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China Sunscreens Regulations

  •   15 Jul 2016
  •    Angelita Hu
  •  3619
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    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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