Cosmetics Toxicology
Comprehensive solutions for safety assessment and regulatory compliance of cosmetic products under Regulation EC 1223/2009.
Toxicological Services for Cosmetics
Specialised expertise to comply with Regulation EC 1223/2009
REACH Monitor can support your company throughout the entire cosmetics process, from research and development to commercialisation under Regulation (EC) No 1223/2009.
Our team of specialised toxicologists, including European Registered Toxicologist (ERT) certified professionals, provides the scientific and regulatory support needed to ensure the safety of your cosmetic products and facilitate their access to the European market.
We offer complete assistance in preparing the dossier for submission to the Scientific Committee on Consumer Safety (SCCS), as well as the preparation of the product information file required by the regulation.
Toxicological Regulatory Services for Cosmetics
Complete solutions for the regulatory compliance of your products
SCCS Dossier Preparation Process
Initial Assessment
Comprehensive analysis of existing documentation, review of available scientific literature and definition of the most appropriate testing strategy to minimise costs and timelines.
Data Collection and Generation
Identification of required data, management of necessary toxicological tests, application of alternative methodologies (QSAR, read-across) and compilation of all technical information.
Complete Safety Assessment
Risk characterisation, calculation of the Margin of Safety (MoS), exposure assessment and analysis of possible adverse effects under normal conditions of use.
Preparation of the Final Dossier
Preparation of the complete dossier according to SCCS requirements, including all technical documentation, test reports, safety assessment and justified conclusions.
Safety Reports
Preparation of the Cosmetic Product Safety Report (CPSR) in accordance with Annex I of Regulation EC 1223/2009, including evaluation of all ingredients and the final product.
- Part A: Information on the safety of the product
- Part B: Assessment of the safety of the product
- Declaration of conformity signed by qualified assessor
Toxicological Profile
Detailed analysis of the toxicological properties of each ingredient, generating a complete safety profile based on reliable scientific data.
- Acute and chronic toxicity
- Local toxicity (skin/eye irritation)
- Skin sensitisation
- Percutaneous absorption
- Reproductive toxicity and teratogenicity
Risk Assessment
Systematic analysis of the risk associated with each ingredient and the final product, considering real conditions of use.
- Calculation of the Margin of Safety (MoS)
- Systemic exposure assessment
- Analysis of ingredient interactions
- Use scenarios by specific population
Product Information File
We prepare the Product Information File (PIF) with all documentation required by the Regulation, including qualitative/quantitative formula, specifications, manufacturing method, efficacy tests and safety data.
CPNP Notifications
We manage notifications through the Cosmetic Products Notification Portal (CPNP), a mandatory requirement prior to commercialisation in the EU.
Nanomaterial Requirements
Specialised advice on specific requirements for ingredients in nanomaterial form, including special notifications and adapted safety assessments.
INCI List Application
Assistance in the inclusion of new ingredients in the Cosmetic Ingredient Inventory (INCI), facilitating their regulated use in cosmetic products.
REACH-Cosmetics Interface
Tailored strategies to comply with both regulations, optimising resources and ensuring simultaneous compliance with both regulatory frameworks.
International Compliance
In addition to the EU, we provide advice on regulatory requirements in other markets such as the United Kingdom, USA, China and Brazil.
QSAR Modelling
We apply advanced computational models to predict the toxicological profile of cosmetic ingredients in the early stages of development, reducing the need for testing.
- Biodegradability prediction
- Skin/eye irritation assessment
- Identification of sensitisation potential
- Analysis of possible genotoxicity
Ingredient Substitution
Expert advice for the identification and validation of safe alternatives to problematic ingredients or those with regulatory restrictions.
- Analysis of alternatives to restricted preservatives
- Substitution of potentially sensitising ingredients
- Comparative evaluation of efficacy and safety
Intelligent Testing Strategies
Design of optimised strategies combining in silico methods, in vitro approaches and read-across to reduce costs and evaluation timelines.
- Tiered approach
- Validated alternative methods
- Substance grouping strategies
- Test protocol optimisation
Notable Examples
Representative cases of our services in cosmetic toxicology