Systematic Reviews for Cosmetic Ingredient Safety and Regulatory Compliance
The EU Cosmetics Regulation demands rigorous safety assessment of every ingredient in a cosmetic product. Puraite delivers systematic, traceable literature reviews aligned with SCCS methodology for safety assessors, responsible persons and ingredient manufacturers.
Request a Cosmetics WalkthroughThe Challenge
Cosmetic ingredient safety assessment requires systematic, comprehensive evidence compilation.
Cosmetic Product Safety Reports (CPSRs)
Under the EU Cosmetics Regulation, every cosmetic product placed on the European market requires a Cosmetic Product Safety Report prepared by a qualified safety assessor. The Part A safety information compilation requires systematic literature review across all relevant toxicological endpoints for each ingredient.
SCCS Safety Opinions
When the European Commission requests a safety opinion on a cosmetic ingredient, the SCCS expects dossiers with comprehensive, systematically compiled toxicological data covering dermal absorption, irritation, sensitisation, mutagenicity, reproductive toxicity and carcinogenicity. The SCCS Notes of Guidance (12th Revision, 2023) define the expected data structure.
Claim Substantiation
Under EU Regulation (EU) No 655/2013 on common criteria for cosmetic claims, all marketing claims must be truthful, supported by adequate and verifiable evidence, understandable to the average consumer, and not misleading. Evidence can include clinical studies, instrumental measurements, published studies on ingredients, expert assessments, or literature analyses. While a systematic literature review is not mandatory, it provides a robust and well-documented evidence base for the Product Information File (PIF) and is increasingly expected by market surveillance authorities.
Cross-Regulatory Complexity
Companies operating globally face overlapping requirements from the EU Cosmetics Regulation, UK Cosmetics Regulation (retained EU law), FDA (OTC monographs and voluntary cosmetic registration), ASEAN Cosmetic Directive and other frameworks, each with different data expectations.
How Puraite Helps
Specific workflows where Puraite accelerates regulated evidence work.
CPSR Toxicological Literature Review
Systematic literature review across all toxicological endpoints required for CPSR Part A: acute toxicity, irritation, sensitisation, dermal absorption, repeated dose toxicity, mutagenicity/genotoxicity, carcinogenicity, reproductive toxicity, photo-induced toxicity, and human data. Structured per SCCS Notes of Guidance.
SCCS Dossier Support
Comprehensive evidence synthesis for ingredient safety dossiers submitted for SCCS opinion. Systematic retrieval and critical appraisal of published and unpublished studies covering all SCCS-required endpoints, with structured data extraction and study quality assessment.
Claim Substantiation Evidence
Systematic review of published clinical studies, in-vitro efficacy data and peer-reviewed evidence supporting cosmetic product claims. Literature-based evidence compilation for efficacy claims, anti-aging assertions and ingredient benefit statements per advertising standards requirements.
Ingredient Restriction or Ban Response
Rapid systematic evidence compilation when an ingredient faces regulatory challenge, whether through Annex II/III amendment proposals, member state notifications or SCCS re-evaluation. Comprehensive, defensible evidence synthesis to support continued use or transition planning.
Preparing a CPSR evidence package or SCCS dossier?
See how Puraite handles cosmetic ingredient safety evidence. Request a 30-minute walkthrough.