China
China Allows the Application for Submission Codes for Compound Ingredients
After the updates of Cosmetic Ingredients Safety Information Submission Platform in September 2023, compound ingredients could not obtain new submission codes through the platform. On November 1, 2023, the platform underwent another update, enabling compound ingredients to obtain new submission codes once again.
China Issues a New Cosmetics Supplementary Testing Method
On November 2, 2023, China National Medical Products Administration (NMPA) released a new cosmetics supplementary testing method, BJH 202302 Determination of Clobetasol Acetate in Cosmetics. Clobetasol Acetate falls under the category of glucocorticoids, which are primarily used in the medical field. According to Safety and Technical Standards for Cosmetics 2015 (STSC 2015), the use of glucocorticoids in cosmetics is strictly prohibited.
China Lifts Consular and Embassy Legalization for Notarized Documents Related to Cosmetic Imports
On November 7, 2023, China officially enacted the Convention of Abolishing the Requirement of Legalisation for Foreign Public Documents. According to it, effective since November 7, notarized documents essential for importing cosmetics, new cosmetic ingredients, and toothpaste from certain countries, including authorization letters and GMP documents, no longer require consular (embassy) legalization.
China NMPA Announces Enhanced Management for New Cosmetic Ingredients
On November 10, 2023, NMPA released an announcement to further standardize the management of new cosmetic ingredients (NCIs) through their life cycles. Consisting of three parts, the announcement emphasizes the NCI's innovation direction, the responsibility of registrants and notifiers for NCI's quality and safety, and the importance of NCI inspections.
China NMPA Unveils the First Unannounced Inspection Failure of Foreign Company
On November 17, 2023, NMPA disclosed that a Japanese cosmetic company failed a recent unannounced inspection. The company was found to have made unauthorized changes to the production process of a black hair cream product. This marks the first instance of an overseas company receiving unannounced inspections under China's new cosmetics regulations, signaling heightened official supervision in the cosmetics market. Furthermore, oversight of cosmetics violations is now extended to overseas companies, reinforcing equal treatment for both Chinese and foreign entities.
China Finalizes Detailed Dossier Requirements for Toothpaste Notification
On November 22, 2023, NMPA unveiled the definitive edition of the Provisions for Management of Toothpaste Notification Dossiers. Shaped by two rounds of public consultations in January 2021 and September 2023, this final version specifies the responsibilities and obligations of toothpaste notifiers, the user-information-related dossiers, and the necessary documentation for initial toothpaste notification. It has taken effect since December 1, 2023, marking the era of strict supervision in China's toothpaste market.
On November 24, 2023, China National Institutes for Food and Drug Control (NIFDC) initiated a public consultation on 20 draft testing methods. 16 of these pertain to toothpaste determination, covering aspects such as pH value, free formaldehyde content, heavy metal content, and microbiological test. The remaining 4 methods are related to cosmetic ingredients and toxicological tests. Stakeholders with any comments can mail to hzpbwh@nifdc.org.cn before December 15, 2023.
China NMPA Approves 13 NCIs
In November, NMPA updated the notification status of 13 NCIs. The basic information about these new NCIs is as follows:
1. Nicotinamide Mononucleotide (CAS No. 1094-61-7), notified on November 1, 2023
2. 3,3,5-Trimethylcyclohexyl Succinate Dimethylamide (CAS No. 1449076-27-0), notified on November 3, 2023
3. Aminolevulinic Acid HCl (CAS No. 5451-09-2), notified on November 7, 2023
4. Sorbeth-230 Tetraoleate (CAS No. 63089-86-1), notified on November 7, 2023
5. Bakuchiol (CAS No. 10309-37-2), notified on November 13, 2023
6. Phosphatidylserine (CAS No. 84776-79-4), notified on November 14, 2023
7. Isomaltooligosaccharide, notified on November 16, 2023
8. Bis-Polycitronellyl Succinate (CAS No. 2810894-78-9), notified on November 21, 2023
9. Bis-Polycitronellyl Azelate (CAS No. 2810894-79-0), notified on November 21, 2023
10. Silicone Quaternium-16/Glycidoxy Dimethicone Crosspolymer (CAS No. 853411-22-0), notified on November 21, 2023
11. Butyl Methacrylate / HEMA / Methacryloxyethyl Phosphorylcholine Copolymer, notified on November 23, 2023
12. Bakuchiol (CAS No. 10309-37-2), notified on November 28, 2023
13. Sodium Colanate, notified on November 29, 2023
Guangzhou and Beijing Authorities Publish FAQs Regarding Cosmetics Notification
In November, Guangzhou Administration for Market Regulation (AMR) and Beijing Municipal Medical Products Administration (MPA) released three batches of FAQs. They cover various topics related to general cosmetics notification, especially the requirements for aspects such as notification dossiers, product testing, safety assessment, product labelling, the filling and submission of toothpaste's formula, etc.
Release Date | Regulatory Authority | Batch |
November 24, 2023 | Guangzhou AMR | |
November 24, 2023 | Guangzhou AMR | |
November 29, 2023 | Beijing Municipal MPA |
China Issues Nine Cosmetics-related Standards in November
In November, China issued nine cosmetics-related standards. The essential information is as follows:
Release Date | Initiator | Standard Name | Effective Date |
November 1, 2023 | Guangdong Cosmetics Association | / | |
November 7, 2023 | Guangdong Institute of Cosmetics Science and Technology | / | |
November 8, 2023 | / | ||
November 8, 2023 | / | ||
November 9, 2023 | Guangdong Cosmetics Association | General Principle for Safety Evaluation of Cosmetic Formulations for Pregnant and Lactating Women | November 9, 2023 |
November 14, 2023 | Zhejiang Health Products & Cosmetics Industry Association | / | |
November 14, 2023 | / | ||
November 14, 2023 | / | ||
November 14, 2023 | / |
Japan
PMDA: 111 Cosmetics and Quasi-drugs Products Recalled in November
In November 2023, Japan Pharmaceuticals and Medical Devices Agency (PMDA) issued a total of 111 batches of non-compliant cosmetic and quasi-drug products. Among them, unqualified quasi-drug products accounted for 86%, all because of the failed labeling of mandatory ingredients. Additionally, a considerable number of cosmetics were discovered to be stored in facilities without manufacturing permits, and subsequently sold as final products in the market. Based on Japanese cosmetic regulations, stakeholders who want to carry out final packaging, labeling, and storage of the product must obtain a manufacturing license (packaging, labeling, and storage). However, those who only possess this license are not eligible to sell cosmetics.
South Korea
South Korea Revises the Guidelines for Management of Cosmetic Labelling and Advertisements
The Ministry of Food and Drug Safety (MFDS) revised the Guidelines for Management of Cosmetic Labelling and Advertisements on November 24, 2023. The revisions include the addition of methods and examples for indicating the extract content in cosmetics, as well as the reference materials required for calculating the extract content.
South Korea Modifies the Cosmetic Safety Standard: Ingredients and CAS Numbers
As MDFS revealed on November 30, 2023, modifications related to seven prohibited ingredients and three restricted ingredients are included in the Regulation on Safety Standards, etc. for Cosmetics. Besides, the prohibited ingredients and restricted ingredients are added with the relevant CAS Number and chemical name. The regulation has been effective since November 30, 2023, except for the changes related to hair dye ingredients, which will be implemented six months later.
Philippines
Philippines to Adopt New Strategy in Regulating Functional Cosmetics
On October 31, 2023, the Philippines Food and Drug Administration (FDA) announced the launch of the Functional Pop Beauty (F-Pop) Initiative, with the goal of establishing a more effective approach in the regulation of functional cosmetics. As part of the policymaking process for the F-Pop Initiative, FDA will conduct workshops and activities to benchmark its regulations for functional cosmetics, and draw reference from the provisions in South Korea, China, and Japan.
Thailand
Thailand Revises Notification Review Standard for Mouth Spray Cosmetics
In October 2023, the Thai Food and Drug Administration (Thai FDA) introduced a comprehensive update to the Criteria for Reviewing Notification of Mouth Spray Products. This revised standard specifically addresses claims, container characteristics, naming rules, and notification documentation requirements for mouth spray cosmetics.
The Thai FDA Discloses Data on Non-Compliant Cosmetics in November 2023
On November 15, 2023, the Thai FDA reported the non-compliance of 8 batches of cosmetics during inspection and analysis. The affected products are mainly found in whitening creams and sunscreens categories. The cause of the non-compliance was the detection of prohibited ingredients, including mercury compounds, hydroquinone, glucocorticoids (clobetasol propionate, and betamethasone 17-valerate), and retinoic acid.
Indonesia
Indonesia Amends Time Requirements for Obtaining Cosmetics Import Certificate
On November 8, 2023, Indonesian Agency for Drug and Food Control (BPOM) issued amendments to the Regulation for Supervision on the Entry of Drugs and Food into the Territory of Indonesia. The amended Regulation introduces a change to the cosmetic import certificate, replacing SKI Post Border with SKI Border. The main distinction is that SKI Post Border shall be acquired before or within seven days after the goods are released from the customs area, while SKI Border must be obtained prior to the release from the customs area.
Indonesia Proposes to Amend Limitations for Contamination in Cosmetics
On November 9, 2023, Indonesia released the amended draft of Regulation Concerning Limitations for Contamination in Cosmetics for public consultation. This draft proposes revisions to the contamination limits for chemicals in cosmetics, while the contamination limits for microorganisms and heavy metals remain unchanged.
Indonesia Proposes to Amend Cosmetic Labeling Requirements
On November 9, 2023, Indonesia released the amended draft of Technical Requirements for Cosmetic Labeling for public consultation. Compared with the current Regulation, the draft adds some detailed requirements for labeling, and clarifies the labeling requirements for refillable cosmetics.
Indonesia Proposes to Amend Cosmetic Adverse Reaction Report Requirements
On November 9, 2023, Indonesia released the amended draft of Regulation for Cosmetics Adverse Reaction Monitoring for public consultation. The draft introduces revisions to specific requirements concerning the reporting of adverse reactions.
Indonesia Recognizes Halal Certificates from Nine Foreign Halal Certification Bodies
The Halal World 2023 event in Jakarta resulted in a significant outcome— two Mutual Recognition Agreement (MRA) were signed between the Indonesian Ministry of Religious Affairs' Halal Product Assurance Agency (BPJPH) and 37 foreign Halal Certification Bodies (LHLN). To be more specific, an MRA was signed between BPJPH and 9 LHLNs in terms of mutual recognition and acceptance of halal certificates, and another MRA was signed between BPJPH and 28 LHLNs in an agreement to accelerate the completion of LHLN assessments for recognition and acceptance of halal certificates.
Australia
Australia Adds Two Chemicals to the Australian Inventory of Industrial Chemicals (AIIC)
On November 2, 2023, the Australian Government announced the addition of two industrial chemicals to the AIIC under Section 83 of the Industrial Chemicals Act 2019. The added chemicals are 2H-Pyran-4-ol, 2-(1-ethylpropyl)tetrahydro-4-methyl- (CAS No. 1099648-69-7) and 2-Pentanone, 4-methyl-, oxime (CAS No. 105-44-2), with the former primarily used in fragrance formulations for cosmetics and household products.
Australia Updates the Names of 27 Chemicals in the AIIC
On November 2, 2023, the Australian Government issued a notice to make public the updated names of 27 industrial chemicals that were previously listed in the AIIC, for the reasons that some chemicals' listed names had been varied to the Chemical Abstracts Service (CAS) names or some chemicals' CAS names had been updated. These corrections do not change the identity of the chemical substances themselves.
New Zealand
Updates to New Zealand Cosmetic Product Group Standards: Decision to Be Notified!
According to the Environmental Protection Authority (EPA), the decision-making committee (DMC) closed the public hearing related to the Cosmetic Products Group Standard on November 22, 2023. The decision will be publicly notified no later than January 30, 2024.
The revision of New Zealand's Cosmetic Products Group Standard has drawn the attention of the cosmetic industry. After a long legislation procedure, the revised version is finally to be published in 2024. More details about the Standard, please find ChemLinked News.
The European Union
On October 26, 2023, EU Scientific Committee on Consumer Safety (SCCS) issued an update to the latest version of The SCCS Notes of Guidance for the Testing of Cosmetic Ingredients and Their Safety Evaluation, including an additional footnote on deodorant spray under Table 3A on page 27.
EU SCCS Finalizes Opinions on Three Cosmetic Ingredients
On November 6, 2023, SCCS released the final opinions respectively on Benzyl Salicylate (CAS No. 118-58-1), Butylparaben (CAS No. 94-26-8), and water-soluble zinc salts. These opinions uphold the same conclusions as their preliminary versions.
EU SCCS Consults on the Opinion About Hydroxypropyl p-Phenylenediamine and Its Dihydrochloride Salt
On November 7, 2023, SCCS published the preliminary opinion on the use of Hydroxypropyl p-Phenylenediamine (CAS No. 73793-79-0) and its dihydrochloride salt (CAS No. 1928659-47-5) in oxidative hair colouring products. The opinion is open for comments until January 8, 2024.
EU SCCS Releases the Preliminary Opinion on Hexyl Salicylate
On November 9, 2023, SCCS issued a preliminary opinion regarding the use of Hexyl Salicylate (CAS No. 6259-76-3) in cosmetics. Based on the information provided by the industry, SCCS proposed different concentration limits of Hexyl Salicylate based on product types.
The United Kingdom
UK to Impose Restrictions on the Use of Butylated Hydroxytoluene
On October 27, 2023, UK notified WTO of a draft regulation, proposing to newly include Butylated Hydroxytoluene (CAS No. 128-37-0) as a restricted ingredient in the UK Regulation (EC) 1223/2009 with detailed restrictions. The draft is open for comments until December 26, 2023, and expected to be adopted on January 16, 2024.
The United States
U.S. FDA's New Cosmetic Portal Nears Launch
On November 1, 2023, the U.S. Food and Drug Administration (FDA) disclosed the latest progress and forthcoming initiatives regarding the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), specifically focusing on cosmetic product facility registration and product listing.
U.S. FDA Allows Delay in Enforcement of Cosmetic Facility Registration and Product Listing
On November 8, 2023, the U.S. FDA issued a guidance document titled Compliance Policy for Cosmetic Product Facility Registration and Cosmetic Product Listing. On the one hand, companies are still encouraged to meet the original deadline for MoCRA's facility registration and product listing requirements if they are capable of doing so. On the other hand, the FDA extend the enforcement deadline for these requirements by an extra six months.
On November 14, 2023, the U.S. FDA released an updated version of the Structured Product Labeling (SPL) Implementation Guide with Validation Procedures. This guide encompasses modifications to both cosmetic product facility registrations and product listings that are included within the SPL framework.
INCI Application Fees Are About to Increase
As per the announcement on the official website of the American Personal Care Products Council (PCPC), the International Nomenclature Cosmetic Ingredient (INCI) name's application fee is set to rise from the existing $400 per application to $1,000 per application. This adjustment is scheduled to take effect on January 1, 2024.
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