Guidelines for the RA 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. Now the draft version of the Guidelines has been released and has been translated by REACH24H.
- Authors / Editors:
- REACH24H Consulting Group
- Price:
- € 50
Released in Mandarin Chinese, there are a total of 5 chapters, including the scope, terms and definitions, data required for risk assessment, risk assessment procedure of cosmetic raw materials and risk assessment report of cosmetic raw materials. The Guideline stipulates the China cosmetic raw material risk assessment terms, general principles, technology and requirements. The Guideline also applies to China cosmetic raw materials and finished cosmetics products that create impurities during progress by raw material or in the production process. We have translated the new guidance document into English and it is available for €50.
Highlights
- This Guideline will become one of the Chinese Recommendatory National Standards, and it is the first Guideline to instruct the cosmetic manufacturers or importers how to perform risk assessment on cosmetic raw materials.
- The principles of risk assessment sources ideas from mainly European and U.S. publications e.g. SCCP, EPA, WHO, IPCS.
- It recommends qualitative assessment & quantitative assessment--- the use of indexes like the MOS (Margin of safety) and LCR (Lifetime Cancer Risk) to evaluate the safety of cosmetic raw materials.
- Due to its property as a draft for comments, several parts are still under discussion and undetermined, e.g. the number of this National Standard, the date of issue and implementation, and the department for explanation. All these issues will be confirmed in the final version.
- Once the final version of this guideline is available, REACH24H Consulting Group will update this English version document as soon as possible.
Contents of Guidelines for the RA of Cosmetic Raw Materials (English Translation)
1. Scope
2. Terms and definitions
2.1 Cosmetic raw material
2.2 Hazard
2.3 Risk
2.4 Risk assessment
2.5 Quantitative structure-activity relationship, QSAR
2.6 Dose
2.7 Threshold dose
2.8 No Observed Adverse Effect Level, NOAEL
2.9 Lowest Observed Adverse Effect Level, LOAEL
2.10 Benchmark Dose, BMD
2.11 Threshold compounds
2.12 Non-threshold compounds
2.13 Systemic Exposure Dosage, SED
2.14 Margin of Safety, MOS
2.15 Acceptable risk
2.16 T25
3. Data required for the risk assessment
3.1 Physical and chemical specifications of the cosmetic raw material
3.1.1 Designation
3.1.2 Physical form
3.1.3 Chemical structure, formula and molecular weight
3.1.4 Purity
3.1.5 Solubility
3.1.6 Partition coefficient
3.1.7 Additional relevant physical and chemical specifications
3.1.8 Data on the applications of raw material to be used in cosmetic products
3.1.9 Data for complex raw materials
3.1.10 Data for raw materials of mineral origin
3.1.11 Data for raw materials of botanical origin
3.1.12 Data for raw materials of animal origin
3.1.13 Data for raw materials derived by biotechnology
3.2 Toxicity data
3.2.1 Acute toxicity test data
3.2.2 Irritation and corrosion test data
3.2.3 Skin sensitization test data
3.2.4 Mutagenicity test data
3.2.5 Repeated dose toxicity
3.2.6 Developmental and reproduction toxicity data
3.2.7 Carcinogenicity test data
3.2.8 Photo-induced toxicity data
3.2.9 Percutaneous absorption test data
3.2.10 Data of toxicokinetic studies
3.2.11 Additional toxicity data
3.3 Human safety data
3.3.1 Data of human safety testing
3.3.2 Data of population-based epidemiology
4. Risk assessment procedure of cosmetic raw materials
4.1 Hazard identification
4.1.1 Classification of human health hazards
4.1.2 Determination of hazard identification
4.2 Dose-response assessment
4.2.1 Dose-response assessment of threshold compound
4.2.2 Dose-response assessment of non-threshold compound
4.3 Exposure assessment
4.3.1 Influencing factors to be considered in exposure assessment
4.3.2 Calculation of systemic exposure dosage (SED)
4.4 Risk characterization
4.4.1 Risk characterization of threshold compounds
4.4.2 Risk characterization of non-threshold compounds
5. Risk assessment report of cosmetic raw material
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