Surfachem | Biocidal Product Regulation

Efficacy Testing Requirements

Yes, to place a biocidal product on the market, you must have efficacy test data to support your claims. While this might seem obvious, it’s surprising how many companies either lacked proper data or only had a single test without the necessary equivalents for their claims and product type.

One of the benefits of the Biocidal Products Regulation (BPR)—despite some criticism—is that it ensures any product on the market, following active substance approval, has all the relevant data to substantiate its claims.

EN 1276 – Suspension Test

One of the most recognised tests in the industry is the EN 1276 standard, which evaluates the bactericidal activity of a product in suspension. Over time, the method has evolved, and it now requires a 5-log reduction (≥99.999%) in bacterial count under defined conditions.

This test is conducted against four standard organisms: • Escherichia coli (E. coli) (Gram-negative rod) – ATCC 10536 • Staphylococcus aureus (Gram-positive coccus) – ATCC 6538 • Pseudomonas aeruginosa (Gram-negative rod) – ATCC 15442 • Enterococcus hirae (Gram-positive coccus) – ATCC 10541

While EN 1276 is a robust test for demonstrating general antimicrobial activity, it is a suspension test, meaning it does not fully replicate real-world cleaning conditions, especially for hard surface disinfectants.

EN 13697 – Hard Surface Test

To validate a biocidal product’s efficacy specifically on hard surfaces, EN 13697 is required. This test assesses both bactericidal and fungicidal activity on a non-porous surface, providing a more relevant evaluation for cleaning products intended for use on surfaces such as kitchen counters.

EN 13697 also requires a 5-log reduction for bactericidal claims and a 4-log reduction (≥99.99%) for fungicidal claims. It typically includes the same bacterial strains as EN 1276, along with additional fungal strains such as: • Candida albicans (yeast) – ATCC 10231 • Aspergillus brasiliensis (formerly A. niger) – ATCC 16404

For a biocidal product claim to be fully supported, both EN 1276 and EN 13697 are typically required, ensuring efficacy in both suspension and hard surface conditions.