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Necessary Technical Data(Submission Dossier)
Author:佚名 Hits: Date:2012-08-03 16:03:37 【Font:Large Middle Small

1.Formula

Please provide INCI name, percentage composition and function of each ingredient, the total percentage should be 100%;

Compound ingredients must be declared in compound form and should indicate the percentage of each raw material in the compound ingredient; Special situation, such as contain water of crystallization, materials which have different molecular formula or different constitutional formula should give illustration;

If any of raw material in product derive from petroleum or hydrocarbons of coal tar (single component is not included), should provide CAS number;

Multi-packing product which in sub package (such as hair coloring, perm), or products which in the same package but the contents got different formula, should list the formula of each part.

2.Control requirements for product quality and safety

ISensory index such as color, odor, character etc.

IImicrobiological indicator (except those do not need been tested)chemical indicators of health

IIIProducts in perm category, depilation category , dispel freckle category and products which contain alpha hydroxyl acid 3%w/wshould label the pH index and provide the test method(except water in oil-oil like products, powder, pressed powder and wax based);

IVImported products, should provide the control requirements for product quality and safety which been carried out in country of origin, if it doesnt contain relevant information in clause I)、(II)、(III, should provide another control requirement contain those information;

VThe applicant should provide a letter of commitment to promise the product meet requirements of HYGIENIC STANDARD for COSMETICS.

3.Power of Attorney

Must contain the name and address of both company (the name and address of foreign company should comply with the information on the package of products; the name and address of responsible age agency in China should comply with the information on the business license) ;

The period of authorization is at least 4 years;

Both parts of authorization should sign and seal, the name of company showed on the seal should comply with the demands mentioned above;

The date of each part sign & seal on the letter of attorney;

4.Free sales certificate

Need include name and address of manufacture, these information must comply with the name and address shown in the package of product;

If products are produced through commission processing or other ways that lead to the name of manufacture showed in the document is the name of the actual processing enterprise, the applicant should provide document to give illustration;

Need include name of products, these information must comply with the name shown in the package of products.

Need to be authenticated and issued by local official mission or by an industry association, to authenticate that these products can be manufactured and sold freely in local area;

Should provide the original document, in case you cannot provide the original, you can provide a copy one, but need to be authenticated by the official mission which issued the document or authenticated by the consulate of China;

Need to show the name of the organization which issued the document, and need to be signed (name of the responsible person and the date issued the document)and stamped by the organization;

5.Risk materials evaluation documents

(I)Origin of possible risk materials in cosmetics;

(II)Summarize of possible risk materials, include physicochemical characteristics and biological characteristics of these materials;

(III)Content and test method of risk materials in cosmetics, and provide relevant documents;

(IV)Limited level and brief summarize of possible risk materials mentioned in local or foreign documents, please provide those documents;

(V)Toxicological Information

 

1.Toxicological information of possible risk materials in cosmetics, at least, should include if the materials be seen as carcinogen by IARC(International Agency for Research on Cancer);

2.Provide summarize of toxicological information based on demands of toxicological test methods in “Hygienic Standard for Cosmetics” version 2007.

(VI) If the ingredients of the cosmetics have vegetable materials, the possible existence of the pesticide residues in the vegetable materials which are directly used only after mechanical processing should be illustrated. If the vegetable materials need to be further extracted and prepared besides the mechanical processing, the possible existence of  pesticide residues in the raw materials should be illustrated when it is necessary

(VII)Technical information about how to reduce possible risk materials in cosmetics in current technical conditions, please provide measure of technical improvement;

For the raw materials which have had the assessment reports and conclusions in the world, it will be fine that the assessment reports are directly sent to the administration. For the raw materials without the assessment reports or conclusions, it will be fine that the technical engineers of the production companies or the manufacturers of the raw materials should analyze and evaluate the materials.