All biocidal products must get an authorization before they can be made available on the market. Companies can choose between several alternative processes, depending on their product and the number of countries where they wish to sell it.

If the product will be placed only on a single market, authorization from that country is sufficient.

The Biocidal Products Regulation (BPR, Regulation (EU) 528/2012) concerns the placing on the market and use of biocidal products, which are used to protect humans, animals, materials or articles against harmful organisms like pests or bacteria, by the action of the active substances contained in the biocidal product. This regulation aims to improve the functioning of the biocidal products market in the EU, while ensuring a high level of protection for humans and the environment.

Our laboratory offers the mandatory testing (EN standards) for evaluation of microbiological efficacy of products such as disinfectants, biocides, and skin antiseptics.

Bactericidal Activity

Phase 1- Basic Activity tests

  • EN 1040:2006 – Chemical disinfectants and antiseptics – Quantitative suspension test for the evaluation of basic bactericidal activity of chemical disinfectants and antiseptics
  • EN 1275:2006 – Chemical disinfectants and antiseptics – Quantitative suspension test for the evaluation of basic fungicidal or basic yeasticidal activity of chemical disinfectants and antiseptics

Phase 2 step 1 tests

  • EN 1276:2019 – Chemical disinfectants and antiseptics – Quantitative suspension test for the evaluation of bactericidal activity of chemical disinfectants and antiseptics used in food, industrial, domestic and institutional areas
    Supports claims such as: kills germs/bacteria, kills 99.99% of bacteria (ΕΝ 1276, 1 min*)
  • EN 1650:2019 – Chemical disinfectants and antiseptics — Quantitative suspension test for the evaluation of fungicidal or yeasticidal activity of chemical disinfectants and antiseptics used in food, industrial, domestic and institutional areas
    Supports claims such as: kills fungi  etc.
  • EN 13727:2012+A2:2015 – Chemical disinfectants and antiseptics – Quantitative suspension test for the evaluation of bactericidal activity in the medical area
  • EN 13624:2021- Quantitative suspension test for the evaluation of fungicidal or yeasticidal activity in the medical area

Phase 2 step 2 tests for hand disinfection tests

  • EN 1500 : 2013 – Chemical Disinfectants And Antiseptics – Hygienic Hand rub  (18-22 volunteers)
    Approximately 20 volunteers will participate to this study to evaluate the efficacy of a hygienic hand-rub. A hand rub is defined as a treatment that involves rubbing the hands without the addition of water. This method specifically simulates conditions for establishing if a hygienic hand rub decreases the release of transient flora from the hands.
  • EN 1499:2013 – Chemical disinfectants and antiseptics. Hygienic hand wash (12-15 volunteers)
    EN 1499 describes a test method that stimulates practical conditions to establish whether a product intended for hygienic hand washing effectively reduces the transient microbial flora of the hands during its use. Approximately 13 volunteers will participate to this study to evaluate the efficacy of a hygienic Hand wash.

Phase 2 step 2 tests for surface disinfection test

  • EN 13727:2012+A2:2015 – Chemical disinfectants and antiseptics – Quantitative suspension test for the evaluation of bactericidal activity in the medical area (phase 2, step 1)

Virucidal Activity

  • EN 14476:2013+A2:2019-Virucidal activity – carried out by testing for antiviral activity against poliovirus, murine norovirus and adenovirus
  • EN 14476 is a phase 2 step 1 suspension test to evaluate the virucidal activity of chemical disinfectants intended for use in the medical area.

There are 3 alternatives regarding the virus tested:

  • Antiviral activity against all enveloped viruses – performed by testing antiviral activity against Vaccinia virus.

Claims: Kills H1Ν1, H3Ν2, coronavirus (in general)

  • Antiviral activity against all enveloped viruses as well as norovirus, rotavirus and adenovirus – performed by testing for antiviral activity against murine norovirus and adenovirus.

Claims: Kills H1Ν1, H3Ν2, coronavirus (in general) and HIV

  • Antiviral activity against all enveloped viruses as well as norovirus, rotavirus and adenovirus – performed by testing for antiviral activity against murine norovirus and adenovirus.

Claims: full virulent action, Kills H1Ν1, H3Ν2, coronavirus (in general) and HIV