China - Obtain a Hygiene Certificate

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Procedure

• Arrange and collect all the materials
• Collect sample and prepare documents for Inspection
• Deliver samples to approved inspection institution for testing and inspection
• Submit required documents (i.e. testing report) to the reception office of the SDFA and Safety Evaluation Committee
• Follow up the whole application process for getting the hygiene license or record-keeping certificate.

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Required Documents

• Application form for hygiene license of imported cosmetic
• Product ingredient
• Effective components, evidence of usage and inspection methods
• Manufacturing technique and diagram
• Product quality standard (in-house standard)
• Testing report from a cosmetics testing institution approved by the SDFA and related materials:
  • Application form for inspection
  • Notice of acceptance for inspection
  • Product instruction
  • Inspection report issued by cosmetic inspection organization approved by the SDFA;
• Product package (sales package & product label);
• Certified document for production and sales in the manufacturing country (region);
• The statement on related problems of Mad Cow Disease;(new)
• Apply the power of attorney, if provided by agent;
• Some other documents may be helpful for inspection;
• 3 sealed samples ( as the case may be)

Office Locations & Contacts

China Food and Drug Administration
Address: 26 Xuanwumen Xidajie, Beijing, 100053, P.R. China
Fax: 86-010-68310909
Email: [email protected]

Eligibility

All imported cosmetics can only be sold in the Chinese market after they have obtained Hygiene License for imported cosmetics issued by the SFDA (the State Food and Drugs Administration).

Fees

Explain the fees structure which is required for obtaining the certificate/document.

Validity

Explain the time until which the certificate/document is valid.
e.g. Birth Certificate Valid Forever

Documents to Use

Please attach documents that can be used by people. e.g. links

Sample Documents

Please attach sample completed documents that would help other people.

Processing Time

The duration of application for cosmetics (factors: testing duration, preparation of materials, evaluation and policy of evaluation):

• For nonspecific use cosmetics: 4-6 months
• For specific use cosmetics: 6-12 months

Related Videos

Videos explaining the procedure or to fill the applications. 
Attach videos using the following tag <&video type="website">video ID|width|height<&/video&> from external websites.
Please remove the "&" inside the tags during implementation.
Website = allocine, blip, dailymotion, facebook, gametrailers, googlevideo, html5, metacafe, myspace, revver, 
sevenload, viddler, vimeo, youku, youtube
width = 560, height = 340, Video ID = Can be obtained from the URL of webpage where the video is displayed.
e.g In the following url "http://www.youtube.com/watch?v=Y0US7oR_t3M" Video ID is "Y0US7oR_t3M". 
	

Instructions

Generally, imported cosmetics need to be tested by appointed inspection institution in China. However, if Anti-sunburn cosmetics have had SPF and PA tests in foreign labs, exporters can provide the testing report of the Anti-sunburn cosmetics, as well as some documents on qualification of the labs.

Required Information

• Application form for hygiene license of imported cosmetic
• Product ingredient
• Effective components, evidence of usage and inspection methods
• Manufacturing technique and diagram
• Product quality standard (in-house standard)
• Testing report from a cosmetics testing institution approved by the SDFA and related materials

Need for the Document

It is a document issued by the SFDA approving the import of a cosmetics product to China. Hygiene license is issued for specific use cosmetics.

Information which might help

Import of Cosmetics for Nonspecific Uses

Cosmetics for non-specific uses do not require hygiene license. However, companies shall apply for record-keeping certificate for those products. The first step is to send the sample of a product to a cosmetics testing institution approved by the SDFA for testing.

After receiving application materials (see next page) along with the testing report, the SFDA will decide whether to issue record-keeping certificate or not within 20 working days.

Import of Cosmetics for Specific Uses

Cosmetics for specific use (i.e. deodorants, depilation, pimple removal, sun protection, perm, hair dyes, hair grower, body building and breast beauty) will need the hygiene license. More tests need to be carried out and it takes longer to obtain such license.

After testing, applicant shall gather all required documents (see next page) and send them to Safety Approval Committee of the ministry of health for review. It takes 2 to 8 months for the committee to evaluate one product. Usually, the hygiene license will be issued within 1.5 or 2 months after the official evaluation meeting.

Other uses of the Document/Certificate

Please explain what are other uses of obtaining this document/certificate.
e.g. Birth Certificate can be used as proof of identity.

External Links

China Food, Drug and Cosmetic Regulations

China Food and Drug Administration

Chemical Inspection and Regulation Service (CIRS)

Others

Note: if you export cosmetics for specific use to China, you should submit extra materials: effective components, evidence of usage, inspection methods of products and body safety testing reports.

Cosmetics can be divided into two categories and each category requires different procedure.

• Imported cosmetics for nonspecific uses: For hair, nail (toenail), body care, aroma product, color cosmetics.
• Imported cosmetics for specific uses: Deodorants, depilation, pimple removal, anti-sunburn, perm, hair dyes, hair grower, body building and breast beauty