GLP-Compliant Safety, Efficacy, and Risk Assessment of Biocidal Products

Biocidal products are chemical products used to eliminate or control organisms—such as bacteria, viruses, fungi, rodents, and insects—that harm humans, animals, materials, or the environment. Disinfectants, preservatives, and pest control products fall into this category.

Since these products are widely used by both professional users and the general public, safety and efficacy assessments are a legal requirement.

In Turkey, they are evaluated under the Turkish Ministry of Health and the Public Health Agency, while in the European Union, they are assessed under the Biocidal Products Regulation (BPR, Reg. (EU) No 528/2012). This process requires a comprehensive data package compliant with GLP (Good Laboratory Practice).

The Importance of GLP in Biocidal Products

Due to ethical regulations and legal restrictions, animal testing has been restricted or redirected toward alternative methods in many areas. Consequently, alternative (in vitro) methods are increasingly being used in biocidal safety assessments.

The GLP quality system ensures the reliability and regulatory compliance of data obtained from these alternative methods through:

• Organizational structure
• Staff competence
• SOPs (Standard Operating Procedures)
• Data recording and archiving
• Quality assurance audits

Key Test Groups for Biocidal Products

1. Physicochemical Properties and Stability

The chemical and physical properties of biocidal products are of critical importance for product quality:

• pH, density, viscosity, flash point, solubility
• Active ingredient purity and stability
• Chemical integrity throughout the shelf life
• Packaging compatibility and migration tests

2. Efficacy (Biocidal Activity) Tests

The product’s efficacy against target microorganisms is evaluated according to EN standards:

• Bactericidal, fungicidal, virucidal, sporicidal, and mycobactericidal tests
• Standards such as EN 1276, EN 13697, and EN 14476
• Protocols specific to surface, hand, and air disinfectants
• Tests under challenging conditions such as soil load, contact time, and temperature

3. Toxicological Assessment (Human Health Risks)

Risks to human health are determined through GLP-compliant toxicology studies:

• Acute toxicity (oral, dermal, inhalation)
• Skin and eye irritation/corrosivity
• Skin sensitization (allergenic potential)
• Repeated-dose toxicity (28/90 days)
• Genotoxicity (Ames test, micronucleus test)
• Carcinogenicity and reproductive toxicity when required

Note: In Turkey and the EU, certain animal tests may still be required in active ingredient approval processes; however, the use of alternative methods is increasing.

4. Exposure and Risk Assessment

Risk analyses are conducted based on user type:

• Separate scenarios for professional users and the general public
• Dermal, oral, and inhalation exposure calculations
• Software developed by ECHA, such as EUSES
• Risk characterization and safe use limits

5. Environmental Risk Assessment

The environmental impacts of biocidal products are also comprehensively assessed:

Aquatic organisms (fish, Daphnia, algae)

Soil organisms and bees

Biodegradability (OECD 301)

Adsorption/desorption (OECD 106)

• Photodegradation studies

The safe and effective marketing of biocidal products is possible not only by demonstrating their efficacy but also by scientifically proving that they are safe for human health and the environment.

This process is ensured through GLP-compliant laboratory tests, alternative methods, and comprehensive risk assessments. The modern approach prioritizes both human health and environmental sustainability.