prohibited;
2. Sale Ban: As of December 31, 2027, the sale of cosmetic products containing PFAS will be banned;
3. Product Disposal: All remaining cosmetic products containing PFAS must be disposed of by June 30, 2028. This ensures the complete removal of these products from the market and minimizes potential PFAS exposure.

Conclusion

In conclusion, recent global regulatory updates demonstrate ongoing efforts to enhance and refine the cosmetics regulatory framework. China, in particular, is exploring ways to optimize safety assessment management. It is crucial for enterprises to stay updated on these management measures.

Furthermore, updates related to ingredients, especially the prohibition of certain substances, remain a significant area of focus in multiple countries globally. Stakeholders are advised to closely monitor these updates, adjust their strategies to comply with regulatory requirements, and ensure the quality and safety of cosmetic products in the market.

Further Reading

• China May Provide Six-month Transition Period for Submission of Cosmetic Safety Assessment Report (Full Version)
• EU Amends the Use Requirements for 13 Nanomaterials in Cosmetics
• MoCRA Updates: FDA Unveils Additional Submission Tools for Cosmetic Facility Registration and Product Listing
• New Zealand EPA Bans PFAS in Cosmetics

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Characteristics of new cosmetic ingredients notified in China from Q1 to Q3 2023:

• NCIs sources: chemical sources remain dominant; plant extracts are on the rise;
• Use purpose: skin protectant, moisturizer and antioxidant account for more than half;
• Notifiers: Chinese domestic enterprises account for 74.3%;
• Future trends: the total number of NCI notifications is expected to grow, with a focus on ingredients that have already been allowed for use in cosmetics abroad and ingredients sourced from diverse fields.

Following explosive growth in 2022, the number of NCI notifications continues to grow in 2023. According to information from NMPA’s data query platform, 35 NCIs were notified from Q1 to Q3 2023. This trend suggests that ingredient innovation has become a core focus for beauty enterprises to maintain a competitive edge.

Characteristics of NCIs Notified from Q1 to Q3 2023

1. NCIs sources: chemical sources remain dominant; plant extracts are on the rise

From Q1 to Q3 2023, most of the notified NCIs were derived from chemical sources, while a few were from plants, biotechnology, animals and hydrolysis technology.

Due to the low safety risk associated with the ingredient structure of chemical ingredients (polymers), only skin and eye irritation/corrosion tests and skin phototoxicity tests are required. These alternative test methods are already incorporated into the Safety and Technical Standards for Cosmetics (STSC). As many foreign countries/regions, including the EU, the US, and Japan, currently prohibit animal testing in cosmetics, notifiers from these countries/regions prefer to notify chemical ingredients (polymers).

Despite the dominance of chemical ingredients, enterprises are increasingly interested in plant-derived ingredients. As consumers are increasingly seeking out safe, clean, and sustainable beauty products, products that contain plant-derived ingredients are gaining greater recognition. This trend is demonstrated by the rise in plant-derived NCIs notifications. “Consumers are becoming more conscious of the safety of the products they use, and they prefer ingredients that are both effective and safe. Therefore, many enterprises are focusing on developing ingredients using plant extraction technology and fermentation technology,” according to Lei Zhang, Chief Engineer of Tianjin Shangmei.

2. Use purpose: skin protectant, moisturizer and antioxidant account for more than half

Most notified NCIs are primarily used as skin protectants, followed by those for moisturizing and anti-oxidation purposes.

“Skin protectant is a relatively general type of ingredient, which can include functions such as moisturizing, repairing, nourishing, firming, etc. The reason why functional ingredients are notified as skin protectants is to allow for more possibilities in their development. The current technology may limit the research of NCIs. To avoid the application for an update of the NCI’s technical requirements in case new functions are discovered in subsequent research, it’s more convenient to notify the ingredient as a skin protectant.” Zhang explained.

3. Notifiers: Chinese domestic enterprises account for 74.3%

According to NMPA’s data query platform, overseas enterprises are the main notifiers of the 42 NCIs notified in 2022. However, from Q1 to Q3 2023, 26 out of the 35 NCIs notified are from Chinese domestic enterprises, accounting for 74.3%. Among these, Shenzhen Winkey Pharmaceutical R&D Co., Ltd. (hereinafter referred to as “Winkey”) is the most active applicant, with 4 NCIs notified within nine months.

According to the marketing department head of Winkey, the increase in Chinese domestic notifiers this year can be attributed to their experience gained in the past. Previously, these enterprises were still in a groping stage, but they have since learned from their experiences and are now considering how to utilize R&D resources and platforms to better prepare for NCI notifications and avoid detours.

New regulations and market demands have motivated Chinese enterprises to challenge the monopoly of overseas enterprises in the cosmetic ingredients field. Their high enthusiasm to notify NCI indicates that the NCI market is very thriving.

4. Future trends: the total number of NCI notifications is expected to grow, with a focus on ingredients that have already been allowed for use in cosmetics abroad

1) A Significant Increase in NCI Notifications

Lei Zhang predicts a significant increase in NCI notifications in the long term. She said, “market competition has intensified, and many enterprises are actively pursuing this track.”

2) Focus on Ingredients Allowed for Use in Cosmetics Abroad

Shuquan Lao, the China Regional Director of Symrise’s Cosmetic Ingredients Department, believes that future NCI notifications may include ingredients that have been included in the international ingredient catalogue but have not yet been listed in Inventory of Existing Cosmetic Ingredients in China (IECIC). Notably, among the 35 NCIs notified from Q1 to Q3 2023, the majority have already been allowed for use in cosmetics abroad and are included in the International Cosmetic Ingredient Dictionary and Handbook and have their own INCI name.

The International Cosmetic Ingredient Dictionary and Handbook (16th Edition) currently includes 22,620 cosmetic ingredients, while IECIC only includes 8,972. This significant difference in the number of ingredients listed in Chinese and international catalogues means that there is a huge space for the great number of ingredients that have been used in cosmetics abroad to be introduced into China for NCI notification.

3) Focus on Ingredients Sourced from Diverse Fields

Companies are currently placing emphasis on ingredients that find applications across multiple industries. Some of the notified NCIs are sourced from diverse fields such as medicine, food, and health food. Examples of such ingredients include Acetylneuraminic Acid, Tissue Culture of Saussurea Involucrata, and Euphausia Superba Oil. Of particular interest is the increasing number of notifications for β-Nicotinamide Mononucleotide (NMN), which has garnered the attention of four companies that have completed a total of five notifications for NMN.

NMN holds significant popularity as a health food ingredient in certain countries, where it is renowned for its claimed anti-aging function and has earned the moniker of the “elixir of aging.” The skincare industry also anticipates the use of NMN for its anti-aging function.

However, it is important to note that NMN has yet to receive approval for use in drugs, health foods, and foods in China. Its notification as a new cosmetic ingredient represents just the initial step towards market availability. The notified NCIs will then undergo a three-year monitoring period, during which additional research data and clinical applications will be accumulated to establish its safety.

Further Reading

• China Consults on Guidelines for Determination of New Cosmetic Ingredients
• Navigating China’s New Cosmetic Ingredient Notification and Registration Process (Video)
• Practical Insights on Registering and Notifying Plant-derived New Cosmetic Ingredients in China (Video)

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