Did you know we are now one of the approved laboratories by Association for Applied Hygiene (VAH) in Germany? If you are thinking of penetrating the disinfection market in Germany, come learn about VAH certification and its efficacy requirements with us.
What is VAH certification?
VAH certification is a unique quality mark for disinfectant products granted by VAH, a recognized authority for disinfection quality assurance in Germany, that is independent from formal registration approvals by regulatory authorities. Although it is not a mandatory criterion in order to market disinfectants in Germany, the VAH-certified quality mark carries significant weight and has a strong influence on the disinfection solution’s competitiveness and market position. In other words, a VAH certification is almost necessary for the use of disinfection solutions in Germany and many institutions use this as a benchmark in deciding their disinfectant purchases.
What are the efficacy requirements to be VAH-certified?
Regardless of the field of application of your product, the basic efficacy requirements to be exhibited are bactericidal and yeasticidal activity. It is obligatory for all products to demonstrate passable data against bacteria and yeast through suspension tests (Phase 2, Step 1) and simulated-use tests (Phase 2, Step 2). Further optional tests may be added to provide more extensive data on your product’s spectrum of activity may it be virucidal, mycobactericidal, and more. The table below shows the suitable tests required to be VAH-certified for each field of application.
FIELD OF APPLICATION |
SPECTRUM OF ACTIVITY |
|||||||||||
BACTERICIDAL |
YEASTICIDAL |
FUNGICIDAL |
TUBERCULOCIDAL/
|
VIRUCIDAL |
SPORICIDAL |
|||||||
PHASE, STEP |
2,1 |
2,2 |
2,1 |
2,2 |
2,1 |
2,2 |
2,1 |
2,2 |
2,1 |
2,2 |
2,1 |
2,2 |
Hygienic handwash |
EN 13727 |
EN 1499 |
EN 13624 |
* |
* |
* |
* |
* |
EN 14476 |
* |
* |
* |
Hygienic handrub |
EN 1500 |
* |
* |
* |
* |
* |
* |
* |
* |
|||
Surgical handrub |
EN 12791 |
EN 12791 |
* |
* |
* |
* |
* |
* |
* |
* |
||
Skin antiseptics |
Method 13 |
Method 13 |
* |
* |
* |
* |
EN 14476 |
* |
* |
* |
||
Surface disinfection
|
EN 13727 |
EN 17387 |
EN 13624 |
EN 17387 |
EN 13624 |
EN 17387 |
EN 14348 |
Method 14.1 |
EN 14476 |
EN 16777 |
EN 17126 |
* |
Surface disinfection
|
EN 16615 |
EN 16615 |
Method 14.2 |
Method 14.2 |
* |
Method 19 |
||||||
Instrument disinfection |
EN 13727 |
EN 14561 |
EN 13624 |
EN 14562 |
EN 13624 |
EN 14562 |
EN 14348 |
EN 14563 |
EN 14476 |
EN 17111 |
EN 17126 |
* |
*No standards currently available |
||||||||||||
How is this different from EN 14885 guidelines?
“My product has been tested according to the EN 14885 guidelines. Can this data be used to obtain a VAH certification?”—The short answer is no. The VAH Disinfectants Commission has developed test methodologies termed VAH Methods which are equivalent to the European (EN) Standards we are all so familiar with, but in some ways, have more stringent requirements with regards to the scope of testing compared to the EN standards.
“In no instance are the VAH Methods’ requirements
lower than those of the EN standards.”
And because of this, while testing according to the EN equivalent standards, they do still have to incorporate the tighter VAH requirements in order for them to be accepted for VAH certification. So, how exactly do they differ? The table below outlines the overview of the difference between EN and VAH requirements.
| EN REQUIREMENTS | VAH REQUIREMENTS | |
| Obligatory test organisms |
Standard 3 or 4 bacteria strains based on field of application | Requires testing of additional Gram-negative bacteria (Escherichia coli and Proteus mirabilis) and more representative viruses for acceptance of claim |
| Test contact time | Only claimed contact time required | At least 3 contact times are required for suspension tests and 2 contact times for simulated-use tests, including 1 below the claimed contact time |
| Test concentration | Minimum 3 concentrations including one in the active range and one in the non-active range | At least 3 concentrations specifically chosen in a stepwise manner for recording efficacy limits, higher limitations in the selected concentrations |
| Neutralization control | Neutralization of neat product, no dilutions required | At least two 10-fold dilutions of test neutralization is required to determine its validity |
| Test replications | In Phase 2, Step 2 tests, only 1 test surface used for each strain | In simulated-use tests, 2 test runs and 2 test surfaces are required to demonstrate reproducibility of data |
| Evaluation | Single test report from accredited laboratory | At least 2 independent test reports from accredited and VAH approved laboratories with expert opinions |
Overall, the requirements for VAH certifications are more rigorous to ensure that VAH-certified disinfectants are a sure-fire quality product that deems effective against its approved claims. With that said, if we turn our bot question around, products successfully tested according to VAH requirements should have more than enough data to fulfil the EN requirements.
Once the product has obtained the VAH certification, they remain valid for three years. After that, VAH certification may be renewed or extended with the submission of at least 2 independent test reports with expert opinions and this recertification shall be valid for another 3-year cycle.
How can TECOLAB help you achieve VAH certification?
While there are many laboratories all around the world that may be able to perform the VAH methods and/or EN standards required, the VAH committee has shortlisted a handful of laboratories they deem equipped to generate reports that are acceptable for VAH certification and the good news is TECOLAB is one of them! We offer most of the testing required for mandatory and optional spectrum of activity.
Check out more information on the essential testing conditions for each activity spectrum here or just reach out to us here today! Our team of experts are always ready to consult you on what is needed for your products and claims that adheres to the VAH requirements.
TECOLAB would like to declare that the information in this blog is solely based on the interpretations of our team of experts on the VAH methods and requirements.
References:
1. Requirements and Methods for VAH Certification of Chemical Disinfection Procedures https://vah-online.de/files/download/ebooks/eBook_VAH_RequirementsandMethods.pdf
2. Testing disinfectants in accordance with the VAH Methods and Requirements for VAH certification and listing or testing in accordance with the European standards – what is the difference? https://vah-online.de/files/download/vah-mitteilungen/2022_VAH_Requirements_Methods_EN_Methods.pdf
3. Annex V (Requirements for virucidal efficacy) https://vah-online.de/files/download/english/2021_11_VAH_Methods_Requirements_Annex%20Virucidal%20activity.pdf