Safety Test
Laboratory Accreditation
The testing institution has been accredited by ILAC (International Laboratory Accreditation Cooperation),
and its test results are internationally recognized worldwide.
safety-test
Patch Test
A Patch Test, also known as a human patch test, is a testing method used to evaluate whether cosmetics, skincare products, or other topical products may cause adverse skin reactions such as irritation or sensitivity.
Primary Irritation Test
Purpose: Evaluate the irritation potential of a product on the skin
Test Duration: 72 hours (24-hour application + 48-hour observation)
Subjects: Can be conducted on normal skin or specific skin types (e.g., sensitive skin, reactive skin, atopic-prone skin)
Number of Subjects: 30 participants
Also known as the 24-Hour Patch Test.
Patches containing different concentrations of the test product are applied to the skin of participants.
The patches remain on the skin for 24 hours, after which participants return to the testing site for patch removal.
Following removal, the test area is evaluated immediately, as well as 24 and 48 hours later,
for signs of irritation such as redness, dryness, or other skin reactions.
Repeated Insult Patch Test (RIPT)
Purpose: Evaluate the sensitization potential of a product on the skin
Test Duration: 6 weeks
Subjects: Normal skin
Number of Subjects: 50 / 100 participants
The first phase is the Induction Phase, during which the participant’s skin is repeatedly exposed to the test product.
After completion of this phase, participants undergo a two-week rest period.
During this time, if a participant is allergic to the product,
the immune system may develop specific proteins that can trigger an allergic response upon subsequent exposure.
The second phase is the Challenge Phase,
where the product is reapplied to a new area of the participant’s skin to determine whether repeated exposure induces an allergic reaction.
Preservative Effectiveness Test
Purpose: Evaluate the effectiveness of preservative systems in cosmetics against microbial contamination during product use
Test Duration: 4 weeks
Also known as the Challenge Test.
The Antimicrobial Effectiveness Test is performed to assess the preservative capability of a product,
ensuring that it remains resistant to microbial contamination and spoilage during normal use.
* Products considered low microbiological risk, single-use products,or products with non-openable packaging may be exempt from preservative challenge testing.
Microbiological Testing
Purpose: Evaluate whether a product has been contaminated by microorganisms before release
Test Duration: 72 hours
The microbiological limits for cosmetics must comply with the regulations stated in the “Microbial Limits for Cosmetics” announced by the Ministry of Health and Welfare (MOHW).
Total Microbial Count
-
Cosmetics intended for children under 3 years old, products used around the eyes, or products applied to mucosal areas:
≤ 100 CFU/g or CFU/mL -
Other cosmetic products:
≤ 1000 CFU/g or CFU/mL
The Following Microorganisms Must Not Be Detected
-
Escherichia coli
-
Pseudomonas aeruginosa
-
Staphylococcus aureus
-
Candida albicans
* Although products considered to have lower microbiological risk may be exempt from microbiological testing under certain regulations, there is still a possibility of excessive microbial contamination. Therefore, strict quality control remains essential to ensure product safety.
Physicochemical Factors of Formula Ingredients
pH
Anhydrous Products
Water Activity (aw)
Alkaline Compounds
Ethanol / Other Alcohols
Polar Organic Solvents
Hydrogen Peroxide
Aluminum Chlorohydrate and Related Salts
Filling Temperature
Criteria
≤ 3 or ≥ 10
–
≤ 0.75
Ammonia: ≥ 0.5% / Monoethanolamine: ≥ 1%
≥ 20%
> 10%
≥ 3%
≥ 20%
≥ 65°C
Definition of Low Microbiological Risk Products (ISO 29621:2017)
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