Compliance Guide for Cosmetic Safety Assessment

I. Key Dates and Scope

• The Technical Guidelines for Cosmetic Safety Assessment (2021 Edition) took effect on May 1, 2021.
• Since January 1, 2022, all applicants for “Special Cosmetics” or “General Cosmetics” must conduct safety assessments and submit safety data based on these guidelines before registration or notification.
• The Several Measures to Optimize Cosmetic Safety Assessment Management took effect on May 1, 2024.
• Starting May 1, 2025, a full version of the safety assessment report must be submitted for all registration and notification applications.
• These guidelines apply to the safety assessment of both cosmetic ingredients そして finished products.

II. Qualifications for Safety Assessors

Cosmetic safety assessors must meet the following requirements:

• Expertise: Have professional knowledge in fields like medicine, pharmacy, biology, chemistry, or toxicology. They must understand how products and ingredients are made and how quality is controlled.
• Experience: Have at least 5 years of relevant professional experience.
• Analytical Skills: Be able to find, analyze, and interpret information from scientific literature and toxicological data.
• Objectivity: Be able to analyze safety fairly. They must base their work on all available data and actual usage conditions. They are responsible for the report’s accuracy and reliability.
• Continuous Learning: Keep their knowledge up to date through regular training on new assessment theories and technologies.

III. The Four-Step Risk Assessment Process

The risk assessment for ingredients and substances involves these four steps:

1. Hazard Identification: Determining if a substance could potentially harm human health based on lab tests, clinical studies, or reports of bad reactions. This covers things like skin irritation, allergies, and long-term toxicity.
2. Dose-Response Assessment: Finding the relationship between the amount of exposure and the severity of the reaction. The goal is to find the NOAEL (the highest dose where no harmful effects are seen).
3. Exposure Assessment: Calculating the SED (Systemic Exposure Dosage)—how much of the substance actually gets into the human body based on where it’s applied, how often, and for how long.
4. Risk Characterization: Determining if the product is safe. For most substances, we calculate the MoS (Margin of Safety). Generally, an MoS of 100 or higher is considered safe.

IV. Core Principles for Assessment

1. Ingredient Assessment

• Ingredients listed in the Safety and Technical Standards for Cosmetics (e.g., restricted ingredients, preservatives, sunscreens, colorants) must follow the specific limits in those standards.
• Assessors can use safety limits or conclusions published by international authorities (like the WHO, FAO, or IFRA for fragrances).
• For ingredients with very little data, specific scientific methods like TTC (Threshold of Toxicological Concern) or Read-across (comparing with similar chemicals) can be used.

2. Product Assessment

• Assessment should be “exposure-oriented,” considering how the product is used and where it is applied.
• For a series of products with the same base formula but different scents or colors, only the changed parts need to be assessed.
• Children’s Cosmetics: Must account for children’s physical differences. Generally, ingredients meant for whitening, acne, or hair growth/dyeing are not allowed.

V. Testing for Harmful Substances

• Required Tests: All products must be tested for Mercury ($\le1$ mg/kg), Lead ($\le10$ mg/kg), Arsenic ($\le2$ mg/kg), and Cadmium ($\le5$ mg/kg).
• Dioxane: Currently $\le30$ mg/kg; this will drop to $\le10$ mg/kg on January 1, 2027.
• Asbestos: Products containing talcum powder must not contain any detectable asbestos.
• Children’s Products: Extra attention is paid to allergens in fragrances and impurities like Diethylene Glycol in Glycerin ($\le0.1\%$).

VI. 2024 Update: How to Submit Reports

Cosmetics are now divided into two categories for submission:

• Category 1 (High Risk): Special cosmetics, children’s products, and products using “new ingredients” still under monitoring. A full safety assessment report must be submitted.
• Category 2 (Standard Risk): General cosmetics.
  • Scenario A (e.g., anti-wrinkle, acne, aerosols, or products used with tools): If the company has a good quality system, they can submit a summary/conclusion and keep the full report on file.
  • Scenario B (All other general cosmetics): If the quality system is good, they only need to submit the basic conclusion.

VII. Record Keeping

Safety assessment records must be kept for at least 10 years after the expiration date of the last batch of the product sold.