Interpretation: "freckle whitening special cosmetics technical guidelines (draft)" released

Release time:

2022-08-22 09:10

On August 1, 2022, the China Institute for Food and Drug Control issued the "Notice on Publicly Soliciting Opinions on the" Technical Guiding Principles for Freckle-removing and Whitening Special Cosmetics (Draft for Comment) "(hereinafter referred to as the" Draft for Comment "). The registrant of whitening special cosmetics and the review by the drug regulatory department provide technical reference.

Based on the draft for comments and existing regulations/standards and other documents, we share our views on several issues of general concern about freckle whitening special cosmetics for your reference:

The basic principles of the role of whitening cosmetics

The column of basic principles of cosmetic-like effects on spot whitening in the draft for comments distinguishes the common mechanisms of action of cosmetics claiming whitening on the market, such as physical covering, cutin peeling and sun protection. It is clearly pointed out that the freckle whitening effect of freckle whitening cosmetics should conform to the definition of cosmetics, and the production, transportation and metabolism of melanin in the skin can be regulated to a limited extent by inhibiting the activity of tyrosinase, so as to achieve a certain freckle whitening effect. It shall not be for the purpose of medical treatment, and shall not have a severe or irreversible impact on the physiological functions of the human body.

Soliciting the Judgment Standard of Spot-removing and Whitening Cosmetics

Based on the "Classification Rules and Catalogue of Cosmetics" and the above-mentioned basic principles of freckle-removing and whitening effects, the draft for comments determines that the products applicable to the declaration of freckle-removing and whitening products mainly refer to cosmetics that help reduce or slow down skin pigmentation and achieve skin whitening and whitening effects, as well as products that improve acne marks caused by pigmentation. If the skin whitening and whitening effect is achieved only through physical covering, it can be declared as "freckle removing and whitening (only with physical covering effect)", but it is not applicable to the draft for soliciting opinions.

The use of freckle whitening agent

The "Regulations on the Supervision and Administration of Cosmetics" defines freckle whitening raw materials as high-risk raw materials. In the product formula of freckle whitening cosmetics, there should be a clear freckle whitening agent, and its use should be scientific and reasonable, with a certain basis for use.

In countries or regions that are similar to the skin types of the main population in my country, if they have been announced by regulations or approved by the regulatory authorities for use as freckle-removing and whitening efficacy raw materials, relevant regulations and data can be provided as the basis for the use of efficacy ingredients. At the same time, enterprises are encouraged to actively carry out independent research, and can provide their own scientific basis for the mechanism of action of raw materials and technical information such as efficacy evaluation reports, as the basis for the use of freckle whitening agents. In the draft for soliciting opinions, the basic requirements of relevant technical data are put forward, and several kinds of whitening mechanisms and research methods that are widely used at present are provided, which can be used as technical reference.

Efficacy Evaluation of Spot-removing Whitening Cosmetics

According to the "cosmetic efficacy claim evaluation specification", with freckle whitening effect of cosmetics should:

(1) Evaluation of efficacy claims through human efficacy evaluation tests;

(2) Cosmetics registration and filing inspection agencies shall carry out human efficacy evaluation tests and issue reports in accordance with the requirements of mandatory national standards and technical specifications.

(3) Optional methods: Announcement No. 17 of 2021 "Cosmetic Freckle Whitening Efficacy Test Method" "First Method Ultraviolet Induced Human Skin Blackening Model Freckle Whitening Efficacy Test Method" "Second Method Human Open Use Freckle Whitening Efficacy Test Method"

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