Frequently Asked Questions

• Acute Toxicity : Adverse health effects resulting from a single exposure or multiple exposures within 24 hours. This primarily includes acute oral toxicity, acute dermal toxicity, and acute inhalation toxicity (if there is a potential for inhalation exposure). Includes acute oral toxicity and acute dermal toxicity. Substances of safety concern with moderate or higher acute toxicity are highly likely to cause health hazards.
• Irritation/Corrosion : The extent to which a substance causes reversible irritation or irreversible corrosion to the skin or eyes. This includes both skin and eye irritation/corrosion.
• Skin Sensitization : The potential for and severity of allergic reactions following repeated skin exposure. It is an immune-mediated skin reaction to a substance. In humans, this reaction may be characterized by itching, erythema, papules, vesicles, and confluent vesicles. Animal responses differ and may manifest only as skin erythema and edema.
• Skin Phototoxicity : A toxic skin reaction resulting from a single exposure to a substance followed by ultraviolet (UV) radiation.
• Skin Photoallergy : An abnormal skin response caused by repeated exposure in the presence of ultraviolet radiation.
• Genotoxicity : The potential to cause genetic damage, including gene mutations and chromosomal aberrations.
• Repeated-Dose Toxicity : Functional and/or structural changes in tissues and target organs resulting from repeated exposure over a specified period. This primarily covers three exposure routes: oral, dermal, and inhalation.
• Reproductive and Developmental Toxicity : Adverse effects on parental reproductive function, maternal pregnancy, embryonic development, and the structure and function of the offspring prenatally, perinatally, and postnatally.
• Chronic Toxicity/Carcinogenicity : Toxic effects resulting from exposure over the majority of a normal lifespan and the potential to induce tumors.

Health risks from safety-risk substances can lead to adverse reactions in humans. These are categorized by severity into general cosmetic adverse reactions, serious cosmetic adverse reactions, and those with significant social impact.

Common manifestations of general cosmetic adverse reactions include localized symptoms such as itching, burning, erythema, papules, and edema. Specific reactions vary based on product ingredients and individual differences.

A serious cosmetic adverse reaction is defined as a reaction occurring under normal use that results in any of the following :

(1) Temporary or permanent loss of function affecting normal physical or social activities, such as persistent skin lesions, scarring, permanent hair loss, or significant disfigurement ;

(2) Systemic damage, such as abnormal liver or kidney function or anaphylactic shock ;

(3) Hospitalization, or cases where a medical institution deems hospitalization necessary ;

(4) Other serious harm, life-threatening conditions, or death .

A cosmetic adverse reaction with significant social impact refers to reactions caused by the normal use of the same product within a specific region that lead to widespread public concern or serious harm to multiple individuals.

Safety-risk substances are typically introduced into products as impurities, residues, or degradation products from raw materials or packaging. Some risk substances are trace impurities naturally present in raw materials that are technically unavoidable; others are generated during production because current purification techniques cannot achieve 100% purity; and some migrate from packaging materials into the product.

Effective quality control is essential to prevent safety-risk substances from harming human health. These methods generally include :

• Quality Control of Raw Materials and Packaging: Auditing supplier quality standards and conducting necessary testing for safety-risk substances in raw materials and packaging.
• Production Process Control: Manufacturing in strict compliance with Good Manufacturing Practice (GMP) requirements to minimize the introduction of safety-risk substances.
• Finished Product Safety Assessment and Testing: Conduct safety risk assessments to ensure products are safe under normal use, supported by systematic validation through risk substance testing, stability and preservative challenge tests, packaging compatibility studies, toxicological evaluations, and human safety trials.