China to Amend Cosmetic Prohibited Ingredient Lists: 17 Newly Prohibited Ingredients and Stricter Ban on Drug Ingredients

With reference to the international laws and regulations, and combined with Chinese assessment results of the restricted ingredients, permitted ingredients in Safety and Technical Standards for Cosmetics (STSC), and some ingredients in IECIC, the draft Inventories newly include ingredients that may have safety risks

3-Benzylidene Camphor, 3-and 4-(4-Hydroxy-4-methylpentyl) cyclohex-3-ene-1-carbaldehyde (HICC), Tagetes erecta L.(Tagetes erecta flower extract; Tagetes erecta flower oil), 2-chlorobenzene-1,4-diamine (2-Chloro-p-Phenylenediamine) and its sulfate, Boric acid, Borates and tetraborates and other borates and esters, Sodium perborate, Formaldehyde, Paraformaldehyde, Dichloromethane; methylene chloride, etc.

According to Chinese safety assessment conclusions, the draft Inventories newly include ingredients that may have safety risks when used in cosmetics

Phenacetin

With reference to other countries’(regions’) regulatory updates, combined with Chinese assessment results, the draft Inventories newly include ingredients that may have safety risks

2,6-Dihydroxy-4-methyl-benzaldehyde (atranol), 3-Chloro-2,6-Dihydroxy-4-methyl-benzaldehyde (chloroatranol), Clorofene; chlorophene; 2-benzyl-4-chlorophenol, Cyclohexylamine, Imidazole

Standardize ingredient name

"Antibiotics" amended to "Anti-infectives"

Add 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. 1332-21-4), 1,4-Dihydroxybenzene   (Hydroquinone) (CAS No. 123-31-9), Isopropyl 4-hydroxybenzoate (INCI: Isopropylparaben) (CAS No. 4191-73-5), Sodium salt or Salts of Isopropylparaben, Isobutyl 4-hydroxybenzoate (INCI: Isobutylparaben) (CAS No. 4247-02-3), Sodium salt or Salts of Isobutylparaben, 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.

Add EC number

o-Tolidine based dyes (EC No. 611-030-00-4),   etc.

Correct CAS number

Residues (petroleum),atm.tower (CAS No. 64741-45-3), etc.

Standardize ingredient name

Adjust “Illicium L. (Illiciaceae) (except. Illicium verumt)” to “Illicium L.(Schisandraceae) (except. Illicium verumt)”

Standardize ingredient   naming format

1. Adjust 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)”

2. Adjust the naming format of the Latin name or English name of the plant component (species) to "Latin name   (part/description/English name)"

Inula helenium L.(Alanroot oil), Ficus carica L.(Fig leaf absolute), Laurus nobilis L.(Oil from the seeds)

Unify 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.

Standardize scientific name and synonym

With reference to the Flora of China, the draft lists adjust the Chinese and Latin scientific names of plant ingredient (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, Aucklandia costus Falc.; Saussurea lappa (synonym)(Costus root oil), 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)., Aloysia citriodora Palau; Lippia citriodora Kunth(Synonym).(Verbena essential oils), Sauromatum giganteum(Engler)Cusimano & Hetterscheid; Typhonium giganteum(synonym)

Anti-infectives

Include but are not limited to 3,4',5-Tribromosalicylanilide (Tribromsalan (INN) ), Antibiotics, Dihydrotachysterol (INN), Ethionamide (INN), Furazolidone (INN), Ketoconazole, Metronidazole, Nitrofurantoin (INN), Sulphonamides (sulphanilamide and its derivatives obtained by substitution of one or more H-atoms of the -NH2 groups) and their salts, Thiamazole (INN)

Antihistamines

Include but are not limited to Brompheniramine (INN) and its salts, Chlorphenoxamine (INN), Diphenhydramine (INN) and its salts, Doxylamine (INN) and its salts, Hydroxyzine (INN) (CAS No. 68-88-2), Tripelennamine (INN), etc.

Hormones

Include but are not limited to Anti-androgens of steroidal structure, Epinephrine (INN), Glucocorticoids   (Corticosteroids), Oestrogens, Progestogens, Substances with androgenic effect, etc.

Note: The coverage of the above three categories of drug ingredients includes but is not limited to the listed examples. All drug ingredients belonging to these three categories are prohibited ingredients for cosmetics.