EU Risk Assessment

A comprehensive risk assessment is essential for ensuring that biocidal products meet the safety, health, and environmental requirements under the EU Biocidal Products Regulation (BPR) [Regulation (EU) No 528/2012]. Our Risk Assessment Services help companies evaluate and mitigate potential hazards associated with their biocidal products, ensuring regulatory compliance and market approval.

What is a Biocidal Product Risk Assessment?

A risk assessment evaluates the potential health and environmental risks of a biocidal product based on its active substances, exposure scenarios, and intended uses. It involves:

🔹 Human Health Risk Assessment – Evaluating potential risks to consumers, workers, and bystanders.

🔹 Environmental Risk Assessment – Assessing the impact on soil, water, and non-target organisms.

🔹 Exposure Scenario & Risk Characterization – Determining exposure levels through various application methods.

🔹 Toxicological & Ecotoxicological Analysis – Identifying adverse effects and establishing safe-use conditions.

🔹 Risk Management & Mitigation Strategies

Our Biocidal Product Risk Assessment Services

1. Human Health Risk Assessment

✅ Toxicological Evaluation – Assessing acute and chronic toxicity (oral, dermal, inhalation exposure)

✅ Irritation & Sensitization Studies – Evaluating skin/eye irritation, corrosion, and allergic reactions

✅ Mutagenicity & Carcinogenicity Assessment – Identifying long-term health risks

✅ Dermal Absorption & Exposure Assessment – Determining risk levels for direct contact scenarios

✅ Acceptable Daily Exposure (ADE) & Threshold Limit Values (TLV) – Establishing safe exposure limits

2. Environmental Risk Assessment (ERA)

✅ Ecotoxicological Studies – Evaluating the impact on aquatic and terrestrial ecosystems

✅ Biodegradability & Persistence Testing – Assessing environmental degradation potential

✅ Soil, Water, and Air Contamination Risk – Identifying possible environmental hazards

✅ Environmental Fate & Behavior Modeling – Predicting the product’s behavior in different environmental conditions

✅ Risk Mitigation Strategies – Developing control measures to minimize adverse effects

3. Exposure Scenario & Risk Characterization

✅ Occupational Exposure Assessment – Evaluating risks for workers handling the product

✅ Consumer Exposure Analysis – Assessing risks for end-users and the general population

✅Application-Specific Risk Scenarios – Identifying potential hazards based on product use (e.g., disinfectants, insecticides, preservatives)

4. Risk Management & Mitigation Strategies

✅ Safety Measures & Precautionary Labeling – Providing appropriate hazard warnings

✅ Personal Protective Equipment (PPE) Recommendations – Ensuring safe handling instructions

✅ Product Reformulation Consultation – Advising on modifications to reduce toxicity and risk

5. Regulatory Compliance & Dossier Support

✅ Risk Assessment Report Preparation – Generating dossier-ready reports for BPR submissions

✅ Data Gap Analysis & Study Recommendations – Identifying missing information and required testing

✅ Submission & Follow-up – Managing risk assessment approvals

Who Needs a Biocidal Product Risk Assessment?

✔ Manufacturers of Biocidal Active Substances & Formulations

✔ Importers & Distributors of Biocidal Products

✔ Producers of Biocidal-Treated Articles

Why Choose Us?

🔹 Expert Risk Assessment Team – Experienced toxicologists and regulatory specialists

🔹 Regulatory Compliance Assurance – Ensuring full alignment with EU BPR requirements

🔹 Comprehensive & Tailored Approach – Risk assessments customized to your specific biocidal product