Documents Lists and Requests for First Time Imported Cosmetics Registration

时间： 2022-03-03 作者：来源：

导读： Documents needed to be submitted Application form for registrationNomenclature Criteria For Products;Product ingredients;Product qua

Documents needed to be submitted

Application form for registration
Nomenclature Criteria For Products;
Product ingredients;
Product quality control requirements
Product original package (include label, instruction); if has special package for Chinese market, its required as well (include label, instruction)
Testing report and related materials from a cosmetics testing institution approved by CFDA
Safety assessment of the possible safety risk materials in the products
The copy of power of attorney and business license from Chinese declaring company. With stamp on.
The statement of the raw materials related to the mad cow disease
Free sales certificate in producing country (area) or manufacturing country (area)
Other documents may be helpful for inspection
Manufacturing description and diagram
Technical requirements of the products–paper and electronic

And attached with a sealed sales sample

Tianjianhuacheng: Apply for the special cosmetics, the documents are mostly the same as the normal cosmetics. Hair care, bodybuilding and breast beauty cosmetics should provide functional ingredients and the related scientific literature.

Requirements of the registration documents

Basic requirements:

1. One original copy of registration documents. Tianjianhuacheng: Special cosmetics should provide four copies.

2. 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.

3. Use A4 size paper to print, and use visible mark, and arrange them as requirements, and binding.

4. Use Chinese legal units of measurement.

5. Content of the documents should be complete, clear, and all same projects should be exactly the same.

6. 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.

7. Registration again after termination, it should provide reasons about why registration again; if registration again if have been refused before, is should provide the copy of not accept the registration from CFDA, the reasons of apply again, and written description of whether the refusing involving safety problems.

8. Products’ ingredients text version and electronic version.

9. Content of text version and electronic version should be exactly the same.

10. Certification of free manufacturing and sales, ISO, good manufacturing practice (GMP), confirmation letter of different manufacturing companies belong to the same organizations, and the authorized manufacturing letter. These certification letters can list many products, and if these products registration 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 registration products.

11. Fill in products technical requirements in electronic on CFDA website.

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Detail requirements

1. Submit the documents as in order.

2. Fill in the application form of administrative license according to the instructions.

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, they should be notarized.

The commitment letter about the application form of administrative license should have the signature of legal person or his representative person and the stamp of responsible company who declaration in China. 

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. The products’ ingredients should have the confirmation letter from the testing institution, and its confirming date is the same as the testing date.

4. 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).

5. Because of the small size (like lip rouge, lip balm) has no instruction or print the instruction on the container, it should provide the explanation about the package.

6. The testing report from testing institutions specified by CFDA and related documents should have the following requirements:

(1). The testing report should contain following:

1). Testing application form

2). Testing acceptance notice letter.

3). Instruction

4). Hygiene safety testing report (microorganism, sanitary chemistry, toxicology).

5). These documents should be submitted as well if have:

①. Human safety testing report (like human test experiment)

②. Other new added testing report (like asbestos testing report)

Tianjianhuacheng: Special cosmetics: ③SPF, PFA or PA testing report.

(2) Use SPF testing report from foreign laboratory, should submit the following documents:

1) If the laboratory has been qualified, it should provide qualification certification.

2) If the laboratory has not been qualified, it should provide GCP (Good Clinical Practice) or GLP (Good Laboratory Practice).

3) Other documents may help the registration.

First time submit the above documents, should attach with the notary certificate issued by local commitment association, Chinese embassy, confirmation letter from notary public (include translation copy). After CFDA confirmation, the re-registration only needs to submit the copy one.

Foreign laboratory testing report should provide the original copy. And the confirmation letter should show the relation between the testing samples and the testing report.

(3). Apply for the change of name of the manufacturer, the address of manufacturer, and the Chinese name of the products on testing report, and related testing institution provide the supplement of testing report and give explanation.

7. The certification of manufacture and sales from manufacture country (area) or origin country (area) should have the following:

(1). Issue by government department or trade association from manufacture country (area) or origin country (area). If cannot provide origin copy can provide copy one which confirmed by issuing agency or Chinese embassy.

(2). Should have the name of the product, name of the manufacture company, and the name of the issuing agency with agency’s stamp or legal person (or his representative)’s signature on, and the issuing date.

(3). The name of products and manufacture company should be exactly the same; if its authorized or other kinds to manufacture, and name is different from the registration one, applicant should give explanation in written description; if it’s a kind of different forms of product which need to be used in cooperatively, you can just provide part of the certificate of manufacture and sales.

(4). If the certificate is written in English, it should be translated into Chinese and notarized by Chinese notary public.

8. If the registration product belongs to following situation, it should provide:

(1). The registration product is authorized to be manufactured, it should provide:

1). The authorization manufacture certificate from client and assigner.

2). Imported products should submit the authorized company’s ISO or GMP (good manufacturing practice) certificate, or confirmation letter about the manufacture company under the law of local country (area).

3). Domestic manufacturer authorize abroad to manufacture, these imported products no need to provide power of attorney from Chinese responsible declaring company, certification of manufacture and sales, and origin package, you should provide package design.

4). ISO or GMP (good manufacturing practice) certificate or certificate conforms to country (area) law from authorized company should have following requirements:

①. Issued or approved by notary public or the third party. If cannot provide origin, copy is acceptable, and notarized by notary public in Chinese or Chinese embassy.

②. The name and address of the manufacture company should be exactly the same as the registration content.

(2). The actual manufacture company and the cosmetics producing company (applicant) are belong to the same organization, it should provide quality warranty from the organization.

9. Multiple actual manufacturers produce one product, one actual manufacturer should provide the following besides the above:

(1). Involve in the manufacture relationship, authorized manufacture agreement should be submitted, and imported products should provide ISO or GMP (good manufacturing practice) or the certification conformed to country (area)’s laws.

(2). Manufactures belong to the same organization, and it should provide the confirmation letter and quality warranty from organization.

(3). Origin package from other actual manufacturers.

(4). Hygiene (microorganism, sanitary chemistry, toxicology) testing report from other actual manufacturers.

(5). The statement of the raw materials related to the mad cow disease from other actual manufacturers.

10. The following types of package should register as requests:

(1). One sample package has two or more individual small package or can be separated (like eye shadows, powder, blusher and so on, it should applied as one product, submit each products’ ingredients and testing report; dependent package or samples cannot be separated, it should provide one testing report and provide each part’s ingredients.

(2). Sample package cannot be separated, and apply as one product, but its physical states are different, it should provide ingredients and testing report separately. 

(3). Two forms or mare must be used cooperatively, should submit as one product. According to whether these forms are mixed to use, provide the testing report of the mixed one or each form separately.

(4). One manufacturer apply for 2 or more package which have the same English name on package but has different appearance, the applicant form and manufacture and sales certificate should have the words of products’ appearance, to show the difference and attach with related instructions.
11. Multiple colors non-special cosmetics, with the same ingredients, and apply for sampling toxicology test, can apply as a same group products. Registration documents of each product should attach the series name, basis ingredients, colorant list and sampling products list.

12. Domestic company authorized abroad to manufacture imported samples, submit samples as domestic products.

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