The Spring of New Cosmetic Ingredients Filing in China

Analysis of filing data of new cosmetic ingredients in 2021

Since the launch of the Cosmetics Supervision and Administration Regulations (CSRA, State Order No. 727) on June 29, 2020, a series of supporting regulations have been introduced, including new regulations related to the new cosmetic ingredients registration and filing such as the Measures for the Administration of Cosmetic Registration and Filing, Provisions on the Administration of New Cosmetic Ingredients Registration and Filing Data and Technical Guidelines for Cosmetics Safety Assessment, etc. Starting from May 1, 2021, the registration and filing of new cosmetic ingredients should be applied via the cosmetics declaration and review system of the NMPA online office hall. Since the implementation of the new regulations, a total of 7 new cosmetic ingredients have been filed between May 1, 2021 and January 24, 2022. Among them, 5 are new domestic cosmetic ingredients (see Table 1 for detailed information), and 2 are new imported cosmetic ingredients (see Table 2 for detailed information). The personal and home care products team of CIRS Group China successfully assisted two ingredient suppliers to complete the filing of the first and second imported new ingredients.

Table 1 New domestic cosmetic ingredients information filed under new regulations

Filing Number	國妝原備字20210001	國妝原備字20210002	國妝原備字20210003	國妝原備字20210004	國妝原備字20220001
Standard Chinese Name	N-乙酰神經氨酸	月桂酰丙氨酸	β-丙氨酰羥脯氨酰二氨基丁酸芐胺	雪蓮培養物	鯨蠟基二甘油三（三甲基硅氧基）硅乙基聚二甲基硅氧烷
INCI Name	Acetylneuraminic Acid	Lauroyl Alanine	β-Alanyl Hydroxyprolyldiaminobutyroyl Benzylamide		Cetyl Diglyceryl Tris (Trimethylsiloxy) silylethyl Dimethicone
CAS Number	131-48-6	52558-74-4			1466529-58-7
Use Purpose	Moisturizer	Cleaner	Skin Protectant	Antioxidants	Emulsifier
Application Scope	Can be used for skin care of the whole body	Can be used in all kinds of cosmetics; no special limit to the scope of use	Rinse-off products：cleansing products, massage products Leave-on products：toner, lotion, cream, essence and mask, etc. Make-up cosmetics: foundation and all kinds of base cream.	Can be used in all kinds of cosmetics; no special limit to the scope of use
Safe Usage	≤2%	≤20%	0.00001%-1.0%	≤4%	2%~8%
Filing Date	28 Jun 2021	28 Jun 2021	6 Aug 2021	13 Aug 2021	17 Jan 2022
Filer	武漢中科光谷綠色生物技術有限公司	蘇州維美生物科技有限公司	深圳市維琪醫藥研發有限公司	大連普瑞康生物技術有限公司	陶氏（張家港）投資有限公司

Data Source: NMPA website

Table 2 New imported cosmetic ingredients information filed under new regulations

Filing Number	國妝原備字20210005	國妝原備字20210006
Standard Chinese name	四氟丙烯	月桂酰甲基羥乙基磺酸鈉
INCI name	Tetrafluoropropene	Sodium Lauroyl Methyl Isethionate
CAS number	29118-24-9	928663-45-0
Use purpose	Propellants	Cleaner
Application scope	Leave-on products: skin and hair care cosmetics Rinse-off products: skin and hair care cosmetics	Cleaning cosmetics such as shampoo, shower, facial cleanser
Safe usage	≤90%	≤11%
Filing date	2 Dec 2021	8 Dec 2021
Filer	Honeywell	Innospec

Data Source: NMPA website

According to the notice regarding transitional treatment of new cosmetic ingredients issued by National Institute for Food and Drug Control (NIFDC) on April 23, 2021, there are two ways to deal with the new cosmetic ingredients that have been accepted by the original cosmetic administrative licensing system and have not yet made administrative licensing decisions: 1) The applicant can withdraw the application for administrative license before May 1, 2021 and go through the procedures of returning the application materials; 2) If the applicant fails to submit the application for withdrawing the administrative license on time, from May 1, 2021, NIFDC will continue to complete the review and approval work according to the data requirements of the Provisions on the Administration of New Cosmetic Ingredients Registration and Filing Data. The 3 filed new cosmetic ingredients mentioned above belong to the new cosmetic ingredients (37 in total) that have been accepted by the original cosmetic administrative licensing system and have not yet made administrative licensing decisions.

According to article 12 of Chapter 2 New Cosmetic Ingredients Registration and Filing Management of the Measures for the Administration of Cosmetic Registration and Filing, the registration or filing application is required as the new cosmetic ingredient where the purpose of use and/or safe usage of used cosmetic ingredients are adjusted. It indicates that in the process of using the filed new cosmetics ingredients, the purpose of use, scope of application and safe usage need to refer to the published filing information. If the information is updated or adjusted, a new application should be made according to the registration and filing requirements of new cosmetic ingredients.

Analysis of Registration Data of New Cosmetics Ingredients under the Old Legal System

A total of 14 new cosmetic ingredients were approved from 2004 to May 1, 2021 under the old regulation “Regulations on Hygiene Supervision and Administration of Cosmetics” (see Table 3 for details).

Table 3 New cosmetic ingredients approved from 2004 to 1 May 2021

No	Name of Ingredient	Safe Concentration	Approval Time	Notes
1	十六烷基三甲基氯化氨 ALKYL(C12-22)TRIMONIUM CHLORIDE(BROMIDE)	When used as a non-preservative： Rinse-off products: unlimited Non rinse-off products: ≤0.25%	14 Jun 2004
2	甲氧基水楊酸鉀 Potassium Methoxysalicylate	≤3%	26 Apr 2007
3	甲基異噻唑啉酮Methylisothiazolinone	≤0.01% (limited to be used as preservative)	28 May 2007
4	左旋肉堿酒石酸鹽 Carnitine(and)Tartaric Acid	≤3%	3 Jun 2008
5	香甜豌豆花提取物 LATHYRUS ODORATUS FLOWER EXTRACT	≤1%	6 Aug 2008
6	低聚果糖 FRUCTOOLIGOSACCHARIDES	≤5%	6 Aug 2008
7	聚甲基丙烯酰基賴氨酸 POLYMETHACRYLOYL LYSINE	≤3%	19 Mar 2012	Purpose of use: To be used as a humectant and a skin-conditioning agent Scope of use: all kinds of cosmetics, no special restrictions on the scope of use
8	二甲氧基甲苯基-4-丙基間苯二酚 Dimethoxytolyl Propylresorcinol	≤2%	19 Mar 2012	Purpose of use: Topically applied skin and skin tone regulator Scope of use: face cream, lotion, gel, mask and other skin care products
9	苯乙基間苯二酚 Phenylethyl Resorcinol	≤0.5%	5 Dec 2012	Purpose of use: Whitening skin and inhibiting the formation of melanin by inhibiting tyrosinase activity. Scope of use: all kinds of skin care products
10	翅果(Elaeagnus mollis diel)油 Elaeagnus mollis diel Oil		30 Oct 2014	Purpose of use: Matrix in skin care cosmetics, fatting agent, moisturizer, antioxidant, anti-aging. Scope of use：Skin care, moisturizing, anti-aging and sunscreen cosmetics; excipients can be used in massage oils and compounded essential oils.
11	甲氧基 PEG-23 甲基丙烯酸酯／甘油二異硬脂酸酯甲基丙烯酸酯共聚物 METHOXY PEG-23 METHACRYLATE/GLYCERYL DIISOSTEARATE METHACRYLATE COPOLYMER	≤2%	28 Dec 2020	Purpose of use: Used as a moisturizer and humectant Scope of use: 1) Rinse-off skin care products: cleansing products, massage products 2) Leave-on skin care products: lotion, emulsion, cream, beauty solution, mask, etc. 3) Color cosmetics: foundation, base, etc.
12	磷酰基寡糖鈣 CALCIUM PHOSPHORYL OLIGOSACCHARIDES	≤5%	28 Dec 2020	Purpose of use: Moisturizer Scope of use: Can be used for all types of cosmetics for the face, scalp, and body except for eye care cosmetics
13	硬脂醇聚醚-200 Steareth-200	≤1%（when used with oxidizing agent for oxidative hair dyes, 1.0% is the maximum concentration of mixture）	28 Dec 2020	Purpose of use: Emulsifier, solubilizer Scope of use: Hair care cosmetics
14	月桂酰精氨酸乙酯 HCl ETHYL LAUROYL ARGINATE HCL	≤0.4%	28 Dec 2020	Purpose of use: Cosmetic preservatives Scope of use: Can be used for all types of cosmetics except lip care products, oral hygiene products and aerosol products

Data Source: Official website of competent authority

The ingredients No.1-6 in the above table had been approved by the former Ministry of Health, the ingredients No.7-10 had been approved by the former State Food and Drug Administration (SFDA) or China Food and Drug Administration (CFDA), and the ingredients No.11-14 had been approved by National Medical Products Administration (NMPA). The approval process for these ingredients has also experienced the changes of the relevant national institutions. In September 2008, the administrative health licensing of cosmetics was transferred from the Ministry of Health to the State Food and Drug Administration (SFDA). On March 22, 2013, the State Food and Drug Administration (SFDA) was renamed as the China Food and Drug Administration. Hereinafter referred to as the CFDA. On April 10, 2018, the former "China Food and Drug Administration" was changed into "National Medical Products Administration" as a result of institutional reform of the State Council.

Development process of Chinese new cosmetics ingredients regulations

• Regulations on Hygiene Supervision and Administration of Cosmetics in 1989

According to article 9 of Regulations on Hygiene Supervision and Administration of Cosmetics, the use of new cosmetics ingredients for the production of cosmetics must be approved by the health administrative departments under the State Council. New cosmetics ingredients refer to natural or artificial raw materials used in the production of cosmetics for the first time in China.

• Guidelines for the New Cosmetic Ingredients Registration and Review in 2011

The document was implemented on July 1, 2011. It includes the definition of new cosmetics ingredients, safety requirements, registration data requirements and review principles.

• Notice regarding Further Regulating the Administrative Licensing of New Cosmetic Ingredients in 2011

The notice clarifies the data requirements before toxicity tests and the requirements of toxicological test reports, etc.

• CFDA Notice regarding the Issue of the Inventory of Existing Cosmetic Ingredients in China (2015 edition) in 2015

According to relevant provisions of Regulations on Hygiene Supervision and Administration of Cosmetics, CFDA had adjusted the Inventory of Existing Cosmetic ingredients issued on June 30, 2014 into another new version of 2015.

This inventory contains 8,783 cosmetic ingredients and is regarded as a basis to determine whether it is a new cosmetic ingredient.

• Cosmetics Supervision and Administration Regulations in 2020

According to the Article 4 of the Cosmetics Supervision and Administration Regulations, cosmetic ingredients are divided into new cosmetic ingredients and existing cosmetic ingredients. The registration management should be implemented for new cosmetic ingredients with high safety risk, and filing management should be implemented for other new cosmetic ingredients.

According to Article 11 of the Cosmetics Supervision and Administration Regulations, new cosmetic ingredients are natural or artificial raw materials used for the first time in cosmetics in China. New cosmetic ingredients with the functions of anti-corrosion, sunscreen, coloring, hair dying, anti-freckle and whitening can be used after approval by NMPA. Other new cosmetic ingredients should be filed with NMPA before use. NMPA can adjust the scope of new cosmetic ingredients subject to the registration management and implement the adjusted scope after approval by the State Council.

• NMPA Notice regarding the Issue of Inventory of Existing Cosmetic Ingredients in China (2021 edition) in 2021

According to the relevant provisions of the Cosmetics Supervision and Administration Regulations, NMPA has organized the revision of the Inventory of Existing Cosmetic Ingredients in China (2015 Edition) and formed the Inventory of Existing Cosmetic Ingredients in China (2021 Edition), which was hereby published and effective from May 1, 2021. This inventory contains 8972 cosmetic ingredients.

• Provisions on the Administration of New Cosmetic Ingredients Registration and Filing Data in 2021

It covers the registration and filing dossier requirements of new cosmetic ingredients.

• Notice regarding Transitional Treatment of New Cosmetic Ingredients in 2021

It is related to the treatment measures of new cosmetic ingredients of which the registration dossiers have been accepted by the original cosmetics administrative licensing system but the administrative licensing decisions have not been made.

• NMPA Notice regarding Piloting Electronic Registration Certificate of Cosmetics in 2021

Starting from January 1, 2022, electronic registration certificates will be issued to special cosmetics and new cosmetic ingredients that have been applied and approved according to the Measures for the Administration of Cosmetic Registration and Filing.

Comparison of Old and New Regulatory Systems

Under the old regulatory system in the past, the reasons for taking a long time in the process of official review and for the difficulty of passing official review of new cosmetics ingredients registration are mainly reflected in the following aspects:

1. In the early stage, there is no unified reference catalogue to determine whether it belongs to a new cosmetic ingredient;
2. As none of the detailed classification of new cosmetic ingredients on the Regulations Concerning Hygiene Supervision and Administration of Cosmetics, the high registration requirements of new cosmetic ingredients and none of detailed explanation of dossier requirements on the Guidelines for the New Cosmetic Ingredients Registration and Review, there is inconsistency between experts and enterprises on the understanding of review requirements in the process of technical review. Ingredient enterprises are unwilling to provide enough information for manufacturers to protect trade secrets;
3. The management system of cosmetic ingredients is imperfect, for instance, there is no conclusions settled on how to supervise the new cosmetic ingredients after approval. For the launch of a new cosmetic ingredient registration project, Personal and Home Care team of CIRS Group usually suggested that the enterprise should prepare for more than five years. The approved new cosmetic ingredients were made public through official notice, which means that all enterprises can directly produce or use the approved new ingredients. Such management mode is difficult to encourage the ingredient suppliers to apply for the registration of new cosmetic ingredients so that it is unbeneficial to promote the industrial innovation;
4. Mandatory requirements of animal testing data contradict with EU cosmetics regulations on animal testing ban in 2013. This makes it difficult for many imported new cosmetic ingredients projects, especially from European cosmetic ingredient suppliers, to start or die halfway;
5. No communication window to the public so as to communicate directly with the review experts to discuss the review comments;
6. The necessity of technological innovation in the beauty industry is less than the pharmaceutical and food industries.

Under the new regulatory system, the changes in the management of new cosmetic ingredients are mainly as follows:

1. New cosmetic ingredients are managed as the way of level-to-level administration according to the degree of risk so as to replace the old regulatory system under the "one-size-fits-all" approach, retaining the original management model for new cosmetic ingredients with high safety risk. Adopting record management for the new cosmetic ingredients without high safety risk so that the official review time has been greatly reduced. With the experience of personal and home care team of CIRS Group China, more than half of the project cycle for the new cosmetic ingredients registration under the old regulatory system hovered between the data correction and official review process;
2. Compared to Guidelines for the New Cosmetic Ingredients Registration and Review issued on July 1, 2011, the cosmetic registration and filing data requirements on the Provisions on the Administration of New Cosmetic Ingredients Registration and Filing Data issued on May 1 2021 is undoubtedly more complete and clearer. Compared with the old regulatory system, the registration dossier requirements under the new regulatory system has not been reduced but rather increased, such as the basis of efficacy, supporting docs of having history of safe use, etc;
3. Provisions on the Administration of New Cosmetic Ingredients Registration and Filing Data specify the requirements of alternative methods, which means door of “alternative methods” is open to the new cosmetic ingredients finally, but it needs to confirm whether the alternative methods have been included in the international authority of alternative method validation and related supporting docs have to be submitted to prove that the methods can accurately predict the toxicological endpoints when the alternative methods are not included in the Safety and Technical Standards for Cosmetics. Although more and more alternative methods are gradually accepted in China, it is still limited for alternative methods already accepted so that it will be a concern for international ingredient suppliers to promote the new cosmetic ingredient registration and filing project in the early stage of the new regulation implementation
4. For some functional new raw materials without high safety risk such as anti-hair loss, anti-acne, anti-wrinkle (except physical anti-wrinkle), anti-dandruff, deodorization, although they are managed under filing system, the requirements of toxicological data are consistent with the new cosmetic ingredients with high safety risk.
5. Refine the toxicological experiments such as only the new raw materials with the effect of health hazards (excluding local toxicity), if used for the first time at home and abroad, need toxicokinetics test. And for the completely new cosmetic ingredients with high safety risk at home and abroad, new raw materials with higher biological activity and new nano-ingredients, the long-term human trial safety test, skin absorption / transdermal test, and immunotoxicity test might be performed.
6. Toxicological safety assessment shall refer to the latest Technical Guidelines for Cosmetics Safety Assessment (2021 Edition).
7. For approved or filed new cosmetic ingredients, there are 3 years as the monitoring period. The registrant or filer of new raw materials has the right to use the approved or filed new cosmetic ingredients during the monitoring period, and should report to the NMPA each year on the use status and safety of new cosmetic ingredients

Due to none of classification management of new cosmetic ingredients under the old supervision system, and the review scale is not combined with the characteristics of cosmetic ingredients to refine, so there are only a handful of new cosmetic ingredients approved in China. Although the new regulatory system does not relax the requirements on the safety of new cosmetics ingredients and the registration and filing requirements, the classification management system of new cosmetic ingredients is conducive for new cosmetic ingredients with less safety risk to be filed so as to be marketed as soon as possible. Meanwhile there are 3 years of monitoring period for approved and filed new cosmetic ingredients. The registrant or filer of new raw materials has the right to use the approved or filed new cosmetic ingredients during the monitoring period, and should report to the NMPA each year on the use status and safety of new cosmetic ingredients. Therefore, the setting of the 3-year safety risk monitoring period not only guarantees the interests of the applicants but also allows the enterprises to take the initiative to undertake the responsibility of safety risk monitoring. Undoubtedly, it has greatly promoted industrial innovation and development. Under the scientific supervision system, the spring of new cosmetic ingredients filing has arrived.

About CIRS

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