Following a company request, the European Commission and EU member countries agreed that microbial cleaners - even if containing surfactants - do “not seem to have a cleaning action within the meaning of ISO definition (i.e. ‘the process by which soil is dislodged from the substrate and brought into a state of solution or dispersion’)” and are, therefore, out of the scope of the EU Regulation on Detergents (European Commission, 2009). However, this decision was based on an inquiry for one specific product where the cleaning action is claimed to result from bacteria feeding on the excrement of dust mites. It is not entirely clear if the rationale of this decision would also apply to all microbial products, e.g. to surface cleaner in sanitary facilities.
EU chemical legislation — REACH
All chemical compounds used in microbial cleaners are covered by the new EU chemical legislation REACH. Living micro-organisms and spores, however, do not meet the definition of “substance” as they can neither be understood as “well-defined substances” nor as UVCB substances (substances of unknown, variable composition, complex reaction products or biological materials) (European Chemical Agency, 2012). Manufacturers claim that this view has been confirmed by the Dutch and the Finnish national competent authorities. Still, some uncertainty remains. The Manual of Decisions of the EU chemical legislation prior to REACH explicitly excluded living (micro-) organisms from the scope of the legislation (European Chemicals Bureau, 2006; European Commission, 2008a) whereas the REACH guidance document does not (European Chemical Agency, 2012). It also remains unclear if the enzymes produced by the microbes and secreted outside the cells can be considered as UVCBs under REACH in analogy to enzyme (mixtures) added to cleaners. In fact, the very similar enzymes sometimes added to the microbial cleaner in addition to the microbes are covered by REACH, whereas those produced by the microbes are not. Despite the absence of a legal requirement, some manufacturers mention microbes in the Material Safety Data Sheets (MSDS), but not all manufacturers, and not in a consistent manner.