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Formulation

화장품 출시 전 필수 테스트 종류 : 안전성, 유효성, 규제 준수

by 쥐끼리 2024. 11. 13.

소비자 안전과 효과를 위한 화장품 필수 테스트 : 종류, 정의, 방법. 

화장품 연구소에서 소비자에게 전달되기까지 수많은 과정을 거치는 데 그중에서 가장 중요한 과정 중 하나가 안전성, 유효성 테스트이다. 모든 테스트를 다 거치는 것은 아니고 각 화장품의 제형, 쓰임에 따라서 거쳐야 하는 테스트가 다르다. 그렇기 때문에 테스트의 종류와 정의를 알아두면 도움이 많이 된다. 

 

1. Stability testing 

Purpose: Ensures the product maintains quality, safety, and performance over time. 
Temperature
Stability
Products are stored at different temperatures (often 4°C, 25°C, 40°C) to check if they remain stable. The product's appearance, color, odor, and viscosity are evaluated at intervals. 
The period is usually 3 to 6 months. 
Freeze-Thaw
Cycles
To test resilience in extreme conditions, it undergoes repeated cycles of freezing (usually at -5°C ) and thawing at room temperature. After each cycle, it is checked for changes in texture, separation, or color. 
Light Stability Tests for color, scent, and formula stability under UV light or sunlight exposure. Light stability chambers may be used to simulate prolonged sunlight exposure.
Packaging
Compatibility
Products are stored in their final packaging at different temperatures to see if any interaction (like leaching of chemicals from the packaging or changes in the product) occurs.

 

 

2. Microbiological Testing

Purpose: Ensure that the product is free from harmful microorganisms and is safe for use. 
Preservative
Efficacy

Testing (PET)

Verifies that preservatives can effectively inhibit microbial growth.
The product is inoculated with various microorganisms (e.g., bacteria, yeast, mold). Over several days or weeks, samples are taken to measure microbial levels, ensuring that the preservatives effectively reduce or inhibit growth.
Microbial
Limits Testing 

Tests the product for bacterial, yeast, and mold counts to ensure it’s within safe limits.
Samples are incubated on agar plates or in liquid media specific to bacteria, yeast, and mold, and then observed to ensure contamination levels are within acceptable limits.
Challenge
Testing 

Purposefully contaminates the product with microbes to see if the preservatives can kill or inhibit them.
The product is contaminated intentionally with specific microbes to verify preservative effectiveness. Microbial counts are measured at specific time intervals to ensure they decrease as expected.  

 

 

3. Safety Testing 

Purpose: Assesses the product's potential for causing skin irritation, allergic reactions, or other adverse effects.
Patch 
Testing 

Applies the product to the skin to check for irritation, especially leave-on products.
Put a small amount of product on a patch, and then applied to the test subject's skin for 24-72 hours. Skin is observed for redness, itching, or other reactions. 
Eye irritation
Testing

Especially for products used around the eyes, to ensure no irritation.
Samples are applied to animal-free eye models (e.g., artificial human cornea equivalents) to assess irritation. The redness, swelling, or cell viability is then evaluated.
Sensitization 
Test

Ensures that repeated exposure doesn’t lead to allergic reactions or sensitization.
The product is repeatedly applied to test subjects or artificial skin models over some time to check if cumulative exposure causes allergic reactions.
Toxicological 
Assessment 

Includes an evaluation of ingredient toxicology to ensure safety at the intended usage levels.
Toxicologists assess the toxicity of each ingredient based on exposure levels and existing data, ensuring that they fall within safe limits for human use.

 

 

4. Efficacy Testing

Purpose: Verifies that the product performs as claimed (e.g., “moisturizing,” “anti-aging,” or “brightening”).
Clinical Trials Tests on human subjects to assess the actual effects (hydration, wrinkle reduction, etc.).
Consumer
Perception Test
Participants use the product and provide feedback on their experience and perceived effects.
In-vitro Testing  Uses laboratory techniques under controlling to analyze product effects on skin cells, collagen production, etc.

 

 

5. Dermatological Testing

Purpose: Ensures the product is compatible with skin and does not cause adverse reactions.
Dermatologist-Tested Claims Verifies that the product has been evaluated and endorsed by dermatologists.
Hypoallergenic Testing Assesses the product’s potential to cause allergic reactions; products that pass may be labeled “hypoallergenic.”

 

 

6. Product- Specific Tests

Purpose: Additional tests for products with specific functions, like sunscreen or anti-dandruff treatments.
SPF Testing Verifies the sun protection factor (SPF) for sunscreen products. Appling product on the test subject or skin substitutes, which are then exposed to UV light. The level of protection (SPF rating) is caculated based on the amount of UV light blocked or reflected. 
Water Resistance Testing Measures the durability of sunscreens in water.
Foam Stability For shampoos, body washes, and other foam-based products, checking if foam production and stability meet standards.

 

 

7. Regulatory Compliance Tests

Purpose: Ensures that the product complies with regional regulatory requirements (e.g., FDA in the U.S., EU Cosmetic Regulation, etc.).
Labeling Compliance  Verifies that ingredient lists, claims, and warnings meet regulatory standards.
Prohibited Ingredients
Testing
Ensures that the product does not contain banned or restricted substances.
Good Manufacturing
Practice (GMP)
Confirms that manufacturing processes meet quality standards.

 

 

8. Sensory Evaluation

Purpose: Evaluate the sensory attributes such as texture, fragrance, and overall feel.
Texture and
Spreadability Tests
Panelists or instrumental tests evaluate the feel of the product on the skin.
Fragrance Stability
Testing 
Ensures that the fragrance doesn’t change or fade undesirably over time.
Color Consistency Verifies that the product’s color remains consistent in different lighting conditions.