Guidance on Substances Risk Assessment for Possible Safety Risks in Cosmetics (2010 Edition)

release time： 2019-09-07 10:42:46.000

1. the meaning of possible safety risk substances in cosmetics
Possible safety risk substances in cosmetics refer to substances that are brought in by cosmetic raw materials, produced or brought in during the production process, and may cause potential harm to human health.
Basic procedures for 2. risk assessment
(I) hazard identification: according to the physical and chemical properties of the substance, toxicological test data, clinical research, population epidemiological investigation, quantitative structure-activity relationship and other data to determine whether the substance will cause potential harm to human health.
(II) Hazard Characterization (Dose-Response Relationship Evaluation): Analytically evaluate the relationship between the toxicity of the substance and exposure. For threshold chemicals, the "No Observed Adverse Effect Dose Level (NOAEL)" or the "Lowest Observed Adverse Effect Dose Level (LOAEL)" is determined ". For non-threshold carcinogens, the actual safe dose (VSD) of the substance can be determined based on the experimental data using an appropriate dose-response relationship extrapolation model.
(III) exposure assessment: generally, the possible exposure dose of safety risk substances in cosmetics to human body can be qualitatively and quantitatively evaluated on the basis of full consideration of possible cosmetic users (including special groups, such as infants, pregnant women, etc.) by declaring the product type and use method of cosmetics, combined with the content or detected amount of possible safety risk substances in cosmetics.

Description of (IV) risk characteristics: determine the probability and scope of harm to human health caused by the substance. For substances with a threshold, a margin of safety (MOS) is calculated. For substances without a threshold (e. g. carcinogens without a threshold), the difference between the exposure and the actual safe dose (VSD) should be determined.
Form of submission of 3. assessment information
Applicants may submit assessment information on possible safety risk substances in cosmetics in the following two forms:
If the (I) applicant determines that the product does not contain possible safety risk substances through hazard identification, he or she may submit the corresponding undertaking. The letter of commitment shall state the applicant's analysis process for hazard identification of the product and the reasons why the product does not contain possible safety risk substances.
(II) the applicant believes that the product contains possible safety risk substances after hazard identification, the corresponding risk assessment data shall be submitted.
4. Risk Assessment Data Requirements
For substances with limited values in the relevant regulations of cosmetics in China, it is not necessary to provide relevant risk assessment data; if foreign authorities have established relevant limit values or have relevant evaluation conclusions, the applicant can provide corresponding safety evaluation reports and other information, and there is no need to carry out risk assessment separately.
The risk assessment information submitted by the applicant shall include the following contents:
(I) the source of possible safety risk substances in cosmetics.
An overview of possible safety risk substances in the (II), including the physical and chemical properties and biological properties of the substance.
(III) the content of possible safety risk substances in cosmetics (or raw materials) and their corresponding detection methods, and provide corresponding information.
(IV) a brief review of domestic and foreign regulations or literature on the possible safety risk substances in cosmetics and raw materials, as well as food, water, air and other media (if any).
(V) toxicology related information:
1. A brief description of the toxicological data of the substances that may be safety risks in cosmetics, including at least whether they are included as carcinogens by the International Agency for Research on Cancer (IARC).
2. Provide the corresponding summary of toxicological data with reference to the requirements of the general rules of toxicological test methods in the current Hygienic Standard for Cosmetics. According to the characteristics of the possible safety risk substances, the data of some corresponding items can be increased or decreased.
(VI) risk assessment should follow the basic procedures of risk assessment, combined with the characteristics of the declared products. The risk assessment report shall include the specific assessment content and its conclusions.
If the (VII) formula contains raw materials of plant origin, for the plant raw materials used directly after mechanical processing, it shall be explained that they may contain pesticide residues; for the plant raw materials that need to be further extracted and processed in addition to mechanical processing, if necessary, it shall also be explained that they may contain pesticide residues.
(VIII) the relevant technical data that can reduce the content of possible safety risk substances in the product under the existing technical conditions, and submit process improvement measures if necessary.
The relevant references and materials of the above risk assessment include the applicant's experimental data or scientific literature, including the contents published on the official websites of domestic and foreign countries and the websites of international organizations.
Principles for the review of 5. risk assessment information
If the (I) submits a letter of commitment by the applicant, it shall review whether the product contains any possible safety risk substances related to the prohibited substances stipulated in the Hygienic Standard for Cosmetics and the basis thereof.
The (II) shall review the completeness, reasonableness and scientificity of the risk assessment information submitted by the applicant:
1. Assess whether the content of the information is complete and meets the requirements of the above-mentioned relevant information. If it cannot be fully provided, it should be reasonably explained;
2. Whether the source of information is reliable and whether the information provided is a test, test report or published scientific literature;
3. Whether the source of the possible safety risk substance is clear, whether the physical and chemical characteristics and biological characteristics of the substance are clear, whether the content of the substance and the corresponding detection method are provided, necessary toxicological evaluation data, risk assessment process and assessment conclusion, etc;
4. Whether the basis is scientific, whether the data are sufficient, whether the key data are reasonable, whether the analysis is scientific and logical, and whether the conclusion is correct.
If the (III) considers that there are problems in the letter of commitment after review, the review experts shall put forward specific opinions and relevant basis according to the relevant provisions of cosmetics supervision. The applicant shall, within the prescribed time limit, provide the basis or the corresponding risk assessment information that does not contain possible safety risk substances.
(IV), with the development of scientific understanding, the State Food and Drug Administration may re-review the risk assessment data related to the possible safety risk substances in cosmetics that have been approved or filed.