On 12 June 2023, China National Institute for Drug Control released a Draft for Comments. In this draft, 5 ingredients (Table 1) are proposed to be listed as prohibited cosmetic ingredients in China! Stakeholders are encouraged to send opinions to hzpbwh@nifdc.org.cn until 15 July 2023.
Table 1 Prohibited Ingredients for Cosmetic Products
Number | Chinese Name | English Name | |
1286 | 比马前列素 | Bimatoprost（CAS No. 155206-00-1） | |
1287 | 拉坦前列素 | Latanoprost（CAS No. 130209-82-4） | |
1288 | 他氟前列素 | Tafluprost（CAS No.209860-87-7） | |
1289 | 他氟乙酰胺 | Tafluprost ethyl amide，(5Z)-7-{(1R,2R,3R,5S)-2-[(1E)-3,3-Difluoro-4-phenoxy-1-buten-1-yl]-3,5-dihydroxycyclopentyl}-N-ethyl-5-heptenamide（CAS No. 1185851-52-8） | |
1290 | 曲伏前列素 | Travoprost（CAS No. 157283-68-6） | |
What are the functions of these ingredients?
Bimatoprost (BMP) is a prostaglandin analogue used in medicinal products for glaucoma treatment.
Latanoprost is an eye drop formulation for treating elevated intraocular pressure (IOP) in ocular hypertension or open-angle glaucoma patients. It is a prostaglandin F2 alpha analog. Prostaglandins are most commonly used as the first line of treatment in glaucoma due to their efficacy in reducing the IOP, convenient once-daily dosing, and acceptable safety profile.
Tafluprost ophthalmic is used to treat glaucoma (a condition in which increased pressure in the eye can lead to gradual loss of vision) and ocular hypertension (a condition which causes increased pressure in the eye). Tafluprost is in a class of medications called prostaglandin analogs.
Tafluprost ethyl amide is a prostaglandin derivative. It is capable of intraocular pressure (IOP) reduction and influencing eyelash growth.
Travoprost is a member of the prostaglandin analogue class of intraocular pressure (IOP)-lowering drugs used to treat ocular hypertension and glaucoma.
In general, these ingredients fall under the umbrella of prostaglandins and prostaglandin analog. They are active ingredients to treat glaucoma and ocular hypertension. However, they have a particular side effect: they boost eyelash growth. Hence, They have been used in cosmetic products to improve eyelash growth.
How are these ingredients regulated in the US and the EU?
On February 3, 2022, the Scientific Committee on Consumer Safety (SCCS) issued an opinion on prostaglandins and prostaglandin-analogues used in cosmetic products. The SCCS concluded that these substances have strong pharmacological effects even at low concentrations; thus, they raise safety concerns.
As is stated in National Library Medicine, an official website of the United States Government, prostaglandins and prostaglandin-analogues are regulated as potent pharmacologically active substances for the treatment of glaucoma and ocular hypertension.
What are the side effects of these ingredients?
Prostaglandins have similar side-effect profiles, which include both side effects that occur frequently (e.g., conjunctiva hyperaemia, increase of iris pigmentation and eyelash changes) and rare adverse reactions (e.g., periocular pigmentation, damage to the blood-aqueous barrier and cystoid macular oedema). Conjunctiva hyperaemia, eyelash changes and cystoid macular oedema are reversible, but certain other side effects, such as increased iris pigmentation, are not.
The purpose of cosmetics is cleansing, protecting, beautifying, or grooming and the prerequisite is safety. However, These ingredients, Bimatoprost, Latanoprost, Tafluprost, Tafluprost ethyl amide, Travoprost, are potent pharmacologically active substances and have safety concerns. Therefore, they are proposed to be added to the List of Prohibited Cosmetic Ingredients in China.
China has lists of ingredients allowed to be used, prohibited to be used, and allowed to be used under certain conditions, which are listed in the Safety and Technical Standards for Cosmetics. Get in touch with us for these lists.
For businesses intending to export products to the Chinese market, it is essential and crucial to keep abreast of the latest regulation changes, so as to make adjustments at an early stage, such as formula design, marketing plan, etc.
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