EU biocide legislation
Some microbial cleaners could potentially be considered as biocides, i.e. active substances, intended to destroy or otherwise exert a controlling effect on any harmful organism by chemical or biological means (European Union, 1998: Article 1), which would then be regulated under Directive 98/8/EC (European Union, 1998) for a number of reasons:
- • Micro-organisms can, in principle, be considered as biocides, e.g. two Bacillus spp. including B. subtilis are listed as biocides in the annex to Regulation 1451/2007 (European Union, 2007). B. subtilis is frequently used in microbial cleaners.
- • Drawing on analogies of other borderline cases, it appears possible that the outcompeting of unwanted micro-organisms by other micro-organisms via chemical or biological mechanisms could be considered a biocidal effect if it results from direct action (European Commission, 2003; 2008b). In contrast, a “physical” displacement of unwanted micro-organisms by overgrowing with beneficial micro-organisms or as a consequence of nutrient competition would presumably not be considered as biocidal activity. Manufacturers frequently highlight the latter effects. For many micro-organisms, however, including some species applied in microbial cleaners, it is described in the scientific literature that they can inhibit cell growth or even kill other microbes by producing and releasing bactericides or fungicides. Other microbes can inhibit growth by other means, e.g. lactic acid bacteria by lowering the pH. This type of mechanism could potentially be considered a biocidal activity. The question here is then whether these mechanisms would also apply to some of the strains used in microbial cleaners. Any clarification of this question would require a more comprehensive description of all the mechanisms of action for each micro-organism used.
- • In certain cases, manufacturers are making claims which could be interpreted as claiming biocidal effects, in particular in the case of microbial cleaners used in hospitals, but also for sanitary facilities, for cleaning carpets and upholstery when claiming deodorization or odour control.
According to two manufacturers, the national competent authorities in Belgium have confirmed that EU biocidal legislation does not apply to their products. A similar view was given by the Dutch Food and Consumer Product Safety Authority (VWA, 2004). No information was available on other types of products, from other competent authorities or from the EU level. Consequently, the applicability of the EU biocide legislation remains to be clarified, though, most likely restricted to specific applications and mechanisms of actions.