China is speeding up the approval of new cosmetic ingredients under the CSAR. Four new ingredients, Ethyl Lauroyl Arginate HCL, Methoxy Peg-23 Methacrylate/Glyceryl Diisostearate Methacrylate Copolymer, Calcium Phosphoryl Oligosaccharides and Steareth-200, will be approved as existing cosmetic ingredients.
On December 2, 2020, China National Medical Products Administration (NMPA) opened a public consultation on the approval of Ethyl Lauroyl Arginate HCL, Methoxy Peg-23 Methacrylate/Glyceryl Diisostearate Methacrylate Copolymer, Calcium Phosphoryl Oligosaccharides and Steareth-200 as new cosmetic ingredients.
The basic information about the four new cosmetic ingredients are as follows:
- ETHYL LAUROYL ARGINATE HCL
Chinese Name: 月桂酰精氨酸乙酯 HCl
CAS No.: 60372-77-2
Trade Name:
- LAE-P (The abbreviation of pure substance)
- LAE
- Lauric arginate
- Ethyl Lauroyl arginate
- Mirenat-N
- Aminat
- Lauramide arginine ethyl ester
- LAE TECNICO DESHIDRATADO
Source: Chemical Synthesis
Intended Use: Cosmetic Preservative
Application Scope: Apply to all kinds of cosmetics except lip products, oral hygiene products and spray products
Limit: 0.4%
- METHOXY PEG-23 METHACRYLATE/GLYCERYL DIISOSTEARATE METHACRYLATE COPOLYMER
Chinese Name: 甲氧基 PEG-23 甲基丙烯酸酯/甘油二异硬脂酸酯甲基丙烯酸酯共聚物
CAS No.: /
Trade Name: ISPolymer
Source: High-Molecular Polymer
Intended Use: Skin Conditioning Agents and Humectant
Application Scope:
- Rinse-off skincare products: cleaning products, massage products.
- Leave-on skincare products: toner, lotion, cream, essence, facial mask, etc.
- Makeup cosmetics: foundation, various base creams
Limit: 2%
CALCIUM PHOSPHORYL OLIGOSACCHARIDES
Chinese Name: 磷酰基寡糖钙
CAS No.: 1124316-47-7
Trade Name: POs-Ca
Source: Potato Starch
Intended Use: Skin Conditioning Agents
Application Scope: Applies to all kinds of cosmetics used on face, scalp and whole body, except eye cosmetics
Limit: 5%
Steareth-200
Chinese Name: 硬脂醇聚醚-200
CAS No.: 9005-00-9
Trade Name: Brij S200
Source: High-Molecular Polymer
Intended Use: Emulsifier and Solubilizer
Application Scope: Hair cosmetics
Limit: 1% (When used with oxidized milk (“氧化乳” in mandarin Chinese) in oxidative hair dye, 1.0% shall be the maximum concentration after mixing)
ChemLinked Comments
The current registration process of new cosmetic ingredients in China is tedious as the compliance requirements are quite strict. From 2004 to 2014, only 10 new ingredients have been given the green light for use in cosmetics by the authority, and none since then. This not only hinders industry innovation but also fails to keep pace with consumer demands and global practices.
Approved New Cosmetic Ingredients (since 2004)
- Alkyl (C12-C22) trimethyl ammonium, bromide and chloride (Jun 2004)
- Potassium Methoxysalicylate (Apr 2007)
- Methylisothiazolinone (May 2007)
- Carnitine Tartrate (Jun 2008)
- Lathyrus odoratus flower extract (Aug 2008)
- Fructooligosaccharides (Aug 2008)
- Dimethoxytolyl Propylresorcinol (Mar 2012)
- Polymethacryloyl Lysine (Mar 2012)
- Phenylethyl Resorcinol (Dec 2012)
- Elaeagnus mollis Oil (Oct 2014)
However, the situation is about to change with the introduction of the Cosmetic Supervision and Administration Regulation (CSAR). As per the new regulation, management of cosmetic ingredients will be stratified based on their inherent risk level. Namely, high-risk ingredients such as preservatives, sunscreens, colourants, hair dyes and whitening agents will require registration with the NMPA and be subject to stringent supervision. In contrast, low-risk ingredients are available for use only after quick notifications.
China’s intention to approve the above four new ingredients after 6 years of stagnation is an active signal that the regulatory stance on new cosmetic ingredients is being softened and the classified management of such ingredients is being put in place. ChemLinked expects that more advanced ingredients can be approved and used legally in the Chinese market next year, and the industry will enter a new era of rapid development.
ChemLinked is a leading provider of Asia-Pacific regulatory information and market intelligence across Cosmetic, Chemical, Food and Agrochemical Industries. ChemLinked boasts a multidisciplinary team of scientists, compliance specialists and language experts backed by the vastly experienced technical teams at REACH24H, to ensure over 44,000 registered members to acquire authoritative information and dependable consultancy services. ChemLinked aims to remove any regulatory barriers that prevent you from exporting your products into China and other countries in the Asia-Pacific region
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