CytoSolve®–Enabled Mechanistic Substantiation of Certified C.L.E.A.N.® and Certified R.A.W.® Food Standards

The Certified C.L.E.A.N.® and Certified R.A.W.® standards are consensus-based frameworks developed by a diverse community of stakeholders, including food manufacturers, retailers, scientists, public interest groups, and regulatory bodies. The standards define clear criteria for assessing food and supplement products across multiple dimensions — safety, ethical sourcing, ingredient processing, and nutrient bioavailability — to provide transparent, science-grounded certification outcomes.

Challenge

Government agencies and regulatory reviewers increasingly require quantitative, reproducible, and scientifically defensible evidence when food certification claims are used in labeling or market access decisions. For the Certified C.L.E.A.N.® and R.A.W.® standards, a key technical challenge was:

  • Translating complex food formulation attributes (such as minimal processing and ingredient interactions) into measurable and objective criteria rather than subjective descriptions.
  • Establishing a bioavailability metric that reflects how nutrient components within multi-ingre
Specifically, the Standards needed a methodology that could scientifically evaluate how combinations of ingredients influence nutrient bioavailability, which is a core aspect of both certifications.

How CytoSolve® Helped

CytoSolve® provided a government-grade computational workflow that integrates molecular and systems insights to quantify bioavailability scores within the certification process:

In Silico Bioavailability Modeling

  • CytoSolve®’s platform was employed to compute the bioavailability score of ingredient combinations by modeling how constituent nutrients interact in biological contexts.
  • This score contributes directly to the certification criteria for both Certified R.A.W.® and Certified C.L.E.A.N.®, where “Alive” (for R.A.W.) and “Active” (for C.L.E.A.N.) elements are defined by measurable bioavailability.
Integration with Certification Criteria

For Certified R.A.W.®, the scoring model incorporates:

  • Real (safe, non-GMO and regulatory compliance)
  • Alive (bioavailability as computed by CytoSolve®)
  • Whole (organic content and nutrient density scoring)

For Certified C.L.E.A.N.®, bioavailability scoring factors into:

  • Active (quantitative bioavailability via CytoSolve®)
  • In conjunction with safety, organic/non-GMO, and nourishing criteria.

Government Filing-Ready Documentation

  • CytoSolve® outputs are structured with clear assumptions, reproducible methods, and traceability to peer-reviewed data — fulfilling expectations for government and regulatory documentation.
  • Quantitative scoring results, methodological descriptions, and computational rationale can be included directly in technical appendices for government filings that support the Standards’ criteria.

Key Benefits Realized

  • Objective Bioavailability Scoring – Established a reproducible, computationally derived metric for ingredient bioavailability
  • Support for Regulatory Criteria – Bioavailability scores align with safety and processing requirements under federal and international guidelines
  • Consensus-Based Standards Integration – CytoSolve® modeling is formally incorporated as part of Certified R.A.W.® and C.L.E.A.N.® criteria
  • Reproducible, Transparent Outputs – Computational evidence is documented for clarity, traceability, and external review
  • Stakeholder Confidence – Backed by participation of academia, manufacturers, and government-related reviewers in standard development

Outcome

The integration of CytoSolve®’s computational bioavailability modeling into the Certified C.L.E.A.N.® and Certified R.A.W.® Standards has established a rigorous, science-based foundation for evaluating complex foods and supplements. This government-filing ready evidence supports transparent certification decisions grounded in measurable criteria, enabling regulators, manufacturers, and consumers to assess claims objectively. Through this collaboration, the certification program advances a modern, systems-based approach to defining “good food” that meets regulatory expectations for safety, minimal processing, and nutrient functionality.