Inventories of Cosmetic Ingredients in China are Fully Updated

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-羟基喹啉硫酸盐

OXYQUINOLINE SULFAT

二硫化硒

SELENIUM DISU

二氨基嘧啶氧化物

DIAMINOPYRIMIDINE OXID

邻伞花烃-5-醇

O-CYMEN-5-OL

聚氨丙基双胍

POLYAMINOPROPYL BIGUANID

1,3-双-(2,4-二氨基苯氧基)丙烷盐酸盐

1,3-BIS-(2,4-DIAMINOPHENOXY)PROPANE HCL

2,4-二氨基苯氧基乙醇盐酸盐

2,4-DIAMINOPHENOXYETHANOL HCL

2,6-二甲氧基-3,5-吡啶二胺盐酸盐

2,6-DIMETHOXY-3,5-PYRIDINEDIAMINE HCL

6-甲氧基-2-甲氨基-3- 氨基吡啶盐酸盐 (HC蓝7号)

6-METHOXY-2-METHYLAMINO-3-AMINOPYRIDINE HCL

羟乙基-3,4-亚甲二氧基苯胺盐酸盐

HYDROXYETHYL-3,4-METHYLENEDIOXYANILINE HCL

羟丙基双(N-羟乙基对苯二胺)盐酸盐

HYDROXYPROPYL BIS(N-HYDROXYETHYL-P-PHENYLENEDIAMINE) HCL

间氨基苯酚盐酸盐

M-AMINOPHENOL HCL

对氨基苯酚盐酸盐

P-AMINOPHENOL HCL

对甲基氨基苯酚

P-METHYLAMINOPHENOL

对苯二胺盐酸盐

P-PHENYLENEDIAMINE HCL

Add 8 ingredients:

溶藻弧菌(VIBRIO ALGINOLYTICUS)提取物

VIBRIO ALGINOLYTICUS EXTRACT

长耳齿状藻(ODONTELLA AURITA)提取物

ODONTELLA AURITA EXTRACT

长耳齿状藻(ODONTELLA AURITA)油

ODONTELLA AURITA OIL

葛仙米(NOSTOC SPHAEROIDES)提取物

NOSTOC SPHAEROIDES EXTRACT

八氯羟铝锆GLY配位化合物

ALUMINUM ZIRCONIUM OCTACHLOROHYDREX GLY

苄氯酚

CHLOROPHENE

细茎石斛(DENDROBIUM CANDIDUM)茎提取物

DENDROBIUM CANDIDUM STEM EXTRACT

细茎石斛(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:

2,6-二羟基-4-甲基苯甲醛(苔黑醛)

2,6-Dihydroxy-4-methyl-benzaldehyde (atranol) (CAS No. 526-37-4)

2-氯对苯二胺,2-氯对苯二胺硫酸盐

2-chlorobenzene-1,4-diamine (2-Chloro-p-Phenylenediamine) (CAS No. 615-66-7) and its sulfate (CAS No. 61702-44-1)

新铃兰醛(3-和4-(4-羟基-4-甲基戊基)-3-环己烯-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-亚苄基樟脑

3-Benzylidene Camphor (CAS No. 15087-24-8)

3-氯-2,6-二羟基-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、硼酸盐和四硼酸盐

Boric acid (CAS No. 10043-35-3), Borates and tetraborates

苄氯酚

Clorofene; chlorophene; 2-benzyl-4-chlorophenol (CAS No. 120-32-1)

环己胺

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)

过硼酸钠

Sodium perborate (CAS No. 7632-04-4)

乙酸乙烯酯

Vinyl acetate (CAS No. 108-05-4)

万寿菊花(TAGETES ERECTA)提取物, 万寿菊花(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:

抗感染类药物,包括但不限于三溴沙仑、抗生素类、二氢速甾醇、乙硫异烟胺、呋喃唑酮、酮康唑、甲硝唑、呋喃妥因、磺胺类药物(磺胺和其氨基的一个或多个氢原子被取代的衍生物)及其盐类、甲巯咪唑等

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).

抗组胺药,包括但不限于溴苯那敏及其盐类、氯苯沙明、苯海拉明及其盐类、多西拉敏及其盐类、羟嗪、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).

激素类,包括但不限于甾族结构的抗雄激素物质、肾上腺素、糖皮质激素类(皮质类固醇)、雌激素类、孕激素类、具有雄激素效应的物质等

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

乌洛托品

Methenamine (CAS No. 100-97-0)

过氧苯甲酰

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)叶提取物

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)