What do the applicant and the declaration unit in China refer to when applying for the registration of imported non-special purpose cosmetics?

The letter of commitment in the administrative license application form should be legally mandated by the unit responsible for reporting administrative license in China. The representative or legal representative authorizes the signatory of the unit to sign and affix the official seal of the unit responsible for applying for administrative license in China.

Process:

1. Project name: Registration of imported non-special-purpose cosmetics

2. License content: Registration of imported non-special-purpose cosmetics for the first time

3. Legal basis for establishing and implementing licenses: "Regulations on Cosmetics Hygiene Supervision", "Details for the Implementation of the Regulations on Hygiene Supervision of Cosmetics", "Hygiene Administrative Licensing Procedures for Health-Related Products", "Regulations on Acceptance of Applications for Cosmetics Administrative Licensing", " Key Points for Acceptance and Review of Cosmetic Administrative Licensing"

4. Charges: No charge

5. Quantity Limitation: There is no quantity limit for this license

6. Applicant submission Material catalog:

Material number (1) Application form for administrative license for imported non-special purpose cosmetics.

Data number (2) The basis for naming the product in Chinese.

Data number (3) product formula.

Document number (4) Product quality and safety control requirements.

Data No. (5) Original product packaging (including product labels and product instructions); if you plan to design packaging specifically for the Chinese market, you must also submit product design packaging (including product labels and product instructions).

Data No. (6) Inspection reports and related information issued by a licensed inspection agency recognized by the State Food and Drug Administration;?

Data No. (7) There may be safety hazards in the product Safety assessment information on sexually risky substances.

Document No. (8) A copy of the authorization letter of the registered unit responsible for applying for administrative license in China and a copy of the business license of the unit responsible for applying for administrative license in China with the official seal.

Document number (9) Commitment letter that the raw materials used in cosmetics and the sources of raw materials comply with the prohibition and restriction requirements of high-risk substances in mad cow disease-affected areas.

Data No. (10) Documents proving that the product is produced and sold in the country (region) or country of origin (region); Data No. (11) Other data that may be helpful for administrative licensing.

Document No. (12) Brief description and diagram of the production process.

Document No. (13) Text version and electronic version of product technical requirements.

Attached is also a commercially available sample that has been sealed and unopened by a licensed inspection agency.

7. Requirements for application materials:

(1) General requirements for application materials:

1. Submit 1 original copy of application materials.

2. In addition to inspection reports, notarized documents, official certification documents and third-party certification documents, the original application materials should be stamped with the official seal or sewn seal by the applicant page by page; imported cosmetics (new raw materials) application materials The original document should also be stamped page by page with the official seal or seal of the responsible unit for applying for administrative license in China.

3. Print on A4 size paper, use obvious distinguishing marks, arrange in the specified order, and bind into a book.

4. Use Chinese legal measurement units.

5. The application content should be complete and clear, and the same items should be filled in consistently.

6. All foreign languages ??(except overseas addresses, website addresses, registered trademarks, patent names, SPF, PFA or PA, UVA, UVB, etc. that must be in foreign languages) should be translated into standardized Chinese, and the translations Attached to the corresponding foreign language materials.

7. If you apply again after terminating the application, you should also explain the reasons for terminating the application and re-application; if you apply again after denying administrative permission, you should submit a copy of the decision not to grant administrative permission (change/continuation) and explain the reasons for re-applying. At the same time, a written explanation of whether the reason for not granting administrative license involves product safety should be submitted.

8. The product formula should be submitted in both text and electronic versions.

9. The filled-in content in the text version and the electronic version should be consistent.

10. Proof documents such as production and sales certification, quality management system or good production practices, certification that production companies in different countries belong to the same group company, and entrusted processing agreements can list multiple products at the same time. product. If these products are declared at the same time, one product must use the original, and other products can use copies, and the name of the declared product where the original is located must be stated in writing; if these products are not declared at the same time, one product must use the original, and other products must use notarized copies. , and state in writing the name of the declared product where the original document is located.

11. The electronic version of product technical requirements should be filled in the online application system for cosmetics administrative licensing of the State Food and Drug Administration.

(2) Specific requirements for application materials:

1. Submit various materials item by item.

2. All items in the application form should be filled in according to the instructions in the application form.

The letter of guarantee for the administrative license application form should be signed by the legal representative of the imported cosmetics manufacturing enterprise or the imported cosmetics new raw material manufacturing enterprise or the authorized signatory of the manufacturing enterprise or the authorized signatory of the responsible reporting unit in China. Signature; if there is no official seal, it should be noted at the signature place of the manufacturer of the guarantee letter.

The letter of commitment on the administrative license application form should be signed by the legal representative of the unit responsible for applying for administrative license in China or the signatory authorized by the legal representative of the unit and stamped with the official seal of the unit responsible for applying for administrative license in China.

When authorizing a signature, a notarized copy of the power of attorney and its Chinese translation should be provided, and the Chinese translation should be notarized to be consistent with the original content. According to the requirements of Article 24 of the "Document Requirements", each time an application for administrative licensing is submitted, the original power of attorney or a notarized copy should be submitted at the same time, and the name of the declared product where the original signed power of attorney is located should be stated in writing. The content of the authorized signature should not be included in the authorization letter of the responsible unit for applying for administrative license in China.

3. The product formula should include the confirmation certificate of the imported product formula by the licensed inspection agency, and the confirmation date should be consistent with the acceptance date of the inspection sample.

4. Product quality and safety control requirements should include product quality and safety control requirements implemented in the country of origin (foreign language version and Chinese translation) and a commitment that the product meets the requirements of the "Hygienic Specifications for Cosmetics".

5. If there is no product instructions or the instructions are printed on the product container due to the small size (such as lipstick, lipstick, etc.), the relevant instructions should be submitted in the product packaging part of the application materials.

6. Inspection reports and related materials issued by licensed inspection agencies recognized by the State Food and Drug Administration should meet the following requirements:

(1) Inspection reports issued by licensed inspection agencies , should include the following information:

1) Inspection application form.

2) Inspection acceptance notice.

3) Product instructions.

4) Health and safety inspection report (microbiology, health chemistry, toxicology).

5) If you have the following information, you should submit it:

①

Human safety test report (such as human trial test).

②

Test reports for other new items (such as asbestos test reports in cosmetics, etc.).

(2) If you apply to change the name of the production company, the address of the production company, or the Chinese name of the product in the cosmetics administrative licensing inspection report, the relevant licensing inspection agency should issue a corresponding supplementary inspection report and explain the reasons.

7. Documents proving that the product is produced and sold in the country (region) of production or country (region) of origin should meet the following requirements:

(1) By the country (region) where the product is produced ( Region) or country (region) of origin ***Issued by the competent department or industry association. If the original document cannot be submitted, a copy can be submitted. The copy should be confirmed by the issuing agency or the Chinese embassy (consulate).

(2) The name of the product, the name of the manufacturing company, the name of the organization that issued the document, the seal of the organization or the signature of the legal representative (or his authorized person) and the date of issuance of the document should be stated.

(3) The product name and the name of the manufacturer stated should be completely consistent with the declared content; if it is commissioned processing or other methods of production, the manufacturer stated in the certification document must be the same as the declared content. If the contents are inconsistent, the applicant shall issue supporting documents to explain; for multi-dose products that must be used together, only the production and sales certification documents for the imported part of the product may be submitted.

(4) If the production and sales certification documents are in a foreign language, they should be translated into standardized Chinese, and the Chinese translation should be notarized by a Chinese notary office.

8. If the declared product falls into the following circumstances, in addition to submitting the information in accordance with the above provisions, the following information must also be submitted separately:

(1) If the declared product is produced through entrusted processing, The following information should be submitted:

1)

The entrusted processing agreement signed between the entrusting party and the entrusted party.

2)

Imported products should submit certification documents of the quality management system or good production practices of the entrusted production enterprise or cosmetics production qualifications that comply with the regulations of the country (region) where the production enterprise is located. Supporting documents.

3)

Domestic production enterprises entrusting overseas enterprises to produce imported products do not need to submit the authorization letter of the responsible unit for administrative licensing in China, the certification documents for production and sales and the original packaging of the product. Submit product packaging design.

4)

The quality management system or good production practice certification documents of the entrusted production enterprise or the cosmetics production qualification certification documents that comply with the regulatory requirements of the country (region) where the production enterprise is located should comply with The following requirements:

①

Issued or recognized by a certification body or a third party. If the original cannot be submitted, a copy can be submitted. The copy should be notarized by a Chinese notary or confirmed by the Chinese embassy (consulate).

②

The name and address of the manufacturer stated should be completely consistent with the declared content.

(2) If the actual production enterprise and the cosmetics production enterprise (applicant) belong to the same group company, the certification documents and enterprise group that the actual production enterprise and the cosmetics production enterprise (applicant) belong to the same group company should be submitted Product quality assurance documents issued by the company.

9. Multiple actual manufacturers producing the same product can apply for it at the same time. Products produced by one of the actual manufacturers should submit all the information in accordance with the above regulations. In addition, the following information should also be submitted:

< p> (1) If a contracted production and processing relationship is involved, a contracted production and processing agreement shall be submitted. For imported products, certification documents of the quality management system or good production practices of the contracted production enterprise shall also be submitted or documents that comply with the laws and regulations of the country (region) where the production enterprise is located. Cosmetics production qualification certification documents.

(2) If the production enterprises belong to the same group company, submit the certification documents that the production enterprises belong to the same group company and the product quality assurance documents issued by the enterprise group.

(3) Original packaging of products produced by other actual manufacturers.

(4) Hygiene (microbiology, sanitary chemistry) inspection reports of other actual production enterprise products.

(5) Letter of commitment from other actual manufacturing companies that the raw materials used in cosmetics and the sources of raw materials comply with the prohibition and restriction requirements for high-risk substances in mad cow disease-affected areas.

10. Samples that meet the following packaging types should be declared in accordance with the following regulations:

(1) One sample package contains two or more (including two) independent small packages or can be separated For samples (such as eye shadow, powder, blush, etc.), and declared under one product name, the product formula and inspection report should be submitted separately; for samples that are not independently packaged or cannot be separated, an inspection report should be submitted, and each part should be submitted separately Product formulation.

(2) The samples are inseparable combination packages and are declared under one product name. If their physical states and raw material composition are different, product formulas and inspection reports should be submitted separately.

(3) Products that must be used together in two or more doses should be declared as one product. Depending on the actual situation of whether multiple dosage forms are mixed and used, submit a mixed inspection report or submit an inspection report for each dosage form separately.

(4) For two or more imported products declared by the same manufacturer with the same foreign name in original packaging but different appearance, the product should be added to the foreign name in the application form and production and sales certification documents. Appearance words are used to indicate the difference, and relevant explanations are attached.

11. Multi-color series of non-special purpose cosmetics with the same basic formula and application for sampling for toxicological testing can be declared as a group of products at the same time. Each product application document should be accompanied by a list of series products, a list of basic formulas and colorants, and a list of randomly inspected products.

12. Imported samples produced and processed by domestic enterprises entrusted by overseas enterprises shall be submitted for review as domestic products.

8. Schematic diagram of the application process:

9. Licensing procedure:

(1) Acceptance:

The applicant shall submit to the administrative acceptance service The center submits an application and submits the application materials in accordance with the catalog listed in Article 6 of this "Instructions". The staff of the Administrative Acceptance Service Center will conduct a formal review of the application materials in accordance with the "Regulations on the Acceptance of Applications for Cosmetics Administrative Licensing" and related formal review requirements. Application matters are in accordance with the law If it is not necessary to obtain an administrative license, the applicant shall be informed immediately that the application will not be accepted; if the application matters do not fall within the scope of the administrative authority according to law, a decision shall be made immediately not to accept the application and the applicant shall be informed to apply to the relevant administrative agency; if the application materials exist, If errors are corrected on the spot, the applicant shall be allowed to make corrections on the spot; if the application materials are incomplete or do not comply with the legal form, the applicant shall be notified on the spot or within 5 days of all the contents that need to be supplemented and corrected at once. The application shall be accepted as of the date of application; if the application matters fall within the scope of this administrative agency, the application materials are complete and comply with the legal form, or the applicant submits all supplementary and corrected materials in accordance with the requirements of this administrative agency, the administrative license application shall be accepted.

< p> (2) Administrative licensing decision:

The State Food and Drug Administration will complete the administrative review within 20 days from the date of receiving the technical review conclusion, and make an administrative licensing decision on whether to approve it in accordance with the law; If a decision is made, it can be extended for 10 days, and a "Notice of Extension of Administrative Licensing Decision" will be issued to inform the applicant of the reasons for the extension.

(3) Delivery:

National Food. The State Administration of Drug Administration shall issue and deliver the relevant administrative license documents within 10 days from the date of making the administrative licensing decision.

10. Commitment time limit:

(1) Acceptance: National Administration. The acceptance service center will make a decision on whether to accept the application within 5 days after receiving the application materials.

(2) Administrative licensing decision: The State Food and Drug Administration shall make an approval decision within 20 days; it cannot be made within 20 days. If a decision is made, it can be extended for 10 days, and a "Notice of Extension of Administrative Licensing Decision" will be issued to inform the applicant of the reasons for the extension.

(3) Delivery: The State Food and Drug Administration shall make the drug on its own. The relevant administrative license shall be issued and delivered within 10 days from the date of registration approval decision

11. Implementing agency:

Implementing agency: State Food and Drug Administration

Place of acceptance: Administrative Acceptance Service Center of the State Food and Drug Administration

12. Validity period and extension of license:

The cosmetics registration certificate is valid for four years.

If the applicant applies to extend the validity period of the cosmetics registration certificate, the application should be submitted 4 months before the expiration of the cosmetics registration certificate. 13. Annual review or inspection of the license: None

14. Agencies that accept inquiries and complaints:

Consultation: State Food and Drug Administration

Complaints: Supervision Bureau and Legal Affairs Department of the State Food and Drug Administration

Note: The working period in this notice is calculated in working days, excluding statutory holidays

Applicant: must be a foreign cosmetics business or manufacturing enterprise. The responsible unit for declaration in China is a Chinese company with independent legal personality, and the responsible unit for declaration in China may have nothing to do with the company's business

The letter of commitment on the administrative license application form should be written by the legal representative of the unit responsible for filing administrative license in China. Or the legal representative authorizes the signatory of the unit to sign and stamp it with the official seal of the unit responsible for applying for administrative license in China.

Process:

1. Project name: Registration of imported non-special-purpose cosmetics

2. License content: First-time import of non-special-purpose cosmetics Filing of purpose cosmetics

3. Legal basis for establishment and implementation of licensing: "Cosmetics Hygiene Supervision Regulations", "Cosmetics Hygiene Supervision Regulations Implementation Rules", "Health-related Products Hygiene Administrative Licensing Procedures", "Cosmetics Administration" "Regulations on Acceptance of Licensing Applications", "Key Points for Acceptance and Review of Administrative Licensing of Cosmetics"

4. Charges: No charge

5. Quantity restrictions: There is no quantity limit for this license. Domestic production in 2014 is not special. How to apply for registration of special-purpose cosmetics

State Food and Drug Administration-Cosmetics-Online Service-Registration of Domestic Non-Special-Purpose Cosmetics

Enterprise Registration-Submit Information-Waiting for Review-On-site Review Imported cosmetics require non-special use Is there a registration certificate for special purpose cosmetics?

Dear, it is necessary. There are currently two ways to apply for the "Registration Certificate for Imported Non-Special Use Cosmetics": First, apply for registration with the China Food and Drug Administration in Beijing. After this registration is obtained, your registered cosmetics can be imported at ports across the country. It used to take 1-2 years to apply for registration, but now it takes 4-6 months, but the premise is that you find the right agency. Second, if your company is registered in Pudong New Area, Shanghai, you can apply directly there, and the approval time is 1-3 months. However, products can only be imported through Pudong New Area. I hope the above content is helpful to you. If you have any questions, you can leave a message at any time. What are the application forms for declaration of domestic special-purpose cosmetics?

(1) Application form for hygienic administrative license of domestic special-purpose cosmetics;

(2) Provincial health supervision department (food Review opinions on production hygienic conditions issued by the Drug Supervision Department);

(3) If applying for hair growth, bodybuilding, and breast cancer products, the functional ingredients and usage basis should be submitted;

(4) Enterprise standards;

(5) Inspection reports and related materials issued by accredited cosmetics inspection agencies, arranged in the following order:

1. Inspection application form;

p>

2. Inspection acceptance notice;

3. Product instructions;

4. Hygiene (microbiology, physical and chemical) inspection report;

5. Toxicological safety test report;

6. Human safety test report.

(6) If applying on behalf of an agent, proof of entrustment should be provided;

(7) Other information that may be helpful for the review.

1 original copy and 4 copies of the above information. Attached is an unopened sample. Does any expert who has imported cosmetics know how special-purpose cosmetics and non-special-purpose cosmetics are classified?

Special-purpose cosmetics are used to change the local state of the human body, or to promote human body beauty, or to eliminate A type of cosmetics that are detrimental to human body beauty. This type of cosmetics is characterized by semi-permanent decorative properties (such as perms) or therapeutic effects (such as freckle removal). Special-purpose cosmetics must be approved by the Ministry of Health and can only be produced and sold after obtaining the approval number.

Special-purpose cosmetics include the following categories:

1. Hair growth cosmetics: cosmetics that help hair growth, reduce hair loss and hair breakage;

2. Hair dyeing cosmetics: cosmetics that can change hair color;

3. Perm cosmetics: Cosmetics that can change the curvature of hair and maintain relative stability;

4. Hair removal cosmetics: Cosmetics that can reduce and eliminate body hair;

5. *** Cosmetics: Cosmetics that help *** bodybuilding;

6. Bodybuilding cosmetics: cosmetics that help to make the body fit;

7. Deodorizing cosmetics: cosmetics used to eliminate body odor such as underarm odor;

8. Freckle removal cosmetics: Cosmetics used to reduce pigmentation on the skin's epidermis;

9. Sunscreen cosmetics: Cosmetics that absorb ultraviolet rays and reduce skin damage caused by sun exposure.

How to check the registration of domestic non-special use cosmetics

In order to strengthen the management of domestic non-special use cosmetics, the State Food and Drug Administration organized the formulation of the "Regulations on the Registration and Management of Domestic Non-Special Use Cosmetics" and recently issued them. The "Measures" regulate the registration management of domestic non-special use cosmetics, the conditions that designated inspection agencies should have, the selection of inspection agencies, the requirements for inspection agencies and inspection work, and the domestic non-special use cosmetics that will be put on the market for the first time since October 1, 2011. The filing requirements for cosmetics have been clarified. What are the procedures for filing imported special-purpose cosmetics?

Prepare first

samples of the products that need to be filed. There are still many requirements

The foreign authorization certificate must be notarized by a foreign notary office.

Overseas sales records of this product this year

Product ingredient analysis table, the sum must reach 100%.

Label sample, Chinese label

Business license. Qualifications for selling such products are required.

Filing usually takes 3-6 months.

After filing, import and clear customs as normal trade.

Regarding filing, we have a way to submit it once, instead of having to submit multiple times like other companies. Is the filing of domestic non-special purpose cosmetics valid?

It is not a question of invalidity, but a problem of ineffectiveness. It is a mandatory condition now. If your brand has not been registered, safety supervision, drug administration or industry and commerce will check the registration of this product. If it is found that no filing has been made, you will understand the consequences! Do domestic non-special purpose cosmetics need to be registered?

The state implements a registration and registration supervision system for cosmetics. All products that are to be put on the market normally need to be registered. For other questions, you can also send a private message,