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Resource of K.Beauty’s Expertise


Specialized in Reviewing and Revising Cosmetic Labels

We ensure labels for U.S.-bound cosmetic products comply with FD&C Act requirements, 21 CFR 701 & 740, and the Fair Packaging and Labeling Act. This helps prevent misbranding issues and ensures all mandatory FDA label statements are met.

Drawing on the development of more than 300 private-label cosmetic products for major U.S. retailers, we have built an internal label review database by analyzing FDA Warning Letters, 
Import Alerts, and litigation cases. We can adjust label wording to reduce or eliminate the need for clinical tests where possible.

Resource of K.Beauty’s Expertise

Specialized in Reviewing and Revising Cosmetic Labels

We ensure labels for U.S.-bound cosmetic products comply with FD&C Act requirements, 21 CFR 701 & 740, and the Fair Packaging and Labeling Act. This helps prevent misbranding issues and ensures all mandatory FDA label statements are met.

Drawing on the development of more than 300 private-label cosmetic products for major U.S. retailers, we have built an internal label review database by analyzing FDA Warning Letters.

Import Alerts, and litigation cases. We can adjust label wording to reduce or eliminate the need for clinical tests where possible.

Specialized in Cosmetic Ingredient Review

process starts with ingredient label verification. We examine each component against U.S. regulations (e.g., Prop 65, state-level banned substances), known allergens, and more. Unlike standard reviews that only check INCI names, CAS numbers, and functions, we assess every ingredient across 12 different criteria to confirm safety. We also compile preemptive documentation for any flagged ingredients, creating a robust foundation to meet MoCRA standards.

Specialized in Cosmetic Ingredient Review


Our Formula Review Worksheet (FRW) process starts with ingredient label verification. We examine each component against U.S. regulations (e.g., Prop 65, state-level banned substances), known allergens, and more. Unlike standard reviews that only check INCI names, CAS numbers, and functions, we assess every ingredient across 12 different criteria to confirm safety. We also compile preemptive documentation for any flagged ingredients, creating a robust foundation to meet MoCRA standards.

What is a Formula Review Worksheet (FRW)?

A FRW is a document for assessing the safety of cosmetic products. Each ingredient is cross-checked against 12 review criteria (ECHA/CIR/Prop 65/Whole Foods Premium/Whole Foods Base/EU 60 allergens/State Banned/California Safe Cosmetics Program, etc.) to determine its safety. If an ingredient cannot be fully verified through this process, we recommend obtaining additional safety documentation from the raw material supplier.


What is a Formula Review Worksheet (FRW)?

A FRW is a document for assessing the safety of cosmetic products. Each ingredient is cross-checked against 12 review criteria (ECHA/CIR/Prop 65/Whole Foods Premium/Whole Foods Base/EU 60 allergens/State Banned/California Safe Cosmetics Program, etc.) to determine its safety. If an ingredient cannot be fully verified through this process, we recommend obtaining additional safety documentation from the raw material supplier.

1. In the United States, the PCPC (Personal Care Products Council) evaluates the safety of cosmetic ingredients through the Cosmetic Ingredient Review (CIR). From a company’s perspective, ingredients are classified as Safe, Safe Question (conditionally safe), or Insufficient (insufficient data).
2. In Europe, the European Chemicals Agency (ECHA) assesses each ingredient for potential “Danger/Warning” risks—covering skin and eye irritation, respiratory issues, and the safety of personnel who regularly handle cosmetic raw materials. This identifies any hazardous or warning components in the product.
3. Under in-house standards, ingredients are evaluated against the ingredient guidelines of Whole Foods Market (the largest organic supermarket in the U.S.) to determine whether they are acceptable. Whole Foods’ standards are considered among the strictest in the U.S. from a consumer perspective. (The “Premium” category applies to Whole Foods’ private-label products.)

4. In-House Baseline: We distinguish between permissible and non-permissible ingredients based on the formulations of other brands’ products sold at organic supermarkets.

5. Under the U.S. California Safe Cosmetics Act (CSCA) and the Cosmetic Fragrance and Flavor Ingredient Right to Know Act (CFFIRKA), each ingredient is evaluated for any potential safety concerns.
6. We check whether any ingredient is listed under California Proposition 65 (Prop 65) for carcinogenic substances.
7. State Banned ingredients have recently been updated. We check whether any ingredient is prohibited in certain states. (For example, triethanolamine—commonly used in Korea—has been banned in some U.S. states, making it unusable in those markets.)
8. Allergen-related ingredients are also updated from the “European allergen 26” list to a “60 allergen” list. We verify whether any of those allergens are present.
9. Health Canada: We additionally review any ingredients that are banned in Canada.
10. Washington TFCA: In line with the Washington Toxic-Free Cosmetics Act (effective 2025), we check for prohibited ingredients. Notably, lead levels must not exceed 1 ppm under these stricter standards.
11~12. Walmart and Sephora Clean List: We verify whether the product meets the standards of Walmart’s and Sephora’s “Clean Beauty” categories by identifying any excluded ingredients listed.
Example of an Ingredient 
Review Document

Example of an Ingredient Review Document
We create a Formula Review Worksheet (FRW) according to the format required by major U.S. distribution channels. This FRW covers CIR (Cosmetic Ingredient Review), Prop 65 (carcinogenic substances), the California Safe Cosmetics Act, state-banned ingredients, and the European Commission inventory. For any ingredients not proven safe by the CIR, we verify whether they should be classified as Warning/Danger. We also check the strict standards set by major U.S. distribution channels—such as Whole Foods Market—before finalizing the FRW.

Following this, we conduct a Toxicology Risk Assessment (TRA) to confirm the product’s overall safety. This involves reviewing the product’s microbiological test results, preservative efficacy test, heavy metals test, and each ingredient’s safety verification (via the FRW). We also assess fragrances in line with IFRA guidelines. Once all safety checks are complete, we issue the final TRA.


Comprehensive Services for MoCRA Compliance

· Set up client accounts on Cosmetic Direct for facility and product registration. 


· Serve as a U.S. Agent for manufacturing facilities. 


· Coordinate with GLP-certified global testing labs for product safety testing (microbial, heavy metals, preservative efficacy). 


· Partner with GCP-certified clinical labs approved by major U.S. retailers for products that require clinical testing. 


· Facilitate DUNS and FEI number issuance. 

Comprehensive Services for MoCRA Compliance

· Set up client accounts on Cosmetic Direct for facility and product registration.

· Serve as a U.S. Agent for manufacturing facilities.

· Coordinate with GLP-certified global testing labs for product safety testing (microbial, heavy metals, preservative efficacy).

· Partner with GCP-certified clinical labs approved by major U.S. retailers for products that require clinical testing.

· Facilitate DUNS and FEI number issuance.

Resource Of K-Beauty Co.,Ltd.

Address: 7-3, Gwanggyo Jungang-ro 248beon-gil, Yeongtong-gu, Suwon-si, Gyeonggi-do, Republic of Korea

Contact : support@rokbeauty.co.kr

Resource Of K-Beauty Co.,Ltd.

Address: 7-3, Gwanggyo Jungang-ro 248beon-gil, Yeongtong-gu, Suwon-si, Gyeonggi-do, Republic of Korea

Contact : support@rokbeauty.co.kr