CIRS Group China Assisted Innospec in Obtaining the Filing Number of New Imported Cosmetics Ingredients (SLMI)

Since June 29, 2020, the Cosmetics Supervision and Administration Regulations (CSRA, State Order No. 727) was released, a series of secondary regulations have been introduced, including new regulatory documents related to the registration and filing of new cosmetic ingredients such as 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. Since May 1, 2021, the registration and filing of new cosmetic ingredients need to be applied via the cosmetics declaration and review system of the NMPA online office hall. Since the implementation of the new regulations, four new domestic cosmetic ingredients have been filed, and on December 7, 2021, the first new imported cosmetic ingredient filing number was announced, and another new imported cosmetic ingredient filing number was obtained by Innospec with the assistance of CIRS Group China.

The specific information of the four new domestic cosmetic ingredients and two new imported cosmetic ingredients filed under the new regulations is listed in Table 1 and Table 2 separately.

Table 1 Filing info of new domestic cosmetic ingredients

Filing number	国妆原备字20210001	国妆原备字20210002	国妆原备字20210003	国妆原备字20210004
Standard Chinese name	N-乙酰神经氨酸	月桂酰丙氨酸	β-丙氨酰羟脯氨酰二氨基丁酸苄胺	雪莲培养物
INCI name	Acetylneuraminic Acid	Lauroyl Alanine	β-Alanyl Hydroxyprolyldiaminobutyroyl Benzylamide
CAS number	131-48-6	52558-74-4
Use purpose	Moisturizer	Cleaner	Skin Protectant	Antioxidants
Application Scope	Can be used for the full body skin care treatments	Can be used in all kinds of cosmetics, no special restrictions on the scope of use	1) Rinse-off skin care products: cleansing products, massage products 2) Leave-on skin care products: lotions, emulsions, creams, beauty solutions, masks, etc. 3) Color cosmetics: foundations, bases, etc.	Can be used in all kinds of cosmetics, no special restrictions on the scope of use
Safe usage	≤2%	≤20%	0.00001%-1.0%	≤4%
Filing date	28 Jun 2021	28 Jun 2021	6 Aug 2021	13 Aug 2021
Filer	武汉中科光谷绿色生物技术有限公司	苏州维美生物科技有限公司	深圳市维琪医药研发有限公司	大连普瑞康生物技术有限公司

Table 2 Filing info of new imported cosmetic ingredients

Filing number	国妆原备字20210005	国妆原备字20210006
Standard Chinese name	四氟丙烯	月桂酰甲基羟乙基磺酸钠
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

A total of 14 new ingredients were approved from 2004 until 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 May 1, 2021

In September 2008, the administrative health licensing of cosmetics was transferred from the Ministry of Health to the State Food and Drug Administration (SFDA). Six of the new cosmetic ingredients in Table 2 were approved by the Ministry of Health, four were approved by SFDA/CFDA. Four were approved by NMPA.

Note: 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.

In the past, under the old regulatory system, the reasons for the low approval rate of new cosmetic ingredients were mainly in the following aspects: 1) no unified reference catalog to determine the new cosmetic ingredients; 2) cosmetic ingredients management system is imperfect, such as how to supervise the approved new ingredients; for a new cosmetic ingredients project, the personal and home care team of CIRS Group China will advise companies to be prepared for more than five years. Approved new ingredients were public through official notice, meaning that all companies can directly produce and/or use the approved new ingredients. (3) 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 cosmetics projects, especially European cosmetics ingredient suppliers, to start or die halfway; (4) the actual technical review requirements are far more than the contents of "Guidelines for the New Cosmetic Ingredients Registration and Review "; (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.

New cosmetic ingredients management under the new regulatory system changes are mainly manifested in: 1) adopting level-to-level administration for new cosmetic ingredients 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 contain the requirements of alternative methods. Which means door of “alternative methods” is open to the new cosmetic ingredients finally, but it is still difficult to meet the corresponding conditions especially when the alternative methods are not included in the Chinese technical standards. Although the alternative methods are gradually improving 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 report should be prepared according to the "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.