Introduction

A Toxicological Risk Assessment (TRA) is the first step in evaluating a cosmetic product's safety. It examines every ingredient and assesses whether the product is safe for human use under normal and foreseeable conditions. The TRA forms the basis for the Cosmetic Product Safety Report (CPSR) required under EU Regulation (EC) No 1223/2009 and the UK Cosmetic Regulation 2020 (SI 2020/1466). The CPSR is the legal document proving that a cosmetic product is safe prior to market placement.

As a safety consultant for beauty and cosmetic fragrance products, Phoenix Safety Consultants integrates safety regulatory standards and applied toxicology to ensure that your formulations comply with UK and EU safety regulations.

Legal & Regulatory Framework

The Toxicological Risk Assessment (TRA) is a legal requirement under Annex I of Regulation (EC) No 1223/2009, which outlines the CPSR structure. The same applies to the UK Cosmetic Regulation 2020 (Schedule 34), where the TRA is required for every cosmetic product marketed in Great Britain or Northern Ireland.

Annex I, Part A, defines the need for detailed analysis of toxicological data, exposure, and ingredient properties. Part B requires a qualified safety assessor to review and integrate this data, evaluate safety relative to intended use, and determine risk acceptability.

Each assessment must consider:

• Ingredient restrictions under Annex II–VI (prohibited, restricted, colourants, preservatives, and UV filters).
• Exposure pathways (dermal, inhalation, ocular, or oral).
• Vulnerable populations such as children and pregnant women.
• Cumulative or combined exposure effects.

Phoenix Safety Consultants conducts all TRAs in accordance with the SCCS Notes of Guidance (12th Edition) and OECD toxicological principles, producing defensible assessments that meet the scrutiny of regulatory authorities and auditors.

Purpose of Toxicological Risk Assessment

The purpose of a TRA is to ensure that a cosmetic product’s safety is scientifically validated for its intended use. This process identifies, measures, and minimises health risks associated with ingredient and product exposure.

Our toxicologists assess factors including:

• Chemical identity and purity of each ingredient.
• Toxicological effects such as irritation, sensitisation, mutagenicity, carcinogenicity, and systemic toxicity.
• Product type, body surface area, and exposure frequency and duration.
• Interactions among ingredients that may affect safety.

Each ingredient is assigned a Margin of Safety (MoS), demonstrating that consumer exposure levels remain far below toxic thresholds. This is a legal requirement underpinning consumer protection and compliance across UK and EU cosmetic markets.

Scientific Process Overview

Phoenix Safety Consultants applies a structured, evidence-based approach aligned with SCCS and OECD methodologies. Each assessment is traceable, scientifically justified, and auditable for regulatory review.

Ingredient Review

All raw materials are reviewed for identity, function, and safety. Toxicological data are compiled from SCCS opinions, ECHA databases, and peer-reviewed literature, and verified against Annex II–VI of Regulation (EC) No 1223/2009.

NOAEL (No Observed Adverse Effect Level) Determination

NOAEL represents the maximum exposure level at which no adverse effects occur. Phoenix Safety Consultants derives NOAEL values from validated animal, in vitro, and human studies to establish safe exposure limits.

Margin of Safety (MoS) Calculation

The MoS is calculated by comparing NOAEL to the Systemic Exposure Dose (SED)—the estimated exposure level during product use. An MoS ≥100 generally indicates sufficient systemic safety.

Exposure and Sensitisation Risk

Exposure assessment includes product application type (leave-on, rinse-off, aerosol, or fragrance) and frequency. Potential for irritation or sensitisation from allergens and reactive ingredients is evaluated.

Cumulative and Systemic Toxicity

When multiple components share toxicity pathways, synergistic and additive effects are analysed. For fragrances, inhalation exposure is quantified per IFRA and SCCS guidelines.

Conclusion on Safety

The Part B Safety Assessment summarises the findings and includes the assessor’s signature, credentials, and data references—formally declaring the product safe for use.

Phoenix Safety Consultants’ Expertise

Our toxicological assessments are conducted by specialists in cosmetic chemistry, toxicology, and risk analysis. We combine scientific accuracy with regulatory experience to deliver internationally recognised documentation.

Our expertise includes:

• Comprehensive Ingredient Analysis – Evaluation of toxicological and SCCS/REACH data for all ingredients.
• Deterministic MoS and Exposure Modelling – Realistic use scenarios based on body surface area and absorption data.
• Risk Evidence Justification – Clear, data-driven reasoning supporting each safety conclusion.
• Integration into PIF and CPSR – TRAs are structured to integrate seamlessly into Product Information Files and CPSR Part B.
• Auditable Transparency – Full citations of data sources, assumptions, and methodologies for inspection readiness.

Phoenix ensures consistency, scientific credibility, and compliance with SCCS and OECD guidance across all assessments.

Service Coverage

Phoenix Safety Consultants provides two specialised TRA services to account for product category differences:

• TRA for Beauty Products – For creams, serums, shampoos, cleansers, and other topical formulations. This includes systemic exposure analysis, dermal absorption studies, and irritation/sensitisation endpoints relevant to skin applications.
• TRA for Fragrances – For perfumes, body sprays, and volatile formulations. Evaluates inhalation exposure, sensitisation thresholds, and IFRA category compliance to ensure safe use.

Both single-variant and multi-variant product assessments are supported, ensuring uniform safety validation across your full product range.

Documentation, Timelines & Deliverables

Required Information:

• Complete INCI list with precise ingredient concentrations (%).
• Safety Data Sheets (SDS) and raw material technical specifications.
• Product usage information (area of application, frequency, and quantity used).
• PIF or CPSR Part A data (if available).

Deliverables:

• Signed TRA report by a qualified safety assessor.
• Margin of Safety (MoS) table for each ingredient.
• Toxicological profile summary referencing SCCS and OECD data sources.
• Safety conclusion statement for CPSR Part B integration.

Turnaround Time: 3–5 working days, depending on documentation completeness and formulation complexity.

Pricing

We offer Toxicological Risk Assessment (TRA) services starting at £75 and up to £110 per formulation, depending on product type and data availability.

Your cosmetic or fragrance formulations can achieve maximum safety and toxicological compliance with Phoenix Safety Consultants.

→ Ask For Toxicological Risk Assessment Service
→ Read About Cosmetic Product Safety Reports (CPSR)
→ Navigate to Product Information File (PIF) Services