Regulatory Services

Prop 65 Compliance

Navigate Proposition 65 with Confidence: The Mérieux NutriSciences Strategic Compliance Blueprint

California’s Proposition 65 is a complex "right-to-know" law that mandates public warnings for products containing any of over 900 identified cancer-causing and reproductive toxins. Navigating these requirements is a moving target with massive legal implications. With new California regulations taking effect on January 1, 2028, businesses can no longer rely on a generic short-form warning as a litigation avoidance strategy; you will be required to identify at least one specific chemical on your product labels.

Combined with aggressive private enforcement and the fact that many targeted chemicals lack established "safe harbor" levels, relying on guesswork leaves your brand highly vulnerable to costly lawsuits and penalties.

You need more than just a lab test—you need a strategic compliance blueprint. Mérieux NutriSciences provides a comprehensive, phased approach designed to protect your budget while delivering legally defensible regulatory confidence.

Our 3-Stage Proposition 65 Compliance Pathway:

• Stage 1: Initial Assessment and Blueprint Development: We conduct deep-dive research into your product formulations to identify the most probable chemicals of concern based on the nature of your products. Before you commit to heavy lab fees, we provide a clear evaluation pathway and a transparent testing quote. This built-in "client pause point" empowers you to make calculated, fiscally sound business decisions right from the start.

• Stage 2: Precision Testing Protocols: If testing is financially viable for your business, your products will undergo rigorous analysis in our ISO 17025 accredited MXNS laboratories. Equipped with advanced ICP-MS capabilities, we test representative lot samples to establish an accurate baseline, detecting whether chemicals are present or if they meet state safe harbor levels.

• Stage 3: Regulatory Evaluation: We translate your raw testing data into definitive regulatory action. Our expert team evaluates the results to determine your exact Prop 65 warning and packaging requirements. For complex matrices or chemicals without an established safe harbor level, an expert toxicologist will be consulted to execute complex, legally defensible daily exposure calculations.

 Contact us today to start your initial assessment and get your strategic compliance blueprint. 

GRAS Dossier Services

Navigate Proposition 65 with Confidence: The Mérieux NutriSciences Strategic Compliance Blueprint

The FDA is eliminating the independent GRAS "self-affirmation" pathway, requiring companies to formally submit GRAS notices for new substances and "Subpart F" submissions for existing ones to avoid severe enforcement actions. To mitigate these risks and ensure seamless market access, businesses should proactively evaluate their portfolios and compile comprehensive, seven-part GRAS dossiers that scientifically demonstrate the safety of their ingredients.

GRAS support services:

• Portfolio Review and Gap Analysis: Our team of experts can evaluate the status of the ingredients within your portfolio to determine whether they have a confirmed GRAS status or whether a Subpart F submission or GRAS Notice is necessary.

• Technical Review and Dossier Development: Evaluation of your dossier specifically to verify regulatory and scientific robustness. We review the core components to identify any material gaps that could cause a panel or the FDA to reject the data and compromise the GRAS status of the substance.

• GRAS Expert Panel Coordination: We manage end-to-end recruitment and credentialing of your expert panel to ensure full transparency and objectivity. We facilitate the formal panel review meeting and collate all expert commentary to deliver a final written Panel Consensus Statement that officially affirms your ingredient's safety.

Don't let new FDA regulations disrupt your supply chain. Contact our GRAS experts today to schedule a portfolio review and secure your market access.