Quantitative risk assessment, safety substantiation, and regulatory documentation aligned with FDA MoCRA, EU Cosmetics Regulation, IFRA, and California Prop 65.
The Agyekum Group (Aᴳ) conducts independent toxicological evaluations for cosmetics, personal care products, fragrances, and consumer goods. Assessments are exposure-driven, quantitatively supported, and documented for regulatory review, retail compliance, and enforcement-relevant decision-making.
Personal Care and Cosmetics
Independent Toxicology & Safety Assessment for Personal Care Products
The Aᴳ conducts independent toxicological evaluation and risk assessment for cosmetic and personal care products across all product categories.
Work is focused on science based-safety evaluation, risk interpretation, and preparation of defensible documentation aligned with regulatory expectations.
Scope of Services
✔ Ingredient & Formula-Level Toxicology
✔ Safety evaluation of cosmetic ingredients, mixtures, and finished formulations
✔ Review of known and emerging hazards including irritation, sensitization, and systemic toxicity
✔ Assessment of cumulative exposure across product categories and use patterns
Exposure & Margin of Safety Analysis
✔ Quantitative exposure modeling for rinse-off and leave-on products
✔ Margin of Safety (MoS) determinations using established toxicological benchmarks
✔ Consideration of frequency, duration, and vulnerable population exposure
Regulatory & Risk Alignment
✔ Support for U.S. and international cosmetic frameworks
✔ Evaluation of compliance with ingredient restrictions and use conditions
✔ Science-based interpretation of regulatory requirements without overstatement
✔ Claims & Substantiation Support
✔ Assessment of safety-related claims and product positioning
✔ Scientific rationale to support internal review and external scrutiny
✔ Clear documentation suitable for legal, regulatory, and brand teams
Ingestibles and Supplements
Independent Toxicology and exposure-based risk assessment for ingestible products
As beauty and wellness portfolios expand into ingestibles, exposure-based safety evaluation, scientific defensibility, and governance suitable for third-party review are required.
The Aᴳ conducts independent toxicological assessment and risk evaluation for dietary supplements and ingestible wellness products. Documentation is prepared to support regulatory submission, retailer review, and internal risk-based decision-making.
Scope of Services
✔ Ingredient-Level Toxicology Review
✔ Active ingredients, excipients, botanicals, bioactives, flavors, and processing aids
✔ Identification of known, suspected, and emerging toxicological concerns
✔ Evaluation of cumulative exposure and sensitive populations
✔ Oral Exposure & Margin of Safety Analysis
✔ Exposure modeling based on serving size, frequency, and intended use
✔ Margin of Safety (MoS) calculations using NOAEL, LOAEL, TTC, and benchmark dose data
✔ Identification of ingredients approaching conservative safety thresholds
Contaminant & Impurity Risk Context
✔ Scientific interpretation of heavy metals, solvents, residuals, and processing contaminants
✔ Risk-based context for trace findings vs. actionable concern
✔ Support for data-driven decisions beyond pass/fail lab results
Claims & Population Considerations
✔ Pregnancy-adjacent, breastfeeding-adjacent, hormone-active, and youth-adjacent ingredients
✔ Science-based guidance to support responsible claims boundaries
✔ Alignment with retailer expectations for ingestible marketing integrity
✔ Retailer-Ready Documentation
✔ Independent toxicology opinions suitable for merchant, sustainability, and legal review
Clear risk categorization:
✔ Low Concern | Requires Clarification | Reformulation Recommended | Not Aligned
✔ Consistent methodology designed to integrate with existing submission platforms
✔ Our assessments are structured to enable scalable, repeatable ingestibles governance without requiring retailers to own the underlying scientific liability.
Fine Fragrance
Fragrance Toxicological Evaluations
Fragrance materials and mixtures require exposure-based toxicological evaluation to address sensitization risk, systemic exposure, and regulatory limits across jurisdictions.
The Aᴳ conducts independent toxicological assessment of fragrance ingredients and finished blends, including evaluation of sensitization potential, exposure characterization, and alignment with IFRA standards and applicable global regulatory frameworks.
Assessments may include:
- Ingredient-level hazard and exposure evaluation
- Review of IFRA standards and use-level restrictions
- Evaluation of claims-relevant safety considerations (e.g., skin sensitivity)
- Documentation prepared for retail review, regulatory submission, and third-party due diligence
- Exposure-based assessment to inform fragrance load and formulation decisions
Evaluations are conducted for fragrance materials ranging from individual naturals to complex multi-component accords, with documentation prepared for regulatory and third-party review.
Ingredient Safety & Sustainability
Ingredient Safety & Hazard Review
Ingredient Safety and Hazard Characterization
Evaluation of individual raw materials, blends, and functional components, including identification of toxicological considerations such as sensitization, irritation, systemic exposure, and emerging hazard signals. Review includes assessment of restricted, monitored, or otherwise scrutinized substances under applicable regulatory frameworks.
Risk-Based Ingredient Screening
Science-driven prioritization of materials based on hazard and exposure considerations to support informed substitution or reformulation decisions. Documentation is prepared to support internal governance and third-party review.
Regulatory and Stakeholder Context
Interpretation of ingredient safety expectations across global markets, with documentation structured to support internal governance processes, supplier communication, retailer inquiries, and cross-functional review.
Modernization of Cosmetics Regulation Act (MOCRA) Compliance
MOCRA
The Modernization of Cosmetics Regulation Act (MoCRA) establishes expanded federal requirements for cosmetic product safety substantiation, manufacturing practices, adverse event reporting, facility registration, and product listing in the United States. The statute also expands FDA records-access authority and expectations for inspection-ready documentation.
The Aᴳ conducts independent toxicological evaluation and safety substantiation activities aligned with MoCRA requirements. Work is structured to support regulatory inspection, records access, and third-party review under FDA oversight.
Scope of MoCRA Aligned Evaluations
Safety Substantiation
Exposure-based toxicological evaluation and documentation supporting MoCRA safety substantiation requirements for cosmetic products and ingredients.
Adverse Event Reporting Frameworks
Technical input and documentation supporting systems for collection, evaluation, and reporting of serious adverse events in accordance with statutory requirements.
Manufacturing and Governance Context
Review of safety and documentation practices in relation to FDA-enforced Good Manufacturing Practice (GMP) expectations as they intersect with toxicological substantiation.
Product Listing, Facility Registration, and Labeling Context
Evaluation of safety and risk documentation relevant to product listing, facility registration, and labeling considerations under MoCRA.
Toxicological Risk Assessment
Ingredient-level and formulation-level risk assessment supporting exposure characterization, hazard evaluation, and defensible safety conclusions.
Prop 65 Compliance
California Proposition 65 – Exposure Assessment and Legal Context
California’s Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65) requires evaluation of consumer exposure to listed chemicals and, where applicable, provision of warnings when exposures exceed established Safe Harbor Levels. Applicability is exposure-driven and enforcement-focused, and extends across a broad range of consumer products and materials.
The Aᴳ conducts independent toxicological and exposure assessment for Proposition 65–listed substances. Work is structured to support regulatory review, retailer compliance programs, and enforcement-relevant decision-making.
Scope of Proposition 65 Evaluation
Exposure Assessment
Quantitative estimation of consumer exposure to listed chemicals across relevant pathways, including dermal contact, oral ingestion, and inhalation, using conservative, enforcement-relevant assumptions.
Safe Harbor Comparison
Comparison of estimated daily exposure to applicable OEHHA No Significant Risk Levels (NSRLs) and Maximum Allowable Dose Levels (MADLs), including documentation of assumptions, calculations, and uncertainty.
Product and Material Evaluation
Assessment of finished products, components, and materials of concern, including interpretation of analytical data, migration or transfer considerations, and use-scenario relevance.
Warning and Governance Context
Evaluation of exposure findings in relation to warning applicability and documentation prepared to support internal governance, retailer review, and third-party assessment.
Regulatory and Legal Context
Preparation of technical documentation suitable for regulatory inquiry, enforcement proceedings, and legal review, including exposure defensibility and scientific interpretation.
PFAS Consultation
PFAS in Consumer Products – Exposure and Governance Considerations
Per- and polyfluoroalkyl substances (PFAS) are subject to increasing regulatory scrutiny due to persistence, bioaccumulation potential, and evolving toxicological benchmarks. Evaluation of PFAS in consumer products is exposure-driven and jurisdiction-specific, with implications for regulatory compliance, retailer governance, and enforcement actions.
The Aᴳ conducts independent toxicological and exposure assessment for PFAS-related considerations in consumer products and materials. Evaluation includes characterization of relevant exposure pathways, interpretation of toxicological reference values, and alignment with applicable state, federal, and international regulatory frameworks.
Scope of PFAS Evaluation
Exposure Characterization
Quantitative or qualitative assessment of potential consumer exposure to PFAS across relevant use scenarios and pathways.
Toxicological Context
Interpretation of available toxicological data and evolving reference values relevant to PFAS compounds and subclasses.
Regulatory and Governance Context
Assessment of PFAS findings in relation to applicable regulatory requirements, retailer restrictions, and product governance programs.
Documentation for Third-Party Review
Preparation of technical documentation suitable for regulatory inquiry, retailer review, and enforcement-relevant decision-making.
Independent, exposure-driven toxicological assessment
Professional Scope and Approach
The Aᴳ operates as an independent toxicological assessors, providing exposure-based risk evaluation and safety documentation for products subject to regulatory, retail or enforcement scrutiny.
Work is conducted with professional independence and documented to support third-party review, including regulatory inspections, retailer compliance programs =, and legal proceedings. Assessments emphasize conservative assumptions, transparency of methodology, and alignment with current regulatory guidance.