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2024 Outlook: New Regulatory Requirements and Expiring Transitional Policies in Global Major Countries

ChemLinked summarized the upcoming regulatory requirements and expiring transition policies in 2024, covering major countries across the globe, including China, Japan, South Korea, ASEAN, EU, UK and US.

1. January

Effective Date

Region

Title

Main Content

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January 1, 2024

Chinese Mainland

China to Require Submission of Safety   Information on All Ingredients

Starting from January 1, 2024, when applying for registration of special cosmetics and notification of general cosmetics, the cosmetic registrant and notifier must provide ingredient safety information documents for all ingredients used in the product formula.

 

This can be done by either submitting ingredient safety information as per Annex 14 of the Provisions for Management of Cosmetic Registration and Notification Dossiers or obtaining an ingredient submission code from the National Medical Products Administration (NMPA). The latter option allows companies to conveniently link the ingredient safety information by filling in the obtained code during the product registration/notification process.

ChemLinked News

January 1, 2024

EU

Transition Period for Products Containing   Two Ingredients to Expire

On November 11, 2022, the EU issued Commission Regulation (EU) 2022/2195, introducing amendments to the use requirements for cosmetic ingredients in Regulation (EC) No 1223/2009 (Cosmetics Regulation).

 

The amendments involve the addition of Butylated Hydroxytoluene and Acid Yellow 3 as restricted ingredients, effective from July 1, 2023, with a six-month transition period. As of January 1, 2024, cosmetics sold in the EU market that contain Butylated Hydroxytoluene and non-oxidative hair dye products containing Acid Yellow 3 must adhere to the updated ingredient use requirements.

ChemLinked News

January 1, 2024

US

House Bill 22-1345 to be Effective

Governor of Colorado signed HB 22-1345 into law on June 3, 2022, prohibiting the intentional use of perfluoroalkyl and polyfluoroalkyl substances (PFAS) in consumer products like cosmetics, food packaging, and upholstered furniture.

 

This legislation will become effective on January 1, 2024. Cosmetic products are granted a one-year grace period to comply with the bill. Starting from January 1, 2025, the sale, distribution, and use of cosmetic products containing intentionally added PFAS chemicals will be prohibited in Colorado.

Official   Announcement

2. February

Effective Date

Region

Title

Main Content

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February 2, 2024

Indonesia

Transition Period for Products with Non-compliant PIF to Expire

On August 2, 2023, the Indonesian Food and Drug Authority (BPOM) released and implemented the updated Guidelines for Product Information File (PIF). For products that had already obtained a notification number prior to August 2, 2023, the owners of the notification numbers are required to update their PIF within six months from the implementation date of the updated PIF. Therefore, starting from February 2, 2024, all products available on the market must have a PIF that compliant to the new regulations.

ChemLinked News

3. March

Effective Date

Region

Title

Main Content

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March 1, 2024

Chinese Mainland

China to Adopt Five Revised Testing   Methods

On August 28, 2023, NMPA announced amendments to the Safety and Technical Standards for Cosmetics (2015 Edition) (STSC). Amendments encompass modifications to prohibited ingredients and testing methods for cosmetics. All other new provisions took immediate effect upon publication, except for the five revised testing methods, which are scheduled to be enforced on March 1, 2024.

ChemLinked News

4. April

Effective Date

Region

Title

Main Content

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April 1, 2024

Chinese Mainland

China to Implement Two National Standards

China will implement two national standards:

 

1) GB/T 43197-2023 Determination of prohibited acid red 73 and solvent red 1 in cosmetics—Liquid chromatography–tandem mass spectrometry. This standard describes the principles, reagents and materials, instruments and equipment, test steps, data processing steps, recovery rate requirements, precision requirements, and other relevant information for the analysis of acid red 73 (CI 27290) and solvent red 1 (CI 12150) in cosmetics by using liquid chromatography–tandem mass spectrometry.

 

2) GB/T 26513-2023 Lip moisturizer (gel, cream). This standard provides definitions for lip balm, lip gel, and lip cream, and specifies product classification and marking, test methods, inspection rules, as well as labeling, packaging, transportation, storage, and shelf life requirements.

l  GB/T 43197-2023

l  GB/T 26513-2023

5. May

Effective Date

Region

Title

Main Content

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May 1, 2024

Chinese Mainland

China to Require the Submission of the Full Version of Product Safety Assessment Report

Currently, companies have the option to submit a simplified safety assessment report when applying for cosmetic product registration and notification. However, starting from May 1, 2024, cosmetic registrants and notifiers will be obligated to submit the full version of the product safety assessment report. This full version will be subject to more extensive requirements, including preservative challenge testing and packaging material compatibility testing.

 

The mandatory implementation of the full safety assessment report will lead to increased costs and greater complexity in report preparation.

ChemLinked News

May 11, 2024

ASEAN

Enforcement of Revised Two Ingredient Usage Requirements

The 35th ASEAN Cosmetic Scientific Body (ACSB) meeting was held in May 2022, which approved amendments to cosmetic ingredients in the Annexes of the ASEAN Cosmetic Directive (ACD). The amendments pertain to the usage requirements for Titanium Dioxide and Polyaminopropyl biguanide will come into effect on May 11, 2024.

ChemLinked News

May 30, 2024

South Korea

Enforcement of Prohibited Ingredient Addition and Revised Hair Dye Usage Requirements

The South Korean Ministry of Food and Drug Safety (MFDS) announced a revision to the Regulation on   Safety Standards, etc. for Cosmetics on November 30, 2023. This revision includes the addition of seven prohibited ingredients and one UV filter ingredient, the reduction in the upper limit of concentration for two restricted hair dye ingredients, as well as the inclusion of CAS numbers and general chemical names for certain prohibited and restricted ingredients.

 

Among them, the addition of prohibited ingredients and the revision of hair dyes’ usage requirements will take effect from May 30, 2024.

ChemLinked News

6. June

Effective Date

Region

Title

Main Content

Source

June 1, 2024

Chinese Mainland

Transition Period for Small-packaged   Cosmetics to Expire

On June 19, 2023, China State Administration for Market Regulation (SAMR) announced a transitional period for commodities, including cosmetics, with net content of less than 1 gram. These products were granted a 12-month grace period to comply with the Measures on Metrological Supervision and Administration of Quantitatively Packed Commodities (Measures), which came into effect on June 1, 2023.

 

Starting from June 1, 2024, the transitional period will conclude. Small-packaged cosmetics must fully adhere to the Measures. Commodities that were produced or imported before the end of the transition period can continue to be sold until their designated shelf life expires.

Official Announcement

7. July

Effective Date

Region

Title

Main Content

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July 1, 2024

Chinese Mainland

Marketed Toothpastes with Labeling Issues Must be Updated in Accordance with the New Regulations

NMPA announced on September 25, 2023, that toothpastes supervision regulations would be implemented, and notification document requirements would be simplified for toothpastes already available in the market.

 

For toothpastes that had already been on the market prior to December 1, 2023, any labels with formatting issues must be updated to comply with the new regulations by July 1, 2024.

ChemLinked News

July 1, 2024

Taiwan, China

Specific Purpose Cosmetics to Be Regulated as General Cosmetics

Starting from July 1, 2024, all specific purpose cosmetics will be regulated as general cosmetics, whose pre-market obligation will be changed to notification and the establishment of a PIF.

 

This means that specific purpose cosmetics will no longer undergo the cumbersome registration process but instead be involved in a more streamlined notification system. This change is expected to reduce the burden on specific purpose cosmetics companies and expedite the product launch process.

ChemLinked Cosmepedia

July 1, 2024

US

US to Require Companies to Complete Facility Registration and Product Listing

The US FDA originally required companies to complete facility registration and product listing submissions before December 29, 2023. In order to provide the industry with additional preparation time, the FDA announced an extension of a six-month grace period. This extension allows stakeholders to complete the facility registration and product listing process by July 1, 2024.

ChemLinked News

July 6, 2024

UK

UK to Restrict the Use of Methyl-N-methylanthranilate

On July 6, 2023, UK published a regulation to amend the lists of restricted ingredients and permitted UV filters, including the inclusion of Methyl-N-methylanthranilate as a restricted ingredient, subject to specific usage constraints. The restrictions will come into force on July 6, 2024.

ChemLinked News

July 31, 2024

EU

Transition Period for Products Containing   Formaldehyde to Expire

On July 11, 2022, the EU announced amendment to the labelling requirement for formaldehyde releasers, which came into effect on July 31, 2022. Under the new amendment, the labelling threshold was reduced from 0.05% (500 ppm) to 0.001% (10 ppm).

 

The EU Commission proposed a 24-month period for products to be placed on the market. Products containing more than 0.001% formaldehyde without the "contains formaldehyde" labelling can still be placed on the Union market by July 31, 2024.

ChemLinked News

8. August

None

9. September

Effective Date

Region

Title

Main Content

Source

September 30, 2024

Japan

Japan Updates Requirements for Manufacturing and Sales License Applications of Quasi-Drugs

On March 27, 2023, the Ministry of Health, Labour and Welfare (MHLW) released Notification 0327 No. 1 and Notification 0327 No. 5, which resulted in minor adjustments to the description of certain reagents and test solutions in the Japanese Standards of Quasi-drug Ingredients 2021 (JSQI 2021). Consequently, the application documents for the manufacturing and sales licenses of quasi-drugs have also been revised accordingly.

 

However, until September 30, 2024, it is still permissible to apply for the manufacturing and sales license based on the pre-revised standards. Starting from this date, all applications for manufacturing and sales licenses of quasi-drugs must be submitted in adherence to the new requirements.

ChemLinked News

10. October

Effective Date

Region

Title

Main Content

Source

October 1, 2024

South Korea

Transition Period for Products Containing Two Ingredients to Expire

On April 1, 2022, MFDS introduced an updated Regulation on Safety Standards, etc. for Cosmetics. This revision adds prohibited ingredients, restricted ingredients and their respective usage limits, as well as the clarification of exemption conditions for the use of prohibited ingredients.

 

To be specific, amendments include the prohibition of Benzalkonium Chloride (BKC) in spray products, and the inclusion of Indigofera tinctoria Leaf Powder as a permitted hair dye ingredient with an upper usage limit.

 

Immediate implementation was applied to all other amendments, except those pertaining to BKC and Indigofera Leaf Powder, which took effect from October 1, 2022. Moreover, a two-year transition period was granted for products containing any of these two ingredients. As of October 1, 2024, any products available for sale in the market that contain any of these two ingredients must comply with the new requirements.

ChemLinked News

11. November

Effective Date

Region

Title

Main Content

Source

November 21, 2024

ASEAN

ASEAN Amends Cosmetic Ingredient Annexes to ACD: 42 New Ingredients Included and 10 Ingredients Revised

In January 2023, ASEAN introduced the latest amendments to the ingredient annexes to ASEAN Cosmetic Directive (ACD). These amendments were approved in the 36th ASEAN Cosmetic Scientific Body (ACSB) meeting, and will officially take effect on November 21, 2024.

ChemLinked News

12. December

Effective Date

Region

Title

Main Content

Source

December 13, 2024

EU

New EU Regulation on General Product Safety to Take Effect in 2024

On May 23, 2023, EU published the new Regulation (EU) 2023/988 on General Product Safety (GPSR) in its Official Journal, repealing Directive 87/357/EEC and Directive 2001/95/EC. This new regulation aims to strengthen the protection of consumers while enhancing the functioning of the internal market. It entered into force on June 12, 2023, with a transitional period of 18 months. From December 13, 2024, it shall be fully enforced in all Member States.

ChemLinked News

December 29, 2024

US

US Contact for Adverse Reaction Report Shall Be Labeled

Starting from December 29, 2023, companies operating in the US are mandated to maintain records of adverse events and report any serious adverse events. Additionally, starting from   December 29, 2024, cosmetic labels in the US must include the contact information for adverse event report.

ChemLinked Cosmepedia


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