Guidance On The Declaration And Review Of New Raw Materials For Cosmetics Registration
First, the definition of new raw materials Cosmetics Registration
Cosmetics Registration new raw materials refers to the first domestic use in cosmetics for the production of natural or artificial raw materials.
Second, cosmetics registration of new raw materials safety requirements
Cosmetics Registration new raw materials in normal and reasonable, predictable use conditions, shall not be harmful to human health.
Cosmetic registration of new materials Toxicological evaluation data should include a review of toxicological safety assessment, necessary toxicological test data and possible safety assessment data for potentially hazardous substances.
Cosmetics registration of new raw materials generally need to carry out the following toxicology test:
(A) acute oral and acute percutaneous toxicity test;
(B) skin and acute eye irritation / corrosive tests;
(C) skin allergy test;
(D) skin phototoxicity and light sensitivity test (raw material with UV absorption characteristics need to do the test);
(5) Mutagenesis tests (including at least one mutation test and one chromosome aberration test);
(Vi) Subchronic oral and percutaneous toxicity tests;
(7) teratogenic tests;
(8) chronic toxicity / carcinogenicity test;
(9) toxic metabolic and kinetic tests;
(10) Depending on the nature and use of the raw materials, other necessary tests may also be considered. If the new feedstock is similar to the chemical structure and properties of the raw materials already used in cosmetics, it may be considered to reduce certain tests.
Toxicology test data for the principle of the requirements, according to the physical and chemical properties of raw materials, quantitative structure-activity relationship, toxicological information, clinical research, population epidemiological survey and similar compounds such as toxicity, increase or reduce the pilot project.
Third, cosmetics registration of new raw materials administrative license to declare information requirements
Application for cosmetics registration of new raw materials administrative license should be submitted according to the provisions of the administrative approval of cosmetics submitted to the information. Specific requirements are as follows:
(A) cosmetics registration of new raw materials administrative license application form
(B) development of the report
1. The background, process and related technical information of raw material research and development.
2. Raw material name, source, relative molecular mass, molecular formula, chemical structure, physical and chemical properties.
(1) Name: Chemical name (IUPAC and / or CAS), INCI name and Chinese translation, trade name and CAS number of the raw material. The name of the raw material should also indicate the use of the raw materials specifications.
Natural raw materials should also provide Latin scientific name.
(2) Source: Raw materials should not be compounded, except for solvents, stabilizers, carriers, etc. that are unavoidable in the raw materials due to technical reasons.
Natural raw materials should be a single source, and provide the use of parts and so on. The whole plant has been allowed to be used as a raw material for cosmetics, and no part of the plant needs to be declared by new raw materials.
(3) relative molecular mass, molecular formula, chemical structure: should provide the basis for the confirmation of chemical structure (such as nuclear magnetic resonance spectroscopy, elemental analysis, mass spectrometry, infrared spectrum, etc.) and its analytical results, the polymer should also provide a relative average molecular weight And its distribution.
(4) Physical and chemical properties: including color, odor, state, solubility, melting point, boiling point, specific gravity, vapor pressure, pH value, pKa value, refractive index, optical rotation and so on.