EU cosmetics safety assessment

Biorius can help with your EU cosmetics safety assessment (for ingredients and products). You will find all the necessary information for the EU cosmetics safety assessment for ingredients hereunder and will find all the necessary information for the EU cosmetics safety assessment for products HERE.

EU cosmetics safety assessment ingredients: Are you certain that the ingredients used in your cosmetic formulations are safe? Can you use specific information as marketing claims for your cosmetic products? Do you need regulatory assistance for your cosmetic ingredients?

BIORIUS’ toxicological expertise is here to assist you.

There are three types of ingredient safety assessment reports:

Summary report
Brief report
Full report

The safety assessment summary report serves as a conclusion for each endpoint.

The brief report presents a brief description of each ingredient and concisely details the most reliable study available for each endpoint.

The full report presents the ingredients along with their toxicological data. Several studies are detailed for each endpoint. In the absence of toxicological data on the ingredient in the literature, a predictive toxicological evaluation is carried out. In silico tools (such as the QSAR – Quantitative Structure-Activity Relationship), read-across approaches and TTCs (Threshold of Toxicological Concern) are used to fill in any data gaps. The full report also includes an exposure assessment, characterization and risk management information.

BIORIUS conducts a review of toxicological data available in the literature.

Each toxicological endpoint of interest is evaluated in terms of:

Acute toxicity
Local effects: eye irritation, skin irritation, skin sensitization and phototoxicity (for instances of sun exposure)
Repeated dose toxicity
Genotoxicity
Carcinogenicity
Reproductive/Developmental toxicity
Pharmacokinetics (including dermal absorption)

To ensure consumer safety:

we characterize the systemic toxicity risk related to the use of the ingredient via the application of a Margin of Safety (MoS). The MoS assigns a ratio to the hazard of an ingredient and a consumer’s exposure to it. The higher the ratio, the more the consumer is protected against potential systemic effects.

An evaluation of the consumer’s exposure to the ingredient can be made for a product category or can be tailored to your product and its specific properties. Consumer exposure depends on the concentration of the ingredient in the product and the use of the product.

If your ingredient is found to be a skin sensitizer, the QRA methodology is applied, which specifies the acceptable maximum concentration of the ingredient in the product or product category.

Together, these toxicological results allow us to draw conclusions regarding the safety of an ingredient for a given cosmetic product or product category.

The manufacturing method and any toxicological data regarding the raw material in which the ingredient is contained is a benefit for the safety assessment.

For the full report, the concentration of the ingredient in the cosmetic product and instructions for using the product are required for the exposure assessment.

With its experience in regulatory toxicology, BIORIUS evaluates the safety of your ingredients, including the safety of your complex natural extracts.

1. Before the evaluation

Communication with your suppliers
Conduct the composition analysis
Data collection, organization and storage

2. During evaluation

Preparation of the toxicological profile of the ingredients
Preparation of the toxicological profile of the raw materials
Implementation and execution of a test plan
Evaluation of the exposure, evaluation and management of risks

3. After the evaluation

We provide:

A thorough safety evaluation, including an evaluation of the risks and a set of toxicological profiles.
A safety certificate

Performance Assessment of cosmetic ingredients

BIORIUS evaluates the performance of cosmetics ingredients and/or raw materials and develops the most appropriate test plan. Based on the results and concentrations in the formula composition, our experts can guide you through the best marketing claims for your cosmetic products.

How does it work?

1. We plan and order the tests

We define which tests are needed based on your ingredients and manage the process of conducting them.

2. We analyze the tests results

We analyze the test results and provide you with a report describing the studies performed and conclusions drawn. We then indicate which claims can be made for which ingredients and at which concentrations. We always try to obtain the best claims possible while remaining fully compliant.