Beijing Oriental Chemical Information Co.,Ltd.
The China Products Regulatory Consultant and Services Provider

New Cosmetic Ingredient

    Registration Service Procedure

    Necessary Technical Data (Submission Dossier):

    I.Application Form for New Cosmetic’s Material

    II.Research & Develop Report

    Material’s R&D background, process and relative technical information;

    (Relative technical information should including safety compare with other cosmetic material which has similar chemical structure and functional compare with other cosmetic material which has same function when used in cosmetics, and related test reports should also be provided.)

    Name, origin, relative molecular weight, molecular formula, chemical structure and physicochemical property of the material;

    Name: Chemical name (IUPAC name and/or CAS name), INCI name in both English and Chinese, trade name and CAS number etc. Material’s operational specification should be given. For nature resourced material, should provide its Latin name.

    Origin: Material should not make by blending, except blend with necessary solvent, stabilizer and carrier etc.

    For nature resourced material, it should be single origin and should expound that the material extracted from which part of the nature resource.

    Relative molecular weight, molecular formula and chemical structure: Should provide confirmed basis such as infrared, NMR, mass spectra and their analysis. For polymer should provide its average molecular weight and its distribution.

    Physicochemical property: color, scent, state, solubility, melting point, boiling point, specific gravity, vapor pressure, pH value, pKa value, refractive index, optical rotation etc.

    (Please list all of these properties, if any of it not available for the material, please note as “not available” or “no data”)

    Using purpose/range/limit/basis, matters need attention, warning etc.

    (Test data to confirm using range, limit and basis should be provided.)

    Documents to illustrate whether this material used in cosmetics in foreign areas.

    III.Production Process and it Flow Chart

    (Describe the production process, including main step, process and parameters, such as list all the raw materials used, the reactive condition (temperature, pressure, auxiliaries etc.), by-products etc. the more detailed the better.)

    IV.Specification and Test Methods

    Specification: Including purity, impurities in the material and their % concentration, for polymer should provide name of residual monomers and % concentration. Should list names, % concentrations of necessary solvents, stabilizers and carriers. Besides, other physicochemical parameters, quality guarantee period and storage requirement should be provided. For nature resourced extracts should confirm its quality and safety control index.

    Test method: Qualitative and quantitative test methods of the material and impurities in it.

    Possible risky materials and control.

    V.Toxicological Reports and Safety Assessment

    (All of the toxicological test reports should be original document or copied document with signature and seal from the test facility which issued the reports.)

    VI.Copied Letter of Authorization and Copied Business License of Responsible Agent in China.

    VII.Other Supporting Documents.

    Toxicological Tests Breakdown

    Acute Oral Toxicity Test Phase I: Acute toxicity and animal dermal, mucosa test. 急性经口毒性试验
    Acute Dermal Toxicity Test 急性经皮毒性试验
    Dermal Irritation/Corrosion Test 皮肤刺激性/腐蚀性试验
    Acute Eye Irritation/Corrosion Test 急性眼刺激性/腐蚀性试验
    Skin Sensitization Test 皮肤变态反应试验
    Skin Phototoxicity Test 皮肤光毒性和光敏感试验*
    (原料具有紫外线吸收特性时需做该两项试验)
    Subchronic Oral Toxicity Test Phase II: Subchronic Toxicity test and teratogenicity test. 亚慢性经口毒性试验
    Subchronic Dermal Toxicity Test 亚慢性经皮毒性试验
    Teratogenicity Test 致畸试验
    Salmonella Typhimurium/Reverse Mutation Assay Phase III: Mutation test (At least including one gene mutation test and one chromosome aberration test.) 鼠伤寒沙门氏菌/回复突变试验
    In Vitro Mammalian Cells Chromosome Aberration Test 体外哺乳动物细胞染色体畸变试验
    In Vitro Mammalian Cell Gene Mutation Test 体外哺乳动物细胞基因突变试验
    In Vivo Mammalian Bone Marrow Cell Chromosome Aberration Test 哺乳动物骨髓细胞染色体畸变试验
    Mammalian Erythrocyte Micronucleus Test 体内哺乳动物细胞微核试验
    Testicle Cells Chromosome Aberration Test 睾丸生殖细胞染色体畸变试验
    Chronic Toxicity Phase IV: Chronic toxicity and carcinogenicity test 慢性毒性试验
    Carcinogenicity Test 致癌性试验
    Human Skin Patch Test Phase V: Safety and Efficacy Evaluation in Human 人体皮肤斑贴试验
    Safety Evaluation of Using Tests of Cosmetics on Human Body 人体试用试验安全性评价
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