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SAFEGUARDS | Cosmetics, Personal Care & HouseholdNO. 041/16

SafeGuardS cosmetics

China Food and Drug Administration has released a notice (No. 2015-268) on 23rd December 2015 and announced the new cosmetics standard, Safety and Technical Standards for Cosmetics (Version 2015), is already approved by the committee of Cosmetics Standard and it is now released. The new standard will replace the Hygienic Standard of Cosmetics (Version 2007) since 1st December 2016.

The Hygienic Standard of Cosmetics is updated to Safety and Technical Standards for Cosmetics which is divided into eight sections with following outlines.

Section 1

  • Scope, terms and definition, as well as general requirements

Section 2

  • Prohibited list of substances in cosmetic products

Section 3

  • Restricted list of substance in cosmetic products, including preservatives, UV filters, colorants and hair dyes.

Section 4

  • Method of chemical analysis

Section 5

  • Method of microbiological analysis

Section 6

  • Method of toxicological assessment

Section 7

  • Human patch test

Section 8

  • Method of performance test

 1 A Change of Limits of Heavy Metals and Hazardous Substances

In Safety and Technical Standards for Cosmetics, tolerance limit of Lead (Pb) and Arsenic (As) is adjusted, while tolerance limit of Cadmium (Cd) is newly added. The Standard also incorporated the requirement of 1,4-doxane and asbestos from technical document

Hazardous Substances Limit (mg/kg) Remarks
Lead (Pb) 10 Except organic mercury containing cosmetics which is intended for use in eye area.
Arsenic (As) 2
Mercury (Hg) 1
Cadmium (Cd) 5
Methanol 2,000
1,4-DIoxane 30
Asbestos Not Detected

Microbiological Limit for Cosmetics

Microbiological parameters Limit Remarks
Total Aerobic Microbial Count ≤ 500 cfu/g or ≤ 500 cfu/mL Cosmetics intended to be used on eye and/or lip areas and children cosmetics
≤ 1,000 cfu/g or ≤ 1,000 cfu/mL Other cosmetics
Total Combined Molds and Yeasts Count ≤ 100 cfu/g or ≤ 100 cfu/mL
Staphylococcus Aureus Not detected /g or Not detected /mL
Pseudomonas Aeruginosa Not detected /g or Not detected /mL
Thermotolerant coliform Bacteria Not detected /g or Not detected /mL

2 Amendments on Prohibited and Restricted List of Substances

The Safety and Technical Standards for Cosmetics has amended the lists of prohibited and restricted substances in Hygienic Standard of Cosmetics. These are the changes:

Section 2
Prohibited List of substances In total of 1388 items, with addition of 133 items and amendments of 137 items
Restricted List of substances In total of 47 items, with addition of 1 item, amendments of 31 items, and deletion of 27 items

Section 3
Allowed List of preservatives In total of 51 items, with amendment of 14 items and deletion of 5 items
Allowed List of UV filters In total of 27 items, with amendment of 6 items and deletion of 1 item
Allowed List of colorants In total of 157 items, with addition of 1 item and amendments on 69 items
Allowed List of hair dyes In total of 75 items, with amendment of 63 items and deletion of 21 items


3 Amendments on test methods for cosmetics assessments

In this new Standard, there are an additional 60 test methods on prohibited and restricted substances in cosmetics. Test methods for Strontium and total Fluorine are out of scope for this Standard and hence deleted from Hygienic Standard for Cosmetics. Apart from chemical analysis, it also standardizes the format on microbiological and toxicological test methods. Safety testing on humans and performance testing are amended and separately described in this Standard. Among the performance testing are preparation methods for P2 and P3 products and are included for SPF test.

SGS solution:

It is crucial for all cosmetic, personal care and household products to be safe, effective and stable. SGS provides testing, inspection, auditing and consulting services to manufacturers, distributors and importers to ensure a high level of product quality in every area. Our state of the art laboratories offer custom-made solutions for chemical, biophysical, microbiological, stability and biological aspects. We also have extensive capabilities in performance testing, claim support studies and consumer panels. Our testing is conducted according to customer specific or recognised standard methods, some of which were developed by SGS. Our cosmetic safety assessors and other technical experts can support customers by making sure new products comply with regulatory requirements.

Reference Sources: 1. CFDA Notice No. 2015-268

For enquiries, please contact:

Queenie Tse
Technical Service Executive, Cosmetics, Personal Care & Household
t: +852 2765 3672

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