National Food and Drug Administration Supervision [2010] No. 339

Food and Drug Administration (Drugs and Drugs Supervision Bureaus) of provinces, autonomous regions, and municipalities directly under the Central Government:

In order to guide the development of cosmetic safety evaluation, the Bureau organized the “Guidance on Risk Assessment of Substances that May Occur in Cosmetics” and is hereby issued and issued.

State Food and Drug Administration

August 23, 2010

Possible Safety Risks in Cosmetics Material Risk Assessment Guide

I. The meaning of the possible safety risk substances in cosmetics

The safety risk substances that may exist in cosmetics are substances that are brought into or produced during the production process by cosmetic raw materials and may pose a potential hazard to human health.

Second, the basic procedures for risk assessment

(I) Hazard identification: According to the physicochemical properties of materials, toxicological data, clinical studies, population epidemiological investigations, quantitative structure-activity relationships, etc. to determine whether the substance will cause potential harm to human health.

(B) Description of hazard characteristics (dose-response relationship assessment): Analyze and evaluate the relationship between toxicity and exposure of the substance. For threshold chemicals, determine "no effective dose level (NOAEL)" or "lowest observed dose (LOAEL)." For non-threshold carcinogens, an actual dose-response (VSD) for the substance can be determined from the experimental data using an appropriate dose-response relationship extrapolation model.

(C) Exposure assessment: generally through the declaration of cosmetic product types and methods of use, combined with the possible presence of safe risk substances in cosmetics or the amount of detection, in full consideration of the possible use of cosmetics (including special groups, such as infants On the basis of infants, pregnant women, etc.) qualitative and quantitative evaluation of the possible exposure doses of substances that may exist in cosmetics.

(IV) Description of risk characteristics: determine the probability and scope of the hazards caused by the substance to human health. For substances with thresholds, calculate the safety margin (MOS). For substances without a threshold (eg, thresholdless carcinogens), the difference between the exposure and the actual safe dose (VSD) should be determined.

Third, the submission of assessment data

Applicants may submit safety risk assessment materials that may be present in cosmetics in the following two forms:

(1) If the applicant identifies through hazard identification and judges that the product does not contain any possible safety risk substance, it may submit a corresponding commitment letter. The letter of commitment shall state the analysis process of the applicant's hazard identification of the product and the reason why the product does not contain any possible safety risk substances.

(2) If, after the hazard identification, the applicant believes that the product contains possible safety risk substances, it shall submit corresponding risk assessment data.

Fourth, risk assessment data requirements

For those substances that have already had a limited amount of value in the relevant provisions of cosmetics in China, relevant risk assessment materials are not required to be provided; if foreign authorities have established relevant limit values ​​or already have relevant evaluation conclusions, the applicant may provide relevant safety evaluation reports, etc. No additional risk assessment is required.

The risk assessment data submitted by the applicant should include the following:

(A) The sources of possible safety risk substances in cosmetics.

(b) An overview of possible safety hazards, including the physicochemical characteristics and biological characteristics of the substance.

(3) The content of dangerous substances that may be present in cosmetics (or raw materials) and the corresponding detection methods, and provide corresponding information.

(4) A brief summary of the limits or levels of potential safety risk substances in cosmetics and raw materials and in food, water, air and other media (if any) in domestic and foreign laws and regulations or in the literature.

(V) Toxicological related data:

1. Potential Safety Risks in Cosmetics A brief description of the toxicological information of substances includes at least whether or not they have been included as carcinogens by the International Agency for Research on Cancer (IARC).

2. According to the requirements of the current General Principles of Toxicology Test of Cosmetic Hygiene Practices, provide corresponding toxicological information. According to the characteristics of possible safety risk substances, the data of certain corresponding items may be increased or decreased.

(6) The risk assessment shall follow the basic procedures for risk assessment, combined with the characteristics of the declared products. The risk assessment report should include the specific assessment content and its conclusions.

(7) If the formula contains plant-derived raw materials, the plant raw materials used directly after mechanical processing shall be described. The situation may include the presence of pesticide residues; for the plant processing materials that require further extraction and processing besides mechanical processing, if necessary, , should also indicate that it may contain pesticide residues.

(8) Under the existing technical conditions, technical data that can reduce the safety risk substance content that may exist in the product, and if necessary, submit technical improvement measures.

The relevant reference materials and materials for the above risk assessment include the applicant's test data or scientific literature materials, including the content published by official websites at home and abroad and websites of international organizations.

V. Principles for reviewing risk assessment data

(1) Where the applicant submits a commitment letter, the product shall be reviewed for possible existence of safety-risk substances and their basis in relation to banned substances etc. stipulated in the Hygiene Standards for Cosmetics.

(2) Where the applicant submits risk assessment materials, it shall review its completeness, rationality and scientific nature:

1. The assessment of the content of the data is complete and meets the requirements of the above-mentioned relevant data, and there should not be a reasonable explanation for the complete supply.

2. Is the source of information reliable and the information provided is a test, test report or published scientific literature;

3. Possible existence of safety risk Material source is clear, whether the physical and chemical characteristics, biological characteristics of the substance are clear, whether to provide the content of the substance and the corresponding detection method, necessary toxicological evaluation data, risk assessment process and evaluation conclusion Wait;

4. Based on whether it is scientific, whether the information is sufficient and whether the key data are reasonable, whether the analysis is scientific and logical, and whether the conclusion is correct.

(3) After the review concludes that there is a problem with the commitment letter, the review expert shall submit specific opinions and relevant basis according to the relevant provisions of cosmetic supervision. The applicant shall provide the basis or corresponding risk assessment information that does not contain possible safety risk substances within the prescribed time limit.

(4) With the development of scientific understanding, the State Food and Drug Administration may re-evaluate the risk assessment materials related to possible safety risk substances in cosmetics that have been approved or filed.