According to the Turkish Biocidal Products Regulation, the risk assessment of biocidal products is a prerequisite for market authorisation. Risk assessment involves evaluating the potential effects of biocidal products and their active substances and substances of concern on human health, animal health, and the environment during the stages of production, storage, packaging, marketing, import, and export.
Chemleg’s Risk Assessment of Biocidal Products service ensures that your products comply with regulatory requirements and meet the safety standards set by the Turkish Ministry of Health (MoH).
Key Components of Risk Assessment of Biocidal Products
- Research Reports and Test Methods: The administrative and technical procedures and principles regarding tests to be conducted on substances or mixtures to determine their physicochemical, toxicological, and ecotoxicological properties arising from their intrinsic characteristics are regulated by the “Regulation on Test Methods to be Applied in the Determination of the Physicochemical, Toxicological and Ecotoxicological Properties of Substances and Mixtures”.
- Required Documents: Information and documents necessary for evaluating relevant characteristics and effects must be submitted.
- Good Laboratory Practice (GLP): Toxicological and ecotoxicological tests presented in the application dossier for active substances and biocidal products must be conducted in compliance with the provisions of the the Good Laboratory Practice Regulations.
- Request for Additional Information: The Ministry may request samples or supplementary information from the applicant if additional data is needed to complete the risk assessment during dossier evaluation.
How Chemleg Supports You in the Risk Assessment of Biocidal Products
Chemleg helps you bring your biocidal products to the market in a compliant, safe, and sustainable manner. Through Chemleg’s technical expertise and support services—including data collection, dossier preparation, and Ministry application management—you can ensure successful market access in Türkiye.
Our BPR Risk Assessment Services
- 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
- Exposure estimation calculations: Determining exposure scenarios and calculating exposure estimates in accordance with the application methods of the product
- 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 potential environmental hazards
- Environmental Fate & Behaviour Modelling: Predicting product behaviour under various environmental conditions
- Exposure estimation calculations: Estimation of the PEC (predicted environmental concentration), which is the concentration expected to be reached when a substance is released into the environment (e.g. water, soil, air)
- 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 and Risk Characterization: Identifying hazards based on intended use (e.g. disinfectants, insecticides, preservatives) and determining whether the product presents any risk in its relevant field of use
- Risk Management & Mitigation Strategies
- Safety Measures & Precautionary Labelling: Providing appropriate hazard warnings
- Personal Protective Equipment (PPE) Recommendations: Ensuring safe handling instructions
- Product Reformulation Consultation: Advising on modifications to reduce toxicity and risk
- 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
- Turkish Ministry of Health Submission & Follow-up: Managing risk assessment approvals
You can schedule a consultation with our experts by filling out the form below.
Frequently Asked Questions
Who is the main authority responsible for the risk assessment process, and what are the key evaluations conducted?
The risk assessment process is carried out by Republic of Türkiye Ministry of Health. The Ministry’s main responsibilities include:
- Assessing the hazardous effects on humans,
- Evaluating human health risk assessments,
- Evaluating environmental risk assessments,
- Ensuring human, animal, and environmental exposure and efficacy evaluations,
- Assessing risks and effects on humans and, when necessary, on animals.
What are the main risk criteria for authorizing or registering a biocidal product?
For a biocidal product to be authorized, the following requirements must be met:
- The product must be sufficiently effective, without causing resistance or cross-resistance in target organisms, or unnecessary pain and suffering in vertebrates.
- The product or its residues must not have adverse effects on human health, animal health, or the environment.
- The product must not have undesirable effects on non-target organisms.
- The properties and quantities of active substances must comply with the relevant conditions specified in the regulation.
- The physical and chemical characteristics of the product must be appropriate for its intended use, storage, and transport.
Chemleg ensures that your products are placed on the market in full compliance with regulatory requirements.
Are there any special risk conditions for the authorization of low-risk biocidal products?
Yes. Low-risk biocidal products must pose low risks to humans, animals, and the environment under their intended conditions of use and must not contain any substances of concern.
