Antifouling Biocidal Products

Biocidal products are chemical or biological agents used to control, neutralize, or eliminate microorganisms. According to the Biocidal Products Regulation (BPR), published in the Official Gazette dated December 31, 2009, No. 27449 (4th repeated issue), Biocidal Products are classified into four main groups: Disinfectants and General Biocidal Products, Preservatives, Pest Control Products, and Other Biocidal Products. Antifouling Biocidal Products fall under the fourth category, "Other Biocidal Products."

What does “Antifouling products” mean?

Antifouling Products are used to prevent biological contamination in aquatic environments. Surfaces such as ship hulls, fish farm equipment, underwater structures, and pipelines operating in seas, lakes, or other aquatic environments are susceptible to microorganisms, algae, marine plants, and shellfish invasion. This invasion negatively impacts both the functionality and economic efficiency of these structures. Antifouling products are developed to prevent these issues.

As defined in Annex V of the Biocidal Products Regulation (BPR), "antifouling products" are described as follows:

• Product Type 21: Antifouling products

Products used to control the growth and settlement of organisms (microbes and higher plant and animal species) on boats, aquaculture equipment, and other structures used in water.

Licensing Requirements for Antifouling Biocidal Products

Preparation of the Licensing Dossier

The licensing dossier for Antifouling Biocidal Products must include:

• Biocidal Product Licensing Dossier (as per Annex IIB)
• Active Substance Dossier for Biocidal Products (as per Annex IIA)
• Risk Assessment Report for Biocidal Products (as per Annex VI)
• Biocidal Product Label (as per Annex XII)
• Safety Data Sheet of the Biocidal Product (as per Annex II of the KKDIK Regulation)
• Formulation and Specification Documents of the Biocidal Product
• Packaging Compatibility Statement of the Biocidal Product
• Test Results of the Biocidal Product

 

Testing Requirements

The testing requirements for biocidal products are outlined in the Guideline on Biocidal Product Analyses and Authorized Laboratories, issued with official approval E.519 dated January 28, 2019. According to this guideline, all analyses must be conducted in laboratories accredited for Good Laboratory Practices (GLP) or for the specific analysis parameters.

Antifouling Biocidal Products must undergo the following tests:

• Physicochemical Tests:

Analysis of appearance, physical form, pH, density and active substance/auxiliary substance if necessary.

• Short-Term Stability Tests:

Stability tests conducted over 2-18 weeks depending on the product’s nature.

• Long-Term Stability Tests:

Stability tests performed throughout the declared shelf life of the product.

• Efficacy Tests:

Tests demonstrating the product’s effectiveness against declared organisms.

General Considerations Regarding Testing

• All tests must be performed on samples produced from the same serial/batch number.
• Physicochemical and stability tests must be conducted in the same laboratory.
• In cases where the efficacy test needs to be performed in a different laboratory, physical-chemical tests should also be performed in the same laboratory on the first day.
• The efficacy test results must not be older than ten years at the time of licensing application.
• The Ministry of Health may accept the results of tests conducted abroad for import product license applications, provided that the tests meet certain conditions within the scope of the regulation.
• Currently, there are no laboratories in Turkey conducting efficacy tests for antifouling products. During tests conducted abroad, special attention should be paid to the first three points mentioned above.

 

Test Standards

According to the Guideline on Biocidal Product Analyses and Authorized Laboratories, issued with official approval E.519 dated January 28, 2019, the required test standards for Antifouling Biocidal Products are provided in the table below.

Table 1: Required Test Standards for Antifouling Biocidal Products

Test Type	Standard Method	Standard Title	Summary of Standard Content
Laboratory Tests	EN ISO 10253	Water quality — Marine algal growth inhibition test with Skeletonema sp. and Phaeodactylum tricornutum	Suitable for testing substances that dissolve easily in water and are not significantly degraded or removed from the test environment.
	ASTM-G21	Standard Practice for Determining Resistance of Synthetic Polymeric Materials to Fungi	The synthetic polymer portion of these materials is generally resistant to fungal growth and does not serve as a carbon source.
Representative Field Tests	ASTM D6990	Standard Practice for Evaluating Biological Fouling Resistance and Physical Performance of Marine Coating Systems
	CEPE Antifouling Working Group, 2012	Efficacy evaluation of antifouling products. Antifouling paint application and reporting efficacy evaluation trials.	The International Paint and Printing Ink Council also adopt this methodology.
	AS 1580.481.5	Paints and related materials - Methods of test - Coatings – Durability and Resistance to fouling - Marine underwater paint systems
	ASTM D5479	Standard Practice for Testing Biofouling Resistance of Marine Coatings Partially Immersed	Designed as a screening test to evaluate the performance of applied coating systems and other materials intended to resist biofouling settlement.
	ASTM 3623	Standard Test Method for Testing Antifouling Panels in Shallow Submergence	This test method includes a procedure for testing toxic paint compositions in shallow marine environments and the use of a standard antifouling panel with known performance as a control in antifouling studies.
Field Tests	ASTM D4939	Standard Test Method for Subjecting Marine Antifouling Coating to Biofouling and Fluid Shear Forces in Natural Seawater	Designed as a screening test to evaluate antifouling coating systems under conditions of hydrodynamic stress caused by alternating water flow and static exposure to fouling environments.
	ASTM D5618	Standard Test Method for Measurement of Barnacle Adhesion Strength in Shear	This test method measures barnacle adhesion on surfaces exposed to marine environments. It is used to determine a surface's ability to reduce biological fouling adhesion. Surfaces with known shear adhesion strength are included as controls.

 

For your questions about antifouling biocidal products, contact us at [email protected] or benefit from our Biocidal Product Consultancy service.