Inventories of Cosmetic Ingredients in China are Fully Updated - Regulatory News - Personal and Home Care Products

CIRS has developed a free Chinese cosmetic ingredient regulatory database (China CosIng) that allows enterprises to quickly search whether a cosmetic ingredient or substance is listed in the latest version of the Inventory of Existing Cosmetic Ingredients in China (IECIC).

Under the old cosmetics regulatory system in China, the Chinese authorities supervise the safety of cosmetics and cosmetic ingredients based on the following lists of cosmetic ingredients.

Inventory of Existing Cosmetic Ingredients in China (2015 Edition) (IECIC 2015)
Use: Determine whether it is a new cosmetic ingredients
Safety and Technical Standards for Cosmetics (2015 Edition) (STSC 2015) Table 1 List of prohibited substances in cosmetics
Use: Ingredients in this catalogue shall not be intentionally added for the production and sale of cosmetics
Safety and Technical Standards for Cosmetics (2015 Edition) (STSC 2015) Table 2 List of prohibited plant (animal) substances in cosmetics
Use: The animal and plant ingredients in this catalogue shall not be intentionally added for the production and sale of cosmetics
Safety and Technical Standards for Cosmetics (2015 Edition) (STSC 2015) Table 3 List of restricted substances in cosmetics
Use: The use of the ingredients in this catalogue must meet the corresponding restriction requirements, such as the application scope, the maximum allowable concentration in cosmetics, impurities, the users, and the labeling requirements.
Safety and Technical Standards for Cosmetics (2015 Edition) (STSC 2015) Table 4 List of preservatives allowed in cosmetics
Use: The preservatives in this catalogue are allowed to be used in cosmetics and need to meet the corresponding restriction requirements
Safety and Technical Standards for Cosmetics (2015 Edition) (STSC 2015) Table 5 List of sunscreen agents allowed in cosmetics
Use: The sunscreen agents in this catalogue are allowed to be used in cosmetics and need to meet the corresponding restriction requirements
Safety and Technical Standards for Cosmetics (2015 Edition) (STSC 2015) Table 6 List of colorants allowed in cosmetics
Use: The colorants in this catalogue are allowed to be used in cosmetics and need to meet the corresponding restriction requirements
Safety and Technical Standards for Cosmetics (2015 Edition) (STSC 2015) Table 7 List of hair dyes allowed in cosmetics
Use: The hair dyes in this catalogue are allowed to be used in cosmetics and need to meet the corresponding restriction requirements
Catalogue of Standard Chinese Names of International Cosmetic Ingredient (2010 Edition)
Use: It is used as a reference for standard Chinese names of cosmetic ingredients

In order to further standardize the management of cosmetic ingredients and strengthen the supervision of safety, NMPA revised the Inventory of Existing Cosmetic Ingredients in China, List of prohibited substances in cosmetics and List of prohibited plant (animal) substances in cosmetics to form the Inventory of Existing Cosmetic Ingredients in China (2021 Edition), List of banned ingredients in cosmetics, List of banned plant (animal) ingredients in cosmetics. Therefore, under the new regulatory system of cosmetics in China, the competent authority will supervise the cosmetics and cosmetic ingredients based on the following lists of cosmetic ingredients.

Inventory of Existing Cosmetic Ingredients in China (2021 Edition)" (IECIC 2021)
Safety and Technical Standards for Cosmetics (STSC 2015) Table 1 List of banned ingredients in cosmetics
Safety and Technical Standards for Cosmetics (STSC 2015) Table 2 List of banned plant (animal) ingredients in cosmetics
Safety and Technical Standards for Cosmetics (STSC 2015) Table 3 List of restricted substances in cosmetics
Safety and Technical Standards for Cosmetics (STSC 2015) Table 4 List of preservatives allowed in cosmetics
Safety and Technical Standards for Cosmetics (STSC 2015) Table 5 List of sunscreen agents allowed in cosmetics
Safety and Technical Standards for Cosmetics (STSC 2015) Table 6 List of colorants allowed in cosmetics
Safety and Technical Standards for Cosmetics (STSC 2015) Table 7 List of hair dyes allowed in cosmetics
Catalogue of Standard Chinese Names of International Cosmetic Ingredient (2010 Edition)
Catalogue of Standard Chinese Names of International Cosmetic Ingredient (2010 Edition) (2018; Draft)

Background

Inventory of Existing Cosmetic Ingredients in China (Draft)

In 2014, the former CFDA issued the Inventory of Existing Cosmetic Ingredients in China on the basis of sorting out and objectively collecting the cosmetic ingredients used in marketed cosmetics, which was revised in 2015. Inventory of Existing Cosmetic Ingredients in China (2015 Edition) (IECIC 2015) contains a total of 8783 used ingredients. The safety of cosmetic ingredients is closely related to the safety of cosmetic products. A complete database of raw materials is the basis of cosmetic risk assessment. However, IECIC 2015 only specifies the name of the used ingredients without sorting out the use information of the ingredients, which cannot provide reference for risk assessment. The catalog also has the problem that the relationship between the prohibited and restricted components and permitted components of cosmetics specified in the Safety and Technical Standards for Cosmetics (2015 Edition) is not clear, and some ingredients information needs to be improved.

On Jan. 26, 2021, the National Institutes for Food and Drug Control (NIFDC) organized an amendment to the IECIC and formed a new draft version of IECIC, a comparison table of adjusted contents of the IECIC and revision instructions of the IECIC for public consultation. The deadline of public opinions is on Feb. 18, 2021.

Compared with the 8783 ingredients in IECIC 2015, the new draft of IECIC contains 8980 ingredients. The following aspects have been mainly adjusted:

1) The maximum historical usage of ingredients was added
Supplement the maximum historical usage of cosmetic ingredients in the formula according to the leave-on and rinse-off products respectively to IECIC (2021,Draft) by selecting the special use cosmetics and imported ordinary cosmetics that have been approved in the cosmetics administrative license management system from 2010 to Mar. 2020. Remark: The maximum historical usage info is based on the approved cosmetics info in the cosmetic administrative licensing management system. If there is only the maximum historical usage info of leave-on products, it can be referred for rinse-off products.
2) Supplement approved cosmetic ingredients (7)
Hump Oil Elaeagnus Mollis Diel Oil Glabridin ETHYL LAUROYL ARGINATE HCL Methoxy Peg-23 Methacrylate/Glyceryl Diisostearate Methacrylate Copolymer Calcium Phosphoryl Oligosaccharides Steareth-200
3) The restricted substances, allowed preservatives, sunscreen agents, colorants and hair dyes included in STSC 2015 but not listed in IECIC 2015 are regarded as used ingredients. They are added to the IECIC (2021, Draft)
According to the specific use of cosmetic ingredients in the cosmetics administrative license management system, the specific names of cosmetic ingredients used in the category ingredients of IECIC 2015 are added to the IECIC (2021, Draft) (63)
Plankton Extract: 3 Brown algae: 4 Algae extract: 27 Orchid (ORCHID) extract: 9 Vegetable oil: 9 Hydrogenated vegetable oil: 11
5) According to the International Cosmetic Ingredients Dictionary and Handbook, Chinese Pharmacopoeia, Chinese Flora, etc., if an ingredient serial number has two ingredient names in the IECIC 2015, one of the standardized names shall be retained (19)
6) Standardize the naming of some ingredients (Chinese/English/INCI Name) (437)
7) Delete some identical ingredients names (4)
Acrylic/Behenyl Acrylate/Dimethicone Methacrylate Copolymer Lime (CITRUS AURANTIFOLIA) Fruit Extract Litchi (LITCHICHINENSIS) Seed Extract Rose (ROSA RUGOSA) Flower Extract
8) Delete some ingredients with no history of use and unclear sources by comparison of product information in the cosmetics administrative license management system (3)
Black Ants, Dipterocarp, Hops

Inventory of Existing Cosmetic Ingredients in China (2021 Edition) (IECIC 2021)

On April 30, 2021, NMPA issued the IECIC (2021 Edition) which is effective on May 1, 2021. Compared with the 8980 ingredients of the IECIC (2021,Draft), the IECIC (2021 Edition) includes 8972 ingredients, the main changes are as follows:

Remove 16 duplicate ingredients:

月桂酰精氨酸乙酯HCl	ETHYL LAUROYL ARGINATE HCL
8-羥基喹啉硫酸鹽	OXYQUINOLINE SULFAT
二硫化硒	SELENIUM DISU
二氨基嘧啶氧化物	DIAMINOPYRIMIDINE OXID
鄰傘花烴-5-醇	O-CYMEN-5-OL
聚氨丙基雙胍	POLYAMINOPROPYL BIGUANID
1,3-雙-(2,4-二氨基苯氧基)丙烷鹽酸鹽	1,3-BIS-(2,4-DIAMINOPHENOXY)PROPANE HCL
2,4-二氨基苯氧基乙醇鹽酸鹽	2,4-DIAMINOPHENOXYETHANOL HCL
2,6-二甲氧基-3,5-吡啶二胺鹽酸鹽	2,6-DIMETHOXY-3,5-PYRIDINEDIAMINE HCL
6-甲氧基-2-甲氨基-3- 氨基吡啶鹽酸鹽 (HC藍7號)	6-METHOXY-2-METHYLAMINO-3-AMINOPYRIDINE HCL
羥乙基-3,4-亞甲二氧基苯胺鹽酸鹽	HYDROXYETHYL-3,4-METHYLENEDIOXYANILINE HCL
羥丙基雙(N-羥乙基對苯二胺)鹽酸鹽	HYDROXYPROPYL BIS(N-HYDROXYETHYL-P-PHENYLENEDIAMINE) HCL
間氨基苯酚鹽酸鹽	M-AMINOPHENOL HCL
對氨基苯酚鹽酸鹽	P-AMINOPHENOL HCL
對甲基氨基苯酚	P-METHYLAMINOPHENOL
對苯二胺鹽酸鹽	P-PHENYLENEDIAMINE HCL

Add 8 ingredients:

溶藻弧菌（VIBRIO ALGINOLYTICUS）提取物	VIBRIO ALGINOLYTICUS EXTRACT
長耳齒狀藻（ODONTELLA AURITA）提取物	ODONTELLA AURITA EXTRACT
長耳齒狀藻（ODONTELLA AURITA）油	ODONTELLA AURITA OIL
葛仙米（NOSTOC SPHAEROIDES）提取物	NOSTOC SPHAEROIDES EXTRACT
八氯羥鋁鋯GLY配位化合物	ALUMINUM ZIRCONIUM OCTACHLOROHYDREX GLY
芐氯酚	CHLOROPHENE
細莖石斛（DENDROBIUM CANDIDUM）莖提取物	DENDROBIUM CANDIDUM STEM EXTRACT
細莖石斛（DENDROBIUM CANDIDUM）提取物	DENDROBIUM CANDIDUM EXTRACT

Inventory of Banned Ingredients in Cosmetics (Draft) and "Inventory of Banned Plant (Animal) Ingredients in Cosmetics (Draft)

On Jan. 22, 2021, NMPA organized the China Food and Drug Administration to revise the list of banned cosmetics ingredients and other related documents, forming the Table 1 Inventory of Banned Ingredients in Cosmetics (Draft), Table 2 Inventory of Banned Plant (Animal) Ingredients in Cosmetics (Draft), Table 3 Comparison Table before and after Revision of Inventory of Banned Ingredients in Cosmetics, Table 4 Comparison Table before and after Revision of Inventory of Banned Plant (Animal) Ingredients in Cosmetics and Revision Instructions of Inventory of Banned Ingredients in Cosmetics for public consultation. The deadline of public opinions is on Feb. 18, 2021.

The original List of Prohibited Substances in Cosmetics (Table 1) and List of Prohibited Plant (Animal) Substances in Cosmetics (Table 2) in the Safety and Technical Standards for Cosmetics (2015) have 1290 banned components and 98 banned plant (animal) components respectively. Table 1 Inventory of Banned Ingredients in Cosmetics (Draft) and Table 2 Inventory of Banned Plant (Animal) Ingredients in Cosmetics (Draft) contain 1309 banned ingredients and 112 banned plant (animal) ingredients respectively. In contrast, the main adjustments are as follows:

Add 17 banned cosmetic ingredients:
2,6-二羥基-4-甲基苯甲醛（苔黑醛）	2,6-Dihydroxy-4-methyl-benzaldehyde (atranol) (CAS No. 526-37-4)
2-氯對苯二胺，2-氯對苯二胺硫酸鹽	2-chlorobenzene-1,4-diamine (2-Chloro-p-Phenylenediamine) (CAS No. 615-66-7) and its sulfate (CAS No. 61702-44-1)
新鈴蘭醛（3-和4-(4-羥基-4-甲基戊基)-3-環己烯-1-甲醛）	3-and4-(4-Hydroxy-4-methylpentyl) cyclohex-3-ene-1-carbaldehyde (HICC) (CAS No. 51414-25-6) (CAS No. 31906-04-4)）
3-亞芐基樟腦	3-Benzylidene Camphor (CAS No. 15087-24-8)
3-氯-2,6-二羥基-4-甲基-苯甲醛（氯化苔黑醛）	3-Chloro-2,6-Dihydroxy-4-methyl-benzaldehyde (chloroatranol)(CAS No. 57074-21-2)
硼酸、硼酸鹽和四硼酸鹽	Boric acid (CAS No. 10043-35-3), Borates and tetraborates
芐氯酚	Clorofene; chlorophene; 2-benzyl-4-chlorophenol (CAS No. 120-32-1)
環己胺	Cyclohexylamine (CAS No. 108-91-8)
二氯甲烷	Dichloromethane; methylene chloride (CAS No. 75-09-2)
甲醛	Formaldehyde (CAS No. 50-00-0)
咪唑	Imidazole (CAS No. 288-32-4)
硝基甲烷	Nitromethane (CAS No. 75-52-5)
多聚甲醛	Paraformaldehyde (CAS No. 30525-89-4)
非那西丁	Phenacetin (CAS No. 62-44-2)
過硼酸鈉	Sodium perborate (CAS No. 7632-04-4)
乙酸乙烯酯	Vinyl acetate (CAS No. 108-05-4)
萬壽菊花(TAGETES ERECTA)提取物, 萬壽菊花(TAGETES ERECTA)油	Tagetes erecta L. (Tagetes erecta flower extract; Tagetes erecta flower oil)
Revise 13 banned cosmetic ingredients:
Standardize some raw materials’ names, supplement CAS/EC no of some ingredients, etc.
Classify and combine 3 types of prohibited drug components:
抗感染類藥物，包括但不限于三溴沙侖、抗生素類、二氫速甾醇、乙硫異煙胺、呋喃唑酮、酮康唑、甲硝唑、呋喃妥因、磺胺類藥物(磺胺和其氨基的一個或多個氫原子被取代的衍生物)及其鹽類、甲巰咪唑等	Anti-infectives, including but not limited to 3,4',5-Tribromosalicylanilide (Tribromsalan (INN) )(CAS No. 87-10-5), Antibiotics, Dihydrotachysterol (INN) (CAS No. 67-96-9), Ethionamide (INN) (CAS No. 536-33-4), Furazolidone (INN) (CAS No. 67-45-8), Ketoconazole (CAS No. 65277-42-1), Metronidazole (CAS No. 443-48-1), Nitrofurantoin (INN) (CAS No. 67-20-9), Sulphonamides (sulphanilamide and its derivatives obtained by substitution of one or more H-atoms of the -NH2 groups) and their salts, Thiamazole (INN) (CAS No. 60-56-0).
抗組胺藥，包括但不限于溴苯那敏及其鹽類、氯苯沙明、苯海拉明及其鹽類、多西拉敏及其鹽類、羥嗪、曲吡那敏、西咪替丁等	Antihistamines, including but not limited to Brompheniramine (INN) (CAS No. 86-22-6)and its salts, Chlorphenoxamine (INN) (CAS No. 77-38-3), Diphenhydramine (INN) (CAS No. 58-73-1) and its salts, Doxylamine (INN) (CAS No. 469-21-6) and its salts, Hydroxyzine (INN) (CAS No. 68-88-2), Tripelennamine (INN) (CAS No. 91-81-6), Cimetidine（INN）(CAS No. 51481-61-9).
激素類，包括但不限于甾族結構的抗雄激素物質、腎上腺素、糖皮質激素類(皮質類固醇)、雌激素類、孕激素類、具有雄激素效應的物質等	Hormones, including but not limited to Anti-androgens of steroidal structure, Epinephrine (INN) (CAS No. 51-43-4), Glucocorticoids (Corticosteroids), Oestrogens, Progestogens, Substances with androgenic effect.
Revise 27 prohibited plant(animal) ingredients in cosmetics
Standardize raw materials’ names, naming formats and proper/alternative names

Public Opinions on the Inclusion of Multiple Cannabinoid Substances such as Cannabidiol as Prohibited Components in Cosmetics

On Mar. 26, 2021, the National Institutes for Food and Drug Control (NIFDC) issued a notice regarding the public opinions on the revision of banned ingredients in cosmetics. According to the relevant national drug control policies, it is proposed to include ingredients such as CANNABIS SATIVA FRUIT, CANNABIS SATIVA SEED OIL, CANNABIS SATIVA LEAF EXTRACT and CANNABIDIOL as prohibited components in cosmetics, and consult public opinions before Apr 19, 2021.

Inventory of Banned Ingredients in Cosmetics and Inventory of Banned Plant (Animal) Ingredients in Cosmetics

On May 26, 2021, NMPA issued an announcement on updating the list of banned ingredients in cosmetics. The Inventory of Prohibited Substances in Cosmetics (Table 1) and Inventory of Prohibited Plant (Animal) Substances in Cosmetics (Table 2) in Chapter 2 of the Safety and Technical Standards for Cosmetics (2015) were revised to form the List of Banned Ingredients in Cosmetics and the List of Banned Plant (Animal) Ingredients in Cosmetics. And this announcement shall take effect from the date of promulgation.

The Inventory of Prohibited Ingredients in Cosmetics has 1284 ingredients. Compared with the Table 1 Inventory of Prohibited Ingredients in Cosmetics (Draft), the main adjustments are as follows:

Correct the numbering order
Classification and combination

Include Cyclizine (INN) (CAS No. 82-92-8) and its salts as antihistamines
Include Ephedrine (CAS No. 299-42-3) and its salts, Isoprenaline (INN) (CAS No. 7683-59-2), Naphazoline (INN) (CAS No. 835-31-4) and its salts), Noradrenaline (CAS No. 51-41-2) and its salts, Otto Octodrine (INN) (CAS No. 543-82-8) and its salts as the adrenergic receptor agonists
Include Parametasone (INN) (CAS No. 53-33-8) as the hormones
Include Thyrothricine (CAS No. 1404-88-2) as the anti-infective drugs

New banned ingredients

烏洛托品	Methenamine (CAS No. 100-97-0)
過氧苯甲酰	Benzoyl peroxide (CAS No. 94-36-0)
大麻二酚	Cannabidiol (CAS No. 13956-29-1)

The Inventory of Banned Plant (Animal) Ingredients in Cosmetics contains 109 ingredients. Compared with the Table 2 Inventory of Banned Plant (Animal) Ingredients in Cosmetics (Draft), the main adjustments are as follows:

Correct the numbering order
Add the prohibition condition for the use of INULA HELENIUM Oil as a component of flavour and fragrance
New banned plant (animal) ingredients

大麻（CANNABIS SATIVA）仁果	CANNABIS SATIVA FRUIT
大麻（CANNABIS SATIVA）籽油	CANNABIS SATIVA SEED OIL
大麻（CANNABIS SATIVA）葉提取物	CANNABIS SATIVA LEAF EXTRACT

CIRS Summary

Compared with the original IECIC 2015, IECIC 2021 mainly adds the info of maximum historical usage of ingredients as one of the references for the cosmetics safety assessment; the total number of cosmetic ingredients is increased from 8783 to 8972, including the supplement of cosmetic ingredients approved by previous review, the restricted ingredients, preservatives, sunscreens, colorants, hair dyes of STSC that have not been included to IECIC 2015, and inclusion of specific ingredients already used for category ingredients in IECIC 2015. At the same time, some duplicated ingredients and ingredients with no history of use and unknown origin have been also removed.
The new version of Inventory of Banned Ingredients in Cosmetics and Inventory of Banned Plant (Animal) Ingredients in Cosmetics contain 1393 ingredients. 23 new banned ingredients (including prohibited plant and animal ingredients) have been added. There are Cannabidiol (CAS No. 13956-29-1) and three cannabinoid substances included in IECIC 2015 (Cannabis Sativa Fruit, Cannabis Sativa Seed Oil, Cannabis Sativa Leaf Extract) among them. It marks that China becomes the first country to ban Cannabidiol (CAS No. 13956-29-1)) and all cannabinoid substances in cosmetics internationally.

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Source:

Notice on the Solicitation of Opinions on the Inventory of Banned Ingredients in Cosmetics

Notice on the Solicitation of Opinions on the Inventory of Existing Cosmetic Ingredients in China

NIFDC Notice on Public Consultation of Revising List of Prohibited Substances in Cosmetics

NMPA Announcement on the Publishment of Inventory of Existing Cosmetic Ingredients in China(2021 Edition) (No. 62, 2021)

NMPA Announcement on Updating the Inventory of Banned Ingredients in Cosmetics (No. 74, 2021)

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