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The Basic Process of Applying for Registration Credence of Imported Cosmetics for Non-Special Purpose and Hygiene Permit Document of Imported Cosmetics for Special Purpose with the China Food and Drug Administration

 

 

The China Food and Drug Administration requires that imported cosmetics must obtain Registration Credence of Imported Cosmetics for Non-Special Purpose (hereafter referred to as Credence) or Hygiene Permit Document of Imported Cosmetics for Special Purpose (hereafter referred to as Document) before they enter the market of Mainland China. Those who sell imported cosmetics for non-special purpose without Credence and/or imported cosmetics for special purpose without Document in the market of Mainland China will be punished with confiscation of all the products and illegal earnings, and with a fine of 3 to 5 times of the illegal earnings. In the case that the consumer is physically harmed or poisoned, the manufacturing enterprise, the distributing enterprise or the persons who are directly responsible for the consequences must compensate the loss. If the case has incurred serious consequences, the responsible party shall be prosecuted for the penalty by the justice in Mainland China.

 

Source:

 

The Hygiene Supervision Regulations on Cosmetics approved by the State Council, the People's Republic of China on Sep. 26th, 1989 and released by the Ministry of Health, P.R.C. on November 13th, 1989 (hereafter referred to as the Regulations)

 

The Notice of Simplifying the Procedure of Hygiene Permit of Imported Cosmetics for Non-Special Purpose, Document No. 217 released by the Ministry of Health, P.R.C. on July 1st, 2004 (hereafter referred to as the Notice)

 

The Stipulation of Application and Acceptance of Administration Permit of Cosmetics released by the China Food and Drug Administration P.R.C. on December 25th, 2009 (hereafter referred to as the Stipulation)

 

I. Basic Process of Applying for Credence and Document

 

1. Product inspection:

Those who apply for hygiene permit should present samples to the inspection institutions designated by the China Food and Drug Administration for evaluation of hygienic safety and inspection of hygienic quality.

Source:

 

Chapter 4 of Detailed Rules of Implementation of the Hygiene Supervision Regulation on Cosmetics released by the Ministry of Health, P.R.C. on March 27th, 1991 (hereafter referred to as Detailed Rules of Implementation)

 

The Hygiene Administrative Permit Process for Health-related Products (hereafter referred to as the Process)

 

The Stipulation

 

2. Five copies of application documents for each declared product (one original and four photocopies) for Document or one original copy of application documents for Credence should be presented to the China Food and Drug Administration.

 

Source:

 

Announcement No.1 by the National Center for Health Inspection and Supervision of the Ministry of Health, P.R.C. in 2004

 

The Stipulation

Each set of Application Document of the Hygiene Permit of Imported Cosmetics consists of:

 

(1) Reference of selecting Chinese name of product;

 

(2) Formula of product (including all ingredients with exact percentages, complex ingredients with percentages of each component);

 

(3) Manufacturing process and technical flow chart of cosmetic product;

 

(4) Quality and safety control requirements;

 

(5) An analytical report on the active ingredient(s) and its/their effects, technical reference for hair-growing, body fitness or breast-beautifying cosmetic products;

 

(6) Inspection report and relevant documents issued by the inspection institutions designated by the China Food and Drug Administration;

 

(7) Product Instruction and warning;

 

(8) Safety assessment data for substances with potential safety risk;

 

(9) Principle of designing the formula (including the overall analysis report of the formula), the principle and requirements of selecting raw materials, manufacturing process and quality and safety control requirements and relevant documents based on the safety concerns (for pregnant women, nursing women, children or infants cosmetics);

 

(10) Business registration license of Registration Responsible Party, which should be an independent legal entity in Mainland China (photocopy with company stamp);

 

(11) Packaging of the product (including labels);

 

(12) Free Sales Certificate for manufacturing and selling the declared product in the manufacturing country or region, which must be notarized by a Chinese notary public;

 

(13) Letter of Authorization from the Manufacturer to the Registration Responsible Party in Mainland China for the products;

 

(14) Other materials helpful to the verification;

 

(15) One sample with intact packaging.

 

All the application materials in foreign languages, except the formula and foreign addresses, must be translated into formal Chinese, and the translation should be attached to the correspondent original material in foreign languages.

 

Source:

 

Regulation 15 of the Regulations

 

Chapter 4 of Detailed Rules of Implementation

 

The Stipulation

 

3. When the China Food and Drug Administration accepts the application, it will issue the Notice of Acceptance for Administrative Permit Application. If the institution finds the application material does not comply with the requirements, it will issue the Notice of Supplement for Application Materials. If the institution refuses the application, it will issue the Notice of Refusal for Administrative Permit Application, and send back the application form, product samples and relevant materials.

 

4. The China Food and Drug Administration will organize relevant experts and technical personnel to assess and evaluate the application materials. If needed, they will also organize on-site inspection to the manufacturing facility or inspection institutions. If the product passes the assessment and evaluation, it will be presented to the China Food and Drug Administration for approval.

 

5. When the application is approved by the China Food and Drug Administration, Hygiene Permit Document of Imported Cosmetics for Special Purpose with the Approval Code, or Registration Credence of Imported Cosmetics for Non-Special Purpose with the Registration Code will be issued.

 

Source:

 

Chapter 4 of the Regulations

 

Chapter 4 of Detailed Rules of Implementationn

 

The Process

 

The Stipulation

 

II. Explanations on Several Items:

 

1. Product inspection:

 

Those who apply for hygiene permit should present samples to the inspection institutions designated by the China Food and Drug Administration for evaluation of hygienic safety and inspection of hygienic quality.

 

Source:

 

Chapter 4 of Detailed Rules of Implementation

 

The Process

 

The Stipulation

 

(1) Deliver samples to the inspection institution and fill in the Inspection Application Form of Health-related Product, and pay the inspection fee;

 

(2) The sample quantity needed for registration and the amount of inspection fee are listed as below:

The above Inspection Fees are quoted from the standard rate of Guangdong Centre of Disease Control and Prevention (hereafter referred to as Guangdong CDC) located in Guangzhou or Shanghai Centre of Disease Control & Prevention (hereafter referred to as Shanghai CDC). The rates for different inspection institutions may differ.

 

The above-quoted inspection fees and sample quantities are based on the most up-to-date information.

 

The inspection institutions are entitled to make adjustment to the above information.

 

(3) The inspection institution issues the Notice of Inspection Acceptance of Health-related Products, and starts the inspection of the products;

 

Source:

 

Item 15 of the Process

 

(4) The inspection time ranges from 25 to 180 days depending on the product category;

Nail products and Fragrance products

Source:

 

The Inspection Stipulation for Cosmetics Hygiene Administrative Permit (2010 Edition)

 

(5) The inspection institution issues the inspection report. The inspection report together with the Inspection Application Form of Health-related Product, the Notice of Inspection Acceptance of Health-related Products and other relevant documents should be presented to the China Food and Drug Administration.

 

Source:

 

Chapter 4 of the Regulation

 

The Stipulation

 

2. The formula of the product should meet the following requirements:

 

 (1) All ingredients added during the manufacturing process should be declared, including preservatives, stabilizers or any other additives added to the raw material;

 

 (2) The accurate percentage of each ingredient must be provided in the formula;

 

 (3) Ingredients should be in INCI names instead of trade names;

 

 (4) Colorants in the formula, if any, must be named with their CI codes;

 

 (5) Ingredients originated from plants, animals, microbes, or minerals must be presented in Latin names;

 

 (6) For any extract from animal viscera in the ingredients, the manufacturer should provide a Certificate of Origin, a quality specification and a certificate for free use in cosmetics in the manufacturing country or region of the raw material;

 

 (7) If any complex ingredients, the proportion of each substance should be declared;

 

 (8) The formulas of set products (such as hair perm and hair dye) should be listed respectively;

 

 (9) The purpose for use of each ingredient must be provided in the formula.

 

(10) The formula should be stamped by the inspection institution.

 

Source:

 

The Stipulation

 

3. The Free Sales Certificate should meet the following requirements:

 

 (1) The original copy should be provided. If only a photocopy is available, the photocopy should be verified by the issuing party or by the Chinese Embassy in the manufacturing country or region;

 

 (2) The Free Sales Certificate should state clearly the name of the issuing party, the name of the manufacturing enterprise, the name of the product, and the issue date of the certificate;

 

(3) The Free Sales Certificate should be issued by the department-in-charge of the government in the manufacturing Country or region, or the local association;

 

(4) The Free Sale Certificate should have the stamp of the issuing organization or the signature of the authorized representative;

 

(5) The name of the manufacturing enterprise and the product stated in the Free Sale Certificate should be consistent with those in other application documents;

 

(6) The Chinese translation of the Free Sale Certificate should be notarized by a Chinese notary public.

 

Source:

 

The Stipulation

4. Credence or Document is valid for 4 years. Within this period, the product can be imported and sold freely in the market of Mainland China. Credence or Document can be renewed. The application for renewal of Credence or Document should be submitted at least 4 months before the expiry date.

 

Source:

 

Chapter 4 of Detailed Rules of Implementation

 

Chapter 6 of the Process

 

The Stipulation

 

5. The expenses for the whole process:

 

(1) Inspection fee: from RMB 2,970 to RMB 36,800 for each product according to different categories, collected by the inspection institution;

 

(2) Notarization Fee: around RMB2,200 for each product, collected by a Chinese notary public.

 

The standard rates may differ among different institutions. The inspection fees listed here are the lowest among the institutions.

 

In many cases the inspection fee may be higher. For example, products containing Alcohol or Isopropyl Alcohol of a certain quantity require an additional methanol content test, which costs RMB87. Products containing α-hydroxy acid (eg. glycolic acid, malic acid or lactic acid) require an additional α-hydroxy acid content test and pH value test, which costs RMB662.

 

6. The quantity of sample needed for the whole process:

 

(1) Samples for inspection required by the inspection institution (quantity as stipulated) ;

 

(2) Samples for assessment and evaluation required by the China Food and Drug Administration (1 intact sample for each product).

 

Source:

 

The Inspection Stipulation for Cosmetics Hygiene Administrative Permit (2010)

 

The Stipulation

 

7. Time needed for the application for Document:

 

(1) Time needed for the application for Document consists of time for product inspection plus time for evaluation and verification by the China Food and Drug Administration;

 

(2) Please see the aforesaid item II 1 (4) for the time needed for product inspection;

 

(3) Evaluation and verification by the China Food and Drug Administration for Document application is held every month;

 

(4) The deadline for accepting application for Document is the 10th day of each month;

 

(5) Legal duration of the evaluation and verification for Document as regulated by the China Food and Drug Administration: not more than 8 months for each evaluation and verification from the time when the Notice of Acceptance is signed and delivered. For example, if the evaluation and verification is signed and delivered in March, the result will be issued no later than October 31st. If more time is needed, the China Food and Drug Administration should issue a Notice of Prolonging the technical assessment of Administrative Permit.

 

8. Time needed for the application for Credence:

 

(1) Time needed for the application for Credence consists of time for product inspection plus time for registration verification by the China Food and Drug Administration;

 

(2) Please see the aforesaid item II 1 (4) for the time needed in product inspection;

 

(3) Legal duration of registration verification for Credence as regulated by the China Food and Drug Administration: 20-30 working days after acceptance of the application for Credence by the China Food and Drug Administration.

 

 

 

 

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