Regulatory Compliance For Cosmetics
Bringing a cosmetic product to market means more than just a great formula—it means proving safety, stability, and compliance every step of the way. Our regulatory services help ensure your products meet both local and international standards for your region of sales, with clear documentation and expert testing.
Stability & Compatibility Testing
What this product Includes:
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pH, Viscosity, Colour, Odour, Appearance @ 40℃ & Room Temperature
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Checkpoints: 1 week, 4 week, 8 week, 12 week
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Leak Testing • Formula Compatibility with Packaging • Freeze-Thaw Testing
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Report: Stability & Compatibility Report issued after 12 weeks
Stability and compatibility testing ensures your product remains safe and effective throughout its shelf life. We evaluate physical and chemical consistency—colour, odour, texture, and overall appearance—at both room and elevated temperatures. Packaging is tested for leaks and formula interaction, while freeze-thaw cycles confirm durability across climate extremes. A comprehensive report is issued upon completion.
Strongly Recommended for all formulas – Conducted in final packaging. If selected, Standard Stability Testing is not required.
Standard Stability Testing
Includes:
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pH, Viscosity, Colour, Odour, Appearance @ 40℃ & Room Temperature
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Checkpoints: 1 week, 4 week, 8 week, 12 week
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Report: Stability Report issued after 12 weeks
Standard stability testing evaluates how your cosmetic formulation maintains its quality, safety, and performance over time when exposed to various environmental conditions. This assessment focuses solely on the product formula, independent of its packaging. While Stability & Compatibility Testing is recommended for the most accurate results, we understand that packaging timelines can cause delays. In these cases, our lab conducts stability testing using packaging that closely replicates your intended final components, ensuring reliable and representative data.
Note: Not required if Stability & Compatibility Testing is selected.
Preservative Efficacy Testing (PET)
Standard: BS EN ISO 11930:2019
PET determines whether a product’s preservative system effectively resists microbial contamination. Controlled microorganisms are introduced into the product, and microbial count reductions are measured over time. Passing results confirm robust product protection and long-term safety. A PET Report is issued after 8 weeks.
Microbial Testing
Includes:
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TAMC (Total Aerobic Microbial Count)
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TYMC (Total Yeast & Mould Count)
Each production batch is tested to verify safety and hygiene compliance. This ensures your cosmetics are free from harmful microorganisms and meet regulatory microbial limits before shipment. If requested, a Microbial Report can be included with your production order at the time of shipping and $290.00 will be added to your balance invoice.
In Vivo Testing – On Request
Examples: Patch Test • Sensitive Skin Claims • Product Efficacy Claims
In vivo testing evaluates safety and performance under real-life conditions using human volunteers. It confirms product tolerability, supports claims such as “suitable for sensitive skin,” and validates consumer-facing performance claims. Speak to one of our friendly consultants for more information.
EU & UK Compliance Documentation (PIF)
Includes the full Product Information File (PIF):
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Finished Product Description
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Safety Report (CPSR)
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Stability Compatibility Report
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PET Report
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GMP Statement
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Formulation (% withheld)
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QA/QC Specs
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Animal Testing Data
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Fragrance Data (IFRA & Allergen Reports)
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Certificate of Analysis (CoA)
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Safety Data Sheet (SDS)
A Product Information File (PIF) is a legal requirement under EU Regulation (EC) No 1223/2009. It contains all documentation necessary to demonstrate product safety and compliance, and must be retained for 10 years after the last batch is sold.
USA Compliance Documentation
Includes:
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Facility Registration (FDA Registered Manufacturer)
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Cosmetic Product Listing
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Safety Substantiation Documentation
This package ensures compliance with the Modernization of Cosmetics Regulation Act (MoCRA) 2022, covering all FDA requirements for manufacturing registration, product listing, and safety substantiation.