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Cosmetic safety assessment

In order to ensure the safety of cosmetics and standardize the safety assessment of cosmetics, the safety of raw materials is a prerequisite for the safety of cosmetic products.
The risk assessment of cosmetic raw materials includes the raw materials themselves and the risk substances that may be introduced; cosmetic products can generally be considered as a combination of various raw materials, and the assessment should be based on all raw materials and risk substances.
In the case of biological interactions, the risky substances and/or potential safety risks arising from the interaction shall be evaluated.
The safety evaluation of cosmetics shall follow the principle of evidence, based on existing scientific data and related information, and follow the principles of science, fairness, and The principles of transparency and case-by-case analysis should ensure the independence of safety assessment work during the implementation process.

Laws

In order to implement the "Regulations on Supervision and Administration of Cosmetics," and to standardize and guide the safety assessment of cosmetics, the State Food and Drug Administration announced:
1. Starting from January 1, 2022, before applying for special cosmetics registration or general cosmetics registration, cosmetics registrants and recorders must carry out cosmetic safety assessments in accordance with the requirements of the "Technical Guidelines for Cosmetic Safety Assessment (2021 Edition)" and submit Product safety assessment data.
2. In order to standardize and guide the safety assessment of cosmetics, the "Technical Guidelines for Cosmetic Safety Assessment (2021 Edition)" provides examples of the full version and simplified version of the cosmetic product safety assessment report. Before May 1, 2024, cosmetics registrants and recorders can submit a simplified version of the product safety assessment report in accordance with the relevant requirements of the Technical Guidelines.

Safety assessment personnel qualification

Have medical, pharmacy, biology, chemistry or toxicology related professional knowledge of cosmetics quality and safety, understand the production process of cosmetic finished products or raw materials and quality and safety control requirements, and have more than 5 years of relevant professional experience.

Risk assessment procedures

1.1Hazard identification
1.2Assessment of dose-response relationship
1.3Exposure assessment
1.4Risk characterization
Evaluation principle
The safety assessment of cosmetic products should be exposure-oriented, combining the use of the product, the location of use, the amount of use, residue and other exposure levels to conduct a safety assessment of the cosmetic product to ensure product safety.

Safety assessment report of cosmetic products

The safety assessment report of cosmetic products usually includes abstract, product introduction, product formula, formula design principles (only for children's cosmetics), safety assessment of each ingredient in the formula, assessment of possible risk substances, risk control measures or recommendations, and safety assessment conclusions , Security evaluator’s signature and resume, references and appendices, etc.