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 General rule

Since June 1, 2014, domestic non-special purpose cosmetics should be listed in accordance with the "domestic non-special purpose cosmetics information for the record requirements" requirements, product information online filing, filing information by the provincial food and drug regulatory authorities confirmed by the state Food and Drug Administration Administration of the unified release of government, for public inquiries, the provincial food and drug supervision and management departments are no longer issued "domestic non-special purpose cosmetics record certificate." The food and drug supervision and administration department shall be punished in accordance with the provisions of Article 45, paragraph 7, of the Regulations on the Implementation of the Regulations on the Supervision of Cosmetics and Hygiene.

 

Filing

Domestic non - special use of cosmetics information for the record requirements

一、  where the production in the People's Republic of China non-special purpose cosmetics, production enterprises should be required by the provisions of the product information for the record.

 the production enterprises should be listed in the product before the sale, the product formula (not including content, except for restricted substances) and sales of packaging (including product labels, product brochures) information as required through a unified network platform submitted to the administrative area Within the provincial food and drug regulatory authorities. Product safety assessment information, product production process brief, product production equipment list, product technical requirements and product inspection reports and other information provided by the production enterprises for future reference.

三、 commissioned by the production of products, commissioned by the two sides should be the administrative region of the provincial food and drug supervision and management departments to submit filing information. Only for export, by the actual production enterprises to the administrative region of the provincial food and drug supervision and management departments to submit the record information.

四、 the provincial food and drug supervision and management departments to receive the company's record information, it should be completed within 5 working days to verify the integrity of the record data. Meet the requirements of the State Food and Drug Administration through the State Council announced the product record information for public inquiries.

五、 for those who do not belong to the scope of filing products, filing information is not complete or filing information does not meet the prescribed form, the provincial food and drug supervision and management departments should inform enterprises within 5 working days and explain the reasons. There is a clear violation of the circumstances, should be ordered to immediately correct, not on sale.

六、 the provincial food and drug supervision departments should be within three months after filing to carry out the substantive review of the filing products, found that does not meet the relevant provisions of the state, should be investigated and dealt with according to law.

七、 has been filed for the product, to change the original record of the matter, should be changed before the relevant changes submitted to the record. Involving the record management department to change, should take the initiative to apply for cancellation of the original record information, the direct application for re-filing.

八、 has been filed for the product, since the date of filing every four years should be re-submitted in accordance with the provisions of the product record information.

Nine, product formula information submitted should meet the following requirements:

1. All raw materials should be specified in detail the standard Chinese name, raw material serial number, limited substance content, the use of purpose and so on.

2. The compound material should be filled in a compound form, and the standard Chinese name of each component should be indicated. Flavors do not specify the type and content of the specific fragrance components.

3. Raw materials (including the ingredients in the compound raw materials) should be in accordance with the "International Cosmetics Raw Materials Standard Chinese name directory" using the standard Chinese name, no international cosmetics raw material name (INCI) or not included in the "International Cosmetics raw materials standard Chinese name directory" , Should use the "Chinese Pharmacopoeia" in the name or chemical name or plant Latin name, shall not use the trade name or common name, but with the exception of raw materials.

4. The colorant should provide the colorant index number (referred to as CI number) as specified in the Cosmetic Hygiene Code, except for the CI number.

5. Where a hydrocarbon derived from petroleum or coal tar is used in the product formulation (except for a single component), the chemical abstract index number (CAS number) of the relevant raw material should be indicated.

6. The use of animal organs and blood products extract raw materials, should be collected from the source of raw materials, quality specifications and raw materials to allow the use of proof of production and other documents for future reference.

7. The use of "Cosmetics Hygienic Standard" on the restricted substances have specifications of raw materials, should be collected by the raw material manufacturers to produce raw materials quality specifications for archival filing.

8. (Including the overall analysis of the formula), raw material selection principles and requirements, production process, quality control and other content should be in accordance with the "Children's cosmetics declaration and review guide" (National Food and Drug Administration (National Food and Drug Administration) (2012) No. 291), the relevant information should be filed for future reference.

10, the preparation of technical requirements of the product with reference to the "Notice on the issuance of technical specifications for cosmetic products" (National Food and Drug Administration [2010] 454) required to implement; inspection requirements with reference to "issued on the issuance of cosmetics administrative licensing inspection management notice" (2010) No.82), in which the enterprise undertakes a risk assessment with reference to the Notice on the Issuance of a Risk Assessment Guide for Safety Hazardous Substances in Cosmetics (National Food and Drug Administration [2010] No. 339) And confirm the product safety, and can be exempted from toxicology related testing. 

 

Domestic non - special purpose cosmetics for the record requirements

Where the non-special use cosmetics produced in the territory of the People's Republic of China, the following information shall be submitted for product filing:

1. Product formula (not including content, except for restricted substances. The same below);

2. Product sales packaging (including product labels, product brochures);

3. Product production process brief;

4. Product technical requirements;

5. Product inspection report;

6. Commissioned a copy of the production agreement (commissioned by the production of products).

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