Toxicological Risk Assessment for Beauty Products

Introduction

In the UK and the European Union, the law requires that every single cosmetic and skincare product sold in the market undergoes a Toxicological Risk Assessment (TRA). This means each formulation (cream, lotion, serum, cleanser, etc.) is SAFE for human use under normal and foreseeable conditions, before every product is sold in the market.

Phoenix Safety Consultants complies with Annex I of Regulation (EC) No 1223/2009 and the UK Cosmetic Regulation 2020 (SI 2020/1466) to provide professionally tailored toxicological assessments for your beauty products. Each signed assessment by our safety assessors is scientifically validated and forms the basis of your Cosmetic Product Safety Report (CPSR).

Regulatory Context

Regulation (EC) No 1223/2009, specifically Annex I, states all cosmetics must be assessed for safety prior to market placement. This requirement is retained under the UK Cosmetic Regulation 2020 and is overseen by the Office for Product Safety and Standards (OPSS).

Annex I divides the safety evaluation into two parts:

• Part A – Safety Information: Consists of the toxicological information of the ingredients, their chemical composition and characteristics, exposure levels, and use scenarios for the product.
• Part B – Safety Assessment: Contains the safety assessment and conclusion of the toxicologist, declaring the product safe and suitable for its intended purposes.

The TRA forms the scientific foundation for preparing Part A and is essential for the assessor to complete Part B. The TRA ensures every component is compliant with Annex II–VI (prohibited and restricted substances, colorants, preservatives, and UV filters) and adheres to the limits established by the SCCS (Scientific Committee on Consumer Safety) Notes of Guidance (12th Edition).

In summary, without a compliant TRA, there is no CPSR—and therefore, no cosmetic product is legally marketable in the UK or EU.

Phoenix Safety Consultants’ Approach

Phoenix Safety Consultants performs Toxicological Risk Assessments for beauty products using a systematic, scientifically rigorous methodology based on validated toxicological principles, OECD testing guidelines, and the latest SCCS regulatory updates.

Ingredient Safety Data and SCCS Evaluation

Each formulation’s ingredients are evaluated for chemical identity, purity, toxicological profile, and function. Reference sources include SCCS opinions, ECHA dossiers, supplier Safety Data Sheets (SDS), and peer-reviewed toxicological literature. Cross-referencing against Annex II and Annex III–VI ensures legal conformity.

Toxicological Endpoint Identification

For each ingredient, relevant toxicological endpoints are examined, including:

• Acute and chronic toxicity
• Skin and eye irritation
• Skin sensitization and allergenicity
• Mutagenicity, carcinogenicity, and reproductive toxicity
• Systemic and dermal absorption

This ensures that all potential adverse effects are identified and quantified before risk characterization.

Calculating NOAEL and Margin of Safety (MoS)

Each ingredient’s No Observed Adverse Effect Level (NOAEL) is determined from human or animal data to calculate the Systemic Exposure Dose (SED). The Margin of Safety is then calculated as:

MoS = NOAEL / SED

An MoS ≥100 indicates that consumer exposure is well below hazardous levels and therefore acceptable for safe use.

Exposure Modeling Scenarios

Exposure is estimated based on product category, application area, frequency of use, and contact duration. For example:

• Leave-on products (creams, serums, lotions) have higher dermal absorption potential.
• Rinse-off products (cleansers, scrubs) result in shorter exposure and lower systemic absorption.

All exposure modeling follows SCCS and OECD guidance, reflecting realistic consumer usage conditions.

Safety Assessment and Conclusion

Each Phoenix assessor provides a final safety conclusion after evaluating exposure, toxicological data, and formulation-specific risk. This assessment includes safety margins and a defensible formulation appraisal, confirming that the product is safe for its intended cosmetic use.

This toxicological evaluation serves as the evidence base for CPSR Part A and Part B, enabling Responsible Persons to demonstrate full regulatory compliance.

Phoenix’s Expertise

Toxicological assessments at Phoenix Safety Consultants are carried out by professionals specialising in cosmetic safety, toxicology, and regulatory science. Each assessment upholds scientific objectivity, transparency, and traceability in line with global standards.

Our Expertise Includes:

• Extensive understanding of EU Regulation (EC) No 1223/2009, UK Cosmetic Regulation 2020, and SCCS guidance.
• Dermal toxicology, ingredient hazard evaluation, and Margin of Safety modelling.
• Review of SCCS opinions, IFRA Standards, and REACH toxicological databases.
• Integration of ISO 22716 Good Manufacturing Practice (GMP) and quality documentation into safety assessments.

Every TRA report references relevant scientific data, provides full citations, and is tailored to withstand OPSS or EU competent authority scrutiny. Phoenix combines regulatory precision with practical skincare formulation expertise to produce scientifically robust and compliant TRA reports.

Documentation & Inputs Required

A complete Toxicological Risk Assessment can only be performed when Phoenix receives verified documentation for the product. This ensures accurate exposure estimation and defensible toxicological conclusions.

Required Documentation Includes:

• Complete INCI ingredient list with percentage composition (% w/w).
• Safety Data Sheets (SDS) and technical data for each raw material.
• Product category and intended use (e.g., face cream, eye serum, hand lotion).
• Product type (leave-on or rinse-off).
• Physical form (liquid, cream, gel, or lotion).
• Application frequency and target area (e.g., body, face, hands).

Optional but valuable data include stability reports, microbiological test results, and preservative challenge tests. Providing complete information ensures the assessment meets all UK and EU legal standards.

Deliverables & Turnaround

Upon completion of the toxicological review, clients receive a full TRA report ready for inclusion in the Cosmetic Product Safety Report (CPSR).

Deliverables Include:

• Signed Toxicological Summary Report containing ingredient-level analyses.
• MoS Table including NOAEL, SED, and MoS calculations.
• Consolidated formulation safety conclusion.
• CPSR documentation prepared for inclusion in Part A and Part B.

Turnaround Time: 3–5 business days for standard delivery, depending on formulation complexity and data completeness. Expedited options are available for urgent projects or product launches. All assessments are securely archived for traceability during audits or reformulations.

Pricing

Toxicological Risk Assessments for Beauty Products start at £75 and can cost up to £110 per formulation, depending on complexity and data volume.

Don’t risk non-compliance or compromise your brand’s safety credibility. Get your tailored toxicological safety assessment completed by Phoenix Safety Consultants.

Ensure your cosmetic products are scientifically safe, legally compliant, and ready for the UK and EU markets.

→ Order a Toxicological Assessment
→ Learn About CPSR and PIF Services
→ Read About Fragrance Toxicology Assessments