Safety evaluation of new cosmetic ingredients guide
This guide is intended to guide cosmetic safety evaluation of new materials.
First, the definition of new cosmetic ingredients
New cosmetic raw material is used in cosmetics in the country for the first time the production of natural or artificial materials.
Second, the new cosmetic raw materials security requirements
New cosmetic raw material usage in cosmetics, in the normal and reasonable foreseeable conditions of use shall not cause harm to human health.
Toxicological evaluation of new information on cosmetic ingredients should include toxicological safety evaluation review, the necessary toxicology testing information security risks and possible materials for safety assessment data.
New cosmetic ingredients, which normally takes the following toxicology tests:
(A) acute oral and acute dermal toxicity test;
(B) the skin and acute eye irritation / corrosion test;
(C) the skin allergy test;
(D) and light-sensitive skin phototoxicity test (UV absorption properties of raw materials has to be done to the pilot);
(E) mutation test (should at least include a gene mutation test and a chromosome aberration test);
(F) sub-chronic oral and dermal toxicity test;
(G) teratogenic test;
(H) chronic toxicity / carcinogenicity test combination;
(Ix) toxicokinetics and dynamics test;
(X) according to the material characteristics and uses, but also consider other necessary tests.
If the new material has been used in cosmetic raw materials and chemical structure and properties of similar, you can consider reducing some of the test.
This guide provides information for the principle requirements of toxicology tests, according to the material physical and chemical properties, toxicology data, clinical research, population epidemiology, QSAR, toxic chemicals and other similar information and to increase or reduce pilot projects.
According to the product of exposure pathways, provide acute or repeated toxicity toxicology data. If 100% skin absorption to calculate the systemic exposure (SED), can be sub-chronic oral toxicity test in the NOAEL for risk assessment, can no longer be sub-chronic dermal toxicity test. For sub-chronic oral and dermal toxicity tests, such as less than 90-day trial period, should be increased safety factor.
Third, apply cosmetics, new materials the specific requirements of the administrative licensing information
Administrative licensing application for new cosmetic ingredients should be "cosmetic declaration accepting the administrative licensing requirement" to submit information. Specific requirements are as follows:
(A) development report
1 material development background, process and related technical information. Natural raw materials should also include the chemical composition, function, toxicological and other research literature or experimental data.
(2) source of raw materials, molecular weight, molecular formula, chemical structure, physical and chemical properties.
(1) sources of raw materials: raw materials should indicate the name, including chemical name, INCI name (the name of the international cosmetics raw materials) (if any) and the Chinese translation, CAS name and CAS number (if any), trade name, should be made clear as natural or artificial materials , the raw material should be a single substance (due to technical reasons such as the compound must be excluded); should be a single source of natural raw materials, should provide the Latin name and the use of parts, etc.; should provide an average molecular weight and polymer molecular weight distribution.
(2) physical and chemical properties: such as sensory properties, solubility, stability, melting point, boiling point, specific gravity, vapor pressure, pH, pKa, refractive index, optical rotation and so on.
3 raw materials used in cosmetics purpose, scope, and based on limited basis for safe use.
(B) the production process description and diagram
Description of new cosmetic ingredients should be involved in the production process the main process parameters, such as the use of raw materials, reaction conditions (temperature, pressure, etc.), catalysts, stabilizers, intermediates and by-products, refining processes; If the natural extract, and should be on its processing, extraction methods, including processing, extraction conditions, the use of solvents, or solvent may be residual impurities such.
(C) the raw material quality and safety control requirements, including specifications, test methods, there may be a security risk substances and their control measures
1. Specifications include: purity, content and other impurities and chemical parameters, shelf life and storage conditions; If the natural extract, and should be clear indicators of its quality control; the case of polymer, monomer and its content should be described ;
2 detection methods: qualitative and quantitative material testing methods, impurity testing methods;
3 may be a security risk substances and their control measures.
(D) safety evaluation of toxicological data, including raw materials, there may be security risks in the safety assessment of material information
Toxicology test data can be the applicant's test data or scientific literature, including domestic and foreign official website, the content of websites of international organizations.
1 apply for new cosmetic ingredients, cosmetics, new materials generally should be required to submit toxicological safety testing data.
2. One of the following circumstances, according to toxicology test data submitted to the following provisions:
(1) Where no included in the "Hygienic Standard for Cosmetics" in preservatives, sunscreens, colorants and dyes, and from a security point of view need not be included in the restricted substances in cosmetics, new materials, should submit the following information:
① acute oral and acute dermal toxicity test;
② skin and acute eye irritation / corrosion test;
③ skin allergy test;
④ skin phototoxicity and light sensitivity test (UV absorption properties of raw materials has to be done when the two trials);
⑤ mutagenicity test (should at least include a gene mutation test and a chromosome aberration test);
⑥ sub-chronic oral and dermal toxicity test;
⑦ teratogenicity test (using the cross-reference to be informed of new cosmetic ingredients except toxicity).
According to the characteristics and use of raw materials, if necessary, may request additional relevant experimental data.
(2) When some parts of the plant extracts have been allowed to be used as cosmetic ingredients, cosmetics, other parts of the application of new materials, should submit the following information:
① acute oral and acute dermal toxicity test;
② skin and acute eye irritation / corrosion test;
③ skin allergy test;
④ skin phototoxicity and light sensitivity test (UV absorption properties of raw materials has to be done when the two trials);
⑤ mutagenicity test (should at least include a gene mutation test and a chromosome aberration test).
When the whole plant have been allowed to be used as cosmetic ingredients, then all parts of the plant material without a new application then.
According to the characteristics and use of raw materials, if necessary, may request additional relevant experimental data.
(3) Where a history of safe human consumption, such as food ingredients, announced the State Council administrative department of food and medicine and other dual-use items, or foreign authority has concluded that the evaluation of the use in cosmetics or food is safe, or in a foreign country or cosmetics in areas approved by the new materials allow the use of cosmetics. Should submit the following information:
① skin and acute eye irritation / corrosion test;
② skin allergy test;
③ skin phototoxicity and light sensitivity test (UV absorption properties of raw materials has to be done to the pilot).
According to the characteristics and use of raw materials, if necessary, may request additional relevant experimental data.
(4) contains at least three monomer units of sequence elements, the at least one additional monomer unit or other reactant connected by covalent bonds, the average molecular weight greater than 1000 daltons cosmetics new polymer materials, should submit the following information:
① skin and acute eye irritation / corrosion test;
② skin phototoxicity test (UV absorption properties of raw materials has to be done to the pilot).
According to the characteristics and use of raw materials, if necessary, may request additional relevant experimental data.
(5) no carcinogenic, mutagenic structure of early warning and systemic exposure (SED) is lower than 1.5ug/kg/day cosmetics new ingredients, should submit the following information:
① acute skin and eye irritation / corrosion test;
② skin allergy test;
③ skin phototoxicity test (UV absorption properties of raw materials has to be done to the pilot).
According to the characteristics and use of raw materials, if necessary, may request additional relevant experimental data.
(6) chemically inert (no active reactive group, such as compounds, inorganic substances, hydrocarbons, etc.) or volatile (boiling point lower than 100 ℃, or the boiling point of between 50 to 260 ℃ and the saturated vapor pressure at room temperature for more than 133.322Pa) The new cosmetic raw materials, should submit the following information:
① skin and acute eye irritation / corrosion test;
② skin phototoxicity and light sensitivity test (UV absorption properties of raw materials has to be done to the pilot).
According to the characteristics and use of raw materials, if necessary, may request additional relevant experimental data.
Fourth, the principle of new cosmetic ingredients review
(A) for the applicant to submit the safety evaluation of new cosmetic ingredients data integrity, reasonable and scientific conduct of the review:
1 safety evaluation of information content is complete and meets the above information requirements;
2 new cosmetic raw material source is clear, the physical and chemical properties of new materials, biological characteristics are clear, the availability of new materials used in cosmetic purpose, basis, scope, use levels, the necessary toxicological testing methods and evaluation of information, etc. ;
3 based on whether the scientific, data adequacy, reasonableness of key data, analysis is scientific, logical, conclusion is correct.
(B) The review considered cosmetic safety evaluation of new raw material problems, the experts should review the relevant provisions of cosmetics regulatory and scientific basis, to make specific comments. The applicant within the prescribed time limit should provide appropriate safety evaluation.
(C) With the development of scientific research, the State Food and Drug Administration has approved the cosmetics can be re-review of new materials, new types of other safety evaluation of cosmetic raw material requirements separately.
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