Cosmetic Claims in EU: Compliance Under Regulation (EC) No 1223/2009

At SciQra, a leading Toxicology Consulting Partner, we deliver expert Toxicological Risk Assessment and Regulatory Support for Cosmetics, Medical Devices, Pharmaceuticals, Dietary Supplements, Consumer Products, and Chemicals. Our expertise includes Cosmetic Product Safety Report (CPSR) Preparation, Product Information File (PIF) Compilation, Cosmetic Ingredients Safety Evaluation, Systemic Exposure Calculation, Margin of Safety (MoS) Derivation, and Impurity Qualification. Whether you require a Biocompatibility Gap Assessment aligned with ISO 10993 and FDA standards for Medical Devices, or Raw Material Safety Evaluation for Cosmetic Products, our team ensures compliance with Global Safety and Regulatory Requirements.

We also support global brands with Hazard Identification, GRAS Determinations, Claim Substantiation, Toxixological Risk Assessment of Extractables & Leachables (E&L), Preclinical Documents for IND/CTA Submission, and Health-based Exposure Limit (PDE/OEL) Determinations. From EU Cosmetic Regulation (EC) No 1223/2009 compliance to USFDA’s MoCRA Requirements, SciQra bridges regulatory expectations across markets to deliver robust compliance solutions.

With a strong focus on Cosmetic and Consumer Product Toxicology Assessment and Regulatory Support, SciQra helps businesses launch safe, effective, and compliant products worldwide. Whether you need an expert opinion on Prototype Formula, Cosmetic Safety Certification, Dietary Supplement Safety Evaluation, or Regulatory Toxicology Strategy for global product launches, we deliver science-driven, tailored solutions.