Beijing Tianjianhuacheng International Investment Consulting Co., Ltd.
Cosmetics Department
Documents needed for extension:
1. Cosmetics administrative licensing lengthen application form
2. Original copy of cosmetics registration certificate
3. Product nomenclature basis (except those submitted already on the first tine registration and do not change this time)
4. Product formula
5. Product quality and safety control requirements
6. Package of product (including label, instruction)
7. The copy of the power of attorney from the responsible applying company in China, and copy of its business license with stamps on.
8. The product has TALC in, and on the first time of registration, the company did not submit the TALC report, then on the extension, the company should submit the TALC testing report conform to the “cosmetics administrative permission testing regulations”
9. If the applicant did not submit the safety assessment about the risk raw materials, then when apply for the certificate lengthen, the applicant should submit the documents as following requirements,
The applicant had hazard identification, and the formula does not contain safety risk materials, then the company should submit the letter of commitment.
The applicant had hazard identification, and the formula may have risk materials, then the company should submit the relevant risk assessment in accordance with the “cosmetics safety risk assessment evaluation guidance”.
10. Other documents may helpful to the registration
11. Manufacturing process description and flow chart
12. Product technical requirements text and electronic edition
And attached with sealed sales sample
Requirements of the registration documents:
Basic requirements of the registration documents
1. Apart from the testing report, notarization certificate, official approval document, and third party confirming documents, the original copy of each should have stamps or seal on the perforation from applicant; imported cosmetics (new raw materials) original copy should have the stamps or seal on the perforation from Chinese responsible company.
2. Use A4 size paper to print, using visible mark and arrange them as requirements, then binding.
3. Use Chinese legal units of measurement.
4. Content of the documents should be complete, clear, and all same projects should be exactly the same.
5. All documents (except foreign address, websites, register trademark, patent name, SPF, PFA or PA, UVA, UVB those must use English)should translated into Chinese, and attach the Chinese translation before the related English documents.
6. Registration again after termination, it should provide reasons about why registration again; Tianjianhuacheng: if the registration has been refused before, it should provide the copy about the unaccepted documents from CFDA, the reasons of apply again, and written description of whether CFDA’s refusing involving safety problems.
7. Provide text and electronic versions of products’ formula.
8. Content of text version and electronic version should be exactly the same.
9. Free manufacturing and sales certificate, ISO, good manufacturing practice (GMP), confirmation letter of different manufacturing companies belong to the same organizations, and the authorized manufacturing letter. Tianjianhuacheng: These certification letters can list many products, and if these products are applied at the same time, you can provide one product’s original copy and the copies of others with notarized letter, and provide written description about the name of products.
10. The applicant can only apply one of lengthen, change, reissue or modification of the registration at one time, and after one of them is finished, then the applicant can apply the other. But when applicant applies for the change of the registration documents, applicant can apply for more than one change.
11. The electronic version of technical requirements can be found on CFDA website.
Detailed requirements of the registration documents:
1. Submit the documents as in order.
2. Fill in the application form of administrative license according to these instructions:
2.1. The warranty letter about the application form of administrative license should have the signature of legal person from imported cosmetics manufacturing company or raw materials manufacturing company or Chinese declaration and responsible company; if there are no stamps on, it should be noticed beside the signature on the warranty letter.
2.2. The commitment letter about the application form of administrative license should have the signature of legal person or his representative person and the stamp from the responsible company in China.
2.3. The power of attorney should be notarized that the Chinese and English part are exactly the same. And according to “the information requests” number 24, you should provide original copy of power of attorney or copy after notarized, and illustrate name of the products on the power of attorney in written description. The content of authorized signature should not include in the power of attorney from responsible declaration company.
3. Products quality safety control should have the quality safety control requirements from original manufacturing country (both foreign language and its Chinese translation) and the commitment of GMP (good manufacturing practice).
4. Because of the small size (like lip rouge, lip balm) has no instruction or the instruction printed on the container, applicant should provide the explanation about the package. (To know more about the cosmetics registration information, please send your email to: zhuceabc@zhuceabc.com)
首次进口非特殊用途化