Disinfectants and General Biocidal Products (1st MAIN GROUP)
1st Main Group Biocidal Products
Biocidal products are chemical or biological substances used to control, neutralize, or eliminate microorganisms. According to the Biocidal Products Regulation (BPR) No. 27449 (4th Duplicate) dated December 31, 2009, biocidal products are categorized into four main groups: Disinfectants and General Biocidal Products, Preservatives, Pest Control Products, and Other Biocidal Products. This article will discuss the first main group, “Disinfectants and General Biocidal Products.”
What is a disinfectant?
Disinfectants are chemical or biological substances used to eliminate or neutralize microorganisms (bacteria, viruses, fungi, and other pathogens). Disinfectants play a critical role in maintaining health and hygiene, with applications ranging from hospitals to homes, food production facilities to personal hygiene products.
Product Types in the First Main Group
The types of products under the Disinfectants and General Biocidal Products group as defined in Annex V of the Biocidal Products Regulation (BPR) are listed below:
- Product Type 1: Human hygiene
These biocidal products are used for human hygiene and are primarily intended to disinfect skin and scalp through application to or contact with human skin and scalp. - Product Type 2: Disinfectants and algaecides not intended for direct application to humans or animals
These products are used to disinfect surfaces, materials, equipment, and furniture not in direct contact with food or feed. Areas of use include swimming pools, aquariums, air conditioning systems, and other public, private, industrial, and professional premises. These are products used in the disinfection of air, water used other than for human or animal consumption, chemical toilets, wastewater, hospital waste and garbage. Products for algae treatment in swimming pools and aquariums, as well as for the preservation of construction materials, are also included. These are products used to treat textiles, fabrics, masks, paints and other items or materials for the purpose of producing disinfectant treated articles. - Product Type 3: Veterinary hygiene
These include disinfectants used for veterinary hygiene purposes, soaps with disinfectant properties, oral or body hygiene products, or products with antimicrobial effects. They are also used to disinfect materials and surfaces related to animal housing or transport. - Product Type 4: Food and feed area
Products in this category are used to disinfect equipment, containers, utensils, surfaces, or pipelines associated with food or feed production, transportation, storage, or consumption, including drinking water. - Product Type 5: Drinking water
These products are used for the disinfection of drinking water for humans and animals.
Licensing Requirements for Disinfectants and General Biocidal Products
Preparation of the Licensing Dossier
The licensing dossier for products in the first main group must include the following:
- Biocidal Product Licensing Dossier (as per Annex IIB)
- Biocidal Product Active Substance Dossier (as per Annex IIA)
- Biocidal Product Risk Assessment Report (as per Annex VI)
- Biocidal Product Label (as per Annex XII)
- Biocidal Product Safety Data Sheet (as per KKDIK Annex II)
- Biocidal Product Formulation and Specification Documents
- Biocidal Product Packaging Compatibility Declaration
- Biocidal Product Test Results
Testing Requirements
The testing requirements for biocidal products are specified in the Directive on Biocidal Product Analyses and Authorized Laboratories, published under Approval No. E.519 dated January 28, 2019. All analyses must be conducted in laboratories certified with Good Laboratory Practice (GLP) or accredited for the relevant analytical parameters.
The following tests must be conducted for biocidal products in the first main group:
- Physicochemical Tests:
Appearance, physical form, pH, density, and active substance/auxiliary substance analysis (if necessary). - Short-Term Stability Tests:
Stability tests conducted over a period of 2–18 weeks depending on the product characteristics. - Open Packaging Stability Tests:
Stability tests conducted according to the declared stability period of the opened product (e.g., 3 months, 6 months, 9 months). - Long-Term Stability Tests:
Stability tests conducted over the declared shelf life of the product. - Efficacy Tests:
Tests demonstrating the product's efficacy against the declared microorganisms.
General Provisions Regarding Tests
- All tests must be conducted on samples produced from the same batch/lot.
- Physicochemical and stability tests must be conducted in the same laboratory.
- If efficacy tests need to be conducted in a different laboratory, physicochemical tests must also be conducted in the same laboratory on the first day.
- The date of efficacy tests must not exceed ten years prior to the license application date.
- For imported products, the Ministry of Health may accept results from tests conducted abroad if they meet the conditions specified in the regulation.
Test Standards
According to the Instruction on Biocidal Product Analysis and Authorized Laboratories published with the Official Approval No. E.519 dated 28.01.2019, the required test standards for 1st Main Group Biocidal Products are given in the table below.
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Table 1: Required Test Standards for 1st Main Group Biocidal Products
|
Product Type |
Usage Area |
Disinfectant Type |
Target Organism/Standard |
|
2 |
Public and Personal Area |
Equipment Disinfectant |
Bacteria: TS EN 1276 |
|
Public and Personal Area |
Surface Disinfectant |
Bacteria: TS EN 1276 |
|
|
Medical Area |
Surface Disinfectant |
Bacteria: TS EN 13727+A2 |
|
|
Public and Personal Area |
Pool Water |
Bacteria: OECD ENV/JM/MONO 15 |
|
|
Public and Personal Area |
Paints (Dry Paint Film) |
Bacteria: TS ISO 22196 |
|
|
Medical Area |
Paints (Dry Paint Film) |
Bacteria: TS ISO 22196 |
|
|
2-3-4-5 |
In all areas of use, depending on the desired product type. |
|
Virus: |
|
3 |
Veterinary |
Equipment and Surface Disinfectant |
Bacteria: TS EN 1656 |
|
|
Disinfectants used for animal hygiene purposes / Teat disinfectant |
Bacteria: TS EN 1656 |
|
|
4 |
Food and Feed Areas |
Equipment and Surface Disinfectant |
Bacteria: TS EN 1276 |
|
5 |
Drinking Water |
Drinking water disinfectant |
Bacteria: AOAC 965.13 |