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Regulatory Updates

China Opens Consultation on Cosmetic Standards Including PFOS, D4, Dioxane, and BP-3, Aligning with International Regulations
Publication date:2025-09-15

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On September 15,2025, China's National Institutes for Food and Drug Control (NIFDC) has released 18 draft cosmetic standards for public consultation. The public consultation period will remain open until October 9, 2025.

 

The drafts include newly added prohibited ingredients, revised microbial limits for eye, lip, and children's cosmetics, and adjusted usage limits for certain permitted, restricted, and prohibited substances.

 

Detailed standards are as follows:

 

Modification Type

No.

Name

Remark

Eye, Lip, and Children's Cosmetics

1

Microbial Limits for Eye, Lip, and Children's Cosmetics

China's Safety Technical Standards for Cosmetics(STSC) currently set a microbial limit of 500 CFU/g (or CFU/mL) for eye, lip, and children's cosmetics; the draft revision proposes lowering this limit to 100 CFU/g (or CFU/mL), aligning with regulations in the EU, US, Japan, Russia, and ISO standards. 

Limits for Dioxane

2

Dioxane

A risk substance in cosmetics due to technical limitations, now has a revised limit in China's prohibited ingredients list from 30 mg/kg to 10 mg/kg.

New Addition for the List of Prohibited Substance

3

4-Methylbenzylidene Camphor

It is currently a permitted UV filter under China's STSC and is proposed for inclusion in the prohibited ingredients list, aligning with regulations in EU, US, and Japan.

4

6-Amino-m-cresol

It is currently a permitted hair dye under China's STSC and is proposed for inclusion in the prohibited ingredients list, aligning with regulations in EU and South Korea.

5

Butylphenyl methylpropional

It is currently included in China's IECIC and is proposed for inclusion in the prohibited ingredients list, aligning with regulations in EU, UK and ASEAN.

6

Cyclotetrasiloxane

It is currently included in China's IECIC and is proposed for inclusion in the prohibited ingredients list, aligning with EU and Thailand regulations.

7

Perfluorooctane sulfonic acid (PFOS) and its salts

PFOS and its salts are proposed for inclusion in China's prohibited ingredients list, aligning with regulations in the EU, US, and ASEAN countries.

8

Perfluorooctanoic acid (PFOA) and its salts

PFOA and its salts are proposed for inclusion in China's prohibited ingredients list, aligning with regulations in EU, US, and ASEAN countries.

9

Pyrithione zinc (INN)

It is currently a restricted ingredient and permitted preservative under China's STSC, and is proposed for inclusion in the prohibited ingredients list, aligning with regulations in EU.

Revised Usage Limit for Restricted Substance

10

Salicylic acid

It is currently a restricted ingredient in China, with a 2.0% limit for leave-on and rinse-off skin products and 3.0% for rinse-off hair products (not for use in products for children under three, except shampoos).

The revision proposes lowering the limit to 0.5% for body lotions, eye shadows, mascaras, eyeliners, lipsticks, and deodorants, keeping 2.0% for other skin products, and adding bans for products for children under three and those with inhalation risk, aligning with EU requirements.

Revised Usage Limit for Permitted Preservatives

11

Climbazole

It is currently a permitted preservative under China's STSC with a 0.5% limit, is proposed to be revised to 0.5% in rinse-off shampoos and 0.2% in leave-on hair and facial products, basically aligning with regulations in EU.

12

Methylisothiazolinone

It is currently a permitted preservative under China's STSC with a 0.01% limit, is proposed to be revised to 0.0015% for rinse-off products, aligning with EU and Canadian requirements.

13

Polyaminopropyl biguanide

It is currently a permitted preservative under China's STSC with a 0.3% limit, is proposed to be revised to 0.1%, with added restrictions against use in products with inhalation risk and a standardized English name, aligning with EU and other international regulations.

Revised Usage Limit for Permitted UV Filters

14

Benzophenone-3

It is currently a permitted UV filter under China's STSC with a 10% limit, is  proposed to be revised to 6% for face, hand, and lip products (excluding sprays/aerosols) and 2.2% for body products (including sprays/aerosols), aligning with regulations in EU and UK.

15

Homosalate

It is currently a permitted UV filter under China's STSC with a 10% limit, is proposed to be revised to 7.34% for facial products (non-aerosols), aligning with regulations in EU and ASEAN.

16

Octocrylene

It is currently a permitted UV filter under China's STSC with a 10% limit (as acid), is proposed to be revised to 9% for aerosol products and 10% for other products, aligning with EU regulations.

Revised Usage Limit for Permitted Hair Dyes

17

Toluene-2,5-diamine

There two are currently permitted hair dyes under China's STSC with a 4.0% limit (as free base) and labeling requirement "contains phenylenediamines,"  are proposed to be revised to 2.0% (as free base) for oxidative hair dye products, aligning with EU requirements.

18

Toluene-2,5-diamine sulfate