Cosmetic Product Safety Substantiation Services
What Is Cosmetic Product Safety Substantiation?
Under MoCRA, “adequate safety substantiation” means having tests, studies, research, analyses, or other evidence reviewed by qualified experts to demonstrate a reasonable certainty that your cosmetic product is safe. Our cosmetic product safety assessment services ensure every product reaching consumers is backed by solid scientific evidence.
What’s Included in Our Safety Review
Our comprehensive cosmetic product safety report covers all critical aspects of your product:
- Product Composition: Qualitative and quantitative analysis of the formulation
- Ingredient Review: Toxicological profile and risk assessment
- Raw Materials & Product Characteristics: Physical, chemical, and microbiological evaluation
- Exposure Assessment: Routes, frequency, amount, and Margin of Safety calculation
- Good Manufacturing Practices: Verification of compliance
- Adverse Events & Label Review: Tracking, documentation, and regulatory alignment
Expert Cosmetic Product Safety Substantiation for Global Markets
Our Taobé experts review every aspect of your cosmetic product and create a thorough Cosmetic Product Safety Assessment. Working with us ensures your products are fully compliant in the US and provides a strong foundation for international expansion. The US report can also serve as a basis for your EU/UK Cosmetic Product Safety Report (CPSR), simplifying compliance across multiple markets.
Adverse Event Management
MoCRA requires serious adverse events to be reported to the FDA within 15 business days. Taobé helps you:
- Set up an organized system to receive, document, and report events
- Submit reports using MedWatch Form 3500A via email
- Quickly identify and respond to potential safety risks
With a well-structured process, your brand can react faster to incidents and maintain consumer safety.
Who Is Responsible for Safety Substantiation?
The US Responsible Person must ensure all cosmetic products meet FDA and MoCRA requirements. This includes maintaining complete and up-to-date safety documentation and making it available to authorities upon request.
Taobé ensures your Cosmetic Product Safety Report is thorough, accurate, and fully compliant, reducing risk and giving your brand confidence in the US market.
When should the safety substantiation be updated?
Safety is an ongoing commitment. We continuously update your Cosmetic Safety Assessment to ensure every aspect of your product remains safe and compliant, including:
- Analysing any reported adverse effects
- Reassessing the safety of the product based on newly gathered data
- Reviewing changes to applicable regulations
- Considering new safety data for substances present in the formulation
This ensures your products remain compliant and safe throughout their lifecycle.
Safety Substantiation Frequently Asked Questions
What is safety substantiation?
It is the evidence showing that a cosmetic product is safe for its intended use, based on tests, research, analyses, or expert evaluation.
Who is responsible for safety substantiation?
The US Responsible Person must maintain complete safety substantiation and make it available to the FDA upon request.
What is included in a safety substantiation?
It includes review of product composition, ingredients, raw materials, packaging, exposure assessment, Good Manufacturing Practices, adverse events, and label compliance.
When should safety substantiation be updated?
It must be updated whenever adverse effects are reported, new safety data arises, or regulations change.
Contact us
Why choose Taobé Consulting for your Cosmetic Product Safety Substantiation?
Taobé Consulting has extensive experience in cosmetic safety assessment in Europe and the UK, now applied to the US MoCRA market. Our streamlined process is designed to make compliance simple and efficient for cosmetic brands:
- Direct collaboration with expert safety assessors
- Fast, clear, and straightforward data submission using our in-house FastReg* tool
- A transparent, efficient process that makes every step easy to follow
*FastReg is an expert in-house tool developed to facilitate the data collection and management including all raw materials documentation. Using the tool helps keep track of the project’s progress with its clear dashboard showing the step the product is in and the next deadlines to reach. An automatic email reminder system keeps you informed of the missing or non-compliant data as well as of the deadlines to meet to ensure a fast and trouble-free market launch.
Our Mocra Services
FDA cosmetic labeling requirements
Develop compliant cosmetic labels that meet FDA standards and applicable state regulations, ensuring accurate product information and proper disclosure requirements.
Cosmetic formula check
Carry out a comprehensive ingredient review to confirm your cosmetic formulations comply with FDA rules, safety standards, and state-level requirements.
US responsible person
Appoint a qualified US Responsible Person to oversee regulatory responsibilities, manage submissions, and maintain ongoing FDA compliance.
Cosmetic product listing
Prepare and submit precise cosmetic product listings in line with FDA requirements to support smooth and compliant US market entry.
FDA Facility Registration Services
Register your manufacturing or processing facility with the FDA under MoCRA to ensure full regulatory compliance and operational transparency.
US FDA agent
Designate an experienced FDA agent to manage official communications and provide ongoing regulatory support for your cosmetic operations.
