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China Sunscreens Regulations

In China not all products claiming sun protection are regulated as special use cosmetics that have to register with CFDA and are subject to stricter examination and review. According to the regulations, products only containing physical UV filters (e.g. zinc oxide and titanium dioxide) which do not indicate SPF/PA value are considered as non-special use cosmetics and subject to a comparatively simple filing process and shorter testing period of 2-3 months. However products containing chemical UV filters require registration and a long testing period of 8-10 months.

What testing is mandatory?

Testing items

Category

Physical Products

Chemical Products

Microbiological Testing

Microbiological Testing

Mercury

Hygienic Chemical Testing

Lead

Hygienic Chemical Testing

Arsenic

Hygienic Chemical Testing

UV Filters

Hygienic Chemical Testing

 

Phenol and Hydroquinone

Hygienic Chemical Testing

 

Repeated Dermal Irritation Testing

Toxicological Testing

Skin Sensitization Testing

Toxicological Testing

 

Skin Phototoxicity Test

Toxicological Testing

 

Skin Patch Test

Human Trial

 

SPF

Human Trial

 

Water Resistance

Human Trial

 

Based on claim

PFA

Human Trial

 

Based on claim

Broad-spectrum

Human Trial or Instrumental Analysis

 

Based on claim

Note: The above three toxicological testing is conducted on animals.

In terms of testing SPF, water resistance, PFA and broad-spectrum, testing periods and costs are based on the efficacy claims of each product. Testing institutions follow a set of complicated rules to calculate the cost and generally speaking the fee is expensive. So imported companies are recommended to submit UV testing reports of SPF value, water resistance and PFA value from overseas labs (click here to learn how to use an overseas UV testing reports in China). In China, only sunscreen filing applications can be supplemented with overseas testing reports.

Permitted UV Filters for Use in Cosmetics

China adopts a positive list to regulate UV filters (click here to see the positive list). Cosmetic companies can only use UV filters included in the positive list, otherwise applications will be rejected

At present there are 28 UV filters permitted for use in cosmetics while as of the implementation of Safety and Technical Standards for Cosmetics 2015 on December 1st 2016 4-Aminobenzoic acid (PABA) will be banned and removed from the positive list. In fact, the ingredient has already been prohibited in Europe since the end of 2008.

More information about sunscreen labeling requirements:

China Implements New Labeling Requirements for Sunscreens

Impacts of China’s New Sunscreen Labeling Requirements

China New Sunscreen Labeling Requirements: Compliance Q&A

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