Using an Overseas UV Testing Reports in China

According to Chinese Cosmetic Regulations "Guidance on Cosmetic Technology Review" and "Hygienic Standard for Cosmetics 2007" (China's Key cosmetic Technical Standard), the CFDA (China Food and Drug Administration) can accept UV test reports from overseas labs under certain conditions.

In general, those tests include SPF value determination, water resistant testing and PFA value determination.

Early this month, the NIFDC(National Institutes for Food and Drug Control) released the revised draft of the Hygienic Standard for Cosmetics 2007 and renamed it as "Safety Technical Standard for Cosmetics".

In the draft, big steps have been taken to make the standard more compatible with international practices.

Tests	Labeling	Reference	TEST ITERMS
SPF	SPF value	Cosmetics-Sun protection test method-In vivo determination of the sun protection factor (SPF) (International standard ISO 24444 First edition, 2010-10-15) Testing Procedure, Federal Register, 21 CFR. Parts 201 and 310, 2011 "SPF50+" is allowed to be used.	Reference formulas of the low SPF(P7) and high SPF(P2,P3) are consistent with the ISO/FDIS24444:2010(E)
SPF	Water Resistance (Marked with SPF of after bath or both the before and after)	Sunscreen Water Resistant Testing Procedure, Federal Register/Vol 64, No 98/1999	If the after result is 50% less than the before, products are not allowed tobear "Water Resistance" on their packaging or label.
PFA	PFA or PA+～PA++	Cosmetics-Sun protection test Method-In vivo determination of sunscreen UVA protection. (International standard ISO 24442 First edition, 2011-12-15)	PFA Test Report
Broad- Spectrum	"UVA product" or "Broad-Spectrum"		UVA Absorbance- Critical Wavelength Determination test(in vitro) or PFA (in vivo)(Critical Wavelength is 370nm or greater)

There are also requirements about the overseas laboratory qualification and the format of testing reports:

Firstly, the overseas testing agencies should provide materials below:

A Laboratory accreditation certificate;
If without a certificate in 1), testing agencies should strictly follow the Good Clinical Practice (Good Clinical Practice, GCP) or "Good Laboratory Practice" (Good Laboratory Practice, GLP ) standards;
Any other documents pertaining to laboratory qualification

Secondly, the laboratory should test on the samples from the same batch, and provide corresponding reports.

Submission of the original documents is also a requirement. However in cases where it is impossible or difficult to submit the originals, the applicant can submit copies, and supporting documents (authorized by the embassy to which it belongs, the local Chinese embassy or a officially recognized notarizing agency).

The test results should be displayed in table format, including The details of every subjects (Number, Sex, Age), Standard DEV(SE),STD Error ,Mean SPF, 95%CI.

In summary, if an overseas sunscreen value testing report is used for CFDA product registration, the testing method, quality data and the reports form should be self-checked by the applicant.

In addition, according to the "Cosmetic Testing Management Ordinance", multicolor sunscreen products refer to any series of sunscreen products with similar formulas except for the colorants used (including category or content of colorants).For those products, applicants are subject to the following rules for sampling inspection:

1）Choose the product with the lowest amount of colorants under the same as test sample.

2）The sampling rate should be 20% of total. No less than 5 samples shall be submitted.