QB/T 4256-2011 English PDF (QBT4256-2011)

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QB/T 4256-2011: Guideline for evaluation of cosmetics moisturization efficacy
QB/T 4256-2011
LIGHT INDUSTRY STANDARD OF
THE PEOPLE’S REPUBLIC OF CHINA
ICS 71.100.70
Classification No.: Y42
Filing No.: 34974-2012
Guideline for evaluation of cosmetics moisturization efficacy
ISSUED ON: DECEMBER 20, 2011
IMPLEMENTED ON: JULY 01, 2012
Issued by: Ministry of Industry and Information Technology of PRC
Table of Contents
Foreword ... 3 
1 Scope ... 4 
2 Normative references ... 4 
3 Basic principles ... 4 
4 Principles ... 5 
5 Test conditions and volunteer requirements ... 5 
6 Reagents and materials ... 5 
7 Instruments ... 6 
8 Measurement steps ... 6 
9 Result calculation ... 7 
10 Result judgment ... 7 
11 Test report ... 7 
Guideline for evaluation of cosmetics moisturization efficacy
1 Scope
This standard specifies a method for evaluating the moisturization efficacy of cosmetics
- Capacitance method to determine the moisture content of the stratum corneum of the
skin.
This standard is applicable to the determination of moisturization efficacy of skin care
creams, lotions, cosmetic products. Other types of cosmetics, which are claimed having
moisturization efficacy, can refer to this standard for evaluation.
2 Normative references
The following documents are essential to the application of this document. For the dated
documents, only the versions with the dates indicated are applicable to this document;
for the undated documents, only the latest version (including all the amendments) is
applicable to this standard.
Hygienic specifications for cosmetics
3 Basic principles
3.1 Cosmetics to be tested shall be products that have passed the physical, chemical,
hygienic tests. Before the human test, it shall complete the necessary toxicological tests,
in accordance with the "Hygienic specifications for cosmetics", AND issue a written
certificate. The sample, which fails in the toxicological tests, will not be subject to the
human test.
3.2 Human test of cosmetic's moisturization efficacy shall comply with the basic
principles of the International Declaration of Helsinki, requiring subjects to sign
informed consent and take necessary medical protective measures, to protect the
interests of subjects to the greatest extent.
3.3 The guidelines for the evaluation of moisturization efficacy of cosmetics are
applicable to the measurement of products before and after use.
The test of the same subject must be completed by the same measuring personnel, using
the same instrument. The measuring probe shall be cleaned, between the two
measurements.
During the use of the product, if there is an adverse reaction on the skin of the volunteer,
it shall terminate the test immediately AND provide medical treatment for the volunteer
appropriately. Adverse reactions shall be recorded.
9 Result calculation
Descriptive statistics are performed on the measured values of each test area, including
quantity, mean, standard deviation, minimum, median, maximum values, etc.
Calculate the difference, between the initial value of each test area and the measured
value at other time points; then use this difference, to statistically analyze the difference
between the product area and the blank control area, at different time points.
If the test data is normally distributed, the t-test method is used for statistical analysis;
if the test data is non-normally distributed, the rank-sum test method is used for
statistical analysis.
Two-tailed inspection is used for statistical methods; the test level is α = 0.05.
10 Result judgment
Positive result: Before and after the use of the product, if there is a significant difference
in the moisture content of the stratum corneum in the test area, it indicates that the test
sample has a moisturization efficacy.
Negative result: Before and after the product is used, if there is no significant difference
in the moisture content of the stratum corneum in the test area, it indicates that the test
sample does not have a moisturization efficacy.
Note: This criterion is not the only method for determining the moisturization efficacy of
cosmetics.
11 Test report
The test report shall include:
a) All the information, which is required to identify the tested cosmetic;
b) The method used for the test;
c) The setting time for the test;