China Cosmetic Regulatory Updates
| New Cosmetics Ingredients
In April 2024, six new cosmetic ingredients were filed with the China National Medical Products Administration (NMPA). They include:
|
Ingredient Name in CN & EN |
Filing No. |
Filer in CN |
|
青稞籽提取物 （HORDEUM VULGARE VAR. COELESTE EXTRACT） |
20240024 |
东方淼森 |
|
杜香叶油 (Ledum Palustre Leaf Oil) |
20240025 |
大兴安岭林下 |
|
环六肽-9 (Cyclohexapeptide-9) |
20240026 |
上海中翊 |
|
甲基苯并噻唑偶氮甲苯胺双-（三乙氧基硅丙基氨基甲酰基PEG-5/PPG-5乙醇） |
20240027 |
莹特丽 |
|
双-(苯基偶氮甲苯胺双-(三乙氧基硅丙基氨基甲酰基PEG-5/PPG-5乙醇)砜 |
20240028 |
莹特丽 |
|
驴乳粉 (Donkey Milk Powder) |
20240029 |
桑阳生物 |
The technical requirements for the six new cosmetic ingredients mentioned above have not been disclosed, and they have not yet entered the monitoring period.
| Regulations & Policies
On April 3, 2024, China NIFDC released two FAQs responding to ingredient supplier and packaging specification changes for special cosmetics, further clarifying related matters concerning such modifications.
On April 9, 2024, China NIFDC issued a FAQ regarding cosmetic evaluation, addressing inquiries on how registrants should implement newly added inspection methods in the Safety and Technical Standards for Cosmetics. Read the previous report here.
On April 10, 2024, China NIFDC released 6 draft guidelines regarding cosmetic safety assessment and new cosmetic ingredients, aiming to standardize cosmetic safety assessments and promote the orderly implementation of the cosmetic safety assessment system. Read the previous report here.
On April 12, 2024, the Guangzhou Administration for Market Regulation (AMR) issued the 56th "FAQs on Registration of General Cosmetics," which provides explanations on questions related to safety assessments for products with two or more mixed ingredients, exemptions for systematic toxicological assessment, and common toxicological data query platforms.
On April 16, 2024, the Shanghai Administration for Market Regulation issued the local standard Requirements for Filing Documents of General Cosmetics, which specifies the requirements for filing documents for general cosmetics, including application forms, product formulas, labels, etc. This standard will be implemented starting from August 1, 2024.
On April 19, 2024, the National Adverse Drug Reaction Monitoring Center released Cosmetics Adverse Reactions Collection and Reporting Guidelines for Registrants and Filers (Trial), giving the cosmetic registrants and filers a further guide and standardization of the collection and reporting of adverse reactions. Read the previous report here.
On April 22, 2024, the China National Medical Products Administration (NMPA) released an Announcement on Implementing Several Measures to Optimize Cosmetic Safety Assessment Management, which explicitly states that until May 1, 2025, cosmetic registrants or filers can still submit simplified version of safety assessment reports that comply with the requirements of the Technical Guidelines for Cosmetic Safety Assessment (2021 Edition). Read the previous report here.
On April 22, 2024, Guangzhou AMR issued the 57th "FAQs on Registration of General Cosmetics," offering clarifications on the definition of cosmetic samples, registration filing, labeling requirements, and production operations.
On April 26, 2024, China NMPA issued the Measures on Cosmetic Inspection Management to strengthen the supervision and regulation of cosmetics and standardize inspection procedures. The regulation will come into effect on November 1, 2024.
On April 22, 2024, Guangzhou AMR issued the 58th "FAQs on Registration of General Cosmetics," providing explanations on questions such as whether the product name can be changed after the submission of filing documents, regulations on the use of cosmetic trademarks, and whether specific ingredient names can be used as suffixes in cosmetic product names, etc.
On April 30, 2024, China NIFDC issued three announcements comprising seven technical documents and guidelines, including Index of International Authoritative Institution Cosmetic Safety Assessment Data, Information on Ingredients Used in Marketed Products, Guidelines for Submission of Cosmetic Safety Assessment Data, etc.
Simultaneously, China NIFDC published seven official FAQs, providing explanations and clarifications on relevant questions concerning the seven documents mentioned above. Read the previous report here.
| Industry Environment
On April 28, 2024, the General Administration of Customs published the list of non-compliant imported cosmetics in March 2024. The Guerlain Imperial Bee Eye Cream was not allowed to be imported due to failure to provide the required certificates or qualification documents.
International Cosmetic Regulatory Updates
| Europe
On April 4, 2024, the European Union issued Regulation (EU) 2024/996, amending Annexes of Cosmetic Regulation (EC) No 1223/2009. It bans 4-Methylbenzylidene Camphor (4-MBC) as a prohibited ingredient and removes it from the authorized UV filter list. Additionally, it includes eight ingredients, Alpha-Arbutin, Arbutin, Genistein, Daidzein, Kojic Acid, Retinol, Retinyl Acetate, and Retinyl Palmitate in the restricted substances list, while revising the usage requirements of Triclocarban and Triclosan, two preservatives.
On April 4, 2024, the European Commission's Scientific Committee on Consumer Safety (SCCS) issued its final opinions (SCCS/1660/23, SCCS/1662/23) regarding the safety of Benzophenone-4 and aluminum and its compounds in cosmetics, establishing maximum safe usage concentrations. This assessment did not address the environmental safety of Benzophenone-4.
On April 4, 2024, SCCS issued the preliminary opinion (SCCS/1664/24) on Triphenyl phosphate, thinking the SCCS can't conclude on the safety of Triphenyl Phosphate because the genotoxicity potential cannot be excluded based on the currently available information. Also, this assessment did not address the environmental safety of Benzophenone-4.
On April 4, 2024, SCCS issued the preliminary opinion (SCCS/1665/24) on silver, seeking feedback on the use requirements of Silver ingredients in cosmetics. Key points include a maximum usage of 0.05% for micronized silver particles in body lotions and oral care products and 0.2% in eye shadow, lip balm, and certain facial creams.
On April 4, 2024, SCCS issued the preliminary opinion (SCCS/1666/24), seeking views on the use requirements of Citral in cosmetics. Specific details indicate that based on the assessment using the QRA2 method, Citral can be considered safe for induction of sensitization when used at the proposed concentrations for cosmetics.
On April 4, 2024, the French National Assembly unanimously adopted a bill to restrict the manufacture and sale of products containing per- and polyfluoroalkyl substances — also known as PFAS or "forever chemicals." According to the amendment, starting from January 1, 2026, France will prohibit the production, import, and sale of non-essential products containing PFAS, including cosmetics, ski wax, and clothing.
On April 10, 2024, the UK notified WTO of a draft regulation, The Cosmetic Products (Restriction of Chemical Substances) (No. 2) Regulations 2024, applicable to England, Wales, and Scotland. The proposed amendment intends to permit using up to 1% Triciquine in facial and hand products. Expected to pass by June 25, 2024, cosmetics placed on the market before April 20, 2025, can continue to be supplied until August 20, 2025.
Sources: Official regulatory authorities in respective countries/regions.
