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Monthly Recap: Global Cosmetic Regulatory Updates | July 2023

Chinese Mainland

Shanxi Provincial Medical Products Administration (MPA) Releases Two Measures for Supervision and Management of Cosmetics Operations

Shanxi MPA released two new measures on July 3, 2023, aiming at improving the supervision and management of cosmetics operations. The two measures are Measures for Supervision and Management of Cosmetics Operations by Hierarchy and Classification and Administration Measures for the Risk Classifications of Cosmetics Production Quality and Safety. The measures provide guidelines for evaluating the risk levels of cosmetics manufacturers and operators, and introducing classification supervision measures. Both measures will take effect on January 1, 2024.

China Consults on National Standard of Restricting Excessive Packaging for Commodity - General Rule

The China Packaging Federation (CPF) issued a letter on July 5, 2023, soliciting opinions on the national standard of Restricting Excessive Packaging for Commodity - General Rule. The deadline for comments is September 3, 2023.

China National Institutes for Food and Drug Control (NIFDC) Seeks Project Undertaking Units to Revise Safety and Technical Standards for Cosmetics

China NIFDC has established a project to revise Safety and Technical Standards for Cosmetics and formulate relevant standards, and opened a public call for project undertaking units on July 14, 2023. The deadline for submission is August 4, 2023.

Shanghai to Implement New Provisions for On-site Personalized Cosmetic Services in August

On July 20, 2023, Shanghai MPA released the Provisions for Management of On-site Personalized Cosmetic Services in Pudong New Area of Shanghai (Trial) (the Trial Provisions) to further standardize the personalized cosmetic services. The Trial Provisions will be in effect for two years from August 20, 2023, to August 19, 2025.

China General Administration of Customs (GACC) Simplifies Entry Procedures for Cosmetics Intended Solely for China International Import Expo

China GACC released the Instructions for Customs Clearance of the Sixth China International Import Expo in 2023 and Convenience Measures for Customs to Support the Sixth China International Import Expo in 2023 on July 20, 2023. The two measures introduce simplified entry procedures for cosmetics intended solely for exhibition purposes. Specifically, cosmetics only for the exhibition are exempt from affixing Chinese labels and sampling inspection. Additionally, cosmetics for a small scale of trial sales at the exhibition site can also be exempted from affixing Chinese labels.

France May Cooperate with China to Formulate Shared Standards for Cosmetics

During the ninth China-France High-Level Economic and Financial Dialogue on July 29, French Minister of Economy and Finance Bruno Le Maire visited China to discuss the mutual economic and financial cooperation, including intellectual property issues in the luxury and cosmetics sector.

During the visit, an official stated that Bruno Le Maire expressed interest in collaborating with China to establish a joint body to develop shared standards for efficacy claims and cosmetic safety. These standards would clarify the requirements for French-produced cosmetics to be sold in China.

GACC Reports Rejection of Six Batches of Cosmetics in June

According to the latest update from GACC on July 28, 2023, six batches of cosmetics were rejected in June. Three batches imported from Japan failed customs inspection due to non-compliant labeling, while another three batches from Japan and Australia were rejected due to the lack of required qualified documentation.

China NMPA Approves Five New Cosmetic Ingredients

In July, NMPA updated the notification status of five NCIs. The basic information about these new NCIs is as follows:

1. Galactomannan, notified on July 10, 2023

2. Paris Fargesii Rhizome Extract, notified on July 11, 2023

3. Cellulose Acetate Propionate (CAS No. 9004-39-1), notified on July 11, 2023

4. Pandanus Amaryllifolius Leaf Extract, notified on July 25, 2023

5. Ludwigia Adscendens Extract, notified on July 26, 2023

China Issues a New Cosmetic Supplementary Testing Method and Three Cosmetic Ingredient Testing Methods

In July 2023, China National Medical Products Administration (NMPA) and NIFDC released four cosmetic testing methods, including a new supplementary testing method and three draft testing methods for cosmetic ingredients.

Type

Method Name

Supplementary testing method

BJH 202301 Determination of Tacrolimus and Pimecrolimus in Cosmetics

Testing methods for cosmetic ingredients (draft)

Determination of Azelaic Acid and Potassium Azeloyl Diglycinate in Cosmetics

Reactive Oxygen Species (ROS) Assay for Photoreactivity in Cosmetics

Determination of Selenium Disulfide in Cosmetics

Guangzhou, Shenzhen, Chongqing, Jiangsu, and Zhejiang Authorities Issue Notices to Cancel the Notification of Chinese Domestic General Cosmetics Failing the Annual Report Submission

In July 2023, Guangzhou and Shenzhen Administration for Market Regulation (AMR), as well as Chongqing, Jiangsu and Zhejiang MPA, issued notices to cancel the notification of Chinese domestic general cosmetics failing the annual report submission.

Guangzhou and Beijing Authorities Publish FAQs Regarding Cosmetics Notification

In July, Beijing Municipal MPA and Guangzhou AMR released two batches of FAQs concerning general cosmetics notification, including requirements for cosmetic labelling, efficacy claim evaluation, product formula, ingredient safety information submission, the use of new cosmetic ingredients, product’s annual report, etc.

Release Date

Regulatory Authority

Batch

July 24, 2023

Beijing Municipal MPA

The 23rd Batch

July 24, 2023

Guangzhou AMR

The 43rd Batch

China Issues Five Cosmetics-related Group Standards in July

In July, China issued five cosmetics-related group standards. The essential information is as follows:

Release Date

Initiator

Standard Name

Effective Date

July 6, 2023

China Food and Drug Corporation Quality and Safety Promotion Association

T/FDSA 041—2023 Technical Requirements for Dissoluble Microneedling Cosmetics

August 1, 2023

July 16, 2023

Baotou Bayan Obo Mining District Rare Earth Industry Standardization Association

T/BYXT 027.1—2023 Rare Earth Antibacterial Cosmetics Part 1: Herbal Essential Oil

July 15, 2023

July 18, 2023

Guangdong Cosmetic Quality Management Association

T/GDCQMA 002—2023 Specification for Stability Testing of Cosmetics

July 20, 2023

July 21, 2023

Beijing Daily Chemical Association

T/BDCA 0003—2023 Guideline for Quality Management of Cosmetic Botanical Ingredient

August 1, 2023

July 31, 2023

Shanghai Daily Chemistry Trade Association

T/SHRH 040.2—2023 Specification for Acceptance Management of Cosmetic Inner Packaging Materials for the Oriental Beauty Valley Part 2: General Test Methods

August 30, 2023

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Taiwan, China

Taiwan Releases One Test Method for Cosmetics

On July 5, 2023, Taiwan Food and Drug Administration (TFDA) released a test method for determining eight prostaglandin analogs in cosmetics, including Bimatoprost, Cloprostenol, Fluprostenol, Travoprost, etc. According to TFDA, these substances are prohibited for use in cosmetics.

South Korea

South Korea Consults on Cosmetic Ingredient Analysis Guidelines

On July 4, 2023, the National Institute of Food and Drug Safety Evaluation (NIFDS) consults on the amendments to Guidelines for the Analysis of Cosmetics Ingredients. To ensure the safety of distributed cosmetics, the authority mainly proposed to modify the analysis methods of four preservatives, six UV filters, and five other cosmetic ingredients.

ASEAN

ASEAN Introduces Amendments to the Ingredient Lists of ASEAN Cosmetic Directive

The 37th ASEAN Cosmetic Scientific Body (ACSB) meeting was held on May 8-9, 2023. In the meeting, ASEAN adopted the following amendments to the ingredient annexes to ASEAN Cosmetic Directive (ACD):

1) List of prohibited ingredients: 19 entries added

2) List of restricted ingredients: 2 ingredients added

3) List of permitted preservatives: 1 ingredient revised

4) List of permitted UV filters: 2 ingredients revised

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Malaysia

Malaysia Amends Cosmetic Ingredient Use Requirements: 19 Prohibited Ingredients Added and 5 Ingredients Revised

On July 4, 2023, Malaysia National Pharmaceutical Regulatory Agency (NPRA) released Circular No. 2/2023 Information on the Updated Status of Ingredients in the Annexe of the Guidelines for Control of Cosmetic Products in Malaysia. According to the Circular, 19 prohibited ingredients and 2 restricted ingredients are added; 1 restricted ingredient, 1 permitted preservative and 1 permitted UV filter are revised.

Vietnam

Vietnam Amends Cosmetic Ingredient Use Requirements

Drug Administration of Vietnam (DAV) released official letter No. 8314/QLD-MP on July 28, 2023, to announce the updated use requirements for cosmetic ingredients. The changes align with the updates to the ASEAN Cosmetics Directive (ACD) passed by the 37th ASEAN Cosmetic Scientific Body (ACSB) meeting.

Vietnam Announces Administrative Application Fees for Pharmaceuticals and Cosmetics

DAV released official letter No. 8345/QLD-VP on July 31, 2023, to announce the administrative application fees for pharmaceuticals and cosmetics. The document became effective on August 1, 2023.

The European Union

EU Announces the Second Revision of Guidance on the Safety Assessment of Nanomaterials in Cosmetics

On June 26, 2023, EU Scientific Committee on Consumer Safety (SCCS) released the updated Guidance on the Safety Assessment of Nanomaterials in Cosmetics (Guidance). Compared to its predecessor, the updated Guidance introduces the new overarching definition of nanomaterials, presents the key attributes that trigger safety concerns over nanomaterials, and details the important physicochemical parameters of nanomaterials' assessments.

EU SCCS Refines the Scientific Opinion on Water-soluble Zinc Salts

On July 4, 2023, SCCS published a refined scientific opinion on the use of water-soluble zinc salts in oral hygiene products. Compared to the previous opinion, this refined version takes into account considerations such as dietary exposure and the age-dependent usage of oral care products by consumers.

EU to Ban 30 More CMR Substances in Cosmetics from December 2023

In November 2022, the EU notified WTO of a draft regulation, proposing to newly include 30 more carcinogenic, mutagenic, and reprotoxic (CMR) substances into the prohibited ingredients list of Regulation (EC) No 1223/2009 (Cosmetics Regulation). On July 20, 2023, the EU introduced Commission Regulation (EU) 2023/1490, finalizing the ban on these substances in cosmetics starting from December 1, 2023.

EU Amends the Restricted Ingredients List Regarding the Labelling of Fragrance Allergens 

On July 27, 2023, the EU released Commission Regulation 2023/1545, amending the restricted ingredients list by adding 45 new entries, revising 17 existing entries, and deleting 10 entries. The regulation will enter into force on August 16, 2023, with a transitional period of three to five years. With this update, individual labelling will be required for 56 additional fragrance allergens in accordance with the Cosmetics Regulation.

The United Kingdom

UK Revises the Lists of Restricted Ingredients and Permitted UV Filters

On July 20, 2023, the UK published The Cosmetic Products (Restriction of Chemical Substances) (No. 2) Regulations 2023, introducing new amendments to ingredients' use requirements. Based on the opinions from the Scientific Advisory Group on Chemical Safety in Consumer Products (SAG-CS), the UK added one restricted ingredient and two permitted UV filters to the ingredient lists of the UK Regulation (EC) 1223/2009.

The United States

Washington State Restricts the Use of Certain Toxic Chemicals in Consumer Products

On July 1, 2023, the US’ Washington State officially implemented a new rule, Chapter 173-337 WAC “Safer Products Restrictions and Reporting”, with the goal of reducing toxic chemicals in consumer products and improving ingredient transparency. Regarding the influences to the cosmetics industry, the rule prohibits the intentional addition of ortho-phthalates to fragrance ingredients in beauty and personal care products from January 1, 2025.

Canada

Canada Proposes to Amend Cosmetic Ingredient Use Requirements

On July 13, 2023, Health Canada released a notice concerning the review of several amendments to the Cosmetic Ingredient Hotlist. The proposed amendments are:

1) 2 prohibited ingredients added;

2) 6 restricted ingredients added;

3) Requirements for 2 prohibited ingredients revised;

4) Requirements for 9 restricted ingredients revised.

Australia

Australia Updates Poisons Standard

On July 3, 2023, Australia’s Therapeutic Goods Administration (TGA) released the latest edition of the Therapeutic Goods (Poisons Standard - July 2023) Instrument 2023, which supersedes the previous version issued in June 2023. The updated Poisons Standard includes a number of modifications to the previous entries and the addition of several new specified substances for the first time.

Australia Invites Public Feedback on Proposed Changes to Poisons Standard

On July 13, 2023, TGA opened a public consultation on proposed amendments to the Poisons Standard. The consultation pertains to the substances discussed during the March 2023 meetings of the Advisory Committee on Medicines Scheduling (ACMS) and Advisory Committee on Chemicals Scheduling (ACCS), including celecoxib, bromoxynil, dioxane, and azelaic acid. Interested parties are encouraged to provide their feedback on the proposed changes until August 10, 2023.

Australia Requires Annual Authorization for DecaBDE and PFOA Chemicals

On July 14, 2023, the Australian government announced the adoption of new rules for decaBDE, PFOA and its salts, as well as PFOA-related compounds. Effective from July 21, 2023, now the import and export of these chemicals requires annual authorization from the Australian Industrial Chemicals Introduction Scheme (AICIS). However, the new rules do not apply if the chemicals are being introduced solely for research or analysis, and the volume imported or exported is 100 kg or less during one AICIS registration year (September 1 to August 31).

Saudi Arabia

Saudi Arabia Sets Usage Requirements for Methyl N-Methyl Anthranilate (MNM) in Cosmetics

On July 28, 2022, Saudi Arabian Food and Drug Administration's Announcement No. 87121 set usage requirements for methyl N-methyl anthranilate (MNM) in cosmetics, which took effect from July 1, 2023.

Saudi Arabia to Formulate Guidelines for Cosmetic Product for Professional Use

The Ministry of Health of Saudi Arabia published a consultation document on July 20, 2023, to establish guidelines for cosmetic product for professional use. The document aims to clarify the requirements and restrictions for cosmetic manufacturers and importers. Interested parties can provide feedback until August 20, 2023.

Others

IFRA Releases the 51st Amendment to the IFRA Standards

The International Fragrance Association (IFRA) released the 51st Amendment to the IFRA Standards on June 30, 2023, which became effective in July 2023. Mandatory for IFRA members, these standards promote the safe and responsible use of fragrances in consumer products. IFRA requires member companies to ensure their fragrances comply with the 51st Amendment within the specified transition period.

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