Monthly Recap: Global Cosmetic Regulatory Updates | January 2023

On Dec. 29, 2022, China National Medical Products Administration (NMPA) released the finalized Regulations on Supervision and Administration of Enterprises in Implementing Entity Responsibility for Cosmetic Quality and Safety, which will be implemented it on Mar. 1, 2023.

China Releases Six Draft Determination Methods and Proposes to Add a Prohibited Ingredient

On Dec. 30, 2022, China National Institutes for Food and Drug Control (NIFDC) released six draft determination methods and proposed to add 5-[(E)-2-phenylethenyl]-2-(propan-2-yl)benzene-1, 3-diol (Benvitimod, Tapinarof) (CAS No. 79338-84-4) as a prohibited ingredient for cosmetics. The six draft determination methods are listed in the table below.

China to Implement the Strictest Cosmetic Sampling Testing Regulation

On Jan. 12, 2023, NMPA released the finalized Measures for the Management of Cosmetic Sampling Testing, which will be implemented on Mar. 1, 2023. The Measures is divided into 8 chapters and 61 articles, providing detailed requirements on the formulation of sampling testing work plan, sampling, testing and result submission, objection and re-testing, verification and disposal of unqualified products, as well as information disclosure.

China General Administration of Customs (GACC): One Batch of Cosmetics Rejected in December

On Jan. 16, 2023, GACC updated the list of rejected food and cosmetics in December. One batch of cosmetics from Japan failed customs inspection for inconsistencies between the product and the certificate.

China Allows Stakeholders of Low-risk General Cosmetics to Submit Self-testing Reports When Applying for Notification

On Jan. 18, 2023, NMPA issued a notice, further optimizing the management measures for the testing of general cosmetics notification. Under certain conditions, notifiers or entrusted manufacturers of Chinese domestic low-risk cosmetics are allowed to conduct self-testing and submit the product self-testing reports as part of notification dossiers.

Guangdong MPA Promotes a New Intelligent Review Model for Cosmetics Notification

On Jan. 18, 2023, Guangdong Medical Products Administration (MPA) issued an announcement clarifying that it will promote the new intelligent review model for cosmetics notification in Guangdong province. The new model was firstly created by Zhongshan Administration for Market Regulation (AMR) under Guangdong province. The new model established a database of regulations and standards, a database of risk information, and the first intelligent review system for general cosmetics notification in China, which has improved notification review efficiency and speed.

Shanghai and Guangdong MPA Cancels the Notification of Two Batches of General Cosmetics

In Jan. 2023, Shanghai and Guangdong MPA respectively released two announcements, canceling the notification of 8,351 Chinese domestic and imported general cosmetics. The reason for cancellation is that the enterprises neither fulfill the obligation of submitting the annual report, nor make corrections within the prescribed time limit.

China Consults on Guidelines for Determination of New Cosmetic Ingredients

On Jan. 19, 2023, China NIFDC released the draft of Technical Guidelines for Determination of New Cosmetic Ingredients for public consultation. The draft regulates the principles for the determination, classification and naming of new cosmetic ingredients. All notifiers and registrants of new cosmetic ingredients shall conduct research and safety assessments in accordance with the requirements.

Chongqing MPA Reminds Notifiers to Submit General Cosmetics Annual Report

On Jan. 30, 2023, Chongqing MPA released an announcement to remind notifiers to submit the annual report of general cosmetics that have been notified for at least one year through the registration and notification platform before March 31, 2023. For products with overdue annual reports, the regulatory authorities will cancel the notification in accordance with relevant regulations.

China Proposes to Abolish a Mandatory National Standard: Procedures and Methods for Safety Evaluation of Cosmetics

On Jan. 31, 2023, China Standardization Administration released an announcement to propose abolishing the GB7919-1987 Procedures and Methods for Safety Evaluation of Cosmetics promulgated by the former Ministry of Health in 1987. The reason for the abolition is that there are multiple regulatory documents on cosmetic safety requirements, such as Safety and Technical Standards for Cosmetics and Technical Guidelines for Cosmetic Safety Assessment. Any objections can be mailed fuyun@samr.gov.cn before Mar. 30, 2023.

China NMPA Approves Three New Cosmetic Ingredients

In Jan. 2023, NMPA updated the notification information of three new cosmetic ingredients (NCIs). The basic information about these new NCIs is as follows:

1) Donkey oil, notified on Jan. 4, 2023

2) Azelamidopropyl Dimethyl Amine, notified on Jan. 4, 2023

3) Potassium Dihydroavenous Alkaloid D, notified on Jan. 6, 2023

Guangzhou AMR and Beijing Municipal MPA Publish FAQs Regarding Cosmetics Notification

In Jan. 2023, Guangzhou AMR and Beijing Municipal MPA released four batches of FAQs concerning cosmetics notification, such as requirements for cosmetic labelling, product formula, product executive standard, product annual report, etc.

China Issues 7 Cosmetics-related Standards in January

In Jan. 2023, China issued 7 cosmetics-related standards. The basic information is as follows:

PMDA: Six Batches Cosmetics Recalled in January

In Jan. 2023, Japan Pharmaceuticals and Medical Devices Agency (PMDA) notified six batches of non-compliant hair conditioner products and ordered recall. The reason for the recall is that the application for the production and sales of cosmetics has not been submitted in advance.

JCIA Announces the Amount of Plastic Containers and Packaging Used in the Cosmetics Industry (FY2021)

On Jan. 30, 2023, Japan Cosmetic Industry Association (JCIA) released an announcement about the amount of plastic containers and packaging used in the cosmetics industry during 2021. According to the announcement, the waste reduction rate for refills and replacements in the six main categories is 52%. Among them, detergent for hand washing have the highest rate of plastic packaging reuse. Besides, in beauty products, makeup remover products have higher rates than that of makeup products.

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

The 36th ASEAN Cosmetic Scientific Body (ACSB) meeting was held in November 2022. In the meeting, ASEAN adopted new amendments to the ingredient annexes to ASEAN Cosmetic Directive (ACD):

1) Annex II: List of prohibited ingredients – 42 added and 1 revised

2) Annex III: List of restricted ingredients – 4 revised

3) Annex IV: List of permitted colorants – 1 revised

4) Annex VI: List of permitted preservatives – 3 revised

5) Annex VII: List of permitted UV filters – 1 revised

Indonesia BPOM Releases Legislative Plan for 2023

On Jan. 10, 2023, the Indonesian Food and Drug Administration (BPOM) released the 2023 legislative plan. BPOM will amend or release the finalized version of the regulations in the legislative plan in 2023. Those related to cosmetics are listed in the following table.

Malaysia Amends Cosmetic Ingredient Use Requirements

On Jan. 12, 2023, Malaysia National Pharmaceutical Regulatory Agency (NPRA) released Circular No. 1/2023 Information on the Updated Status of Ingredients in the Annex of the Guidelines for Control of Cosmetic Products in Malaysia. Most revisions are in line with those adopted by the 36th ASEAN Cosmetic Scientific Body (ACSB) meeting.

1) Annex II: List of prohibited ingredients – 42 added

2) Annex IV: List of permitted colorants – 1 revised

3) Annex VI: List of permitted preservatives – 1 revised

4) Annex VII: List of permitted UV filters – 1 revised

Vietnam Amends Cosmetic Ingredient Use Requirements

On Jan. 30, 2023, Vietnam Drug Administration released Official Letter No. 817/QLD-MP on Updating Regulations on Ingredients Used in Cosmetics. Most revisions are in line with those adopted by the 36th ASEAN Cosmetic Scientific Body (ACSB) meeting.

1) Annex II: List of prohibited ingredients – 42 added

2) Annex III: List of restricted ingredients – 1 revised

3) Annex IV: List of permitted colorants – 1 revised

4) Annex VI: List of permitted preservatives – 1 revised

5) Annex VII: List of permitted UV filters – 1 revised

Philippines to Impose New Requirements on the PIF Audit for Cosmetic Products

On Jan. 19, 2023, the Philippines FDA released the finalized version of the Updated Guidelines on Product Information File (PIF) for Cosmetic Products Repealing FDA Circular No. 2018-001“Reiterating the Mandatory Implementation of Article 8 of the ASEAN Cosmetic Directive, Product Information” (the Updated Guidelines). Compared to Circular No. 2018-001 currently in force, the Updated Guidelines adopts proper classification to make the previously included Guidelines more clear and logical, and provides important supplements to PIF Audit.

Australia Amends the Current Poisons Standard

On Nov. 4, 2022, Australia announced to release a new version of the Poisons Standard, aiming to improve readability and clarity. The amendments are largely to the structure, readability and clarity, as well as formatting of the information in the standard. The updated standard took effect on Feb. 1, 2023.

Australia AICIS Launches a Decision Tool for Judging the Reported Introduction Categories

On Jan. 31, 2023, Australia AICIS released an updated decision tool for companies to determine whether their chemical introductions fall within the reported category. The updated tool includes nine new questions to guide companies derive a result.

EU SCCS Consults on Opinion as to Hydroxyapatite (nano)

On Jan. 11, 2023, EU Scientific Committee on Consumer Safety (SCCS) released the preliminary opinion SCCS/1648/22 on Hydroxyapatite (nano). According to the safety assessment based on the available relevant data, SCCS considers it safe when Hydroxyapatite (nano) is used at concentrations up to 10% in toothpaste, and up to 0.465% in mouthwash.

New York Bans Mercury in Cosmetics and Personal Care Products

On Dec. 23, 2022, the Governor of New York State signed a bill (S8291A/A8630A), banning the distribution and sales of cosmetics and personal care products containing mercury in the state. The bill will take effect on June 1, 2023.

US Extends the Consultation Period on Proposed Increase in Color Additive Certification Fees

On Nov. 2, 2022, the US FDA opened a public consultation on the fee increase for color additives certification services until Jan. 3, 2023. On Jan. 24, 2023, FDA reopened the comment period for interested parties to develop and submit comments. The extended consultation period will close on Mar. 10, 2023.

Further Reading

1. Monthly Recap: Global Cosmetic Regulatory Updates | December 2022

2. Monthly Recap: Global Cosmetic Regulatory Updates | November 2022