Prop 65 Compliance for Soy Lecithin

Why Soy Lecithin Is Under Scrutiny

Soy lecithin is widely used as an emulsifier in food, supplements, and packaged goods — but its compliance risk comes from what it may carry, not what it is. Key risk drivers:

• Trace Contaminants: Potential residual solvents from extraction and processing.
• Heavy Metals: Soy sourcing can introduce trace lead or cadmium from agricultural inputs.
• Processing Variability: Different suppliers = different impurity profiles.
• Ubiquity: Found in nearly all processed food categories, increasing exposure frequency.

Why It Matters Under Prop 65

Soy lecithin itself is not the issue — **impurities and exposure pathways are.**

• Food Category Exposure: Ingestion creates direct systemic exposure.
• Cumulative Intake: Present in multiple daily food items.
• Supply Chain Variability: No single standardized chemical profile.

Enforcement Reality

• Food & Supplement Category: Largest Prop 65 enforcement segment.
• Private Litigation Model: Enforcement driven by private attorneys.
• Trace-Level Claims: Even minimal detected contaminants can trigger action.

Exposure Pathway

Soy lecithin is consumed through multiple daily food applications.

• Direct Ingestion: Primary exposure route under Prop 65.
• Repeated Daily Use: Found in chocolate, baked goods, supplements.
• Low-Dose Accumulation: Chronic exposure is the key risk model.

Business Impact of Non-Compliance

• 60-Day Notice Exposure: Immediate legal response requirement.
• Settlement Risk: $20K–$100K+ per SKU.
• Retailer Pressure: Ingredient-level documentation required.
• Reformulation Costs: Supplier changes or ingredient substitution.

Most enforcement actions succeed due to missing documentation, not unsafe products.

Why Prop65Compliance.com

• Compliance-Focused: Prevent litigation through system design.
• Ingredient-Level Mapping: Focus on impurities, not assumptions.
• Managed by Consultare Inc. Group: Structured oversight.
• Systems-Based Approach: Repeatable compliance architecture.

What We Deliver

• Ingredient Risk Assessment
• Contaminant Screening Oversight
• Exposure Evaluation
• Compliance Determination
• Supplier Verification Program
• Documentation System
• Ongoing Monitoring

Core Technical Components

• Heavy Metal Screening: Lead, cadmium, arsenic evaluation.
• Residual Solvent Review: Processing-related contaminants.
• Exposure Calculations: Daily intake modeling.
• COA Verification: Supplier documentation validation.
• Batch-Level Tracking: Lot-based compliance records.

Supply Chain Control

• Supplier Attestation: Verification of sourcing practices.
• Raw Material Mapping: Soy origin and processing risk.
• COA Tracking: Per-batch validation.
• Corrective Actions: Supplier compliance enforcement.

The SystemsBuilder Approach

One system. Infinite SKUs. You don’t manage soy lecithin — you manage the system behind it.

How It Works

Step 1 — Setup

• Product intake
• Risk classification
• Testing framework
• Documentation setup

Step 2 — Implementation

• Lab coordination
• Exposure modeling
• Compliance determination
• Label guidance

Step 3 — Monitoring

• Ongoing review
• Batch tracking
• Supplier updates
• Audit readiness

Pricing

Setup Pricing

$1,500 up to 3 products
+$150 per additional product

Monthly Monitoring

$500/month up to 7 products
+$50/month per additional product

Testing Monitoring

$35 per event
Lab fees excluded

Built for Defensibility

• Documented Decisions
• Verified Lab Data
• Traceable Supply Chain
• Structured Compliance System

Build a Defensible Prop 65 Compliance System

Consultare Inc. Group builds system-based compliance programs for food and ingredient manufacturers — from raw material risk to finished SKU defensibility.

Schedule a Compliance Consultation