Biocidal Products Risk Assessment Guideline under Turkey BPR (2026)
The Biocidal Products Risk Assessment Guideline has been published to define the principles and procedures for conducting risk assessments within the scope of biocidal product authorisation and licensing processes.
The Guideline has been prepared in accordance with Annex VI – Common Principles for the Evaluation of Biocidal Product Dossiers of the Biocidal Products Regulation and entered into force with the official letter dated 30.12.2025 and numbered E-19020089-105.99-299627592.
As of this date, the toxicology and ecotoxicology sections of biocidal product authorisation applications must be prepared in line with the requirements set out in this Guideline.
Scope of Risk Assessment for Biocidal Products
Risk assessment shall always be conducted for:
The active substance contained in the biocidal product, and
Each substance of concern (SVHC) present in the formulation.
The assessment covers both the normal intended use of the biocidal product and worst-case scenarios, including potential risks arising during production, use, and disposal stages.
Risk assessment includes hazard identification, dose (concentration)–response assessment, exposure assessment, risk characterisation, and the final overall risk conclusion for the product.
Identification of Substances of Very High Concern (SVHC)
Substances may be identified as SVHC if they meet one or more of the following criteria:
Classified as carcinogenic, mutagenic or toxic for reproduction (CMR Category 1A or 1B) under the CLP Regulation
Identified as persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB) in accordance with Annex XIII of the REACH Regulation
Substances causing an equivalent level of concern on a case-by-case basis
SVHC screening shall be conducted with reference to the ECHA Candidate List of Substances of Very High Concern for Authorisation.
Main Stages of the Risk Assessment Process
A) Hazard Identification
Hazard identification involves defining the inherent adverse effects of the biocidal product based on the properties of the active substance(s) and substances of concern, including:
Acute and chronic toxicity
Irritation and corrosivity
Skin and respiratory sensitisation
Repeated dose toxicity
Mutagenicity and carcinogenicity
Reproductive toxicity
Neurotoxicity
Other effects related to physico-chemical properties
B) Dose (Concentration)–Response Assessment
This stage evaluates the relationship between the level of exposure and the severity of the observed effect.
Where applicable, the following values are used:
NOAEL (No Observed Adverse Effect Level)
LOAEL (Lowest Observed Adverse Effect Level)
LD₅₀ / LC₅₀, where NOAEL or LOAEL cannot be determined
For genotoxic carcinogens and mutagens, numerical dose descriptors are not derived; instead, the Negligible Exposure approach applies.
C) Exposure Assessment
Exposure assessment estimates the level of exposure for each relevant population group, including:
Trained professional users
Professional and industrial users
Non-professional users
Indirectly exposed individuals (secondary exposure)
Exposure may be assessed using quantitative or qualitative methods, based on available data and realistic use scenarios.
D) Risk Characterisation
For human health, risk characterisation is conducted using the Margin of Safety (MOS) approach:
MOS ≥ 100 → Acceptable risk
MOS < 100 → Unacceptable risk
For environmental risk assessment, the PEC/PNEC ratio is applied:
PEC/PNEC < 1 → Acceptable
PEC/PNEC > 1 → Unacceptable
E) Risk Management Measures and Final Evaluation
Based on the risk assessment results, the biocidal product is concluded to be either:
SAFE, or
NOT SAFE
Where necessary, risk mitigation measures such as the mandatory use of personal protective equipment (PPE) may be imposed as a condition of authorisation. Biocidal products requiring PPE during use are not authorised for non-professional users.
Reference Documents and Models
Risk assessments shall be conducted in accordance with guidance published by ECHA, WHO and OECD, using recognised modelling tools such as EUSES, ConsExpo, ECETOC TRA and Chesar.
General Evaluation
The Biocidal Products Risk Assessment Guideline establishes a structured, science-based and harmonised framework for evaluating risks to human health and the environment within biocidal product authorisation processes as of 2026.
Manufacturers and authorisation applicants are therefore required to ensure full compliance with the Guideline when preparing and submitting biocidal product dossiers.