Guidelines for the Risk Assessment of Cosmetic Raw Materials (draft)

A Commission from the Ministry of Health of the People's Republic of China to produce 'Guidelines for Risk Assessment of Cosmetic Raw Materials (draft)' was undertaken by the Chinese Center for Disease Control and Prevention (CDC) in 2008. After compilation of the Guidelines, the CDC allowed consultation until 30th April, 2011.

• Scope

• Terms and definitions

• Cosmetic raw material

• Hazard

• Risk

• Risk assessment

• Quantitative structure-activity relationship, QSAR

• Dose

• Threshold dose

• No Observed Adverse Effect Level, NOAEL

• Lowest Observed Adverse Effect Level, LOAEL

• Benchmark Dose, BMD

• Threshold compounds

• Non-threshold compounds

• Systemic Exposure Dosage, SED

• Margin of Safety, MOS

• Acceptable risk

• T25

• Data required for the risk assessment

• Data of human safety testing

• Data of population-based epidemiology

• Acute toxicity test data

• Irritation and corrosion test data

• Skin sensitization test data

• Mutagenicity test data

• Repeated dose toxicity

• Developmental and reproduction toxicity data

• Carcinogenicity test data

• Photo-induced toxicity data

• Percutaneous absorption test data

• Data of toxicokinetic studies

• Additional toxicity data

• Designation

• Physical form

• Chemical structure, formula and molecular weight

• Purity

• Solubility

• Partition coefficient

• Additional relevant physical and chemical specifications

• Data on the applications of raw material to be used in cosmetic products

• Data for complex raw materials

• Data for raw materials of mineral origin

• Data for raw materials of botanical origin

• Data for raw materials of animal origin

• Data for raw materials derived by biotechnology

• Physical and chemical specifications of the cosmetic raw material

• Toxicity data

• Human safety data

• Risk assessment procedure of cosmetic raw materials

• Risk characterization of threshold compounds

• Risk characterization of non-threshold compounds

• Influencing factors to be considered in exposure assessment

• Calculation of systemic exposure dosage (SED)

• Dose-response assessment of threshold compound

• Dose-response assessment of non-threshold compound

• Classification of human health hazards

• Determination of hazard identification

• Hazard identification

• Dose-response assessment

• Exposure assessment

• Risk characterization

• Risk assessment report of cosmetic raw material