NEW | SPECIAL EDITION
Cosmetic formulation screening according to California Proposition 65 requirements, now integrated into ToxTool®.
A new Special Edition designed to support cosmetic companies and industry professionals in identifying critical substances, calculating exposure levels, and assessing applicable Proposition 65 thresholds.
An advanced tool to help navigate the specific regulatory challenges of the California market with greater confidence.
Small note: New functionality currently in beta testing – Information and access upon request.
THE NEW SPECIAL EDITIONFrom formulation to Proposition 65 screening. Automatically.
A new analysis tool integrated into the ToxTool® environment.
ToxTool® California Proposition 65 Edition introduces a dedicated functionality for screening cosmetic formulations against the chemicals included in the Proposition 65 List.
Based on the formulation entered and the available substance information, the system automatically generates a structured screening table, identifying potentially critical chemicals and highlighting any applicable exposure thresholds.
THE PROCESSHow it works
Data. Analysis. Results.
Three steps to integrate Proposition 65 screening into the cosmetic formulation assessment process.
THE REGULATORY CONTEXTIs an EU-compliant cosmetic formula ready for California?
Two different regulatory approaches. The need for a dedicated assessment.
California Proposition 65 establishes particularly stringent requirements concerning exposure to certain chemicals, including substances that may be present in cosmetic products as impurities.
For certain chemicals, specific reference levels have been established: NSRL (No Significant Risk Level) and MADL (Maximum Allowable Dose Level), expressed in micrograms per day. However, many chemicals included in the list have no officially established thresholds.
Exposure assessment criteria also differ from those commonly applied under European cosmetic regulations.
As a result, compliance with EU Regulation (EC) No. 1223/2009 alone is not sufficient to demonstrate compliance with California Proposition 65 requirements.
A preliminary assessment of the formulation, its ingredients, and potential impurities is therefore an essential step for companies operating in the California market.
STEP 1Enter your formulation
Use ToxTool® to enter the cosmetic product composition and the available information on substances and potential impurities.
STEP 2Run the screening
The new functionality automatically screens the formulation against the Proposition 65 List, identifies applicable thresholds, and performs exposure calculations.
STEP 3Review and simulate
Explore the results table, identify critical elements, and simulate different scenarios by adjusting concentrations and exposure parameters.
PREVENTING POTENTIAL ISSUESFOCUS / STRATEGIC VALUE
A proactive assessment makes the difference.
Proposition 65 includes an enforcement mechanism that may also involve private parties and result in a 60-Day Notice of Violation.
In such situations, companies need to promptly provide appropriate technical and scientific evidence supporting their assessments.
Identifying a potential issue before placing a product on the market means being better prepared to address it.
Identifying critical chemicals in advance, verifying exposure levels, and properly documenting available information allows companies to approach the specific requirements of the California market with greater preparation.
ToxTool® California Proposition 65 Edition is designed to facilitate this preliminary assessment, providing operational support for a company’s risk assessment and management strategy.
THE ROLE OF THE PROFESSIONALAdvanced technology. Professional judgment.
A decision-support tool, not a replacement for the Safety Assessor.
ToxTool® California Proposition 65 Edition automates an important part of the analysis, but it does not replace professional expertise or a company’s strategy for managing substances and impurities.
Identifying potential impurities requires appropriate raw material information and a dedicated assessment. Likewise, chemicals without officially established NSRL/MADL values may require further investigation and specific scientific justification.
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