China Implements Amended Cosmetic Prohibited Ingredient Inventories: 24 Newly Prohibited Ingredients Including Cannabidiol (CBD)

On Jan. 22, 2021, China opened a public consultation on the draft amended Inventory of Prohibited Ingredients for Cosmetics and Inventory of Prohibited Plant (Animal) Ingredients for Cosmetics. Based on the collected public opinions, on May 28, National Medical Products Administration (NMPA) released and implemented the finalized Inventory of Prohibited Ingredients for Cosmetics and Inventory of Prohibited Plant (Animal) Ingredients for Cosmetics. ¹

These two new inventories replaced the previous inventories of prohibited cosmetic ingredients and were included in the corresponding chapters of Safety and Technical Standards for Cosmetics (STSC).

Names of the New Inventories

Chapters in STSC

Total Number of Ingredients

Main Amendments

Inventory of Prohibited Ingredients for Cosmetics

Chapter 2 Prohibited and Restricted Ingredients Used in Cosmetics

1 Prohibited Ingredients Used in Cosmetics (Inventory 1)

1284

Add 20 prohibited ingredients for cosmetics;
Amend the names and CAS numbers of prohibited ingredients for cosmetics;
Classify and merge prohibited drug ingredients for cosmetics.

Inventory of Prohibited Plant (Animal) Ingredients for Cosmetics

Chapter 2 Prohibited and Restricted Ingredients Used in Cosmetics

2 Prohibited Plant (Animal) Ingredients Used in Cosmetics (Inventory 2)

109

Add four prohibited plant (animal) ingredients for cosmetics;
Standardize the names of prohibited plant (animal) ingredients for cosmetics;
Clarify that five plant (animal) ingredients are prohibited from using in cosmetics as fragrance ingredients.

Detailed Amendments

1. Add 24 prohibited ingredients

Compared with the previous inventories, 24 prohibited cosmetic ingredients have been added to the two new inventories.

No.	Ingredient Name	Inventory Name
1	2,6-Dihydroxy-4-methyl-benzaldehyde（atranol）（CAS No. 526-37-4）	Inventory of Prohibited Ingredients for Cosmetics
2	2-chlorobenzene-1,4-diamine（2-Chloro-p-Phenylenediamine）（CAS No. 615-66-7） and its sulfate salts（CAS No. 61702-44-1）
3	3-and 4-（4-Hydroxy-4-methylpentyl）cyclohex-3-ene-1-carbaldehyde（HICC)（CAS No. 51414-25-6 / CAS No. 31906-04-4）
4	3-Benzylidene Camphor（CAS No. 15087-24-8）
5	3-Chloro-2,6-Dihydroxy-4-methyl-benzaldehyde（chloroatranol）（CAS No. 57074-21-2）
6	Borates and tetraborates（CAS No. 1330-43-4 / CAS No. 1303-96-4 / CAS No. 10377-81-8 / CAS No. 68003-13-4）
7	Boric acid（CAS No. 10043-35-3 /CAS No. 11113-50-1）
8	Clorofene; chlorophene; 2-benzyl-4-chlorophenol （CAS No. 120-32-1）
9	Cyclohexylamine（CAS No. 108-91-8）
10	Dichloromethane; methylene chloride（CAS No. 75-09-2）
11	Formaldehyde（CAS No. 50-00-0）
12	Imidazole（CAS No. 288-32-4）
13	Nitromethane（CAS No. 75-52-5）
14	Paraformaldehyde（CAS No. 30525-89-4）
15	Phenacetin（CAS No. 62-44-2）
16	Sodium perborate（CAS No. 15120-21-5）
17	Vinyl acetate（CAS No. 108-05-4）
18	Methenamine（CAS No. 100-97-0）
19	Benzoyl peroxide（CAS No. 94-36-0）
20	Cannabidiol（CAS No. 13956-29-1）
21	Tagetes erecta flower extract; Tagetes erecta flower oil	Inventory of Prohibited Plant (Animal) Ingredients for Cosmetics
22	CANNABIS SATIVA FRUIT
23	CANNABIS SATIVA SEED OIL
24	CANNABIS SATIVA LEAF EXTRACT

From May 28, 2021, cosmetic registrants and notifiers are not allowed to produce or import products containing prohibited ingredients stipulated in the new inventories. As for the products containing the newly prohibited ingredients that have been produced or imported, the NMPA will issue transitional measures to clarify the deadline for their sales.

Companies entering China through CBEC are also recommended to pay close attention to the prohibited ingredients updates. The mainstream CBEC platforms in China, such as Tmall Global, banned the sales of products containing prohibited ingredients prescribed by NMPA on the platform. The CBEC platforms may later update their platform rules to be in line with Chinese prohibited ingredient requirements.

In addition, among the 24 newly prohibited ingredients, CBD and three other Cannabis Sativa derived ingredients are included, which means that CBD cosmetics are prohibited from being produced and imported in China. Visit ChemLinked article for the impact of CBD ban in China.

2. Amend the names, CAS numbers and notes of prohibited ingredients

1) Amendments to ingredient names and CAS numbers

Inventory of Prohibited Ingredients for Cosmetics

Amendments	Examples
Standardizes ingredient name	"Antibiotics" amended to "Anti-infectives."
Adds CAS number	Dextropropoxyphene (a-(+)-4-dimethylamino-3-methyl-1,2-diphenyl-2-butanol propionate ester) (CAS No. 469-62-5), Diphenoxylate hydrochloride (ethyl ester of 1-(3-cyano-3,3-diphenylpropyl)-4- phenylisonipecotic acid) (CAS No. 915-30-0), Asbestos (CAS No. 12001-28-4), 1,4-Dihydroxybenzene (Hydroquinone) (CAS No. 123-31-9), Isopropyl 4-hydroxybenzoate (INCI: Isopropylparaben) Sodium salt or Salts of Isopropylparaben (CAS No. 4191-73-5), Isobutyl 4-hydroxybenzoate (INCI: Isobutylparaben) (CAS No. 4247-02-3), Sodium salt or Salts of Isobutylparaben（CAS No. 84930-15-4）, Phenyl 4-hydroxybenzoate (INCI: Phenylparaben) (CAS No. 17696-62-7), Benzyl 4-hydroxybenzoate (INCI: Benzylparaben) (CAS No. 94-18-8), Pentyl 4-hydroxybenzoate (INCI: Pentylparaben) (CAS No. 6521-29-5), Thyrothricine (CAS No. 1404-88-2), etc.
Corrects CAS number	Residues (petroleum),atm.tower (CAS No. 64741-45-3 ), etc.

Inventory of Prohibited Plant (Animal) Ingredients for Cosmetics

Amendments		Examples
Standardizes ingredient name		Adjust “Illicium L. (Illiciaceae) (except. Illicium verumt)” to “Illicium L.(Schisandraceae) (except. Illicium verumt)."
Standardizes ingredient naming format	Adjusts the naming format of the Latin name or English name of the plant component (genus) to “genus (family) + Latin name."	Adjust “Strophanthus species” to “Strophanthus DC,(Apocynaceae)”
Unifies ingredient Latin name or English name	If plant ingredients (species) have multiple Latin scientific names or English names, put the scientific names first, followed by synonyms. The synonym format is “genus name + specific epithet" and is marked with "synonym."	Amorphophallus konjac K. Koch;Amorphophallus rivieri (synonym), Clematis chinensis Osbeck, Convallaria majalis L.;Convallaria keiskei (synonym), Garcinia hanburyi Hook. F.; Garcinia morella(synonym)
	Refer to the Flora of China, if the Chinese name of the plant ingredient (species) corresponds to multiple Latin scientific names, but the multiple Latin scientific names do not refer to the same plant ingredients, then split the plant ingredient (species) into multiple items.	Amorphophallus konjac K. Koch;Amorphophallus rivieri (synonym), Clematis chinensis Osbeck, Hydnocarpus anthelminthicus Pierre in Laness., Ipomoea nil (L.) Roth;Pharbitis nil (synonym), Phytolacca acinosa Roxb
	If one item contains two ingredients, then split it into multiple items.	Brassica juncea (L.) Czern., Sinapis alba L.
Standardizes scientific name and synonym	With reference to the Flora of China, the new inventories adjust the Chinese and Latin scientific names of plant ingredients (species) to scientific names. For ingredients whose original names are synonyms/common names, keep the original names and add the scientific names. Put the scientific names first, followed by synonyms. The synonym format is “genus name + specific epithet" and is marked with "synonym."	Alocasia odora (Roxb.) K. Koch; Alocasia macrorrhiza(synonym), Carapichea ipecacuanha (Brot.) L.Andersson;Cephaelis ipecacuanha (Synonym) and related species, Costus root oil（Saussurea lappa Clarke）, Crotalaria sessiliflora L, Drosera peltata Willd.; Drosera peltata var. multisepala (synonym), Hyoscyamus niger L., Nerium oleander L.;Nerium indicum (synonym), Periploca sepium Bge., Ipomoea nil (L.) Roth;Pharbitis nil (synonym), Cullen corylifolium(L.)Medik.; Psoralea corylifolia(synonym), Tanacetum cinerariifolium(Trevir.)Sch.-Bip.; Pyrethrum cinerariifolium(synonym), Flueggea suffruticosa (Pall.) Baill.;Securinega suffruticosa (synonym), Drimia maritima (L.) Stearn;Urginea scilla (Synonym)., Sauromatum giganteum(Engler)Cusimano & Hetterscheid; Typhonium giganteum(synonym)

2) Clarify that five plant (animal) ingredients are prohibited from using in cosmetics as fragrance ingredients

Ingredient Name	Notes
Alanroot oil（Inula helenium L.）（CAS No. 97676-35-2）	Prohibited from using in cosmetics as fragrance ingredients
Costus root oil（Saussurea lappa Clarke)（CAS No. 8023-88-9）
Exudation of Myroxylon pereirae（Royle）Klotzch（Peru balsam, crude)（CAS No. 8007-00-9）
Fig leaf absolute（Ficus carica L.)（ CAS No. 68916-52-9 ）
Verbena essential oils（Lippia citriodora Kunth.） and derivatives other than absolute（CAS No. 8024-12-2）

3. Classify and merge prohibited drug ingredients

With reference to Chinese Pharmacopoeia 2020, Clinical Medication Instructions 2015, and Martindale the Extra Pharmacopoeia, the new inventories classify and merge some prohibited drug ingredients into Anti-infectives, Antihistamines, Hormones, and Adrenergic Agents.

Categories	Examples
Anti-infectives	Include 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）, Thyrothricine（CAS No. 1404-88-2）
Antihistamines	Include but not limited to Brompheniramine （INN)（CAS No. 86-22-6）and its salts, Chlorphenoxamine （INN）（CAS No. 77-38-3）, Cyclizine（INN）（CAS No. 82-92-8） and its salts, 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）
Hormones	Include but not limited to Anti-androgens of steroidal structure, Glucocorticoids（Corticosteroids）, Oestrogens, Paramethasone（INN）（CAS No. 53-33-8）, Progestogens, Substances with androgenic effect.
Adrenergic Agents	Include but not limited to Ephedrine（CAS No. 299-42-3） and its salts, Epinephrine （INN）（CAS No. 51-43-4）, 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, Octodrine（INN）（CAS No. 543-82-8）and its salts.
Note: The coverage of the above categories of drug ingredients includes but is not limited to the listed examples. All drug ingredients belonging to these categories are prohibited ingredients for cosmetics.