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‘The list with the broadest overview of products on the German market that are effective against viruses’

INTERVIEW:
New IHO list of disinfectants

Anna-Sophia Neitmann, Public Relations Manager at the German Industrial Association for Hygiene and Surface Protection (IHO)
Anna-Sophia Neitmann, Public Relations Manager at the German Industrial Association for Hygiene and Surface Protection (IHO)

‘The list with the broadest overview of products on the German market that are effective against viruses’

The familiar IHO list of virucidal products was expanded last year and is now called the IHO list of disinfectants. Anna-Sophia Neitmann, Public Relations Manager at the German Industrial Association for Hygiene and Surface Protection (IHO), explains in an interview with the BODE SCIENCE CENTER what users can expect from the revised IHO list.

Ms Neitmann, the IHO list of virucidal products has become the IHO list of disinfectants. What has changed apart from the name? Why have the changes been made?

A lot has happened since the IHO list was first published in 2008. For one thing, the legislation has changed and for another, the number of products and manufacturers on the market has grown considerably. At the same time, digitalisation has progressed further. We want to reflect all these complex changes in the new IHO list. 

In the past, for example, there were many different national methods used to test the efficacy of disinfectants. Now, the European Biocidal Products Regulation (BPR), recommends that the efficacy of disinfectants is tested on the basis of European standards. This is a new component of the authorisation as a biocide product. This requirement has been in force for medicinal products and medical devices for some time. Furthermore, the use of biocidal products is also regulated in the authorisation, which means that users are obliged to use the products as the manufacturer prescribes.  The new IHO list of disinfectants does justice to this: it provides a digital overview of the efficacy of disinfectants – regardless of whether the user is looking for a biocidal product, a medical device or a medicinal product. Along with products for hand disinfection, surface disinfection and instrument disinfection, the new list includes products used in food hygiene and public and industrial areas. Products used in animal hygiene for surface and teat disinfection are also included. New are products for laundry disinfection. The user no longer has to search in different lists. For example, the new features enable him to see whether a disinfectant can be used both in hospitals and in the kitchen.  Technically, we have also kept pace with the times: filter options and expanded functions such as a mouseover function reveal which European standards underlie the efficacy that has been awarded for the product.


The new list no longer contains just products with virucidal activity. Why was the type of products expanded?

According to the BPR, approved products must have at least bactericidal and yeasticidal activity. This applies for all areas of application, regardless of whether the product is for hand disinfection or is used in animal husbandry. Efficacy against bacteria and yeasts is a requirement for submitting a dossier for marketing authorisation. These activities must be covered by products with limited spectrum of virucidal activity as well. This requirement is reflected in the IHO list of disinfectants. Users can, for example, find products with sporicidal activity in the IHO list.

Since its revision, the IHO list of disinfectants is still the list with the broadest overview of products on the German market that are effective against viruses. For all products with virucidal activity on the IHO list, it has been assured that they satisfy the Europe-wide harmonised quality and efficacy requirements of the BPR and, if applicable, the Medical Device Regulation and medicinal products legislation. Since the start of the coronavirus crisis, we have had ample confirmation of how helpful the ISO list is as a source of information: many users were grateful to be able to access the list as a practical tool for selecting reliable products with virucidal activity.


What requirements does a disinfectant have to satisfy to be listed?

The efficacy of a listed product must be registered according to European standards. The higher-level standard is EN 14885, from which all subordinate standards for all areas of application originate. The entries in the columns of the list must be based on the granted authorisation according to the European standards or, during the transition phase, on expert reports, documentation and study results that comply with the valid European standards at the time of application. Evidence of efficacy must be provided by the testing facility that implemented the obligatory audited quality assurance systems. The applicant is responsible for ensuring that the submitted evidence of efficacy applies to the formulation currently on the market. The efficacy statements for each formulation currently on the market must be demonstrably met. 


National standards are still not considered. Why are EU standards only used for testing?

Country-specific characteristics are only considered in the European legislation if there is no European standard available. The adopted laws and regulations must be implemented in all EU countries with a strict schedule. The European harmonisation of standards for disinfectant testing creates uniform standards. The expertise of national specialist associations has definitely been incorporated, however. The European standard methods that are now conventional are based on the experience of renowned national organisations such as DGHM, ÖGHMP, RKI, VAH, AFNOR, DVG and DVV* as well as on the knowledge of experts from industry and universities and other educational institutions. The test methods are also subject to continuous improvement and adapted to the state of the art. 


Which standards are actually used for testing the different products? 

Products for disinfection are biocidal products in many areas and are subject to Regulation (EU) 528/2012. The reprocessing of medical devices – a special area in healthcare – is carried out using disinfectants that are subject to the EU Medical Device Regulation 2017/745. Both regulations have in common that they are binding legal acts that all EU countries must implement in full. The evidence of efficacy of biocidal products is based on the valid European harmonised standards. The evidence of efficacy is part of the authorisation documents, the biocidal product dossier, which every manufacturer must submit to ECHA, the European Chemicals Agency, or to a corresponding national authority. The authorisation documents are reviewed in the EU member states. Hand disinfectants are an exception: in Europe they are subject to the Biocidal Products Regulation and can therefore be sold as biocidal products. In Germany, however, we have a special situation in that hand disinfectants can also be authorised as medicinal products for historical reasons. For disinfectants that fall under the European Medical Device Regulation, because they are intended for instrument disinfection, for example, evidence of the efficacy based on the harmonised European standards must also be employed. This ensures that compliant and safe medical devices are sold throughout the entire European Economic Area. The conformity of the medical devices with the legal requirements is regularly reviewed by the notified bodies and confirmed by assigning the CE mark. There are only very few areas in which the European harmonisation has not progressed to this point. For example, in the veterinary area for determining the efficacy against parasites or viruses. The German Veterinary Medical Society is a trailblazer in this regard. 


How does the IHO list of disinfectants differ from other familiar lists such as the RKI or VAH lists?

Lists such as the IHO, VAH or the DVG lists are market overviews that have no legally binding character. The list of tested and approved disinfectants and disinfection methods from the Robert Koch Institute differs because it is stipulated in the German Protection against Infection Act. The RKI list is used in the case of an officially proclaimed outbreak for disinfection and decontamination measures that are decreed by the authorities according to paragraph 18 of the German Protection against Infection Act. In this case RKI listed products must be used. It must also be noted that the products on this list generally have higher concentrations of active substances and working concentrations to implement the possibly more stringent requirements for protection against epidemics. 


The IHO list of disinfectants is, as you have explained, based on the European standards. However, it is a national initiative. Would it not be desirable to have a list that is supported throughout Europe?

Our list should definitely be considered a European list because it is based on the European legislation. It is also currently available in English and can therefore be used outside Germany. Not only IHO members can list products on the IHO list but also manufacturers from every European member state – provided that their product has an authorisation based on European legislation. This is one of the benefits of the Europe-wide harmonisation: it makes it easier for users and manufacturers to find their bearings across national borders as well. The coronavirus pandemic in particular has shown just how important a harmonised market is. Therefore, together with its partners, IHO will advocate for transparency in the market beyond Germany’s borders – for safe and effective products. 


* DGHM: Deutsche Gesellschaft für Hygiene und Mikrobiologie [German Society for Hygiene and Microbiology], ÖGHMP: Österreichische Gesellschaft für Hygiene, Mikrobiologie und Präventivmedizin [Austrian Society for Hygiene, Microbiology and Preventive Medicine], RKI: Robert Koch Institute, VAH: Verbund für Angewandte Hygiene [Association for Applied Hygiene], AFNOR: Association française de normalisation [French national organisation for standardisation], DVG: Deutsche Veterinärmedizinische Gesellschaft [German Veterinary Medical Society], DVV: Deutsche Vereinigung zur Bekämpfung der Viruskrankheiten [German Registered Association for Combating Viral Diseases]