CTFAS Flashcards
How to calculate risk? (Cosmetic product safety principle)
Risk = Hazard X Exposure
How to calculate the margin of safety?
MOS = NOAEL / SED (more than or equal to 100)
How do we account for babies and children with the adults’ calculated MOS?
Cover an additional factor of “10”
Why is stability testing required?
- product safety
- product quality during storage, transportation, use
- Shelf-life
- Optimise formulation, process, and appropriate packaging
What is the purpose of microbiological limits test?
- Done on raw materials
* Assess and detect the presence of primary contamination during manufacturing
What is the purpose of the microbiological challenge test?
- Final products
* Assess preservation efficiency for preventing secondary contamination due to consumer uses
What is the purpose of the microbiological in-use tests?
- Confirm preservation efficiency for preventing secondary contamination
- Not included in test guidelines and not mandatory currently
What are low-risk products exempted from microbiological (challenge) testing?
- Soap bars
- > /= 20% ethanlol
- > /= 65oC
- > /= 10% for organic solvents
What is the acceptance criteria for yeast / molds and E.coli for microbiological limit test?
- Yeasts/Mold: 1X10^2 CFU/g or mL
- E. coli: Absence
What are the acceptance criteria for finished products for children under 3 years?
- Normal: =< 1000 cfu/g or mL
- Babies: =< 500 cfu/g or mL
Exceptions: P. aeruginosa, S. aureus, C. albicans (all absent)
What does CTFAS stand for?
The cosmetic toiletry and fragrance association of Singapore
How much does Singapore contribute to ASEAN in terms of cosmetic sales?
5%
Of all cosmetic products, which products contribute to 55% of the overall market for ASEAN in personal care?
Hair care and skin care
