In 1998 the European legislator adopted the Biocidal Products Directive (since September 2013: Biodical Products Regulation (EU) No 528/2012). This piece of legislation prescribes the Europe-wide registration and authorization of disinfectants. In the future, the efficacy of biocidal products will have to be assessed by the competent authorities within the authorization procedure – and exclusively European standards (harmonized test methods) can be applied for the proof of efficacy, unless no such standards are available to furnish the proof of efficacy as required.
For historical reasons, the various Member States had (and still have) national tests based on different methods for determining the efficacy of disinfectants. The test guidelines in Germany are issued by human and veterinary medical societies while there are entirely different test standards, for example, in France or the Netherlands.
In order to harmonize the standards and requirements for the efficacy of disinfectants in Europe, the European Committee for Standardization (CEN) has been developing since 1988 harmonized test methods (standards) in the fields of foodstuffs, animal keeping and medicines. 33 countries are participating in the CEN; Germany is represented by the Deutsches Institut für Normung (DIN).
Against this backdrop, the IHO member companies decided at an early stage to have their disinfectants tested according to European standards, with a view to making their efficacy data more transparent for users.
This list of disinfectants constitutes an overview of the efficacies of chemical disinfectants for use in all areas of animal keeping, food production and processing, food preparation and other institutional sectors.
Test methods and fields of application
For obtaining information on the efficacy against bacteria, fungi, viruses and bacterial spores, within the European standardization concept the test methodology is described in several test phases:
Testing of phase 1 consists of quantitative suspension tests, in order to confirm that active substances or products undergoing development have a bactericidal, fungicidal or sporicidal effect, without specifying any field of application. Tests of phase 1 cannot be resorted to for use recommendations.
Testing of phase 2 comprises of two stages:
(1) Phase 2, stage 1 (2/1) consists of quantitative suspension tests, in order to confirm that a product has a bactericidal, fungicidal, levurocidal, mycobactericidal, tuberculocidal, sporicidal or virucidal effect – under simulated practical conditions that are suitable for the intended use of the product. This testing proves the irreversible inactivation of non-dried microorganisms by the tested product solution.
(2) Phase 2, stage 2 (2/2) consists of quantitative laboratory tests, in order to confirm that a product has a bactericidal, fungicidal, levurocidal, mycobactericidal, tuberculocidal, sporicidal or virucidal effect when the product is applied onto a surface or the skin under simulated practical conditions (e.g. surface and hand disinfection tests; so-called “germ carrier tests”). This testing provides information on the effect against dried microorganisms on surfaces.
Tests of phase 3 are field tests under practical conditions. At present, modes of procedure are not available as yet for this type of testing.
All tests need to be carried out according to the minimum requirements set out in the standards (mandatory conditions).
Depending on the claim for a given product, tests have to be performed under additional conditions (test organisms, temperatures, application times and interfering substances), according to the requirements of the standard (additional conditions).
Testing of phases 2/1 and 2/2 are generally necessary in combination, in order to substantiate the efficacy claims for disinfectants. Deviations from this principle are possible only in exceptional cases (e.g. CIP application). Both test results need to be taken into account when deciding on the product claim (also see points 4.4 and 4.5 of prEN 14885:2014).
An overview of the standards available for the various fields of application and their uses is included in EN 14885 (prEN 14885:2014).
The efficacy data compiled in the IHO List of Disinfectants are based on the requirements of prEN 14885 (under current terms and conditions). These data serve as a basis for manufacturers who wish to issue concrete use recommendations for their products, depending on the field of application under practical conditions. These particulars should be taken from the relevant information provided by the manufacturers.
IHO List of Disinfectants
This list comprises exclusively disinfectants tested according to DIN EN standard for use in veterinary hygiene, food production and processing, food preparation and other institutional sectors. The list is also accessible to disinfectant manufacturers and distributors who are not IHO members.
The rights and obligations regarding this listing are laid down in a contract between the manufacturer/distributor and the IHO. The information provided is based on testing according to existing European standards; the individual companies provide such information exclusively at their own responsibility. Proof of efficacy can be furnished by both independent and in-house test facilities on condition that these have implemented obligatory and audited quality systems.
As operator of this listing, the IHO runs a quality assurance programme for the data in the IHO List of disinfectants. Within a working group specifically set up for this purpose, experts from IHO member companies examine the entries in the list. They check the compliance of the entries with the legal framework conditions and with the conditions for authorization. Furthermore, the entered data are checked at least with regard to their plausibility. Should questions or unclear points arise, the manufacturing companies are contacted and asked for clarification. If no clarification can be achieved in this way, the IHO is entitled to request submission of the original expert opinions and to check the entries in that manner. In cases of infringement of the contractual obligations, the IHO reserves the right to delete the entry for the product at issue or, where this is justified, all entries of the concerned manufacturer/distributor from the list.
Unfailing topicality and responsibility
At their own responsibility the manufacturers/distributors ensure that the existing proof of efficacy applies to currently marketed formulations across their entire shelf-life, and they update the entries in the IHO List reflecting the state of the art. Only those products are included in the list which have been registered with the German registration authority (Federal Institute for Occupational Safety and Health/BAuA) according to the German Ordinance on Notification of Biocidal Products (Biozidmelde-Verordnung) and are thus eligible for placing on the market. Manufacturers/distributors accept their contractual obligation to be always in a position to substantiate their entries.
The IHO member companies are firmly convinced that this list makes a valuable contribution to using disinfectants in a manner which is both reasonable and adequate for the given indications.
- DIN EN 14885:2006; Chemical disinfectants and antiseptics – Application of European Standards for chemical disinfectants and antiseptics
- prEN 14885:2014 Chemical disinfectants and antiseptics – Application of European Standards for chemical disinfectants and antiseptics
- European Committee for Standardization (CEN), http://www.cen.eu/
- European biocides legislation
- German procedure for the authorization of biocidal products
Important additional note
The IHO is the sole copyright holder of this list of disinfectants. Duplication of this list and dissemination of this list are not allowed without the express consent of the copyright holder. The incorporation of data from this list into other websites is not permitted, either. Linking from other websites outside the IHO is welcomed but requires the written consent of the IHO.