China Cosmetic Regulatory Updates
| New Cosmetics Ingredients (NCI)
In July 2024, 9 new cosmetic ingredients were filed with the China National Medical Products Administration (NMPA). They include:
Ingredient Name in CN |
Filing No. |
Filer in CN |
无柄灵芝菌丝体发酵产物滤液 |
20240047 |
水羊生物 |
亚异丙基甘油 |
20240048 |
索尔维(上海) |
鸢尾苷元 |
20240049 |
上海澄穆 |
紫檀芪 |
20240050 |
柏瑞医药 |
苦参碱水杨酸盐 |
20240051 |
敷尔佳 |
10-羟基-2-癸烯酸 |
20240052 |
福瑞达 |
金线莲(ANOECTOCHILUS ROXBURGHII)提取物 |
20240053 |
远想生物 |
梁王茶(METAPANAX DELAVAYI)提取物 |
20240054 |
贝泰妮 |
乳酸杆菌/小粒咖啡(COFFEA ARABICA)籽发酵产物滤液 |
20240055 |
护家科技 |
The technical requirements for the 9 new cosmetic ingredients mentioned above have not been disclosed, and they have not yet entered the monitoring period.
Additionally, by the first half of 2024, 46 NCI had been filed, compared to 24 during the same period last year. Of these, 18 are chemical ingredients, 17 are plant-based, 10 are biotech-derived, and 1 is animal-derived. Regarding the companies involved, international firms are primarily focused on chemical ingredients, while Chinese companies are making significant progress in the area of plant-based ingredients.
| Regulation Updates
On July 8, 2024, China's National Medical Products Administration (NMPA) announced the full implementation of electronic submission for cosmetics (including toothpaste) and NCI registration and filing materials. This change will reduce the effort companies must exert and lower their manpower costs. Read the full content.
On July 8, 2024, the China National Institute for Food and Drug Control (NIFDC) released four technical guidelines aimed at enhancing cosmetic safety assessments. These guidelines include Technical Guidelines for Cosmetic Stability Assessment; Technical Guidelines for Preservative Effectiveness Testing of Cosmetics; Technical Guidelines for Compatibility Assessment of Cosmetic Packaging Materials and Technical Guidelines for Application of Skin Sensitization Integrated Testing and Assessment Strategies. Read the full content.
On July 8, 2024, China's NIFDC released the Common Technical Q&A for New Cosmetic Ingredients (Vol. 1 and 2), which outlines specific requirements for various aspects of new NCI development. These requirements cover background research, ingredient composition, usage specifications, physicochemical properties, and the accuracy of sources for plant- and animal-derived ingredients. The guidelines also clarify the selection of toxicological testing methods, requirements for test substances, exposure assessment, inhalation toxicity risk evaluation, and the identification and assessment of hazardous substances.
On July 23, 2024, China NMPA released a series of interpretations for the Guidelines for Submitting Cosmetic Safety Assessment Documentation (hereinafter referred to as Guidelines). These interpretations provide insights into the background and scope of the Guidelines and its annexes, the detailed classification of cosmetics based on risk management principles, and the requirements for submitting safety assessment documentation.
On July 24, 2024, China NMPA held a founding meeting for the Cosmetics Standardization Technical Committee in Beijing. During the meeting, the committee's charter, member management regulations, and procedures for the development and revision of cosmetic standards were reviewed and approved.
| Administrative Penalty
On July 9, 2024, the General Administration of Customs of China (GACC) published the list of non-compliant imported food and cosmetic products in May 2024. The list included 5 batches of cosmetics, all from France, which were rejected due to failure to provide required certificates or proof of compliance and inadequate packaging. Among them, one batch was Fresh Brown Sugar Body Polish, while the other four batches consisted of Atelier Cologne Perfume (2 batches) and Maison Margiela Perfume (2 batches).
On July 3, 2024,China NMPA reported on 3 typical cosmetic cases involving: altering the expiration dates of cosmetics, unauthorized formulation of cosmetics, and using recycled cosmetics to produce new products. The companies involved in these cases were each subjected to administrative penalties by the regulatory authorities.
In July 2024, China NMPA reported a total of 113 batches of non-compliant cosmetics, primarily affecting hair dyes and sunscreens. The government has mandated that investigations be conducted into the registrants, filers, and contract manufacturers of these non-compliant products. Affected companies are required to immediately implement risk control measures and carry out self-inspections and corrective actions in accordance with the law.
| Industry Development
On July 15, 2024, the National Bureau of Statistics of China released data showing that from January to June 2024, the total retail sales of consumer goods amounted to 23.5969 trillion yuan, an increase of 3.7% year-on-year. Of this, retail sales of cosmetics were 216.8 billion yuan, up by 1%. In June, the total retail sales of consumer goods reached 4.0732 trillion yuan, a 2.0% increase year-on-year, with cosmetics retail sales at 40.5 billion yuan, down by 14.6%.
International Cosmetic Regulatory Updates
In earlier July, 2024, the World Health Organization’s International Agency for Research on Cancer (IARC) has recently classified Talc as “probably carcinogenic” to humans. Talcum powder is commonly used in baby powders and cosmetics. Read the full content.
| Europe
On July 3, 2024, the European Union's Scientific Committee on Consumer Safety (SCCS) released its final opinion on Silver (SCCS/1665/24). See the original source for details.
On July 26, 2024, the SCCS issued its final scientific opinion on Triphenyl phosphate, following the preliminary opinion released on April 4, 2024. See the original source for details.
On July 29, 2024, the SCCS proposed adding an appendix to its final scientific opinion on Hexyl Salicylate (SCCS/1668/23) regarding the use of it in cosmetics for children aged 0-3 years (SCCS/1668/24). The deadline for comments is September 23, 2024. See the original source for details.
| Asia
On July 5, 2024, the Philippines Food and Drug Administration issued Announcement No. 2024-005, which revises the ASEAN Cosmetic Directive and will take effect 15 days after publication. The main updates include: 1) adding several substances, such as Diethyltoluamide (DEET) and Quaternium-15, to the list of prohibited ingredients in cosmetics; 2) revising the usage conditions and limit requirements for several substances, including Benzophenone-3. See the original source for details.
On July 9, 2024, the Vietnamese Drug Administration issued Announcement No. 2365/QLD-MP, which revises the regulations on cosmetic ingredient requirements. Key changes include: 1) Updated list of substances allowed in cosmetics with specific concentration limits; 2) New requirements for the use of certain chemicals, such as salicylic acid, in cosmetics. This announcement is effective immediately from the date of publication.
On July 11, 2024, the Thai Food and Drug Administration launched a public consultation on the newly proposed amendments to the country's cosmetic ingredient lists, which involves the addition of 56 prohibited ingredient and one restricted ingredient, along with revision to another restricted ingredient. These changes aim to be in line with the updates to the ASEAN Cosmetic Directive adopted at the 36th, 37th, and 38th ASEAN Cosmetic Scientific Body (ACSB) meeting.
On July 12, 2024, Japan's Ministry of Health, Labour and Welfare issued Announcement No. 243, revising the standards and regulations for cosmetics. The updates primarily involve adding Cysteamine Hydrochloride in Standards for Cosmetics, with a Maximum Allowable Concentration of 8.63g per 100g for use in rinse-off hair care products.
| America
On July 1, 2024, the U.S. Food and Drug Administration officially began enforcing mandatory regulations for cosmetics. According to the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), passed on December 29, 2022, cosmetics manufacturers must register their facilities and list their products with the FDA by July 1, 2024. This regulation aims to enhance oversight of the cosmetics industry and ensure consumer health and safety.
On July 5, 2024, the U.S. Office of Information and Regulatory Affairs (OIRA) released the "Spring 2024 Unified Agenda of Regulatory and Deregulatory Actions" (the Unified Agenda), which includes updates on several proposed rules concerning cosmetics in the United States.
Among these updates, two notable proposed rules under MoCRA have been delayed from their original timelines, with further delays possible, these include: 1) Disclosure of Fragrance Allergens in Cosmetic Labeling; 2) Testing Methods for Detecting and Identifying Asbestos in Talc-Containing Cosmetics.
Sources: Official regulatory authorities in respective countries/regions.