Toxicological risk assessment is a procedure for estimating whether and under what conditions a substance can be harmful to human health. It typically consists of an evaluation of the hazardousness of the substance (hazard assessment) and an estimation of the actual exposure, i.e. how, how often and in what quantity people come into contact with the substance.

The results form the basis for legal decisions - for example on classification and labeling (e.g. according to CLP) or on the safe use of chemicals under the REACH regulation. Without a well-founded toxicological risk assessment, a substance or product may often not be placed on the market.

Toxicological assessments are mandatory in many industries - especially where chemicals come into direct or indirect contact with humans. These include

• Industrial chemicals (REACH registration obligation)
• Mixtures and products with mandatory labeling (CLP)
• Biocidal products (e.g. disinfectants)
• Cosmetic products (in accordance with the EU Cosmetics Regulation)
• Toys, food contact materials and medical devices (in some cases)

If your company manufactures, imports or uses substances, a toxicological assessment may be necessary - even if you do not sell them directly to consumers.

We will be happy to advise you when an assessment is mandatory and to what extent.

Usually the responsibility for the toxicological assessment lies with the distributor - i.e. the company that places the substance or product on the market. In European chemicals legislation, these are usually manufacturers or importers. Under certain circumstances, however, downstream users (e.g. formulators, distributors or industrial users) may also be obliged to carry out or supplement toxicological assessments - especially if they introduce new uses or formulations. We support all parties along the supply chain in fulfilling their obligations safely.

A toxicological assessment is carried out in several steps:

1. Data collection: first, existing toxicological data is researched (e.g. studies, literature, databases).
2. Hazard assessment: the health effects are evaluated (e.g. skin irritation, sensitization, carcinogenicity).
3. Exposure assessment: how people could come into contact with the substance is determined - via skin, inhalation or ingestion.
4. Risk assessment: hazard and exposure are combined to assess the actual risk.
5. Documentation: the results are summarized in a report, e.g. as part of a REACH dossier or safety report.

We take care of the entire process for you - from research to communication with the authorities.

Missing data is not uncommon - especially for new or rarely used substances. In such cases, we first check whether data from comparable substances can be transferred (read-across). If this is not possible, we recommend suitable test strategies, e.g. in vitro or in silico methods, in order to find solutions that are as animal-free and cost-efficient as possible. If necessary, we will assist you in commissioning GLP-compliant laboratory studies and ensure that the results can be used for regulatory purposes. In this way, you avoid unnecessary costs and delays.

The time and costs involved depend heavily on the individual case: the type of substance, available data, complexity of the application and applicable regulations all play a decisive role. A simple assessment based on existing literature data can be completed within a few days. Comprehensive assessments with additional exposure assessment or new studies require more time. We offer you a realistic estimate of the duration and costs in advance - transparent and predictable. In many cases, our experience and standardized processes can save you considerable time and money.

The duration of an Environmental Risk Assessment (ERA) for pharmaceuticals can vary depending on the scope and complexity of the assessment. In general, the process takes between 2 and 6 months, depending on the availability of the required data, the type of pharmaceutical and the regulatory requirements of the respective market.

For pharmaceuticals based on an existing dossier, the process can be completed more quickly. However, new pharmaceuticals with many unknown environmental effects require more comprehensive studies and detailed analysis.

Our experts at CSB Compliance do everything they can to make the ERA as efficient and smooth as possible without compromising quality or regulatory requirements.

CSB Compliance supports companies in carrying out a complete and legally compliant Environmental Risk Assessment (ERA) for pharmaceuticals. Our experienced team of experts offers you:

• Advice on data collection and evaluation: we will help you identify and evaluate the relevant data required for the ERA.
• Exposure assessment and risk calculations: We use our sophisticated models and tools to calculate the exposure of your pharmaceuticals and their impact on the environment.
• Preparation of ERA reports: We produce detailed reports that meet regulatory requirements and help you obtain authorization from the competent authorities.
• Regulatory support: We assist you in communicating with authorities and ensure that all requirements are met on time and in full.

Our approach combines scientific precision with practical experience to ensure that you go through the ERA process efficiently and safely.