China Cosmetic Regulatory Updates
| New Cosmetics Ingredients (NCI) Notification in China
In September 2024, 6 new cosmetic ingredients were filed with the China National Medical Products Administration (NMPA). They include:
|
Notification No. |
Ingredient Name in CN & EN |
Notifier in CN |
|
20240065 |
吡咯并喹啉醌二钠盐 (Pyrroloquinoline Quinone Disodium Salt) |
润辉生物技术 |
|
20240066 |
3,4-二羟基苯乙醇 (Hydroxytyrosol) |
上海华茂药业 |
|
20240067 |
金露梅（DASIPHORA FRUTICOSA）提取物 (Dasiphora Fruticosa Extract) |
贝泰妮 |
|
20240068 |
β-烟酰胺单核苷酸 (Nicotinamide Mononucleotide) |
邦泰生物 |
|
20240069 |
L-高丝氨酸 (L-Homoserine) |
盛德百泰生物 |
|
20240070 |
麦芽糖酸 (Maltobionic Acid) |
上海克琴 |
The technical requirements for the 6 NCI mentioned above have not been disclosed, and they have not yet entered the monitoring period.
In September, the China NMPA announced the cancellation of notifications for three NCI: Galacto-Mannan, Hydrolyzed Alpha-Glucan Polysaccharide, and Aminolevulinic Acid HCl. The first two cancellations were due to these ingredients being classified as "cosmetic ingredients already in use." Additionally, Nicotinamide Mononucleotide, notified by Winkey Technology, was denotified without any remarks.
| Regulation Updates
Starting September 1, 2024, China’s National Medical Products Administration (NMPA) will fully implement electronic submissions for cosmetics (including toothpaste) and new cosmetic ingredient (NCI) registration and notification materials. Companies will no longer need to mail paper documents, as the entire process can be handled electronically. This change will reduce the effort required from companies and lower their manpower costs. For more details, please see past news.
On September 3, 2024, the NMPA responded to a proposal from Chinese People's Political Consultative Conference (CPPCC) member Zheng Chunyang regarding the improvement of the safety assessment system and the cultivation of new productive forces in the cosmetics industry. The NMPA plans to enhance its approach by: a) developing technical guidelines for new cosmetic ingredients, b) increasing the utilization of data on existing product ingredients in safety assessments, and c) accelerating the promotion of alternative testing methods to animal testing.
On the same day, the NMPA addressed CPPCC member Shi Huajun's proposal concerning the limited application of human-derived stem cell exosome ingredients and the scarcity of cosmetic ingredient varieties in China. Moving forward, the NMPA will advance the construction of a standardized system for cosmetic ingredients, establish relevant systems and mechanisms, and promote the application of new technologies, methods, and standards in cosmetic R&D innovation.
On September 6, 2024, the Guangzhou Medical Products Administration released "FAQs on the Registration of General Cosmetics" (Vol. 66), which provided specific requirements regarding the usage restrictions for permissible coloring agents and preservatives in cosmetics, as well as enhanced account management for the cosmetics (toothpaste) information service platform.
On September 14, 2024, the NMPA published the draft of the Management Measures for Cosmetic Safety Risk Monitoring for public consultation until October 8. This draft includes six chapters with a total of 30 articles covering general provisions, planning formulation, sampling and testing, investigation and handling, application of monitoring results, and supplementary provisions.
On September 27, 2024, the NMPA issued a notice regarding the 2024 Cosmetic Standards Project Plan, which encompasses 54 cosmetic standards. Notably, this notice removes one item from the 2024 Plan announced on August 7, 2024: the Toothpaste Classification Catalogs. For more details, please see past news.
| Administrative Penalty
On September 10, 2024, China NMPA released the 2023 National Cosmetic Sampling Inspection Annual Report, detailing the results of sampling inspections for cosmetics conducted in 2023. The inspections covered 12 categories, including hair dye, whitening products, makeup, sunscreen, children's cosmetics, and acne treatment claims, with a total of 20,936 product batches sampled. Of these, 20,388 batches met the requirements, as determined by testing conducted by 33 cosmetic inspection agencies, resulting in a compliance rate of 97.38%.
On September 11, 2024, the NMPA published a notice regarding three batches of cosmetics that contained prohibited ingredients. A week later, on September 18, 2024, the NMPA issued a public notice indicating that a Spanish cosmetic company is suspected of using the prohibited ingredient "Diflorasone Propionate" in its products. For more details, please see past news.
International Cosmetic Regulatory Updates
| Europe
On September 19, 2024, the European Commission published Regulation (EU) 2024/2462, amending Annex XVII of Regulation (EC) 1907/2006. This amendment includes provisions concerning "perfluorohexanoic acid (PFHxA) and its salts, as well as PFHxA-related substances." The recent revision to the REACH regulation will affect the marketing of cosmetics containing PFHxA substances in the EU. Companies should be mindful of the regulation's effective date and adjust their production plans accordingly to mitigate potential risks. See the original source for details.
| America
In August 2024, the U.S. FDA reported the rejection of 115 batches of imported cosmetics, with skincare products constituting the largest share. The main reasons for rejection included the misclassification of drugs as cosmetics and issues related to labeling and color additives.
| Asia
On September 18, 2024, Indonesian Food and Drug Authority (BPOM) announced new regulations on contaminant limits in cosmetics to replace the 2019 standards, set to take effect in 12 months later. The 2024 limits include testing and requirements for three main categories: microorganisms, heavy metals, and chemical contaminants. Compared to the previous regulations, the new rules introduce restrictions on acrylamide and diglycol. Currently, contaminant-related testing is only permitted in laboratories certified by the BPOM. See the original source for details.
On September 24, 2024, South Korea’s Ministry of Food and Drug Safety (MFDS) published the draft of the Enforcement Rule of the Cosmetics Act for public feedback. The draft aims to establish exceptions for labeling information on cosmetics' external packaging, prohibit labeling and advertising practices that exceed the scope of cosmetics, and optimize administrative provisions. Stakeholders are encouraged to submit their suggestions to the MFDS by November 11, 2024. See the original source for details.
On September 24, 2024, South Korea’s MFDS released the latest version of the Regulation on Labeling Cosmetics Precautions for Use and Fragrance Allergens. The updates primarily address precautions for small-packaged cosmetics and eyelash perm products. The regulation is effective upon issuance, but the provisions concerning small-packaged cosmetics will be implemented starting July 10, 2025. See the original source for details.
Sources: Official regulatory authorities in respective countries/regions.
