On April 26, 2023, the SkinCeuticals store located in Shanghai Pudong New Area was granted a cosmetic production license for on-site personalized service by the Shanghai Municipal Medical Products Administration (MPA). This license allows the enterprise to provide consumers with personalized services that involve direct contact with cosmetic contents at the store. As the first license of its kind in China, it marks a milestone in the development of China's personalized cosmetic industry.
On May 4, 2023, China National Institutes for Food and Drug Control (NIFDC) started a public feedback process for the draft Technical Guidelines for Skin Sensitization Test. Consisting of five parts, the draft introduces the basic test principles and contents, and gives instructions on result analysis and evaluation.
On May 4, 2023, NIFDC released the draft Technical Guidelines for Filling in and Submitting Cosmetic Formula for public consultation. The draft provides instructions for enterprises seeking to register or notify special/general cosmetics, and outlines the requirements for completing the cosmetic formula table.
On May 4, 2023, NIFDC initiated a public consultation on the Technical Guidelines for Filling in and Submitting Safety Information of Cosmetic Ingredients (the Guidelines). Consisting of 11 parts, the Guidelines systematically outlines the vital points and technical principles for filling in and submitting the ingredient safety information, covering aspects of ingredient's basic information, brief descriptions of ingredient's production technique, necessary quality control requirements, limitation requirements for risk substances, etc.
On May 12, 2023, NIFDC started a public commenting period on the Guidelines for Submitting Information Through the Cosmetic Ingredient Safety Information Submission Platform. This draft is developed to provide guidance to ingredient manufacturers on the correct use of the Ingredient Safety Information Submission Platform, and standardize the submission of ingredient safety information. Its main contents include the basis, purpose, application scope, submitting entity, submission content, the generation and use of ingredient submission codes, etc.
On May 15, 2023, Zhejiang MPA published the draft of Guidelines for Compiling the Simplified Safety Assessment Report of General Cosmetics in Zhejiang (the Guidelines) for public comments. The draft is formulated as per the Key Points for Reviewing of General Cosmetics Safety Assessment Report (Simplified Version) released by National Medical Products Administration (NMPA) in February 2022. Specifically, the Guidelines emphasizes the essential compiling requirements for different parts of the report, and provides exposure information sheet, IFRA product classification list, description template of adverse reaction monitoring, etc., for cosmetic notifiers' reference.
To further regulate the cosmetics market, on May 25, 2023, Guangzhou Administration for Market Regulation (AMR) implemented the local standard Quality Management Specification of Cosmetics Business. Closely based on the actual cosmetic operation in Guangzhou, this standard stipulates the types and responsibilities of cosmetic enterprises, as well as the requirements of personnel, quality management, file management, etc.
On May 28, 2023, GACC updated the list of rejected food and cosmetics in April. Two batches of cosmetics imported from Germany failed customs inspection due to unqualified labels.
China NMPA Approves Nine New Cosmetic Ingredients
In May, NMPA updated the notification status of nine new cosmetic ingredients (NCIs). The basic information about these new NCIs is as follows:
Gynura Procumbens Extract, notified on May 5, 2023
Hydroxymethoxyphenyl Decanone (CAS No. 27113-22-0), notified on May 5, 2023
Hexyl/Succinyl Dimethicone Crosspolymer (CAS No. 2486020-17-9), notified on May 10, 2023
Acetyl Carnosine (CAS No. 56353-15-2), notified on May 16, 2023
Mesembryanthemum Crystallinum Callus Extract, notified on May 16, 2023
Fuscoporia Obliqua / Betula Alba Juice Ferment, notified on May 17, 2023
Tocopheryl Retinoate (CAS No. 40516-49-2), notified on May 18, 2023
TEA-Acrylate / TEA-Acryloyldimethyl Taurate Copolymer, notified on May 22, 2023
Ilex Latifolia Leaf Extract, notified on May 30, 2023
Guangzhou and Beijing Authorities Publish FAQs Regarding Cosmetics and Toothpaste Regulation
In May, Guangzhou AMR and Beijing Municipal MPA released five batches of FAQs concerning cosmetics and toothpaste regulations, including requirements for self-testing and the submission of the testing reports, the filling and submission of ingredient safety information, toothpaste notification,
|Release Date||Regulatory Authority||Batch|
|May 8, 2023||Guangzhou AMR||The 36th Batch|
|May 11, 2023||The 37th Batch|
|May 18, 2023||The 38th Batch|
|May 29, 2023||Beijing MPA||The 21st Batch|
|May 29, 2023||Guangzhou AMR||The 39th Batch|
China Issues 11 Cosmetics-related Standards in May
In May, China issued 11 cosmetics-related standards. The essential information is as follows:
May 9, 2023
Beijing Daily Chemical Association
May 11, 2023
Guangzhou Huangpu Cosmetic Industry Association
May 15, 2023
May 15, 2023
Beijing Daily Chemical Association
June 1, 2023
May 15, 2023
Shanghai Research Institute of Fragrance & Flavor Industry
May 22, 2023
Ministry of Industry and Information Technology of the People's Republic of China
November 1, 2023
May 23, 2023
Guangdong Chamber of Daily Used Chemicals
May 23, 2023
Zhejiang Health Products & Cosmetics Industry Association
May 23, 2023
May 23, 2023
National Oral Care Standardization Technical Committee
December 1, 2023
May 23, 2023
December 1, 2023
Subject to Cosmetic Hygiene and Safety Act, the pre-market registration requirement for specific purpose cosmetics will be replaced with notification and the establishment of a product information file (PIF) starting on July 1, 2024. In line with this transition, on May 19, 2023, Taiwan Food and Drug Administration (TFDA) proposed to revise Particulars of Specific Purpose Cosmetics That May Be Voluntarily Modified. Once the amendment takes effect, cosmetic enterprises will be allowed to delete the separately-listed specific purpose ingredients from product labels at their discretion.
The Ministry of Food and Drug Safety (MFDS) unveiled the draft of Regulation on Safety Standards, etc. for Cosmetics for public opinions on May 4, 2023. Following the risk assessment results, the authority proposes to designate seven restricted ingredients as new prohibited ingredients. Stakeholders can send suggestions to MFDS prior to July 4, 2023.
In recent years, the Korean cosmetic industry is seeing three creative movements, including the refilling station, AI robot for custom cosmetics, and package-free cosmetics. The latest trends in and experiences of South Korea can inspire overseas cosmetic enterprises to develop new products and better arrange their business plans. Check the details here.
On May 2, 2023, MFDS released the Guideline of Alternative Animal Testing Methods for Cosmetics (Skin Absorption: in vitro Method). This guideline provides an easy-to-understand explanation of the animal alternative test (Skin Absorption: in vitro Method) for cosmetics, explaining the test principles, limitations and considerations, test method, data and records, and test reports.
In May 2023, the Thai Food and Drug Administration introduced the updated criteria for reviewing notifications of ampoule, vial, and syringe cosmetics. The revised standard provides clearer the guidelines regarding container's characteristics, notification application documents, and labeling requirements for cosmetics packaged in ampere, vial, and syringe containers.
On May 17, 2023, India's Ministry of Health and Family Welfare launched a 45-day public consultation on proposed amendments to the Cosmetics Rules 2020. The proposed amendments seek to clarify terms like "use before" and "date of expiry", introduce new rules on license cancellation and suspension, expand options for record retention, streamline the labeling requirements for exported cosmetics, modify the conditions for obtaining a license, etc.
On May 30, 2023, the Australian Government announced the inclusion of the industrial chemical Benzene, [2-[(2-methyl-1-undecen-1-yl)oxy]ethyl]- (CAS No. 2489743-82-8) to the Australian Inventory of Industrial Chemicals (AIIC) under Section 83 of the Industrial Chemicals Act 2019.
The chemical has undergone assessment for the following uses:
Imported as a fragrance component into Australia at up to 10 tonnes per year;
Imported at up to 100% concentration for local reformulation into finished cosmetic and household products;
Imported or reformulated as a component of finished cosmetic and household products at less than 1% concentration; except for the following:
a. up to 2% concentration in candles
b. up to 10% concentration in continuous and electrical air care products
On May 30, 2023, the Australian Government published the assessment statements for four industrial chemicals used in cosmetics. The chemicals are as follows:
Oils, sandalwood, santalene synthase-modified Rhodobacter sphaeroides-fermented, from D-glucose, oxidized;
Benzene, [2-[(2-methyl-1-undecen-1-yl)oxy]ethyl]-; and
Acetic acid, 2-cyano-2-[3-[(3-methoxypropyl)amino]-2-cyclohexen-1-ylidene]-, 2-ethoxyethyl ester, (2Z)-.
The first three chemicals were assessed for their use as fragrance ingredients in fine fragrances, cosmetics, and household products; while the fourth chemical was assessed as a UV filter in cosmetic sunscreen products.
On May 15, 2023, Israel notified WTO of revised Pharmacists' Regulations (Cosmetics) 5783-2022. According to the notification, the following revisions were conducted:
Lowering the particular training requirements for responsible representatives;
Allowing for the reporting of cosmetic composition in notifications related to its marketing;
Lowering the particular requirements for the storage and transportation of cosmetic products;
Deleting the special requirements for marking special warnings of cosmetic products;
Clarifying that the labelling requirement applies to either the outer or inner packaging.
The European Union
On May 8, 2023, EU Scientific Committee on Consumer Safety (SCCS) published the updated scientific advice on the use of HC Blue 18 in cosmetics. Compared to the previous opinion on this substance, SCCS/1560/15, the newly released opinion adequately quantifies the impurities in HC Blue 18, and fully assesses the detected impurities' potential genotoxic property.
On May 16, 2023, SCCS introduced a draft opinion on the use of Methyl Salicylate in cosmetics intended for children. Based on all available information, SCCS set concentration limits of Methyl Salicylate in cosmetic categories to which children of two age groups (aged 0.5-3 years and 3-6 years) are commonly exposed.
On May 16, 2023, SCCS released the 12th Revision of The SCCS Notes of Guidance for the Testing of Cosmetic Ingredients and Their Safety Evaluation (the Notes of Guidance). Compared to its predecessor, the newly released Notes of Guidance updates animal-free alternative testing methods, emphasizes aggregate exposure and children's exposure in specific ingredients' assessments, and gives instructions on assessing children's exposure to cosmetics.
In February 2022, EU introduced a draft to ban the use of 12 nanomaterials in cosmetics. Following recent opinions from SCCS, on May 23, 2023, EU notified WTO of a revised draft, which newly includes the prohibition of Colloidal Silver (nano) and the restriction of Hydroxyapatite (nano). The draft is currently open for comments until July 22, 2023.
China's updated Cosmetic Supervision and Administration Regulation (CSAR) in 2021 has brought significant changes in the cosmetic industry. With two and a half years of implementation, what is the current situation of cosmetic supervision under the CSAR framework? What are the key requirements affecting businesses in the subsidiary regulations? What are the common reasons for non-compliance of enterprises?
To address these questions, ChemLinked organized this webinar that provides a detailed account of the current supervision situation, the key regulatory requirements and changes under the CSAR regulatory framework, and an analysis of non-compliance cases.
The regulatory landscape for new cosmetic ingredients (NCIs) in China has undergone significant changes in 2021, which have addressed the previous challenges of a difficult, expensive, and time-consuming registration process for NCIs, while also introducing a "3-year safety monitoring period" to ensure a protection period for these ingredients in the Chinese market.
To assist global stakeholders to navigate the evolving regulatory environment, successfully complete NCI applications, and expedite the introduction of innovative ingredients to the Chinese market, ChemLinked will present a webinar on this topic on June 21, 2023. Click here for registration now!