Cosmetics for the record-Shenzhen Monika Testing & Certification Service Co., Ltd

Ordinary cosmetics for the record:

Domestic non-special use cosmetics for the record requested non-special purpose cosmetics production within the territory of People's Republic of China shall be the following requirements for product registration: 

First, the filing procedures related requirements 

(A) the company shall, before the product goes on sale and documentations following information: 

1. Product formulation (not including content, restricted substances except the same below.); 

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

3. Description of production process; 

4. Technical requirements; 

5. Product inspection report; 

6. Commissioned the production copy of the agreement (contract manufacturing products). 

1 and 2 of the information should be requested through a unified network platform to submit the location of the administrative area of the provincial food and drug regulatory authorities, the information provided by other companies records. 

(B) commissioned the production of products, commissioned by the parties to the provincial food and drug supervision departments of the administrative area of the location information to be filed separately. Domestic enterprises overseas enterprises commissioned the production of goods and domestic production for export only products submitted for the record by the actual manufacturer information to the provincial food and drug regulatory authorities the location of administrative areas. 

(C) Upon receipt of the provincial food and drug supervision departments corporate filing information, should be done on whether aspects of the product scope of the record, the record information is complete, the record information for compliance and other forms of verification within five working days of the organization. Product registration information to meet the requirements, confirmed after the provincial food and drug regulatory authorities, the Food and Drug Administration of the unified government website published some of the information products for the public inquiry. 

(Iv) For the record does not belong to the product range, the record information is not complete or does not comply with the provisions in the form of food and drug regulatory authorities shall inform the enterprise within five working days and explain the reasons. Food and drug regulatory authorities found that the record information confirmation process product obvious illegal situation, not yet marketed product shall be ordered to make corrections; already marketed products, should be investigated and dealt with according to law, and record information relevant section in the product to be marked . 

(V) the provincial food and drug regulatory authorities shall, after the organization filed within three months to carry out checks on the record products that do not meet the requirements, ordered to make corrections; found illegal, according to investigation, and shall be in the product record information relevant section callout. 

(F) the product has been filed, the proposed changes to the original filing matters, should be changed before the relevant change information through the network platform to re-submitted for the record; involves changes in record management departments should take the initiative to re-apply after the cancellation of the original record information for the record. 

(Vii) the product has been filed, from the date of filing shall, at least every four years to re-confirm the product record information. No longer in production, enterprises should take the initiative to cancel the Original record information. 

Second, the filing information requirements 

(A) product formulation information should meet the following requirements: 

1. All materials should be set out in detail the standard Chinese name, material number, restricted substances content, purpose and so on. 

2. Compound feed should be complex in furnished shall be marked with the name of each component of standard Chinese. Flavor is not required to specify the type and content of the specific perfume components.

3. In addition to compound feed, the cosmetics raw materials (including compound feed the components) should press the "international standard Chinese name cosmetics raw materials directory" using a standard Chinese name. No standard Chinese name, it should use the "People's Republic of China Pharmacopoeia" contains the name, chemical name or plant Latin name, trade name or common name shall not be used. 

4. Coloring agent should provide a "Hygienic Standard for Cosmetics," stated colorant index number (referred to as CI No.), except no CI number. 

5. Derived from petroleum, coal tar hydrocarbons (except single component) materials, shall be indicated Chemical Abstracts index number (referred to as CAS number). 

(B) product suite, in combination with the use of the packaging or, respectively in the following manner submit product registration information: 

1. There are two more in the suite of products (including two) independent packaging, each product separately filing; 

2. Inseparable combination packaging to a report prepared by product name, product formulations were submitted; 

3. With the use of two or more of the products, according to a filing products were submitted to the product formulation. 

(Iii) raw materials derived from animal tissue and blood products extracts, the source of the raw material should be collected, specifications and quality raw materials to produce proof of the country allowed to use information such as records. 

(Iv) using the "Hygienic Standard for Cosmetics" on the restricted substances specifications of the raw material, the raw material should be collected and issued by the manufacturer of raw material quality specifications proof records. 

Referring to the preparation of (E) technical requirements "on the issuance of cosmetic product technical requirements specification of the notice" (State Food and Drug Administration Xu [2010] No. 454) requires execution. 

(F) reference to the product inspection requirements "on the issuance of cosmetics administrative license notice inspection management approach" (State Food and Drug Administration Xu [2010] No. 82) execution. 

(Vii) Refer to "on the issuance of cosmetics that may exist in the security risk substances risk assessment guidelines notice" (State Food and Drug Administration Xu [2010] No. 339) requirements for risk assessment. Risk assessment can fully confirm the safety of the product, the product may be exempted from the relevant toxicological tests. 

(Viii) claims for the product, formulation design principles used by children or babies (including formulations overall analysis report), select the principles and requirements, production processes, quality control of raw materials, etc. should be in accordance with "Cosmetics for children Application and Evaluation Guide" (State food and Drug Administration of Paul [2012] No. 291) requires the preparation of the relevant information should be archived for future reference.

Imported cosmetics for the record:

All imported cosmetics (special and non-special) must be approved by China Ministry of Health approved the record (particularly the competent authorities prior to sale: State Food and Drug Administration food license.

2 procedures for sample preparation process / data --- inspection --- declaration --- ---- prepare submittals information obtained approvals

3 Cycle Cost

cycle

1. Food and Drug Administration for the record period:

Common products: the entire application process lasts about four months.

Special products: to declare the whole process lasted about six months.

2. Chinese label verification:

This import clearance carried out without prior record.

cost

Including inspection fees, reporting fees, Details are as follows:

Project a single product cost (million / month) Remarks

0.48 to 0.78 ordinary inspection fees

Special about 0.71 to 3

4 required information

(1) imported cosmetics health permit application form

(2) product formulation

(3) the effectiveness of ingredients, and the use of test methods based on the efficacy of ingredients (special purpose cosmetics)

(4) production process and sketch

(5) product quality standards (enterprise standard)

(6) The Ministry of Health inspection report identified cosmetic inspection agency issued

(7) product packaging (including product labels)

(8) product specifications

(9) entrusted with reporting units shall be submitted to the commission to declare the power of attorney

(10) products in the producing country (region) to allow the production and sale of documents

(11) from the occurrence of "mad cow" country products should be required to provide official quarantine certificates;

Other information (12) may contribute to the assessment of

Attached unopened complete small package three product samples.

5 relevant regulations

After the April 2010 declaration of imported cosmetics which are required to submit registration information and requirements? (Newly added in bold)

A: According to the latest report reception desk provisions states:

1, apply for special use cosmetics imports administrative license shall submit the following information:

(A) special purpose imported cosmetics administrative license application form;

(B) the product name Chinese name basis;

(Iii) product formulation;

(Iv) Description of the production process and diagrams;

(E) product quality and safety control requirements;

(F) original packaging (including product labels, product brochures), to be designed specifically for the Chinese market packaging, the need to submit product design packaging (including product labels, product brochures);

(Vii) permit inspection agency inspection report by the State Food and Drug Administration (USFDA) issued and related information;

There may be information on the safety assessment of the security risk material (viii) products;

(Ix) Application of Hair, body, breast products, and their use should be submitted Ingredients based on scientific literature;

(J) the administrative licensing has been filed to declare the responsible units of the power of attorney and a copy of the administrative license in China business license and official seal to declare the responsible units in China;

(Xi) the use of cosmetic raw materials and sources of raw materials in line with BSE infected areas of high risk material requirements Restriction Undertaking;

(Xii) product (Region) documents proving the producing country (region) or country of origin sales;

(Xiii) other information might help administrative license.

Commercial Sample attached license inspection agency did not like closure unsealed one.

2, imports of non-special use cosmetics application filing, shall submit the following information:

(A) imports of non-special use cosmetics administrative license application form;

(B) the product name Chinese name basis;

(Iii) product formulation;

(Iv) product quality and safety control requirements;

(V) original packaging (including product labels, product brochures); intends to design packaging for the Chinese market, the need to submit product design packaging (including product labels, product brochures);

Inspection Report (6) to permit inspection agency by the State Food and Drug Administration (USFDA) issued and related information;

There may be related to safety assessment material safety risk material (vii) products;

(Viii) the administrative licensing has been filed to declare the responsible units in China, power of attorney and a copy of a copy of a license administrative business unit in China reporting responsibilities and official seal;

(Ix) cosmetic raw materials and sources of raw materials in line with BSE infected areas of high risk material requirements Restriction Undertaking;

(X) product (Region) documents proving the producing country (region) or country of origin sales;

(XI) may help to record other information.

Commercial Sample attached license inspection agency did not like closure unsealed one.

3, apply for new cosmetic raw material administrative license shall submit the following information:

(A) new cosmetic raw material administrative license application form;

(B) Development Report

(1) raw materials research and development background, process and related technical information;

Source (2) raw materials, physical and chemical properties, chemical structure, molecular formula, molecular weight;

(3) the use of raw materials in cosmetics purpose, basis, scope and limit of use.

(Iv) raw material quality and safety control requirements, including specifications, test methods, there may be a security risk substances and their control;

(E) toxicological safety evaluation data, including potential security risk assessment information relating to the safety of the feed material;

(F) Acting declaration, should be submitted to the administrative licensing has been filed to declare the responsible units in China, power of attorney and a copy of the administrative license in China business license and official seal units reporting obligations;

(Vii) Other information may help administrative license.

Attach a sample submittal.

4, the application of domestic special-purpose cosmetics administrative license shall submit the following information:

(A) Domestic special use cosmetics administrative license application form;

(B) the product name name basis;

(Iv) product design packaging (including product labels, product brochures);

(V) permit inspection agency inspection report by the State Food and Drug Administration (USFDA) issued and related information;

There may be information on the safety assessment of the security risk material (VI) products;

(Vii) the provincial food and drug administration issued an audit opinion the production of sanitary conditions;

(Viii) Application of Hair, body, breast products, and their use should be submitted Ingredients based on scientific literature;

(Ix) other information might help administrative license.

Attached provincial food and drug supervision and management departments like closure unsealed samples one does not.

5, the above apply cosmetics administrative license shall be in accordance with "cosmetic declaration accepting the administrative licensing regulations" requirement to submit relevant information, general requirements for disclosure of information as follows:

(A) for the first time to apply for special use cosmetics administrative license, submit one original and 4 copies, copies should be clear and consistent with the original; (ii) for the record, continuation, change, replacement of documents of approval, submit 1 original ;

(C) In addition to the inspection reports, notary documents, official documents and third-party documents, the applicant shall declare the original document page by page or Jifeng stamp;

(Iv) use A4 size paper to print, use the clear distinguishing mark, arranged in a predetermined order, and bound into a book;

(E) the use of Chinese legal units of measurement;

(Vi) declarations should be complete, clear, complete the same project should be consistent;

(Vii) all foreign language (foreign address, website, registered trademarks, patents, names, SPF, PFA or PA, UVA, UVB and other foreign languages must be used except) should be translated into standard Chinese and foreign language translation attached to the corresponding data before;

(Viii) product formulations should be submitted text and electronic versions;

(Ix) the text version and the electronic version of the fill in the content should be consistent.

Cosmetics administrative licensing requirements for disclosure of information: The first application of cosmetics administrative license shall submit relevant information in accordance with "cosmetic declaration accepting the administrative licensing regulations" requirements, general requirements for disclosure of information is as follows:

(A) for the first time to apply for special use cosmetics administrative license, submit one original and 4 copies, copies should be clear and consistent with the original;

(B) for the record, continuation, change, replacement of documents of approval, submit 1 original;

(C) In addition to the inspection reports, notary documents, official documents and third-party documents, the applicant shall declare the original document page by page or Jifeng stamp;

(Iv) use A4 size paper to print, use the clear distinguishing mark, arranged in a predetermined order, and bound into a book;

(E) the use of Chinese legal units of measurement;

(Vi) declarations should be complete, clear, complete the same project should be consistent;

(Viii) product formulations should be submitted text and electronic versions;

(Ix) the text version and the electronic version of the fill in the content should be consistent.

The second application of domestic special-purpose cosmetics administrative license shall submit the following information:

(A) Domestic special use cosmetics administrative license application form;

(B) the product name name basis;

(Iv) product design packaging (including product labels, product brochures);

(V) permit inspection agency inspection report by the State Food and Drug Administration (USFDA) issued and related information;

There may be information on the safety assessment of the security risk material (VI) products;

(Vii) the provincial food and drug administration issued an audit opinion the production of sanitary conditions;

(Viii) Application of Hair, body, breast products, and their use should be submitted Ingredients based on scientific literature;

(Ix) other information might help administrative license.

Attached provincial food and drug supervision and management departments like closure unsealed samples one does not.

Article application for an import special use cosmetics administrative license shall submit the following information:

(A) special purpose imported cosmetics administrative license application form;

(B) the product name Chinese name basis;

(Iii) product formulation;

(Iv) Description of the production process and diagrams;

(E) product quality and safety control requirements;

(F) original packaging (including product labels, product brochures); intends to design packaging for the Chinese market, the need to submit product design packaging (including product labels, product brochures);

(Vii) permit inspection agency inspection report by the State Food and Drug Administration (USFDA) issued and related information;

There may be information on the safety assessment of the security risk material (viii) products;

(Ix) Application of Hair, body, breast products, and their use should be submitted Ingredients based on scientific literature;

(Xi) the use of cosmetic raw materials and sources of raw materials in line with BSE infected areas of high risk material requirements Restriction Undertaking;

(Xii) product (Region) documents proving the producing country (region) or country of origin sales;

(Xiii) other information might help administrative license.

Commercial Sample attached license inspection agency did not like closure unsealed one.

Article 4 To apply import non-special use cosmetics for the record, it should submit the following information:

(A) imports of non-special use cosmetics administrative license application form;

(B) the product name Chinese name basis;

(Iii) product formulation;

(Iv) product quality and safety control requirements;

Inspection Report (6) to permit inspection agency by the State Food and Drug Administration (USFDA) issued and related information;

There may be related to safety assessment material safety risk material (vii) products;

(Ix) cosmetic raw materials and sources of raw materials in line with BSE infected areas of high risk material requirements Restriction Undertaking;

(X) product (Region) documents proving the producing country (region) or country of origin sales;

(XI) may help to record other information.

Commercial Sample attached license inspection agency did not like closure unsealed one.

Article administrative license application for new cosmetic raw materials, and shall submit the following information:

(A) new cosmetic raw material administrative license application form;

(B) Development Report

1. Materials research and development background, process and related technical information;

2. Source of raw materials, physical and chemical properties, chemical structure, molecular formula, molecular weight;

3. Raw material in cosmetics purpose, basis, scope and limit of use.

(Iv) raw material quality and safety control requirements, including specifications, test methods, there may be a security risk substances and their control;

(E) toxicological safety evaluation data, including potential security risk assessment information relating to the safety of the feed material;

(Vii) Other information may help administrative license.

Attach a sample submittal.

Article VI declaration item belongs to the following conditions, in addition to the above provisions to submit information shall be submitted separately following information:

(A) declare the product produced by processing manner, should submit the following information:

1. Entrusting party and entrusted party signed commission processing agreement;

2. Imported products shall be submitted documentation was commissioned production enterprises quality management system or good manufacturing practices or in compliance with the production of cosmetics production enterprises qualifications country (region) regulatory requirements documentation;

3. Overseas producers entrust domestic production of domestic products should also declare the administrative licensing unit in China, the responsibility for the record submitted to the administrative licensing unit in China reporting responsibilities authorization;

4. Domestic production enterprises overseas enterprises commissioned the production of imported products may not be submitted to the administrative licensing unit in China reporting responsibilities authorization, production and sale of original documents and product packaging, product packaging design should be submitted.

(B) the actual manufacturer and cosmetics manufacturer (applicant) belong to the same group of companies, should be submitted to the actual manufacturer and cosmetics manufacturer (applicant) belong to the same group of companies and enterprise groups supporting documents issued by the company's product quality assurance documents .

Article VII of the plurality of actual production enterprises of the same product can be declared at the same time, one of the actual manufacturer of products specified above shall submit all the information should also submit the following information:

(A) relates to the production and processing commissioned relations, production and processing agreement submitted to commission, imported products should also be submitted documentation was commissioned production quality management system or good manufacturing practices or in compliance with the country where the manufacturer (region) regulatory requirements for cosmetics production qualification documents;

(2) the production belong to the same group of companies, production enterprises are submitted to the same group of companies and enterprise groups supporting documents issued by the product quality assurance documentation;

(Iii) other actual manufacturer producing original packaging, packaging design of domestic products may be submitted;

(Iv) Health (microbial, chemical health) inspection reports of other actual manufacturer of the product;

(V) domestic products shall be submitted to the actual producers of other location provincial food and drug administration issued by the department of health conditions production audit opinion;

(F) imported products, should be submitted to the actual producers of other cosmetic raw materials and sources of raw materials in line with a high BSE risk material PFA Restriction requirements undertaking.

Article VIII of the applicant without a declaration or termination of administrative licensing product again declared, it should submit a new application and submit the application materials. After the termination of the declaration declared again, it should also indicate the termination and the reasons for the declaration again declared; administrative license after not declared again, should not be submitted to the administrative licensing (change / continuation) a copy of the written decision and explain the reasons again declared .

Except no administrative licensing reasons not related to product safety, may be used to restate the original copies of inspection reports, the domestic cosmetics for special purposes can also use a copy of the original production sanitation audit opinion, but the original data has been returned to the applicant's declaration .

Article IX apply for the continuation of the administrative license (for the record) is valid, it should submit the following information:

(A) the continuation of cosmetics administrative license application form;

(Ii) cosmetics administrative permit approval document (record certificate) original;

(Iv) product formulation;

(E) product quality and safety control requirements;

(Vi) commercially available product packaging (including product labels, product brochures), domestic products if not listed, you can submit product design packaging (including product labels, product brochures);

(Vii) domestic products, the applicant shall submit the provincial food and drug administration issued by the department on production, market, product supervision submissions or unlisted audit opinion;

(Viii) Acting declaration, should be submitted to the administrative licensing has been filed to declare the responsible units in China, power of attorney a copy, and reporting responsibilities of administrative licensing unit in China business license and a copy of the official seal;

(Ix) other information might help administrative license.

Attached unopened commercially available products 1.

Article 10 An applicant changed the administrative license shall submit the following information:

(A) cosmetics administrative license change request form;

(Ii) cosmetics administrative permit approval document (record certificate) original;

(C) Acting declaration, should be submitted to the administrative licensing has been filed to declare the responsible units in China, power of attorney and a copy of the business license and official seal;

(D) submit the following information are based on the content of the application for the change:

1. Product name changes:

(1) An application for product changes Chinese name, and shall state the reasons in the change in the application form and submit the proposed changes to the product Chinese name name basis and intends to change product design packaging (including product labels, product brochures); imports foreign name can not be change;

(2) An application to change sunscreen SPF, PFA or PA values, should submit the appropriate SPF, PFA or PA inspection reports and submit the proposed changes to the product design packaging (including product labels, product brochures).

2. Change the company name, address (including autonomous changes or mergers and acquisitions):

(1) domestic product manufacturer name or address changes, should submit original documents to local industrial and commercial administration issued by the department or by a copy of the notarized copy of health permit production enterprises;

(2) imported product manufacturer name or address changes, shall submit the relevant documents producing countries government departments or agencies issued, wherein, due to acquisitions, mergers between the proposed legal changes to name of manufacturer and to be submitted to the parties signed copy of acquisition or merger contract documents be translated into standardized Chinese, Chinese translation should be notarized Chinese notary public;

(3) inside the territory conglomerate adjustment shall submit the relevant documents issued by the administrative department for industry and commerce; involving Taiwan, Hong Kong and Macao-funded enterprises or foreign-invested enterprises, can submit a notarized "People's Republic of China foreign investment enterprise approval certificate" or "People's Republic of China Taiwan, Hong Kong overseas investment enterprise approval certificate" copy;

(4) relates to a change in the production site shall be submitted to the proposed changes to the company's hygiene products (microbial, chemical health) inspection reports; for domestic products should be submitted to the company intends to change the location of the provincial food and drug administration issued by the department production hygiene audit opinion.

3. Change of imported products, the company's Chinese name (English name unchanged):

(1) the reasons the company's Chinese name change;

(2) intends to change product design packaging (including product labels, product brochures).

4. Administrative license in China reporting responsibilities change units:

(1) to submit the proposed changes to the administrative licensing unit reporting responsibilities original power of attorney filed in China;

(2) intends to change the administrative licensing unit of power of attorney a copy of the declaration of responsibility in China;

Change the original documents (3) the administrative licensing unit in China reporting responsibilities name or address changes should be submitted to the local industrial and commercial administrative department issued or notarized copies;

Administrative license revocation of the original case (4) issued by the manufacturer to declare the responsible units in China and explained by the notary public.

(1) relates to the production and processing commissioned relations, production and processing agreement submitted to commission, imported products should also be submitted documentation was commissioned production quality management system or good manufacturing practices or in compliance with the country where the manufacturer (region) regulatory requirements for cosmetics production qualification documents;

(2) manufacturing enterprises belonging to the same group of companies, production enterprises are submitted to the same group of companies and enterprise groups supporting documents issued by the company's product quality assurance documentation;

(3) intends to change the actual production of production of the products in original packaging;

(4) Health (microbial, chemical health) inspection report intends to change the actual production of production of products;

(5) domestic products, the proposed changes should be submitted to the actual producers of the provincial food and drug administration issued by the department of health conditions production audit opinion;

(6) the imported products should be submitted to the actual production of production of products and raw materials and sources of raw materials in line with a high BSE risk material PFA Restriction requirements undertaking.

6. Change special use cosmetics category, should submit the appropriate information in accordance with the requirements of each category.

7. Apply other changes, should detail the reasons and submit the relevant documents.

Article XI apply for a replacement administrative permit approval document (registration certificate) shall submit the following information:

(A) cosmetics administrative permit approval document (registration certificate) replacement application form;

(B) An administrative permit approval document (record certificate) apply for a replacement of damaged, shall be submitted to cosmetic administrative permit this document (registration certificate) original;

(Iii) An administrative permit approval document (record certificate) apply for a replacement of lost, shall be submitted to the provincial level above (including provincial) newspaper published in the original statement of loss, loss reissue application should be lost from the date of declaration of timely published 20 days ;

(D) reporting agents shall be submitted to the administrative licensing has been filed to declare the responsible units in China, power of attorney a copy, as well as business license administrative licensing unit in China reporting responsibilities and official seal.

Article 12 Applications Administrative Permit Document (record certificate) correction shall submit the following information:

(A) cosmetics administrative permit approval document (record certificate) correction application form;

(Ii) cosmetics administrative permit approval document by the signature of the applicant (registration certificate) copy;

(C) cosmetics administrative permit approval document (record certificate) original surrender when receiving the new document (registration certificate).

Article XIII supplement to the State Food and Drug Administration review of institutional information shall submit the following information:

(A) a notice of review comments;

(B) Supplementary information on issues raised by the order of the review comments.

Article XIV product formulation data should meet the following requirements:

(A) shall be in tabular form in the same table provided that contains raw numbers, materials INCI names (INCI name) (except domestic product), the standard Chinese name, percentage content, purpose of use, etc. of the recipe table, font size no smaller than small V Arial;

(Ii) should provide the name of all the raw materials, the actual content in percentage terms, and indicate the effective matter content (not specified caught in an effective matter content 100% of the total); compound material must be declared in complex form, and should be marked in which each component content (in percent); special circumstances, such as those containing crystal water, raw materials there are different formula or structure type, etc. should be described, according to the content of all the raw materials in descending order;

(C) Formulation of raw materials (including compound material of each component) Chinese name should be "international standard Chinese name cosmetics raw materials directory" using a standard Chinese name, or no INCI name included in the "international standard Chinese name cosmetics raw materials directory "you should use the" Chinese Pharmacopoeia "in the chemical name or plant name or Latin name, trade name or common name shall not be used, but with the exception of complex raw materials;

(Iv) a coloring agent should provide the "Hygienic Standard for Cosmetics," stated colorant index number (referred to as CI No.), except no CI number;

(V) contain animal tissue and blood products extracts should be submitted source of raw materials, quality specifications and raw material producing countries allow the use of proof;

(Vi) where the use of products derived from oil in the formulation, coal tar hydrocarbons (except single component) shall be indicated in the relevant raw material Chemical Abstracts index number (referred to as CAS number) in product formulations;

(G) "Hygienic Standard for Cosmetics" on the restricted substances specifications of raw material should be submitted to the quality specifications of the raw material by a certificate issued by the manufacturer;

(Viii) dispensing group with multiple product formulations (such as hair color, perm class), present in the same or different formulations can not split the contents of the package of a combination product, each part of the formula should be listed separately;

(Ix) permit inspection agency confirmed that imported product formulations proved its acknowledgment should be consistent with the date of the acceptance date of the test sample;

(X) purporting to pregnant and lactating women, children or infants products, should be provided based on the formulation design principles of safety considerations (including formulations overall analysis report), select the principles and requirements of raw materials, production processes, quality control, etc. information content.

There may be a security risk substances in Article XV of products related to information security assessment should be based on the cosmetic use of raw materials and product characteristics proposed, and include the following:

And there may be a substance having a name of a security risk (including raw materials into the material generated in the production process), and test data correlation detection methods (a) products;

(Ii) evaluation report for possible security risks in product safety risk material;

(C) under the existing technical conditions, can reduce the technical information security risks that may exist in the material content of the product, process improvement, if necessary, submit measures;

Raw material (d) of vegetable origin should be submitted may contain pesticide residues and other contaminants or impurities in the extraction process into the case.

Article XVI product quality and safety control requirements should include the following elements:

(A) the color, odor, character and other sensory indicators;

(B) microbial indicators (except without detection), chemical health indicators;

(C) perm, hair removal category, freckle products and claims containing α- hydroxy acid or with minor claims containing α- hydroxy acids, but the total amount of ≥3% (w / w) of the product should have a pH value of the index (oil water (oil products), with the exception of powder, powder type, wax-based classes) and detection methods;

(Iv) imported products, should be submitted in the country of origin of goods and the implementation of quality and safety control requirements (foreign language version and Chinese translation). Country of origin product quality and safety control requirements for the implementation of this section does not include (a), (b), (c) items should be submitted at the same time the quality of products containing the corresponding index information security control requirements;

(V) The applicant shall submit product commitments in line with "Hygienic Standard for Cosmetics" requirements.

Article XVII of domestic special-purpose cosmetics hygiene audit opinion shall include the following information:

(A) the production of cosmetics hygiene assessment of the application form;

(Ii) the production of cosmetics health conditions examination table;

(Iii) product formulation;

(Iv) Description of the production process and diagrams;

(V) the list of production equipment;

(F) manufacturers health permits copy.

Article 18 licensed inspection agency inspection reports State Food and Drug Administration (USFDA) issued and related information, shall meet the following requirements:

(A) cosmetic license inspection report including health and safety inspection (microbiological, chemical hygiene, toxicology) reports and human safety inspection report, which examined the sample should be the same product name, the same production date / batch number of the product;