Efficacy in Biocidal Products: Compliance with New Regulations

Efficacy and Safety Analysis of Biocidal Products

Biocidal products are chemical or biological substances used to control harmful microorganisms. They have a wide range of uses, from disinfectants to insect repellents, wood preservatives to antibacterial surface coatings. However, biocidal products are subject to strict regulations due to their impact on human health, environmental safety and food hygiene.

In recent years, regulations on the efficacy and safety of biocidal products have been tightened and it has become mandatory for companies to comply with these regulations. So, how is the effectiveness of biocidal products analyzed, what are the safety tests and what do the new regulations require attention to?

What is a Biocidal Product?

Biocidal products are defined as substances that prevent, destroy or control the growth of microorganisms. The Biocidal Products Regulation introduces certain standards to ensure that such products are used effectively without harming human health.

Biocidal products are divided into four main groups:

1. Disinfectants and General Biocidal Products
• Hand and surface sanitizers
• Water treatment chemicals
• Veterinary hygiene products
2. Protectors
• Wood preservatives
• Textile, leather and paper protection agents
3. Pesticides (Pest Control Products)
• Insect repellents
• Rodent control products
4. Other Biocidal Products
• Antifouling agents
• Embalming fluids

In order for biocidal products to be placed on the market in a safe and effective manner, they must be analyzed for efficacy and comply with safety criteria.

Efficacy Analysis in Biocidal Products

Biocidal efficacy tests are applied to determine whether biocidal products are effective. These tests evaluate the performance of the product against microorganisms and determine under which conditions it is effective.

Biocidal efficacy analysis is carried out in accordance with the following standards:

• EN 1276 - Efficacy test against bacteria
• EN 1650 - Efficacy test against fungi and yeasts
• EN 13697 - Efficacy of surface disinfectants
• EN 14476 - Efficacy testing against viruses

These tests determine whether biocidal products provide adequate protection against specified microorganisms. If a product fails these tests, it cannot be placed on the market in accordance with the regulation.

Safety Tests for Biocidal Products

Since biocidal products may pose a risk to human health and the environment, comprehensive safety tests should be carried out in addition to efficacy analyses. These tests are carried out to determine the toxicological and ecotoxicological effects of the products.

The main biocidal safety tests are as follows:

1. Acute and Chronic Toxicity Tests
• Determines the possible short and long-term effects of the product on human health.
2. Skin and Eye Irritation Tests
• Assesses whether the product causes skin or eye irritation on contact.
3. Respiratory Safety Tests
• Analyzes the effects of biocidal products in aerosol form on the lungs when inhaled.
4. Environmental Impact Tests (Ecotoxicological Tests)
• It examines how long the product remains in the environment after its release into nature and the risks it may pose to ecosystems such as water and soil.

New Regulations and Legislative Updates on Biocidal Products

The placing of biocidal products on the market is regulated under the EU Biocidal Products Regulation (BPR - 528/2012) and the Biocidal Products Regulation in Turkey.

In line with these regulations, companies must comply with the following requirements:

• Licensing and Approval Process: Each biocidal product must be approved by the Ministry of Health before being placed on the market.
• Active Ingredient Evaluation: The active ingredients used in the product must be evaluated for safety and efficacy.
• Product Labeling and Packaging Standards:
• Product content must be clearly stated.
• Instructions for use and safety precautions must be complete.
• Withdrawability and Traceability: Companies must establish a system to ensure that their products are monitored against possible risks after they are placed on the market.

Companies that do not comply with the new regulations may lose their authorization to sell biocidal products on the market and face heavy penalties.

Nanolab Laboratories Group continues to provide services within the scope of Biocidal Analysis. We also provide services in Efficacy Tests.

Contact us for more information.

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