US Cosmetic Service
The Scope of Our USA Cosmetics Services
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Facility Registration and Product Listing
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US Agent Service for Facility Compliance
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Preparation of Toxicological Assessments to Support Safety
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Conducting Efficacy Tests
Modernization of Cosmetics Regulation Act of 2022 (MoCRA) significantly expanded FDA’s authority to regulate cosmetic products.
MoCRA Requirements
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Facility Registration: Manufacturers and processors must register their facilities with FDA and renew their registration every two years.
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Product Listing: A responsible person must list each marketed cosmetic product with FDA, including product ingredients, and provide any updates annually.
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Safety Substantiation: Companies and individuals who manufacture or market cosmetics have a responsibility to ensure the safety of their products.
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Allergens disclosure: Each fragrance allergen must be listed on the label of the cosmetic product.
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GMP: FDA is in the process of creating binding regulations on Good Manufacturing Practices for Cosmetic Products.
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Adverse Event Reporting: Manufacturers are required to report any serious adverse event within 15 business days and store records of health-related adverse events.
Neither the law nor FDA regulations require specific tests to demonstrate the safety of individual products or ingredients. However, manufacturers are required to ensure the safety of their products. All data used to support the safety must be derived from scientifically robust methods.
A Toxicological Assessment for cosmetic products is a scientific evaluation to determine the potential health risks associated with the ingredients used in a cosmetic product. The assessment aims to ensure that the product is safe for human use, particularly when applied to the skin, hair, or other body parts, and that it does not cause adverse effects over both short-term and long-term exposure.
Key Components of a Toxicological Assessment:
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Identification of Ingredients
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Toxicological Data Review
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Exposure Assessment
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Risk Characterization
Importance of Toxicological Assessment
The primary goal of a toxicological assessment is to protect consumers from harmful effects, such as allergic reactions, skin irritation, or long-term health risks.
For cosmetic developers, a toxicological assessment helps in formulating safe products, identifying safe ingredient alternatives, and avoiding harmful chemicals.
Toxicological Assessment for cosmetic products is a critical step in ensuring that a product is safe for consumers, meets regulatory standards, and performs as intended without causing harm.
We provide technical support to assist in the Registration for compliance with the US FDA Requirements.
Contact us today, and let's embark on this journey together.
Contact SOAR & PARTNERS to assure compliance and swiftly enter the USA market.