Context and Challenge
Regulation (EC) No. 1223/2009 requires that every cosmetic product placed on the European market be accompanied by a comprehensive safety assessment prepared by a qualified expert. This assessment must follow the 11th Revision of the SCCS “Notes of Guidance” (NoG) (Scientific Committee on Consumer Safety), identified by code SCCS/1628/21, the European guidelines for testing and safety evaluation of cosmetic ingredients, integrating toxicological hazard data and consumer exposure.
Cosmetic sector SMEs often lack the internal resources to conduct such assessments with the required methodological rigor. The absence of automated and integrated tools leads to delays in time-to-market and incomplete or undocumented evaluations.
Solution: VERMEER Cosmolife
VERMEER Cosmolife is a tool developed within the research project “Life Vermeer – Integrating VEGA, ToxRead, MERLIN-Expo, and ERICA in a platform for risk assessment and substitution of risky substances” (LIFE16 ENV/IT/000167), coordinated by the Mario Negri Institute for Pharmacological Research IRCCS. This tool is integrated for chemical risk assessment in cosmetics, implementing the entire SCCS framework in a structured workflow consisting of four sequential phases.
Phase 1 – Hazard Identification
The system queries VEGA QSAR models to estimate the toxicological properties of ingredients lacking experimental data. The models make predictions on genotoxicity, skin sensitization, reproductive toxicity, and endocrine interference.
Phase 2 – Exposure Assessment
The daily systemic exposure (SED) is calculated by combining standard SCCS values for the amount of product applied per cosmetic category with skin retention factors. For low-toxicity substances, the toxicological threshold of concern (TTC) is applied according to the Kroes et al. hierarchy.
Phase 3 – Dose-Response Assessment
The NOAEL (No Observed Adverse Effect Level) is retrieved from the literature (SCCS, EFSA, US EPA) or estimated through QSAR models when unavailable. The system maintains a structured database of reference toxicological values.
Phase 4 – Risk Characterisation
The Margin of Safety (MoS) is calculated as the NOAEL/SED ratio. The adopted threshold value is MoS greater than or equal to 100, as indicated by the SCCS. If the MoS is below the threshold, the system flags the need for additional data or reduction of the concentration in the final use.
Usage Modes
The tool supports three types of assessment:
Mode 1: Full formulation assessment
Input of the entire formula with percentage concentrations of each ingredient. Cumulative assessment by hazard category.
Mode 2: Single ingredient monograph
In-depth analysis of a single ingredient with structured report. Useful for regulatory documentation.
Mode 3: Impurities assessment
Analysis of non-intentionally added substances (impurities) with estimation of residual exposure and comparison with TTC thresholds
Application Example: Hand Soap
Use Case: Hand wash soap formulation (7 ingredients)
SCCS Category: Rinse-off | Processing time: less than 4 seconds
Key result:
- 6 ingredients: MoS > 1,000 – no toxicological concern
- METHYLISOTHIAZOLINONE: flagged as skin sensitizer (QSAR alert), MoS calculated > 1,000,000 for rinse-off use
- Report generated in PDF format with SCCS-compliant summary table
Impact and Benefits
| Efficiency | Significant reduction in assessment time compared to manual processes. |
| Compliance | Full adherence to the 11th Revision of SCCS “Notes of Guidance” (NoG). |
| Documentation | Structured reports for building product safety dossiers. |
| Accessibility | Usable by SMEs without internal toxicologists. |
| Traceability | Complete log of data sources and models used. |