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Notification on Cosmetic Regulations Adjustment

Dear Client,

 

On 21st September 2011, China SFDA released two Notifications on cosmetic registration. The two notifications have been in effect from 23rd September 2011. China SFDA partly adjusted the current registration procedure and the requirements on the registration documents.

 

Based on the information about the two new notifications we commanded, we would like to present to you the following information:

 

  Alteration on Chinese Registration Responsible Party

 

() If a manufacturer applies for alteration on a new Chinese Registration Responsible Party, it should have the new Chinese Registration Responsible Party recorded in China SFDA before the registration, handing in a new Letter of Authorization. And the manufacturer is expected to submit the following documents:

 

1. Original copies of the new Letter of Authorization for alteration on Chinese Registration Responsible Party and other related notarized documents.

 

2. Business license of the new Chinese Registration Responsible Party(Reprographic copy);

 

3. A notarized document to declare canceling the authorization to the former Chinese Registration Responsible Party issued by the manufacturer.

 

() China SFDA DO NOT accept the application for the alteration on the information of the Chinese Registration Responsible Party appeared on an already issued Hygiene Permit. But after China SFDA accepts the new Letter of Authorization, the information of the Chinese Registration Responsible Party will be updated in new hygiene permits when Hygiene Permit renewals or any alteration applications (except alteration for the Chinese Registration Responsible Party) are officially approved.

 

()  Although the Authorization Letter of new Chinese Registration Responsible Party was recorded by China SFDA, the former Chinese Registration Responsible Party will be still responsible for the application of on-going products under verification in China SFDA, meanwhile the information of the former Chinese Registration Responsible Party will be printed on the Hygiene Permit of these products.

 

 Detailed requirements on Letter of Authorization

 

China SFDA required that Authorization Letter shall have no validity period. Presently, China SFDA Registration Application Acceptance Office has suspended verifying on the application of the Authorization Letter with validity period till the Registration Approving Office confirms whether the Authorization Letter with validity period is acceptable.

 

 Detailed requirements on Product Specification

 

It should include the following contents:

 

() Index of Senses

 

1. Color;

 

2. Property;

 

3. Odor (specific odor should be defined)

 

() Index of hygiene-chemistry and Microbiology

Test methods should be provided on each test item on the product specification (If the test method has been publicized by the government, the name of the test method should be listed, otherwise, a full description of the entire test method procedure should be provided.)

 

()  Storage

Storage conditions such as temperature or shelter, etc. should be listed in this item. And these descriptions should conform to those on the product label or in the product introduction booklet.

 

() Shelf life

 

Shelf life of the product should be specified in this item , such as 6 months (or 6 years). And it should be written in the format of “manufacturing date and shelf life” or “lot number and expiring date”.

 

In the adjustment on registration procedure and the requirements on the registration documents this time, China SFDA adjusted the latter one more. Moreover some of these requirements are not clear. For example, how detailed the description on odor should be and what the requirements Product Specification of oversea products are. Therefore, the chance of being questioned on Product Specification by China SFDA is expected to increase greatly in the near future.

 

Besides these latest notifications from China SFDA, we also learned that China SFDA is going to release new regulations on cosmetics category soon in the future. With this, part of the non-special purpose cosmetic products currently will possibly be classified as special purpose cosmetic products in the future, such as anti-aging products, whitening products, body essential oil, etc. We predict that the coming adjustments on cosmetic category will be released along with those on product registration procedure and application requirements on registration documents.

 

In recent years, China SFDA has been adjusting the requirements frequently. We will keep close attention on and follow up any new development in order to obtain the most accurate explanation on the regulations. Once we get it, we will inform you without delay. No doubt that the adjustments on the cosmetic regulations must affect the on-going registering products, we hope that you can understand the impact caused by the change of the cosmetic regulations, and keep a smooth and good cooperation between us, in order to solve the problems together.

 

If you have anything unclear, please do not hesitate to contact us! 

 

Quality and Technology Certification and Consultation Service Centre,

Guangdong Beauty and Cosmetic Association

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